[Federal Register Volume 88, Number 220 (Thursday, November 16, 2023)]
[Rules and Regulations]
[Pages 78818-80047]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24184]



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Vol. 88

Thursday,

No. 220

November 16, 2023

Part II





Department of Health and Human Services





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Centers for Medicare & Medicaid Services





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42 CFR Parts 405, 410, 411, et al.





Medicare and Medicaid Programs; CY 2024 Payment Policies Under the 
Physician Fee Schedule and Other Changes to Part B Payment and Coverage 
Policies; Medicare Shared Savings Program Requirements; Medicare 
Advantage; Medicare and Medicaid Provider and Supplier Enrollment 
Policies; and Basic Health Program; Final Rule

  Federal Register / Vol. 88, No. 220 / Thursday, November 16, 2023 / 
Rules and Regulations  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 405, 410, 411, 414, 415, 418, 422, 423, 424, 425, 455, 
489, 491, 495, 498, and 600

[CMS-1784-F]
RIN 0938-AV07


Medicare and Medicaid Programs; CY 2024 Payment Policies Under 
the Physician Fee Schedule and Other Changes to Part B Payment and 
Coverage Policies; Medicare Shared Savings Program Requirements; 
Medicare Advantage; Medicare and Medicaid Provider and Supplier 
Enrollment Policies; and Basic Health Program

AGENCY: Centers for Medicare & Medicaid Services (CMS), Health and 
Human Services (HHS).

ACTION: Final rule.

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SUMMARY: This major final rule addresses: changes to the physician fee 
schedule (PFS); other changes to Medicare Part B payment policies to 
ensure that payment systems are updated to reflect changes in medical 
practice, relative value of services, and changes in the statute; 
payment for dental services inextricably linked to specific covered 
medical services; Medicare Shared Savings Program requirements; updates 
to the Quality Payment Program; Medicare coverage of opioid use 
disorder services furnished by opioid treatment programs; updates to 
certain Medicare and Medicaid provider and supplier enrollment 
policies, electronic prescribing for controlled substances for a 
covered Part D drug under a prescription drug plan or an MA-PD plan 
under the Substance Use-Disorder Prevention that Promotes Opioid 
Recovery and Treatment for Patients and Communities Act (SUPPORT Act); 
updates to the Ambulance Fee Schedule regulations and the Medicare 
Ground Ambulance Data Collection System; codification of the Inflation 
Reduction Act and Consolidated Appropriations Act, 2023 provisions; 
expansion of the diabetes screening and diabetes definitions; pulmonary 
rehabilitation, cardiac rehabilitation and intensive cardiac 
rehabilitation expansion of supervising practitioners; appropriate use 
criteria for advanced diagnostic imaging; early release of Medicare 
Advantage risk adjustment data; a social determinants of health risk 
assessment in the annual wellness visit and Basic Health Program.

DATES: These regulations are effective on January 1, 2024.

FOR FURTHER INFORMATION CONTACT: 
    [email protected], for any issues not 
identified below. Please indicate the specific issue in the subject 
line of the email.
    [email protected], for the following issues: 
practice expense, work RVUs, conversion factor, and PFS specialty-
specific impacts; the comment solicitation on strategies for updates to 
practice expense data collection and methodology, caregiver training 
services, community health integration services, social determinants of 
health risk assessment, and principal illness navigation services; 
potentially misvalued services under the PFS, direct supervision using 
two-way audio/video communication technology, telehealth, and other 
services involving communications technology; teaching physician 
services, advancing access to behavioral health services, PFS payment 
for evaluation and management services, geographic practice cost 
indices (GPCIs), payment for skin substitutes, supervision of 
outpatient therapy services, KX modifier thresholds, diabetes self-
management training (DSMT) services, and DSMT telehealth services, and 
dental services inextricably linked to specific covered services.
    Laura Ashbaugh, (410) 786-1113, and Erick Carrera, (410) 786-8949, 
Zehra Hussain, (214) 767-4463, or 
[email protected], for issues related to dental 
services inextricably linked to specific covered medical services.
    Laura Kennedy, (410) 786-3377, Adam Brooks, (202) 205-0671, and 
Rachel Radzyner, (410) 786-8215, for issues related to Drugs and 
Biological Products Paid Under Medicare Part B.
    [email protected], for issues related to 
complex drug administration.
    Laura Ashbaugh, (410) 786-1113, and Ariana Pitcher, (667) 290-8840, 
or [email protected] for issues related to Clinical Laboratory 
Fee Schedule.
    Lisa Parker, (410) 786-4949, or [email protected], for issues 
related to FQHC payments.
    Michele Franklin, (410) 786-9226, or [email protected], for issues 
related to RHC payments.
    Kianna Banks, (410) 786-3498 and Cara Meyer, (667) 290-9856, for 
issues related to RHCs and FQHCs definitions of staff and Conditions 
for Certification or Coverage.
    Sarah Fulton, (410) 786-2749, for issues related to pulmonary 
rehabilitation, cardiac rehabilitation and intensive cardiac 
rehabilitation expansion of supervising practitioners.
    Lindsey Baldwin, (410) 786-1694, Ariana Pitcher, (667) 290-8840, or 
[email protected], for issues related to Medicare coverage of 
opioid use disorder treatment services furnished by opioid treatment 
programs.
    Sabrina Ahmed, (410) 786-7499, or [email protected], 
for issues related to the Medicare Shared Savings Program (Shared 
Savings Program) Quality performance standard and quality reporting 
requirements.
    Janae James, (410) 786-0801, or Elizabeth November, (410) 786-4518, 
or [email protected], for issues related to Shared 
Savings Program beneficiary assignment and benchmarking methodology.
    Lucy Bertocci, (410) 786-3776, or [email protected], 
for issues related to Shared Savings Program advance investment 
payments, and eligibility requirements.
    Rachel Radzyner, (410) 786-8215, and Michelle Cruse, (443) 478-
6390, for issues related to preventive vaccine administration services.
    Mollie Howerton, (410) 786-5395, for issues related to Medicare 
Diabetes Prevention Program.
    Sarah Fulton, (410) 786-2749, for issues related to appropriate use 
criteria for advanced diagnostic imaging.
    Frank Whelan, (410) 786-1302, for issues related to Medicare and 
Medicaid provider and supplier enrollment regulation updates.
    Daniel Feller, (410) 786-6913 for issues related to expanding 
diabetes screening and definitions.
    Daniel Feller, (410) 786-6913 for issues related to a social 
determinants of health risk assessment in the annual wellness visit.
    Mei Zhang, (410) 786-7837, and Kimberly Go, (410) 786-4560, for 
issues related to requirement for electronic prescribing for controlled 
substances for a covered Part D drug under a prescription drug plan or 
an MA-PD plan (section 2003 of the SUPPORT Act).
    Amy Gruber, (410) 786-1542, or [email protected], 
for issues related to the Ambulance Fee Schedule (AFS) and the Medicare 
Ground Ambulance Data Collection System.
    Mary Rossi-Coajou, (410) 786-6051, for issues related to hospice 
Conditions of Participation.

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    Cameron Ingram, (410) 409-8023 for issues related to 
Histopathology, Cytology, and Clinical Cytogenetics Regulations under 
CLIA of 1988.
    Meg Barry, (410) 786-1536, for issues related to the Basic Health 
Program (BHP) provisions.
    Renee O'Neill, (410) 786-8821, or Sophia Sugumar, (410) 786-1648, 
for inquiries related to Merit-based Incentive Payment System (MIPS) 
track of the Quality Payment Program.
    Richard Jensen, (410) 786-6126, for inquiries related to 
Alternative Payment Models (APMs).

SUPPLEMENTARY INFORMATION: 
    Addenda Available Only Through the internet on the CMS website: The 
PFS Addenda along with other supporting documents and tables referenced 
in this final rule are available on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html. Click on the link on the left side of the 
screen titled, ``PFS Federal Regulations Notices'' for a chronological 
list of PFS Federal Register and other related documents. For the CY 
2024 PFS final rule, refer to item CMS-1784-F. Readers with questions 
related to accessing any of the Addenda or other supporting documents 
referenced in this final rule and posted on the CMS website identified 
above should contact [email protected].
    CPT (Current Procedural Terminology) Copyright Notice: Throughout 
this final rule, we use CPT codes and descriptions to refer to a 
variety of services. We note that CPT codes and descriptions are 
copyright 2020 American Medical Association. All Rights Reserved. CPT 
is a registered trademark of the American Medical Association (AMA). 
Applicable Federal Acquisition Regulations (FAR) and Defense Federal 
Acquisition Regulations (DFAR) apply.

I. Executive Summary

A. Purpose

    This major final rule revises payment polices under the Medicare 
PFS and makes other policy changes, including to the implementation of 
certain provisions of the Consolidated Appropriations Act, 2023 (Pub. 
L. 117-328, September 29, 2022), Inflation Reduction Act of 2022 (IRA) 
(Pub. L. 117-169, August 16, 2022), Consolidated Appropriations Act, 
2022 (Pub. L. 117-103, March 15, 2022), Consolidated Appropriations 
Act, 2021 (CAA, 2021) (Pub. L. 116-260, December 27, 2020), Bipartisan 
Budget Act of 2018 (BBA of 2018) (Pub. L. 115-123, February 9, 2018) 
and the Substance Use-Disorder Prevention that Promotes Opioid Recovery 
and Treatment for Patients and Communities Act (SUPPORT Act) (Pub. L. 
115-271, October 24, 2018), related to Medicare Part B payment. In 
addition, this major final rule includes provisions regarding other 
Medicare payment policies described in sections III. and IV.
    This rulemaking updates the Rural Health Clinic (RHC) and Federally 
Qualified Health Clinic (FQHC) Conditions for Certification and 
Conditions for Coverage (CfCs), respectively, to implement the 
provisions of the Consolidated Appropriations Act (CAA), 2023 (Pub. L. 
117-328, December 29, 2022), now allowing payment under Medicare Part B 
for services furnished by a Marriage and Family Therapist (MFT) or 
Mental Health Counselor (MHC).
    This rulemaking also updates the Hospice Conditions of 
Participation (CoPs) to implement division FF, section 4121 of the CAA 
2023 regarding the addition of marriage and family therapists (MFTs) or 
mental health counselors (MHCs) as part of the hospice 
interdisciplinary team and make changes to the hospice personnel 
requirements.
    This rulemaking also seeks to further advance Medicare's overall 
value-based care strategy of growth, alignment, and equity through the 
Medicare Shared Savings Program (Shared Savings Program) and the 
Quality Payment Program (QPP). The structure of the programs enables us 
to develop a set of tools for measuring and encouraging improvements in 
care, which may support a shift to clinician payment over time into 
Advanced Alternative Payment Models (APMs) and accountable care 
arrangements which reduce care fragmentation and unnecessary costs for 
patients and the health system.
    This rulemaking also updates the public reporting requirements of 
procedure volume data (Part B non-institutional claims) on clinician 
profile pages of the Compare Tool to include Medicare Advantage (MA) 
encounter data. This enables us to use and analyze MA encounter data as 
part of the aggregated information disclosed through the Care Compare 
website, more broadly fulfilling the public reporting requirements of 
section 104 of the MACRA and section 10331 of the ACA and providing 
beneficiaries with useful and appropriate information when selecting a 
provider. This rulemaking also amends Sec.  422.310(f)(3) to permit the 
release of the MA encounter data on the timeframe(s) used for 
disclosure and release of the data on the Care Compare website.
    This rulemaking also updates the Ambulance Fee Schedule regulations 
to implement division FF, section 4103 of the CAA 2023 regarding the 
ground ambulance extenders provisions and also provides further changes 
and clarifications to the Medicare Ground Ambulance Data Collection 
System.
    This rulemaking also updates Medicare and Medicaid provider and 
supplier enrollment regulations.

B. Summary of the Major Provisions

    The statute requires us to establish payments under the PFS, based 
on national uniform relative value units (RVUs) that account for the 
relative resources used in furnishing a service. The statute requires 
that RVUs be established for three categories of resources: work, 
practice expense (PE), and malpractice (MP) expense. In addition, the 
statute requires that each year we establish, by regulation, the 
payment amounts for physicians' services paid under the PFS, including 
geographic adjustments to reflect the variations in the costs of 
furnishing services in different geographic areas.
    The statute requires us to establish payments under the PFS, based 
on national uniform relative value units (RVUs) that account for the 
relative resources used in furnishing a service. The statute requires 
that RVUs be established for three categories of resources: work, 
practice expense (PE), and malpractice (MP) expense. In addition, the 
statute requires that we establish each year by regulation the payment 
amounts for physicians' services paid under the PFS, including 
geographic adjustments to reflect the variations in the costs of 
furnishing services in different geographic areas.
    In this major final rule, we are establishing RVUs for CY 2024 for 
the PFS to ensure that our payment systems are updated to reflect 
changes in medical practice and the relative value of services, as well 
as changes in the statute. This final rule also includes discussions 
and provisions regarding several other Medicare Part B payment 
policies, Medicare and Medicaid provider and supplier enrollment 
policies, and other policies regarding programs administered by CMS.
    Specifically, this final rule addresses:

 Background (section II.A.)
 Determination of PE RVUs (section II.B.)
 Potentially Misvalued Services Under the PFS (section II.C.)
 Payment for Medicare Telehealth Services Under Section 1834(m) 
of the

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Social Security Act (the Act) (section II.D.)
 Valuation of Specific Codes (section II.E.)
 Evaluation and Management (E/M) Visits (section II.F.)
 Geographic Practice Cost Indices (GPCI) (section II.G.)
 Payment for Skin Substitutes (section II.H.)
 Supervision of Outpatient Therapy Services, KX Modifier 
Thresholds, Diabetes Self-Management Training (DSMT) Services by 
Registered Dietitians and Nutrition Professional, and DSMT Telehealth 
Services (section II.I.)
 Advancing Access to Behavioral Health Services (section II.J.)
 Policies on Medicare Parts A and B Payment for Dental Services 
Inextricably Linked to Specific Covered Services (section II.K.)
 Drugs and Biological Products Paid Under Medicare Part B 
(section III.A.)
 Rural Health Clinics (RHCs) and Federally Qualified Health 
Centers (FQHCs) (section III.B.)
 Rural Health Clinics (RHCs) and Federally Qualified Health 
Centers (FQHCs) Conditions for Certification or Coverage (CfCs) 
(section III.C.)
 Clinical Laboratory Fee Schedule: Revised Data Reporting 
Period and Phase-in of Payment Reductions (section III.D.)
 Pulmonary Rehabilitation, Cardiac Rehabilitation and Intensive 
Cardiac Rehabilitation Expansion of Supervising Practitioners (section 
III.E.)
 Modifications Related to Medicare Coverage for Opioid Use 
Disorder (OUD) Treatment Services Furnished by Opioid Treatment 
Programs (OTPs) (section III.F.)
 Medicare Shared Savings Program (section III.G.)
 Medicare Part B Payment for Preventive Vaccine Administration 
Services (section III.H.)
 Medicare Diabetes Prevention Program Expanded Model (section 
III.I.)
 Appropriate Use Criteria for Advanced Diagnostic Imaging 
(section III.J.)
 Medicare and Medicaid Provider and Supplier Enrollment 
(section III.K.)
 Expand Diabetes Screening and Diabetes Definitions (section 
III.L.)
 Requirement for Electronic Prescribing for Controlled 
Substances for a Covered Part D Drug under a Prescription Drug Plan or 
an MA-PD Plan (section 2003 of the SUPPORT Act) (section III.M.)
 Changes to the Regulations Associated with the Ambulance Fee 
Schedule and the Medicare Ground Ambulance Data Collection System 
(GADCS) (section III.N.)
 Hospice: Changes to the Hospice Conditions of Participation 
(section III.O.)
 RFI: Histopathology, Cytology, and Clinical Cytogenetics 
Regulations under the Clinical Laboratory Improvement Amendments (CLIA) 
of 1988 (section III.P.)
 Changes to the Basic Health Program Regulations (section 
III.Q.)
 Updates to the Definitions of Certified Electronic Health 
Record Technology (section III.R.)
 A Social Determinants of Health Risk Assessment in the Annual 
Wellness Visit (section III.S.)
 Updates to the Quality Payment Program (section IV.)
 Collection of Information Requirements (section V.)
 Response to Comments (section VI.)
 Regulatory Impact Analysis (section VII.)

C. Summary of Costs and Benefits

    We have determined that this final rule is economically 
significant. For a detailed discussion of the economic impacts, see 
section VII., Regulatory Impact Analysis, of this final rule.

II. Provisions of the Final Rule for the PFS

A. Background

    In accordance with section 1848 of the Act, CMS has paid for 
physicians' services under the Medicare physician fee schedule (PFS) 
since January 1, 1992. The PFS relies on national relative values that 
are established for work, practice expense (PE), and malpractice (MP), 
which are adjusted for geographic cost variations. These values are 
multiplied by a conversion factor (CF) to convert the relative value 
units (RVUs) into payment rates. The concepts and methodology 
underlying the PFS were enacted as part of the Omnibus Budget 
Reconciliation Act of 1989 (OBRA '89) (Pub. L. 101-239, December 19, 
1989), and the Omnibus Budget Reconciliation Act of 1990 (OBRA '90) 
(Pub. L. 101-508, November 5, 1990). The final rule published in the 
November 25, 1991 Federal Register (56 FR 59502) set forth the first 
fee schedule used for Medicare payment for physicians' services.
    We note that throughout this final rule, unless otherwise noted, 
the term ``practitioner'' is used to describe both physicians and 
nonphysician practitioners (NPPs) who are permitted to bill Medicare 
under the PFS for the services they furnish to Medicare beneficiaries.

B. Determination of PE RVUs

1. Overview
    Practice expense (PE) is the portion of the resources used in 
furnishing a service that reflects the general categories of physician 
and practitioner expenses, such as office rent and personnel wages, but 
excluding malpractice (MP) expenses, as specified in section 
1848(c)(1)(B) of the Act. As required by section 1848(c)(2)(C)(ii) of 
the Act, we use a resource-based system for determining PE RVUs for 
each physicians' service. We develop PE RVUs by considering the direct 
and indirect practice resources involved in furnishing each service. 
Direct expense categories include clinical labor, medical supplies, and 
medical equipment. Indirect expenses include administrative labor, 
office expense, and all other expenses. The sections that follow 
provide more detailed information about the methodology for translating 
the resources involved in furnishing each service into service specific 
PE RVUs. We refer readers to the CY 2010 Physician Fee Schedule (PFS) 
final rule with comment period (74 FR 61743 through 61748) for a more 
detailed explanation of the PE methodology.
2. Practice Expense Methodology
a. Direct Practice Expense
    We determine the direct PE for a specific service by adding the 
costs of the direct resources (that is, the clinical staff, medical 
supplies, and medical equipment) typically involved with furnishing 
that service. The costs of the resources are calculated using the 
refined direct PE inputs assigned to each CPT code in our PE database, 
which are generally based on our review of recommendations received 
from the Relative Value Scale Update Committee (RUC) and those provided 
in response to public comment periods. For a detailed explanation of 
the direct PE methodology, including examples, we refer readers to the 
5-year review of work RVUs under the PFS and proposed changes to the PE 
methodology in the CY 2007 PFS proposed rule (71 FR 37242) and the CY 
2007 PFS final rule with comment period (71 FR 69629).
b. Indirect Practice Expense per Hour Data
    We use survey data on indirect PEs incurred per hour worked, in 
developing the indirect portion of the PE RVUs. Prior to CY 2010, we 
primarily used the PE/HR by specialty that was obtained from the AMA's 
Socioeconomic Monitoring System (SMS). The AMA administered a new

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survey in CY 2007 and CY 2008, the Physician Practice Information 
Survey (PPIS). The PPIS is a multispecialty, nationally representative, 
PE survey of both physicians and NPPs paid under the PFS using a survey 
instrument and methods highly consistent with those used for the SMS 
and the supplemental surveys. The PPIS gathered information from 3,656 
respondents across 51 physician specialty and health care professional 
groups. We believe the PPIS is the most comprehensive source of PE 
survey information available. We used the PPIS data to update the PE/HR 
data for the CY 2010 PFS for almost all of the Medicare recognized 
specialties that participated in the survey.
    When we began using the PPIS data in CY 2010, we did not change the 
PE RVU methodology itself or the manner in which the PE/HR data are 
used in that methodology. We only updated the PE/HR data based on the 
new survey. Furthermore, as we explained in the CY 2010 PFS final rule 
with comment period (74 FR 61751), because of the magnitude of payment 
reductions for some specialties resulting from the use of the PPIS 
data, we transitioned its use over a 4-year period from the previous PE 
RVUs to the PE RVUs developed using the new PPIS data. As provided in 
the CY 2010 PFS final rule with comment period (74 FR 61751), the 
transition to the PPIS data was complete for CY 2013. Therefore, PE 
RVUs from CY 2013 forward are developed based entirely on the PPIS 
data, except as noted in this section.
    Section 1848(c)(2)(H)(i) of the Act requires us to use the medical 
oncology supplemental survey data submitted in 2003 for oncology drug 
administration services. Therefore, the PE/HR for medical oncology, 
hematology, and hematology/oncology reflects the continued use of these 
supplemental survey data.
    Supplemental survey data on independent labs from the College of 
American Pathologists were implemented for payments beginning in CY 
2005. Supplemental survey data from the National Coalition of Quality 
Diagnostic Imaging Services (NCQDIS), representing independent 
diagnostic testing facilities (IDTFs), were blended with supplementary 
survey data from the American College of Radiology (ACR) and 
implemented for payments beginning in CY 2007. Neither IDTFs, nor 
independent labs, participated in the PPIS. Therefore, we continue to 
use the PE/HR that was developed from their supplemental survey data.
    Consistent with our past practice, the previous indirect PE/HR 
values from the supplemental surveys for these specialties were updated 
to CY 2006 using the Medicare Economic Index (MEI) to put them on a 
comparable basis with the PPIS data.
    We also do not use the PPIS data for reproductive endocrinology and 
spine surgery since these specialties currently are not separately 
recognized by Medicare, nor do we have a method to blend the PPIS data 
with Medicare recognized specialty data.
    Previously, we established PE/HR values for various specialties 
without SMS or supplemental survey data by crosswalking them to other 
similar specialties to estimate a proxy PE/HR. For specialties that 
were part of the PPIS for which we previously used a crosswalked PE/HR, 
we instead used the PPIS based PE/HR. We use crosswalks for specialties 
that did not participate in the PPIS. These crosswalks have been 
generally established through notice and comment rulemaking and are 
available in the file titled ``CY 2024 PFS final rule PE/HR'' on the 
CMS website under downloads for the CY 2024 PFS final rule athttp://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
c. Allocation of PE to Services
    To establish PE RVUs for specific services, it is necessary to 
establish the direct and indirect PE associated with each service.
(1) Direct Costs
    The relative relationship between the direct cost portions of the 
PE RVUs for any two services is determined by the relative relationship 
between the sum of the direct cost resources (that is, the clinical 
staff, medical supplies, and medical equipment) typically involved with 
furnishing each of the services. The costs of these resources are 
calculated from the refined direct PE inputs in our PE database. For 
example, if one service has a direct cost sum of $400 from our PE 
database and another service has a direct cost sum of $200, the direct 
portion of the PE RVUs of the first service would be twice as much as 
the direct portion of the PE RVUs for the second service.
(2) Indirect Costs
    We allocate the indirect costs at the code level based on the 
direct costs specifically associated with a code and the greater of 
either the clinical labor costs or the work RVUs. We also incorporate 
the survey data described earlier in the PE/HR discussion. The general 
approach to developing the indirect portion of the PE RVUs is as 
follows:
     For a given service, we use the direct portion of the PE 
RVUs calculated as previously described and the average percentage that 
direct costs represent of total costs (based on survey data) across the 
specialties that furnish the service to determine an initial indirect 
allocator. That is, the initial indirect allocator is calculated so 
that the direct costs equal the average percentage of direct costs of 
those specialties furnishing the service. For example, if the direct 
portion of the PE RVUs for a given service is 2.00 and direct costs, on 
average, represent 25 percent of total costs for the specialties that 
furnish the service, the initial indirect allocator would be calculated 
so that it equals 75 percent of the total PE RVUs. Thus, in this 
example, the initial indirect allocator would equal 6.00, resulting in 
a total PE RVU of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75 
percent of 8.00).
     Next, we add the greater of the work RVUs or clinical 
labor portion of the direct portion of the PE RVUs to this initial 
indirect allocator. In our example, if this service had a work RVU of 
4.00 and the clinical labor portion of the direct PE RVU was 1.50, we 
would add 4.00 (since the 4.00 work RVUs are greater than the 1.50 
clinical labor portion) to the initial indirect allocator of 6.00 to 
get an indirect allocator of 10.00. In the absence of any further use 
of the survey data, the relative relationship between the indirect cost 
portions of the PE RVUs for any two services would be determined by the 
relative relationship between these indirect cost allocators. For 
example, if one service had an indirect cost allocator of 10.00 and 
another service had an indirect cost allocator of 5.00, the indirect 
portion of the PE RVUs of the first service would be twice as great as 
the indirect portion of the PE RVUs for the second service.
     Then, we incorporate the specialty specific indirect PE/HR 
data into the calculation. In our example, if, based on the survey 
data, the average indirect cost of the specialties furnishing the first 
service with an allocator of 10.00 was half of the average indirect 
cost of the specialties furnishing the second service with an indirect 
allocator of 5.00, the indirect portion of the PE RVUs of the first 
service would be equal to that of the second service.
(3) Facility and Nonfacility Costs
    For procedures that can be furnished in a physician's office, as 
well as in a facility setting, where Medicare makes a separate payment 
to the facility for its costs in furnishing a service, we establish two 
PE RVUs: facility and nonfacility. The methodology for

[[Page 78822]]

calculating PE RVUs is the same for both the facility and nonfacility 
RVUs but is applied independently to yield two separate PE RVUs. In 
calculating the PE RVUs for services furnished in a facility, we do not 
include resources that would generally not be provided by physicians 
when furnishing the service. For this reason, the facility PE RVUs are 
generally lower than the nonfacility PE RVUs.
(4) Services With Technical Components and Professional Components
    Diagnostic services are generally comprised of two components: a 
professional component (PC); and a technical component (TC). The PC and 
TC may be furnished independently or by different providers, or they 
may be furnished together as a global service. When services have 
separately billable PC and TC components, the payment for the global 
service equals the sum of the payment for the TC and PC. To achieve 
this, we use a weighted average of the ratio of indirect to direct 
costs across all the specialties that furnish the global service, TCs, 
and PCs; that is, we apply the same weighted average indirect 
percentage factor to allocate indirect expenses to the global service, 
PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum 
to the global.)
(5) PE RVU Methodology
    For a more detailed description of the PE RVU methodology, we 
direct readers to the CY 2010 PFS final rule with comment period (74 FR 
61745 through 61746). We also direct readers to the file titled 
``Calculation of PE RVUs under Methodology for Selected Codes'' which 
is available on our website under downloads for the CY 2024 PFS final 
rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. This file 
contains a table that illustrates the calculation of PE RVUs as 
described in this final rule for individual codes.
(a) Setup File
    First, we create a setup file for the PE methodology. The setup 
file contains the direct cost inputs, the utilization for each 
procedure code at the specialty and facility/nonfacility place of 
service level, and the specialty specific PE/HR data calculated from 
the surveys.
(b) Calculate the Direct Cost PE RVUs
    Sum the costs of each direct input.
    Step 1: Sum the direct costs of the inputs for each service.
    Step 2: Calculate the aggregate pool of direct PE costs for the 
current year. We set the aggregate pool of PE costs equal to the 
product of the ratio of the current aggregate PE RVUs to current 
aggregate work RVUs and the projected aggregate work RVUs.
    Step 3: Calculate the aggregate pool of direct PE costs for use in 
ratesetting. This is the product of the aggregate direct costs for all 
services from Step 1 and the utilization data for that service.
    Step 4: Using the results of Step 2 and Step 3, use the CF to 
calculate a direct PE scaling adjustment to ensure that the aggregate 
pool of direct PE costs calculated in Step 3 does not vary from the 
aggregate pool of direct PE costs for the current year. Apply the 
scaling adjustment to the direct costs for each service (as calculated 
in Step 1).
    Step 5: Convert the results of Step 4 to an RVU scale for each 
service. To do this, divide the results of Step 4 by the CF. Note that 
the actual value of the CF used in this calculation does not influence 
the final direct cost PE RVUs as long as the same CF is used in Step 4 
and Step 5. Different CFs would result in different direct PE scaling 
adjustments, but this has no effect on the final direct cost PE RVUs 
since changes in the CFs and changes in the associated direct scaling 
adjustments offset one another.
(c) Create the Indirect Cost PE RVUs
    Create indirect allocators.
    Step 6: Based on the survey data, calculate direct and indirect PE 
percentages for each physician specialty.
    Step 7: Calculate direct and indirect PE percentages at the service 
level by taking a weighted average of the results of Step 6 for the 
specialties that furnish the service. Note that for services with TCs 
and PCs, the direct and indirect percentages for a given service do not 
vary by the PC, TC, and global service.
    We generally use an average of the 3 most recent years of available 
Medicare claims data to determine the specialty mix assigned to each 
code. Codes with low Medicare service volume require special attention 
since billing or enrollment irregularities for a given year can result 
in significant changes in specialty mix assignment. We finalized a 
policy in the CY 2018 PFS final rule (82 FR 52982 through 59283) to use 
the most recent year of claims data to determine which codes are low 
volume for the coming year (those that have fewer than 100 allowed 
services in the Medicare claims data). For codes that fall into this 
category, instead of assigning specialty mix based on the specialties 
of the practitioners reporting the services in the claims data, we use 
the expected specialty that we identify on a list developed based on 
medical review and input from expert interested parties. We display 
this list of expected specialty assignments as part of the annual set 
of data files we make available as part of notice and comment 
rulemaking and consider recommendations from the RUC and other 
interested parties on changes to this list on an annual basis. Services 
for which the specialty is automatically assigned based on previously 
finalized policies under our established methodology (for example, 
``always therapy'' services) are unaffected by the list of expected 
specialty assignments. We also finalized in the CY 2018 PFS final rule 
(82 FR 52982 through 52983) a policy to apply these service-level 
overrides for both PE and MP, rather than one or the other category.
    We did not make any proposals associated with the list of expected 
specialty assignments for low volume services, however we received 
public comments on this topic from interested parties. The following is 
a summary of the comments we received and our responses.
    Comment: Several commenters stated that they had performed an 
analysis to identify all codes that meet the criteria to receive a 
specialty override under this CMS policy and drafted updated 
recommendations for CY 2024. Commenters stated that the purpose of 
assigning a specialty to these codes was to avoid the major adverse 
impact on MP RVUs that result from errors in specialty utilization data 
magnified in representation (percentage) by small sample size. These 
commenters submitted a list of several dozen low volume HCPCS codes 
with recommended expected specialty assignments.
    Response: After reviewing the information provided by the 
commenters to determine that the submitted specialty assignments were 
appropriate for the services in question, we are finalizing the 
additions to the list of expected specialty assignments for low volume 
services identified in Table 1. We agreed with the commenters that CPT 
code 33230 should be crosswalked to the Cardiac Electrophysiology 
specialty and that CPT code 96446 should be crosswalked to the 
Gynecological Oncology specialty. However, we do not have PE/HR data 
for these specialties as they were not part of the PPIS when it was 
conducted in 2007; therefore, we are crosswalking these CPT codes to 
the Cardiology and Obstetrics/Gynecology specialties, respectively, as 
listed on Table 1.
    We disagreed with the commenters that CPT code 44384 should be

[[Page 78823]]

crosswalked to the Gastroenterology specialty and that CPT code 60505 
should be crosswalked to the General Surgery specialty. In each case, 
there was another specialty which was reported more than twice as often 
in the claims data as the requested specialty. Therefore, we are 
crosswalking CPT code 44384 to the Urology specialty and CPT code 60505 
to the Otolaryngology specialty as these were the dominant specialties 
in the claims data. These crosswalks are included in Table 1.
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[[Page 78825]]


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BILLING CODE 4120-01-C
    Comment: A commenter noted that the CMS expected specialty 
assignment list in the public use file that was part of the CY 2024 
proposed rule also includes a column specifying if a service that 
previously had an anticipated specialty override continues to meet the 
criteria for the override to be applied for CY 2024. The commenter 
provided a list of approximately a dozen CPT codes and requested 
additional information as to why the expected specialty override was 
not being applied in these cases.
    Response: We reviewed the CPT codes identified by the commenter and 
can provide the following information about their expected specialty 
override status for CY 2024. CMS did not apply the specialty override 
to CPT codes 33238, 33254, 33475, and 33507 as each code exceeded 100 
allowed services in the Medicare claims data. CMS did not apply the 
specialty override to CPT codes 33602, 33619, 33778, and 43045 because 
they were unneeded, with the entirety of their very small number of 
allowed services already reported under their expected specialty. CPT 
codes 33600, 33710, and 43312 did have their respective specialty 
overrides applied; this was correctly detailed in the public use file 
for the CY 2024 proposed rule for CPT code 43312 but was missing from 
CPT codes 33600 and 33710, due to a technical error in the generation 
of the public use file.
    We also note for commenters that each HCPCS code that appears on 
the list of expected specialty assignments for low volume services 
remains on the list from year to year, even if the code in question is 
not a low volume service for a certain calendar year because the volume 
rises to over 100 services. The HCPCS codes and expected specialty 
assignment remain on the list, and will be applied should the code fall 
below the low volume threshold (below 100 services) in any calendar 
year; as a result, there is no need to ``reactivate'' individual codes 
as some commenters have suggested in past submissions.
    After consideration of the public comments, we are finalizing the 
updates to the list of expected specialty assignments for low volume 
services as detailed Table 1.
    Step 8: Calculate the service level allocators for the indirect PEs 
based on the percentages calculated in Step 7. The indirect PEs are 
allocated based on the three components: the direct PE RVUs; the 
clinical labor PE RVUs; and the work RVUs.
    For most services the indirect allocator is: indirect PE percentage 
* (direct PE RVUs/direct percentage) + work RVUs.
    There are two situations where this formula is modified:
     If the service is a global service (that is, a service 
with global, professional, and technical components), then the indirect 
PE allocator is: indirect percentage (direct PE RVUs/direct percentage) 
+ clinical labor PE RVUs + work RVUs.
     If the clinical labor PE RVUs exceed the work RVUs (and 
the service is not a global service), then the indirect allocator is: 
indirect PE percentage (direct PE RVUs/direct percentage) + clinical 
labor PE RVUs.
    (Note: For global services, the indirect PE allocator is based on 
both the work RVUs and the clinical labor PE RVUs. We do this to 
recognize that, for the PC service, indirect PEs would be allocated 
using the work RVUs, and for the TC service, indirect PEs would be 
allocated using the direct PE RVUs and the clinical labor PE RVUs. This 
also allows the global component RVUs to equal the sum of the PC and TC 
RVUs.)
    For presentation purposes, in the examples in the download file 
titled ``Calculation of PE RVUs under Methodology for Selected Codes'', 
the formulas were divided into two parts for each service.
     The first part does not vary by service and is the 
indirect percentage (direct PE RVUs/direct percentage).
     The second part is either the work RVU, clinical labor PE 
RVU, or both depending on whether the service is a global service and 
whether the clinical PE RVUs exceed the work RVUs (as described earlier 
in this step).
    Apply a scaling adjustment to the indirect allocators.
    Step 9: Calculate the current aggregate pool of indirect PE RVUs by 
multiplying the result of step 8 by the average indirect PE percentage 
from the survey data.
    Step 10: Calculate an aggregate pool of indirect PE RVUs for all 
PFS services by adding the product of the indirect PE allocators for a 
service from Step 8 and the utilization data for that service.
    Step 11: Using the results of Step 9 and Step 10, calculate an 
indirect PE adjustment so that the aggregate indirect allocation does 
not exceed the available aggregate indirect PE RVUs and apply it to 
indirect allocators calculated in Step 8.
    Calculate the indirect practice cost index.
    Step 12: Using the results of Step 11, calculate aggregate pools of 
specialty specific adjusted indirect PE allocators for all PFS services 
for a specialty by adding the product of the adjusted indirect PE 
allocator for each service and the utilization data for that service.
    Step 13: Using the specialty specific indirect PE/HR data, 
calculate specialty specific aggregate pools of indirect PE for all PFS 
services for that specialty by adding the product of the indirect PE/HR 
for the specialty, the work time for the service, and the specialty's 
utilization for the service across all services furnished by the 
specialty.
    Step 14: Using the results of Step 12 and Step 13, calculate the 
specialty specific indirect PE scaling factors.
    Step 15: Using the results of Step 14, calculate an indirect 
practice cost index at the specialty level by dividing each specialty 
specific indirect scaling factor by the average indirect scaling factor 
for the entire PFS.
    Step 16: Calculate the indirect practice cost index at the service 
level to ensure the capture of all indirect costs. Calculate a weighted 
average of the practice cost index values for the specialties that 
furnish the service. (Note: For services with TCs and PCs, we calculate 
the indirect practice cost index across the global service, PCs, and 
TCs. Under this method, the indirect practice cost index for a given 
service (for example, echocardiogram) does not vary by the PC, TC, and 
global service.)
    Step 17: Apply the service level indirect practice cost index 
calculated in Step 16 to the service level adjusted indirect allocators 
calculated in Step 11 to get the indirect PE RVUs.

[[Page 78826]]

(d) Calculate the Final PE RVUs
    Step 18: Add the direct PE RVUs from Step 5 to the indirect PE RVUs 
from Step 17 and apply the final PE budget neutrality (BN) adjustment. 
The final PE BN adjustment is calculated by comparing the sum of steps 
5 and 17 to the aggregate work RVUs scaled by the ratio of current 
aggregate PE and work RVUs. This adjustment ensures that all PE RVUs in 
the PFS account for the fact that certain specialties are excluded from 
the calculation of PE RVUs but included in maintaining overall PFS BN. 
(See ``Specialties excluded from ratesetting calculation'' later in 
this final rule.)
    Step 19: Apply the phase-in of significant RVU reductions and its 
associated adjustment. Section 1848(c)(7) of the Act specifies that for 
services that are not new or revised codes, if the total RVUs for a 
service for a year would otherwise be decreased by an estimated 20 
percent or more as compared to the total RVUs for the previous year, 
the applicable adjustments in work, PE, and MP RVUs shall be phased in 
over a 2-year period. In implementing the phase-in, we consider a 19 
percent reduction as the maximum 1-year reduction for any service not 
described by a new or revised code. This approach limits the year one 
reduction for the service to the maximum allowed amount (that is, 19 
percent), and then phases in the remainder of the reduction. To comply 
with section 1848(c)(7) of the Act, we adjust the PE RVUs to ensure 
that the total RVUs for all services that are not new or revised codes 
decrease by no more than 19 percent, and then apply a relativity 
adjustment to ensure that the total pool of aggregate PE RVUs remains 
relative to the pool of work and MP RVUs. For a more detailed 
description of the methodology for the phase-in of significant RVU 
changes, we refer readers to the CY 2016 PFS final rule with comment 
period (80 FR 70927 through 70931).
    Comment: Several commenters referenced the CY 2018 PFS finalized 
policy for the adjustment to allocation of indirect PE for some office-
based services, generally services associated with behavioral health 
(82 FR 52999 through 53000). Commenters stated that for each of the 
services that qualify for the indirect PE allocation adjustment, CMS 
first establishes an indirect PE floor using the work RVU for the 
qualifying service and the ratio between the indirect PE RVUs and the 
work RVUs for the marker code (currently CPT code 99213). Commenters 
stated that CMS then identifies the difference between the indirect PE 
RVU for the qualifying service produced under standard methodology and 
the indirect PE floor; the modified methodology then increases the 
allocation of indirect PE RVUs to one quarter of that difference. 
Commenters stated that they supported the current policy, since they 
believe that the current PFS reimbursement rate methodology undervalues 
behavioral health services and recommended that CMS expand the indirect 
PE floor methodology by increasing the minimum value for non-facility 
indirect PE RVUs by adding the full difference between the indirect PE 
floor RVUs and indirect PE RVUs calculated for the eligible codes under 
the standard methodology (instead of one quarter of the distance). 
Commenters stated that this expansion of the current indirect PE floor 
policy would assure that a more appropriate number of indirect PE RVUs 
are allocated to these services and would provide greater resources to 
behavioral health practitioners providing services to Medicare 
beneficiaries with behavioral and mental health needs.
    Response: We appreciate the support from the commenters for our 
previously finalized policy for the adjustment to allocation of 
indirect PE for some office-based services. While we share the concern 
of the commenters in ensuring that behavioral health practitioners have 
the proper resources that they need to provide services to Medicare 
beneficiaries, we note that we did not propose to make any adjustments 
to this indirect PE policy for CY 2024 and we are not finalizing any 
adjustments to this indirect PE policy for CY 2024. We will consider 
the recommendations from the commenters for potential use in future 
rulemaking.
(e) Setup File Information
     Specialties excluded from ratesetting calculation: For the 
purposes of calculating the PE and MP RVUs, we exclude certain 
specialties, such as certain NPPs paid at a percentage of the PFS and 
low volume specialties, from the calculation. These specialties are 
included for the purposes of calculating the BN adjustment. They are 
displayed in Table 2.
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BILLING CODE 4120-01-C
     Crosswalk certain low volume physician specialties: 
Crosswalk the utilization of certain specialties with relatively low 
PFS utilization to the associated specialties.
     Physical therapy utilization: Crosswalk the utilization 
associated with all physical therapy services to the specialty of 
physical therapy.
     Identify professional and technical services not 
identified under the usual TC and 26 modifiers: Flag the services that 
are PC and TC services but do not use TC and 26 modifiers (for example, 
electrocardiograms). This flag associates the PC and TC with the 
associated global code for use in creating the indirect PE RVUs. For 
example, the professional service, CPT code 93010 (Electrocardiogram, 
routine ECG with at least 12 leads; interpretation and report only), is 
associated with the global service, CPT code 93000 (Electrocardiogram, 
routine ECG with at least 12 leads; with interpretation and report).
     Payment modifiers: Payment modifiers are accounted for in 
the creation of the file consistent with current payment policy as 
implemented in claims processing. For example, services billed with the 
assistant at surgery modifier are paid 16 percent of the PFS amount for 
that service; therefore, the utilization file is modified to only 
account for 16 percent of any service that contains the assistant at 
surgery modifier. Similarly, for those services to which volume 
adjustments are made to account for the payment modifiers, time 
adjustments are applied as well. For time adjustments to surgical 
services, the intraoperative portion in the work time file is used; 
where it is not present, the intraoperative percentage from the payment 
files used by contractors to process Medicare claims is used instead. 
Where neither is available, we use the payment adjustment ratio to 
adjust the time

[[Page 78828]]

accordingly. Table 3 details the manner in which the modifiers are 
applied.
[GRAPHIC] [TIFF OMITTED] TR16NO23.003

    We also adjust volume and time that correspond to other payment 
rules, including special multiple procedure endoscopy rules and 
multiple procedure payment reductions (MPPRs). We note that section 
1848(c)(2)(B)(v) of the Act exempts certain reduced payments for 
multiple imaging procedures and multiple therapy services from the BN 
calculation under section 1848(c)(2)(B)(ii)(II) of the Act. These MPPRs 
are not included in the development of the RVUs.
    Beginning in CY 2022, section 1834(v)(1) of the Act required that 
we apply a 15 percent payment reduction for outpatient occupational 
therapy services and outpatient physical therapy services that are 
provided, in whole or in part, by a physical therapist assistant (PTA) 
or occupational therapy assistant (OTA). Section 1834(v)(2)(A) of the 
Act required CMS to establish modifiers to identify these services, 
which we did in the CY 2019 PFS final rule (83 FR 59654 through 59661), 
creating the CQ and CO payment modifiers for services provided in whole 
or in part by PTAs and OTAs, respectively. These payment modifiers are 
required to be used on claims for services with dates of service 
beginning January 1, 2020, as specified in the CY 2020 PFS final rule 
(84 FR 62702 through 62708). We applied the 15 percent payment 
reduction to therapy services provided by PTAs (using the CQ modifier) 
or OTAs (using the CO modifier), as required by statute. Under sections 
1834(k) and 1848 of the Act, payment is made for outpatient therapy 
services at 80 percent of the lesser of the actual charge or applicable 
fee schedule amount (the allowed charge). The remaining 20 percent is 
the beneficiary copayment. For therapy services to which the new 
discount applies, payment will be made at 85 percent of the 80 percent 
of allowed charges. Therefore, the volume discount factor for therapy 
services to which the CQ and CO modifiers apply is: (0.20 + (0.80* 
0.85), which equals 88 percent.
    For anesthesia services, we do not apply adjustments to volume 
since we use the average allowed charge when simulating RVUs; 
therefore, the RVUs as calculated already reflect the payments as 
adjusted by modifiers, and no volume adjustments are necessary. 
However, a time adjustment of 33 percent is made only for medical 
direction of two to four cases since that is the only situation where a 
single practitioner is involved with multiple beneficiaries 
concurrently, so that counting each service without regard to the 
overlap with other services would overstate the amount of time spent by 
the practitioner furnishing these services.

 Work RVUs: The setup file contains the work RVUs from this 
final rule.
(6) Equipment Cost per Minute
    The equipment cost per minute is calculated as:

(1/(minutes per year * usage)) * price * ((interest rate/(1 (1/((1 + 
interest rate)- life of equipment)))) + maintenance)

Where:
minutes per year = maximum minutes per year if usage were continuous 
(that is, usage=1); generally, 150,000 minutes.
usage = variable, see discussion below in this final rule.
price = price of the particular piece of equipment.
life of equipment = useful life of the particular piece of 
equipment.
maintenance = factor for maintenance; 0.05.
interest rate = variable, see discussion below in this final rule.

    Usage: We currently use an equipment utilization rate assumption of 
50 percent for most equipment, with the exception of expensive 
diagnostic imaging equipment, for which we use a 90 percent assumption 
as required by section 1848(b)(4)(C) of the Act.
    Useful Life: In the CY 2005 PFS final rule we stated that we 
updated the useful life for equipment items primarily based on the 
AHA's ``Estimated Useful Lives of Depreciable Hospital Assets'' 
guidelines (69 FR 66246). The most recent edition of these guidelines 
was published in 2018. This reference material provides an estimated 
useful life for hundreds of different

[[Page 78829]]

types of equipment, the vast majority of which fall in the range of 5 
to 10 years, and none of which are lower than 2 years in duration. We 
believe that the updated editions of this reference material remain the 
most accurate source for estimating the useful life of depreciable 
medical equipment.
    In the CY 2021 PFS final rule, we finalized a proposal to treat 
equipment life durations of less than 1 year as having a duration of 1 
year for the purpose of our equipment price per minute formula. In the 
rare cases where items are replaced every few months, we noted that we 
believe it is more accurate to treat these items as disposable supplies 
with a fractional supply quantity as opposed to equipment items with 
very short equipment life durations. For a more detailed discussion of 
the methodology associated with very short equipment life durations, we 
referred readers to the CY 2021 PFS final rule (85 FR 84482 through 
84483).
     Maintenance: We finalized the 5 percent factor for annual 
maintenance in the CY 1998 PFS final rule with comment period (62 FR 
33164). As we previously stated in the CY 2016 PFS final rule with 
comment period (80 FR 70897), we do not believe the annual maintenance 
factor for all equipment is precisely 5 percent, and we concur that the 
current rate likely understates the true cost of maintaining some 
equipment. We also noted that we believe it likely overstates the 
maintenance costs for other equipment. When we solicited comments 
regarding sources of data containing equipment maintenance rates, 
commenters were unable to identify an auditable, robust data source 
that could be used by CMS on a wide scale. We noted that we did not 
believe voluntary submissions regarding the maintenance costs of 
individual equipment items would be an appropriate methodology for 
determining costs. As a result, in the absence of publicly available 
datasets regarding equipment maintenance costs or another systematic 
data collection methodology for determining a different maintenance 
factor, we did not propose a variable maintenance factor for equipment 
cost per minute pricing as we did not believe that we have sufficient 
information at present. We noted that we would continue to investigate 
potential avenues for determining equipment maintenance costs across a 
broad range of equipment items.
     Interest Rate: In the CY 2013 PFS final rule with comment 
period (77 FR 68902), we updated the interest rates used in developing 
an equipment cost per minute calculation (see 77 FR 68902 for a 
thorough discussion of this issue). The interest rate was based on the 
Small Business Administration (SBA) maximum interest rates for 
different categories of loan size (equipment cost) and maturity (useful 
life). The Interest rates are listed in Table 4.
[GRAPHIC] [TIFF OMITTED] TR16NO23.004

    We did not propose any changes to the equipment interest rates for 
CY 2024.
3. Adjusting RVUs To Match the PE Share of the Medicare Economic Index 
(MEI)
    In the past, we have stated that we believe that the MEI is the 
best measure available of the relative weights of the three components 
in payments under the PFS--work, practice expense (PE), and malpractice 
(MP). Accordingly, we believe that to assure that the PFS payments 
reflect the relative resources in each of these PFS components as 
required by section 1848(c)(3) of the Act, the RVUs used in developing 
rates should reflect the same weights in each component as the cost 
share weights in the Medicare Economic Index (MEI). In the past, we 
have proposed (and subsequently, finalized) to accomplish this by 
holding the work RVUs constant and adjusting the PE RVUs, MP RVUs, and 
CF to produce the appropriate balance in RVUs among the three PFS 
components and payment rates for individual services, that is, that the 
total RVUs on the PFS are proportioned to approximately 51 percent work 
RVUs, 45 percent PE RVUs, and 4 percent MP RVUs. As the MEI cost shares 
are updated, we would typically propose to modify steps 3 and 10 to 
adjust the aggregate pools of PE costs (direct PE in step 3 and 
indirect PE in step 10) in proportion to the change in the PE share in 
the rebased and revised MEI cost share weights, and to recalibrate the 
relativity adjustment that we apply in step 18 as described ``3. 
Adjusting RVUs To Match PE Share of the Medicare Economic Index (MEI)'' 
of the CY 2023 PFS final rule (87 FR 69414 and 69415) and CY 2014 PFS 
final rule (78 FR 74236 and 74237). The most recent recalibration was 
done for the CY 2014 RVUs.
    In the CY 2014 PFS proposed rule (78 FR 43287 through 43288) and 
final rule (78 FR 74236 through 74237), we detailed the steps necessary 
to accomplish this result (see steps 3, 10, and 18). The CY 2014 
proposed and final adjustments were consistent with our longstanding 
practice to make adjustments to match the RVUs for the PFS components 
with the MEI cost share weights for the components, including the 
adjustments described in the CY 1999 PFS final rule (63 FR 58829), CY 
2004 PFS final rule (68 FR 63246 and 63247), and CY 2011 PFS final rule 
(75 FR 73275).
    In the CY 2023 PFS final rule (87 FR 69688 through 69711), we 
finalized to rebase and revise the Medicare Economic Index (MEI) to 
reflect more current market conditions faced by physicians in 
furnishing physicians' services. We also finalized a delay of the 
adjustments to the PE pools in steps 3 and 10 and the recalibration of 
the relativity adjustment in step 18 until the public had an 
opportunity to comment on the rebased and revised MEI (87 FR 69414 
through 69416). Because we finalized significant methodological and 
data source changes to the MEI in the CY 2023 PFS final rule and 
significant time has elapsed since the last rebasing and revision of 
the MEI in CY 2014, we believed that delaying the

[[Page 78830]]

implementation of the finalized CY 2023 rebased and revised MEI was 
consistent with our efforts to balance payment stability and 
predictability with incorporating new data through more routine 
updates. We refer readers to the discussion of our comment solicitation 
in the CY 2023 PFS final rule (87 FR 69429 through 69432), where we 
reviewed our ongoing efforts to update data inputs for PE to aid 
stability, transparency, efficiency, and data adequacy. We also 
solicited comment in the CY 2023 PFS proposed rule on when and how to 
best incorporate the CY 2023 rebased and revised MEI into PFS 
ratesetting, and whether it would be appropriate to consider a 
transition to full implementation for potential future rulemaking. We 
presented the impacts of implementing the rebased and revised MEI in 
PFS ratesetting through a 4-year transition and through full immediate 
implementation, that is, with no transition period in the CY 2023 PFS 
proposed rule. We also solicited comment on other implementation 
strategies for potential future rulemaking in the CY 2023 PFS proposed 
rule. In the CY 2023 PFS final rule, we discussed that many commenters 
supported our proposed delayed implementation and many commenters 
expressed concerns with the redistributive impacts of the 
implementation of the rebased and revised MEI in PFS ratesetting. Many 
commenters also noted that the AMA has stated it intends to collect 
practice cost data from physician practices in the near future which 
could be used to derive cost share weights for the MEI and RVU shares.
    In light of the AMA's intended data collection efforts in the near 
future and because the methodological and data source changes to the 
MEI finalized in the CY 2023 PFS final rule would have significant 
impacts on PFS payments, we continue to believe that delaying the 
implementation of the finalized 2017-based MEI cost share weights for 
the RVUs is consistent with our efforts to balance payment stability 
and predictability with incorporating new data through more routine 
updates. Therefore, we did not propose to incorporate the 2017-based 
MEI in PFS ratesetting for CY 2024.
    As discussed above, in the CY 2023 PFS rulemaking, we finalized to 
rebase and revise the MEI to reflect more current market conditions 
faced by physicians in furnishing physicians' services. The final 2017-
based MEI relies on a methodology that uses publicly available data 
sources for input costs that represent all types of physician practice 
ownership, not limited to only self-employed physicians. The 2006-based 
MEI relied on the 2006 AMA PPIS survey data; as of this CY 2024 
rulemaking, this survey had not been updated. Given the changes in the 
physician and supplier industry and the time since the last update to 
the base year, we finalized a methodology that would allow us to update 
the MEI on a consistent basis in the future. The 2017-based MEI cost 
share weights are derived predominantly from the annual expense data 
from the U.S. Census Bureau's Services Annual Survey (SAS, https://www.census.gov/programs-surveys/sas.html). We supplement the 2017 SAS 
expense data by using several data sources to further disaggregate 
compensation costs and all other residual costs (87 FR 69688 through 
69708).
    We continue to review more recently available data from the Census 
Bureau Services Annual Survey, the main data source for the major 
components of the 2017-based MEI cost share weights. Data is currently 
available through 2021. Given that the impact of the PHE may influence 
the 2020 and 2021 data, we continue to evaluate whether the recent 
trends are reflective of sustained shifts in cost structures or were 
temporary as a result of the COVID-19 PHE. The 2022 data from the 
Services Annual Survey will be available later this year. We will 
monitor that data and any other data that may become available related 
to physician services' input expenses and will propose any changes to 
the MEI, if appropriate, in future rulemaking.
    The following is a summary of the comments we received and our 
responses.
    Comment: Many commenters supported our continued delayed 
implementation of the rebased and revised MEI in PFS ratesetting. Most 
of these commenters urged CMS to pause consideration of other sources 
for the MEI until the AMA's efforts to collect practice cost data from 
physician practices have concluded. A few commenters urged CMS to 
implement the MEI for PFS ratesetting as soon as possible.
    Response: We appreciate commenters' feedback, specifically as it 
relates to updating PFS ratesetting, and will consider the commenters' 
feedback in future rulemaking.
    Comment: One commenter stated that the methodology for deriving the 
2017-based MEI cost share weights is flawed because the use of the SAS 
data as the primary data source for expenses omits facility-based 
physicians which, according to BLS Occupational Employment and Wage 
Statistics (OEWS) data, accounts for 36 percent of physicians who are 
employed in the health sector. The commenter states that correcting for 
the omission would result in an increase to the physician work cost 
share weight and a much smaller reduction to the professional liability 
insurance (PLI) cost share weight in the MEI.
    The commenter noted that in response to a similar comment in the CY 
2023 PFS final rule, CMS responded that ``for physicians who are 
employed in other healthcare settings directly, such as hospitals, we 
do not believe that including costs for physicians that do not incur 
any operating expenses associated with running a practice would be 
technically appropriate.'' However, the commenter stated that this 
fails to consider that the MEI cost share weights also cover physician 
compensation and professional liability insurance. The commenter stated 
that by excluding NAICS 6221 General Medical and Surgical Hospitals in 
the CMS MEI cost share weights analysis, CMS inadvertently omitted over 
$30 billion in physician compensation and over $7 billion in 
professional liability insurance compensation. Also, the commenter 
noted that physician practices do still have some indirect PE costs 
even for providers who are solely facility-based (coding, billing, 
scheduling, etc.). The commenter claimed that the CMS analysis of the 
US Census SAS data captured a large majority of PE covered by the PFS 
but only a subset of the physician compensation and professional 
liability insurance premiums.
    The commenter requested that CMS make changes to the methodology 
for deriving the MEI cost share weights to correct for the omission of 
costs for facility-based physicians.
    Response: We appreciate the commenter's concern regarding the 
methodology for the 2017-based MEI. As explained in the 2023 PFS final 
rule (87 FR 69688 through 69710), the development of the MEI cost share 
weights (which would reflect all costs including work, PE and PLI) is 
intended to be consistent with costs associated with providing 
physician services as paid for by the PFS. Thus, we are using a data 
source that reflects the nature of those costs, which we have 
determined to be the U.S. Census Bureau's Services Annual Survey. This 
data source shows all ownership types of physicians' offices as 
determined by the North American Industrial Classification System 
(NAICS). Unfortunately, there is currently no data source available 
that would provide a comprehensive

[[Page 78831]]

collection of physician expense data for physicians that directly 
contract with hospitals or other healthcare settings. While there are 
compensation costs for employed physicians working in an alternative 
setting such as a hospital or SNF and other associated expenses, 
including those for PLI, those costs would be captured in reporting for 
those other settings--such as hospitals, home health agencies, or 
skilled nursing facilities. For example, if a physician is directly 
employed by a hospital, that is, not just a hospital-owned physician 
practice, then those costs would be captured in the reported SAS 
expenses for NAICS 622 (Hospitals) and on the Medicare cost report 
submitted by the hospital. Unfortunately, there is currently no 
mechanism for identifying those specific expenses distinct to providing 
physician services separately from the provider's other expenses. 
Therefore, we have used a data source that we believe reflects the most 
up-to-date, comprehensive, and regularly published data on physician 
expenses for the majority of physicians (which would be captured in 
NAICS 621111--Offices of Physicians). We welcome the public to provide 
any other data source that could be considered, in concert with the SAS 
data, to address the commenters concerns. Additionally, we understand 
that the AMA is currently collecting data on physician expenses and we 
will analyze the data if made available to CMS. We note that CMS did 
not propose changes to the methodology for deriving the MEI cost share 
weights for CY 2024.or.
4. Changes to Direct PE Inputs for Specific Services
    This section focuses on specific PE inputs. The direct PE inputs 
are included in the CY 2024 direct PE input public use files, which are 
available on the CMS website under downloads for the CY 2024 PFS final 
rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
a. Standardization of Clinical Labor Tasks
    As we noted in the CY 2015 PFS final rule with comment period (79 
FR 67640 through 67641), we continue to make improvements to the direct 
PE input database to provide the number of clinical labor minutes 
assigned for each task for every code in the database instead of only 
including the number of clinical labor minutes for the preservice, 
service, and post service periods for each code. In addition to 
increasing the transparency of the information used to set PE RVUs, 
this level of detail would allow us to compare clinical labor times for 
activities associated with services across the PFS, which we believe is 
important to maintaining the relativity of the direct PE inputs. This 
information would facilitate the identification of the usual numbers of 
minutes for clinical labor tasks and the identification of exceptions 
to the usual values. It would also allow for greater transparency and 
consistency in the assignment of equipment minutes based on clinical 
labor times. Finally, we believe that the detailed information can be 
useful in maintaining standard times for particular clinical labor 
tasks that can be applied consistently to many codes as they are valued 
over several years, similar in principle to the use of physician 
preservice time packages. We believe that setting and maintaining such 
standards would provide greater consistency among codes that share the 
same clinical labor tasks and could improve relativity of values among 
codes. For example, as medical practice and technologies change over 
time, changes in the standards could be updated simultaneously for all 
codes with the applicable clinical labor tasks, instead of waiting for 
individual codes to be reviewed.
    In the CY 2016 PFS final rule with comment period (80 FR 70901), we 
solicited comments on the appropriate standard minutes for the clinical 
labor tasks associated with services that use digital technology. After 
consideration of comments received, we finalized standard times for 
clinical labor tasks associated with digital imaging at 2 minutes for 
``Availability of prior images confirmed'', 2 minutes for ``Patient 
clinical information and questionnaire reviewed by technologist, order 
from physician confirmed and exam protocoled by radiologist'', 2 
minutes for ``Review examination with interpreting MD'', and 1 minute 
for ``Exam documents scanned into PACS'' and ``Exam completed in RIS 
system to generate billing process and to populate images into 
Radiologist work queue.'' In the CY 2017 PFS final rule (81 FR 80184 
through 80186), we finalized a policy to establish a range of 
appropriate standard minutes for the clinical labor activity, 
``Technologist QCs images in PACS, checking for all images, reformats, 
and dose page.'' These standard minutes will be applied to new and 
revised codes that make use of this clinical labor activity when they 
are reviewed by us for valuation. We finalized a policy to establish 2 
minutes as the standard for the simple case, 3 minutes as the standard 
for the intermediate case, 4 minutes as the standard for the complex 
case, and 5 minutes as the standard for the highly complex case. These 
values were based upon a review of the existing minutes assigned for 
this clinical labor activity; we determined that 2 minutes is the 
duration for most services and a small number of codes with more 
complex forms of digital imaging have higher values. We also finalized 
standard times for a series of clinical labor tasks associated with 
pathology services in the CY 2016 PFS final rule with comment period 
(80 FR 70902). We do not believe these activities would be dependent on 
number of blocks or batch size, and we believe that the finalized 
standard values accurately reflect the typical time it takes to perform 
these clinical labor tasks.
    In reviewing the RUC-recommended direct PE inputs for CY 2019, we 
noticed that the 3 minutes of clinical labor time traditionally 
assigned to the ``Prepare room, equipment and supplies'' (CA013) 
clinical labor activity were split into 2 minutes for the ``Prepare 
room, equipment and supplies'' activity and 1 minute for the ``Confirm 
order, protocol exam'' (CA014) activity. We proposed to maintain the 3 
minutes of clinical labor time for the ``Prepare room, equipment and 
supplies'' activity and remove the clinical labor time for the 
``Confirm order, protocol exam'' activity wherever we observed this 
pattern in the RUC-recommended direct PE inputs. Commenters explained 
in response that when the new version of the PE worksheet introduced 
the activity codes for clinical labor, there was a need to translate 
old clinical labor tasks into the new activity codes, and that a prior 
clinical labor task was split into two of the new clinical labor 
activity codes: CA007 (Review patient clinical extant information and 
questionnaire) in the preservice period, and CA014 (Confirm order, 
protocol exam) in the service period. Commenters stated that the same 
clinical labor from the old PE worksheet was now divided into the CA007 
and CA014 activity codes, with a standard of 1 minute for each 
activity. We agreed with commenters that we would finalize the RUC-
recommended 2 minutes of clinical labor time for the CA007 activity 
code and 1 minute for the CA014 activity code in situations where this 
was the case. However, when reviewing the clinical labor for the 
reviewed codes affected by this issue, we found that several of the 
codes did not include this old clinical labor task, and we also noted 
that several of the reviewed codes that contained the

[[Page 78832]]

CA014 clinical labor activity code did not contain any clinical labor 
for the CA007 activity. In these situations, we continue to believe 
that in these cases, the 3 total minutes of clinical staff time would 
be more accurately described by the CA013 ``Prepare room, equipment and 
supplies'' activity code, and we finalized these clinical labor 
refinements. For additional details, we direct readers to the 
discussion in the CY 2019 PFS final rule (83 FR 59463 through 59464).
    Following the publication of the CY 2020 PFS proposed rule, one 
commenter expressed concern with the published list of common 
refinements to equipment time. The commenter stated that these 
refinements were the formulaic result of the applying refinements to 
the clinical labor time and did not constitute separate refinements; 
the commenter requested that CMS no longer include these refinements in 
the table published each year. In the CY 2020 PFS final rule, we agreed 
with the commenter that these equipment time refinements did not 
reflect errors in the equipment recommendations or policy discrepancies 
with the RUC's equipment time recommendations. However, we believed 
that it was important to publish the specific equipment times that we 
were proposing (or finalizing in the case of the final rule) when they 
differed from the recommended values due to the effect that these 
changes can have on the direct costs associated with equipment time. 
Therefore, we finalized the separation of the equipment time 
refinements associated with changes in clinical labor into a separate 
table of refinements. For additional details, we direct readers to the 
discussion in the CY 2020 PFS final rule (84 FR 62584).
    Historically, the RUC has submitted a ``PE worksheet'' that details 
the recommended direct PE inputs for our use in developing PE RVUs. The 
format of the PE worksheet has varied over time and among the medical 
specialties developing the recommendations. These variations have made 
it difficult for both the RUC's development and our review of code 
values for individual codes. Beginning with its recommendations for CY 
2019, the RUC has mandated the use of a new PE worksheet for purposes 
of their recommendation development process that standardizes the 
clinical labor tasks and assigns them a clinical labor activity code. 
We believe the RUC's use of the new PE worksheet in developing and 
submitting recommendations will help us to simplify and standardize the 
hundreds of different clinical labor tasks currently listed in our 
direct PE database. As we did in previous calendar years, to facilitate 
rulemaking for CY 2024, we are continuing to display two versions of 
the Labor Task Detail public use file: one version with the old listing 
of clinical labor tasks, and one with the same tasks crosswalked to the 
new listing of clinical labor activity codes. These lists are available 
on the CMS website under downloads for the CY 2024 PFS final rule at 
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
b. Updates to Prices for Existing Direct PE Inputs
    In the CY 2011 PFS final rule with comment period (75 FR 73205), we 
finalized a process to act on public requests to update equipment and 
supply price and equipment useful life inputs through annual 
rulemaking, beginning with the CY 2012 PFS proposed rule. Beginning in 
CY 2019 and continuing through CY 2022, we conducted a market-based 
supply and equipment pricing update, using information developed by our 
contractor, StrategyGen, which updated pricing recommendations for 
approximately 1,300 supplies and 750 equipment items currently used as 
direct PE inputs. Given the potentially significant changes in payment 
that would occur, in the CY 2019 PFS final rule we finalized a policy 
to phase in our use of the new direct PE input pricing over a 4-year 
period using a 25/75 percent (CY 2019), 50/50 percent (CY 2020), 75/25 
percent (CY 2021), and 100/0 percent (CY 2022) split between new and 
old pricing. We believed that implementing the proposed updated prices 
with a 4-year phase-in would improve payment accuracy, while 
maintaining stability and allowing interested parties the opportunity 
to address potential concerns about changes in payment for particular 
items. This 4-year transition period to update supply and equipment 
pricing concluded in CY 2022; for a more detailed discussion, we refer 
readers to the CY 2019 PFS final rule with comment period (83 FR 59473 
through 59480).
    For CY 2024, we proposed to update the price of 16 supplies and two 
equipment items in response to the public submission of invoices 
following the publication of the CY 2023 PFS final rule. The 16 supply 
and equipment items with proposed updated prices were listed in the 
valuation of specific codes section of the preamble under Table 15, CY 
2024 Invoices Received for Existing Direct PE Inputs (88 FR 52348).
    We did not propose to update the price of another eleven supplies 
which were the subject of public submission of invoices. Our rationale 
for not updating these prices is detailed below:
     Extended external ECG patch, medical magnetic tape 
recorder (SD339): We received additional invoices for the SD339 supply 
from an interested party. Upon review of the invoices, we determined 
that they contained the identical price point that we previously 
incorporated into last year's rule when we finalized a price of $260.35 
for the supply item (87 FR 69514 through 69516). Since these invoices 
did not contain any new information, we stated in the proposed rule 
that we are maintaining the previously finalized price of $260.35 for 
the SD339 supply.
     Permanent marking pen (SL477), Liquid coverslip (Ventana 
650-010) (SL479), EZ Prep (10X) (Ventana 950-102) (SL481), Cell 
Conditioning 1 (Ventana 950-124) (SL482), and Hematoxylin II (Ventana 
790-2208) (SL483): We received invoices from interested parties for use 
in updating the price of these laboratory supplies. In each case, 
however, we were able to find the same supply item available for sale 
online at the current price or cheaper. Therefore, we do not believe 
that the submitted invoices represent typical market pricing for these 
supplies and we did not propose to update their prices.
     Mask, surgical (SB033), scalpel with blade, surgical (#10-
20) (SF033), eye shield, non-fog (SG049), gauze, non-sterile 4in x 4in 
(SG051), and towel, paper (Bounty) (per sheet) (SK082): We received 
invoices from interested parties for use in updating the price of these 
common supply items. In each case, we received a single invoice and 
once again we were able to find the same supply items available for 
sale online at the current price or cheaper. Generally speaking, we 
avoid updating the price for common supply items like the SB033 
surgical mask (included in approximately 380 HCPCS codes) based on the 
submission of a single invoice, as an invoice unrepresentative of 
current market pricing will have far-reaching effects across the PFS. 
We did not find that the typical price for a surgical mask had 
increased by more than 60 percent since the supply and equipment 
pricing update concluded in CY 2022, and as such we stated in the 
proposed rule that we are maintaining the current price for these 
supply items.

[[Page 78833]]

    We received the following comments on our proposed updates to 
supply and equipment pricing:
    Comment: Several commenters stated that they supported the proposed 
pricing updates of the following supplies and equipment items: SC084, 
SC085, SM008, SL491, EP034, EP111, SA110, SL077, SL495, SL475, SL488, 
SL474, and SL486. The commenters urged CMS to finalize the updates as 
proposed.
    Response: We appreciate the support for our proposed pricing from 
the commenters.
    Comment: A commenter stated that they had submitted invoices during 
the pre-rulemaking period, in February 2023, to support CMS with 
identifying the appropriate direct PE inputs for equipment and supplies 
used in physician pathology services. The commenter listed ten supply 
and equipment items with updated pricing in the proposed rule (EP034, 
EP111, SA110, SL077, SL474, SL475, SL486, SL488, SL491, SL495) and 
stated that they supported the proposed pricing changes for these items 
and urged CMS to finalize them as proposed in the final rule.
    Response: We appreciate the support for our proposed pricing from 
the commenter.
    Comment: Several commenters stated that they appreciated CMS' 
conclusion that the current price of $260.35 should be maintained for 
supply item SD339 (extended external ECG patch, medical magnetic tape 
recorder) for CY 2024. The commenters stated that the proposed pricing 
represented much-needed payment stability for providers of the long 
term electrocardiographic (LT-ECG) monitoring service and it was in the 
best interest of Medicare beneficiaries for CMS to support continued 
patient access to these services through the maintenance of fair and 
stable provider reimbursement.
    Response: We appreciate the support for our proposed pricing from 
the commenters.
    Comment: A commenter submitted approximately 50 invoices with the 
intention of persuading CMS to update the pricing for the Tubing set, 
blood warmer (SC084) and Tubing set, plasma exchange (SC085) supplies. 
The commenter stated that these invoices were based on sales to U.S. 
customers in June and July 2023 and requested that CMS update their 
prices to reflect the data contained on the invoices.
    Response: We appreciate the large quantity of pricing data provided 
by the commenter for use in updating the pricing of the SC084 and SC085 
supplies. After reviewing the invoices, we agree with the commenter 
that the Tubing set, blood warmer (SC084) supply is more accurately 
priced at $16.27 and the Tubing set, plasma exchange (SC085) supply is 
more accurately priced at $277.20. We are finalizing these updated 
prices based on the market-based pricing contained in this large sample 
of submitted invoices.
    The following are additional comments that we received associated 
with supply and equipment pricing:
    Comment: A commenter stated that the non-facility reimbursement is 
significantly undervalued for CPT code 36836 (Percutaneous 
arteriovenous fistula creation, upper extremity, single access of both 
the peripheral artery and peripheral vein, including fistula maturation 
procedures (e.g., transluminal balloon angioplasty, coil embolization) 
when performed, including all vascular access, imaging guidance and 
radiologic supervision and interpretation). The commenter stated that 
an angiography room (EL011) should be included in the equipment item 
inputs for CPT code 36836, since it is included in CPT code 36837, 
instead of the current vascular ultrasound room (EL016). The commenter 
also stated that CMS should update the pricing for the Ellipsys 
Vascular Access Catheter (SD351) supply item as the price of $6,000 is 
not representative of the current cost of the device. The commenter 
submitted approximately 70 invoices with the intention of persuading 
CMS to update the pricing for the SD351 supply to $7,378.75.
    Response: We disagree with the commenter that the use of an 
angiography room would be more typical than the use of a vascular 
ultrasound room for CPT code 36837; the vascular ultrasound room was 
recommended by the RUC and finalized by CMS in CY 2023 rulemaking (87 
FR 69485 through 69489). However, we appreciate the submission of a 
large quantity of pricing data provided by the commenter for use in 
updating the pricing of the SD351 supply. We previously wrote in CY 
2023 rulemaking that we were concerned that the submission of a single 
invoice would represent an increase from $6,000 to $8,950 for the SD351 
supply, an extraordinary increase in the span of 6 months since the 
service was reviewed at the January 2022 RUC meeting, and that we would 
consider supply pricing in future updates to this service.
    With the much larger batch of invoice data supplied by the 
commenter, it is clear that the Ellipsys Vascular Access Catheter 
(SD351) supply item has a bimodal pricing structure, with almost 
exactly half of the submitted invoices listed at the current price of 
$6,000 while the other half were priced at $8,950. Based on this 
updated pricing data, we therefore agree that the commenter's suggested 
price change to $7,378.75 is an appropriate update to the price of the 
SD351 supply as it falls between the two poles of the pricing 
distribution. We are finalizing this update to the price of the SD351 
supply to more accurately reflect the typical market price.
    Comment: A commenter submitted a series of approximately 100 
invoices for use in pricing a new supply item known as the WatchPAT One 
device. The commenter stated that this was a separate supply from the 
WatchPAT pneumo-opt slp probes (SD263) item currently listed in the CMS 
supply database priced at $73.32. The commenter detailed the clinical 
benefits associated with the WatchPAT One device and provided to CMS 
copies of purchase invoices reflecting sales of approximately 3,000 
units across all geographic regions of the country to support the 
commenter's requested value of $98.20 for the supply item.
    Response: We appreciate the submission of this large quantity of 
pricing data associated with the WatchPAT One device. Although there 
are no HCPCS codes that currently include the WatchPAT One device as a 
supply item, we will add the WatchPAT One device to our supply database 
with its own supply code (SD362) at the requested price of $98.20 so 
that it can be used in future reviews of services that typically make 
use of this product.
    Comment: A commenter stated that there are numerous discrepancies 
between the aggregated cost of some of the supply packs and the 
individual item components contained within. The commenter stated that 
these mathematical errors should be rectified as soon as possible by 
CMS to ensure that the sum correctly matches the totals from the 
individual items, and the commenter recommended that CMS resolve these 
pricing discrepancies in the supply packs during CY 2024 rulemaking. 
The commenter submitted RUC workgroup recommendations to update pricing 
for a series of supply packs along with their comment letter.
    Response: We appreciate the additional information and RUC 
workgroup recommendations provided by the commenter regarding 
discrepancies in the aggregated cost of some supply packs. However, due 
to the projected significant cost revisions in the pricing of supply 
packs, and because we did not propose to address supply pack pricing in 
the CY 2024 proposed

[[Page 78834]]

rule, we believe that this issue would be better addressed in future 
rulemaking. For example, the cleaning and disinfecting endoscope pack 
(SA042) is included as a supply input in more than 300 HCPCS codes 
which could have a sizable impact on the overall valuation of these 
services, and which was not incorporated into the proposed RVUs 
published for the CY 2024 proposed rule. We believe that interested 
parties will be better served if CMS addresses this topic in a 
comprehensive manner during a potential future rulemaking in which 
commenters could provide feedback in response to proposed pricing 
updates.
    Comment: A commenter reviewed the issue of skin adhesives and 
identified several generic alternatives to the use of the skin adhesive 
(Dermabond) (SG007) supply. The commenter stated that there are 
multiple skin adhesive products, at different price points, available 
that work similarly to Dermabond and requested that generic 
alternatives should be used overall in place of brand names in the CMS 
supply database. The commenter made a series of suggestions for CMS to 
create new medical supply item codes to encompass the generic 
formulations of cyanoacrylate skin adhesive in multidose form and 
single use sterile application.
    Response: We note that these revisions to the skin adhesive 
supplies were incorporated into the recommendations from the April 2023 
RUC meeting where several skin adhesive procedures were reviewed. As we 
stated with respect to the pricing of supply packs above, we believe 
that this issue would be better addressed in a potential future 
rulemaking, for example as part of the RUC review of these skin 
adhesive procedures for the upcoming CY 2025 cycle. This would allow 
CMS to make any potential revisions to the skin adhesive supplies while 
the HCPCS codes in question are also under formal review to minimize 
disruption to existing services.
    Comment: Several commenters recommended that CMS separately 
identify and pay for high-cost disposable supplies. Commenters stated 
that this would address the outsized impact that high-cost disposable 
supplies have within the current PE RVU methodology; if high cost 
supplies were paid separately with appropriate HCPCS codes, their 
indirect expense would no longer be associated with that service. 
Commenters stated that the result would be that indirect PE RVUs would 
be redistributed throughout the specialty PE pool and the PE for all 
other services. Commenters recommended that CMS separately identify and 
pay for high-cost disposable supplies priced more than $500 using 
appropriate HCPCS codes.
    Response: We have received a number of prior requests from 
interested parties, including the RUC, to implement separately billable 
alpha-numeric Level II HCPCS codes to allow practitioners to be paid 
the cost of high cost disposable supplies per patient encounter instead 
of per CPT code. We stated at the time, and we continue to believe, 
that this option presents a series of potential problems that we have 
addressed previously in the context of the broader challenges regarding 
our ability to price high cost disposable supply items. (For a 
discussion of this issue, we direct the reader to our discussion in the 
CY 2011 PFS final rule with comment period (75 FR 73251)).
    After consideration of the comments, we are finalizing updates to 
the pricing of the supply and equipment items as listed in Table 17 and 
detailed above. These supply and equipment items with updated prices 
are listed in the valuation of specific codes section of the preamble 
under Table 17, CY 2024 Invoices Received for Existing Direct PE 
Inputs.
(1) Invoice Submission
    We remind readers that we routinely accept public submission of 
invoices as part of our process for developing payment rates for new, 
revised, and potentially misvalued codes. Often these invoices are 
submitted in conjunction with the RUC-recommended values for the codes. 
To be included in a given year's proposed rule, we generally need to 
receive invoices by the same February 10th deadline we noted for 
consideration of RUC recommendations. However, we will consider 
invoices submitted as public comments during the comment period 
following the publication of the PFS proposed rule and would consider 
any invoices received after February 10th or outside of the public 
comment process as part of our established annual process for requests 
to update supply and equipment prices. Interested parties are 
encouraged to submit invoices with their public comments or, if outside 
the notice and comment rulemaking process, via email at 
[email protected].
c. Clinical Labor Pricing Update
    Section 220(a) of the PAMA provides that the Secretary may collect 
or obtain information from any eligible professional or any other 
source on the resources directly or indirectly related to furnishing 
services for which payment is made under the PFS, and that such 
information may be used in the determination of relative values for 
services under the PFS. Such information may include the time involved 
in furnishing services; the amounts, types, and prices of PE inputs; 
overhead and accounting information for practices of physicians and 
other suppliers, and any other elements that would improve the 
valuation of services under the PFS.
    Beginning in CY 2019, we updated the supply and equipment prices 
used for PE as part of a market-based pricing transition; CY 2022 was 
the final year of this 4-year transition. We initiated a market 
research contract with StrategyGen to conduct an in-depth and robust 
market research study to update the supply and equipment pricing for CY 
2019, and we finalized a policy in CY 2019 to phase in the new pricing 
over a period of 4 years. However, we did not propose to update the 
clinical labor pricing, and the pricing for clinical labor has remained 
unchanged during this pricing transition. Clinical labor rates were 
last updated for CY 2002 using Bureau of Labor Statistics (BLS) data 
and other supplementary sources where BLS data were not available; we 
refer readers to the full discussion in the CY 2002 PFS final rule for 
additional details (66 FR 55257 through 55262).
    Interested parties raised concerns that the long delay since 
clinical labor pricing was last updated created a significant disparity 
between CMS' clinical wage data and the market average for clinical 
labor. In recent years, a number of interested parties suggested that 
certain wage rates were inadequate because they did not reflect current 
labor rate information. Some interested parties also stated that 
updating the supply and equipment pricing without updating the clinical 
labor pricing could create distortions in the allocation of direct PE. 
They argued that since the pool of aggregated direct PE inputs is 
budget neutral, if these rates are not routinely updated, clinical 
labor may become undervalued over time relative to equipment and 
supplies, especially since the supply and equipment prices are in the 
process of being updated. There was considerable interest among 
interested parties in updating the clinical labor rates, and when we 
solicited comment on this topic in past rules, such as in the CY 2019 
PFS final rule (83 FR 59480), interested parties supported the idea.
    Therefore, we proposed to update the clinical labor pricing for CY 
2022, in conjunction with the final year of the supply and equipment 
pricing update (86 FR 39118 through 39123). We

[[Page 78835]]

believed it was important to update the clinical labor pricing to 
maintain relativity with the recent supply and equipment pricing 
updates. We proposed to use the methodology outlined in the CY 2002 PFS 
final rule (66 FR 55257), which draws primarily from BLS wage data, to 
calculate updated clinical labor pricing. As we stated in the CY 2002 
PFS final rule, the BLS' reputation for publishing valid estimates that 
are nationally representative led to the choice to use the BLS data as 
the main source. We believe that the BLS wage data continues to be the 
most accurate source to use as a basis for clinical labor pricing and 
this data will appropriately reflect changes in clinical labor resource 
inputs for purposes of setting PE RVUs under the PFS. We used the most 
current BLS survey data (2019) as the main source of wage data for our 
CY 2022 clinical labor proposal.
    We recognized that the BLS survey of wage data does not cover all 
the staff types contained in our direct PE database. Therefore, we 
crosswalked or extrapolated the wages for several staff types using 
supplementary data sources for verification whenever possible. In 
situations where the price wages of clinical labor types were not 
referenced in the BLS data, we used the national salary data from the 
Salary Expert, an online project of the Economic Research Institute 
that surveys national and local salary ranges and averages for 
thousands of job titles using mainly government sources. (A detailed 
explanation of the methodology used by Salary Expert to estimate 
specific job salaries can be found at www.salaryexpert.com). We 
previously used Salary Expert information as the primary backup source 
of wage data during the last update of clinical labor pricing in CY 
2002. If we did not have direct BLS wage data available for a clinical 
labor type, we used the wage data from Salary Expert as a reference for 
pricing, then crosswalked these clinical labor types to a proxy BLS 
labor category rate that most closely matched the reference wage data, 
similar to the crosswalks used in our PE/HR allocation. For example, 
there is no direct BLS wage data for the Mammography Technologist 
(L043) clinical labor type; we used the wage data from Salary Expert as 
a reference and identified the BLS wage data for Respiratory Therapists 
as the best proxy category. We calculated rates for the ``blend'' 
clinical labor categories by combining the rates for each labor type in 
the blend and then dividing by the total number of labor types in the 
blend.
    As in the CY 2002 clinical labor pricing update, the proposed cost 
per minute for each clinical staff type was derived by dividing the 
average hourly wage rate by 60 to arrive at the per minute cost. In 
cases where an hourly wage rate was not available for a clinical staff 
type, the proposed cost per minute for the clinical staff type was 
derived by dividing the annual salary (converted to 2021 dollars using 
the Medicare Economic Index) by 2080 (the number of hours in a typical 
work year) to arrive at the hourly wage rate and then again by 60 to 
arrive at the per minute cost. We ultimately finalized the use of 
median BLS wage data, as opposed to mean BLS wage data, in response to 
comments in the CY 2022 PFS final rule. To account for the employers' 
cost of providing fringe benefits, such as sick leave, we finalized the 
use of a benefits multiplier of 1.296 based on a BLS release from June 
17, 2021 (USDL-21-1094). As an example of this process, for the 
Physical Therapy Aide (L023A) clinical labor type, the BLS data 
reflected a median hourly wage rate of $12.98, which we multiplied by 
the 1.296 benefits modifier and then divided by 60 minutes to arrive at 
the finalized per-minute rate of $0.28.
    After considering the comments on our CY 2022 proposals, we agreed 
with commenters that the use of a multi-year transition would help 
smooth out the changes in payment resulting from the clinical labor 
pricing update, avoiding potentially disruptive changes in payment for 
affected interested parties, and promoting payment stability from year-
to-year. We believed it would be appropriate to use a 4-year 
transition, as we have for several other broad-based updates or 
methodological changes. While we recognized that using a 4-year 
transition to implement the update means that we will continue to rely 
in part on outdated data for clinical labor pricing until the change is 
fully completed in CY 2025, we agreed with the commenters that these 
significant updates to PE valuation should be implemented in the same 
way, and for the same reasons, as for other major updates to pricing 
such as the recent supply and equipment update. Therefore, we finalized 
the implementation of the clinical labor pricing update over 4 years to 
transition from current prices to the final updated prices in CY 2025. 
We finalized the implementation of this pricing transition over 4 
years, such that one quarter of the difference between the current 
price and the fully phased-in price is implemented for CY 2022, one 
third of the difference between the CY 2022 price and the final price 
is implemented for CY 2023, and one half of the difference between the 
CY 2023 price and the final price is implemented for CY 2024, with the 
new direct PE prices fully implemented for CY 2025. (86 FR 65025) An 
example of the transition from the current to the fully-implemented new 
pricing that we finalized in the CY 2022 PFS final rule is provided in 
Table 5.
[GRAPHIC] [TIFF OMITTED] TR16NO23.005

(1) CY 2023 Clinical Labor Pricing Updates
    For CY 2023, we received information from one interested party 
regarding the pricing of the Histotechnologist (L037B) clinical labor 
type. The interested party provided data from the 2019 Wage Survey of 
Medical Laboratories which supported an increase in the per-minute rate 
from the $0.55 finalized in the CY 2022 PFS final rule to $0.64. This 
rate of $0.64 for the L037B clinical labor type is a close match to the 
online salary data that we had for the Histotechnologist and matches 
the $0.64

[[Page 78836]]

rate that we initially proposed for L037B in the CY 2022 PFS proposed 
rule. Based on the wage data provided by the commenter, we proposed 
this $0.64 rate for the L037B clinical labor type for CY 2023; we also 
proposed a slight increase in the pricing for the Lab Tech/
Histotechnologist (L035A) clinical labor type from $0.55 to $0.60 as it 
is a blend of the wage rate for the Lab Technician (L033A) and 
Histotechnologist clinical labor types. We also proposed the same 
increase to $0.60 for the Angio Technician (L041A) clinical labor type, 
as we previously established a policy in the CY 2022 PFS final rule 
that the pricing for the L041A clinical labor type would match the rate 
for the L035A clinical labor type (86 FR 65032).
    Based on comments received on the CY 2023 proposed rule, we 
finalized a change in the descriptive text of the L041A clinical labor 
type from ``Angio Technician'' to ``Vascular Interventional 
Technologist''. We also finalized an update in the pricing of three 
clinical labor types: from $0.60 to $0.84 for the Vascular 
Interventional Technologist (L041A), from $0.63 to $0.79 for the 
Mammography Technologist (L043A), and from $0.76 to $0.78 for the CT 
Technologist (L046A) based on submitted wage data from the 2022 
Radiologic Technologist Wage and Salary Survey (87 FR 69422 through 
69425).
(2) CY 2024 Clinical Labor Pricing Update Proposals
    We did not receive new wage data or other additional information 
for use in clinical labor pricing from interested parties prior to the 
publication of the CY 2024 PFS proposed rule. Therefore, our proposed 
clinical labor pricing for CY 2024 was based on the clinical labor 
pricing that we finalized in the CY 2023 PFS final rule, incremented an 
additional step for Year 3 of the update:
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[[Page 78838]]


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BILLING CODE 4120-01-C
    As was the case for the market-based supply and equipment pricing 
update, the clinical labor rates will remain open for public comment 
over the course of the 4-year transition period. We updated the pricing 
of a number of clinical labor types in the CY 2022 and CY 2023 PFS 
final rules in response to information provided by commenters. For the 
full discussion of the clinical labor pricing update, we direct readers 
to the CY 2022 PFS final rule (86 FR 65020 through 65037).
    We received the following comments on our clinical labor pricing 
update proposals for CY 2024:
    Comment: Several commenters stated that CMS created a rank order 
anomaly in the pricing of the cytotechnologist (L045A) clinical labor 
type when it increased the clinical labor rates for the vascular 
interventional technologist (L041A), mammography technologist (L043A), 
and CT technologist (L046A) in CY 2023. The commenters stated that the 
education requirements for a cytotechnologist were greater than the 
requirements for these clinical labor types and that the 
cytotechnologist should be valued 10 percent more than the CT 
technologist based on Salary Expert data. Commenters stated that 
cytotechnologists are responsible for more intensive clinical 
responsibilities than MRI technologists, such as preparing and 
evaluating human cellular samples from all body sites, to detect and 
highlight for the pathologist's attention cells with pre-cancerous 
changes, cancer cells, benign tumors, infectious agents, and 
inflammatory processes. Commenters requested that CMS crosswalk the 
cytotechnologist clinical labor type to the BLS 29-9092 category 
(genetic counselors) at a rate of $0.85 to correct this pricing anomaly 
and supported their request with data from the 2021 American Society of 
Clinical Pathologists (ASCP) Wage Survey of Medical Laboratories, in 
which the average cost per minute for cytotechnologists was $0.86.
    Response: We appreciate the additional information surrounding the 
cytotechnologist (L045A) clinical labor type supplied by the 
commenters, especially the 2021 ASCP wage survey containing wage data 
on this clinical labor type. After reviewing the information submitted 
by the commenters, we concur that a crosswalk to the BLS 29-9092 
category at a rate of $0.85 would be more accurate for the L045A 
clinical labor type, based on the wage data provided by Salary Expert 
and the 2021 ASCP wage survey. We are finalizing this update in the 
clinical labor pricing of the L045A clinical labor type from $0.76 to 
$0.85 based on this new information.
    Comment: Several commenters expressed their disagreement with the 
ongoing clinical labor pricing update. Commenters stated that the 
pricing update continued to apply a huge and unfair burden on 
specialties that require expensive supplies and/or equipment to care 
for their patients, and that while the increase in clinical labor 
pricing was appropriate, it was not appropriate that some physicians 
were negatively impacted by the change. Commenters stated that these 
dramatic cuts will also further exacerbate disparities in access to 
care and health outcomes, among rural and minority populations, by 
constraining and in some cases preventing physicians in community-based 
office settings from providing critical patient care to underserved 
populations. Commenters asked CMS to hold harmless the specialties that 
were most affected by the clinical labor pricing update and not move 
forward with the third year of the phase-in. One commenter disagreed 
with the finalized BLS 2021 benefit multiplier of 1.296 and stated that 
CMS should use the originally proposed 1.366 benefits multiplier 
instead.
    Response: We finalized the implementation of the clinical labor 
pricing update 2 years ago in the CY 2022 PFS final rule (86 FR 65020 
through 65037) where we previously addressed these same comments. As we 
stated at that time, although we recognize that payment for some 
services will be reduced because of the pricing update, due to the 
budget neutrality requirements of the PFS, we do not believe that this 
is a reason to refrain from updating clinical labor pricing to reflect 
changes in resource costs over time. The PFS is a resource-based 
relative value payment system that necessarily relies on accuracy in 
the pricing of resource inputs; continuing to use clinical labor cost 
data that are nearly 2 decades old would maintain distortions in 
relativity that undervalue many services which involve a higher 
proportion of clinical labor. As noted above, we also finalized the 
implementation of the pricing update through a 4-year transition to 
help address the concerns of the commenters about stabilizing RVUs and 
reducing large fluctuations in year-to-year payments.
    For CY 2024, we solicited comments regarding new wage data or other 
additional information for use in clinical labor pricing from 
interested parties. The clinical labor pricing update itself, including 
its pricing methodology, was previously finalized through rulemaking 
and the first 2 years of the 4-year transition have already been 
implemented; as such, these comments are out of scope for CY 2024 
rulemaking.
    After consideration of the comments, we are finalizing the clinical 
labor prices as shown in Table 7; aside from the Cytotechnologist 
(L045A) clinical labor type detailed above, all other clinical labor 
pricing remains unchanged from the proposed rule.
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[[Page 78839]]

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[[Page 78840]]


[GRAPHIC] [TIFF OMITTED] TR16NO23.009

BILLING CODE 4120-01-C
    As was the case for the market-based supply and equipment pricing 
update, the clinical labor rates will remain open for public comment 
over the remaining course of the 4-year transition period. We welcome 
additional feedback on clinical labor pricing from commenters in next 
year's rulemaking cycle, especially any data that will continue to 
improve the accuracy of our finalized pricing.
d. Technical Corrections to Direct PE Input Database and Supporting 
Files
    Following the publication of the CY 2023 PFS proposed rule, an 
interested party notified CMS that CPT code 86153 (Cell enumeration 
using immunologic selection and identification in fluid specimen (e.g., 
circulating tumor cells in blood); physician interpretation and report, 
when required) appeared to be missing its work time in the Physician 
Work Time public use file. We reviewed the request from the interested 
party and determined that this was indeed an unintended technical 
error; we stated in the CY 2013 PFS final rule that we were finalizing 
0 minutes pre-service time, 20 minutes intraservice time, and 0 minutes 
post-service time to CPT code 86153 (77 FR 69059); however, work time 
was inadvertently completely missing for this code. Therefore, we 
proposed to add the correct 20 minutes of intraservice work time to CPT 
code 86153 for CY 2024.
    Comment: A commenter stated that they agreed with the correction of 
this error and urged CMS to finalize the update of 20 minutes of intra 
service work time for CPT code 86153.
    Response: We appreciate the support for our proposal from the 
commenter. We received no other comments regarding this proposal, and 
we are finalizing the addition of the correct 20 minutes of 
intraservice work time to CPT code 86153 for CY 2024, as proposed.
    We received the following comments on technical corrections to the 
direct PE input database and supporting files:
    Comment: A commenter stated that transcatheter valve procedures are 
extremely technical in nature and require a highly functional multi-
disciplinary surgical and operating room team, which was not reflected 
in the indicators currently assigned to certain Category III codes 
associated with this service. The commenter stated that these Category 
III codes should have their assistant surgeon, co-surgeon, and team 
surgeon indicators match CPT codes 33418 and 33419. Specifically, the 
commenter requested that CMS change the assistant surgeon payment 
policy indicator from ``0'' to ``2'' for the following transcatheter 
valve CPT codes: 0483T, 0544T, 0545T, 0569T, 0570T and 0646T; change 
the co-surgeon payment policy indicator from ``0'' to ``1'' for 
transcatheter valve CPT codes 0544T, 0545T, 0569T and 0570T, and to 
``2'' for CPT code 0646T; and change the team surgeon payment policy 
indicator from ``0'' to ``1'' for CPT code 0646T.
    Response: We appreciate the feedback from the commenter regarding 
the need for greater consistency in the indicators for these Category 
III transcatheter valve procedures. After reviewing the request from 
the commenter, we concur that these Category III codes should match the 
assistant surgeon, co-surgeon, and team surgeon indicators for CPT 
codes 33418 and 33419 which had a national coverage determination 
released to this effect in 2014 and 2015 (see https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/MM9002.pdf). 
Therefore, we are finalizing the indicator changes requested by the 
commenter in the previous paragraph.
    Comment: Several commenters raised the topic of indirect PE 
allocation for the home PT/INR monitoring services described by HCPCS 
codes G0248 and G0249. Commenters stated their appreciation that CMS 
acknowledged their concerns about the lack of a specialty designation 
that accurately reflects the indirect costs of home PT/INR monitoring 
suppliers in the CY 2021 PFS rulemaking cycle and agreed to update the 
indirect factors for home PT/INR monitoring by crosswalking to the 
General Practice Specialty (85 FR 84477 through 84478). Commenters 
stated that proposed policies in the CY 2023 PFS rule completely 
negated the limited benefit from this crosswalk to General Practice, 
and they again appreciated that CMS changed the crosswalk for PT/INR 
suppliers to the All Physician specialty which more closely reflected 
indirect-to-direct cost ratios for home PT/INR monitoring services (87 
FR 69417 through 69419). Commenters noted that CMS did not propose any 
changes in the crosswalk for these services and requested that the 
crosswalk remain as previously finalized for CY 2024.
    Response: As the commenters noted, we did not propose any changes 
to the specialty crosswalk for indirect PE allocation for home PT/INR 
monitoring services and we are not finalizing any changes to the 
crosswalk for PT/INR monitoring services. Nevertheless, we appreciate 
the support from the commenters for our previously finalized policies.
    Comment: A commenter questioned the proposed PE RVU for CPT code 
97610 (Low frequency, non-contact, non-thermal ultrasound, including 
topical application(s), when performed, wound assessment, and 
instruction(s) for ongoing care, per day) in the nonfacility setting. 
The commenter stated that the proposed reduction was an unfair decrease 
that was specific only to CPT code 97610 when other clinically similar 
CPT wound care codes were not similarly reduced. The commenter 
requested that the nonfacility PE RVU for CPT code 97610 be reviewed 
for accuracy and increased

[[Page 78841]]

to match its previous valuation for CY 2024.
    Response: We reviewed CPT code 97610 in response to the commenter's 
concerns and we can confirm that there are no technical errors 
affecting the valuation of this code. We did not make any specific 
proposals regarding CPT code 97610 for CY 2024; however, the valuation 
for this code is being affected by the ongoing clinical labor pricing 
transition. Supply costs make up 94.5 percent of the direct PE inputs 
for CPT code 97610 and, as a result, the increased pricing for clinical 
labor across all services on the PFS translates into a lower valuation 
for CPT code 97610, after budget neutrality is applied to the PE. For 
additional information on this topic, we direct readers to the extended 
discussion of the clinical labor pricing update in the CY 2022 final 
rule (86 FR 65020 through 65037).
    Comment: A commenter stated that StrategyGen's market-based supply 
and equipment research contained numerous flaws in how it arrived at 
the cost of the external counterpulsation (ECP) system (EQ012) used in 
HCPCS code G0166 (External counterpulsation, per treatment session) for 
CY 2021. The commenter stated that they appreciated CMS' assistance in 
recent years to correct some of these errors, but the continued phase-
in of PE RVU decreases associated with equipment costs, as well as the 
clinical labor pricing updates adversely impacting services with high 
capital expenses, continued to place incredible stress on the 
reimbursement for ECP therapy. The commenter stated that the 
reimbursement for a full course of therapy has decreased from 2018 to 
2023 by nearly the cost of the routinely purchased supplies necessary 
for delivering this service, and as a result it is no surprise that 
practices that do not specialize in ECP therapy would rather abandon 
the service than continue to pay the expensive system maintenance 
costs.
    Response: We note for the commenter that we did not make any 
proposals specifically regarding HCPCS code G0166 or the EQ012 
equipment for CY 2024 and the commenter did not supply invoices or 
other data to support a change in pricing. If the commenter has reason 
to believe that the EQ012 equipment is inaccurately priced, interested 
parties are encouraged to submit invoices containing pricing data with 
their public comments or, if outside the notice and comment rulemaking 
process, via email at [email protected]. If the 
commenter believes that HCPCS code G0166 may be potentially misvalued, 
we encourage them to consider nominating the code under our potentially 
misvalued process (detailed in section II.C. of this final rule) for 
additional review.
5. Soliciting Public Comment on Strategies for Updates to Practice 
Expense Data Collection and Methodology
a. Background
    The AMA PPIS was first introduced in 2007 as a means to collect 
comprehensive and reliable data on the direct and indirect PEs incurred 
by physicians (72 FR 66222). In considering the use of PPIS data, the 
goal was to improve the accuracy and consistency of PE RVUs used in the 
PFS. The data collection process included a stratified random sample of 
physicians across various specialties, and the survey was administered 
between August 2007 and March 2008. Data points from that period of 
time are integrated into PFS calculations today. In the CY 2009 PFS 
proposed rule (73 FR 38507 through 3850), we discussed the indirect PE 
methodology that used data from the AMA's survey that predated the 
PPIS. In CY 2010 PFS rulemaking, we announced our intent to incorporate 
the AMA PPIS data into the PFS ratesetting process, which would first 
affect the PE RVU. In the CY 2010 PFS proposed rule, we outlined a 4-
year transition period, during which we would phase in the AMA PPIS 
data, replacing the existing PE data sources (74 FR 33554). We also 
explained that our proposals intended to update survey data only (74 FR 
33530 through 33531). In our CY 2010 final rule, we finalized our 
proposal, with minor adjustments based on public comments (74 FR 61749 
through 61750). We responded to the comments we received about the 
transition to using the PPIS to inform indirect PE allocations (74 FR 
61750). In the responses, we acknowledged concerns about potential gaps 
in the data, which could impact the allocation of indirect PE for 
certain physician specialties and suppliers, which are issues that 
remain important today. The CY 2010 PFS final rule explains that 
section 212 of the Balanced Budget Refinement Act of 1999 (BBRA) (Pub. 
L. 106-113, November 29, 1999) directed the Secretary to establish a 
process under which we accept and use, to the maximum extent 
practicable and consistent with sound data practices, data collected or 
developed by entities and organizations to supplement the data we 
normally collect in determining the PE component. BBRA required us to 
establish criteria for accepting supplemental survey data. Since the 
supplemental surveys were specific to individual specialties and not 
part of a comprehensive multispecialty survey, we had required that 
certain precision levels be met in order to ensure that the 
supplemental data was sufficiently valid, and acceptable for use in the 
development of the PE RVUs. At the time, our rationale included the 
assumption that because the PPIS is a contemporaneous, consistently 
collected, and comprehensive multispecialty survey, we do not believe 
similar precision requirements are necessary, and we did not propose to 
establish them for the use of the PPIS data (74 FR 61742). We noted 
potential gaps in the data, which could impact the allocation of 
indirect PE for certain physician and suppliers. The CY 2010 final rule 
adopted the proposal, with minor adjustments based on public comments, 
and explained that these minor adjustments were in part due to non-
response bias that results when the characteristics of survey 
respondents differ in meaningful ways, such as in the mix of practices 
sizes, from the general population (74 FR 61749 through 61750).
    Throughout the 4-year transition period, from CY 2010 to CY 2013, 
we gradually incorporated the AMA PPIS data into the PFS rates, 
replacing the previous data sources. The process involved addressing 
concerns and making adjustments as necessary, such as refining the PFS 
ratesetting methodology in consideration of interested party feedback. 
For background on the refinements that we considered after the 
transition began, we refer readers to discussions in the CY 2011 
through 2014 final rules (75 FR 73178 through 73179; 76 FR 73033 
through 73034; 77 FR 98892; 78 FR 74272 through 74276).
    In the CY 2011 PFS proposed rule, we requested comments on the 
methodology for calculating indirect PE RVUs, explicitly seeking input 
on using survey data, allocation methods, and potential improvements 
(75 FR 40050). In our CY 2011 PFS final rule, we addressed comments 
regarding the methodology for indirect PE calculations, focusing on 
using survey data, allocation methods, and potential improvements (75 
FR 73178 through 73179). We recognized some limitations of the current 
PFS ratesetting methodology but maintained that the approach was the 
most appropriate at the time. In the CY 2012 PFS final rule, we 
responded to comments related to indirect PE methodology, including 
concerns about allocating indirect PE to specific services and using 
the AMA PPIS data for certain specialties (76 FR

[[Page 78842]]

73033 through 73034). We indicated that CMS would continue to review 
and refine the methodology and work with interested parties to address 
their concerns. In the CY PFS 2014 final rule, we responded to comments 
about fully implementing the AMA PPIS data. By 2014, the AMA PPIS data 
had been fully integrated into the PFS, serving as the primary source 
for determining indirect PE inputs (78 FR 74235). We continued to 
review data and the PE methodology annually, considering interested 
party feedback and evaluating the need for updates or refinements to 
ensure the accuracy and relevance of PE RVUs (79 FR 67548). In the 
years following the full implementation of the AMA PPIS data, we 
further engaged with interested parties, thought leaders and subject 
matter experts to improve our PE inputs' accuracy and reliability. For 
further background, we refer readers to our discussions in final rules 
for CY 2016 through 2022 (80 FR 70892; 81 FR 80175; 82 FR 52980 through 
52981; 83 FR 59455 through 59456; 84 FR 62572; 85 FR 84476 through 
84478; 86 FR 62572).
    In our CY 2023 PFS final rule, we issued an RFI to solicit public 
comment on strategies to update PE data collection and methodology (87 
FR 69429 through 69432). We solicited comments on current and evolving 
trends in health care business arrangements, the use of technology, or 
similar topics that might affect or factor into PE calculations. We 
reminded readers that we have worked with interested parties and CMS 
contractors for years to study the landscape and identify possible 
strategies to reshape the PE portion of physician payments. The 
fundamental issues are clear but thought leaders and subject matter 
experts have advocated for more than one tenable approach to updating 
our PE methodology.
    As described in last year's rule, we have continued interest in 
developing a roadmap for updates to our PE methodology that account for 
changes in the health care landscape. Of various considerations 
necessary to form a roadmap for updates, we reiterate that allocations 
of indirect PE continue to present a wide range of challenges and 
opportunities. As discussed in multiple cycles of previous rulemaking, 
our PE methodology relies on AMA PPIS data, which may represent the 
best aggregated available source of information at this time. However, 
we acknowledge the limitations and challenges interested parties have 
raised about using the current data for indirect PE allocations, which 
we have also examined in related ongoing research. We noted in last 
year's rule that there are several competing concerns that CMS must 
take into account when considering updated data sources, which also 
should support and enable ongoing refinements to our PE methodology.
    Many commenters last year asked that CMS wait for the AMA to 
complete a refresh of AMA survey data. We responded to these comments 
by explaining the tension that waiting creates in light of concerns 
raised by other interested parties. Waiting for refreshed survey data 
would result in CMS using data nearly 20 years old to form indirect PE 
inputs to set rates for services on the PFS. We reminded readers that 
many of the critical issues discussed in the background and history 
above are mainly unchanged and possibly would not be addressed by an 
updated survey alone but may also require revisions to the PFS 
ratesetting methodology.
b. Summary of the Comments and Responses for the Request for 
Information
    In the CY 2024 PFS proposed rule, we continued to encourage 
interested parties to provide feedback and suggestions to CMS that give 
an evidentiary basis to shape optimal PE data collection and 
methodological adjustments over time. We stated that submissions should 
discuss the feasibility and burden of implementing any suggested 
adjustments and highlight opportunities to optimize the cadence, 
frequency, and phase-in of resulting adjustments. We stated that we 
were continuing to consider ways that we may engage in dialogue with 
interested parties to better understand how to address possible long-
term policies and methods for PFS ratesetting. We believe some of those 
concerns may be alleviated by having ways to refresh data and make 
transparent how the information affects valuations for services payable 
under the PFS more accurately and precisely.
    Considering our ratesetting methodology and prior experiences 
implementing new data, we issued a follow-up solicitation for general 
information. We solicited comments from interested parties on 
strategies to incorporate information that could address known 
challenges we experienced in implementing the initial AMA PPIS data. 
Our current methodology relies on the AMA PPIS data, legislatively 
mandated supplemental data sources (for, example, we use supplemental 
survey data collected in 2003, as required by section 1848(c)(2)(H)(i) 
of the Act to set rates for oncology and hematology specialties), and 
in some cases crosswalks to allocate indirect PE as necessary for 
certain specialties and provider types.
    We also sought to understand whether, upon completion of the 
updated PPIS data collection effort by the AMA, contingencies or 
alternatives may be necessary and available to address the lack of data 
availability or response rates for a given specialty, set of 
specialties, or specific service suppliers who are paid under the PFS.
    In light of the considerations discussed above, we requested 
feedback on the following:
    (1) If CMS should consider aggregating data for certain physician 
specialties to generate indirect allocators so that PE/HR calculations 
based on PPIS data would be less likely to over-allocate (or under-
allocate) indirect PE to a given set of services, specialties, or 
practice types. Further, what thresholds or methodological approaches 
could be employed to establish such aggregations?
    (2) Whether aggregations of services, for purposes of assigning PE 
inputs, represent a fair, stable and accurate means to account for 
indirect PEs across various specialties or practice types?
    (3) If and how CMS should balance factors that influence indirect 
PE inputs when these factors are likely driven by a difference in 
geographic location or setting of care, specific to individual 
practitioners (or practitioner types) versus other specialty/practice-
specific characteristics (for example, practice size, patient 
population served)?
    (4) What possible unintended consequences may result if CMS were to 
act upon the respondents' recommendations for any of highlighted 
considerations above?
    (5) Whether specific types of outliers or non-response bias may 
require different analytical approaches and methodological adjustments 
to integrate refreshed data?
    We received public comments on this RFI. The following is a summary 
of the comments we received and our responses.
    Comment: Most commenters stated that CMS should defer significant 
changes until the AMA PPIS results become available. In responding to 
our RFI, the AMA RUC provided a set of responses, which many other 
commenters repeated in their separate, individual comments. In summary, 
the AMA RUC letter responds to all five prompts in the RFI with 
rationales that support the assertion that CMS should not consider 
further changes until PPIS data collection and analysis is complete.

[[Page 78843]]

    Response: We thank the AMA RUC for commenting. In totality, the AMA 
comments generally do not support any change to the methodology and 
assert that CMS should wait to consider any further changes until PPIS 
updates become available. Further, we note that through its contractor, 
Mathematica, the AMA secured an endorsement for the PPIS updates from 
each State society, national medical specialty society, and others 
prior to fielding the survey.\1\ We believe the AMA's approach may 
possibly mitigate nonresponse bias, which created challenges using 
previous PPIS data. However, we remain uncertain about whether 
endorsements prior to fielding the survey may inject other types of 
bias in the validity and reliability of the information collected.
---------------------------------------------------------------------------

    \1\ Refer to the AMA's summary of the PPIS, available at https://www.ama-assn.org/system/files/physician-practice-information-survey-summary.pdf.
---------------------------------------------------------------------------

    Comment: Some commenters did not recommend that CMS defer 
significant changes until the AMA PPIS results become available. These 
commenters stated that reliance on the PPIS updates may not improve the 
accuracy and stability of the PE methodology because of the survey 
design, possible implementation challenges, and a possible lack of 
transparency or granularity in resulting datasets.
    Response: We thank commenters for their feedback. We believe it 
remains important to reflect on the challenges with our current 
methodology, and to continue to consider alternatives that improve the 
stability and accuracy of our overall PE methodology. We reiterate our 
discussion summarizing the responses to last year's RFI in the CY 2023 
final rule (refer to 87 FR 69429 through 69432). In last year's RFI, we 
signaled our intent to move to a standardized and routine approach to 
valuation of PE and we solicited feedback. We solicited comment on the 
appropriate instrument, methods, and timing for updating PE data, and 
requested information on any alternatives that would result in more 
predictable results, increased efficiencies, or reduced burdens, for 
subsequent updates in later years CMS continues to seek alternatives 
that use verifiable, more objective data sets in the future to 
supplement or augment survey data used to establish PE RVUs for PFS 
services.
    Comment: Some commenters stated that regardless of whether one 
supports or does not support updating and using updated PPIS data, the 
duration between updates and the expense of fielding a survey 
instrument may promote further market consolidation. Additionally, 
other commenters stated that dependence on the PPIS or survey data in 
general, due to timing and frequency constraints, may continue to 
jeopardize independent practice and discourage fair competition among 
suppliers and providers of services paid under the PFS. These 
commenters assert that if current trends continue, it will result in 
far fewer independent practices and more consolidation before the 
availability of updated survey data, undermining the sampling 
methodology of any survey and the general goals of our PE methodology 
updates.
    Response: We thank commenters for their feedback, and we encourage 
interested parties to continue to engage with us regarding the 
intersection of PE data and these important issues
    Comment: We received a comment co-signed by a broad and varied set 
of interested parties (for example, professional membership 
organizations, vendors, practitioners, health systems) that requested a 
separate RFI. The authors asked that CMS address topics regarding 
machine learning, AI, and software and explore a means outside our 
annual rulemaking cycle, so that CMS may address changes in healthcare 
related to these topics and better account for such changes in payment 
moving forward. Commenters asserted that the rapid pace of innovation 
may require far more significant changes than would be practical to 
address in a given calendar year. The commenters also highlighted the 
AMA's efforts to develop Appendix S of the CPT Manual, which 
establishes a taxonomy for medical AI.
    Response: We remain committed to fostering dialogue with interested 
parties on a variety of PE issues, including how to most appropriately 
incorporate new and evolving technologies in both collection of PE data 
and the PE methodology itself. Further, we acknowledge the efforts of 
the AMA to establish a taxonomy for AI, which was informed by 
engagement with HHS ONC and others (refer to https://www.healthit.gov/sites/default/files/page/2020-02/GettingerModeratorSlidesAIPanelsforONCAnnualMeeting12720Final.pdf). We 
encourage readers to review general resources that provide overviews of 
efforts across HHS that address these topics. Examples include ONC's AI 
Showcase, held in late 2022, available at https://www.healthit.gov/news/events/onc-artificial-intelligence-showcase-seizing-opportunities-and-managing-risks-use-ai and this year's issuance of a notice of 
proposed rulemaking for Health Data, Technology, and Interoperability: 
Certification Program Updates, Algorithm Transparency, and Information 
Sharing (HTI-1), (88 FR 23746); as well as the FDA's Artificial 
Intelligence/Machine Learning (AI/ML)-Based Software as a Medical 
Device (SaMD) Action Plan, available at https://www.fda.gov/media/145022/download and Good Machine Learning Practice for Medical Device 
Development: Guiding Principles, available at https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles.

C. Potentially Misvalued Services Under the PFS

1. Background
    Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a 
periodic review, not less often than every 5 years, of the relative 
value units (RVUs) established under the PFS. Section 1848(c)(2)(K) of 
the Act requires the Secretary to periodically identify potentially 
misvalued services using certain criteria and to review and make 
appropriate adjustments to the relative values for those services. 
Section 1848(c)(2)(L) of the Act also requires the Secretary to develop 
a process to validate the RVUs of certain potentially misvalued codes 
under the PFS, using the same criteria used to identify potentially 
misvalued codes, and to make appropriate adjustments.
    As discussed in section II.E. of this final rule, under Valuation 
of Specific Codes, each year we develop appropriate adjustments to the 
RVUs taking into account recommendations provided by the American 
Medical Association (AMA) Resource-Based Relative Value Scale (RVS) 
Update Committee (RUC), MedPAC, and other interested parties. For many 
years, the RUC has provided us with recommendations on the appropriate 
relative values for new, revised, and potentially misvalued PFS 
services. We review these recommendations on a code-by-code basis and 
consider these recommendations in conjunction with analyses of other 
data, such as claims data, to inform the decision-making process as 
authorized by statute. We may also consider analyses of work time, work 
RVUs, or direct PE inputs using other data sources, such as Department 
of Veteran Affairs (VA), National Surgical Quality Improvement Program 
(NSQIP), the Society for Thoracic Surgeons (STS), and the Merit-based 
Incentive Payment System (MIPS) data. In addition to considering the 
most recently available data, we assess the results of physician 
surveys and

[[Page 78844]]

specialty recommendations submitted to us by the RUC for our review. We 
also considered information provided by other interested parties such 
as from the general medical-related community and the public. We 
conducted a review to assess the appropriate RVUs in the context of 
contemporary medical practice. We note that section 1848(c)(2)(A)(ii) 
of the Act authorizes the use of extrapolation and other techniques to 
determine the RVUs for physicians' services for which specific data are 
not available and requires us to take into account the results of 
consultations with organizations representing physicians who provide 
the services. In accordance with section 1848(c) of the Act, we 
determine and make appropriate adjustments to the RVUs.
    In its March 2006 Report to the Congress (http://www.medpac.gov/docs/default-source/reports/Mar06_Ch03.pdf?sfvrsn=0), MedPAC discussed 
the importance of appropriately valuing physicians' services, noting 
that misvalued services can distort the market for physicians' 
services, as well as for other health care services that physicians 
order, such as hospital services. In that same report, MedPAC 
postulated that physicians' services under the PFS can become misvalued 
over time. MedPAC stated, ``When a new service is added to the 
physician fee schedule, it may be assigned a relatively high value 
because of the time, technical skill, and psychological stress that are 
often required to furnish that service. Over time, the work required 
for certain services would be expected to decline as physicians become 
more familiar with the service and more efficient in furnishing it.'' 
We believe services can also become overvalued when PE costs decline. 
This can happen when the costs of equipment and supplies fall, or when 
equipment is used more frequently than is estimated in the PE 
methodology, reducing its cost per use. Likewise, services can become 
undervalued when physician work increases or PE costs rise.
    As MedPAC noted in its March 2009 Report to Congress (http://www.medpac.gov/docs/default-source/reports/march-2009-report-to-congress-medicare-payment-policy.pdf), in the intervening years since 
MedPAC made the initial recommendations, CMS and the RUC have taken 
several steps to improve the review process. Also, section 
1848(c)(2)(K)(ii) of the Act augments our efforts by directing the 
Secretary to specifically examine, as determined appropriate, 
potentially misvalued services in the following categories:

 Codes that have experienced the fastest growth.
 Codes that have experienced substantial changes in PE.
 Codes that describe new technologies or services within an 
appropriate time-period (such as 3 years) after the relative values are 
initially established for such codes.
 Codes which are multiple codes that are frequently billed in 
conjunction with furnishing a single service.
 Codes with low relative values, particularly those that are 
often billed multiple times for a single treatment.
 Codes that have not been subject to review since 
implementation of the fee schedule.
 Codes that account for the majority of spending under the PFS.
 Codes for services that have experienced a substantial change 
in the hospital length of stay or procedure time.
 Codes for which there may be a change in the typical site of 
service since the code was last valued.
 Codes for which there is a significant difference in payment 
for the same service between different sites of service.
 Codes for which there may be anomalies in relative values 
within a family of codes.
 Codes for services where there may be efficiencies when a 
service is furnished at the same time as other services.
 Codes with high intraservice work per unit of time.
 Codes with high PE RVUs.
 Codes with high cost supplies.
 Codes as determined appropriate by the Secretary.

    Section 1848(c)(2)(K)(iii) of the Act also specifies that the 
Secretary may use existing processes to receive recommendations on the 
review and appropriate adjustment of potentially misvalued services. In 
addition, the Secretary may conduct surveys, other data collection 
activities, studies, or other analyses, as the Secretary determines to 
be appropriate, to facilitate the review and appropriate adjustment of 
potentially misvalued services. This section also authorizes the use of 
analytic contractors to identify and analyze potentially misvalued 
codes, conduct surveys or collect data, and make recommendations on the 
review and appropriate adjustment of potentially misvalued services. 
Additionally, this section provides that the Secretary may coordinate 
the review and adjustment of any RVU with the periodic review described 
in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of 
the Act specifies that the Secretary may make appropriate coding 
revisions (including using existing processes for consideration of 
coding changes) that may include consolidation of individual services 
into bundled codes for payment under the PFS.
2. Progress in Identifying and Reviewing Potentially Misvalued Codes
    To fulfill our statutory mandate, we have identified and reviewed 
numerous potentially misvalued codes as specified in section 
1848(c)(2)(K)(ii) of the Act, and we intend to continue our work 
examining potentially misvalued codes in these areas over the upcoming 
years. As part of our current process, we identify potentially 
misvalued codes for review, and request recommendations from the RUC 
and other public commenters on revised work RVUs and direct PE inputs 
for those codes. The RUC, through its own processes, also identifies 
potentially misvalued codes for review. Through our public nomination 
process for potentially misvalued codes established in the CY 2012 PFS 
final rule with comment period (76 FR 73026, 73058 through 73059), 
other individuals and groups submit nominations for review of 
potentially misvalued codes as well. Individuals and groups may submit 
codes for review under the potentially misvalued codes initiative to 
CMS in one of two ways. Nominations may be submitted to CMS via email 
or through postal mail. Email submissions should be sent to the CMS 
emailbox at [email protected], with the phrase 
``Potentially Misvalued Codes'' and the referencing CPT code number(s) 
and/or the CPT descriptor(s) in the subject line. Physical letters for 
nominations should be sent via the U.S. Postal Service to the Centers 
for Medicare & Medicaid Services, Mail Stop: C4-01-26, 7500 Security 
Blvd., Baltimore, Maryland 21244. Envelopes containing the nomination 
letters must be labeled ``Attention: Division of Practitioner Services, 
Potentially Misvalued Codes.'' Nominations for consideration in our 
next annual rule cycle should be received by our February 10th 
deadline. Since CY 2009, as a part of the annual potentially misvalued 
code review and Five-Year Review process, we have reviewed over 1,700 
potentially misvalued codes to refine work RVUs and direct PE inputs. 
We have assigned appropriate work RVUs and direct PE inputs for these 
services as a result of these reviews. A more detailed

[[Page 78845]]

discussion of the extensive prior reviews of potentially misvalued 
codes is included in the CY 2012 PFS final rule with comment period (76 
FR 73052 through 73055). In the same CY 2012 PFS final rule with 
comment period, we finalized our policy to consolidate the review of 
physician work and PE at the same time, and established a process for 
the annual public nomination of potentially misvalued services.
    In the CY 2013 PFS final rule with comment period (77 FR 68892, 
68896 through 68897), we built upon the work we began in CY 2009 to 
review potentially misvalued codes that have not been reviewed since 
the implementation of the PFS (so-called ``Harvard-valued codes'' \2\). 
In the CY 2019 PFS proposed rule (73 FR 38589), we requested 
recommendations from the RUC to aid in our review of Harvard-valued 
codes that had not yet been reviewed, focusing first on high-volume, 
low intensity codes. In the fourth Five-Year Review of Work RVUs 
proposed rule (76 FR 32410, 32419), we requested recommendations from 
the RUC to aid in our review of Harvard-valued codes with annual 
utilization of greater than 30,000 services. In the CY 2013 PFS final 
rule with comment period, we identified specific Harvard-valued 
services with annual allowed charges that total at least $10,000,000 as 
potentially misvalued. In addition to the Harvard-valued codes, in the 
CY 2013 PFS final rule with comment period we finalized for review a 
list of potentially misvalued codes that have stand-alone PE (codes 
with physician work and no listed work time and codes with no physician 
work that have listed work time). We continue each year to consider and 
finalize a list of potentially misvalued codes that have or will be 
reviewed and revised as appropriate in future rulemaking.
---------------------------------------------------------------------------

    \2\ The research team and panels of experts at the Harvard 
School of Public Health developed the original work RVUs for most 
CPT codes, in a cooperative agreement with the Department of Health 
and Human Services (HHS). Experts from both inside and outside the 
Federal Government obtained input from numerous physician specialty 
groups. This input was incorporated into the initial PFS, which was 
implemented on January 1, 1992.
---------------------------------------------------------------------------

3. CY 2024 Identification and Review of Potentially Misvalued Services
    In the CY 2012 PFS final rule with comment period (76 FR 73058), we 
finalized a process for the public to nominate potentially misvalued 
codes. In the CY 2015 PFS final rule with comment period (79 FR 67548, 
67606 through 67608), we modified this process whereby the public and 
interested parties may nominate potentially misvalued codes for review 
by submitting the code with supporting documentation by February 10th 
of each year. Supporting documentation for codes nominated for the 
annual review of potentially misvalued codes may include the following:
     Documentation in peer reviewed medical literature or other 
reliable data that demonstrate changes in physician work due to one or 
more of the following: technique, knowledge and technology, patient 
population, site-of-service, length of hospital stay, and work time.
     An anomalous relationship between the code being proposed 
for review and other codes.
     Evidence that technology has changed physician work.
     Analysis of other data on time and effort measures, such 
as operating room logs or national and other representative databases.
     Evidence that incorrect assumptions were made in the 
previous valuation of the service, such as a misleading vignette, 
survey, or flawed crosswalk assumptions in a previous evaluation.
     Prices for certain high cost supplies or other direct PE 
inputs that are used to determine PE RVUs are inaccurate and do not 
reflect current information.
     Analyses of work time, work RVU, or direct PE inputs using 
other data sources (for example, VA, NSQIP, the STS National Database, 
and the MIPS data).
     National surveys of work time and intensity from 
professional and management societies and organizations, such as 
hospital associations.
    We evaluate the supporting documentation submitted with the 
nominated codes and assess whether the nominated codes appear to be 
potentially misvalued codes appropriate for review under the annual 
process. In the following year's PFS proposed rule, we publish the list 
of nominated codes and indicate for each nominated code whether we 
agree with its inclusion as a potentially misvalued code. The public 
has the opportunity to comment on these and all other proposed 
potentially misvalued codes. In each year's final rule, we finalize our 
list of potentially misvalued codes.
a. Public Nominations
    In each proposed rule, we seek nominations from the public and from 
interested parties of codes that they believe we should consider as 
potentially misvalued. We receive public nominations for potentially 
misvalued codes by February 10th and we display these nominations on 
our public website, where we include the submitter's name and their 
associated organization for full transparency. We sometimes receive 
submissions for specific, PE-related inputs for codes, and discuss 
these PE-related submissions, as necessary under the Determination of 
PE RVUs section of the rule. We summarize below this year's submissions 
under the potentially misvalued code initiative. For CY 2024, we 
received 10 nominations concerning various codes. The nominations are 
as follows:
(1) CPT Code 59200
    In the CY 2022 PFS proposed rule, an interested party nominated CPT 
code 59200 (Insertion cervical dilator (e.g., laminaria, 
prostaglandin)) (000 zero day global code) as potentially misvalued, 
because the direct PE inputs for this code do not include the supply 
item, Dilapan-S. Previous parties had initially sought to establish a 
Level II HCPCS code for Dilapan-S, but CMS did not find sufficient 
evidence to support that request. The same interested party then 
submitted Dilapan-S to be considered as a practice expense (PE) supply 
input to a Level I CPT code 59200 (86 FR 65045). This year, a different 
interested party nominated CPT code 59200 again, and provided the same 
reasoning as to why this code is potentially misvalued.
    Specifically, the current nominee recommended adding 4 rods of 
Dilapan-S at $80.00 per unit, for a total of $320.00 to this one PE 
supply inputs, as a replacement for the current PE supply item--
laminaria tent (a small rod of dehydrated seaweed that rehydrates, 
absorbing the water from the surrounding tissue). The laminaria tent is 
currently listed at $4.0683 per unit, with a total of 3 units, for a 
total of $12.20. The current nominee stated that Dilapan-S is more 
consistent and reliable, and suggested that it had higher patient 
satisfaction than the laminaria tent, and that it was less likely to 
cause leukocytosis. CPT code 59200 is a relatively low volume code, 
with respect to Medicare claims and, as the nominator stated, this 
service is more typically billed for the Medicaid population, as 
evidenced by 1.3 million Medicaid claims for this service. Medicaid 
programs are able to set their own payment policies, which can be 
different from Medicare payment policies. The current Medicare payment 
for CPT code 59200 in CY 2023 is about $108.10 in the nonfacility/
office setting, which is much less than the typical cost of the 
Dilapan-S supplies requested by the interested party. The requested 4 
rods of Dilapan-S would increase the

[[Page 78846]]

supply costs of CPT code 59200 by a factor of five and represent an 
enormous increase in the direct costs for the service.
    We did not agree that CPT code 59200 was potentially misvalued, and 
we did not agree with interested parties that the use of the Dilapan-S 
supply would be typical for the service. By including the increased 
direct costs of the service ($320.00, the typical cost of four units of 
this supply item, Dilapan-S) in the valuation for this code, the cost 
of this service would expand both Medicare spending and cost sharing 
for any beneficiary who received this service. The cost of Dilapan-S is 
over 19 times higher than the cost of the current supply item 
(laminaria tent) for CPT code 59200. We agreed with the nominator that 
CPT code 59200 was more frequently reported in the Medicaid population, 
and therefore, we suggested that interested parties submit a request 
for new and separate Medicaid payments to Medicaid.
    While we did not propose to consider CPT code 59200 as potentially 
misvalued for CY 2024, we solicited comments on this code. 
Specifically, we asked commenters whether the absence of supply item 
Dilapan-S makes the nonfacility/office Medicare payment for this code 
potentially misvalued.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Several commenters suggested replacing the laminaria tent 
supply item with Dilapan-S, both of which are used to dilate the cervix 
in preparation for the induction of labor. Commenters stated that the 
code and supply input pricing for CPT code 59200 are both outdated 
since the service has evolved and the prices for its PE and supply 
items have increased since the code was last reviewed in 2003. One 
commenter noted that the use of the laminaria tent instead of Dilapan-S 
is not typical of, and does not reflect the standard of care for, term 
induction of labor; and that there are now many methods of cervical 
dilation, including pharmacological, mechanical, and surgical.
    Also, commenters noted that CPT code 59200 only describes the 
insertion of the cervical dilator using the laminaria and/or 
prostaglandins and it does not describe the insertion of the cervical 
dilator with other practice expense supply items. As a result, 
commenters suggested CPT code 59200 should be reviewed.
    Response: We thank commenters for pointing out that CPT code 59200 
is a specific procedure for cervical dilation and that other methods of 
cervical dilation (pharmacological, mechanical, and surgical) have come 
into practice that are not described by CPT code 59200. We also 
appreciate commenters' pointing out that the current market price of 
the laminaria tent has increased since the supply item price was 
established in 2003. Lastly, we acknowledge commenters' suggestion 
regarding the replacement of the supply item laminaria tent with 
Dilapan-S.
    Comment: A number of commenters stated that CPT code 59200 
performed in the office or in the outpatient setting is more efficient 
in many ways (including in overall costs) and helps in inducing labor, 
which in turn, helps promotes vaginal births rather than concluding as 
Cesarean sections when there is not enough dilation. The commenters 
noted that in comparison, vaginal births obviously shorten hospital 
stays and patient recoveries and improves patient satisfaction in the 
birthing method.
    Commenters noted that alternate cervical dilation such as 
prostaglandins medication must be administered as inpatient, and 
mechanical dilation is performed in an outpatient setting, but CPT code 
59200 can typically be performed in the office, which is more 
desirable. Physicians have noted that patient populations today tend to 
have higher incidences of obesity, hypertension, diabetes, and 
advancing maternal age complications and to ensure healthy births and 
maintain the highest standards of care, the induction of labor is 
necessary, which begins with CPT code 59200, cervical dilation. One 
commenter adds that the use of laminaria instead of Dilapan-S is not 
the standard of care for term induction of labor.
    Response: After reviewing the comments concerning CPT code 59200, 
we are mainly concerned with whether the code currently represents how 
the medical procedure is performed today. We agree with commenters that 
CPT code 59200 is a potentially misvalued service since the code has 
not been reviewed in 20 years and the current typical practice of this 
code has likely evolved since then, warranting a comprehensive review. 
As such, we believe that CPT code 59200 could benefit from a review of 
its supply, equipment, and clinical labor items, plus physician work 
RVUs and physician work times. Therefore, based on the information 
provided by commenters regarding the outdated nature of the code and 
supply input pricing, we are finalizing CPT code 59200 as potentially 
misvalued for CY 2024.
(2) CPT Code 27279
    CPT code 27279 (Arthrodesis, sacroiliac joint, percutaneous or 
minimally invasive (indirect visualization), with image guidance, 
includes obtaining bone graft when performed, and placement of 
transfixing device) (090 day global code) was nominated as potentially 
misvalued due to the absence of separate direct PE inputs for this 090 
day global code in the nonfacility office setting. Currently, the PFS 
only prices CPT code 27279 in the facility setting, at about $826.85 
for the physician's professional services, but the nominators were 
seeking separate direct PE inputs for this service to better account 
for valuation when performed in the nonfacility/office setting.
    The nominator claimed that CPT code 27279 could be safely and 
effectively furnished in the nonfacility setting and that this 
procedure has a low-risk profile, similar to kyphoplasty (CPT codes 
22513, 22514, and 22515), which is currently furnished in the 
nonfacility setting. The nominator described Kyphoplasty as ``a 
percutaneous minimally invasive procedure depositing poly methyl 
methacrylate via a cannula into vertebral bodies near neural 
structures.'' The nominator stated that permitting payment for direct 
PE inputs for CPT code 27279 in the nonfacility/office setting would 
increase access to this service for Medicare patients. The nominator 
also submitted one sample invoice for $17,985.00 with three units of 
the itemized supply item IFuse-3D Implant 7.0 mm x 55mm, US ($5,995.00 
per unit) to illustrate the high direct PE costs for CPT code 27279, 
should CMS value this code in the nonfacility/office setting.
    We expressed concern about whether this 090-day surgical service 
could be safely and effectively furnished in the non-facility/office 
setting (for example, in an office-based surgical suite). We welcomed 
comments on the nomination of CPT code 27279 for consideration as 
potentially misvalued.
    The following is a summary of the comments we received and our 
responses.
    Comment: Several commenters supported establishing a nonfacility/
office payment for CPT code 27279. Commenters stated that while the 
procedure is currently performed in ASCs, it can be equally effective, 
with minimal risk, when done in an office setting. Commenters also 
stated that the fact that the service is assigned a 090-day global 
period does not imply that the code should only be performed in an 
inpatient setting nor that the service

[[Page 78847]]

carries a heightened level of risk, since CPT code 27279 is minimally 
invasive. Additionally, to support their recommendation to create a 
nonfacility/office payment for CPT code 27279, the commenters cited the 
dorsal arthrodesis procedure (Dorsal Sacroiliac Joint Arthrodesis CPT 
code 27278 (2X000)) for comparison since it also has a 090 global 
period and a nonfacility-office payment.
    Response: We appreciate the comments in support of establishing a 
nonfacility/office payment for CPT code 27279.
    Comment: Several commenters opposed creating a nonfacility/office 
payment for CPT code 27279 due to patient safety concerns when 
performed in the office setting. Also, some commenters noted that while 
the kyphoplasty codes (CPT codes 22513, 22514, 22515) are often cited 
as an example of codes supporting nonfacility/office payments similar 
to CPT code 27279, those codes have 010 day global periods and do not 
have the same level of risk as CPT code 27279. Commenters supported 
this point by stating that CPT code 27279 is not necessarily minimally 
invasive because it requires the incision and collection of bone as 
well as the placement of titanium implants across the sacroiliac joint.
    Response: We appreciate the comments opposing the establishment of 
a nonfacility/office payment for CPT code 27279.
    We thank the commenters for the multiple perspectives regarding 
nonfacility/office payment for these services. We note that there does 
not appear to be a consensus on whether these services may be safely 
and effectively furnished in the nonfacility/office setting, which is a 
primary concern in our policy consideration. Therefore, for CY 2024, we 
are not finalizing CPT code 27279 as potentially misvalued.
    However, after reviewing the public comments, we note a growing 
number of potentially misvalued code nominations requesting that we 
establish nonfacility payment rates where there currently are none. We 
acknowledge that the practice of medicine continues to evolve in ways 
that, in clinically appropriate and effective circumstances, there may 
be support for a transition of complex procedures into ambulatory 
settings. We also acknowledge that PE inputs for such services should 
be appropriately determined and established to appropriately reflect 
typical clinical practice. We believe services such as those described 
by the nominator would benefit from review by other interested parties, 
such as the AMA RUC and private payors, even as we consider our 
policies for such services.
    We look forward to considering valuation recommendations for such 
services and additional information that may inform our payment policy 
considerations in future rulemaking.
(3) CPT Codes 99221, 99222, and 99223
    An interested party nominated the Hospital Inpatient and 
Observation Care visit CPT codes 99221 (Initial hospital care, per day, 
for the evaluation and management of a patient, which requires these 3 
key components: A detailed or comprehensive history; A detailed or 
comprehensive examination; and Medical decision making that is 
straightforward or of low complexity. Counseling and/or coordination of 
care with other physicians, other qualified health care professionals, 
or agencies are provided consistent with the nature of the problem(s) 
and the patient's and/or family's needs. Usually, the problem(s) 
requiring admission are of low severity. Typically, 30 minutes are 
spent at the bedside and on the patient's hospital floor or unit.), 
99222 (Initial hospital care, per day, for the evaluation and 
management of a patient, which requires these 3 key components: A 
comprehensive history; A comprehensive examination; and Medical 
decision making of moderate complexity. Counseling and/or coordination 
of care with other physicians, other qualified health care 
professionals, or agencies are provided consistent with the nature of 
the problem(s) and the patient's and/or family's needs. Usually, the 
problem(s) requiring admission are of moderate severity. Typically, 50 
minutes are spent at the bedside and on the patient's hospital floor or 
unit.), and 99223 (Initial hospital care, per day, for the evaluation 
and management of a patient, which requires these 3 key components: A 
comprehensive history; A comprehensive examination; and Medical 
decision making of high complexity. Counseling and/or coordination of 
care with other physicians, other qualified health care professionals, 
or agencies are provided consistent with the nature of the problem(s) 
and the patient's and/or family's needs. Usually, the problem(s) 
requiring admission are of high severity. Typically, 70 minutes are 
spent at the bedside and on the patient's hospital floor or unit.) as 
potentially misvalued. We note that CMS reviewed these codes in the CY 
2023 final rule (87 FR 69588) and established new physician work times 
and new work RVU payments for these services. The nominator disagreed 
with these values and asserted that these ``facility-based codes are 
always inherently (or proportionately) more intense than E/M services 
provided in other settings [in particular],'' with patients presenting 
with potentially infectious diseases, such as meningitis; pneumonia; 
tuberculosis; HIV/AIDS; Ebola virus; Zika virus; and, most recently, 
SARS-CoV-2 and mpox, and that the inpatient setting has a predominance 
of more seriously ill patients, who are sometimes immunocompromised 
and/or have multiple drug interaction issues and/or with comorbidities, 
making them extraordinarily more complex than those patients typically 
found in the office setting (with many of these infections being 
healthcare-associated infections and antibiotic-resistant bacterial 
infections). We note that these new requests did not offer appreciably 
new information relative to last year's nomination/consideration.
    The nominator sought a new work RVU value of 1.92 for CPT code 
99221, a new work RVU of 2.79 for CPT code 99222, and a new work RVU 
value of 4.25 for CPT code 99223. Currently, CPT code 99221 has a work 
RVU of 1.63, a reduction of 15.1 percent from its 1.92 work RVU from CY 
2022. CPT code 99222 had a work RVU of 2.61 in CY 2022 and is now at 
2.60. CPT code 99223 had a work RVU of 3.86 in CY 2022. It now has a 
value of 3.50, which is a reduction of 9.3 percent. The nominator 
requested that the work RVU for CPT code 99221 be restored back to 
1.92, that the work RVU of CPT code 99222 be increased to 2.79, and 
that the work RVU of CPT code 99223 be increased to 4.25 (please see 
Table 8 for a comparison of work RVU values for CY 2022, CY 2023, and 
of those requested by the nominator).

[[Page 78848]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.010

    After consideration of these nominations and their requests for 
higher work RVUs for CPT codes 99221, 99222, and 99223, we proposed to 
maintain the values that we finalized for these codes in the CY 2023 
PFS final rule (87 FR 69588). Even so, we welcomed comments on the 
nomination of these codes as potentially misvalued.
    The following is a summary of the comments we received and our 
responses.
    Comment: Many commenters stated that CMS should not have accepted 
the CY 2023 AMA RUC-recommended RVU values for CPT codes 99221, 99222, 
and 99223 because they resulted in payment decreases for all three 
services (partially due to a decrease in survey times), due to 
significant flaws with the AMA RUC evaluation process. Several 
commenters suggested that the work RVUs for CPT codes 99221, 99222, and 
99223 be restored to their original values from before CY 2023 or be 
increased to mimic the increases that the E/M family of codes has 
experienced in recent years.
    Response: We thank commenters for their feedback.
    After consideration of public comments, we do not believe CPT codes 
99221, 99222, and 99223 are potentially misvalued since they were 
recently valued in the CY 2023 final rule (87 FR 69588). In that 
regulation, we accepted the AMA RUC recommendations. We believe that 
the AMA RUC recommendations are still appropriate and best reflect the 
work intensity and time involved in furnishing these services. 
Therefore, for CY 2024, we are not finalizing CPT codes 99221, 99222, 
and 99223 as potentially misvalued.
(4) CPT Codes 36514, 36516, 36522
    An interested party nominated CPT codes 36514 (Therapeutic 
apheresis; for plasma pheresis), 36516 (Therapeutic apheresis; with 
extracorporeal immunoadsorption, selective adsorption or selective 
filtration and plasma reinfusion), and 36522 (Photopheresis, 
extracorporeal) (all 000 day global codes) as potentially misvalued. 
The interested party stated that the direct PE of clinical labor L042A, 
``RN/LPN'' (for labor rate of $0.525 per minute), was incorrect and 
should be changed to a more specific entry of ``a therapeutic apheresis 
nurse specialist (RN)'' (for a labor rate of about $1.06 to $1.14 per 
minute), which would approximately double all three of these codes' 
clinical labor PE entries. In addition, the nominator disagreed with 
the current direct PE of supply item SC085, ``Tubing set, plasma 
exchange'' at $186.12 per item, and believed that this would be worth 
$248.77 per item with CPT code 36514, using a quantity of one item. The 
nominator believed that supply item SC084, ``Tubing set, blood 
warmer,'' which we currently have listed at $8.01 per item, should be 
worth $14.71 per item with CPT code 36514, also using a quantity of one 
item. The nominator submitted sample invoices (not actual invoices) for 
illustration and support. We welcomed comments on whether these codes 
were potentially misvalued.
    The following is a summary of the comments we received and our 
responses.
    Comment: Several commenters were in favor of establishing a 
specific new Therapeutic Apheresis Nurse Specialist labor category for 
CPT codes 36514, 36516, and 36522 because they did not believe the 
current RN/LPN labor code accurately captured their nurses' specialized 
skills, experience, work, and time. Commenters pointed out that 
recruiting and retaining nursing personnel has been challenging, and 
when competing for an experienced specialized apheresis nurse, salary 
demands are higher to attract and keep them. The nominator also 
mentioned that a typical apheresis nurse tends to have an extensive 
clinical background and specialized therapeutic apheresis experience. 
Additionally, commenters noted that these nurses spend significant time 
with patients during apheresis procedures, often not leaving the 
patient's bedside during the long procedure. Commenters noted that 
these nurses are trained to set up specialized equipment, work with 
hospital blood banks to acquire blood products, work with pharmacies 
for required medications, and consult with medical and nursing staff.
    Response: We thank commenters for their detailed description of the 
typical duties of an apheresis nurse and how they might differ from a 
general RN/LPN nurse.
    Comment: Several commenters opposed the nomination of CPT codes 
36514, 36516, 36522 as potentially misvalued and advised us to review 
the results of the forthcoming AMA PPIS survey before making any 
changes. One commenter added that there might be a clinical labor type 
gap that CMS could resolve.
    Response: We thank commenters for their feedback and for 
acknowledging the forthcoming AMA PPIS survey.
    After considering the public comments, we believe there may be a 
possible disparity with the clinical labor type for this service and 
that these codes would benefit from additional review in future 
rulemaking. We believe that it is likely that a general RN/LPN labor 
category is not adequately equivalent to an Apheresis Nurse Specialist 
and while there is currently no Apheresis Nurse category listed in the 
PFS, there may be existing nurse categories that can act as a 
substitute, such as an oncology nurse. Therefore, for CY 2024, we are 
finalizing CPT codes 36514, 36516, and 36522 as potentially misvalued.
(5) CPT Codes 44205 and 44204
    An interested party nominated CPT code 44205 (Laparoscopy, 
surgical; colectomy, partial, with removal of terminal ileum with 
ileocolostomy), as potentially misvalued, requesting that payment for 
this code be made equivalent to the higher payment for CPT code 44204 
(Laparoscopy, surgical; colectomy, partial, with anastomosis). Both 
codes are 090 day global codes, currently valued only in the facility 
setting. CPT code 44204 has a total RVU of 45.62 for CY 2023, and CPT 
code 44205 has a total RVU of 39.62 for CY 2023, with a difference of 
6.00 RVUs. CPT code 44204 is associated with 5 to 6 percent more 
physician work time: 455.0 minutes in total, compared to 428.5 minutes 
for CPT code 44205. The

[[Page 78849]]

work RVU for CPT code 44204 is also 15 percent higher than the work RVU 
for CPT code 44205. The direct PE entries for both codes are the same 
regarding supplies, equipment, and clinical labor, except that in the 
clinical labor and equipment entries, the number of usage minutes is 
higher for CPT code 44204.
    Though these two codes appear to be similar, they are still 
different in their purpose, physician work times, and direct PE, with 
CPT code 44204 involving more time and resources (and having a higher 
payment, accordingly). For these reasons, we disagreed with the 
assertion that CPT code 44205 is potentially misvalued when compared to 
CPT code 44204, and we disagree to modify this payment differential by 
paying more for CPT code 44205. We solicited feedback regarding the 
nomination of CPT code 44205 as potentially misvalued.
    We did not receive public comments on this provision, and 
therefore, we are finalizing our proposal not to nominate this service 
as potentially misvalued.
(6) CPT Codes 93655 and 93657
    An interested party nominated CPT codes 93655 (Intracardiac 
catheter ablation of a discrete mechanism of arrhythmia which is 
distinct from the primary ablated mechanism, including repeat 
diagnostic maneuvers, to treat a spontaneous or induced arrhythmia 
(List separately in addition to code for primary procedure)) and 93657 
(Additional linear or focal intracardiac catheter ablation of the left 
or right atrium for treatment of atrial fibrillation remaining after 
completion of pulmonary vein isolation (List separately in addition to 
code for primary procedure)), as potentially misvalued. We recently 
reviewed these add-on codes in the CY 2022 (86 FR 65108) and CY 2023 
(87 FR 69516) final rules.
    The nominator reiterated that the primary procedures involve ``high 
intensity clinical decision making, complexity in the intraoperative 
skills required for treatment, morbidity/mortality risks to the 
patient, and work intensity'' and that the work RVUs for both of these 
add-on codes should reflect the AMA RUC recommended work RVU of 7.00. 
We disagreed with this value in CY 2022 and continued to believe that a 
work RVU of 5.50 was appropriate for the 60 minutes of physician 
service time for both codes. We saw no reason to reconsider our 
valuation of CPT codes 93655 and 93657 for CY 2022 or CY 2023, and we 
do not consider these codes to be potentially misvalued now and did not 
propose to nominate these codes as potentially misvalued for CY 2024.
    Comment: We received very few comments addressing these two cardiac 
ablation add-on codes, which were finalized in CY 2023. The commenters 
urged CMS to accept the AMA RUC's recommendation for CPT codes 93655 
and 93657 of 7.00 work RVUs.
    Response: We believe the code valuations we established in CY 2023 
are accurate and that these codes are not potentially misvalued; 
however, we will continue to monitor this issue and the Medicare claims 
data for these codes in the coming years.
    We continue to believe that the current code valuations are 
accurate and most appropriate for these services. Therefore, for CY 
2024, we are not finalizing these codes as potentially misvalued.
(7) CPT Code 94762 and 95800
    An interested party nominated CPT code 94762 (Noninvasive ear or 
pulse oximetry for oxygen saturation; by continuous overnight 
monitoring (separate procedure)), a PE-only code as potentially 
misvalued. The nominator noted that the technology behind this code had 
changed considerably over the last 14 years, and because the PE inputs 
were last reviewed in 2009, the PE items included in the service no 
longer reflected current practice. In their submission, the nominator 
listed equipment items for CPT code 94762, including EQ212 ``pulse 
oxymetry recording software (prolonged monitoring)'' and EQ353 ``Pulse 
oximeter 920 M Plus,'' which the nominator asserted are now typically 
found in a one-time use supply item: SD263 ``WatchPAT pneumo-opt slp 
probes'' (extended external overnight pulse oximeter device probe and 
battery with bluetooth, medical magnetic tape recorder) (WatchPAT One 
Device) with a cost of $99.00 each (derived from two sample invoices, 
not actual invoices, included with the nomination). According to our PE 
supply list, item SD263 costs $73.32, which is $25.68 less than the 
amounts found in the sample invoices submitted by the nominators. The 
nominator retained equipment item EQ212 ``pulse oxymetry recording 
software (prolonged monitoring)'', and replaced equipment item EQ353 
with ED021, a ``computer, desktop, w-monitor.
    The same interested party who nominated CPT code 94762, also 
nominated CPT code 95800 (Sleep study, unattended, simultaneous 
recording; heart rate, oxygen saturation, respiratory analysis (e.g., 
by airflow or peripheral arterial tone), and sleep time) as potentially 
misvalued. The nominator requested that CMS update PE items for this 
code, asserting that the PE inputs were last reviewed in 2017. CPT code 
95800 currently includes the entry of a one-time use supply item, SD263 
``WatchPAT pneumo-opt slp probes'' (extended external overnight pulse 
oximeter device probe and battery with bluetooth, medical magnetic tape 
recorder) (WatchPAT One Device), which costs $73.32 per item, in 
contrast to the pricing in the sample invoice--$99.00 each (case of 12 
x $99.00 = $1,188.00).
    The nominator excluded the current equipment for this code (EQ335 
``WatchPAT 200 Unit with strap, cables, charger, booklet and patient 
video'' and EQ336 ``Oximetry and Airflow Device'') and instead included 
ED021 (``computer, desktop, w-monitor'') in the PE for this code. We 
noted that we did not previously include ED021 as a specialized 
equipment item dedicated to this function (and EQ212 ``pulse oxymetry 
recording software (prolonged monitoring)'' was also not included in 
the PE for CPT code 95800, as it was with CPT code 94762). The 
nominator included the PE listings for CPT code 93245 (Heart rhythm 
recording, analysis, interpretation and report of continuous external 
EKG over more than 1 week up to 1 weeks) as an example of how PE supply 
items for CPT code 95800 should be structured, but this code included 
supply item, SD339 ``extended external ECG patch, medical magnetic tape 
recorder'' and equipment item ED021 ``computer, desktop, w-monitor,'' 
which is presumed to be used to record the data from the ECG patch and 
to be used to analyze the data.
    There is no clear evidence whether the WatchPAT One Device needs or 
does not need the specific monitoring and recording system (equipment 
item EQ212 ``pulse oxymetry recording software (prolonged 
monitoring)'') for CPT code 95800, as opposed to any other system/
process. The interested party requested the PE changes discussed above 
to support their argument that these CPT codes are potentially 
misvalued (see Table 9).
BILLING CODE 4120-01-P

[[Page 78850]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.011

BILLING CODE 4120-01-C
We welcomed comments as to whether these codes are potentially 
misvalued.

    The following is a summary of the comments we received and our 
responses.
    Comment: One commenter disagreed with the replacement of various PE 
items with alternative items. For example, for CPT code 94762, the 
existing pulse oximeter 920 M Plus (CMS equipment item EQ353) would be 
replaced with the disposable WatchPAT One supply item (SD263). The 
commenter expressed concern about removing the pulse oximetry devices 
from CPT code 94762 and whether the WatchPAT One supply item properly 
assessed and monitored a patient's sleep, as described by the code.
    Response: We thank commenters for their feedback. There seems to be 
a general misunderstanding from the original nomination regarding which 
PE items should be replaced or retained and which items are considered 
duplicated, according to the public comments received.
    We cannot properly assess if CPT codes 94762 and 95800 are 
potentially misvalued based on the evidence submitted with the original 
nomination and subsequent public comments we received in response to 
the CY 2024 PFS proposed rule. After considering the public comments, 
it is still unclear whether CPT codes 94762 and 95800 are potentially 
misvalued. We invite the original nominator or other parties to 
resubmit their nomination with information providing additional clarity 
for further consideration in future rulemaking. Therefore, for CY 2024, 
we are not finalizing CPT codes 94762 and 95800 as potentially 
misvalued.
(8) CPT Codes 0596T and 0597T
    An interested party nominated CPT codes 0596T (Initial insertion of 
temporary valve-pump in female urethra) and 0597T (Replacement of 
temporary valve-pump in female urethra) as potentially misvalued. This 
nominator generally expressed concern about variability in MAC pricing 
for the contractor-priced service and requested that CMS establish 
national pricing to stabilize payments that more accurately reflected 
the work, professional liability costs, and especially the nonfacility 
PE for these services, including the costs associated with the Vesiflo 
inFlow

[[Page 78851]]

System, the primary supply included in the procedures described by the 
two Category III CPT codes. The nominator stated that the MAC-
determined payment amounts had been inappropriately low and did not 
account for the time and the work involved in furnishing the services 
or all of the PE. In their submission, the nominator discussed their 
expected inputs for both codes. For CPT code 0596T, the nominator 
asserted that a physician would typically spend 60 minutes of work 
inserting the Vesiflo inFlow System. The nominator also discussed the 
PE items used to furnish the procedure. These specified PE items 
included a power table, a mayo stand, an examination light, clinical 
labor time of a RN/LPN/MTA totaling to 73 minutes, and a list of 
supplies summing to $1,902.76, primarily from the inFlow Measuring 
Device of $140.00, the inflow Device of $495.00, and the inflow 
Activator Kit of $1,250.00, with the inflow supply items making up 
about 99 percent of the total cost of supplies.
    For CPT code 0597T, the nominator asserted that a physician would 
typically spend 25 minutes replacing the Vesiflo inFlow System. The 
specified PE items for this service included a power table, a mayo 
stand, an examination light, clinical labor time of a RN/LPN/MTA 
totaling 38 minutes, and a list of supplies summing to $505.30, 
primarily from the inflow device of $495.00, with the inflow supply 
items making up about 98 percent of the total cost of supplies. A 
sample invoice was included in this nomination (as opposed to an actual 
invoice).
    We welcomed comments on whether these two temporary category III 
CPT codes, CPT codes 0596T and 0597T, were potentially misvalued and 
whether these codes should remain contractor-priced.
    The following is a summary of the comments we received and our 
responses.
    Comment: We received several comments supporting our proposal to 
nominate CPT codes 0596T and 0597T as potentially misvalued. These 
commenters recommended that we establish national pricing for these 
services, stating that a change to national pricing would address the 
misvaluation and pricing variability for the service and allow for the 
appropriate inclusion of the Vesiflo system in the code's PE.
    Response: We note that CPT codes 0596T and 0597T are category III 
codes and describe relatively new and low-volume services. Generally, 
category III codes are contractor-priced under the PFS, meaning that 
each MAC can establish pricing for the code for areas within its 
jurisdiction. We appreciate the nominators' and commenters' concerns 
about variability in payment across the different MAC jurisdictions.
    After consideration of public comments, we are not finalizing CPT 
codes 0596T and 0597T as potentially misvalued. These are contractor-
priced codes and they will remain contractor priced for the present. 
However, we encourage interested parties to continue to engage with the 
MACs and provide accurate and appropriate cost data to inform the MAC's 
consideration and pricing of these services.
(9) CPT Code 93000
    An interested party nominated CPT code 93000 (Electrocardiogram, 
routine ECG with at least 12 leads; with interpretation and report) as 
potentially misvalued, arguing that we should increase Medicare payment 
for CPT code 93000 to $35.64 when used in conjunction with other 
supplies and services, to reflect PE costs equivalent to (1) $6.10 for 
EKG leads; (2) $21.19 for a nurse visit of typically 5 minutes (as 
illustrated by CPT code 99211 (Office or other outpatient visit for the 
evaluation and management of an established patient, that may not 
require the presence of a physician or other qualified health care 
professional. Usually, the presenting problem(s) are minimal. 
Typically, 5 minutes are spent performing or supervising these 
services.)); and (3) $7.64 for the interpretation and report for the 
EKG service (as illustrated by CPT code 93010 (Electrocardiogram, 
routine ECG with at least 12 leads; interpretation and report only). 
While the interested party did not provide invoices or other evidence 
for consideration, they asked that we value the grouping of these 
services at $35.64, even though the direct costs for these identified 
PE inputs total to $34.93.
    After consideration of submitted information, we decided not to 
propose to nominate CPT code 93000 as potentially misvalued for CY 
2024. We did not believe that the total of a mix of services is a 
persuasive indication that one code--in this case, CPT code 93000--was 
potentially misvalued.
    We did not receive public comments on this nomination. Therefore, 
for CY 2024, we are not finalizing CPT codes code 93000 as potentially 
misvalued.
(10) 19 Therapy Codes
    An interested party nominated 19 therapy codes as potentially 
misvalued. We noted in the proposed rule that these 19 therapy codes 
were last reviewed by CMS in the CY 2018 PFS final rule (82 FR 53073 
through 53074). The nominators asserted that the direct PE clinical 
labor minutes, as recommended by the AMA Relative Value Scale Update 
Committee (RUC) and Healthcare Professional Advisory Committee (HCPAC) 
Review Board, reflected inappropriate multiple procedure payment 
reductions (MPPR), which are likely duplicative of the CMS MPPR policy 
implemented in CMS' claims processing systems.
    As discussed in the proposed rule, we reviewed the clinical labor 
time entries for these 19 therapy codes. We noted that we did not 
believe a payment reduction should have been applied to the 19 
nominated therapy codes' clinical labor time entries (Table 10) since 
the payment valuation reduction would be duplicative of the MPPR we 
apply during claims processing. We proposed to nominate these 19 codes 
as potentially misvalued for CY 2024, as we believed that the valuation 
of these services would benefit from additional review through the AMA 
RUC HCPAC valuation process. We also sought comment on our proposal. 
The following is a summary of the comments we received and our 
responses.
    Comment: Numerous commenters supported our proposal to nominate 
these 19 therapy codes as potentially misvalued. There were no comments 
asserting that these codes should not be considered potentially 
misvalued.
    Response: After consideration of the public comments for this 
issue, we are finalizing our proposal to consider the 19 therapy codes 
as potentially misvalued for CY 2024.

[[Page 78852]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.012

D. Payment for Medicare Telehealth Services Under Section 1834(m) of 
the Act

    As discussed in prior rulemaking, several conditions must be met 
for Medicare to make payment for telehealth services under the PFS. See 
further details and full discussion of the scope of Medicare telehealth 
services in the CY 2018 PFS final rule (82 FR 53006) and CY 2021 PFS 
final rule (85 FR 84502) and in 42 CFR 410.78 and 414.65.
1. Payment for Medicare Telehealth Services Under Section 1834(m) of 
the Act
a. Changes to the Medicare Telehealth Services List
    In the CY 2003 PFS final rule with comment period (67 FR 79988), we 
established a regulatory process for adding services to or deleting 
services from the Medicare Telehealth Services List in accordance with 
section 1834(m)(4)(F)(ii) of the Act (42 CFR 410.78(f)). This process 
provides the public with an ongoing opportunity to submit requests for 
adding services, which are then reviewed by us and assigned to 
categories established through notice and comment rulemaking. 
Specifically, we assign any submitted request to add to the Medicare 
Telehealth Services List to one of the following two categories:
     Category 1: Services that are similar to professional 
consultations, office visits, and office psychiatry services that are 
currently on the Medicare Telehealth Services List. In reviewing these 
requests, we look for similarities between the requested and existing 
telehealth services for the roles of, and interactions among, the 
beneficiary, the physician (or other practitioner) at the distant site, 
and, if necessary, the telepresenter, a practitioner who is present 
with the beneficiary in the originating site. We also look for 
similarities in the telecommunications system used to deliver the 
service; for example, the use of interactive audio and video equipment.
     Category 2: Services that are not similar to those on the 
current Medicare Telehealth Services List. Our review of these requests 
includes an assessment of whether the service is accurately described 
by the corresponding code when furnished via telehealth and whether the 
use of a telecommunications system to furnish the service produces 
demonstrated clinical benefit to the patient. Submitted evidence should 
include both a description of relevant clinical studies that 
demonstrate the service furnished by telehealth to a Medicare 
beneficiary improves the diagnosis or treatment of an illness or injury 
or improves the functioning of a malformed body part, including dates 
and findings, and a list and copies of published peer reviewed articles 
relevant to the service when furnished via telehealth. Our evidentiary 
standard of clinical benefit does not include minor or incidental 
benefits. Some examples of other clinical benefits that we consider 
include the following:

 Ability to diagnose a medical condition in a patient 
population without access to clinically appropriate in-person 
diagnostic services.
 Treatment option for a patient population without access to 
clinically appropriate in-person treatment options.
 Reduced rate of complications.
 Decreased rate of subsequent diagnostic or therapeutic 
interventions (for example, due to

[[Page 78853]]

reduced rate of recurrence of the disease process).
 Decreased number of future hospitalizations or physician 
visits.
 More rapid beneficial resolution of the disease process 
treatment.
 Decreased pain, bleeding, or other quantifiable signs or 
symptoms.
 Reduced recovery time.
     Category 3: In the CY 2021 PFS final rule (85 FR 84507), 
we created a third category of criteria for adding services to the 
Medicare Telehealth Services List on a temporary basis following the 
end of the public health emergency (PHE) for the COVID-19 pandemic. 
This new category describes services that were added to the Medicare 
Telehealth Services List during the PHE, for which there is likely to 
be clinical benefit when furnished via telehealth, but there is not yet 
sufficient evidence available to consider the services for permanent 
addition under the Category 1 or Category 2 criteria. Services added on 
a temporary, Category 3 basis will ultimately need to meet the criteria 
under Category 1 or 2 in order to be permanently added to the Medicare 
Telehealth Services List. To add specific services on a Category 3 
basis, we conducted a clinical assessment to identify those services 
for which we could foresee a reasonable potential likelihood of 
clinical benefit when furnished via telehealth. We considered the 
following factors:
    ++ Whether, outside of the circumstances of the PHE for COVID-19, 
there are concerns for patient safety if the service is furnished as a 
telehealth service.
    ++ Whether, outside of the circumstances of the PHE for COVID-19, 
there are concerns about whether the provision of the service via 
telehealth is likely to jeopardize quality of care.
    ++ Whether all elements of the service could fully and effectively 
be performed by a remotely located clinician using two-way, audio/video 
telecommunications technology.
    In the CY 2021 PFS final rule (85 FR 84507), we also temporarily 
added several services to the Medicare Telehealth Services List using 
the Category 3 criteria described previously. In this rule, we 
considered additional requests to add services to the Medicare 
Telehealth Services List on a Category 3 basis using the previously 
described Category 3 criteria.
    The Medicare Telehealth Services List, including the additions 
described later in this section, is available on the CMS website at 
https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
    Beginning in CY 2019, we stated that for CY 2019 and onward, we 
intend to accept requests through February 10, consistent with the 
deadline for our receipt of code valuation recommendations from the RUC 
(83 FR 59491). For CY 2024, requests to add services to the Medicare 
Telehealth Services List must have been submitted and received by 
February 10, 2023. Each request to add a service to the Medicare 
Telehealth Services List must have included any supporting 
documentation the requester wishes us to consider as we review the 
request. Because we use the annual PFS rulemaking process as the 
vehicle to make changes to the Medicare Telehealth Services List, 
requesters are advised that any information submitted as part of a 
request is subject to public disclosure for this purpose. For more 
information on submitting a request in the future to add services to 
the Medicare Telehealth Services List, including where to mail these 
requests, see our website at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
b. Requests to Add Services to the Medicare Telehealth Services List 
for CY 2024
    Under our current policy, we add services to the Medicare 
Telehealth Services List on a Category 1 basis when we determine that 
they are similar to services on the existing Medicare Telehealth 
Services List for the roles of, and interactions among, the 
beneficiary, physician (or other practitioner) at the distant site, 
and, if necessary, the telepresenter. As we stated in the CY 2012 PFS 
final rule with comment period (76 FR 73098), we believe that the 
Category 1 criteria not only streamline our review process for publicly 
requested services that fall into this category, but also expedite our 
ability to identify codes for the Medicare Telehealth Services List 
that resemble those services already on the Medicare Telehealth 
Services List.
    We also note that section 4113 of Division FF, Title IV, Subtitle A 
of the Consolidated Appropriations Act, 2023 (CAA, 2023) (Pub. L. 117-
328, December 29, 2022) extends the telehealth policies enacted in the 
Consolidated Appropriations Act, 2022 (CAA, 2022) (Pub. L. 117-103, 
March 15, 2022) through December 31, 2024, if the PHE ends prior to 
that date, as discussed in section II.D.c. of this final rule.
    We received several requests to permanently add various services to 
the Medicare Telehealth Services List effective for CY 2024. We found 
that none of the requests we received by the February 10th submission 
deadline met our Category 1 or Category 2 criteria for permanent 
addition to the Medicare Telehealth Services List. The requested 
services are listed in Table 11.
BILLING CODE 4120-01-P

[[Page 78854]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.013


[[Page 78855]]


[GRAPHIC] [TIFF OMITTED] TR16NO23.014

BILLING CODE 4120-01-C
    We remind interested parties that the criterion for adding services 
to the Medicare telehealth list under Category 1 is that the requested 
services are similar to professional consultations, office visits, and 
office psychiatry services that are currently on the Medicare 
Telehealth Services List, and that the criterion for adding services 
under Category 2 is that there is evidence of clinical benefit if 
provided as telehealth. As explained below and in the CY 2024 PFS 
proposed rule (88 FR 52286 to 52298), we found that none of the 
requested services listed in Table 11 met the Category 1 criterion. 
Below is a summary of the reasons why we did not propose to add these 
services to the Medicare Telehealth Services List on a Category 1 
basis, the comments on the proposed rule, and our responses:
(1) Cardiovascular Procedures
    We received a request to permanently add CPT code 93793 
(Anticoagulant management for a patient taking warfarin, must include 
review and

[[Page 78856]]

interpretation of a new home, office, or lab international normalized 
ratio (INR) test result, patient instructions, dosage adjustment (as 
needed), and scheduling of additional test(s), when performed)) to the 
Medicare Telehealth Services List. We did not consider this service to 
be a Medicare telehealth service, because the service is not an 
inherently face-to-face service--a patient need not be present in order 
for the service to be furnished in its entirety. For example, in many 
instances, clinical staff will not change a patient's warfarin dosage 
as a result of the lab INR test result, and they may or may not confirm 
the need for a follow-up test via phone; either way there is no need 
for a face-to-face encounter with a practitioner. As we have explained 
in previous rulemaking (83 FR 59483), certain kinds of services that 
are furnished remotely using communications technology are not 
considered Medicare telehealth services and are not subject to the 
restrictions articulated in section 1834(m) of the Act. This is true 
for services that were routinely paid separately prior to the enactment 
of section 1834(m) of the Act and do not usually include patient 
interaction such as the remote interpretation of diagnostic tests. We 
did not consider CPT code 93793 to be a telehealth service under 
section 1834(m) of the Act or our regulation at Sec.  410.78. 
Therefore, we did not propose to add this service to the Medicare 
Telehealth Services List on a Category 1 basis.
    Comment: A few commenters requested that CMS update the status 
indicator for CPT code 93793 to a covered status indicator such as A, S 
or V, and that CMS add the service to the telehealth list.
    Response: The request for a status indicator change is outside the 
scope of our telehealth proposals. However, we believe it is important 
to note that the service elements of CPT code 93793 do not describe an 
in-person service that could, instead, be furnished as a Medicare 
telehealth service using interactive communications technology. Because 
CPT code 93793 does not describe an inherently face-to-face service, it 
would not be appropriate to consider or recognize it as a telehealth 
service. We believe that the commenter misunderstands the nature of CPT 
code 93793.
(2) Cardiovascular and Pulmonary Rehab
    We received multiple requests to permanently add the following CPT 
codes to the Medicare Telehealth Services List:
     93797 (Physician or other qualified health care 
professional services for outpatient cardiac rehabilitation; without 
continuous ECG monitoring (per session)); and
     94624 (Physician or other qualified health care 
professional services for outpatient pulmonary rehabilitation; without 
continuous oximetry monitoring (per session)).
    In the CY 2022 PFS final rule (86 FR 65048), we explained that some 
services were added temporarily to the Medicare Telehealth Services 
List on an emergency basis to allow practitioners and beneficiaries to 
have access to medically necessary care while avoiding both risk for 
infection and further burdening healthcare settings during the PHE for 
COVID-19. In the same rule, we considered available evidence and noted 
that as evidence evolves on this subject matter, we welcomed further 
discussions with interested parties on the topic. In subsequent cycles 
of annual rulemaking, we have continued conversations with interested 
parties that furnish, support, and use Cardiovascular and Pulmonary 
Rehabilitation services. In our CY 2022 PFS final rule (86 FR 65055), 
we acknowledged that commenters provided a number of studies on the 
safety and efficacy of these services when furnished via telehealth, 
and we added the codes to the list on a temporary, Category 3 basis.
    We note that some evidence submissions and ongoing discussions with 
interested parties have focused on the clinical benefits of patients 
receiving these services in the home. We note that, while demonstrating 
the clinical benefits of services is important to our decision whether 
to add a service to the Medicare Telehealth Services List, there are 
other considerations when deciding whether to add codes to the list on 
a permanent basis. For example, while the CAA, 2023, does extend 
certain COVID-19 PHE flexibilities, including allowing the 
beneficiary's home to serve as an originating site, such flexibilities 
are only extended through the end of CY 2024. Under current law, 
beginning on January 1, 2025, the beneficiary's home can be an 
originating site only for Medicare telehealth services furnished for: 
(1) the diagnosis, evaluation, or treatment of a mental health 
disorder; or (2) a beneficiary with a diagnosed substance use disorder 
(SUD) for purposes of treatment of the SUD or a co-occurring mental 
health disorder; or (3) monthly ESRD-related clinical assessments 
furnished to a beneficiary who is receiving home dialysis, beginning 
January 1, 2025. Therefore, in the absence of further action by 
Congress, CPT codes 93797 and 94626 will not be able to be furnished 
via telehealth to a beneficiary in the home beginning January 1, 2025. 
As such, we did not propose to include these services permanently on 
the Medicare Telehealth Services List on a Category 1 basis. We instead 
proposed to continue to include these services on the Medicare 
Telehealth Services List through CY 2024. We will then remove CPT codes 
93797 and 94626 from the Medicare Telehealth Services List for CY 2025.
    Comment: Commenters were generally supportive and included 
supportive evidence demonstrating possible clinical benefit for the 
clinical activities described by these codes.
    Response: We thank commenters for the feedback.
    After consideration of public comments, we are finalizing as 
proposed. We will continue to include these services on the Medicare 
Telehealth Services List through CY 2024. We will then remove CPT codes 
93797 and 94626 from the Medicare Telehealth Services List for CY 2025.
(3) Deep Brain Stimulation
    We received a request to permanently add the following CPT codes to 
the Medicare Telehealth Services List:
     95970 (Electronic analysis of implanted neurostimulator 
pulse generator/transmitter (eg, contact group[s], interleaving, 
amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet 
mode, dose lockout, patient selectable parameters, responsive 
neurostimulation, detection algorithms, closed loop parameters, and 
passive parameters) by physician or other qualified health care 
professional; with brain, cranial nerve, spinal cord, peripheral nerve, 
or sacral nerve, neurostimulator pulse generator/transmitter, without 
programming);
     95983 (Electronic analysis of implanted neurostimulator 
pulse generator/transmitter (eg, contact group[s], interleaving, 
amplitude, pulse width, frequency [Hz], on/off cycling, burst, magnet 
mode, dose lockout, patient selectable parameters, responsive 
neurostimulation, detection algorithms, closed loop parameters, and 
passive parameters) by physician or other qualified health care 
professional; with brain neurostimulator pulse generator/transmitter 
programming, first 15 minutes face-to-face time with physician or other 
qualified health care professional); and
     95984 (Electronic analysis of implanted neurostimulator 
pulse generator/transmitter (eg, contact group[s], interleaving, 
amplitude, pulse

[[Page 78857]]

width, frequency [Hz], on/off cycling, burst, magnet mode, dose 
lockout, patient selectable parameters, responsive neurostimulation, 
detection algorithms, closed loop parameters, and passive parameters) 
by physician or other qualified health care professional; with brain 
neurostimulator pulse generator/transmitter programming, each 
additional 15 minutes face-to-face time with physician or other 
qualified health care professional (List separately in addition to code 
for primary procedure)).
    In our CY 2023 proposed rule (85 FR 45891), we explained that these 
services do not meet the Category 1 criterion for permanent addition to 
the Medicare Telehealth Services List. Additionally, we discussed 
concerns about whether the full scope of service elements could be 
furnished via two-way, audio-video communication technology, 
particularly since it is unclear whether the connection between the 
implanted device and the analysis/calibration equipment can be done 
remotely. Additionally, we are concerned about the immediate safety of 
the patient if the calibration of the neurostimulator were done 
incorrectly or if some other problem occurred. However, we did include 
these services on the Medicare Telehealth Services List on a temporary 
basis during the PHE to allow additional time for additional 
information to be gathered and presented. Based on this information, we 
believe there is some possible clinical benefit for these services when 
furnished via telehealth; however, there is not yet sufficient evidence 
available to consider the services for permanent addition under the 
Category 2 criterion. We proposed to keep these services on the 
Medicare Telehealth Services List for CY 2024. We stated that we would 
consider additional evidence in future rulemaking to determine whether 
to add the services to the Medicare Telehealth Services List on a 
permanent basis.
    Comment: Several commenters explained that early evidence shows 
that safe remote programming may set devices to a safe mode in 
instances where remote programming fails. Commenters asserted that 
because evidence shows that patient safety risks may be mitigated 
through such controls, and no evidence of patient harm had been found, 
that CMS should make these services a permanent addition to the 
Medicare Telehealth Services List.
    Response: We consider all evidence submitted and anecdotes shared 
by commenters. We generally do not question the findings and believe 
that the services may be safely furnished using only two-way 
interactive communications technology as a substitute for in-person 
elements of the service. However, we have not received sufficient 
evidence to show that the service, when furnished using only virtual 
interaction, would avoid a subsequent in-person service that addresses 
instances where the beneficiary received less than the complete service 
(when the device enters safe mode, remote programming failed, and 
requires a follow-up in-person visit so that the device may be 
programmed in-person). We believe more time for further study would be 
appropriate, and that adding these services to the Medicare Telehealth 
Services List on a permanent basis beginning in CY 2024 would be 
premature.
    After consideration of public comments, we are finalizing as 
proposed. We are not adding these codes to the Medicare Telehealth 
Services List on a permanent basis.
(4) Therapy
    We received requests to add Therapy Procedures: CPT codes 97110, 
97112, 97116; Physical Therapy Evaluations: CPT codes 97161 through 
97164; Therapy Personal Care services: CPT code 97530; and Therapy 
Tests and Measurements services: CPT codes 97750, 97763 and 
Biofeedback: 90901, to the Medicare Telehealth Services List on a 
Category 1 or 2 basis. We have considered these codes over several 
years, in multiple cycles of annual rulemaking. In the CY 2017 final 
rule (81 FR 80198), we first assessed a request to add CPT codes 97110, 
97112, and 97116 (the therapy codes) to the Medicare Telehealth 
Services List. We did not add the codes to the Medicare Telehealth 
Services List at the time, because there was no emergency waiver 
providing an exception to the requirements under section 1834(m)(4)(E) 
of the Act, and physical therapists, occupational therapists, and 
speech-language pathologists were not eligible telehealth 
practitioners. In the CY 2018 final rule (82 FR 53008 and 53009), we 
reiterated our initial assessment that the codes were not appropriate 
to add to the Medicare Telehealth Services List, because the majority 
of the therapy codes listed above are furnished over 90 percent of the 
time by therapy professionals who are not included on the list of 
distant site practitioners who can furnish telehealth services at 
section 1834(m)(4)(E) of the Act. We stated that we believed that 
adding therapy services to the Medicare Telehealth Services List could 
result in confusion about who is authorized to furnish and bill for 
these services when furnished via telehealth (82 FR 53009).
    Section 3703 of Division A, Title III, Subtitle D of the 
Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Pub. L. 
116-136, enacted March 27, 2020) amended section 1135(b)(8) of the Act 
to give the Secretary emergency authorities to waive or modify Medicare 
telehealth payment requirements under section 1834(m) of the Act during 
the PHE for COVID-19. Using this authority, CMS issued a set of 
emergency waivers that included waiving the restrictions in section 
1834(m)(4)(E) of the Act on the types of practitioners who may furnish 
telehealth services. This allowed for therapy professionals to furnish 
telehealth services for the duration of the PHE. In the CY 2022 final 
rule (86 FR 65051), we reviewed another round of submissions requesting 
that CMS add therapy codes to the Medicare Telehealth Services List, 
and we again determined that these codes did not meet the Category 1 
criterion for addition to the list. In the CY 2023 PFS final rule (87 
FR 69451), through our review of evidence that was submitted by 
interested parties in support of adding these services to the Medicare 
Telehealth Services List on a Category 2 basis, we concluded that there 
was not sufficient information to determine whether all of the 
necessary elements of these services could be furnished remotely.
    In reviewing this year's request, the evidence submission includes 
evidence similar to what was submitted last year, with a few new 
additions suggesting that some elements of the individual services may 
have clinical benefit when furnished via telehealth, but not resolving 
uncertainty about whether other elements of the services can be fully 
furnished remotely via telehealth. The evidence submitted also suggests 
that receiving therapy services via telehealth in the home may offer 
some practical benefits, such as use of actual stairs in therapy 
exercise instead of artificial stairs, or meal preparation instructions 
focused on available kitchen tools and equipment. However, the evidence 
submitted for review leaves open questions as to whether such 
differences in the setting of care translate to a clinical benefit that 
is more than minor or incidental, in typical circumstances for the 
typical population of beneficiaries who may receive therapy services 
via telehealth.
    We note that for any submission, including submissions received for 
these therapy services, we consider all elements of a service as 
described by a particular HCPCS code and apply our

[[Page 78858]]

review criteria to the specific code. While some submitted information 
may focus on an individual service within one specific clinical 
scenario and furnished within one specific individual model of care 
delivery, that information may not be generalizable to the varied 
settings and scenarios under which the service would be typically 
furnished via telehealth. We reiterate that available evidence should 
give a reasonable degree of certainty that all elements of the service 
could fully and effectively be furnished by a remotely-located 
clinician using two-way, audio/video telecommunications technology.
    Based on the evidence we reviewed, we continue to question whether 
the findings from therapy studies that focused on a specific clinical 
issue for a narrow population (for example, joint replacement of a 
specific joint) translate to clinical benefit for some or many of the 
various other clinical issues that would typically be addressed when 
therapists furnish therapy services via telehealth to beneficiaries. 
Despite the evidence, we are still uncertain as to whether all of the 
elements of a therapy service could typically be furnished through use 
of only real-time, two-way audio/video communications technology. 
Because we continue to have these questions, we did not propose to add 
these services to the Medicare Telehealth Services List on a Category 1 
or 2 basis, for the same reasons described in our CY 2018 through CY 
2023 rulemaking cycles. Also, we continue to believe that adding these 
therapy services to the Medicare Telehealth Services List permanently 
would potentially generate confusion. As discussed in last year's final 
rule, we note that we do not have authority to expand the list of 
eligible Medicare telehealth practitioners to include therapists (PTs, 
OTs, or SLPs) after CY 2024 (87 FR 69449 through 69451). We note that 
the CAA, 2023, did not permanently change the list of practitioners who 
can furnish and bill for telehealth services; rather, the CAA, 2023, 
extended the current telehealth flexibilities through the end of CY 
2024. That said, we proposed to keep these therapy services on the 
Medicare Telehealth Services List until the end of CY 2024. We will 
consider any further action with regard to these codes in future 
rulemaking.
    Comment: Commenters requested that CMS continue coverage of the 
therapy codes even though physical therapists, occupational therapists, 
and speech therapists are not currently permitted by statute to provide 
telehealth services after CY 2024.
    Response: We direct readers to our discussion of these codes in the 
proposed rule, and we reiterate that we are still uncertain as to 
whether all of the elements of a therapy service could typically be 
furnished through use of only real-time, two-way audio/video 
communications technology. Further, we note that the scope of our 
proposals did not include coverage status of the codes, merely whether 
CMS should change the status of the codes on the telehealth list.
    After consideration of public comments, we are finalizing as 
proposed. These therapy services will remain on the Medicare Telehealth 
Services List until the end of CY 2024.
(5) Hospital Care, Emergency Department and Hospital
    We received a request to permanently add the following CPT codes to 
the Medicare Telehealth Services List:
     99221 (Initial hospital inpatient or observation care, per 
day, for the evaluation and management of a patient, which requires a 
medically appropriate history and/or examination and straightforward or 
low level medical decision making. When using total time on the date of 
the encounter for code selection, 40 minutes must be met or exceeded.)
     99222 (Initial hospital inpatient or observation care, per 
day, for the evaluation and management of a patient, which requires a 
medically appropriate history and/or examination and moderate level of 
medical decision making. When using total time on the date of the 
encounter for code selection, 55 minutes must be met or exceeded.)
     99223 (Initial hospital inpatient or observation care, per 
day, for the evaluation and management of a patient, which requires a 
medically appropriate history and/or examination and moderate level of 
medical decision making. When using total time on the date of the 
encounter for code selection, 55 minutes must be met or exceeded.)
     99234 (Hospital inpatient or observation care, for the 
evaluation and management of a patient including admission and 
discharge on the same date, which requires a medically appropriate 
history and/or examination and straightforward or low level of medical 
decision making. When using total time on the date of the encounter for 
code selection, 45 minutes must be met or exceeded.)
     99235 (Hospital inpatient or observation care, for the 
evaluation and management of a patient including admission and 
discharge on the same date, which requires a medically appropriate 
history and/or examination and moderate level of medical decision 
making. When using total time on the date of the encounter for code 
selection, 70 minutes must be met or exceeded.)
     99236 (Hospital inpatient or observation care, for the 
evaluation and management of a patient including admission and 
discharge on the same date, which requires a medically appropriate 
history and/or examination and high level of medical decision making. 
When using total time on the date of the encounter for code selection, 
85 minutes must be met or exceeded.)
     99238 (Hospital inpatient or observation discharge day 
management; 30 minutes or less on the date of the encounter)
     99239 (Hospital inpatient or observation discharge day 
management; more than 30 minutes on the date of the encounter)
     99281 (Emergency department visit for the evaluation and 
management of a patient that may not require the presence of a 
physician or other qualified health care professional)
     99282 (Emergency department visit for the evaluation and 
management of a patient, which requires a medically appropriate history 
and/or examination and straightforward medical decision making)
     99283 (Emergency department visit for the evaluation and 
management of a patient, which requires a medically appropriate history 
and/or examination and low level of medical decision making)
    In the March 31, 2020 interim final rule with comment period (IFC-
1) (85 FR 19234), we added the above services to the Medicare 
Telehealth Services List on a Category 2 basis for the duration of the 
PHE for COVID-19, for telehealth services with dates of service 
beginning March 1, 2020 through the end of the PHE (including any 
renewals of the PHE). When we previously considered adding these 
services to the Medicare Telehealth Services List, either through a 
public request or through our own internal review, we considered 
whether these services met the Category 1 or Category 2 criteria. In 
many cases, we reviewed requests to add these services to the Medicare 
Telehealth Services List on a Category 1 basis but did not receive or 
identify information that allowed us to determine whether these 
services should be added on a Category 2 basis (CY 2017 PFS final rule, 
at 81 FR 80194 to 80197). We reiterated that, while we do not believe 
the context of the PHE for COVID-19 changes the assessment of whether 
these services meet the Category 1 criterion, we reassessed all of 
these services to determine whether they meet the criteria for 
inclusion on

[[Page 78859]]

the Medicare Telehealth Services List on a Category 2 basis, in the 
context of the widespread presence of COVID-19 in the community. Given 
the exposure risks for beneficiaries, the health care work force, and 
the community at large, in-person interaction between professionals and 
patients posed an immediate potential risk that would not have been 
present when we previously reviewed these services in 2017. This risk 
created a unique circumstance where health care professionals needed to 
weigh the risks associated with disease exposure. For further 
background, in the CY 2021 final rule (FR 84506 through 84509), we 
explained the reasoning and considerations necessary for assigning a 
Category 3 status to certain codes that were added to the Medicare 
Telehealth Services List on a temporary basis during the PHE for COVID-
19. We believe that some risk of COVID-19 remains, but also remain 
uncertain that available evidence gives clear support for continuing to 
include these services on a permanent basis under the Category 2 
criterion.
    As discussed in the CY 2023 PFS final rule (86 FR 69450), we 
believe these hospital and emergency department services may continue 
to be furnished safely via two-way, audio-video communication 
technology. We did not propose to add these services to the list on a 
permanent basis at this time, but we did propose that they would remain 
available on the Medicare Telehealth Services List through CY 2024.
    Comment: Several commenters stated that because CMS had adopted the 
AMA CPT Editorial Committee's consolidation of E&M inpatient and 
observation codes that CMS should change their status on the telehealth 
list to make these codes permanent.
    Response: We acknowledge the CPT Editorial Panel deleted seven 
observation care codes and revised nine codes effective January 1, 
2023, to create a single set of codes for inpatient and observation 
care and also made changes to codes for inpatient and observation 
discharge. We adopted the E/M inpatient/observation revisions in the CY 
2023 PFS final rule. For further background, refer to 87 FR 69586 
through 69587. In the CY 2023 PFS final rule, when we finalized new 
valuations based on AMA RUC recommendations which included a change in 
code descriptors to reflect ``patient history and/or physical exam'' as 
one element of the service, we removed the legacy codes from the list 
and replaced these with the new code set. To reiterate, we have open 
questions of patient safety that we expect future submissions to 
address in full, as evidence generation builds (for example, 
publication of peer-reviewed literature, updates clinical practice 
guidelines, further study of hospital patient safety risks). We note 
that the initial impetus for including these services on the Medicare 
Telehealth Services List focused on the unique circumstance where 
health care professionals needed to weigh the risks associated with 
disease exposure during PHE for COVID-19. Now that the PHE has ended, 
we expect that future evidence submissions would address study of the 
appropriateness of furnishing these services via telehealth outside the 
context of a global pandemic. We note that we have no immediate 
evidence of patient safety risks associated specifically with 
furnishing these services via telehealth but we remain cautious and 
intend to monitor these services moving forward because of possible 
larger issues of patient safety.\3\ With regard to the code 
consolidation, we reiterate our concerns above, and note that prior to 
consolidation, none of the separate ``legacy'' codes, which are now 
consolidated, were on the Medicare Telehealth Services List on a 
permanent basis.
---------------------------------------------------------------------------

    \3\ Fleisher, L. A., Schreiber, M., Cardo, D., & Srinivasan, A. 
(2022). Health Care Safety during the pandemic and beyond -- 
building a system that ensures resilience. New England Journal of 
Medicine, 386(7), 609-611. https://doi.org/10.1056/nejmp2118285.
---------------------------------------------------------------------------

    After consideration of public comments, we are finalizing as 
proposed and will keep these hospital and emergency department services 
on the Medicare Telehealth Services List temporarily through CY 2024. 
We note that CPT codes 99231 through 99233 are codes that describe 
subsequent services, and are part of the same Hospital or Observation 
Care code family (CPT codes 99218-99236), and have permanent status on 
the Medicare Telehealth Services List. We continue to believe that new 
patients should be seen in person when the temporary telehealth 
flexibilities end, and as a result we are not changing determinations 
of the status of any of these codes.
(6) Health and Well-Being Coaching
    We received a request to permanently add the following three Health 
and Well-being Coaching services to the Medicare Telehealth Services 
List:
     CPT code 0591T (Health and well-being coaching face-to-
face; individual, initial assessment);
     CPT code 0592T (Health and well-being coaching face-to-
face; individual, follow-up session, at least 30 minutes); and
     CPT code 0593T (Health and well-being coaching face-to-
face; group (2 or more individuals), at least 30 minutes).
    We did not propose to add these health and well-being coaching 
services to the Medicare Telehealth Services List on a permanent basis, 
but we proposed to add them to the list on a temporary basis for CY 
2024. The evidence included in the submitter's request notes that these 
codes are similar to others already available on the Medicare 
Telehealth Services List. Further, it appears that all elements of 
these services may be furnished when using two-way interactive 
communications technology to replace the face-to-face elements of the 
service. The submission, which contained two published metanalyses of 
literature on the clinical topic and an additional pre-publication 
meta-analysis that focuses on outcomes and benefits of the delivery of 
virtual health and well-being coaching, leaves some open questions as 
to whether Medicare beneficiaries would receive meaningful clinical 
benefit from receiving virtual-only health and well-being coaching. 
While the evidence is clearly evolving, it does suggest that these 
services could possibly meet Category 2 criteria for inclusion on the 
Medicare Telehealth Services List as more evidence builds. We also 
noted in the proposed rule that the published meta-analyses in the 
submission make clear that further study is necessary for a broader 
range of medical professionals, because conceptual articles and 
research and existing practice articles focus on nurses but are sparse 
or silent about other general categories of medical professionals. We 
stated that we would expect that any evidence in support of adding 
these codes on a permanent basis should also establish clinical benefit 
when delivered directly by or under the supervision of the types of 
professionals who are Medicare telehealth practitioners. The 
metanalyses demonstrate that health coaching only requires a few hours 
of training, and few articles submitted to CMS discussed the intensity 
of health coach training at all. The pre-publication metanalysis 
submitted for review had less than definitive conclusions about 
``potential benefits'' of health and well-being coaching and hedged 
that the authors, ``did not find evidence of long-term benefit, 
possibly due to the paucity of studies examining longer-term outcomes. 
We caution that the certainty in the evidence for the majority of 
outcomes was either very low or low, primarily due to high risk of 
bias, heterogeneity, and impression.'' The submission and its content 
were

[[Page 78860]]

sufficient to serve as a basis for adding the codes to the Medicare 
Telehealth Services List on a temporary basis, and we appreciated the 
thoughtful and transparent way the submission laid out gaps in 
available evidence. More time is needed to potentially close these 
gaps. We are not aware of any evidence to suggest that it would be 
inappropriate to assign a temporary status to these codes. Therefore, 
we proposed to add the services to the Medicare Telehealth Services 
List on a temporary basis.
    Comment: Many commenters requested that CMS change the status of 
these codes to permanent. The commenters referenced that the National 
Board of Health and Wellness Coaches, which is an affiliate of the 
National Board of Medical Examiners, along with other standard-setting 
organizations, represent 28,000 qualified coaching professionals; 
additional evidence submitted addresses the rigor of training and 
certification requirements, as well as findings on clinical 
effectiveness of health and wellness coaching services delivered via 
telehealth to treat chronic disease prevalent in the Medicare 
population (for example, obesity, hypertension, diabetes, and COPD). 
The commenters asserted that over 9,500 health professionals have 
completed a certification exam, and approximately 20 percent of those 
holding certification also hold a clinical State license of some kind.
    Response: We thank commenters for the feedback and additional 
evidence submission. We acknowledge the findings presented in the 
additional evidence, and the qualifications required to achieve 
certification that comments referenced. We note that there are over 4 
million NPIs in the NPPES NPI Registry (http://npiregistry.cms.hhs.gov), and that we do not consider the number of 
certified individuals providing a service in determining the status of 
a service on the Medicare Telehealth List. Rather, when pointing to 
gaps in the available evidence supporting inclusion of a service on the 
list, we ask whether further study is necessary to establish the 
clinical benefit of a service for the Medicare population when the 
individual service is performed using only two-way interactive 
communications technology as a substitute for face-to-face interactions 
between the telehealth practitioner and the patient. The clinical value 
of the service is not at issue when CMS determines whether or how to 
include a service on the Medicare Telehealth Services List.
    We remind readers that one purpose of the telehealth review, and 
our ongoing claims monitoring process that examines utilization of 
telehealth services, is for CMS to act as an appropriate safeguard to 
ensure that beneficiaries can receive all of the elements and benefits 
of a service when that service is furnished via telehealth rather than 
in-person. CMS asks whether it is likely that a typical beneficiary 
receiving the service would receive any clinical benefit beyond mere 
incidental or minor clinical benefits when the service is performed by 
the typical telehealth practitioner. When assessing the clinical 
benefit of a service when furnished as a telehealth service, long-term 
and careful study over a period of years may be necessary. We believe 
the commenters are suggesting that there is potential clinical benefit 
to providing these services via telehealth, and we agree. Our initial 
review of evidence also indicates that these services can and should 
retain their current status on the Medicare Telehealth Services List 
for CY 2024. However, we remain cautious because the evidence and 
analyses provided by commenters appear anecdotal. In future evidence 
submissions, we would expect to see peer-reviewed literature, where the 
study population is typical of the Medicare population (for example, 
specific age bands in study populations), and the methods focus on 
evaluating utilization and outcomes (for example, claims data and 
analysis that includes the specific codes at issue). In summary, there 
is still a lack of scientific study that focuses on use of these codes 
via telehealth, and in clinical practice. We acknowledge that health 
coaches may have many types of backgrounds, and we note that we did not 
intend to question the standards and training of health coaches when we 
mentioned the variation in their credentialling in the proposed rule. 
We agree with commenters that suggested many eligible health 
practitioners would furnish these services to Medicare beneficiaries if 
they remained on the Medicare Telehealth Services List permanently. 
Even so, the clinical benefits of these services when furnished as 
telehealth services for the target population remain an open question 
in need of further study. We believe that this response should provide 
further clarity for the public as to the sorts of data that CMS would 
like to receive and review in future submissions.
    After consideration of public comments, we are finalizing as 
proposed. We will add these health and well-being coaching services to 
the Medicare Telehealth List on a temporary basis for CY 2024.
(7) CMS Proposal To Add New Codes to the List
    We proposed to add HCPCS code G0136 (Administration of a 
standardized, evidence-based Social Determinants of Health Risk 
Assessment tool, 5-15 minutes) to the Medicare Telehealth Services 
List. Our proposal to add HCPCS code G0136 to the list was contingent 
upon finalizing the service code description we proposed in section 
II.E. of the proposed rule. We refer readers to the proposal in section 
II.E. of the proposed rule for further background (88 FR 52293). We 
proposed that HCPCS code G0136, if finalized as proposed, would receive 
a permanent status on the Medicare Telehealth Services List. One 
element of the service describes a face-to-face encounter between the 
clinician and beneficiary. Practitioners use clinical judgement to 
determine whether to complete the SDOH screening with or without direct 
patient interaction. Because the service description, as defined in 
section II.E. of the CY 2024 proposed rule and finalized in section 
II.E. of this final rule, expects that a patient encounter may be 
necessary for accurate and complete screening, we believe that this 
element of the service describes an inherently face-to-face clinical 
activity. Further, using two-way interactive audio-video technology as 
a substitute for in-person interaction means an analogous level of care 
in that using either modality would not affect the accuracy or validity 
of the results gathered via a standardized screening tool. As discussed 
in section II.E. of the proposed rule, we proposed that this service 
must be furnished by the practitioner on the same date they furnish an 
E/M visit, as the SDOH assessment would be reasonable and necessary 
when used to inform the patient's diagnosis, and treatment plan 
established during the visit. Therefore, we noted that we believe HCPCS 
code G0136 describes a service that is sufficiently similar to services 
currently on the Medicare Telehealth Services List, specifically E/M 
services, and that this service should be added to the list on a 
permanent basis.
    Comment: Many commenters supported our proposals to include G0136 
(Administration of a standardized, evidence-based Social Determinants 
of Health Risk Assessment tool, 5-15 minutes) on the Medicare 
Telehealth List as a permanent code.
    Response: We thank commenters for the feedback.

[[Page 78861]]

    After consideration of public comments, we are finalizing as 
proposed and assigning HCPCS code G0136 (Administration of a 
standardized, evidence-based Social Determinants of Health Risk 
Assessment tool, 5-15 minutes) permanent status on the Medicare 
Telehealth List, beginning in CY 2024.
    Comment: Many commenters requested that CMS add Principal Illness 
Navigation (PIN) and Community Health Integration (CHI) services to the 
Medicare Telehealth List.
    Response: We refer readers to our discussion of the PIN and CHI 
services in section II.E. of this final rule. We did not propose to add 
these services to the Medicare Telehealth Services List for CY 2024 
because the elements of the individual services in the code descriptors 
may not typically require a face-to-face interaction, and therefore PIN 
(G0023, G0024, G0140, and G0146) and CHI (G0019, G0022) would not be 
considered as potential Medicare telehealth services under section 
1834(m) of the Act. We note that the possible use of asynchronous 
communications technology to support the provision of these services 
suggests that our policies for other communications-based technology 
services should apply instead.
c. Proposed Clarifications and Revisions to the Process for Considering 
Changes to the Medicare Telehealth Services List
1. Overview
    In CY 2020, CMS issued an array of waivers and new flexibilities 
for Medicare telehealth services to respond to the serious public 
health threats posed by the spread of COVID-19 (85 FR 19230). Our goal 
was to give individuals and entities that provide services to Medicare 
beneficiaries the flexibility to respond effectively to the serious 
public health threats posed by the spread of COVID-19. Recognizing the 
urgency of this situation and understanding that some pre-existing 
Medicare payment rules (including the statutory restrictions on 
telehealth originating sites and telehealth practitioners) needed to be 
modified to allow patients and practitioners to have access to 
necessary care while mitigating the risks from COVID-19, we used waiver 
and regulatory authorities to change certain Medicare payment rules 
during the PHE for COVID-19 so that physicians and other practitioners, 
home health and hospice providers, inpatient rehabilitation facilities, 
rural health clinics (RHCs), and federally qualified health centers 
(FQHCs) would be allowed broad flexibilities to furnish services using 
remote communications technology to avoid exposure risks to health care 
providers, patients, and the community.
    In 2003, as required by section 1834(m)(4)(F)(ii) of the Act, we 
established a process for adding or deleting services from the Medicare 
Telehealth Services List, which included consideration under two 
categories of criteria (Categories 1 and 2) (67 FR 79988). We finalized 
revisions to the Category 2 review criterion in the CY 2012 PFS final 
rule (76 FR 73102). Prior to CY 2020, CMS had not added any service to 
the Medicare Telehealth Services List on a temporary basis. In CY 2020, 
in response to the PHE for COVID-19, we revised the criteria for adding 
or removing services on the Medicare Telehealth Services List using a 
combination of emergency waiver authority and interim final rule 
making, so that some services would be available for the duration of 
the PHE on a ``temporary Category 2 basis.'' (85 FR 19234). In the CY 
2021 PFS final rule (85 FR 84507), we created a third, temporary 
category for services included on the Medicare Telehealth Services List 
on a temporary basis. This new Category 3 includes many, but not all of 
the services that we added temporarily to the Medicare Telehealth 
Services List during the COVID-19 PHE. Specifically, we reviewed the 
services we added temporarily in response to the COVID-19 PHE and 
identified those for which there is likely to be clinical benefit when 
furnished via telehealth, but there is not yet sufficient evidence 
available to add the services as permanent additions to the list. 
Services added to the Medicare Telehealth Services List on a temporary, 
Category 3 basis will ultimately need to meet the Category 1 or 2 
criteria in order to be added to the Medicare Telehealth Services List 
on a permanent basis.
    Between CY 2020 and CY 2023, we added many services to the Medicare 
Telehealth List on a temporary basis during the PHE, and through 
rulemaking, we also added many of these services on a Category 3 basis. 
Subsequent requests and evidence submitted to CMS supported possible 
status changes for some of the services that are currently included on 
the Medicare Telehealth Services List on a Category 3 basis. However, 
submissions sometimes confused our use of waiver authority and 
regulatory flexibilities tied to the COVID-19 PHE which allow us to 
temporarily add services to the Medicare Telehealth Services List 
through the end of the PHE, with the generally applicable categories 
and criteria we use to consider changes to the Medicare Telehealth 
Services List outside the circumstances of the COVID-19 PHE. Now that 
the PHE for COVID-19 has ended, we intend to clarify and modify our 
process for making changes to the Medicare Telehealth Services List. We 
believe these clarifications will help address potential confusion 
among interested parties that submit requests for additions to the 
Medicare Telehealth List stemming from the distinction between services 
that were added to the telehealth list on the basis of COVID-19 PHE-
related authorities versus services that were added temporarily on a 
Category 3 basis, which does not rely on any PHE-related authority. 
Specifically, we created the Category 3 basis for considering changes 
in the Medicare Telehealth Services List as part of the process we are 
required to establish under section 1834(m)(4)(F)(2) for considering 
changes to the list in part because, with the significant expansion of 
remotely-furnished services in response to the COVID-19 PHE, we 
recognized the emergence of new data suggesting that there may be 
clinical benefit when certain services are delivered via telehealth, 
but more time is needed to develop additional evidence to support 
potential addition of the services on a permanent, Category 1 or 
Category 2 basis. Under Category 3, services are added to the list on a 
temporary basis to allow them to continue to be furnished via 
telehealth while additional evidence is developed.
    In brief, throughout the COVID-19 PHE, we have reviewed all 
requests to add services to the Medicare Telehealth Services List and 
assessed whether the services in question should be added to the list, 
temporarily or permanently, under any of the criteria for Category 1, 
2, or 3. Further, we did not reject any submissions from interested 
parties simply because they requested consideration under a specific 
category, and the submitted data did not support adding the service to 
the Medicare Telehealth Services List on that basis. Instead, we 
considered whether the service(s) should be added to the Medicare 
Telehealth Services List on any basis.
    To avoid potential continuing confusion among those who submit 
requests to add services to the Medicare Telehealth Services List, and 
as we consider the expiration of the Medicare telehealth flexibilities 
extended by the CAA, 2023 through the end of CY 2024, we believe it 
would be beneficial to simplify our current taxonomy and multicategory 
approach to considering submitted requests. Further, we believe that 
simplification toward a binary

[[Page 78862]]

classification approach could address the confusion we have noticed 
from interested parties submitting requests during the PHE. The 
simplification restores the simple binary that existed with Category 1 
and 2, without displacing or disregarding the flexibility of Category 
3. We are finalizing our proposal to simply classify and consider 
additions to the Medicare Telehealth Services List as either permanent, 
or provisional.
    As we discussed in our CY 2024 proposed rule (88 FR 52262), to 
consider a request to add a service to the Medicare Telehealth Services 
List, we need evidence that supports how the telehealth service is 
either clinically equivalent to a telehealth service already 
permanently on the list, or evidence that presents studies where 
findings suggest a clinical benefit sufficient for the service to 
remain on the list to allow time for confirmative study. We reemphasize 
the need for clinical evidence because that evidence serves as the 
principal basis for our consideration of a request; and it is sometimes 
missing from submissions we receive.
    For example, we have received some submissions requesting the 
addition of services to the Medicare Telehealth Services List that are 
essentially framed as position papers advocating for changes in 
statutory requirements of section 1834(m) of the Act. While we do give 
such requests due consideration, the omission of clinical evidence to 
support the addition of a service to the Medicare Telehealth Services 
List using our established criteria generally leads us to conclude that 
the service should not be proposed for addition to the list. A fair and 
consistent review process for any and all submissions relies on a 
standard application of uniform, repeatable procedures for any 
individual submission, just as sound evidence should describe 
repeatable methods and replicable findings. Submissions that rely on 
narrative arguments for changes in the substantive requirements do not 
fit within such a fair and consistent review process. Therefore, we 
believe the following restatement of requirements and our review 
process is appropriate. We also proposed some procedural refinements to 
the review process, specifically incorporating additional 
considerations into our evaluation of services, that we believe would 
serve to maintain scope and focus in a post-PHE context. We discussed 
these proposed changes in detail in the CY 2023 PFS proposed rule and 
in the following section.
    Section 1834(m)(4)(F)(ii) of the Act requires that the Secretary 
establish a process that provides, on an annual basis, for the addition 
or deletion of services (and HCPCS codes), to the definition of 
telehealth services for which payment can be made when furnished via 
telehealth under the conditions specified in section 1834(m). As 
specified at Sec.  410.78(f), with the exception of a temporary policy 
that was limited to the PHE for COVID-19, we make changes to the list 
of Medicare telehealth services through the annual physician fee 
schedule rulemaking process. The proposed revisions to our current 
permanent policies, specifically our proposed assignment of a 
``permanent'' or ``provisional'' status to a service and changes in 
status as described below, reflect the stepwise method by which we 
proposed to consider future requests to add services to, remove 
services from, or change the status of, services on the Medicare 
Telehealth Services List, beginning for the CY 2025 Medicare Telehealth 
Services List, which will include submissions received no later than 
February 10, 2024.
2. Proposed Steps of Analysis for Services Under Consideration for 
Addition, or Removal, or a Change in Status, as Updates to the Medicare 
Telehealth Services List
    Step 1. Determine whether the service is separately payable under 
the PFS.
    When considering whether to add, remove, or change the status of a 
service on the Medicare Telehealth Services List, we proposed to first 
determine whether the service, as described by the individual HCPCS 
code, is separately payable under the PFS. Under section 1834(m)(1) of 
the Act, Medicare telehealth services are limited to those for which 
payment can be made to the physician or practitioner when furnished 
using an interactive telecommunications system notwithstanding that the 
practitioner furnishing the services is not in the same location as the 
beneficiary; and under section 1834(m)(2)(A) of the Act, Medicare pays 
the same amount for a telehealth service as if the service is furnished 
in person. As such, Medicare telehealth services are limited to those 
services for which separate Medicare payment can be made under the PFS.
    Thus, through Step 1, we would answer the threshold question of 
whether a service is separately payable under the PFS. During the PHE, 
many submissions for addition to the Medicare Telehealth Services List 
advocated for CMS to change the definition of ``Medicare telehealth 
service'' for their specific service; some of those submissions were 
for services that were not separately payable under the PFS.\4\ (87 FR 
69449). In the proposed rule, we anticipated that Step 1, if finalized, 
would encourage submissions that focus on a separately payable PFS 
service, and that the evidence included with those submissions will 
show how use of interactive, two-way, audio/video telecommunications 
technology allows a practitioner to complete an entire, specific 
service, described by a HCPCS code, that is equivalent to an in-person 
service.
---------------------------------------------------------------------------

    \4\ Services on the Medicare Telehealth List are used in the 
definition of Medicare telehealth. Some submissions may have 
conflated the distinction. Step 1 clarifies. Refer to the CMS 
website instructions for a Request for Addition at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Addition.
---------------------------------------------------------------------------

    We recognize that certain codes that had non-payable or bundled 
(not separately payable) status under the PFS before the PHE for COVID-
19 were temporarily included on the Medicare Telehealth Services List 
to facilitate access to health care services during the PHE. However, 
the PHE for COVID-19 has now expired.
    We believe that proposed Step 1, if finalized, would lessen the 
administrative burden of our telehealth services review process for 
both CMS and the public. We note that before gathering evidence and 
preparing to submit a request to add a service to the Medicare 
Telehealth Services List, the submitter should first check the payment 
status for a given service and ensure that the service (as identified 
by a HCPCS code), is a covered and separately payable service under the 
PFS (as identified by payment status indicators A, C, T, or R on our 
public use files). For a full list of all PFS payment status indicators 
and descriptions, see the Medicare Claims Processing Manual (IOM Pub. 
100-04, chapter 23, section 30.2.2) and the Addendum for the MPFSDB 
File Record Layout. Researchers and others preparing submissions should 
also refer to the data dictionaries available at https://resdac.org/cms-data/files/carrier-ffs/data-documentation, to review whether the 
methodology and conclusions contained in supporting evidence, or a 
submission itself, applies an appropriate methodology to study both 
individual services and individuals that are representative of the 
Medicare population.
    We further proposed that, if we find that a service identified in a 
submission is not separately payable under the PFS, we would not 
conduct any further

[[Page 78863]]

review of that service. We would identify the code submitted for 
consideration and explain that we did not propose it for addition. CMS 
sends confirmation from [email protected] when we 
receive a submission requesting addition of a service to, removal of a 
service from, or a change in status for a service included on, the 
Medicare Telehealth Services List. We proposed to inform each submitter 
in the confirmation whether the submission was complete, lacking 
required information, or outside the scope of issues we consider under 
the process for considering changes in the Medicare Telehealth Services 
List. We noted that we also expect submissions to include copies of any 
source material used to support assertions, which has been the 
longstanding direction included in our website instructions. For 
further background, refer to details available on our website at 
https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Addition.
    Step 2. Determine whether the service is subject to the provisions 
of section 1834(m) of the Act.
    If we determine at Step 1 that a service is separately payable 
under the PFS, we propose to apply Step 2 under which we would 
determine whether the service at issue is subject to the provisions of 
section 1834(m) of the Act. A service is subject to the provisions of 
section 1834(m) of the Act when at least some elements of the service, 
when delivered via telehealth, are a substitute for an in-person, face-
to-face encounter, and all of those face-to-face elements of the 
service are furnished using an interactive telecommunications system as 
defined in Sec.  410.78(a)(3). The aim of this step is to determine 
whether the service is, in whole or in part, inherently a face-to-face 
service. As we discussed in the CY 2018 PFS final rule (83 FR 59483), 
it has long been the case that certain services that are furnished 
remotely using communications technology are not considered Medicare 
telehealth services and are not subject to the requirements of section 
1834(m) of the Act. We proposed Step 2 to emphasize the circumstances 
under which the criteria under section 1834(m) of the Act apply, and 
also highlight circumstances in which the criteria under section 
1834(m) of the Act do not apply. As previously noted, section 1834(m) 
of the Act provides for payment to a physician or practitioner for a 
service furnished via an interactive telecommunications system 
notwithstanding that the furnishing practitioner and patient are not in 
the same location at the same amount that would have been paid if the 
service was furnished without the telecommunications system. We read 
this to mean that the scope of section 1834(m) of the Act is limited to 
services that would ordinarily be furnished with the furnishing 
practitioner and patient in the same location.
    Our application of Step 2 remains consistent with longstanding 
policy. We reiterate that there is a range of services delivered using 
certain telecommunications technology that do not fall within the scope 
of Medicare telehealth services, though they are separately payable 
under the PFS. Such services generally include services that do not 
require the presence of, or involve interaction with, the patient (for 
example, remote interpretation of diagnostic imaging tests, and certain 
care management services). Other examples include virtual check-ins, e-
visits, and remote patient monitoring services which involve the use of 
telecommunications technology to facilitate interactions between the 
patient and practitioner, but do not serve as a substitute for an in-
person encounter, for example, to assess whether an in-person or 
telehealth visit is needed or to transmit health information to the 
practitioner.
    In determining whether a service is subject to the provisions of 
section 1834(m) of the Act, we will consider whether one or more of the 
elements of the service, as described by the particular HCPCS code at 
issue, ordinarily involve direct, face-to-face interaction between the 
patient and practitioner such that the use of an interactive 
telecommunications system to deliver the service would be a substitute 
for an in-person visit. For interested parties preparing a request to 
add a service to the Medicare Telehealth Services List, we believe this 
Step 2 clarifies that a service must be inherently a face-to-face 
service. We believe reframing this Step 2 has the practical advantage 
of refining and improving consistency. We do not believe it would be 
appropriate to add a service to the Medicare Telehealth Services List 
if it is not subject to section 1834(m) of the Act. We would explain 
our finding in notice and comment rulemaking.
    Step 3. Review the elements of the service as described by the 
HCPCS code and determine whether each of them is capable of being 
furnished using an interactive telecommunications system as defined in 
Sec.  410.78(a)(3).
    We believe that the proposed Step 3 is fundamental to our 
commitment to health equity, as this step could have a beneficial 
impact on access to care for vulnerable populations. Step 3 is 
corollary to Step 2, and used to determine whether one or more elements 
of a service are capable of being delivered via an interactive 
telecommunication system as defined in Sec.  410.78(a)(3). In Step 3, 
we consider whether one or more face-to-face component(s) of the 
service, if furnished via audio-video communications technology, would 
be equivalent to the service being furnished in-person, and we seek 
information from submitters to demonstrate evidence of substantial 
clinical improvement in different beneficiary populations that may 
benefit from the requested service when furnished via telehealth, 
including, for example, in rural populations. The services are not 
equivalent when the clinical actions, or patient interaction, would not 
be of similar content as an in-person visit, or could not be completed. 
We note that completing each element of the defined service is a 
different question than whether a beneficiary receives any benefit at 
all from the telehealth-only form of a candidate service. The practical 
basis for Step 3 mirrors the practical basis for proposed Step 1 and 2, 
which is a consistent application of review criteria. Many submissions 
that CMS received during the PHE lacked evidence indicating that some 
or all elements of a service could be completed using an interactive 
telecommunications system without still requiring an in-person 
interaction with a patient to furnish the complete service. We note 
that studies of patient satisfaction alone, and submissions with an 
excessive focus on patient satisfaction alone, present risks of bias in 
many ways, possibly complicating or obfuscating the question of whether 
it is possible, or potentially safe, to deliver an inherently face-to-
face service via telehealth. Step 3 is integral to avoiding the 
possible unintended consequences of creating new gaps in care when 
telehealth is used as a substitute for in-person care.
    Step 4. Consider whether the service elements of the requested 
service map to the service elements of a service on the list that has a 
permanent status described in previous final rulemaking.
    The purpose of the proposed Step 4 of our analysis is to simplify 
and reduce the administrative burden of submission and review. For Step 
4, we proposed to consider whether the service elements of a code that 
we are considering for addition to, or removal from, the Medicare 
Telehealth Services List map to the service elements of a service that 
is already on the list and has a permanent status, because any code 
that satisfies this criterion would require no

[[Page 78864]]

further analysis: if a code describes a service that maps to the 
service elements of a code that is included on the Medicare Telehealth 
Services List on a permanent basis, we would add the code to the 
Medicare Telehealth Services List on a permanent basis.
    We note that section 1834(m)(4)(F)(i) of the Act defines telehealth 
services as professional consultations, office visits, and office 
psychiatry services (as identified as of July 1, 2000, by HCPCS codes 
99241-99275, 99201-99215, 90804-90809, and 90862 (and as subsequently 
modified by the Secretary)), and any additional service specified by 
the Secretary. Over the years, CMS has assigned Category 1 (permanent) 
status to services that were either included in the list of codes 
specified in section 1834(m)(4)(F)(i) of the Act or added as successor 
codes to those enumerated by statute. Successor codes are updates to or 
replacements for the codes listed in section 1834(m)(4)(F)(i) of the 
Act. Therefore, this proposed step would ensure that CMS includes 
successor codes on the Medicare Telehealth Services List. We note that 
even if a code that we are considering for addition to the Medicare 
Telehealth Services List is not a successor code, we would consider 
whether the service described in the submission is similar to 
professional consultations, office visits, and office psychiatry 
services that are already on the Medicare Telehealth Services List on a 
permanent basis. While we have not previously found that the elements 
of service we are considering for addition to the list map to the 
elements of a service that was previously added to the list on a 
permanent basis using the Category 2 criteria, we believe that it would 
be appropriate to apply this step 4 analysis to compare the candidate 
service with any permanent code that is on the list on a permanent 
basis. As such, in step 4, we proposed to maintain any previous 
analytical determinations from Steps 1 through 3 and directly map the 
successor code to a code on the list that has a permanent status 
described in previous final rulemaking. For example, if a code 
currently categorized as a finalized Category 2 permanent code was 
replaced or revised by a successor code in a future year, CMS would 
ensure that these revisions did not change the Step 1-3 results and add 
the successor code under Step 4. We further proposed that if we find 
that the service we are considering satisfies Step 4, we would end our 
review and propose to add the service to the Medicare Telehealth 
Services List on a permanent basis in the next PFS proposed rule. When 
Step 4 is met, further evidence review is not necessary. We proposed to 
continue to Step 5 if Step 4 was not met.
    Step 5. Consider whether there is evidence of clinical benefit 
analogous to the clinical benefit of the in-person service when the 
patient, who is located at a telehealth originating site, receives a 
service furnished by a physician or practitioner located at a distant 
site using an interactive telecommunications system.
    Similar to Steps 3, 4, and 5 above, the purpose of the proposed 
step 5 is to simplify and reduce the administrative burden. Under 
proposed Step 5, we would review the evidence provided with a 
submission to determine the clinical benefit of a service. We would 
then compare the clinical benefit of that service, when provided via 
telehealth, to the clinical benefit of the service if it were to be 
furnished in person. Proposed Step 5 would continue the existing 
standard that we have applied when considering whether to add a code to 
the Medicare Telehealth Services List on a Category 2 basis. We further 
proposed that: if there is enough evidence to suggest that further 
study may demonstrate that the service, when provided via telehealth, 
is of clinical benefit, CMS would assign the code a ``provisional'' 
status on the Medicare Telehealth Services List. Where the clinical 
benefit of a service, when provided via telehealth, is clearly 
analogous to the clinical benefit of the service when provided in 
person, CMS would assign the code ``permanent'' status on the Medicare 
Telehealth Services List, even if the code's service elements do not 
map to the service elements of a service that already has permanent 
status.
    We reminded readers that our evidentiary standard of demonstrated 
clinical benefit does not include minor or incidental benefits (81 FR 
80194), and if finalized, our proposal would not alter or displace this 
longstanding requirement. We will review the evidence submitted by 
interested parties, and other evidence that CMS has on hand. The 
evidence should indicate that the service can be safely delivered using 
two-way interactive audio-video communications technology. Clinical 
practice guidelines, peer-reviewed literature, and similar materials, 
should illustrate specifically how the methods and findings within the 
material establish a foundation of support that each element of the 
defined, individual service described by the existing face-to-face 
service code has been studied in the typical setting of care, typical 
population of beneficiaries, and typical clinical scenarios that 
practitioners would encounter when furnishing the service using only 
interactive, two-way audio-video communications technology to complete 
the visit or encounter with Medicare beneficiaries. This analysis is 
fundamental to either of the current Category 1 or Category 2 
descriptions.
    General evidence may also answer the question of whether a certain 
beneficiary population requiring care for a specific illness or injury 
may benefit from receiving a service via telehealth versus receiving no 
service at all, but must establish that the service is a substitute for 
an equivalent in-person service. Evidence should demonstrate how all 
elements described by the individual service code can be met when two-
way, interactive audio-video communications technology is used as a 
complete substitute for any face-to-face interaction required between 
the patient and practitioner that are described in the individual code 
descriptor. We further remind readers that submissions reflecting 
practitioner services furnished to Medicare beneficiaries are helpful 
in our considerations.
Proposed Assignment of ``Permanent'' or ``Provisional'' Status to a 
Service and Changes in Status
    We proposed to assign ``permanent'' or ``provisional'' status to 
any services for which the service elements map to the service elements 
of a service on the list that has a permanent status described in 
previous final rulemaking (see proposed step 4) or for which there is 
evidence of clinical benefit analogous to the clinical benefit of the 
in-person service when the service is furnished via telehealth by an 
eligible Medicare telehealth physician or practitioner (see proposed 
step 5). These two designations (that is, ``permanent'' or 
``provisional'') are intended to replace the Category 1-3 taxonomy that 
CMS currently uses. This proposed change is intended to reduce 
confusion regarding the status of codes on the Medicare Telehealth 
Services List and to simplify the outcome of our analysis. After a code 
receives the ``provisional'' status, as evidence generation builds, we 
may assign ``permanent'' status in a future year, or we may remove the 
service from the list in the interest of patient safety based on 
findings from ongoing monitoring of telehealth services within CMS and 
informed by publicly available information. We would revisit 
provisional status through our regular annual submissions and 
rulemaking processes where a submission provides new evidence, or our 
claims monitoring shows anomalous activity, or as indicated by patient 
safety

[[Page 78865]]

considerations. CMS would handle changes in status by revisiting the 
same steps 1 through 5 above.
Summary and Request for Feedback on Proposals To Update the Process of 
Review for Adding, Removing, or Changing the Status of Services on the 
Medicare Telehealth List
    In the proposed rule, we noted that the timeline for our proposed 
process to analyze submissions would remain the same. CY 2025 
submissions would be due by February 10, 2024. Additionally, we would 
continue to address each submitted request for addition, deletion, or 
modification of services on the Medicare Telehealth Services List 
through annual notice and comment rulemaking.
    As the end of the PHE for COVID-19 was uncertain at the time of 
last year's rule, many of the submissions for both CY 2023 and CY 2024 
involved requests to change the status of services on the Medicare 
Telehealth Services List from temporary to permanent. In other words, 
many requestors requested that CMS consider changing the status of one 
or more services from Category 3 to Category 1 or 2. Based on the 
number of requests we received asking that CMS assign a different 
status to a given service, we believe a clarification is necessary to 
remind readers of the steps that we take when analyzing a given service 
for addition to, removal from, or a change in status on the Medicare 
Telehealth Services List. Through this proposal, we intended to refine 
our process and reduce confusion going forward.
    To reiterate some of our discussion above, our proposals are 
consistent with the existing principles that CMS has applied to 
requests to add, remove, or change the status of a code during the 
COVID-19 PHE. When reviewing submissions during the PHE, in the absence 
of evidence supporting clinical benefit, but public comment expressing 
support for possible clinical benefit, CMS would generally accept a 
temporary addition to the Medicare Telehealth Services list, allowing 
more time for evidence generation. We anticipated that our approach 
would generally remain consistent with this particular point of 
flexibility if this proposal were finalized; a code could potentially 
receive provisional status on the Medicare Telehealth Services List in 
such a situation, with the caveat that our proposed Steps 1, 2, and 3, 
are thresholds for inclusion on the Medicare Telehealth Services List. 
If CMS finds that a service is not separately payable under the PFS 
(see proposed step 1) or it is not subject to section 1834(m) of the 
Act (see proposed Step 2), that service would not be added to the 
Medicare Telehealth Services List on any basis (and notice of the 
rejection would be provided to the submitter, as noted above). We do 
not intend to reject a submission based solely on the fact that the 
requestor did not request the appropriate basis for consideration; we 
would still analyze the submission based on the proposed steps, and 
then we would propose to add, remove, or change the status of the 
service, or we would explain why we were not doing so.
    We received comments on our proposed analysis procedures for 
additions to, removals from, or changes in status for services on the 
Medicare Telehealth Services List. The following is a summary of the 
comments we received and our responses.
    Comment: Overall, commenters agreed with our proposal. Many 
commenters expressed general support for our proposal to simplify our 
process for managing updates to the telehealth list. We did not receive 
any comments that requested CMS delay or forgo the proposed changes. 
Some commenters requested more clarity about the timing of updates and 
requested greater visibility into determinations of permanent or 
provisional services. Several commenters expressed concern that a 
static list may not be able to keep pace with innovation or asserted 
that CMS has not gone far enough with its temporary services policies 
to allow room for experimentation.
    Response: We note that our flexibility to make subregulatory 
changes to the Medicare Telehealth Services List expired at the end of 
the PHE. As a result, CMS must effectuate any change to the list 
through notice and comment rulemaking. Further, as we explained in our 
restatement of the longstanding criteria in this year's proposed rule, 
the points of evaluation, and timing of review period, both remain 
unchanged under our proposal. However, we believe modifications to our 
procedures may result in less confusion. Study and observation of these 
services in clinical practice add to available evidence, thereby 
continuing to address gaps in evidence. A revised process lends greater 
opportunity to focus on evidence generation. Whether a service has an 
appropriate valuation or whether a clinical action is appropriate as 
described in the service itself are not open questions, so submissions 
need not take up those questions. The matter at hand, is whether audio-
video communication can fully substitute in-person interactions and 
still complete the service while providing clinical benefit. 
Submissions should include verifiable and transparent studies that 
compare the typical beneficiary populations who receive the in-person 
service versus the telehealth service, and set forth methods, analysis, 
observations, and conclusions that address any differences in receiving 
in-person versus telehealth service.
    Comment: Some commenters suggested that CMS need not go beyond Step 
3 to determine whether a service should be included on the list. One 
commenter requested clarification as to whether Step 3 requires, 
``substantial clinical improvement.''
    Response: We disagree with commenters that only Steps 1-3 are 
necessary and remind readers that section 1834(m)(4)(F)(ii) of the Act 
requires that the Secretary establish a process that provides, on an 
annual basis, for the addition or deletion of services (and HCPCS 
codes), to the definition of telehealth services for which payment can 
be made when furnished via telehealth under the conditions specified in 
section 1834(m) of the Act. Since we added many services to the 
Medicare Telehealth List during the PHE, maintaining any of these 
additional services after the PHE would become difficult to administer 
in future years without Steps 4 and 5 (or something analogous) because 
Steps 1-3 only consider whether 1834(m) may apply, whereas later steps 
help us decide whether there is clinical benefit for a service when 
face-to-face interactions are substituted with the use of two-way 
audio-video communications technology.
    Stopping at Step 3 would leave us without some basis that the full 
service could be performed without fundamentally changing the design, 
meaning, and RVUs already established in making the code payable under 
the PFS, for any given code we review for consideration on our Medicare 
Telehealth List. Analysis of the effects of complete substitution of 
any and all of the otherwise in-person elements in a given code happens 
in two ways. If the individual code is so similar to the statutorily 
enumerated codes described in section 1834(m) of the Act, then the code 
may be added without further examination (that is, without Step 4).
    Responsive to concerns that the review process may not keep pace 
with innovation, we disagree that Steps 4 and 5 threaten innovation. We 
also do not believe that the update and review process for the Medicare 
Telehealth List should be the driver for innovation. We note this Step 
3 analysis is different from any substantial clinical improvement 
analysis. Our process is

[[Page 78866]]

intended to strike a balance between the uncertainty of innovation, 
which may not be well-accounted for in the framework of section 1834(m) 
of the Act, with our recent history of regulations promulgated to 
implement the statutory requirements of section 1834(m) of the Act.
    Comment: A few commenters expressed concern that we have hesitated 
or declined to extend telehealth flexibilities over the past 3 years 
and have added significant qualifiers, including in-person 
requirements, to mental health services. Other commenters expressed 
concern that maintaining the PHE flexibilities may interfere with the 
doctor-patient relationship or create the unintended consequence of 
reducing access and clinical benefits of in-person care. There remains 
a diversity of opinions across various interested parties.
    Response: We note that CMS has implemented a broad range of 
telehealth flexibilities and related policies to expand access to 
services and address gaps in care, including a focus on expanding 
access to behavioral health. We believe it is important to note that 
Congress mandated the in-person requirements for Medicare telehealth 
services for diagnosis, evaluation, or treatment of a mental health 
disorder through the CAA, 2021, and has twice delayed the requirement 
in the CAA, 2022 and CAA, 2023. As a result, we have not yet enforced 
the in-person requirement for telehealth services for diagnosing, 
evaluating, or treating a mental health disorder.
    We are finalizing, as proposed, our consolidation of categories for 
services currently on the Medicare Telehealth List, as described in the 
following section.
d. Consolidation of the Categories for Services Currently on the 
Medicare Telehealth Services List
    We also proposed consolidating Categories 1, 2, and 3, as proposed 
above, for all services currently on the Medicare Telehealth Services 
List. For CY 2024, we proposed to redesignate any services that are 
currently on the Medicare Telehealth Services List on a Category 1 or 2 
basis and would be on the list for CY 2024 to the proposed new 
``permanent,'' category while any services currently added on a 
``temporary Category 2'' or Category 3 basis would be assigned to the 
``provisional'' category. We believe redesignations in this calendar 
year would help ease confusion in future years, including in the event 
of subsequent legislation regarding Medicare telehealth services.
    Furthermore, for a code that receives provisional status, as 
evidence generation builds, we may grant the code a permanent status in 
a future year or remove the service from the list in the interest of 
patient safety based on findings from ongoing monitoring of telehealth 
services within CMS and informed by publicly available information. Our 
proposal did not set any specific timing for reevaluation of services 
added to the Medicare Telehealth Services List on a provisional basis 
because evidence generation may not align with a specific timeframe. 
Our proposal not to establish any specific timing for considering 
changes from provisional to permanent status avoids a potential 
situation in which we must remove provisional services from the 
Medicare Telehealth Services List because the set period tolls, only to 
later find evidence demonstrating that the removed service should 
receive permanent status. Under our proposal, we would assign a 
provisional status for codes that satisfy the proposed threshold steps 
(1, 2, and 3), and then the evidence available leaves a ``close call'' 
between permanent and provisional status. We do not assign provisional 
status when it is improbable that the code would ever achieve permanent 
status.
    We received comments on our proposal to consolidate categories for 
services currently on the Medicare Telehealth List. The following is a 
summary of the comments we received and our responses.
    Comment: Overall, commenters expressed support for our proposal to 
consolidate categories for services currently on the list. Some 
commenters requested that CMS set a specific timing, with more 
transparency about the change in status of provisional codes. 
Commenters also asserted that CMS should broaden its narrow 
interpretation of the requirements of section 1834(m) of the Act. Many 
commenters referenced the CONNECT for Health Act, HR 3875/S. 2016 
(refer to congress.gov/bill/118th-congress/house-bill/3875/committees?s=1&r=38).
    Response: We reiterate our discussion of timing and note that CMS 
has no plans to remove any provisional service from the current 
telehealth list where evidence generation remains in-process, and the 
individual code is subject to section 1834(m) of the Act. We would 
remove a provisional service from the list if evidence demonstrated 
patient safety issues. Our consideration of provisional services 
requires us to balance the statutory requirements of section 1834(m) of 
the Act with the availability of clinical evidence. The statutory and 
clinical research landscapes may change on a different timing and 
cadence.
    Regarding the timing and change in status of a provisional code to 
a permanent code, this change in status would depend on a few factors. 
For example, if we become aware of updated clinical guidelines 
reflecting changes that show it is appropriate for the Medicare 
population to receive a telehealth service identified as provisional, 
then we would consider that evidence as support for a potential change 
from provisional to permanent status. For further background, we refer 
readers to the section that follows. We disagree with commenters who 
suggested that our interpretation of section 1834(m) of the Act is 
excessively narrow.
    We believe it remains important to underscore that the purpose of 
designations of permanent versus provisional services on the Medicare 
Telehealth List is to signal where more study is necessary while 
avoiding the unintended consequence where a change in status itself 
drives the formation of new clinical standards or practices.
    Table 11 lists codes we are finalizing for the Medicare Telehealth 
Services List and includes the simplified categorization of each 
service as either provisional or permanent. The provisional services 
are those that are currently temporary, while the permanent services 
are those that are currently permanent as category 1 or 2. As in 
Medicare Telehealth Services Lists included in previous PFS final rules 
and posted on our website at https://www.cms.gov/medicare/coverage/telehealth/list-services, the audio-only column designates those 
services that may be furnished using audio-only technology, including 
telehealth services for mental health (including SUD). We are 
finalizing our proposal to use the simplified ``provisional'' or 
``permanent'' designations for the current year, and to apply our 
revised review process beginning with reviews for the CY 2025 PFS 
proposed rule.
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e. Implementation of Provisions of the CAA, 2023
(1) Overview and Background
    The CAA, 2022 included several provisions that extend certain 
Medicare telehealth flexibilities adopted during the COVID-19 PHE for 
151 days after the end of the PHE. Specifically, sections 301 through 
305 of Division P, Title III, Subtitle A of the CAA, 2022 amended 
section 1834(m) of the Act to generally extend certain PHE-related 
telehealth policies for services that were on the Medicare Telehealth 
Services List as of the date of enactment (March 15, 2021). The CAA, 
2022, temporarily removed restrictions on telehealth originating sites 
for those services to allow telehealth services to patients located in 
any site in the United States at the time of the telehealth service, 
including an individual's home;

[[Page 78872]]

expanded the definition of telehealth practitioners to include 
qualified occupational therapists, qualified physical therapists, 
qualified speech-language pathologists, and qualified audiologists; 
continued payment for telehealth services furnished by FQHCs and RHCs 
using the methodology established for those telehealth services during 
the PHE; delayed the requirement for an in-person visit with the 
physician or practitioner within 6 months prior to initiating mental 
health telehealth services to a beneficiary in their home, and again at 
subsequent intervals as the Secretary determines appropriate, as well 
as similar requirements for RHCs and FQHCs; and continued to provide 
for payment of telehealth services included on the Medicare Telehealth 
Services List as of the March 15, 2020, that are furnished via an 
audio-only telecommunications system. A full discussion of these 
policies available in the CY 2023 PFS final rule at 87 FR 69462.
    In addition, section 309 of the CAA, 2022 authorized the Secretary 
to implement the amendments described above, made by sections 301 
through 305, through program instruction or otherwise. In the CY 2023 
PFS final rule (87 FR 69446), we finalized specific telehealth policies 
to conform to and align with amendments made by the CAA, 2022. In our 
CY 2023 PFS final rule (87 FR 69462-69464), we described how CMS would 
issue program instructions to implement specific requirements of the 
CAA, 2022. We also implemented the provisions enacted in the CAA, 2022 
for a 151-day extension period of certain telehealth flexibilities 
(discussed previously in this final rule). On December 29, 2022, the 
President signed the CAA, 2023 into law. Section 4113 of the CAA, 2023 
further extends the previously-extended PHE-related telehealth 
policies; it requires CMS to extend the telehealth flexibilities that 
were previously extended (initially for 151 days after the end of the 
PHE) under the CAA, 2022, through December 31, 2024.
    We seek to address various telehealth policies that we finalized in 
the CY 2023 final rule, in light of the CAA, 2023. For example, the 
151-day extension period for certain flexibilities discussed in our CY 
2023 final rule (and previously in this final rule) no longer applies, 
since section 4113 of the CAA, 2023 extends these flexibilities until 
December 31, 2024 (the extended flexibilities include: temporary 
expansion of the scope of telehealth originating sites for services 
furnished via telehealth to include any site in the United States where 
the beneficiary is located at the time of the telehealth service, 
including an individual's home; expansion of the definition of eligible 
telehealth practitioners to include qualified occupational therapists, 
qualified physical therapists, qualified speech-language pathologists, 
and qualified audiologists; continued payment for telehealth services 
furnished by FQHCs and RHCs using the methodology established for those 
telehealth services during the PHE; delaying the requirement for an in-
person visit with the physician or practitioner within 6 months prior 
to initiating mental health telehealth services, and again at 
subsequent intervals as the Secretary determines appropriate, as well 
as similar requirements for RHCs and FQHCs; and continued coverage and 
payment of telehealth services included on the Medicare Telehealth 
Services List as of March 15, 2020) until December 31, 2024. Both the 
CAA, 2022 and CAA, 2023 have the same operative effect on the scope of 
Medicare telehealth services; both the CAA, 2022 and CAA, 2023 give the 
Secretary the authority to implement the relevant telehealth provisions 
outside of notice and comment rulemaking through program instruction or 
otherwise. We intend to implement the provisions discussed above, as 
enacted by the CAA, 2023.
    Similar to the goals of our telehealth policies addressed in last 
year's final rule, for CY 2024, we again seek to retain payment 
stability, reduce confusion, and burden, and conform to all statutory 
requirements without unnecessary restrictions on beneficiaries' access 
to telehealth care. Our discussion here does not alter payment amounts 
or billing rules that are in effect as of January 1, 2023, and those 
policies will remain in effect through December 31, 2024. Instead, it 
is our intent in this final rule to clarify that certain telehealth 
flexibilities that were previously extended until 151 days after the 
end of the PHE, by the CAA, 2022, have been extended until December 31, 
2024, in accordance with the amendments made by provisions of the CAA, 
2023.
(2) In-Person Requirements for Mental Health Telehealth
    Section 4113(d)(1) of section FF, Title IV, Subtitle B of the CAA, 
2023 amends section 1834(m)(7)(B)(i) of the Act to delay the 
requirement for an in-person visit with the physician or practitioner 
within 6 months prior to the initial mental health telehealth service, 
and again at subsequent intervals as the Secretary determines 
appropriate. In light of this amendment, the in-person requirements for 
telehealth services furnished for purposes of diagnosis, evaluation, or 
treatment of a mental health disorder will again be effective on 
January 1, 2025. In addition, 4113(d)(2) of section FF, Title IV, 
Subtitle B of the CAA, 2023 modified sections 1834(y) and 1834(o)(4) of 
the Act, respectively, to similarly delay in-person visit requirements 
for mental health visits furnished by Rural Health Clinics and 
Federally Qualified Health Centers via telecommunications technology. 
Therefore, we proposed to revise the regulatory text at Sec.  
[thinsp]410.78(b)(3)(xiv) and (b)(4)(iv)(D) to recognize the delay of 
the in-person requirements for mental health visits furnished by RHCs 
and FQHCs through telecommunication technology under Medicare until 
January 1, 2025, rather than until the 152nd day after the end of the 
PHE, to conform with the CAA, 2023. See section III.B. of this final 
rule for our provision to implement similar changes for RHC and FQHC 
mental health visits.
    We received public comments on the proposal to delay in-person 
requirements for mental health telehealth. The following is a summary 
of the comments we received and our responses.
    Comment: Some commenters supported our proposals to extend the 
delay of in-person requirements for mental health telehealth. We 
received many form letters in a coordinated response from state health 
organizations that requested we make the delay permanent. Some 
commenters highlighted that recent data suggest that even in complex 
patients with significant behavioral health issues, virtual-only care 
does not result in worse outcomes. The feedback also cited findings of 
significant behavioral healthcare workforce shortages that are likely 
to persist.\5\
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    \5\ Many commenters made general statements about shortages 
without specific studies or data. We did receive form letter 
responses with various sources for statistic, and some with sources 
unavailable. CMS staff found the following resource referenced in 
some comments, but at a different location. ``In 2021, health 
centers employed 17,415 full-time behavioral health staff, with 
psychiatrists and licensed clinical psychologists making up 10% of 
that workforce at 5% each. Document at https://www.nachc.org/wp-content/uploads/2023/07/Community-Health-Center-Chartbook-2023-2021UDS.pdf.
---------------------------------------------------------------------------

    Response: We thank commenters for the feedback. We understand why 
some commenters might want us to extend the delay of in-person 
requirements for mental health telehealth permanently, but we remind 
commenters that we are simply revising the regulations to conform to 
the requirements in section

[[Page 78873]]

4113(d) of section FF, title IV, Subtitle B of the CAA, 2023, which 
only delays in-person requirements for telehealth services furnished 
for purposes of diagnosis, evaluation, or treatment of a mental health 
disorder through the end of CY 2024.
    Comment: Some commenters stated that CMS should implement the in-
person requirements when the delay mandated by the CAA, 2023 expires. 
One life sciences company expressed concern that in absence of regular 
in-person care, practitioners may not appropriately manage therapy 
regimens for patients who receive medication to treat certain mental 
health conditions. A State-wide medical professional organization with 
a significant rural population cautioned against further delay of 
requirements and noted concern that direct-to-consumer telehealth 
entities may be engaging with beneficiaries in ways that raise 
concerns.\6\ One commenter stated that an indefinite delay of in-person 
requirements may risk communication benefits that come with in-person 
interactions important in the Medicare population.\7\
---------------------------------------------------------------------------

    \6\ The commenter included a link to investigative journalism 
focused on the issue, available at https://www.codastory.com/
waronscience/pseudohealth/telehealth-companies-misinformation/
#:~:text=Bypassing%20traditional%20healthcare,your%20health%20itself.

    \7\ The commenters referenced recent peer-reviewed literature 
available at https://journals.sagepub.com/doi/full/10.1177/10748407211031980.
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    Response: We thank commenters for the feedback, and we direct them 
to the statutory requirements specified in the CAA, 2023 and described 
in further detail previously in this section.
    We are finalizing as proposed our policy to delay in-person 
requirements for telehealth behavioral health services until January 1, 
2025.
    We remind suppliers of behavioral health services who furnish 
telehealth services to beneficiaries for purposes of diagnosis, 
treatment, and management of behavioral health conditions (including 
SUD), that the in-person requirements for behavioral telehealth 
services set forth in our regulations at Sec.  410.78(b)(3)(xiv) are 
set to take effect beginning for CY 2025. Section 410.78(b)(3)(xiv)(A) 
requires that the initial telehealth service shall be furnished only 
after an in-person visit within 6 months of the initial telehealth 
service; Sec.  410.78(b)(3)(xiv)(B) requires that any subsequent 
telehealth service, that is, for established patients with both a prior 
in-person visit, and an initial telehealth visit, must be furnished 
only when the beneficiary has received an in-person service no longer 
than 12 months prior; and Sec.  410.78(b)(3)(xiv)(B) provides 
flexibility to recognize beneficiary preferences, including that 
concerns of privacy or other burdens and risks may dictate a longer 
interval between the most recent in-person visit and a subsequent 
telehealth visit, when circumstances dictate an exception, the 
documentation substantiating the need for such an exception must be 
documented in the medical record; and Sec.  410.78(b)(3)(xiv)(C) 
specifies that either in-person requirement (initial or subsequent) may 
be met by another practitioner of the same specialty and subspecialty 
in the same group as the practitioner that furnishes the telehealth 
services only when the practitioner who furnishes the telehealth 
service is not available.
    We reiterate rules that we finalized and discussed at length in 
previous rulemaking (87 FR 69463 and 69464; 86 FR 65055 through 65059), 
in response to some confusion expressed by commenters on the scope of 
the in-person requirements, and divergent views on possible unintended 
consequences of maintaining or eliminating the in-person requirements. 
The regulations at Sec.  410.78(b)(3)(xiv) describe two exceptions to 
the in-person requirements that will go into effect on January 1, 2025: 
beneficiaries who already receive telehealth behavioral health services 
and have circumstances where in-person care may not be appropriate 
would have an exception and groups with limited availability for in-
person behavioral health visits would have available the flexibility to 
arrange for practitioners to furnish in-person and telehealth visits 
with different practitioners, based on availability.
(3) Originating Site Requirements
    Section 4113(a)(2) of the CAA, 2023 amended section 
1834(m)(4)(C)(iii) of the Act to temporarily expand the telehealth 
originating sites for any service on the Medicare Telehealth Services 
List to include any site in the United States where the beneficiary is 
located at the time of the telehealth service, including an 
individual's home, beginning on the first day after the end of the PHE 
for COVID-19 through December 31, 2024. The list of telehealth 
originating sites remains as listed in our regulation at Sec.  
410.78(b)(3).
    We received public comments on the proposal to temporarily expand 
telehealth originating sites to include the patient's home, for any 
non-mental health telehealth service on the Medicare Telehealth 
Services List through December 31, 2024. The following is a summary of 
the comments we received and our responses.
    Comment: Commenters urged CMS to maintain the definition of ``the 
patient's home'' under Sec.  410.78(b)(3) to broadly include homeless 
shelters, group homes, or other settings that the beneficiary 
identifies as their home or residence, whether permanent or temporary.
    Response: As discussed in the CY 2022 PFS final rule (FR 86 65059), 
our definition of home, both in general and for this purpose, continues 
to include temporary lodging such as hotels and homeless shelters. As 
stated in that final rule, for circumstances where the patient, for 
privacy or other personal reasons, chooses to travel a short distance 
from the exact home location during a telehealth service, the service 
is still considered to be furnished ``in the home of an individual'' 
for purposes of section 1834(m)(4)(C)(ii)(X) of the Act.
    Comment: We received many comments that requested CMS clarify 
policies related to, but separate from, our originating site proposals. 
Commenters expressed concerns regarding the expiring flexibility for 
telehealth practitioners to use their currently enrolled location 
instead of their home address when providing services from their home. 
CMS issued an FAQ, available at https://www.cms.gov/files/document/physicians-and-other-clinicians-cms-flexibilities-fight-covid-19.pdf, 
which extended the flexibility through December 31, 2023. We also met 
with a coalition of interested parties to receive feedback on this 
particular issue, during the comment period. The interested parties 
suggested that expiration of this flexibility poses a potential and 
imminent threat to public safety (that is, the safety of the health 
care workforce). In these comments and our meeting with the coalition, 
interested parties voiced concerns about the safety and privacy of 
health professionals who work from home and furnish telehealth 
services. Commenters requested that CMS take steps to protect 
telehealth practitioners by adjusting enrollment requirements so that 
individual practitioners did not have to list their home addresses on 
enrollment forms. The commenters also cited recent examples of 
workplace violence in health care facilities, where direct harm to 
nurses and other medical staff occurred. As an additional 
consideration, interested parties explained that a significant number 
of practices and providers would need to change billing practices or 
add their home address to the Medicare enrollment file, coordinating 
with the

[[Page 78874]]

appropriate Medicare Administrative Contractor in their jurisdiction.
    Response: We thank commenters for bringing this issue to our 
attention. Through CY 2024, we will continue to permit the distant site 
practitioner to use their currently enrolled practice location instead 
of their home address when providing telehealth services from their 
home. We will also consider this issue further for future rulemaking 
and request that interested parties provide clear examples of how the 
enrollment process shows material privacy risks to inform future 
enrollment and payment policy development. We request further 
information from interested parties to better understand the scope of 
considerations involved with including a practitioner's home address as 
an enrolled practice location when that address is the distant site 
location where they furnish Medicare telehealth services.
(4) Telehealth Practitioners
    Section 4113(b) of the CAA, 2023 amends section 1834(m)(4)(E) of 
the Act to require that qualified occupational therapists, qualified 
physical therapists, qualified speech-language pathologists, and 
qualified audiologists continue to be included as telehealth 
practitioners beginning on the first day after the end of the PHE for 
COVID-19 through December 31, 2024. Therefore, the list of telehealth 
practitioners remains as described in our CY 2023 final rule. We will 
also recognize marriage and family therapists (MFT) and mental health 
counselors (MHC) as telehealth practitioners, effective January 1, 
2024, in accordance with amendments made by section 4121 of the CAA, 
2023. That section of the CAA, 2023 amends section 1861(s)(2) of the 
Act by adding a new subparagraph (II) that establishes a new benefit 
category under Part B for marriage and family therapist services (as 
defined in section 1861(lll)(1)) of the Act and mental health counselor 
services (as defined in section 1861(lll)(3) of the Act). Further, 
section 4121(a)(5) of the CAA, 2023 amended section 1842(b)(18)(C) of 
the Act to add MFTs and MHCs to the list of practitioners to whom 
Medicare payment may be made for their services on a reasonable charge 
or fee schedule basis only on an assignment-related basis. Because the 
definition of practitioners in section 1834(m)(4)(E) of the Act for 
purposes of Medicare telehealth services includes the practitioners 
described in section 1842(b)(18)(C) of the Act, this provision also has 
the effect of adding MFTs and MHCs as practitioners who can furnish 
telehealth services.
    We proposed to amend Sec.  410.78(b)(2) to add new paragraphs (xi) 
and (xii) to specify that a marriage and family therapist as described 
in proposed Sec.  410.53 and a mental health counselor as described in 
proposed Sec.  410.54 are included as distant site practitioners for 
purposes of furnishing telehealth services.
    We received public comments on the proposal to permanently add MFTs 
and MHCs as distant site practitioners for purposes of furnishing 
telehealth services. The following is a summary of the comments we 
received and our responses.
    Comment: Commenters expressed support for our proposals.
    Response: After consideration of public comments, we are finalizing 
our proposal to add MFTs and MHCs as distant site practitioners for 
purposes of furnishing telehealth services. We are finalizing our 
proposed amendments to add MFTs and MHCs to the list of distant site 
practitioners in the telehealth regulation at Sec.  
410.78(b)(2)(xi),(xii).
(5) Audio-Only Services
    Section 4113(e) of Division FF, Title IV, Subtitle C of the CAA, 
2023 amends section 1834(m)(9) of the Act to require that the Secretary 
shall continue to provide for coverage and payment of telehealth 
services via an audio-only communications system during the period 
beginning on the first day after the end of such emergency period and 
ending on December 31, 2024. This provision applies only to telehealth 
services specified on the Medicare Telehealth Services List under 
section 1834(m)(4)(F)(i) of the Act that are permitted to be furnished 
via audio-only technology as of the date of enactment of the CAA, 2023 
(that is, December 29, 2022).
    As discussed below in the section titled ``Other Clarifications for 
Appropriate Billing,'' CPT codes 99441 through 99443 are on the 
Medicare Telehealth Services List and will remain actively priced 
through 2024. We proposed to continue to assign an active payment 
status to CPT codes 98966 through 98968 for CY 2024.
e. Place of Service for Medicare Telehealth Services
    When a physician or practitioner submits a claim for their 
professional services, including claims for telehealth services, they 
include a Place of Service (POS) code that is used to determine whether 
a service is paid using the facility or non-facility rate. Under the 
PFS, there are two payment rates for many physicians' services: the 
facility rate, which applies when the service is furnished in hospital 
or skilled nursing facility (SNF) setting, and the non-facility rate, 
which applies when the service is furnished in an office or other 
setting. The PFS non-facility rate is the single geographically 
adjusted fee schedule amount paid to a physician or other practitioner 
for services furnished in their office or other non-facility outpatient 
setting. The PFS facility rate is the single, geographically adjusted 
amount paid to a physician or other practitioner when a service is 
furnished in a hospital or SNF setting where Medicare is making a 
separate payment for the services to the facility in addition to the 
payment to the billing physician or practitioner for their professional 
services. This separate payment to the facility (hospital or SNF), 
often referred to as a ``facility fee,'' is made under other payment 
systems and reflects the facility's costs associated with the service 
(clinical staff, supplies, equipment, overhead) and is paid in addition 
to what is paid to the professional under the PFS.
    Prior to CY 2017, Medicare telehealth services were reported using 
the GT modifier. In the CY 2017 PFS final rule, we finalized creation 
of a new Place of Service (POS) code to identify services furnished as 
Medicare telehealth services, POS ``02'' (81 FR 80199-80201). In the CY 
2022 PFS final rule, we created a new POS code ``10'' to identify 
Medicare telehealth services for which the patient's home is the 
originating site (87 FR 70110 and 70111).
    In response to the PHE for COVID-19, we adopted temporary policies 
for POS codes and PFS payment rates applicable to Medicare telehealth 
services. As discussed in the March 31, 2020 IFC, (85 FR 19230), we 
stated that, as physician practices suddenly transitioned a potentially 
significant portion of their services from in-person to telehealth 
visits in the context of the PHE for COVID-19, the relative resource 
costs of furnishing these services via telehealth may not significantly 
differ from the resource costs involved when these services are 
furnished in-person. Therefore, we instructed physicians and 
practitioners who billed for Medicare telehealth services to report the 
POS code that they would have reported had the service been furnished 
in-person. This would allow our systems to make appropriate payment for 
services furnished via Medicare telehealth, which, if not for the PHE 
for COVID-19, would have been furnished in-person, at the same rate 
they would have been paid if the services were furnished in-person. In 
order to effectuate this

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change, we finalized on an interim basis (85 FR 19233) the use of the 
CPT telehealth modifier, modifier ``95'', for the duration of the PHE 
for COVID-19, which is applied to claim lines that describe services 
furnished via telehealth; and that the practitioner should report the 
POS code where the service would have occurred had it not been 
furnished via telehealth. This allowed telehealth services to be paid 
at the PFS non-facility rate.
    We further noted that we were maintaining the facility payment rate 
for services billed using the general telehealth POS code ``02'', 
should practitioners choose to maintain their current billing practices 
for Medicare telehealth during the PHE for COVID-19. In the CY 2023 PFS 
final rule (87 FR 69467), we finalized that we would continue to 
maintain payment at the rate for a service had the service been 
furnished in person, and that this would allow payments to continue to 
be made at the non-facility based rate for Medicare telehealth services 
through the latter of the end of CY 2023 or the end of the calendar 
year in which the PHE ends.
    In the CY 2023 PFS final rule (87 FR 69467), we finalized that, 
following the end of the end of the calendar year in which the PHE 
ends, practitioners will no longer bill claims with Modifier `95' along 
with the POS code that would have applied had the service been 
furnished in person, and telehealth claims will instead be billed with 
the POS indicators:
     POS ``02''--is redefined as Telehealth Provided Other than 
in Patient's Home (Descriptor: The location where health services and 
health related services are provided or received, through 
telecommunication technology. Patient is not located in their home when 
receiving health services or health related services through 
telecommunication technology.); and
     POS ``10''--Telehealth Provided in Patient's Home 
(Descriptor: The location where health services and health related 
services are provided or received through telecommunication technology. 
Patient is located in their home (which is a location other than a 
hospital or other facility where the patient receives care in a private 
residence) when receiving health services or health related services 
through telecommunication technology.).
    We recognize that, beginning with the PHE for COVID-19, behavioral 
health services that otherwise would have been furnished in-person have 
been furnished via telehealth in the patient's home. With few 
exceptions, prior to the PHE for COVID-19, originating sites were 
limited to sites such as physician's offices and hospitals. Now that 
behavioral health telehealth services may be furnished in a patient's 
home, which now may serve as an originating site, we believe these 
behavioral health services are most accurately valued the way they 
would have been valued without the use of telecommunications 
technology, namely in an office setting. There was an increase in 
utilization of these mental health services during the PHE that has 
persisted throughout and after expiration of the PHE for COVID-19. It 
appears that practice patterns for many mental health practitioners 
have evolved, and they are now seeing patients in office settings, as 
well as via telehealth. As a result, these practitioners continue to 
maintain their office presence even as a significant proportion of 
their practice's utilization may be comprised of telehealth visits. As 
such, we stated that we believe their practice expense (PE) costs are 
more accurately reflected by the non-facility rate.
    Therefore, we proposed that, beginning in CY 2024, claims billed 
with POS 10 (Telehealth Provided in Patient's Home) would be paid at 
the non-facility PFS rate. When considering certain practice situations 
(such as in behavioral health settings, where practitioners have been 
seeing greater numbers of patients via telehealth), practitioners will 
typically need to maintain both an in-person practice setting and a 
robust telehealth setting. We expect that these practitioners will be 
functionally maintaining all of their PEs, while furnishing services 
via telehealth. When valuing services, we believe that there are few 
differences in PE when behavioral health services are furnished to a 
patient at home via telehealth as opposed to services furnished in-
person (that is, behavioral health settings require few supplies 
relative to other healthcare services). Claims billed with POS 02 
(Telehealth Provided Other than in Patient's Home) will continue to be 
paid at the PFS facility rate beginning on January 1, 2024, as we 
believe those services will be furnished in originating sites that were 
typical prior to the PHE for COVID-19, and we continue to believe that, 
as discussed in the CY 2017 PFS final rule (81 FR 80199 through 80201), 
the facility rate more accurately reflects the PE of these telehealth 
services; this applies to non-home originating sites such as 
physician's offices and hospitals. In this way, we believe we would be 
protecting access to mental health and other telehealth services by 
aligning with telehealth-related flexibilities that were extended via 
the CAA, 2023, as we will be more accurately recognizing the resource 
costs of behavioral health providers, given shifting practice models.
    We received public comments on the proposal that claims billed with 
POS 10 be paid at the non-facility PFS rate, and claims billed with POS 
02 will continue to be paid at the facility rate. The following is a 
summary of the comments we received and our responses.
    Comment: Many commenters stated that our proposal would enhance 
patient access and protect payment parity. Other commenters supported 
paying claims billed with POS 10 at the non-facility rate but opposed 
maintaining payment for claims billed with POS 02 at the facility rate, 
stating that this will reduce access to telehealth services by 
disincentivizing office-based practices by paying a lower PE RVU in 
instances where there is a site of service differential. A few 
commenters opposed paying the non-facility rate for any telehealth 
service, stating that the facility rate more accurately reflects the 
resource-based costs of telehealth services. Some commenters urged us 
to continue allowing practitioners to report the POS code that they 
would have used had the service been furnished in person. One commenter 
urged us to gather more data on the PE resource costs associated with 
telehealth services for a range of services before paying the higher, 
non-facility rate; this commenter stated that if rates for telehealth 
services continue to be set equal to rates for in-office services, 
providers may face a strong financial incentive to favor these services 
over comparable in-person services, even when an in-person service may 
be more clinically appropriate. A commenter requested that CMS wait 
until the potential implementation of the telemedicine codes that CPT 
is considering for 2025 until revising the current place of service 
policy for telehealth services.
    Response: Telehealth services that are not furnished in the 
patient's home will continue to be furnished in the same types of 
originating sites in which they were furnished prior to the PHE, such 
as hospitals or rural health clinics; therefore, the resource costs 
associated with these services will resemble those of services 
furnished in person in a facility setting as they did prior to the PHE. 
As discussed in the 2017 final rule (81 FR 80199-80200), for telehealth 
services, we believe that facility costs (clinical staff, supplies, and 
equipment) associated with furnishing the service would generally be 
incurred by the originating site, where the patient is located, and not 
by the practitioner at

[[Page 78876]]

the distant site. The statute requires Medicare to pay a fee to the 
site that hosts the patient. This is analogous to the circumstances 
under which the facility PE RVUs are used to pay for services under the 
PFS. That is why we believe that the facility PE RVUs most accurately 
reflect the resource costs for telehealth services when the home is not 
the originating site. We note that beginning in 2025, most telehealth 
services will once again be subject to the statutory restrictions under 
section 1834(m)(4), including the limitation on payment for telehealth 
services to those furnished in specified originating sites and in areas 
that are designated as a rural health professional shortage area or in 
a county that is not included in a Metropolitan Statistical Area and to 
sites that are certain medical facilities such as physician offices, 
hospitals, and skilled nursing facilities. Following 2024, mental 
health telehealth services, as previously noted, as well as certain 
other services including End-Stage Renal Disease (ESRD)-related 
services for home dialysis, will continue to be paid when furnished in 
the patient's home without geographic restrictions. They will more 
likely be furnished by office-based mental health practitioners. 
Practitioners furnishing mental health services via telehealth will 
more typically be practicing in non-facility based settings, rather 
than in facility settings that are associated with originating sites 
that were eligible originating sites prior to the addition of the home 
as an originating site, and they are therefore more likely to have 
office-based practices and so are incurring all of those resource 
costs. Beginning in 2025, in-person visit requirements will apply for 
mental health services furnished via telehealth. This includes a 
required in-person visit within the six months prior to the initial 
telehealth treatment as well as the requirement that subsequent in-
person visits be furnished at least every 12 months. Therefore, mental 
health practitioners necessarily will be maintaining offices as they 
will be required to have in-person visits, and we believe they will be 
incurring the PE costs of maintaining these hybrid models. We also note 
that claims data indicate that during the PHE, the majority of mental 
health services that were furnished via telehealth were billed with the 
POS associated with the office setting. We believe that for mental 
health services furnished via telehealth, resource costs will be 
incurred by the distant site provider, where the practitioner is 
located, and not by the originating site, unlike other telehealth 
services for which we believe the resource costs will continue to be 
incurred by the originating site, where the patient is located, and not 
by the practitioner at the distant site. Therefore, we continue to 
believe that paying for claims billed with POS 10 at the non-facility 
rate while continuing to pay for claims billed with POS 02 at the 
facility rate most accurately captures the resource costs inherent in 
these types of telehealth visits.
    Comment: A commenter requested that CMS clarify that CMS will pay 
the PFS non-facility rate for any service appended with POS 10, not 
just mental health services.
    Response: We clarify that any service appropriately billed with POS 
10 will be paid at the non-facility rate.
    Comment: A few commenters requested that CMS clarify the 
appropriate billing and payment for telehealth services when the 
clinician is in the hospital and the patient is in the home, and 
whether we require that facility-based clinicians should report POS 02.
    Response: We wish to clarify that for telehealth services, when the 
clinician is in the hospital and the patient is in the home, the 
billing practitioner should use a hospital POS code along with modifier 
`95.'
    Comment: Some commenters requested that CMS confirm that all 
outpatient therapy telehealth services will continue to be paid at the 
non-facility rate regardless of the POS code, citing manual language in 
Chapter 12 Section 20.4.2 that states: ``Non-facility rates are 
applicable to outpatient rehabilitative therapy procedures, including 
those relating to physical therapy, occupational therapy and speech-
language pathology, regardless of whether they are furnished in 
facility or non-facility settings.''
    Response: We wish to clarify that, for outpatient therapy services 
furnished via telehealth by PT, OT, or SLP distant site practitioners, 
the furnishing practitioner should continue to append the 95 modifier 
to identify them as telehealth services rather than a telehealth POS 
code. We also note that payment will continue to be made for telehealth 
services furnished by distant site PTs, OTs, or SLPs through the end of 
CY 2024, and that these services will continue to be paid the non-
facility rate.
    Comment: Some commenters expressed uncertainty about whether use of 
POS 10 would be appropriate when furnishing telehealth services to 
beneficiaries located in their homes for reasonable and necessary care 
related to the treatment of an injury or illness for something not 
related to the diagnosis, treatment, or management of an ongoing 
behavioral health, mental health, or SUD issue.
    Response: After consideration of public comments, we are finalizing 
as proposed that beginning in CY 2024, claims for telehealth services 
billed with POS 10 will be paid at the non-facility PFS rate. Claims 
billed with POS 02 will continue to be paid at the facility rate. In 
addition, we are clarifying that modifier '95' should be used when the 
clinician is in the hospital and the patient is in the home, as well as 
for outpatient therapy services furnished via telehealth by PT, OT, or 
SLP.
f. Frequency Limitations on Medicare Telehealth Subsequent Care 
Services in Inpatient and Nursing Facility Settings, and Critical Care 
Consultations
    When adding some services to the Medicare Telehealth Services List 
in the past, we have included certain restrictions on how frequently a 
service may be furnished via Medicare telehealth. These limitations 
include a limit of once every 3 days for subsequent inpatient visits, 
added in in the CY 2011 PFS final rule (75 FR 73317 through 73318), and 
once every 14 days for subsequent nursing facility (NF) visits, added 
in the CY 2016 final rule (80 FR 71062) furnished via Medicare 
telehealth and a limit of once per day for critical care consultation 
services; in establishing these limits, we cited concerns regarding the 
potential acuity of these patients. End-stage renal disease (ESRD)-
related clinical assessments may be furnished via telehealth, subject 
to the frequency limitations in section 1881(b)(3)(B) of the Act, which 
provides that patients must receive a face-to-face visit, without the 
use of telehealth, at least monthly in the case of the initial 3 months 
of home dialysis and at least once every 3 consecutive months after the 
initial 3 months.
    In the March 31, 2020 COVID-19 IFC (85 FR 19241), we stated that as 
it was our assessment that there was a patient population who would 
otherwise not have had access to clinically appropriate in-person 
treatment, and we did not believe these frequency limitations were 
appropriate or necessary under the circumstances of the PHE. Therefore, 
we removed the frequency restrictions for certain subsequent inpatient 
visits, subsequent NF visits, and for critical care consultations 
furnished via Medicare telehealth for the duration the PHE for COVID-
19. The frequency limitations resumed effect beginning on May 12, 2023, 
(upon expiration of the PHE), in accordance with the March 31, 2020

[[Page 78877]]

IFC. However, we stated that, pursuant to waiver authority added under 
section 1135(b)(8) of the Act by the Coronavirus Preparedness and 
Response Supplemental Appropriations Act, 2020,\8\ we were exercising 
enforcement discretion and will not consider these frequency 
limitations through December 31, 2023; and that we anticipated 
considering our policy further through our rulemaking process. As 
discussed below, we proposed once again remove these telehealth 
frequency limitations beginning CY 2024. We proposed to remove the 
telehealth frequency limitations for the following codes:
---------------------------------------------------------------------------

    \8\ https://www.cms.gov/files/document/physicians-and-other-clinicians-cms-flexibilities-fight-covid-19.pdf.
---------------------------------------------------------------------------

1. Subsequent Inpatient Visit CPT Codes
     99231 (Subsequent hospital inpatient or observation care, 
per day, for the evaluation and management of a patient, which requires 
a medically appropriate history and/or examination and straightforward 
or low level of medical decision making. when using total time on the 
date of the encounter for code selection, 25 minutes must be met or 
exceeded.);
     99232 (Subsequent hospital inpatient or observation care, 
per day, for the evaluation and management of a patient, which requires 
a medically appropriate history and/or examination and moderate level 
of medical decision making. when using total time on the date of the 
encounter for code selection, 35 minutes must be met or exceeded.); and
     99233 (Subsequent hospital inpatient or observation care, 
per day, for the evaluation and management of a patient, which requires 
a medically appropriate history and/or examination and high level of 
medical decision making. when using total time on the date of the 
encounter for code selection, 50 minutes must be met or exceeded.)
2. Subsequent Nursing Facility Visit CPT Codes
     99307 (Subsequent nursing facility care, per day, for the 
evaluation and management of a patient, which requires a medically 
appropriate history and/or examination and straightforward medical 
decision making. when using total time on the date of the encounter for 
code selection, 10 minutes must be met or exceeded.);
     99308 (Subsequent nursing facility care, per day, for the 
evaluation and management of a patient, which requires a medically 
appropriate history and/or examination and low level of medical 
decision making. when using total time on the date of the encounter for 
code selection, 15 minutes must be met or exceeded.);
     99309 (Subsequent nursing facility care, per day, for the 
evaluation and management of a patient, which requires a medically 
appropriate history and/or examination and moderate level of medical 
decision making. when using total time on the date of the encounter for 
code selection, 30 minutes must be met or exceeded.); and
     99310 (Subsequent nursing facility care, per day, for the 
evaluation and management of a patient, which requires a medically 
appropriate history and/or examination and high level of medical 
decision making. when using total time on the date of the encounter for 
code selection, 45 minutes must be met or exceeded.)
3. Critical Care Consultation Services: HCPCS Codes
     G0508 (Telehealth consultation, critical care, initial, 
physicians typically spend 60 minutes communicating with the patient 
and providers via telehealth.); and
     G0509 (Telehealth consultation, critical care, subsequent, 
physicians typically spend 50 minutes communicating with the patient 
and providers via telehealth.)
    We proposed to remove the frequency limitations for these codes for 
the duration of CY 2024, which aligns with other telehealth-related 
flexibilities extended by the CAA, 2023. CMS is broadly assessing our 
telehealth regulations, in light of the way practice patterns may have 
changed in the roughly 3 years of the PHE for COVID-19 and, while we 
engage in this assessment, we believe it is reasonable to pause certain 
pre-pandemic restrictions, such as these frequency limitations, to 
allow us to gather more information. We are seeking information from 
interested parties on how practitioners have been ensuring that 
Medicare beneficiaries receive subsequent inpatient and nursing 
facility visits, as well as critical care consultation services since 
the expiration of the PHE.
    We received public comments on our proposals to remove frequency 
limitations for Medicare Telehealth Subsequent Care Services in Nursing 
Facility Settings, Subsequent Nursing Facility Visit, and Critical Care 
Consultations. The following is a summary of the comments we received 
and our responses.
    Comment: Many commenters supported our proposal to remove frequency 
limitations for 2024 for Medicare Telehealth Subsequent Care Services 
in Nursing Facility Settings, Subsequent Nursing Facility Visit, and 
Critical Care Consultations, stating that these frequency limitations 
are arbitrary and would result in decreased access to care, potentially 
leading to negative clinical outcomes. Some commenters urged us to 
remove these limits permanently; according to one such commenter, 
practitioners should be allowed to use their clinical judgment to 
determine the type of visit, how many visits, and the type of treatment 
that is the best fit for the patient so long as the standard of care is 
met. A commenter stated that the lifting these limitations during the 
PHE has been instructive and demonstrates the value of continuing such 
flexibilities. Another commenter stated that removing frequency 
limitations helps practitioners keep patients in SNFs from being 
unnecessarily evaluated in Emergency Departments and prevents 
readmissions. In response to our concerns regarding patient safety and 
program integrity, a commenter urged the agency to closely monitor 
utilization patterns to determine whether the elimination of these 
limitations leads to an increase in inappropriate utilization. A few 
commenters did not support this proposal, stating that continuing to 
waive these limitations without any guardrails will compromise patient 
safety, as they do not believe that it is best practice for patients in 
acute care settings (unless such settings are in rural or underserved 
areas) to be treated daily via non-face-to-face telehealth visits/
consultations in lieu of in-person visits. Similarly, another commenter 
stated that telehealth patient assessments and evaluations are never 
the same as in-person, hands on visits and should not be considered a 
viable replacement with no limitations for in-person care.
    Response: We believe that continuing to suspend these frequency 
limitations on a temporary basis for CY 2024 will allow us more time to 
continue to evaluate patient safety while preserving access in a way 
that is not disruptive to practice patterns that were established 
during the PHE. We look forward to evaluating the information received 
in response to this comment solicitation, as well as utilization data 
and other data as we consider the most appropriate way to balance 
patient safety concerns with the interest of supporting healthcare 
access. We expect to address in future rulemaking.
    Comment: A commenter stated that we should exercise enforcement 
discretion for telehealth frequency limitations for home dialysis 
clinical assessment while gathering information and evaluating changing 
practice

[[Page 78878]]

patterns. The commenter noted that, without explanation, CMS is again 
not extending the enforcement discretion to ESRD clinical assessments, 
even though there has similarly been a change in practice patterns for 
nephrologists during the PHE.
    Response: We appreciate the commenters' concern; however, outside 
of the circumstances of the PHE for COVID-19, we are continuing to 
enforce the statutory requirement for in-person visits associated with 
ESRD-related clinical assessments as established at section 
1881(b)(3)(B) of the Act which requires that an individual determined 
to have end stage renal disease receiving home dialysis receive a face-
to-face visit, without the use of telehealth, at least monthly in the 
case of the initial 3 months of home dialysis and at least once every 3 
consecutive months after the initial 3months
    After consideration of public comments, we are finalizing as 
proposed our proposal for CY 2024 to continue the removal of Medicare 
telehealth services frequency limitations for Subsequent Inpatient 
Visit, Subsequent Nursing Facility Visit, and Critical Care 
Consultation Services.
2. Other Non-Face-to-Face Services Involving Communications Technology 
Under the PFS
a. Direct Supervision via Use of Two-Way Audio/Video Communications 
Technology
    Under Medicare Part B, certain types of services, including 
diagnostic tests, services incident to physicians' or practitioners' 
professional services, and other services, are required to be furnished 
under specific minimum levels of supervision by a physician or 
practitioner. For most services furnished by auxiliary personnel 
incident to the services of the billing physician or practitioner (see 
Sec.  410.26) and many diagnostic tests (see Sec.  410.32), direct 
supervision is required. Additionally, for pulmonary rehabilitation 
services (see Sec.  410.47) and for cardiac rehabilitation and 
intensive cardiac rehabilitation services (see Sec.  410.49), direct 
supervision by a physician, PA, NP, or CNS is required (see also Sec.  
410.27(a)(1)(iv)(B)(1) for hospital outpatient services). Outside the 
circumstances of the PHE, direct supervision requires the immediate 
availability of the supervising physician or other practitioner, but 
the professional need not be present in the same room during the 
service. We have established this ``immediate availability'' 
requirement to mean in-person, physical, not virtual, availability 
(please see the April 6, 2020 IFC (85 FR 19245) and the CY 2022 PFS 
final rule (86 FR 65062)). Through the March 31, 2020 COVID-19 IFC, we 
changed the definition of ``direct supervision'' during the PHE for 
COVID-19 (85 FR 19245 through 19246) as it pertains to supervision of 
diagnostic tests, physicians' services, and some hospital outpatient 
services, to allow the supervising professional to be immediately 
available through virtual presence using two-way, real-time audio/video 
technology, instead of requiring their physical presence. In the CY 
2021 PFS final rule (85 FR 84538 through 84540), we finalized 
continuation of this policy through the later of the end of the 
calendar year in which the PHE for COVID-19 ends or December 31, 2021. 
In the March 31, 2020 IFC (85 FR 19246) and in our CY 2022 PFS final 
rule (see 85 FR 65063), we also noted that the temporary exception to 
allow immediate availability for direct supervision through virtual 
presence facilitates the provision of Medicare telehealth services by 
clinical staff of physicians and other practitioners' incident to their 
own professional services. This is especially relevant for services 
such as physical therapy, occupational therapy, and speech language 
pathology services, since those practitioners were previously only able 
to bill Medicare for telehealth services under Medicare telehealth 
waivers that were effective during the PHE for COVID-19 (based on the 
emergency waiver authority established in section 1135(b)(8) of the 
Act), until the CAA, 2023 extended the time period during which these 
practitioners could bill for Medicare telehealth services through 
December 31, 2024. We noted that sections 1834(m)(4)(D) and (E) of the 
Act specify the types of clinicians who may furnish and bill for 
Medicare telehealth services. After December 31, 2024, the types of 
clinicians who may furnish and bill for Medicare telehealth services 
include only physicians as defined in section 1861(r) of the Act and 
practitioners described in section 1842(b)(18)(C) of the Act. We note 
that this will include mental health counselors (MHCs) and marriage and 
family therapists (MFTs) beginning January 1, 2024.
    We noted in the CY 2021 PFS final rule (85 FR 84539) that, to the 
extent our policy allows direct supervision through virtual presence 
using audio/video real-time communications technology, the requirement 
could be met by the supervising physician (or other practitioner) being 
immediately available to engage via audio/video technology (excluding 
audio-only), and would not require real-time presence or observation of 
the service via interactive audio and video technology throughout the 
performance of the procedure; this was the case during the PHE, and 
will continue to be the case following the PHE. Under current policy as 
described in the CY 2021 final rule (85 FR 84539 and 84540, after 
December 31, 2023, the pre-PHE rules for direct supervision at Sec.  
410.32(b)(3)(ii) would apply. As noted in the CY 2022 PFS final rule 
(86 FR 65062), this means the temporary exception allowing immediate 
availability for direct supervision through virtual presence, which 
facilitates the provision of telehealth services by clinical staff of 
physicians and other practitioners incident to their professional 
services, will no longer apply after CY 2023.
    We are concerned about an abrupt transition to our pre-PHE policy 
that defines direct supervision under Sec.  410.32(b)(3)(ii) to require 
the physical presence of the supervising practitioner beginning after 
December 31, 2023, given that practitioners have established new 
patterns of practice during the PHE for COVID-19. In the absence of 
evidence that patient safety is compromised by virtual direct 
supervision, we believe that an immediate reversion to the pre-PHE 
definition of direct supervision would prohibit virtual direct 
supervision, which may present a barrier to access to many services, 
such as those furnished incident--to a physician's service. We believe 
physicians and practitioners will need time to reorganize their 
practice patterns established during the PHE to reimplement the pre-PHE 
approach to direct supervision without the use of audio/video 
technology. Recognizing these concerns, we proposed to continue to 
define direct supervision to permit the presence and ``immediate 
availability'' of the supervising practitioner through real-time audio 
and visual interactive telecommunications through December 31, 2024. We 
believe that extending this definition of direct supervision through 
December 31, 2024 would align the timeframe of this policy with many of 
the previously discussed PHE-related telehealth policies that were 
extended under provisions of the CAA, 2023. We proposed to revise the 
regulatory text at Sec.  410.32(b)(3)(ii) to state that, through 
December 31, 2024, the presence of the physician (or other 
practitioner) includes virtual presence through audio/video real-time 
communications technology (excluding audio-only).

[[Page 78879]]

    We believe this additional time will allow us further opportunity 
to collect information through the coming year as we consider an 
appropriate more permanent approach to direct supervision policy 
following the PHE for COVID-19. We solicited comment on whether we 
should consider extending the definition of direct supervision to 
permit virtual presence beyond December 31, 2024. Specifically, we 
stated that we were interested in input from interested parties on 
potential patient safety or quality concerns when direct supervision 
occurs virtually; for instance, if virtual direct supervision of 
certain types of services is more or less likely to present patient 
safety concerns, or if this flexibility would be more appropriate for 
certain types of services, or when certain types of auxiliary personnel 
are performing the supervised service. We were also interested in 
potential program integrity concerns such as overutilization or fraud 
and abuse that interested parties may have regarding this policy.
    In the proposed rule, we noted that one potential approach to 
direct supervision which we could consider for future rulemaking, could 
be to extend or permanently establish this virtual presence flexibility 
for services that are valued under the PFS based on the presumption 
that they are nearly always performed in entirety by auxiliary 
personnel. Such services would include any service wholly furnished 
incident to a physician or practitioner's professional service, as well 
as the Level I office or other outpatient evaluation and management 
visit for established patients and the Level I Emergency Department 
visit. Allowing virtual presence for direct supervision of these 
services may balance patient safety concerns with the interest of 
supporting access and preserving workforce capacity for medical 
professionals while considering potential quality and program integrity 
concerns. We solicited comment on this potential approach for CY 2025, 
as well as any other approaches by which direct supervision could occur 
virtually that would both protect patient access and safety, as well as 
quality of care and program integrity concerns following CY 2024.
    We received public comments on our proposals to extend the 
flexibilities for virtual direct supervision. The following is a 
summary of the comments we received and our responses.
    Comment: Many commenters supported our proposal to continue to 
define `immediate availability' to include availability through virtual 
means, stating that it will benefit healthcare providers while greatly 
enhancing patient access to quality care, particularly in underserved 
areas. Many stated that removing overly restrictive supervision 
requirements will help practices free up personnel to ensure more 
Americans have timely access to care. A commenter stated that there has 
been no evidence that this type of direct supervision has caused 
patient safety or quality concerns, and that virtual supervision makes 
workflows more efficient by freeing up practitioners' time. A commenter 
submitted data that they say indicates no clinically meaningful 
statistical difference in patient outcomes for virtual direct 
supervision as compared to direct supervision. Some commenters stated 
that we should extend this flexibility permanently; one such commenter 
stated that failure to allow supervision via interactive 
telecommunications could mean that a patient would be unable to receive 
the service at all, rather than forcing in-person supervision to occur. 
The commenter stated that both patients and CMS rely on physicians' 
professional judgment to determine the most appropriate services to 
deliver; the same principle should apply to how supervision is 
provided. Another commenter encouraged CMS to consider permanently 
permitting the use of remote direct supervision for Level 2 diagnostic 
tests, and that, absent a permanent change, CMS should consider 
extending current flexibilities through at least 2025. Some commenters 
stated that the ``immediate availability'' requirement should be 
defined as including virtual means permanently for Intensive Cardiac 
Rehabilitation (ICR) and cardiac rehab (CR) services, as well as for 
pulmonary rehabilitation (PR) stating that evidence from the PHE 
demonstrated that virtual supervision is safe and effective for the 
delivery of these services. Many commenters noted the importance of 
this flexibility in protecting access specifically for ICR, CR, and PR 
services. One such commenter submitted studies that the commenter says 
demonstrates the effectiveness and safety of virtual CR and PR services 
as well as that virtual and hybrid delivery of CR and PR services 
provided by staff are safe, improve health outcomes and adherence, and 
address barriers to access. Some commenters stated that this should be 
permanently established for external counterpulsation (ECP) therapy 
(HCPCS code G0166). One such commenter stated that as this is a service 
that is entirely provided by auxiliary personnel that it would be 
consistent with our suggested approach included in our comment 
solicitation as discussed above. A commenter submitted information on 
the clinical benefits of ECP and argued that ECP is underutilized and 
that the in-person direct supervision requirement presents an access 
barrier. Some commenters specified that this should be established 
permanently for mental health and substance use disorder related 
services. In response to our patient safety concerns, a commenter 
stated that if CMS were to extend this policy permanently, it should be 
limited to circumstances where the billing practitioner is supervising 
clinical staff who are not authorized to bill the Medicare program 
directly, consistent with MedPAC's recommendations in their June 2019 
report. A few commenters reacted to the potential approach we suggested 
of permanently establishing this virtual presence flexibility for 
services that are valued under the PFS based on the presumption that 
they are nearly always performed in entirety by auxiliary personnel. 
One such comment stated that this approach may prove a conservative 
place to start or could be attempted through pilot tests to collect 
more data to inform future decision-making. Another stated that this 
approach would be overly restrictive and would be contrary to the 
principles of a successful telehealth model, such as increasing 
workforce capacity and reducing patient travel.
    Response: We appreciate the support of commenters, as well as the 
comments received in response to our comment solicitation. We look 
forward to considering this and other information as we consider the 
most appropriate way to balance patient safety concerns with the 
interest of supporting access that we expect to address in future 
rulemaking. We continue to believe that it is appropriate to continue 
to permit direct supervision via virtual means using audio/video real-
time communications technology through the end of CY 2024 given that 
many telehealth flexibilities adopted to address the PHE for COVID-19 
are set to expire under the statute following this time period. We 
believe that this is the most appropriate way to balance patient safety 
with access while avoiding confusion for 2024.
    Comment: A commenter requested that CMS clarify whether, to meet 
the direct supervision requirement using real-time audio-visual 
technology, the physician needs to be constantly present on the real-
time audio-visual technology during the entirety of the provision of

[[Page 78880]]

an ``incident to'' service by their clinical staff.
    Response: As direct supervision as defined at Sec.  410.32 requires 
the supervising practitioner's immediately available to furnish 
assistance and direction throughout the performance of the procedure, 
but not that the supervising practitioner must be present in the room 
when the procedure is performed, when the supervising practitioner 
provides direct supervision using real-time audio-visual technology, 
the supervising practitioner likewise does not need to be virtually 
present throughout the performance of the procedure, but they need to 
be immediately available to provide the virtual presence whenever 
necessary.
    After consideration of public comments, we are finalizing as 
proposed. We will continue to define direct supervision to permit the 
immediate availability of the supervising practitioner through real-
time audio and visual interactive telecommunications through December 
31, 2024.We will consider addressing this topic in possible future 
rulemaking.
(1) Teaching Physician Billing for Services Involving Residents in 
Teaching Settings
    In the CY 2021 PFS final rule (85 FR 84577 through 84584), we 
established a policy that, after the end of the PHE for COVID-19, 
teaching physicians may meet the requirements to be present for the key 
or critical portions of services when furnished involving residents 
through audio/video real-time communications technology (virtual 
presence), but only for services furnished in residency training sites 
that are located outside of an Office of Management and Budget (OMB)-
defined metropolitan statistical area (MSA). We made this location 
distinction consistent with our longstanding interest to increase 
beneficiary access to Medicare-covered services in rural areas and 
noted the ability to expand training opportunities for residents in 
rural settings. For all other locations, we expressed concerns that 
continuing to permit teaching physicians to bill for services furnished 
involving residents when they are virtually present, outside the 
conditions of the PHE for COVID-19, may not allow the teaching 
physician to have personal oversight and involvement over the 
management of the portion of the case for which the payment is sought, 
in accordance with section 1842(b)(7)(A)(i)(I) of the Act. In addition, 
we stated concerns about patient populations that may require a 
teaching physician's experience and skill to recognize specialized 
needs or testing, and whether it is possible for the teaching physician 
to meet these clinical needs while having a virtual presence for the 
key portion of the service. For a more detailed description of our 
specific concerns, we referred readers to the CY 2021 PFS final rule 
(85 FR 84577 through 84584). At the end of the PHE for COVID-19, and as 
finalized in the CY 2021 PFS final rule, we intended for the teaching 
physician to have a physical presence during the key portion of the 
service personally provided by residents in order to be paid for the 
service under the PFS, in locations that were within a MSA. This policy 
applied to all services, regardless of whether the patient was co-
located with the resident or only present virtually (for example, the 
service was furnished as a 3-way telehealth visit, with the teaching 
physician, resident, and patient in different locations). However, 
interested parties expressed concerns regarding the requirement that 
the teaching physician have a physical presence with the resident when 
a service is furnished virtually within a MSA (that is, as a Medicare 
telehealth service). Some interested parties stated that during the PHE 
for COVID-19, when residents provided telehealth services and the 
teaching physician was virtually present, the same safe and high-
quality oversight was provided as when the teaching physician and 
resident were physically co-located. In addition, these interested 
parties stated that during telehealth visits, the teaching physician 
was virtually present during the key and critical portions of the 
telehealth service, available immediately in real-time, and had access 
to the electronic health record. As stated in section II.D.2.a. of this 
final rule, we were concerned that an abrupt transition to our pre-PHE 
policy may present a barrier to access to many services, and we 
understood that practitioners gained clinical experience during the PHE 
for COVID-19, and could identify circumstances for which the teaching 
physician can routinely render sufficient personal and identifiable 
services to the patient, with a virtual presence during the key portion 
of the virtual service. Given these considerations, we proposed to 
allow the teaching physician to have a virtual presence in all teaching 
settings, only in clinical instances when the service is furnished 
virtually (for example, a 3-way telehealth visit, with all parties in 
separate locations). This would permit teaching physicians to have a 
virtual presence during the key portion of the virtual service for 
which payment is sought, through audio/video real-time communications 
technology, for all residency training locations through December 31, 
2024. The virtual presence policy would continue to require real-time 
observation (not mere availability) by the teaching physician, and 
excludes audio-only technology. The documentation in the medical record 
must continue to demonstrate whether the teaching physician was 
physically present or present through audio/video real-time 
communications technology at the time of the virtual service, this 
includes documenting the specific portion of the service for which the 
teaching physician was present through audio/video real-time 
communications technology. This policy does not preclude teaching 
physicians from providing a greater degree of involvement in services 
furnished with residents, and teaching physicians should still use 
discretion to determine whether it is appropriate to have a virtual 
presence rather than in person, depending on the services being 
furnished and the experience of the particular residents involved.
    We announced that we were exercising enforcement discretion to 
allow teaching physicians in all residency training sites, to be 
present through audio/video real-time communications technology, for 
purposes of billing under the PFS for services they furnish involving 
residents. We exercised this enforcement discretion through December 
31, 2023, as we considered our virtual presence policies for services 
involving teaching physicians and residents further through our 
rulemaking process for CY 2024. For more background we referred readers 
to https://www.cms.gov/files/document/frequently-asked-questions-cms-waivers-flexibilities-and-end-covid-19-public-health-emergency.pdf.
    We sought comment and information to help us consider how virtual 
services could be furnished in all residency training locations beyond 
December 31, 2024, to include what other clinical treatment situations 
are appropriate to permit the virtual presence of the teaching 
physician. Specifically, we anticipated considering various types of 
teaching physician services, when it is appropriate for the teaching 
physician and resident to be co-located, and how virtual presence could 
support patient safety for all patients, particularly at-risk patients. 
We also invited commenters to provide data or other information on how 
the teaching physician's virtual presence could continue to support 
patient safety, while meeting the clinical needs for all patients, and 
ensure burden reduction

[[Page 78881]]

without creating risks to patient care or increasing opportunities for 
fraud.
    We received public comments on our proposal to allow teaching 
physicians to have a virtual presence in all teaching settings, only in 
clinical instances when the service is furnished virtually, through 
December 31, 2024. The following is a summary of the comments we 
received and our responses.
    Comment: Some commenters thanked CMS for exercising enforcement 
discretion to allow teaching physicians in all residency training sites 
to be present through audio/video real-time communications technology, 
for purposes of billing under the PFS, for services they furnish 
involving residents through 2024.
    Response: We appreciate the support from commenters but reiterate 
that we are only exercising enforcement discretion through December 31, 
2023.
    Comment: One commenter stated that CMS should not reimburse 
anesthesiologists that are not providing actual anesthesia care, 
through billing for remote so-called ``supervision'' services.
    Response: As stated in our regulation at Sec.  415.172(a)(1), for 
surgical, high risk, interventional, endoscopic, or other complex 
procedures the teaching physician must not only be present for the 
critical portions of the procedure, but also immediately available to 
furnish services during the entire procedure in order for PFS payment 
to be made for the service. Similarly, Sec.  415.178 requires a 
teaching physician to be present during critical (or key) portions of 
the procedure and immediately available to furnish anesthesia services 
during the entire service. We continue to believe the requirements for 
the presence of the teaching physician during all key or critical 
portions of the procedure and immediate availability to furnish 
services during the entire service or procedure is necessary for 
patient safety given the risks associated with these services.
    Comment: One commenter requested clarification on whether the 
proposal to allow teaching physicians to have a virtual presence, only 
in clinical instances when the service is furnished virtually, would 
also include instances where the resident and patient are in one 
location and the supervising physician is in another. The commenter 
stated that the resident should be able to ``dial-in'' the supervising 
physician in these instances.
    Response: The proposed policy would continue to permit PFS payment 
when the teaching physician is present virtually only when the service 
is furnished virtually. The example we provided in the proposed rule is 
a 3-way Medicare telehealth visit, with all parties in separate 
locations. In this situation, the teaching physician and resident would 
not need to be physically co-located during the telehealth service that 
is furnished remotely to the patient. The teaching physician would have 
a virtual presence during the key portion of that Medicare telehealth 
service for which payment is sought, through audio/video real-time 
communications technology. In the example provided by the commenter, 
the service would be furnished with the resident in person at the same 
location with the patient, and only the teaching physician would be 
present virtually through the use of real-time audio/video 
communications technology, and this scenario was not included in the 
proposal. In the commenter's example, the teaching physician would be 
required to have a physical presence with the resident, unless the 
residency training location is outside a MSA. The policy continues to 
exclude audio-only technology.
    Comment: Several commenters requested that CMS consider permanently 
expanding the list of services that can be furnished under the so-
called primary care exception set forth at Sec.  415.174 to include 
high-value primary care services. These commenters stated that the 
flexibilities allowed during the PHE for COVID-19, which allowed level 
4 and 5 E/M visits to be furnished under the primary care exception 
benefitted both patients and primary care training programs. The 
commenters noted that they believe that the absence of high-value 
services under the primary care exception could negatively impact 
resident training and patient outcomes in the long term, and provided a 
list of suggested services to be permanently included under the primary 
care exception.
    Response: The primary care exception permits the teaching physician 
to bill for certain lower and mid-level complexity physicians' services 
furnished by residents in certain types of residency training settings 
even when the teaching physician is not present with the resident 
during the services as long as certain conditions are met, including 
that the services are furnished by residents with more than 6 months of 
training in the approved residency program; and that the teaching 
physician directs the care of no more than four residents at a time, 
remains immediately available and has no other responsibilities while 
directing the care, assumes management responsibility for beneficiaries 
seen by the residents, ensures that the services furnished are 
appropriate, and reviews certain elements of the services with each 
resident during or immediately after each visit. We believe the primary 
care exception was intended to broaden opportunities for teaching 
physicians to involve residents in furnishing services under 
circumstances that preserve teaching physician direction of the care, 
and promote safe, high quality patient care. Although we temporarily 
modified the scope of services that could be provided under the primary 
care exception to address the circumstances of the PHE for COVID-19, we 
did not propose to broaden the array of services that meet the 
conditions for PFS payment set forth in our regulations at Sec.  
415.174. For a more detailed description of the finalized primary care 
exception policy, we refer readers to the CY 2021 PFS final rule (85 FR 
84585 through 84590).
    Comment: Many commenters supported the proposal to allow teaching 
physicians to have a virtual presence in all teaching settings, only in 
clinical instances when the service is furnished virtually, which then 
permits teaching physicians to have a virtual presence during the key 
portion of that Medicare telehealth service, through audio/video real-
time communications technology, for all residency training locations 
through December 31, 2024. However, several commenters encouraged CMS 
to include in-person services to promote access to care and to 
establish this policy permanently. These commenters stated that 
teaching physicians should be allowed to determine when their virtual 
presence would be clinically appropriate, based on their assessment of 
the patient's needs and the competency level of the resident. In 
addition, commenters recommend that CMS consider the Accreditation 
Council for Graduate Medical Education (ACGME) rules that allow 
teaching physicians to concurrently monitor patient care through 
appropriate telecommunication technology when the teaching physician 
and/or patient is not physically present with the resident.
    Response: At this time, we are not extending the proposed policy to 
include in-person services furnished by residents. We may consider 
other clinical instances that could allow teaching physicians to have a 
virtual presence in future rulemaking, and will contemplate the 
comments received to ensure the teaching physician is rendering 
sufficient personal services to exercise full, personal control of the 
key portion of the case. We thank commenters for providing information

[[Page 78882]]

on certain ACGME rules. We note that the ACGME regulates residency 
training programs and their rules ensure that there is appropriate 
teaching physician involvement in care delivery for educational 
purposes. However, our regulations determine when PFS payment is 
appropriate when teaching physicians furnish services that involve 
residents, and the teaching physician has personal oversight and 
involvement over the management of the portion of the case for which 
the payment is sought.
    After consideration of public comments, we are finalizing the 
policy as proposed, to allow teaching physicians to have a virtual 
presence in all teaching settings, only in clinical instances when the 
service is furnished virtually. This permits teaching physicians to 
have a virtual presence during the key portion of the virtual service 
for which payment is sought, through audio/video real-time 
communications technology, for all residency training locations through 
December 31, 2024. As finalized in the CY 2021 PFS final rule (84577 
through 84581), the required physical presence of a teaching physician 
in order to bill under the PFS for their services at a residency 
training site that is located outside of a MSA, can be met through 
interactive, audio/video real-time communications technology, and does 
not include audio-only technology.
b. Clarifications for Remote Monitoring Services
(1) Background and Overview
    In recent years, we have established payment for two code families 
that describe certain remote monitoring services: remote physiologic 
monitoring (RPM) and remote therapy monitoring (RTM).
Remote Physiologic Monitoring
     99453 (Remote monitoring of physiologic parameter(s) (eg, 
weight, blood pressure, pulse oximetry, respiratory flow rate), 
initial; set-up and patient education on use of equipment);
     99454 (Remote monitoring of physiologic parameter(s) (eg, 
weight, blood pressure, pulse oximetry, respiratory flow rate), 
initial; device(s) supply with daily recording(s) or programmed 
alert(s) transmission, each 30 days);
     99457 (Remote physiologic monitoring treatment management 
services, clinical staff/physician/other qualified health care 
professional time in a calendar month requiring interactive 
communication with the patient/caregiver during the month; first 20 
minutes); and
     99458 (Remote physiologic monitoring treatment management 
services, clinical staff/physician/other qualified health care 
professional time in a calendar month requiring interactive 
communication with the patient/caregiver during the month; each 
additional 20 minutes (List separately in addition to code for primary 
procedure)).
Remote Therapeutic Monitoring
     98975 (Remote therapeutic monitoring (eg, therapy 
adherence, therapy response); initial set-up and patient education on 
use of equipment);
     98976 (Remote therapeutic monitoring (eg, therapy 
adherence, therapy response); device(s) supply with scheduled (eg, 
daily) recording(s) and/or programmed alert(s) transmission to monitor 
respiratory system, each 30 days);
     98977 (Remote therapeutic monitoring (eg, therapy 
adherence, therapy response); device(s) supply with scheduled (eg, 
daily) recording(s) and/or programmed alert(s) transmission to monitor 
musculoskeletal system, each 30 days);
     98978 (Remote therapeutic monitoring (eg, therapy 
adherence, therapy response); device(s) supply with scheduled (eg, 
daily) recording(s) and/or programmed alert(s) transmission to monitor 
cognitive behavioral therapy, each 30 days);
     98980 (Remote therapeutic monitoring treatment management 
services, physician or other qualified health care professional time in 
a calendar month requiring at least one interactive communication with 
the patient or caregiver during the calendar month; first 20 minutes); 
and
     98981 (Remote therapeutic monitoring treatment management 
services, physician or other qualified health care professional time in 
a calendar month requiring at least one interactive communication with 
the patient or caregiver during the calendar month; each additional 20 
minutes (List separately in addition to code for primary procedure))
    In our CY 2018 PFS final rule, we summarized feedback from a 
comment solicitation aimed at informing new payment policies that would 
allow for separate payment for remote monitoring services (82 FR 
53014). In our CY 2019 PFS final rule (83 FR 59574 to 59576), we 
established valuations and payment policy for the RPM code family. In 
our CY 2020 PFS final rule (84 FR 62697-8), we explained that the RPM 
code family describes chronic care RPM services that involve the 
collection, analysis, and interpretation of digitally collected 
physiologic data, followed by the development of a treatment plan and 
the managing of a patient under the treatment plan. (84 FR 62697). In 
our CY 2020 PFS final rule, we also discussed that remote monitoring 
codes would be designated as care management services, which means our 
rules for general supervision would apply (84 FR 62698). In our CY 2023 
PFS final rule, in response to comments, we clarified that RTM or RPM 
services could be billed concurrently with Chronic Care Management 
(CCM), Transitional Care Management TCM, Principal Care Management 
(PCM), Chronic Pain Management (CPM), or Behavioral Health Integration 
(BHI) (86 FR 69528-69539).
    We have received many questions from interested parties about 
billing scenarios and requests for clarifications on the appropriate 
use of these codes in general. We believe it is important to share with 
all interested parties a restatement/clarification of certain policies. 
We refer readers to the CY 2021 PFS final rule (85 FR 84542 to 84546) 
for further discussion and explanation of the basis for interim 
policies that expired on the last day of the PHE for COVID-19.
(2) New vs. Established Patient Requirements
    In the CY 2021 PFS final rule (85 FR 84542-6), we established that, 
when the PHE for COVID-19 ends, we again will require that RPM services 
be furnished only to an established patient. Patients who received 
initial remote monitoring services during PHE are considered 
established patients for purposes of the new patient requirements that 
are effective after the last day of the PHE for COVID-19.
(3) Data Collection Requirements
    We have received various comments and inquiries about our temporary 
exception to minimum data collection for remote monitoring. As 
discussed in our CY 2021 final rule, we are not extending beyond the 
end of the PHE the interim policy to permit billing for remote 
monitoring codes, which require data collection for at least 16 days in 
a 30-day period, when less than 16 of days data are collected within a 
given 30-day period. (85 FR 84542 through 84546). As of the end of the 
PHE, the 16-day monitoring requirement was reinstated. Monitoring must 
occur over at least 16 days of a 30-day period. We proposed to clarify 
that the data collection minimums apply to existing RPM and RTM code 
families for CY 2024.

[[Page 78883]]

    The following remote monitoring codes currently depend on 
collection of no fewer than 16 days of data in a 30-day period, as 
defined and specified in the code descriptions:
     98976 (Remote therapeutic monitoring (eg, therapy 
adherence, therapy response); device(s) supply with scheduled (eg, 
daily) recording(s) and/or programmed alert(s) transmission to monitor 
respiratory system, each 30 days);
     98977 (Remote therapeutic monitoring (eg, therapy 
adherence, therapy response); device(s) supply with scheduled (eg, 
daily) recording(s) and/or programmed alert(s) transmission to monitor 
musculoskeletal system, each 30 days);
     98978 (Remote therapeutic monitoring (eg, therapy 
adherence, therapy response); device(s) supply with scheduled (eg, 
daily) recording(s) and/or programmed alert(s) transmission to monitor 
cognitive behavioral therapy, each 30 days);
     98980 (Remote therapeutic monitoring treatment management 
services, physician or other qualified health care professional time in 
a calendar month requiring at least one interactive communication with 
the patient or caregiver during the calendar month; first 20 minutes); 
and
     98981 (Remote therapeutic monitoring treatment management 
services, physician or other qualified health care professional time in 
a calendar month requiring at least one interactive communication with 
the patient or caregiver during the calendar month; each additional 20 
minutes (List separately in addition to code for primary procedure))
    We remind readers that our discussion in the CY 2021 PFS final rule 
addresses the interim policy on data collection minimums, and provides 
notice and the rationale for the data collection policy that is in 
effect now that the PHE for COVID-19 has ended. Remotely monitored 
monthly services should be reported only once during a 30-day period--
and only when reasonable and necessary. As a clarification for either 
RPM or RTM, only one practitioner can bill CPT codes 99453 and 99454, 
or CPT codes 98976, 98977, 98980, and 98981, during a 30-day period, 
and only when at least 16 days of data have been collected on at least 
one medical device as defined in section 201(h) of the FFDCA.
    We reiterate our analysis described in the CY 2021 PFS final rule, 
in which we explained that CPT code descriptor language suggests that, 
even when multiple medical devices are provided to a patient, the 
services associated with all the medical devices can be billed only 
once per patient per 30-day period and only when at least 16 days of 
data have been collected (85 FR 84545). We refer readers to our CY 2021 
PFS final rule (85 FR 84545) for additional background.
(4) Use of RPM, RTM, in Conjunction With Other Services
    Practitioners may bill RPM or RTM, but not both RPM and RTM, 
concurrently with the following care management services: CCM/TCM/BHI, 
PCM, and CPM. These various codes, which describe other care management 
services, may be billed with RPM or RTM, for the same patient, if the 
time or effort is not counted twice. As specified in the CY 2023 PFS 
final rule, if all requirements to report each service are met, without 
time or effort being counted more than once, RPM or RTM (not both RPM 
and RTM) may be billed in conjunction with any one of CCM, TCM, BHI, 
PCM, or CPM codes. According to the 2023 CPT Codebook (pg. 849), CPT 
code 98980 (RTM treatment management) cannot be reported in conjunction 
with CPT codes 99457/99458 (RPM treatment management). Our intention is 
to allow the maximum flexibility for a given practitioner to select the 
appropriate mix of care management services, without creating 
significant issues of possible fraud, waste, and abuse associated with 
overbilling of these services. We continue to gain experience with each 
family of remote monitoring codes, and request feedback from commenters 
that would provide additional context that could inform us as we 
continue to develop and clarify our payment policies for these 
services.
    We proposed to clarify that RPM and RTM may not be billed together, 
so that no time is counted twice by billing for concurrent RPM and RTM 
services. In instances where the same patient receives RPM and RTM 
services, there may be multiple devices used for monitoring, and in 
these cases, we will to apply our existing rules, which we finalized 
when establishing the RPM code family, meaning that the services 
associated with all the medical devices can be billed by only one 
practitioner, only once per patient, per 30-day period, and only when 
at least 16 days of data have been collected; and that the services 
must be reasonable and necessary (85 FR 84544 through 84545).
(5) Other Clarifications for Appropriate Billing
    We have received inquiries from interested parties during public 
forums regarding use of remote monitoring during global periods for 
surgery. In the proposed rule, we clarified that, in circumstances 
where an individual beneficiary may receive a procedure or surgery, and 
related services, which are covered under a payment for a global 
period, RPM services or RTM services (but not both RPM and RTM services 
concurrently) may be furnished separately to the beneficiary, and the 
practitioner would receive payment for the RTM or RPM services, 
separate from the global service payment, so long as other requirements 
for the global service and any other service during the global period 
are met. For an individual beneficiary who is currently receiving 
services during a global period, a practitioner may furnish RPM or RTM 
services (but not both RPM or RTM services) to the individual 
beneficiary, and the practitioner will receive separate payment, so 
long as the remote monitoring services are unrelated to the diagnosis 
for which the global procedure is performed, and as long as the purpose 
of the remote monitoring addresses an episode of care that is separate 
and distinct from the episode of care for the global procedure--meaning 
that the remote monitoring services address an underlying condition 
that is not linked to the global procedure or service.
    We solicited comments on the proposed clarifications, as well as 
issued a request for general feedback from the public that may be 
useful in further development of our payment policies for remote 
monitoring services that are separately payable under the current PFS. 
The following is a summary of the comments we received and our 
responses.
    Comment: Commenters requested changes be made to RPM and RTM coding 
and service requirements and requested that interim policies that 
expired on the last day of the PHE for COVID-19 become permanent.
    Response: We thank commenters for the general feedback that may be 
useful in further development of our payment policies for remote 
monitoring services that are separately payable under the current PFS. 
We refer readers to the CY 2021 PFS final rule (85 FR 84542 through 
84546) for further discussion and explanation of the basis for interim 
policies that expired on the last day of the PHE for COVID-19.
    Comment: Several commenters requested clarification on patient 
requirements for remote therapeutic monitoring. One commenter requested 
clarification on new patients receiving RPM from the end of the PHE 
forward.
    Response: We are offering additional clarification regarding the 
new patient

[[Page 78884]]

requirement and that RPM, not RTM, services require an established 
patient relationship after the end of the PHE. While we have not 
specified in rulemaking whether the RTM services require an established 
patient relationship, we believe that similar to RPM, such services 
would be furnished to a patient after a treatment plan had been 
established. Presumably, a billing practitioner would establish such 
treatment plan after some initial interaction with the patient. We will 
work to clarify this policy further in future rulemaking. We hope to 
continue dialogue with interested parties who may have information that 
could inform our rulemaking. Patients who received initial remote 
monitoring services during the PHE are considered established patients 
for purposes of the new patient requirements that are effective after 
the last day of the PHE for COVID-19. Per our existing policy, any 
patients receiving RPM services from the end of the PHE forward will 
need to be established patients before beginning RPM services.
    Comment: Many commenters inquired about whether RPM or RTM used in 
physical and occupational therapy services were excluded from the 
global period rules for surgery.
    Response: We would like to clarify that the policy that prohibits 
RPM or RTM services being furnished during the global period only 
applies to billing practitioners who are receiving the global service 
payment. Practitioners, such as therapists, who are not receiving a 
global service payment because they did not furnish the global 
procedure, would be permitted to furnish RPM or RTM services during a 
global period. After consideration of public comments, we are 
finalizing that providing RTM or RPM services during the global period 
is permitted if the practitioner is not receiving global service 
payment because they did not furnish the global procedure.
    We note that in the CY 2024 PFS proposed rule, we inadvertently 
listed all of the RTM codes (88 FR 53204) in our discussion of these 
services and had made a general statement about the applicability of 
the 16-day data collection requirement. We would like to offer 
clarification that the 16 day data collection requirement does not 
apply to CPT codes 99457, 99458, 98980, and 98981. These CPT codes are 
treatment management codes that account for time spent in a calendar 
month and do not require 16 days of data collection in a 30-day period.
c. Telephone Evaluation and Management Services
    In the March 31st COVID-19 IFC (85 FR 19264 through 19265), we 
finalized separate payment for CPT codes 99441 through 99443 and 98966 
through 98968, which describe E/M and assessment and management 
services furnished via telephone. CPT codes 99441 through 99443 are on 
the Medicare Telehealth Services List and will remain actively priced 
through 2024. CPT codes 98966 through 98968; however, describe 
telephone assessment and management services provided by a qualified 
non-physician healthcare professional, and they were added on a 
subregulatory basis during the PHE. We proposed to continue to assign 
an active payment status to CPT codes 98966 through 98968 for CY 2024 
to align with telehealth-related flexibilities that were extended via 
the CAA, 2023, specifically section 4113(e) of the CAA, 2023, which 
permits the provision of telehealth services through audio-only 
telecommunications through the end of 2024.
    We received comments on our proposals to keep active payment status 
for CPT codes 98966 through 98968 for CY 2024 to align with policy 
extensions under the CAA, 2023. The following is a summary of the 
comments received and our responses.
    Comment: Commenters were supportive of our proposal to continue to 
pay for physician and non-physician telephone services through December 
31, 2024, and to continue to assign active payment status to CPT codes 
99441 through 99443 as well as to CPT codes 98966 through 98968, which 
they stated supports payment for audio-only visits. The commenters 
stated that these services are a critical component of how care is 
provided to patients and are particularly valuable in connecting with 
patients living in rural areas where regular internet connection and/or 
cellular reception may be entirely unavailable or unreliable.
    Response: In response to comments, we are finalizing our proposal 
to continue active payment status for CPT codes 98966 through 98968. 
These services will be available through the end of CY 2024.
3. Telehealth Originating Site Facility Fee Payment Amount Update
    Section 1834(m)(2)(B) of the Act established the Medicare 
telehealth originating site facility fee for telehealth services 
furnished from October 1, 2001 through December 31, 2002 at $20.00, and 
specifies that, for telehealth services furnished on or after January 1 
of each subsequent calendar year, the telehealth originating site 
facility fee is increased by the percentage increase in the Medicare 
Economic Index (MEI) as defined in section 1842(i)(3) of the Act. We 
proposed to update the telehealth originating site facility fee for 
telehealth services by the expected increase in the MEI of 4.5 percent 
for CY 2024. Furthermore, we proposed that if more recent data became 
available after the publication of the proposed rule and before the 
publication of the final rule (for example, a more recent estimate of 
the MEI percentage increase), we would use such data, if appropriate, 
to determine the CY 2024 MEI percentage increase in the final rule. 
Therefore, the final MEI increase for CY 2024 is 4.6 percent and is 
based on the most recent historical percentage increase of the 2017-
based MEI reflecting historical data through for the second quarter of 
2023.
    Therefore, for CY 2024, the final payment amount for HCPCS code 
Q3014 (Telehealth originating site facility fee) is $29.96. Table 12 
shows the Medicare telehealth originating site facility fee and the 
corresponding MEI percentage increase for each applicable time period. 
We did not receive any comments on this proposal and are finalizing as 
proposed.

[[Page 78885]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.020

4. Payment for Outpatient Therapy Services, Diabetes Self-Management 
Training, and Medical Nutrition Therapy When Furnished by Institutional 
Staff to Beneficiaries in Their Homes Through Communication Technology
a. Background on Outpatient Therapy Services, Diabetes Self-Management 
Training and Medical Nutrition Therapy
    Section 1861(p) of the Act establishes the benefit category for 
outpatient PT, SLP and OT services, (expressly for PT services and, 
through section 1861(ll)(2) of the Act, for outpatient SLP services 
and, through section 1861(g) of the Act, for outpatient OT services). 
Section 1861(p) of the Act defines outpatient therapy services in the 
three disciplines as those furnished by a provider of services, a 
clinic, rehabilitation agency, or a public health agency, or by others 
under an arrangement with, and under the supervision of, such provider, 
clinic, rehabilitation agency, or public health agency to an individual 
as an outpatient; and those furnished by a therapist not under 
arrangements with a provider of services, clinic, rehabilitation 
agency, or a public health agency. As such, section 1861(p) of the Act 
defines outpatient therapy services very broadly to include those 
furnished by providers and other institutional settings, as well as 
those furnished in office settings. Section 1834(k)(3) of the Act 
requires payment for outpatient therapy services to be made based on 
the PFS (via section 1848 of the Act), for all institutional providers 
listed at sections 1833(a)(8) and (9) of the Act. These providers 
include clinics, rehabilitation agencies, public health agencies, 
comprehensive outpatient rehabilitation agencies (CORFs), SNFs, home 
health agencies (HHAs) (to individuals who are not homebound), 
hospitals to outpatients or hospital inpatients who are entitled to 
benefits under part A but have exhausted benefits for inpatient 
hospital services during a spell of illness or is not so entitled to 
benefits under part A), and all other CORF services.
    Section 1861(qq) of the Act defines Diabetes Self-Management 
Training (DSMT) services and authorizes CMS to regulate Medicare DSMT 
outpatient services. A ``certified provider'' of DSMT is further 
defined in section 1861(qq)(2)(A) of the Act as a physician or other 
individual or entity designated by the Secretary who meets certain 
quality requirements described in section 1861(qq)(2)(B) of the Act. In 
CY 2000, we finalized a standalone rule titled ``Medicare Program; 
Expanded Coverage for Outpatient Diabetes Self-Management Training and 
Diabetes Outcome Measurements.'' In that rule, we finalized that 
payment for outpatient DSMT would be made under the PFS (65 FR 83132). 
We further established that, in the case of payments made to other 
approved entities, such as hospital outpatient departments, ESRD 
facilities, and durable medical equipment suppliers, the payment would 
be equal to the amounts established under the PFS and made under the 
appropriate payment systems (65 FR 83142).
    Section 1861(s)(2)(V) of the Act authorizes Medicare Part B 
coverage of medical nutrition therapy services (MNT) for certain 
beneficiaries who have diabetes or a renal disease. In the CY 2000 PFS 
final rule, we established that payment for MNT services furnished in 
the institutional setting, including hospital outpatient departments 
(HOPDs), would be made under the PFS, not under the hospital Outpatient 
Prospective Payment System (OPPS) (66 FR 55279).
    During the PHE for COVID-19, outpatient therapy services, DSMT, and 
MNT could be furnished via a telecommunications system to

[[Page 78886]]

beneficiaries in their homes, and bills for these services were 
submitted and paid either separately or as part of a bundled payment, 
when either personally provided by the billing practitioner or provided 
by institutional staff and billed for by institutions, such as HOPDs, 
SNFs, and HHAs. For professionals, CMS used waiver authority to expand 
the range of practitioners that can serve as distant site practitioners 
for Medicare telehealth services as described in section 1834(m)(4)(E) 
of the Act and Sec.  410.78 (b)(2), as well as to waive the originating 
site requirements for Medicare telehealth services described in section 
1834(m)(4)(C) of the Act. This allowed for outpatient therapy services 
to be furnished and billed by therapists in private practice, as well 
as for outpatient therapy services, DSMT, and MNT to be furnished via 
Medicare telehealth to beneficiaries in urban, as well as rural, areas, 
including to beneficiaries located in their homes.
    When therapists (PTs, OTs and SLPs) were added as distant site 
telehealth practitioners using waiver authority during the PHE for 
COVID-19, CMS generally took the position for services furnished in 
HOPDs that waiver authority was needed to allow hospitals to bill for 
services furnished by hospital staff through communication technology 
to beneficiaries in their homes. CMS implemented the Hospitals Without 
Walls (HWW) policy that relied on waiver authority, which allowed 
hospitals to reclassify patients' homes as part of the hospital. HWW 
allowed hospitals to bill two different kinds of fees for services 
furnished remotely to patients in their homes: (1) hospital facility 
payment in association with professional services billed under the PFS; 
and (2) single payment for a limited number of practitioner services, 
when statute or other applicable rules only allow the hospital to bill 
for services personally provided by their staff. These services are 
either billed by hospitals or by professionals, there would not be 
separate facility and professional billing. This latter category 
includes outpatient therapy services, DSMT, and MNT. However, while 
maintaining that waiver authority was needed to allow hospital billing 
for these services, CMS also issued guidance instructing HOPDs to bill 
using modifiers consistent with those used for Medicare telehealth 
services. For further background, we refer readers to https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf. In the same 
referenced document, CMS also issued specific guidance for other 
institutional providers of therapy services to use modifier 95 
(indicating a Medicare telehealth service), along with the specific 
bill types for outpatient therapy services furnished by their staff.
    The CAA, 2023 extended many of the flexibilities that were 
available for Medicare telehealth services during the PHE for COVID-19 
under emergency waiver authorities, including adding physical and 
occupational therapists and speech-language pathologists as distant 
site practitioners through the end of CY 2024. In developing post-PHE 
guidance, CMS initially took the position that institutions billing for 
services furnished remotely by their employed practitioners (where the 
practitioners do not bill for their own services), would end with the 
PHE for COVID-19 along with the HWW waivers. However, after reviewing 
input from interested parties, as well as relevant guidance, including 
applicable billing instructions, we are considering whether certain 
institutions, as the furnishing providers, can bill for certain 
remotely furnished services personally performed by employed 
practitioners.
b. Proposal To Extend Billing Flexibilities for Certain Remotely 
Furnished Services Through the End of CY 2024 and Comment Solicitation
    While we consider how we might address this ambiguity in future 
rulemaking, in the interests of maintaining access to outpatient 
therapy, DSMT, and MNT services furnished remotely by institutional 
staff to beneficiaries in their homes consistent with the accessibility 
of these services when furnished by professionals via Medicare 
telehealth, we proposed to continue to allow institutional providers to 
bill for these services when furnished remotely in the same manner they 
have during the PHE for COVID-19 through the end of CY 2024. We sought 
comment on current practice for these services when billed, including 
how and to what degree they continue to be provided remotely to 
beneficiaries in their homes. We sought comment as to whether these 
services may fall within the scope of Medicare telehealth at section 
1834(m) of the Act or if there are other relevant authorities CMS might 
consider in future rulemaking.
    For DSMT specifically, the clinical staff personally delivering the 
service may be a type of practitioner authorized to furnish Medicare 
telehealth services under section 1834(m) of the Act; but we also 
understand that DSMT may be provided by other types of staff. 
Accordingly, we noted in sub-regulatory guidance that we are exercising 
enforcement discretion in reviewing the telehealth eligibility status 
of the practitioner personally providing any part of a remotely 
furnished DSMT service, so long as the persons were otherwise qualified 
to provide the service. For more background we refer readers to https://www.cms.gov/files/document/frequently-asked-questions-cms-waivers-flexibilities-and-end-covid-19-public-health-emergency.pdf.
    As we review our telehealth policies following the end of the PHE 
for COVID-19, and consider care delivery and beneficiary access 
concerns raised by practitioners and beneficiary advocates, we broadly 
considered billing and payment for telehealth services in institutional 
settings, including when these services are furnished by practitioners 
who have reassigned their rights to bill under and receive payment from 
the Medicare program (billing rights) to an institution. We acknowledge 
that one such setting where this billing arrangement exists includes 
Critical Access Hospitals (CAHs), where a practitioner has reassigned 
their billing rights to the CAH, and CMS makes payment for the 
practitioner's services under an optional payment method, referred to 
as CAH method II (Pub. 100-04, Chapter 4, Section 250.2). We note that 
in situations when a practitioner is furnishing a telehealth service 
and has reassigned their billing rights to a CAH under Method II, CMS 
makes payment for the telehealth service at the same rate generally 
paid for other in-person services (100 percent of the PFS payment 
amount) rather than the payment amount established under the optional 
method as discussed in Pub. 100-04, Chapter 4, Section 250.2. We are 
interested in and solicited comment on how telehealth services 
furnished under CAH method II arrangements are furnished, and whether 
they would be most accurately characterized in the context of section 
1834(m) of the Act or services of the CAH under Method II.
    Comment: Many commenters supported our proposal to continue to 
allow institutional providers to provide remote outpatient PT, OT, SLP, 
DSMT, and MNT services in patients' homes through CY 2024. Some of 
these commenters told us these services are invaluable for their 
patients who cannot attend on-site services due to, for example, a 
mobility impairment, cancer-related fatigue, they reside in rural and 
underserved areas that are less accessible and lack caregiver transport 
to the healthcare facility.
    Response: We appreciate the commenters support and feedback.

[[Page 78887]]

    Comment: Several commenters supported our proposal for outpatient 
physical therapy, occupational therapy, and speech-language pathology 
services being furnished by other institutional providers of Part B 
services--including comprehensive outpatient rehabilitation facilities, 
rehabilitation agencies, skilled nursing facilities, outpatient 
hospitals, critical access hospitals (CAHs) and home health agencies 
(HHAs) (for individuals not under a HH plan of care)--and their being 
able to continue to bill for these services when furnished remotely 
through CY 2024 in the same manner they have during the COVID-19 PHE 
and CY 2023. Several of these commenters requested that CMS clarify how 
to document the use of telehealth on the institutional claim form (UB-
04), since it lacks a POS field. These commenters requested that CMS 
permit the use of the 95 modifier and instruct contractors to accept 
modifier 95 for telehealth on the institutional claim. Several 
commenters requested that if the 95 modifier could not be used that it 
would cause unsustainable organizational realignment (that is, 
different workflows, EHR modules, billing processes, accounting 
systems, etc.) to migrate hospital-based therapists to CMS-1500 claims 
forms.
    Response: We clarify that it is not necessary to migrate claims for 
PT, OT, or SLP services provided in institutional settings, including 
the hospital, to the 1500 claim form. This is because of statutory 
provisions that require (a) therapists in private practice to furnish 
services only in their offices and in an individual's home (section 
1861(p) of the Act for outpatient PT services (and through sections 
1861(g) and 1861(ll)(2) of the Act for outpatient OT and SLP services, 
respectively)), (b) institutional providers to bill for them (sections 
1833(a)(8) and (9) of the Act), and (c) CMS to make payment for them at 
PFS rates (section 1834(k)(3) of the Act). As we will finalize below, 
CMS will instruct institutional providers to use the 95 modifier on the 
1450 claim form (UB-04) for these services.
    Comment: A number of commenters responded to our request for 
information about their current practice of billing for these services, 
such as how much they continue to provide remotely. One commenter 
stated that although there has been a significant reduction in the 
number of services furnished as telehealth, 10-20 percent of these 
services are currently provided via telehealth by their hospital. The 
same commenter stated that these telehealth therapies allow patients 
throughout the State increased access to care. Another commenter stated 
they are located in a health professional shortage area where people 
oftentimes drive for hours to reach their center for in-person 
treatment--they currently provide services to between 500-700 patients 
per day via telehealth. Another commenter stated that their post-acute 
telehealth program (launched in 2018) in response to CMS's 
Comprehensive Care for Joint Replacement (CJR) program is on pace for 
more than 5,500 telehealth PT visits in 2023, slightly less than those 
in 2022. This commenter also transitioned some of their in-person 
visits to telehealth during the COVID-19 PHE declining each year after 
2020 when it was ~35 percent of telehealth services decreased to 9 
percent, 5 percent, and 4 percent of total visits in 2021 through 2023, 
respectively. Many commenters, while not specifying the amount of 
outpatient therapy, DSMT, and/or MNT services they furnish, remarked 
that patients would lose an invaluable resource should their ability to 
bill for these services as telehealth be discontinued. Additionally, 
some commenters cited studies to show the efficacy of telehealth 
services.
    Response: We appreciate the commenters feedback.
    Comment: Many commenters questioned whether these services may fall 
within the scope of Medicare telehealth at section 1834(m) of the Act 
or if there are other authorities that might be relevant for us to 
consider in future rulemaking. Some commenters requested that CMS make 
these flexibilities permanent and urged CMS to work with Congress to 
gain the statutory authority needed for the institutional settings to 
provide these important services via telehealth. Several commenters 
agreed that the telehealth/virtual outpatient therapy, DSMT and MNT 
services furnished by staff in outpatient hospitals and other 
facilities appropriately fall within the scope of Medicare telehealth 
at section 1834(m) of the Act. We also heard from several commenters 
that suggested we create new remote G-codes for all these services to 
be billed through the OPPS starting January 1, 2025.
    Response: We thank the many commenters for their feedback.
    Comment: Some commenters requested that CMS provide additional 
clarity in the final rule on how institutional providers should bill 
for these services in CY 2024, including the specific use of modifiers. 
Several of these commenters questioned if these instructions would be 
different from the CMS subregulatory policy found in the online 
instruction given for CY 2023, which did not include the use of a 
modifier. The commenters stated that the instruction essentially 
states: ``Through the end of CY2023, hospital and other providers of 
PT, OT, SLP, DSMT, and MNT services that remain on the telehealth list, 
can continue to bill for these services when furnished remotely in the 
same way they have been during the PHE, except that beneficiaries' 
homes will no longer need to be registered as provider-based 
departments of the hospital to allow for hospitals to bill for these 
services.''
    Response: The commenters are correct that our billing policy for CY 
2024 will reflect the online billing policy for CY 2023 that is found 
at: https://www.cms.gov/files/document/hospitals-and-cahs-ascs-and-cmhcs-cms-flexibilities-fight-covid-19.pdf. However, with respect to 
the use of modifiers, we are clarifying that for services furnished 
beginning in CY 2024 that we require the use of the 95 modifier to be 
applied to claims from outpatient hospitals, as soon as hospitals can 
update their systems--in addition to the continued use of the 95 
modifier for outpatient therapy services discussed above for all other 
institutional providers furnishing outpatient therapy services via 
telehealth under Part B. This policy will facilitate our ability to 
track all services in the same manner. Although we did not receive 
comments specifically from CAHs electing Method II, these CAHs will 
continue their longstanding practice of using the GT/GQ modifier, as 
appropriate.
    In addition, we received several public comments that were outside 
the scope of the proposals made in the CY 2024 PFS proposed rule. 
Consequently, we did not summarize or respond to those comments.
    After reviewing the comments, we are finalizing our proposal, with 
one amendment for modifiers, to allow outpatient hospitals and other 
providers of physical therapy, occupational therapy, and speech-
language pathology, DSMT and MNT services that remain on the Medicare 
Telehealth Services List for CY 2024 to bill for these services when 
furnished remotely in the same way they have been during the COVID-19 
PHE and through the end of CY 2023, including that for hospitals, 
beneficiaries' homes will no longer need to be registered as provider-
based departments of the hospital to allow for hospitals to bill for 
these services. Additionally, our final subregulatory policy requires 
all institutional providers that bill for therapy, DSMT, and/or MNT 
services, with the exception of Method II CAHs, to apply the 95 
modifier on each applicable line if these services are furnished via 
telecommunication technology once

[[Page 78888]]

hospitals that need to do so can update their systems. For CAHs opting 
for payment under Method II, these CAHs will continue their long-
standing practice of using the GT/GQ modifier, as appropriate, when 
billing for their services furnished via telehealth.

E. Valuation of Specific Codes

1. Background: Process for Valuing New, Revised, and Potentially 
Misvalued Codes
    Establishing valuations for newly created and revised CPT codes is 
a routine part of maintaining the PFS. Since the inception of the PFS, 
it has also been a priority to revalue services regularly to make sure 
that the payment rates reflect the changing trends in the practice of 
medicine and current prices for inputs used in the PE calculations. 
Initially, this was accomplished primarily through the 5-year review 
process, which resulted in revised work RVUs for CY 1997, CY 2002, CY 
2007, and CY 2012, and revised PE RVUs in CY 2001, CY 2006, and CY 
2011, and revised MP RVUs in CY 2010, CY 2015, and CY 2020. Under the 
5-year review process, revisions in RVUs were proposed and finalized 
via rulemaking. In addition to the 5-year reviews, beginning with CY 
2009, CMS and the RUC identified a number of potentially misvalued 
codes each year using various identification screens, as outlined in 
section II.C. of the proposed rule, Potentially Misvalued Services 
under the PFS. Historically, when we received RUC recommendations, our 
process had been to establish interim final RVUs for the potentially 
misvalued codes, new codes, and any other codes for which there were 
coding changes in the final rule with comment period for a year. Then, 
during the 60-day period following the publication of the final rule 
with comment period, we accepted public comment about those valuations. 
For services furnished during the calendar year following the 
publication of interim final rates, we paid for services based upon the 
interim final values established in the final rule. In the final rule 
with comment period for the subsequent year, we considered and 
responded to public comments received on the interim final values, and 
typically made any appropriate adjustments and finalized those values.
    In the CY 2015 PFS final rule with comment period (79 FR 67547), we 
finalized a new process for establishing values for new, revised and 
potentially misvalued codes. Under the new process, we include proposed 
values for these services in the proposed rule, rather than 
establishing them as interim final in the final rule with comment 
period. Beginning with the CY 2017 PFS proposed rule (81 FR 46162), the 
new process was applicable to all codes, except for new codes that 
describe truly new services. For CY 2017, we proposed new values in the 
CY 2017 PFS proposed rule for the vast majority of new, revised, and 
potentially misvalued codes for which we received complete RUC 
recommendations by February 10, 2016. To complete the transition to 
this new process, for codes for which we established interim final 
values in the CY 2016 PFS final rule with comment period (81 FR 80170), 
we reviewed the comments received during the 60-day public comment 
period following release of the CY 2016 PFS final rule with comment 
period (80 FR 70886), and re-proposed values for those codes in the CY 
2017 PFS proposed rule.
    We considered public comments received during the 60-day public 
comment period for the proposed rule before establishing final values 
in the CY 2017 PFS final rule. As part of our established process, we 
will adopt interim final values only in the case of wholly new services 
for which there are no predecessor codes or values and for which we do 
not receive recommendations in time to propose values.
    As part of our obligation to establish RVUs for the PFS, we 
thoroughly review and consider available information including 
recommendations and supporting information from the RUC, the Health 
Care Professionals Advisory Committee (HCPAC), public commenters, 
medical literature, Medicare claims data, comparative databases, 
comparison with other codes within the PFS, as well as consultation 
with other physicians and healthcare professionals within CMS and the 
Federal Government as part of our process for establishing valuations. 
Where we concur that the RUC's recommendations, or recommendations from 
other commenters, are reasonable and appropriate and are consistent 
with the time and intensity paradigm of physician work, we proposed 
those values as recommended. Additionally, we continually engage with 
interested parties, including the RUC, with regard to our approach for 
accurately valuing codes, and as we prioritize our obligation to value 
new, revised, and potentially misvalued codes. We continue to welcome 
feedback from all interested parties regarding valuation of services 
for consideration through our rulemaking process.
2. Methodology for Establishing Work RVUs
    For each code identified in this section, we conduct a review that 
includes the current work RVU (if any), RUC-recommended work RVU, 
intensity, time to furnish the preservice, intraservice, and 
postservice activities, as well as other components of the service that 
contribute to the value. Our reviews of recommended work RVUs and time 
inputs generally include, but have not been limited to, a review of 
information provided by the RUC, the HCPAC, and other public 
commenters, medical literature, and comparative databases, as well as a 
comparison with other codes within the PFS, consultation with other 
physicians and health care professionals within CMS and the Federal 
Government, as well as Medicare claims data. We also assess the 
methodology and data used to develop the recommendations submitted to 
us by the RUC and other public commenters and the rationale for the 
recommendations. In the CY 2011 PFS final rule with comment period (75 
FR 73328 through 73329), we discussed a variety of methodologies and 
approaches used to develop work RVUs, including survey data, building 
blocks, crosswalks to key reference or similar codes, and magnitude 
estimation (see the CY 2011 PFS final rule with comment period (75 FR 
73328 through 73329) for more information). When referring to a survey, 
unless otherwise noted, we mean the surveys conducted by specialty 
societies as part of the formal RUC process.
    Components that we use in the building block approach may include 
preservice, intraservice, or postservice time and post-procedure 
visits. When referring to a bundled CPT code, the building block 
components could include the CPT codes that make up the bundled code 
and the inputs associated with those codes. We use the building block 
methodology to construct, or deconstruct, the work RVU for a CPT code 
based on component pieces of the code. Magnitude estimation refers to a 
methodology for valuing work that determines the appropriate work RVU 
for a service by gauging the total amount of work for that service 
relative to the work for a similar service across the PFS without 
explicitly valuing the components of that work. In addition to these 
methodologies, we frequently utilize an incremental methodology in 
which we value a code based upon its incremental difference between 
another code and another family of codes. Section 1848(c)(1)(A) of the 
Act specifically defines the work component

[[Page 78889]]

as the resources that reflect time and intensity in furnishing the 
service. Also, the published literature on valuing work has recognized 
the key role of time in overall work. For particular codes, we refine 
the work RVUs in direct proportion to the changes in the best 
information regarding the time resources involved in furnishing 
particular services, either considering the total time or the 
intraservice time.
    Several years ago, to aid in the development of preservice time 
recommendations for new and revised CPT codes, the RUC created 
standardized preservice time packages. The packages include preservice 
evaluation time, preservice positioning time, and preservice scrub, 
dress and wait time. Currently, there are preservice time packages for 
services typically furnished in the facility setting (for example, 
preservice time packages reflecting the different combinations of 
straightforward or difficult procedure, and straightforward or 
difficult patient). Currently, there are three preservice time packages 
for services typically furnished in the nonfacility setting.
    We developed several standard building block methodologies to value 
services appropriately when they have common billing patterns. In cases 
where a service is typically furnished to a beneficiary on the same day 
as an E/M service, we believe that there is overlap between the two 
services in some of the activities furnished during the preservice 
evaluation and postservice time. Our longstanding adjustments have 
reflected a broad assumption that at least one-third of the work time 
in both the preservice evaluation and postservice period is duplicative 
of work furnished during the E/M visit.
    Accordingly, in cases where we believe that the RUC has not 
adequately accounted for the overlapping activities in the recommended 
work RVU and/or times, we adjust the work RVU and/or times to account 
for the overlap. The work RVU for a service is the product of the time 
involved in furnishing the service multiplied by the intensity of the 
work. Preservice evaluation time and postservice time both have a long-
established intensity of work per unit of time (IWPUT) of 0.0224, which 
means that 1 minute of preservice evaluation or postservice time 
equates to 0.0224 of a work RVU.
    Therefore, in many cases when we remove 2 minutes of preservice 
time and 2 minutes of postservice time from a procedure to account for 
the overlap with the same day E/M service, we also remove a work RVU of 
0.09 (4 minutes x 0.0224 IWPUT) if we do not believe the overlap in 
time had already been accounted for in the work RVU. The RUC has 
recognized this valuation policy and, in many cases, now addresses the 
overlap in time and work when a service is typically furnished on the 
same day as an E/M service.
    The following paragraphs discuss our approach to reviewing RUC 
recommendations and developing proposed values for specific codes. When 
they exist, we also include a summary of interested party reactions to 
our approach. We noted that many commenters and interested parties have 
expressed concerns over the years with our ongoing adjustment of work 
RVUs based on changes in the best information we had regarding the time 
resources involved in furnishing individual services. We have been 
particularly concerned with the RUC's and various specialty societies' 
objections to our approach given the significance of their 
recommendations to our process for valuing services and since much of 
the information we used to make the adjustments is derived from their 
survey process. We note that we are obligated under the statute to 
consider both time and intensity in establishing work RVUs for PFS 
services. As explained in the CY 2016 PFS final rule with comment 
period (80 FR 70933), we recognize that adjusting work RVUs for changes 
in time is not always a straightforward process, so we have applied 
various methodologies to identify several potential work values for 
individual codes.
    We have observed that for many codes reviewed by the RUC, 
recommended work RVUs have appeared to be incongruous with recommended 
assumptions regarding the resource costs in time. This has been the 
case for a significant portion of codes for which we recently 
established or proposed work RVUs that are based on refinements to the 
RUC-recommended values. When we have adjusted work RVUs to account for 
significant changes in time, we have started by looking at the change 
in the time in the context of the RUC-recommended work RVU. When the 
recommended work RVUs do not appear to account for significant changes 
in time, we have employed the different approaches to identify 
potential values that reconcile the recommended work RVUs with the 
recommended time values. Many of these methodologies, such as survey 
data, building block, crosswalks to key reference or similar codes, and 
magnitude estimation have long been used in developing work RVUs under 
the PFS. In addition to these, we sometimes use the relationship 
between the old time values and the new time values for particular 
services to identify alternative work RVUs based on changes in time 
components.
    In so doing, rather than ignoring the RUC-recommended value, we 
have used the recommended values as a starting reference and then 
applied one of these several methodologies to account for the 
reductions in time that we believe were not otherwise reflected in the 
RUC-recommended value. If we believe that such changes in time are 
already accounted for in the RUC's recommendation, then we do not make 
such adjustments. Likewise, we do not arbitrarily apply time ratios to 
current work RVUs to calculate proposed work RVUs. We use the ratios to 
identify potential work RVUs and consider these work RVUs as potential 
options relative to the values developed through other options.
    We do not imply that the decrease in time as reflected in survey 
values should always equate to a one-to-one or linear decrease in newly 
valued work RVUs. Instead, we believe that, since the two components of 
work are time and intensity, absent an obvious or explicitly stated 
rationale for why the relative intensity of a given procedure has 
increased, significant decreases in time should be reflected in 
decreases to work RVUs. If the RUC's recommendation has appeared to 
disregard or dismiss the changes in time, without a persuasive 
explanation of why such a change should not be accounted for in the 
overall work of the service, then we have generally used one of the 
aforementioned methodologies to identify potential work RVUs, including 
the methodologies intended to account for the changes in the resources 
involved in furnishing the procedure.
    Several interested parties, including the RUC, have expressed 
general objections to our use of these methodologies and deemed our 
actions in adjusting the recommended work RVUs as inappropriate; other 
interested parties have also expressed general concerns with CMS 
refinements to RUC-recommended values in general. In the CY 2017 PFS 
final rule (81 FR 80272 through 80277), we responded in detail to 
several comments that we received regarding this issue. In the CY 2017 
PFS proposed rule (81 FR 46162), we requested comments regarding 
potential alternatives to making adjustments that would recognize 
overall estimates of work in the context of changes in the resource of 
time for particular services; however, we did not receive any specific 
potential alternatives. As described earlier in this section, 
crosswalks to key reference or similar

[[Page 78890]]

codes are one of the many methodological approaches we have employed to 
identify potential values that reconcile the RUC-recommend work RVUs 
with the recommended time values when the RUC-recommended work RVUs did 
not appear to account for significant changes in time.
    We received several comments regarding our methodologies for work 
valuation in response to the CY 2024 PFS proposed rule and those 
comments are summarized below.
    Comment: Several commenters disagreed with CMS' reference to older 
work time sources and stated that their use led to the proposal of work 
RVUs based on flawed assumptions. Commenters stated that codes with 
``CMS/Other'' or ``Harvard'' work time sources, used in the original 
valuation of certain older services, were not surveyed, and therefore, 
were not resource-based. Commenters also stated that it was invalid to 
draw comparisons between the current work times and work RVUs of these 
services to the newly surveyed work time and work RVUs as recommended 
by the RUC.
    Response: We agree that it is important to use the recent data 
available regarding work times and note that when many years have 
passed since work time has been measured, significant discrepancies can 
occur. However, we also believe that our operating assumption regarding 
the validity of the existing values as a point of comparison is 
critical to the integrity of the relative value system as currently 
constructed. The work times currently associated with codes play a very 
important role in PFS ratesetting, both as points of comparison in 
establishing work RVUs and in the allocation of indirect PE RVUs by 
specialty. If we were to operate under the assumption that previously 
recommended work times had been routinely overestimated, this would 
undermine the relativity of the work RVUs on the PFS in general, in 
light of the fact that codes are often valued based on comparisons to 
other codes with similar work times. Such an assumption would also 
undermine the validity of the allocation of indirect PE RVUs to 
physician specialties across the PFS.
    Instead, we believe that it is crucial that the code valuation 
process take place with the understanding that the existing work times 
that have been used in PFS ratesetting are accurate. We recognize that 
adjusting work RVUs for changes in time is not always a straightforward 
process and that the intensity associated with changes in time is not 
necessarily always linear, which is why we apply various methodologies 
to identify several potential work values for individual codes. 
However, we reiterate that we believe it would be irresponsible to 
ignore changes in time based on the best data available, and that we 
are statutorily obligated to consider both time and intensity in 
establishing work RVUs for PFS services. For additional information 
regarding the use of old work time values that were established many 
years ago and have not since been reviewed in our methodology, we refer 
readers to our discussion of the subject in the CY 2017 PFS final rule 
(81 FR 80273 through 80274).
    Comment: Several commenters disagreed with the use of time ratio 
methodologies for work valuation. Commenters stated that this use of 
time ratios is not a valid methodology for valuation of physician 
services. Commenters stated that treating all components of physician 
time (preservice, intraservice, postservice and post-operative visits) 
as having identical intensity is incorrect, and inconsistently applying 
it to only certain services under review creates inherent payment 
disparities in a payment system, which is based on relative valuation. 
Commenters stated that in many scenarios, CMS selects an arbitrary 
combination of inputs to apply rather than seeking a valid clinically 
relevant relationship that would preserve relativity. Commenters 
suggested that CMS determine the work valuation for each code based not 
only on surveyed work times, but also the intensity and complexity of 
the service and relativity to other similar services, rather than 
basing the work value entirely on time. Commenters recommended that CMS 
embrace the clinical input from practicing physicians when valid 
surveys were conducted and provide a clinical rationale when proposing 
crosswalks for valuation of services.
    Response: We disagree and continue to believe that the use of time 
ratios is one of several appropriate methods for identifying potential 
work RVUs for particular PFS services, particularly when the 
alternative values recommended by the RUC and other commenters do not 
account for survey information that suggests the amount of time 
involved in furnishing the service has changed significantly. We 
reiterate that, consistent with the statute, we are required to value 
the work RVU based on the relative resources involved in furnishing the 
service, which include time and intensity. In accordance with the 
statute, we believe that changes in time and intensity must be 
accounted for when developing work RVUs. When our review of recommended 
values reveals that changes in time are not accounted for in a RUC-
recommended work RVU, the obligation to account for that change when 
establishing proposed and final work RVUs remains.
    We recognize that it would not be appropriate to develop work RVUs 
solely based on time, given that intensity is also an element of work, 
but in applying the time ratios, we are using derived intensity 
measures based on current work RVUs for individual procedures. We 
clarify again that we do not treat all components of physician time as 
having identical intensity. If we were to disregard intensity 
altogether, the work RVUs for all services would be developed based 
solely on time values and that is not the case, as indicated by the 
many services that share the same time values but have different work 
RVUs. For example, among the codes reviewed in this CY 2024 PFS final 
rule, CPT codes 76987 (Intraoperative epicardial cardiac (e.g., 
echocardiography) ultrasound for congenital heart disease, diagnostic; 
including placement and manipulation of transducer, image acquisition, 
interpretation and report), 97550 (Caregiver training in strategies and 
techniques to facilitate the patient's functional performance in the 
home or community (e.g., activities of daily living [adls], 
instrumental adls [iadls], transfers, mobility, communication, 
swallowing, feeding, problem solving, safety practices) (without the 
patient present), face-to-face; initial 30 minutes), and 99497 (Advance 
care planning including the explanation and discussion of advance 
directives such as standard forms (with completion of such forms, when 
performed), by the physician or other qualified health care 
professional; first 30 minutes, face-to-face with the patient, family 
member(s), and/or surrogate) all share the same total work time of 40 
minutes. However, these codes had very different proposed work RVUs of 
1.62, 1.00 and 1.50, respectively. These examples demonstrate that we 
do not value services purely based on work time; instead, we 
incorporate time as one of multiple different factors in our review 
process. Furthermore, we reiterate that we use time ratios to identify 
potentially appropriate work RVUs, and then use other methods 
(including estimates of work from CMS medical personnel and crosswalks 
to key references or similar codes) to validate these RVUs. For more 
details on our methodology for developing work RVUs, we direct readers 
to the discussion CY 2017 PFS final rule (81 FR 80272 through 80277).

[[Page 78891]]

    We also clarify for the commenters that our review process is not 
arbitrary in nature. Our reviews of recommended work RVUs and time 
inputs generally include, but have not been limited to, a review of 
information provided by the RUC, the HCPAC, and other public 
commenters, medical literature, and comparative databases, as well as a 
comparison with other codes within the PFS, consultation with other 
physicians and health care professionals within CMS and the Federal 
Government, as well as Medicare claims data. We also assess the 
methodology and data used to develop the recommendations submitted to 
us by the RUC and other public commenters and the rationale for the 
recommendations. In the CY 2011 PFS final rule with comment period (75 
FR 73328 through 73329), we discussed a variety of methodologies and 
approaches used to develop work RVUs, including survey data, building 
blocks, crosswalks to key reference or similar codes, and magnitude 
estimation (see the CY 2011 PFS final rule with comment period (75 FR 
73328 through 73329) for more information).
    With regard to the commenter's concerns regarding clinically 
relevant relationships, we emphasize that we continue to believe that 
the nature of the PFS relative value system is such that all services 
are appropriately subject to comparisons to one another. Although codes 
that describe clinically similar services are sometimes stronger 
comparator codes, we do not agree that codes must share the same site 
of service, patient population, or utilization level to serve as an 
appropriate crosswalk.
    Comment: Several commenters raised the issue of the refinement 
panel which was last reformed in CY 2016. Commenters stated that the 
refinement panel was not obsolete and was not mutually exclusive with 
the change to include all proposed valuations in each year's proposed 
rule. Commenters stated that for 2 decades, the refinement panel 
process was considered by interested parties to be an appeals process 
and its elimination discontinued CMS' reliance on outside interested 
parties to provide accountability through a transparent appeals 
process. Commenters requested that CMS consider these issues and create 
an objective, transparent and consistently applied formal appeals 
process that would be open to any commenting organization.
    Response: We did not propose any changes to the refinement panel 
for CY 2024. As we stated in the CY 2016 PFS final rule (80 FR 70917 
and 70918), the refinement panel was established to assist us in 
reviewing the public comments on CPT codes with interim final work RVUs 
and in balancing the interests of the specialty societies who commented 
on the work RVUs with the budgetary and redistributive effects that 
could occur if we accepted extensive increases in work RVUs across a 
broad range of services. When developing the CY 2016 proposed rule, and 
continuing to the present, we did not believe that the refinement panel 
had generally served as the kind of ``appeals'' or reconsideration 
process that some interested parties envisioned in their comments. We 
also believe that the refinement panel was not achieving its intended 
purpose. Rather than providing us with additional information, balanced 
across specialty interests, to assist us in establishing work RVUs, the 
refinement panel process generally served to rehash the issues raised 
and information already discussed at the RUC meetings and considered by 
CMS. In contrast to the prior process of establishing interim final 
values and using a refinement panel process that generally was not 
observed by members of the public, we continue to believe that the 
current process of proposing the majority of code values in a proposed 
rule, giving the public the opportunity to comment on those proposed 
values, and then finalizing those values in a final rule offers greater 
transparency and accountability.
    We also note that we did not finalize our proposal to eliminate the 
refinement panel completely in CY 2016. We retain the ability to 
convene refinement panels for codes with interim final values under 
circumstances where additional input provided by the panel is likely to 
add value as a supplement to notice and comment rulemaking. We also 
remind interested parties that we have established an annual process 
for the public nomination of potentially misvalued codes. This process, 
described in the CY 2012 PFS final rule (76 FR 73058), provides an 
annual means for those who believe that values for individual services 
are inaccurate and should be readdressed through notice and comment 
rulemaking to bring those codes to our attention.
    In response to comments, in the CY 2019 PFS final rule (83 FR 
59515), we clarified that terms ``reference services'', ``key reference 
services'', and ``crosswalks'' as described by the commenters are part 
of the RUC's process for code valuation. These are not terms that we 
created, and we do not agree that we necessarily must employ them in 
the identical fashion for the purposes of discussing our valuation of 
individual services that come up for review. However, in the interest 
of minimizing confusion and providing clear language to facilitate 
feedback from interested parties, we stated that we would seek to limit 
the use of the term, ``crosswalk,'' to those cases where we are making 
a comparison to a CPT code with the identical work RVU. (83 FR 59515) 
We note that we also occasionally make use of a ``bracket'' for code 
valuation. A ``bracket'' refers to when a work RVU falls between the 
values of two CPT codes, one at a higher work RVU and one at a lower 
work RVU.
    We look forward to continuing to engage with interested parties and 
commenters, including the RUC, as we prioritize our obligation to value 
new, revised, and potentially misvalued codes; and we will continue to 
welcome feedback from all interested parties regarding valuation of 
services for consideration through our rulemaking process. We refer 
readers to the detailed discussion in this section of the valuation 
considered for specific codes. Table 14 contains a list of codes and 
descriptors for which we are finalizing work RVUs for CY 2024; this 
includes all codes for which we received RUC recommendations by 
February 10, 2023. The proposed work RVUs, work time and other payment 
information for all CY 2024 payable codes are available on the CMS 
website under downloads for the CY 2024 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html).
3. Methodology for the Direct PE Inputs To Develop PE RVUs
a. Background
    On an annual basis, the RUC provides us with recommendations 
regarding PE inputs for new, revised, and potentially misvalued codes. 
We review the RUC-recommended direct PE inputs on a code by code basis. 
Like our review of recommended work RVUs, our review of recommended 
direct PE inputs generally includes, but is not limited to, a review of 
information provided by the RUC, HCPAC, and other public commenters, 
medical literature, and comparative databases, as well as a comparison 
with other codes within the PFS, and consultation with physicians and 
health care professionals within CMS and the Federal Government, as 
well as Medicare claims data. We also assess the methodology and data 
used to develop the recommendations submitted to us by the RUC and 
other public commenters and the rationale for the recommendations. When 
we determine that the RUC's

[[Page 78892]]

recommendations appropriately estimate the direct PE inputs (clinical 
labor, disposable supplies, and medical equipment) required for the 
typical service, are consistent with the principles of relativity, and 
reflect our payment policies, we use those direct PE inputs to value a 
service. If not, we refine the recommended PE inputs to better reflect 
our estimate of the PE resources required for the service. We also 
confirm whether CPT codes should have facility and/or nonfacility 
direct PE inputs and refine the inputs accordingly.
    Our review and refinement of the RUC-recommended direct PE inputs 
includes many refinements that are common across codes, as well as 
refinements that are specific to particular services. Table 15 details 
our refinements of the RUC's direct PE recommendations at the code-
specific level. In section II.B. of this final rule, Determination of 
Practice Expense Relative Value Units (PE RVUs), we address certain 
refinements that will be common across codes. Refinements to particular 
codes are addressed in the portions of that section that are dedicated 
to particular codes. We note that for each refinement, we indicate the 
impact on direct costs for that service. We note that, on average, in 
any case where the impact on the direct cost for a particular 
refinement is $0.35 or less, the refinement has no impact on the PE 
RVUs. This calculation considers both the impact on the direct portion 
of the PE RVU, as well as the impact on the indirect allocator for the 
average service. In this final rule, we also note that many of the 
refinements listed in Table 14 result in changes under the $0.35 
threshold and would be unlikely to result in a change to the RVUs.
    We note that the direct PE inputs for CY 2024 are displayed in the 
CY 2024 direct PE input files, available on the CMS website under the 
downloads for the CY 2024 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. The inputs displayed there have been 
used in developing the CY 2024 PE RVUs as displayed in Addendum B.
b. Common Refinements
(1) Changes in Work Time
    Some direct PE inputs are directly affected by revisions in work 
time. Specifically, changes in the intraservice portions of the work 
time and changes in the number or level of postoperative visits 
associated with the global periods result in corresponding changes to 
direct PE inputs. The direct PE input recommendations generally 
correspond to the work time values associated with services. We believe 
that inadvertent discrepancies between work time values and direct PE 
inputs should be refined or adjusted in the establishment of proposed 
direct PE inputs to resolve the discrepancies.
(2) Equipment Time
    Prior to CY 2010, the RUC did not generally provide CMS with 
recommendations regarding equipment time inputs. In CY 2010, in the 
interest of ensuring the greatest possible degree of accuracy in 
allocating equipment minutes, we requested that the RUC provide 
equipment times along with the other direct PE recommendations, and we 
provided the RUC with general guidelines regarding appropriate 
equipment time inputs. We appreciate the RUC's willingness to provide 
us with these additional inputs as part of its PE recommendations.
    In general, the equipment time inputs correspond to the service 
period portion of the clinical labor times. We clarified this principle 
over several years of rulemaking, indicating that we consider equipment 
time as the time within the intraservice period when a clinician is 
using the piece of equipment plus any additional time that the piece of 
equipment is not available for use for another patient due to its use 
during the designated procedure. For those services for which we 
allocate cleaning time to portable equipment items, because the 
portable equipment does not need to be cleaned in the room where the 
service is furnished, we do not include that cleaning time for the 
remaining equipment items, as those items and the room are both 
available for use for other patients during that time. In addition, 
when a piece of equipment is typically used during follow-up 
postoperative visits included in the global period for a service, the 
equipment time will also reflect that use.
    We believe that certain highly technical pieces of equipment and 
equipment rooms are less likely to be used during all of the preservice 
or postservice tasks performed by clinical labor staff on the day of 
the procedure (the clinical labor service period) and are typically 
available for other patients even when one member of the clinical staff 
may be occupied with a preservice or postservice task related to the 
procedure. We also noted that we believe these same assumptions will 
apply to inexpensive equipment items that are used in conjunction with 
and located in a room with non-portable highly technical equipment 
items since any items in the room in question will be available if the 
room is not being occupied by a particular patient. For additional 
information, we referred readers to our discussion of these issues in 
the CY 2012 PFS final rule with comment period (76 FR 73182) and the CY 
2015 PFS final rule with comment period (79 FR 67639).
(3) Standard Tasks and Minutes for Clinical Labor Tasks
    In general, the preservice, intraservice, and postservice clinical 
labor minutes associated with clinical labor inputs in the direct PE 
input database reflect the sum of particular tasks described in the 
information that accompanies the RUC-recommended direct PE inputs, 
commonly called the ``PE worksheets.'' For most of these described 
tasks, there is a standardized number of minutes, depending on the type 
of procedure, its typical setting, its global period, and the other 
procedures with which it is typically reported. The RUC sometimes 
recommends a number of minutes either greater than or less than the 
time typically allotted for certain tasks. In those cases, we review 
the deviations from the standards and any rationale provided for the 
deviations. When we do not accept the RUC-recommended exceptions, we 
refine the proposed direct PE inputs to conform to the standard times 
for those tasks. In addition, in cases when a service is typically 
billed with an E/M service, we remove the preservice clinical labor 
tasks to avoid duplicative inputs and to reflect the resource costs of 
furnishing the typical service.
    We refer readers to section II.B. of this final rule, Determination 
of Practice Expense Relative Value Units (PE RVUs), for more 
information regarding the collaborative work of CMS and the RUC in 
improvements in standardizing clinical labor tasks.
(4) Recommended Items That Are Not Direct PE Inputs
    In some cases, the PE worksheets included with the RUC's 
recommendations include items that are not clinical labor, disposable 
supplies, or medical equipment or that cannot be allocated to 
individual services or patients. We addressed these kinds of 
recommendations in previous rulemaking (78 FR 74242), and we do not use 
items included in these recommendations as direct PE inputs in the 
calculation of PE RVUs.
(5) New Supply and Equipment Items
    The RUC generally recommends the use of supply and equipment items 
that already exist in the direct PE input

[[Page 78893]]

database for new, revised, and potentially misvalued codes. However, 
some recommendations include supply or equipment items that are not 
currently in the direct PE input database. In these cases, the RUC has 
historically recommended that a new item be created and has facilitated 
our pricing of that item by working with the specialty societies to 
provide us copies of sales invoices. For CY 2024 we received invoices 
for several new supply and equipment items. Tables 17 and 18 detail the 
invoices received for new and existing items in the direct PE database. 
As discussed in section II.B. of this final rule, Determination of 
Practice Expense Relative Value Units, we encourage interested parties 
to review the prices associated with these new and existing items to 
determine whether these prices appear to be accurate. Where prices 
appear inaccurate, we encourage interested parties to submit invoices 
or other information to improve the accuracy of pricing for these items 
in the direct PE database by February 10th of the following year for 
consideration in future rulemaking, similar to our process for 
consideration of RUC recommendations.
    We remind interested parties that due to the relativity inherent in 
the development of RVUs, reductions in existing prices for any items in 
the direct PE database increase the pool of direct PE RVUs available to 
all other PFS services. Tables 17 and 18 also include the number of 
invoices received and the number of nonfacility allowed services for 
procedures that use these equipment items. We provide the nonfacility 
allowed services so that interested parties will note the impact the 
particular price might have on PE relativity, as well as to identify 
items that are used frequently, since we believe that interested 
parties are more likely to have better pricing information for items 
used more frequently. A single invoice may not be reflective of typical 
costs, and we encourage interested parties to provide additional 
invoices so that we might identify and use accurate prices in the 
development of PE RVUs.
    In some cases, we do not use the price listed on the invoice that 
accompanies the recommendation because we identify publicly available 
alternative prices or information that suggests a different price is 
more accurate. In these cases, we include this in the discussion of 
these codes. In other cases, we cannot adequately price a newly 
recommended item due to inadequate information. Sometimes, no 
supporting information regarding the price of the item has been 
included in the recommendation. In other cases, the supporting 
information does not demonstrate that the item has been purchased at 
the listed price (for example, vendor price quotes instead of paid 
invoices). In cases where the information provided on the item allows 
us to identify clinically appropriate proxy items, we might use 
existing items as proxies for the newly recommended items. In other 
cases, we include the item in the direct PE input database without any 
associated price. Although including the item without an associated 
price means that the item does not contribute to the calculation of the 
final PE RVU for particular services, it facilitates our ability to 
incorporate a price once we obtain information and are able to do so.
(6) Service Period Clinical Labor Time in the Facility Setting
    Generally speaking, our direct PE inputs do not include clinical 
labor minutes assigned to the service period because the cost of 
clinical labor during the service period for a procedure in the 
facility setting is not considered a resource cost to the practitioner 
since Medicare makes separate payment to the facility for these costs. 
We address code-specific refinements to clinical labor in the 
individual code sections.
(7) Procedures Subject to the Multiple Procedure Payment Reduction 
(MPPR) and the OPPS Cap
    We noted that the list of services for the upcoming calendar year 
that are subject to the MPPR on diagnostic cardiovascular services, 
diagnostic imaging services, diagnostic ophthalmology services, and 
therapy services; and the list of procedures that meet the definition 
of imaging under section 1848(b)(4)(B) of the Act, and therefore, are 
subject to the OPPS cap; are displayed in the public use files for the 
PFS proposed and final rules for each year. The public use files for CY 
2024 are available on the CMS website under downloads for the CY 2024 
PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. For more 
information regarding the history of the MPPR policy, we refer readers 
to the CY 2014 PFS final rule with comment period (78 FR 74261 through 
74263).
    Effective January 1, 2007, section 5102(b)(1) of the Deficit 
Reduction Act of 2005 (Pub. L. 109-171) (DRA) amended section 
1848(b)(4) of the Act to require that, for imaging services, if--(i) 
The TC (including the TC portion of a global fee) of the service 
established for a year under the fee schedule without application of 
the geographic adjustment factor, exceeds (ii) The Medicare OPD fee 
schedule amount established under the prospective payment system (PPS) 
for HOPD services under section 1833(t)(3)(D) of the Act for such 
service for such year, determined without regard to geographic 
adjustment under paragraph (t)(2)(D) of such section, the Secretary 
shall substitute the amount described in clause (ii), adjusted by the 
geographic adjustment factor [under the PFS], for the fee schedule 
amount for such TC for such year. As required by section 1848(b)(4)(A) 
of the Act, for imaging services furnished on or after January 1, 2007, 
we cap the TC of the PFS payment amount for the year (prior to 
geographic adjustment) by the Outpatient Prospective Payment System 
(OPPS) payment amount for the service (prior to geographic adjustment). 
We then apply the PFS geographic adjustment to the capped payment 
amount. Section 1848(b)(4)(B) of the Act defines imaging services as 
``imaging and computer-assisted imaging services, including X-ray, 
ultrasound (including echocardiography), nuclear medicine (including 
PET), magnetic resonance imaging (MRI), computed tomography (CT), and 
fluoroscopy, but excluding diagnostic and screening mammography.'' For 
more information regarding the history of the cap on the TC of the PFS 
payment amount under the DRA (the ``OPPS cap''), we refer readers to 
the CY 2007 PFS final rule with comment period (71 FR 69659 through 
69662).
    For CY 2024, we identified new and revised codes to determine which 
services meet the definition of ``imaging services'' as defined 
previously in this final rule for purposes of this cap. Beginning for 
CY 2024, we proposed to include the following services on the list of 
codes to which the OPPS cap applies: CPT codes 76883 (Ultrasound, 
nerve(s) and accompanying structures throughout their entire anatomic 
course in one extremity, comprehensive, including real-time cine 
imaging with image documentation, per extremity), 76984 (Ultrasound, 
intraoperative thoracic aorta (e.g., epiaortic), diagnostic), 76987 
(Intraoperative epicardial cardiac (e.g., echocardiography) ultrasound 
for congenital heart disease, diagnostic; including placement and 
manipulation of transducer), 76988 (Intraoperative epicardial cardiac 
(e.g., echocardiography) ultrasound for congenital heart disease, 
diagnostic; placement, manipulation of transducer, and image 
acquisition only), 76989 (Intraoperative epicardial cardiac (e.g.,)

[[Page 78894]]

echocardiography) ultrasound for congenital heart disease, diagnostic; 
interpretation and report only), 93584 (Venography for congenital heart 
defect(s), including catheter placement, and radiological supervision 
and interpretation; anomalous or persistent superior vena cava when it 
exists as a second contralateral superior vena cava, with native 
drainage to heart (List separately in addition to code for primary 
procedure)), 93585 (Venography for congenital heart defect(s), 
including catheter placement, and radiological supervision and 
interpretation; azygos/hemi-azygos venous system (List separately in 
addition to code for primary procedure)), 93586 (Venography for 
congenital heart defect(s), including catheter placement, and 
radiological supervision and interpretation; coronary sinus (List 
separately in addition to code for primary procedure)), 93587 
(Venography for congenital heart defect(s), including catheter 
placement, and radiological supervision and interpretation; venovenous 
collaterals originating at or above the heart (e.g., from innominate 
vein) (List separately in addition to code for primary procedure)), and 
93588 (Venography for congenital heart defect(s), including catheter 
placement, and radiological supervision and interpretation; venovenous 
collaterals originating below the heart (e.g., from the inferior vena 
cava) (List separately in addition to code for primary procedure)). We 
believe that these codes meet the definition of imaging services under 
section 1848(b)(4)(B) of the Act, and thus, should be subject to the 
OPPS cap. We note that we previously proposed to add CPT code 76883 to 
the list of codes to which the OPPS cap applies in the CY 2023 PFS 
proposed rule, but we did not finalize its addition, noting that it was 
not within the statutory scope of services to which the OPPS cap 
applies, as it could not be split into professional and technical 
components at that time (87 FR 69475). Since that time, we have 
reinstated CPT code 76883's PC/TC split based on feedback from billing 
practitioners, therefore we proposed to add it to the OPPS cap list for 
CY 2024.
    Comment: Some commenters requested that CMS remove CPT code 92229 
(Imaging of retina for detection or monitoring of disease; point-of-
care autonomous analysis and report, unilateral or bilateral) from the 
OPPS cap list because it does not include an associated PC or physician 
interpretation and it is primarily utilized in the physician office 
setting. Commenters also noted that this service falls outside the 
scope of the definition of ``imaging services'' under the DRA. One 
commenter stated that, while it may be appropriate for the technical 
components of CPT codes 92227 (Imaging of retina for detection or 
monitoring of disease; with remote clinical staff review and report, 
unilateral or bilateral) and 92228 (Imaging of retina for detection or 
monitoring of disease; with remote physician or other qualified health 
care professional interpretation and report, unilateral or bilateral) 
to be on the OPPS Cap List, the same logic does not apply to CPT code 
92229 despite all three codes being in the same family of codes and 
representing the same imaging service, only differentiated by the 
modality of review and interpretation.
    Response: We appreciate the commenters' feedback regarding CPT code 
92229. We note that CPT codes 92227, 92228, and 92229 have been subject 
to the OPPS cap since their addition to the OPPS cap list for CY 2021 
and we did not make any proposals related to CPT code 92229 for CY 
2024, therefore these comments are considered to be out of scope of the 
proposed rule. We will consider the commenters' suggestions for future 
rulemaking.
    We did not receive public comments on the proposed additions to the 
OPPS cap list for CY 2024. We are finalizing the addition of the 
services listed above to the list of codes to which the OPPS cap 
applies, as proposed.
4. Valuation of Specific Codes for CY 2024
(1) Dorsal Sacroiliac Joint Arthrodesis (CPT Code 27278)
    In September 2022, CPT deleted category III CPT code 0775T 
(Arthrodesis, sacroiliac joint, percutaneous, with image guidance, 
includes placement of intra-articular implant(s) (e.g., bone 
allograft[s], synthetic device[s]) and created a new Category I CPT 
code 27278 (Arthrodesis, sacroiliac joint, percutaneous, with image 
guidance, including placement of intra-articular implant(s) (e.g., bone 
allograft[s], synthetic device[s]), without placement of transfixation 
device), which was surveyed for the January 2023 RUC meeting. CPT codes 
27279 (Arthrodesis, sacroiliac joint, percutaneous or minimally 
invasive (indirect visualization), with image guidance, includes 
obtaining bone graft when performed, and placement of transfixing 
device) and 27280 (Arthrodesis, sacroiliac joint, open, includes 
obtaining bone graft, including instrumentation, when performed) were 
added as family codes to the level of interest (LOI) form for the RUC 
to review. However, the specialty societies indicated that they do not 
consider CPT codes 27279 and 27280 as part of the same code family and 
requested that they not be re-reviewed by the RUC for the January 2023 
meeting. The RUC agreed with the specialty societies and did not review 
these codes at the January 2023 meeting. The RUC stated in their 
recommendations for 27278 that the clinical nature of CPT codes 27279 
and 27280 is extensively disparate from 27278 for both the surgical 
approach and the specialties that perform the procedures. Additionally, 
they stated that no substantive changes were made to CPT codes 27279 
and 27280 at the September 2022 CPT panel meeting and 27279 has been 
reviewed by the RUC as recently as 2018.
    We proposed the RUC-recommended work RVU of 7.86 for CPT code 
27278. We also proposed the RUC-recommended direct PE inputs without 
refinement.
    Comment: Several commenters supported CMS' proposed valuation of 
7.86 work RVUs for CPT code 27278. They also supported CMS' proposed 
RUC-recommended direct PE inputs for the non-facility site of service 
as they noted that current study data has sufficiently demonstrated 
safety and efficacy in the non-facility setting. However, several 
commenters expressed concern that the non-facility site of service is 
not appropriate for this procedure. They stated that the procedure is 
new and without a pre-established safety record.
    Response: We thank commenters for their support of our proposed 
work RVU and non-facility direct PE inputs. However, we also 
acknowledge other commenters' concerns regarding CPT code 27278 being 
performed in the non-facility setting. At this time, we agree with the 
RUC's recommended valuations, including the non-facility direct PE 
inputs. However, given consideration of all comments received, we 
believe that CPT code 27278 could benefit from additional future review 
by the RUC, as a service that includes a new technology supply item 
(dorsal SI joint arthrodesis implant), as well as considerations for 
the site of service. If we were to receive new RUC recommendations at a 
future date, we would consider that information and any discussions 
with interested parties for rulemaking.
    Comment: Some commenters expressed concerns about the cost of the 
direct PE supply item, dorsal SI joint arthrodesis implant, valued at 
$11,500.

[[Page 78895]]

They stated that the high cost of this supply will negatively impact PE 
RVUs and cause undesirable effects on the PFS budget neutrality as a 
service with one of the highest costs on the fee schedule. Commenters 
were also concerned with the potential overutilization of the service 
in the non-facility setting.
    Response: The payment for the dorsal SI joint arthrodesis implant 
is based on invoices received from the manufacturer and a formal review 
to determine if each direct PE input is typical and medically 
necessary, which is part of our standard code review process. While we 
acknowledge that the supply is a high-cost item, we do not believe it 
is appropriate to undervalue a service to minimize impacts on budget 
neutrality. We also remind commenters that the utilization for this new 
CPT category I code is crosswalked from CPT code 0775T. As such, we do 
not anticipate a large impact on budget neutrality and will continue to 
monitor utilization as part of our standard ratesetting process.
    After consideration of the public comments, we are finalizing the 
RUC-recommended work RVU of 7.86 and direct PE inputs as proposed for 
CPT code 27278.
(2) Vertebral Body Tethering (CPT Codes 22836, 22837, and 22838)
    At the September 2022 CPT Panel meeting, two new Category I CPT 
codes, 22836 (Anterior thoracic vertebral body tethering, including 
thoracoscopy, when performed; up to 7 vertebral segments) and 22837 
(Anterior thoracic vertebral body tethering, including thoracoscopy, 
when performed; 8 or more vertebral segments) were established for 
thoracic tethering. In addition, another new Category I CPT code, 22838 
(Revision (e.g., augmentation, division of tether), replacement, or 
removal of thoracic vertebral body tethering, including thoracoscopy, 
when performed) was established for tether revision, replacement or 
removal. This code family was then surveyed for the January 2023 RUC 
meeting.
    We proposed the RUC-recommended work RVUs of 32.00 for CPT code 
22836, 35.50 for CPT code 22837, and 36.00 for CPT code 22838. We also 
proposed the RUC-recommended direct PE inputs without refinement.
    Comment: We received comments in support of the proposed work RVU 
and direct PE inputs for this code family.
    Response: We thank commenters for their support. After 
consideration of the public comments, we are finalizing our work RVU 
and direct PE inputs for the codes in the Vertebral Body Tethering 
family as proposed.
(3) Total Disc Arthroplasty (CPT Codes 22857 and 22860)
    In September 2021, the CPT Editorial Panel created CPT Category I 
code 22860 to describe Total disc arthroplasty (artificial disc), 
anterior approach, including discectomy to prepare interspace (other 
than for decompression); second interspace, lumbar (List separately in 
addition to code for primary procedure) and replace CPT Category III 
code 0163T (Total disc arthroplasty (artificial disc), anterior 
approach, including discectomy to prepare interspace (other than for 
decompression), each additional interspace, lumbar (List separately in 
addition to code for primary procedure)), which prompted CPT codes 
22860 and 22857 (Total disc arthroplasty (artificial disc), anterior 
approach, including discectomy to prepare interspace (other than for 
decompression); single interspace, lumbar) to be surveyed for the 
January 2022 RUC meeting. At the January 2022 RUC meeting, the 
specialty societies indicated, and the RUC agreed, that the survey 
results for both CPT codes 22857 and 22860 were erroneous and that the 
codes should be resurveyed for the April 2022 RUC meeting. Therefore, 
we proposed and finalized to maintain the RUC-recommended work RVU of 
27.13 for CPT code 22857 and contractor pricing for CPT code 22860 for 
CY 2023.
    For CY 2024, we proposed the April 2022 RUC-recommended work RVU of 
27.13 for CPT code 22857, which represents no change from the current 
work RVU. For CPT code 22860, we disagreed with the April 2022 RUC-
recommended survey median work RVU of 7.50 and proposed the survey 
(with experience) 25th percentile work RVU of 6.88. We noted that, of 
the 46 ZZZ-codes with an intraservice time of 60 minutes, only 4 have a 
work RVU higher than the RUC-recommended 7.50.
    We noted that our proposed work RVU of 6.88 will maintain 
relativity with CPT codes 22552 (Arthrodesis, anterior interbody, 
including disc space preparation, discectomy, osteophytectomy and 
decompression of spinal cord and/or nerve roots; cervical below C2, 
each additional interspace (List separately in addition to code for 
primary procedure)) (work RVU = 6.50, 45 minutes intra-service and 50 
minutes total time), which is an anterior approach spine procedure that 
requires less time, and CPT code 22208 (Osteotomy of spine, posterior 
or posterolateral approach, 3 columns, 1 vertebral segment (e.g., 
pedicle/vertebral body subtraction); each additional vertebral segment 
(List separately in addition to code for primary procedure)) (work RVU 
= 9.66, 120 minutes intra-service and 135 minutes total time). As the 
RUC mentioned in their recommendations, these codes appropriately 
bracket CPT code 22860 and demonstrate relativity among similar 
surgical spine add-on codes. The RUC noted that their recommended work 
RVU of 7.50 reflects the increased intensity of spine procedures 
performed from an anterior approach, but we note that CPT code 22226 
(Osteotomy of spine, including discectomy, anterior approach, single 
vertebral segment; each additional vertebral segment (List separately 
in addition to code for primary procedure)), which represents an 
anterior approach, and CPT code 22216 (Osteotomy of spine, posterior or 
posterolateral approach, 1 vertebral segment; each additional vertebral 
segment (List separately in addition to primary procedure)), which 
represents a posterior or posterolateral approach, are both valued at 
6.03 work RVUs and have identical IWPUTs of 0.1005. CPT codes 22216 and 
22226 are ZZZ codes and have identical times as CPT code 22860, and 
therefore, we believe the proposed survey (with experience) 25th 
percentile work RVU of 6.88 for CPT code 22860 is more appropriate than 
the RUC recommended work RVU.
    We proposed the RUC-recommended direct PE inputs for both codes 
without refinement.
    Comment: Some commenters disagreed with the proposed work RVU of 
6.88 for CPT code 22860 and encouraged CMS to finalize the RUC-
recommended work RVU of 7.50. Some commenters reiterated that CPT codes 
22552 and 22208 appropriately bracket CPT code 22860, with work RVUs of 
6.50 and 9.66, respectively. Some commenters also stated that the 
exposure of the second interspace (represented by CPT code 22860) is 
technically more difficult than the initial interspace (represented by 
CPT code 22857) and more intense compared to an osteotomy of the spine 
(represented by CPT codes 22208 and 22226). Commenters generally 
disagreed with the comparison of CPT code 22860 to CPT codes 22216 and 
22226 because they were valued over 25 years ago and had limited survey 
responses.
    Response: We agree with the commenters that the intensity of the 
second interspace exposure (CPT code 22860) is greater than the 
identically timed CPT code 22226, which represents an anterior approach 
osteotomy of the spine, and the technical difficulty of the first 
interspace exposure (CPT code 22857). The proposed work RVU of 6.88 for 
CPT

[[Page 78896]]

code 22860 accurately values the surgeon's 60 minutes of intraservice 
time more than the identical 60 minutes of intraservice time for CPT 
code 22226 and yields a higher intensity (IWPUT) of 0.115 for CPT code 
22860 for the exposure of the second interspace compared to exposure of 
the first interspace in CPT code 22857 of 0.092. Commenters were 
supportive of bracketing a work RVU of 7.50 with CPT codes 22552 and 
22208, with work RVUs of 6.50 and 9.66, respectively, but we note that 
the proposed work RVU of 6.88 is also appropriately bracketed by these 
codes as well.
    After consideration of the public comments, we are finalizing a 
work RVU of 27.13 for CPT code 22857 and a work RVU of 6.88 for CPT 
code 22860, as proposed. We are also finalizing the direct PE inputs as 
proposed.
(4) Phrenic Nerve Stimulation System (CPT Codes 33276, 33277, 33278, 
33279, 33280, 33281, 33287, 33288, 93150, 93151, 93152, and 93153)
    In September 2022, the CPT Editorial Panel created eight new 
Category I CPT codes to describe the insertion, repositioning, removal, 
and removal and replacement of a phrenic nerve stimulator system, as 
well as adding four additional new Category I codes to describe 
activation, interrogation, and programming of a phrenic nerve 
stimulator system. These new codes will replace thirteen Category III 
codes, 0424T-0436T. The twelve new Category I codes were surveyed and 
then reviewed for the January 2023 RUC meeting.
    We proposed the RUC-recommended work RVU for all twelve codes in 
the Phrenic Nerve Stimulation System family. We proposed a work RVU of 
9.50 for CPT code 33276 (Insertion of phrenic nerve stimulator system 
(pulse generator and stimulating lead[s]) including vessel 
catheterization, all imaging guidance, and pulse generator initial 
analysis with diagnostic mode activation when performed), a work RVU of 
5.43 for CPT code 33277 (Insertion of phrenic nerve stimulator 
transvenous sensing lead), a work RVU of 9.55 for CPT code 33278 
(Removal of phrenic nerve stimulator including vessel catheterization, 
all imaging guidance, and interrogation and programming, when 
performed; system, including pulse generator and lead(s)), a work RVU 
of 5.42 for CPT code 33279 (Removal of phrenic nerve stimulator 
including vessel catheterization, all imaging guidance, and 
interrogation and programming, when performed; transvenous stimulation 
or sensing lead(s) only), a work RVU of 3.04 for CPT code 33280 
(Removal of phrenic nerve stimulator including vessel catheterization, 
all imaging guidance, and interrogation and programming, when 
performed; pulse generator only), a work RVU of 6.00 for CPT code 33281 
(Repositioning of phrenic nerve stimulator transvenous lead(s)), a work 
RVU of 6.05 for CPT code 33287 (Removal and replacement of phrenic 
nerve stimulator including vessel catheterization, all imaging 
guidance, and interrogation and programming when performed; pulse 
generator), a work RVU of 8.51 for CPT code 33288 (Removal and 
replacement of phrenic nerve stimulator including vessel 
catheterization, all imaging guidance, and interrogation and 
programming when performed; transvenous stimulation or sensing lead), a 
work RVU of 0.85 for CPT code 93150(Therapy activation of implanted 
phrenic nerve stimulator system including all interrogation and 
programming), a work RVU of 0.80 for CPT code 9X046 (Interrogation and 
programming (minimum one parameter) of implanted phrenic nerve 
stimulator systemX047 (), and a work RVU of 0.43 for CPT code 93153 
(Interrogation, without programming of implanted phrenic nerve 
stimulator system).
    We proposed to refine the CA039 Post-operative visits (total time) 
for CPT code 33287 from 36 minutes to 53 minutes to reflect the fact 
that this code has a Level 4 office visit and not a Level 3 office 
visit included in its global period; we believe that this was an 
unintended technical error in the RUC recommendation. We also proposed 
to refine the equipment time for the exam table (EF023) equipment from 
36 minutes to 53 minutes for CPT code 33287 to conform to this change 
in clinical labor time. For all other codes, we proposed the direct PE 
inputs as recommended by the RUC without refinement.
    Comment: Several commenters stated that they supported the CMS 
proposal of the RUC's recommended work RVUs for all twelve codes in the 
family. Several commenters also stated that they agreed with the 
correction of a clerical error in the CA039 Post-operative visits 
(total time) for CPT code 33287 and otherwise supported the CMS 
proposal of the RUC's recommended direct PE inputs.
    Response: We appreciate the support for our proposals from the 
commenters.
    After consideration of the public comments, we are finalizing the 
work RVUs and direct PE inputs for the code family as proposed.
(5) Posterior Nasal Nerve Ablation (CPT Codes 30117, 30118, 31242, and 
31243)
    In September 2022, the CPT Editorial Panel created two new 
endoscopy codes for ablation of the posterior nasal nerve: CPT code 
31242 (Nasal/sinus endoscopy, surgical; with destruction by 
radiofrequency ablation, posterior nasal nerve), and CPT code 31243 
(Nasal/sinus endoscopy, surgical; with destruction by cryoablation, 
posterior nasal nerve). In preparation for the January 2023 RUC 
meeting, both new posterior nasal nerve codes, 31242 and 31243, as well 
as family CPT codes 30117 and 30118, were surveyed. For CY 2024, the 
RUC recommended a work RVU of 3.91 for CPT code 30117, a work RVU of 
9.55 for CPT code 30118, and a work RVU of 2.70 for both CPT codes 
31242 and 31243.
    We proposed the RUC-recommended work RVU of 3.91 for CPT code 
30117. We proposed to remove the clinical labor for the CA037 (Conduct 
patient communications) activity code for CPT code 30117. This clinical 
labor is associated with patient communications which already take 
place during the CA036 (Discharge day management) activity code for 10-
day and 90-day global procedures. We proposed to remove this clinical 
labor as it would be duplicative with the communications already taking 
place under the CA036 activity code. We proposed to delete supply item 
SB027 (gown, staff, impervious) because supply items SA042 (pack, 
cleaning and disinfecting, endoscope) and SA043 (pack, cleaning, 
surgical instruments) each include this same item. Supply items SA042 
and SA043 are both included in the direct PE inputs for CPT code 30117.
    We disagreed with the RUC-recommended work RVU of 9.55 for CPT code 
30118 and proposed a work RVU of 7.75, based on a direct crosswalk from 
CPT code 28298 (Correction, hallux valgus (bunionectomy), with 
sesamoidectomy, when performed; with proximal phalanx osteotomy, any 
method) which has the same 60 minutes of intra-service time and similar 
total time as CPT code 30118. We believe the work RVU should be lower 
than the RUC recommendation of 9.55 to reflect the decrease in intra-
service time from 105 minutes to 60 minutes, and the decrease in total 
time from 288 minutes to 211 minutes. In the case of CPT code 30118, 
the intra-service work time is decreasing by 43 percent and the total 
work time is decreasing by 27 percent but the RUC-recommended work RVU 
is only decreasing by 4 percent. Although we do not imply that the 
decrease in time

[[Page 78897]]

as reflected in survey values must equate to a one-to-one or linear 
decrease in the valuation of work RVUs, we believe that since the two 
components of work are time and intensity, significant decreases in the 
surveyed work time should be reflected in commensurate decreases to 
work RVUs.
    We also noted that at the RUC-recommended work RVU of 9.55, the 
intensity of CPT code 30118 would be increasing by more than 50 
percent. We disagreed that there would be such a significant increase 
in the intensity for the procedure, as it is transitioning from 
inpatient to outpatient status which suggests that the intensity has 
remained the same or decreased over time. We also disagreed that this 
would be the case since the intensity for CPT code 30117 is decreasing 
at the RUC-recommended work RVU of 3.91. Therefore, we also proposed a 
work RVU of 7.75 because it maintains the current intensity of CPT code 
30118 instead of resulting in an increase in intensity. The work RVU of 
7.75 is supported by the reference CPT codes we compared to CPT code 
30118 with the same 60 minutes of intra-service time and similar total 
time as CPT code 30118; reference CPT code 11970 (Replacement of tissue 
expander with permanent implant) has a work RVU of 7.49, and reference 
CPT code 19325 (Breast augmentation with implant) has a work RVU of 
8.12. We believe the RVU of 7.75 is a more appropriate value overall 
than 9.55 when compared to the range of codes with the same intra-
service time and similar total time.
    We proposed to remove the clinical labor for the CA037 (Conduct 
patient communications) activity code for CPT code 30118. This clinical 
labor is associated with patient communications which already take 
place during the CA036 (Discharge day management) activity code for 10-
day and 90-day global procedures. We proposed to remove this clinical 
labor from CPT code 30118 as it would be duplicative with the 
communications already taking place under the CA036 activity code.
    We proposed the RUC-recommended work RVU of 2.70 for CPT codes 
31242 and 31243. Both CPT codes 31242 and 31243 are endoscopic 
procedures; therefore, we proposed CPT code 31231 (Nasal endoscopy, 
diagnostic, unilateral or bilateral (separate procedure)) as the 
endoscopic base code for both of these codes because the description of 
these procedures includes what is described for CPT code 31231, with 
the additional component of the posterior nasal nerve ablation. Both of 
these procedures are performed with an endoscope. CPT codes 31242 and 
31243 are not add-on codes, and both have a 0-day global period. The 
endoscopic base code that we are assigning to CPT codes 31242 and 31243 
is used in a specific type of multiple procedure payment reduction that 
applies to some endoscopy codes.
    We proposed to refine the RUC-recommended direct PE inputs for both 
CPT codes 31242 and 31243. For CPT code 31242, we are refining the 
equipment time for the ES031 equipment (scope video system (monitor, 
processor, digital capture, cart, printer, LED light)) from 39 minutes 
to 32 minutes. The RUC used the CA025 (clean scope) time of 10 minutes 
instead of the CA024 (clean room/equipment by clinical staff) time of 3 
minutes in the Scope Systems formula, when the time for CA024 is the 
standard; we believe that this was an unintended technical error in the 
RUC recommendation. We are similarly refining the equipment time for 
ES031 from 39 minutes to 34 minutes for CPT code 31243.
    For CPT code 31243, we are refining the equipment time for the 
ES040 equipment (PROXY endoscope, rigid, sinoscopy (0 degrees)) from 39 
minutes to 41 minutes because the RUC used 18 minutes of intra-service 
time for CA018 (Assist physician or other qualified healthcare 
professional--directly related to physician work time (100%)) instead 
of 20 minutes in the standard Scope formula. Also, for both CPT codes 
31242 and 31243, we proposed to delete supply item SB027 (gown, staff, 
impervious) because SA042 (pack, cleaning and disinfecting, endoscope) 
and SA043 (pack, cleaning, surgical instruments) each include this same 
item. Supply items SA042 and SA043 are both included in the PE inputs 
for CPT codes 31242 and 31243.
    The following is a summary of the comments we received and our 
responses.
    Comment: Commenters supported CMS' proposal of the RUC-recommended 
work RVUs for CPT codes 30117, 31242, and 31243.
    Response: We thank the commenters for their support, and we are 
finalizing the RUC-recommended work RVU of 3.91 for CPT code 30117, and 
the work RVU of 2.70 for CPT codes 31242 and 31243, as proposed.
    Comment: For CPT code 30118, we received a few comments that 
disagreed with CMS' proposed work RVU of 7.75. The commenters stated 
that the proposed work RVU of 7.75 fails to maintain relativity within 
the code family of CPT codes 30117, 30118, 31242 and 31243, and it does 
not account for the higher clinical complexity and intraoperative 
intensity for CPT code 30118. Commenters stated that the intra-service 
time required for CPT code 30118 is twice as long as CPT code 30117, 
which is attributable to the difficulty of this procedure. One 
commenter stated that the intensity (IWPUT) for CPT code 30118 is 
0.079, which is more than four times the typical intensity of work 
compared to the IWPUT of 0.018 for CPT code 30117. Commenters stated 
that the proposed CMS crosswalk of CPT code 28298 was completely 
inappropriate in terms of intensity, and the skill needed to perform 
CPT code 30118 is greater than CPT code 28298. Although CPT code 28298 
has similar intra-service time and total time, it has an IWPUT of 0.047 
which is considerably less than the IWPUT for CPT code 30118. In 
addition, commenters stated that the two comparison codes that CMS 
chose as support for the CPT code 28298 crosswalk (CPT codes 11970 and 
19325) do not compare in intensity to CPT code 30118, even though they 
have similar intra-service time and total time. Commenters also stated 
that CPT code 30118 was undervalued in terms of its intensity during 
the initial Harvard valuation.
    Response: We disagree with the commenters and continue to believe 
that a direct crosswalk from CPT code 28298 is appropriate since it has 
the same 60 minutes of intra-service time and similar total time as CPT 
code 30118. We also believe that the nature of the PFS relative value 
system is such that all services are appropriately subject to 
comparisons to one another. Although codes that describe clinically 
similar services are sometimes stronger comparator codes, we do not 
agree that codes must share the same site of service, patient 
population, or utilization level to serve as an appropriate crosswalk. 
The work RVU for CPT code 30118 should be lower than the RUC 
recommendation of 9.55 to reflect the decrease in intra-service time 
from 105 minutes to 60 minutes, and the decrease in total time from 288 
minutes to 211 minutes. Although we do not imply that the decrease in 
time as reflected in survey values must equate to a one-to-one or 
linear decrease in the valuation of work RVUs, we believe that since 
the two components of work are time and intensity, significant 
decreases in the surveyed work time should be reflected in commensurate 
decreases to work RVUs.
    The intensity of CPT code 30118 would increase by more than 50 
percent with the RUC-recommended RVU of 9.55. However, we disagree that 
the intensity for CPT code 30118 would increase in such a significant 
way

[[Page 78898]]

because this procedure is transitioning from an inpatient to an 
outpatient status. We also note that the intensity for CPT code 30117 
has decreased with the RUC-recommended work RVU of 3.91. Therefore, we 
believe that our proposed work RVU of 7.75, which maintains the current 
intensity of CPT code 30118 instead of resulting in an increase in 
intensity, is the most accurate valuation for this service. We continue 
to believe that the proposed work RVU of 7.75 is a more appropriate 
value overall than the RUC's recommended work RVU of 9.55 when compared 
to the range of codes with the same intra-service time and similar 
total time. Therefore, we are finalizing the proposed work RVU of 7.75 
for CPT code 30118.
    Comment: For CPT code 31243, one commenter disagreed with the scope 
video system PE input equipment time refinement from 39 minutes to 34 
minutes for ES031 and requested that we accept the RUC recommendation 
of 39 minutes, which they stated was the appropriate value for this 
input.
    Response: We disagree with the commenter. The standard Scope 
Systems equipment formula the RUC used was incorrect. For CPT code 
31243, the RUC initially recommended 39 minutes for PE input ES031. 
However, the RUC used the CA025 clinical labor task instead of CA024 in 
the formula; this was in error since CA024 is in the standard Scope 
Systems formula and CA025 is not. Using CA024 results in 7 minutes less 
time for ES031. Also, the RUC inadvertently used 18 minutes of intra-
service time for CA018 in the formula instead of 20 minutes. Using the 
correct time of 20 minutes for CA018 results in an increase of 2 
minutes. The net result of these corrections is 34 minutes for ES031 
((39 + 2)-7 = 34). We also note that the RUC comments on the PE inputs 
for CPT code 31243 agreed with our proposed refinement for ES031. 
Therefore, for CPT code 31243 we are finalizing the equipment time 
refinement of 34 minutes for ES031 as proposed.
    Comment: For CPT codes 30117 and 30118, some commenters disagreed 
with the proposal to remove the clinical labor for the CA037 activity 
code from the direct PE inputs. Commenters stated that this is a 
follow-up phone call by staff to see how the patient is doing, 1 to 2 
days after the procedure, and should be included in both the facility 
and non-facility settings. The commenters stated that this staff 
contact with the patient is completely different than, and separate 
from, what occurs the day of the procedure for CA036. While a follow-up 
phone call is outside of the 090-day global standard, this type of 
postoperative communication is evolving and reflects best practice.
    Response: We continue to believe that the CA037 clinical labor task 
should not be included in the PE inputs for CPT codes 30117 and 30118 
since the standard for the post-operative period for 010-day and 090-
day global procedures does not include clinical labor for phone calls 
as a separate direct PE input, and both of these codes are 090-day 
global procedures. We also continue to believe that CA037 is 
duplicative with the communications already taking place under the 
CA036 clinical labor activity. Therefore, we are finalizing the PE 
input refinement to remove the CA037 clinical labor from CPT codes 
30117 and 30118.
    After consideration of the public comments, we are finalizing the 
work RVU values for the Posterior Nasal Nerve Ablation code family (CPT 
codes 30117, 30118, 31242, and 31243) as proposed. We are also 
finalizing the direct PE inputs for CPT codes 30117, 30118, 31242, and 
31243 as proposed.
(6) Cystourethroscopy With Urethral Therapeutic Drug Delivery (CPT Code 
52284)
    In September 2022, the CPT Editorial Panel replaced Category III 
code 0499T (Cystourethroscopy, with mechanical dilation and urethral 
therapeutic drug delivery for urethral stricture or stenosis, including 
fluoroscopy, when performed) with the new Category I CPT code 52284 
(Cystourethroscopy, with mechanical urethral dilation and urethral 
therapeutic drug delivery by drug coated balloon catheter for urethral 
stricture or stenosis, male, including fluoroscopy, when performed) to 
describe cystourethroscopy with mechanical urethral dilation and 
urethral therapeutic drug delivery. For CY 2024, the RUC recommended a 
work RVU of 3.10 for CPT code 52284.
    We proposed the RUC-recommended work RVU of 3.10 for CPT code 
52284. We also proposed the RUC-recommended direct PE inputs for CPT 
code 52284 without refinement.
    Since this is an endoscopic procedure, we proposed CPT code 52000 
(Cystourethroscopy (separate procedure)) as the endoscopic base code 
for CPT code 52284 because the description of this procedure includes 
what is described for CPT code 52000 with the additional component of 
the urethral therapeutic drug delivery. This procedure is performed 
with a cystoscope. CPT code 52284 is not an add-on code, it has a 0-day 
global period. The endoscopic base code that we assigned to CPT code 
52284 is a specific type of multiple procedure payment reduction that 
applies to some endoscopy codes.
    The following is a summary of the comments we received and our 
responses.
    Comment: The commenters supported CMS' proposal of the RUC-
recommended work RVU and direct PE inputs.
    Response: We thank the commenters for their support and are 
finalizing as proposed.
    After consideration of the public comments, we are finalizing the 
work RVU of 3.10 for the CPT code 52284 as proposed. We are also 
finalizing the direct PE inputs for code 52284 without refinement.
(7) Transcervical RF Ablation of Uterine Fibroids (CPT Code 58580)
    In September 2022, the CPT Editorial Panel deleted Category III 
code 0404T (Transcervical uterine fibroid(s) ablation with ultrasound 
guidance, radiofrequency) and created a new Category I CPT code 58580 
(Transcervical ablation of uterine fibroid(s), including intraoperative 
ultrasound guidance and monitoring, radiofrequency) to report and 
describe transcervical radiofrequency ablation of uterine fibroid(s) 
which prompted CPT code 58580 to be surveyed for the January 2023 RUC 
meeting. At the January 2023 RUC meeting, the specialty societies 
indicated, and the RUC agreed, that the survey results for CPT code 
58580 showed that the survey 25th percentile work RVU of 7.21 
appropriately recognizes the work involved in this service.
    We proposed the RUC-recommended work RVU of 7.21 for CPT code 
58580. We note that the RUC recommended in their review that CPT code 
58580 be placed on the New Technology list to be re-reviewed by the RUC 
in 3 years to ensure correct valuation and utilization assumptions. We 
will revisit the valuations of CPT code 58580 in future rulemaking as 
needed, based on our typical annual review process.
    CPT code 58580 includes a medium instrument pack (EQ138) as one of 
the practice expense inputs for this code. Since the medium instrument 
pack is classified as equipment, it should include time for cleaning 
the surgical instrument package. We noted a mistake in one of the 
equipment time formulas for the medium instrument pack (EQ138), which 
used the CA024 clean room/equipment by clinical staff time instead of 
the CA026 clean surgical instrument package time in the equipment 
formula. Therefore, we proposed to refine the medium

[[Page 78899]]

instrument pack equipment time from 65 minutes to 77 minutes to conform 
to our established policy for surgical instrument packs; otherwise, we 
proposed the RUC-recommended direct PE inputs without refinement.
    Comment: Several commenters supported the CMS proposal of the RUC-
recommended work RVU of 7.21. Commenters also agreed with the proposed 
refinement to the medium instrument pack (EQ138) equipment time.
    Response: We appreciate the support for our proposed policies from 
the commenters.
    Comment: A few commenters disagreed with the CMS proposal of the 
RUC-recommended work RVU of 7.21 for CPT code 58580. The commenters 
stated that the RUC's recommendation of a work RVU of 7.21 for this 
procedure was insufficient and suggested that CPT code 58674, to which 
CMS has assigned a work RVU of 14.08, would be more appropriate. 
Another commenter suggested that CMS increase the work RVU for CPT code 
58580 to 8.00 to bring the valuation in line with CPT code 22514, which 
has a work RVU of 7.99 and which the RUC used as a comparator code.
    Response: We thank the commenters for their suggestions; however we 
disagree with the commenters and continue to agree with the RUC that a 
work RVU of 7.21 is the most accurate valuation for CPT code 58580. The 
suggestion from commenters to assign a work RVU of 14.08 based on a 
crosswalk to CPT code 58674 would not be appropriate for CPT code 
58580, as CPT code 58674 is a surgical laparoscopy with more than 
double the intraservice work time. The alternate suggestion of 
finalizing a work RVU of 8.00 based on a near-match of CPT code 22514 
is a better fit, as this code shares the same intraservice work time 
and similar total work time with CPT code 58580. However, we believe 
that CPT code 22514 is a more intensive procedure as compared with CPT 
code 58580 due to its nature as a percutaneous vertebral augmentation, 
which justifies having a higher work RVU.
    At the January 2023 RUC meeting, the specialty societies indicated, 
and the RUC agreed, that the survey results for CPT code 58580 showed 
that the survey 25th percentile work RVU of 7.21 appropriately 
recognizes the work involved in this service. To justify a work RVU of 
7.21, the RUC also referenced top key reference code CPT code 58356 
(Endometrial cryoablation with ultrasonic guidance, including 
endometrial curettage, when performed) with a work RVU= 6.41, intra-
service time of 45 minutes, total time of 167 minutes, and noted that 
although both services involve identical intra-service time, the 
majority of survey respondents that selected this key reference code 
indicated the surveyed code was a more intense and complex service to 
perform (94 percent). While we do not always agree with the RUC, we 
believe that the proposed work RVU of 7.21 accurately captures the work 
completed in this service.
    Comment: One commenter stated that the proposed non-facility 
practice expense RVU for CPT code 58580 would be insufficient for the 
costs expected in an office setting.
    Response: We appreciate the concerns raised by the commenter; 
however, the commenter did not specify which additional PE expenses 
were not being captured in the proposed valuation for CPT code 58580. 
If the commenter has reason to believe that the RUC's recommended 
direct PE inputs failed to capture the costs associated with this 
procedure, we encourage them to consider nominating CPT code 58580 as 
potentially misvalued for addition review. (We direct readers to the 
Potentially Misvalued Services Under the PFS (section II.C.) earlier in 
this final rule for additional details).
    Comment: Several commenters recommended that CMS increase the 
malpractice RVU for CPT code 58580, as they stated that the proposed 
value was insufficient to cover malpractice costs.
    Response: The malpractice RVU for each service is a derived 
valuation largely based on the work RVU and the risk factors associated 
with the specialties reporting that service in claims data. We do not 
propose specific malpractice RVUs which are derived as a result of our 
larger ratesetting process; for additional information, we direct 
readers to the Determination of Malpractice Relative Value Units (RVUs) 
(section II.H.) in last year's final rule (87 FR 69634 through 69641).
    After consideration of the public comments for CPT code 58580, we 
are finalizing the RUC-recommended work RVU of 7.21 as proposed. We are 
also finalizing our proposal to refine the medium instrument pack 
equipment time from 65 minutes to 77 minutes to conform to our 
established policy for surgical instrument packs. Otherwise, we are 
finalizing the RUC-recommended direct PE inputs without refinement.
(8) Suprachoroidal Injection (CPT Code 67516)
    In September 2022, the CPT Editorial Panel introduced category I 
CPT code 67516 as a new code. CPT code 67516 describes suprachoroidal 
injection, which is the injection of medication into the space between 
the choroid and the sclera of the eye with procedure-specific needles 
and an injection kit. CPT code 67516 replaces temporary category III 
CPT code 0465T (Suprachoroidal injection of a pharmacologic agent (does 
not include supply of medication)), which was contractor priced. While 
there are other existing general CPT codes for injections to the eye, 
the AMA RUC is adding CPT code 67516 (Suprachoroidal space injection of 
pharmacologic agent (separate procedure) (Report medication 
separately)) to describe a more specific service to better distinguish 
this procedure from the rest of the codes for eye injections in this 
family. CPT code 67516 is a 000-day global code and currently, there is 
only one FDA-approved medication to treat macular edema associated with 
uveitis which is reported separately with HCPCS J-code J3299 
triamcinolone acetonide (Xipere[supreg]).
    We proposed the RUC-recommended work RVU of 1.53 for CPT code 
67516. We also proposed the RUC-recommended direct PE inputs for the 
code without refinement.
    Comment: We received a few comments for CPT code 67516 in favor of 
establishing this code as a permanent category I code with active 
pricing. We received no comments opposing CPT code 67516.
    Response: We thank commenters for taking the time to submit 
comments.
    After reviewing the comments, we are finalizing the proposed work 
RVU and direct PE inputs for CPT code 67516.
(9) Skull Mounted Cranial Neurostimulator (CPT Codes 61889, 61891, and 
61892)
    In February 2022, the CPT Editorial Panel created codes 61889, 
61891, and 61892 to describe Skull-Mounted Cranial Neurostimulator, and 
these codes were surveyed for the October 2022 RUC meeting.
    We proposed the RUC-recommended work RVU of 25.75 for CPT code 
61889 (Insertion of skull-mounted cranial neurostimulator pulse 
generator or receiver, including craniectomy or craniotomy, when 
performed, with direct or inductive coupling, with connection to depth 
and/or cortical strip electrode array(s)), the RUC-recommended work RVU 
of 11.25 for CPT code 61891 (Revision or replacement of skull-mounted 
cranial neurostimulator pulse generator or receiver with connection to 
depth and/or cortical strip electrode array(s)), and the RUC-
recommended work RVU of 15.00 for CPT code 61892 (Removal of

[[Page 78900]]

skull-mounted cranial neurostimulator pulse generator or receiver with 
cranioplasty, when performed).
    We proposed the RUC-recommended direct PE inputs for CPT codes 
61889, 61891, and 61892 without refinement.
    We did not receive comments on our proposals. We are finalizing as 
proposed the RUC-recommended work RVU and PE inputs for CPT codes 
61889, 61891, and 61892 respectively.
(10) Spinal Neurostimulator Services (CPT Codes 63685, 63688, 64596, 
64597, and 64598)
    For CPT codes 63685 (Insertion or replacement of spinal 
neurostimulator pulse generator or receiver requiring pocket creation 
and connection between electrode array and pulse generator or receiver) 
and 63688 (Revision or removal of implanted spinal neurostimulator 
pulse generator or receiver, with detachable connection to electrode 
array) we proposed the RUC-recommended work RVUs of 5.19 and 4.35, 
respectively. We proposed the RUC-recommended direct PE inputs for CPT 
codes 63685 and 63688 without refinement.
    We agreed with the RUC recommended contractor pricing for CPT codes 
64596 (Insertion or replacement of percutaneous electrode array, 
peripheral nerve, with integrated neurostimulator including imaging 
guidance, when performed; initial electrode array), 64597 (Insertion or 
replacement of percutaneous electrode array, peripheral nerve, with 
integrated neurostimulator including imaging guidance, when performed; 
each additional electrode array), and 64598 (Revision or removal of 
neurostimulator electrode array, peripheral nerve, with integrated 
neurostimulator); and we proposed contractor pricing for these three 
codes.
    Comment: One commenter disagreed with the proposed work RVU of 4.35 
for CPT code 63688, stating that the current work RVU of 5.30 is more 
appropriate. This commenter stated, without further explanation, that 
the valuation of the revision code should be greater than the initial 
insertion, as it is more complex to revise or remove an existing 
implant than to insert a new implant.
    Response: We appreciate the feedback, but we note that the RUC's 
Summary of Recommendations (SOR) for CPT code 63688 contained two key 
reference codes that appropriately support the proposed valuation. 
Without additional data provided by the commenter, we continue to 
believe that the RUC-reviewed survey 25th percentile work RVU of 4.35 
accurately reflects the time and intensity of CPT code 63688.
    Comment: Several commenters stated that they supported the proposal 
of the RUC-recommended work RVUs and direct PE inputs for CPT codes 
63685 and 63688. These commenters also supported our proposal to assign 
contractor pricing to CPT codes 64596, 64597, and 64598.
    Response: We appreciate the support for our proposals from 
commenters.
    After consideration of all comments on our proposals for CPT codes 
63685 and 63688, we are finalizing the RUC-recommended work RVUs of 
5.19 and 4.35, respectively. We are finalizing the RUC-recommended 
direct PE inputs for CPT codes 63685 and 63688 without refinement. We 
are also finalizing the RUC-recommended contractor pricing for CPT 
codes 64596, 64597, and 64598 as proposed.
(11) Neurostimulator Services-Bladder Dysfunction (CPT Codes 64590 and 
64595)
    For CPT codes 64590 (Insertion or replacement of peripheral, 
sacral, or gastric neurostimulator pulse generator or receiver, 
requiring pocket creation and connection between electrode array and 
pulse generator or receiver) and 64595 (Revision or removal of 
peripheral, sacral, or gastric neurostimulator pulse generator or 
receiver, with detachable connection to electrode array) we proposed 
the RUC-recommended work RVUs of 5.10 and 3.79, respectively.
    We requested clarification on the direct PE inputs for CPT code 
64590 in the non-facility setting. Specifically, we believed the RUC 
inadvertently proposed 56 minutes of equipment time for the EQ114 
equipment (electrosurgical generator), instead of 48 minutes using the 
default formula for calculating equipment time. We believed that 48 
minutes of equipment time for EQ114 was appropriate and matched the 
clinical labor time; therefore, we proposed 48 minutes for the EQ114 
equipment for CPT code 64590. We also believed that the EQ209 equipment 
(programmer, neurostimulator (w-printer)) was intended to match the 
same 84 minutes of equipment time listed for the EF031 power table as 
both were indicated to be used during the follow-up office visit. 
Therefore, we proposed 84 minutes of equipment time for EQ209 for CPT 
code 64590.
    We proposed the remaining RUC-recommended direct PE inputs for CPT 
code 64590 without refinement. We also proposed the RUC-recommended 
direct PE inputs for CPT code 64595 without refinement.
    Comment: The RUC agreed with the proposed 48 minutes of equipment 
time for the EQ114 equipment, and 84 minutes of equipment time for 
EQ209 for CPT code 64590.
    Response: We appreciate the additional information provided by the 
RUC to clarify the equipment time.
    Comment: Several commenters stated that they supported the proposal 
of the RUC-recommended work RVUs and direct PE inputs for CPT codes 
64590 and 64595.
    Response: We appreciate the support for our proposed work RVUs and 
direct PE inputs from the commenters.
    After consideration of all comments on our proposals for CPT codes 
64590 and 64595, we are finalizing the RUC-recommended work RVUs of 
5.10 and 3.79, respectively. We are finalizing 48 minutes of equipment 
time for EQ114 and 84 minutes of equipment time for EQ209 for CPT code 
64590. We are also finalizing the remaining RUC-recommended direct PE 
inputs for CPT codes 64590 and 64595 as proposed.
(12) Ocular Surface Amniotic Membrane Placement/Reconstruction (CPT 
Codes 65778, 65779, and 65780)
    CPT code 65778 (Placement of amniotic membrane on the ocular 
surface; without sutures) was identified by the Relativity Assessment 
Workgroup (RAW) via the high-volume growth screen for codes with 
Medicare utilization over 10,000 screen. During the September 2022 RAW 
meeting, the specialty societies stated that CPT codes 65778, 65779 
(Placement of amniotic membrane on the ocular surface; single layer, 
sutured), and 65780 (Ocular surface reconstruction; amniotic membrane 
transplantation, multiple layers) would be surveyed for the January 
2023 RUC meeting.
    For CY 2024, we proposed the RUC-recommended work RVUs for all 
three CPT codes. We proposed a work RVU of 0.84 for CPT code 65778 
(Placement of amniotic membrane on the ocular surface; without 
sutures), a work RVU of 1.75 for CPT code 65779 (Placement of amniotic 
membrane on the ocular surface; single layer, sutured), and a work RVU 
of 7.03 for CPT code 65780 (Ocular surface reconstruction; amniotic 
membrane transplantation, multiple layers). We also proposed the RUC-
recommended direct PE inputs for CPT codes 65778, 65779, and 65780 
without refinement.
    Comment: Several commenters disagreed with the proposed work RVU of 
0.84, stating that the amniotic membrane supply product, Prokera, has

[[Page 78901]]

a higher cost than the proposed rate. These commenters also stated that 
the proposed work RVU does not account for the time spent explaining 
the product at the time of insertion, and stated that the valuation 
should not decrease from the current work RVU of 1.00.
    Response: We did not receive additional pricing data from these 
commenters to support a change in the pricing of the amniotic membrane 
supply. Additionally, we did not receive information supporting a 
change to the proposed work RVU. The RUC-recommended time values have 
remained unchanged since the code was last valued in 2015. However, the 
previous valuation was based on a crosswalk and marked not to use to 
validate physician work for other services in the RUC database. 
Therefore, the RUC determined that the survey 25th percentile work RVU 
of 0.84 appropriately accounts for the work required to perform this 
service. We continue to agree with the RUC-recommended work RVU for CPT 
code 65778.
    Comment: A commenter disagreed with the proposed pricing of the 
human amniotic membrane allograft mounted on a non-absorbable self-
retaining ring (SD248) supply. The commenter stated that the proposed 
pricing of $872.50 was not typical for the SD248 supply and submitted 
more than 100 invoices to support their recommendation of increased 
pricing.
    Response: We appreciate the submission of such a large quantity of 
invoices for more accurate pricing of the human amniotic membrane 
allograft mounted on a non-absorbable self-retaining ring (SD248) 
supply. The submitted invoices all displayed the identical price of 
$1049 for the Prokera Plus item, and we agree with the commenter that 
this is the current market price for the Prokera Plus device. However, 
we disagree that using the Prokera Plus would necessarily be typical 
for use in CPT code 65778. We also received invoices in the RUC's 
recommended materials for this code family containing prices for the 
Prokera Slim ($850) and Prokera Classic ($895) devices which the RUC 
indicated would also be appropriate for use in CPT code 65778. The 
manufacturer's website described the Prokera Plus as an item that 
``maximizes the therapeutic benefit,'' which is intended ``for patients 
who need intensive treatment.'' As a result, we do not believe it would 
be appropriate to use the pricing for the Prokera Plus item for the 
SD248 supply as we do not believe that it would be typical for 
providers to use the most intensive and expensive product as the 
standard of care. We are instead averaging together the invoice prices 
of the Prokera Slim, Prokera Classic, and Prokera Plus to price the 
SD248 supply at $931.33, which is an increase of $58.83 above our 
proposed price of $872.50. We believe that averaging these products' 
prices together will more accurately capture the market-based pricing 
of the devices currently used in CPT code 65778.
    After consideration of the public comments, we are finalizing the 
RUC-recommended work RVUs of 0.84 for CPT code 65778, 1.75 for CPT code 
65779, and 7.03 for CPT code 65780. We are finalizing $931.33 as the 
price for the SD248 supply item for CPT code 65778, and the remaining 
direct PE inputs for this code as proposed. We are also finalizing the 
RUC-recommended direct PE inputs for CPT codes 65779 and 65780 without 
refinement.
(13) Fractional Flow Reserve With CT (CPT Code 75580)
    For CY 2018, the CPT Editorial Panel established four new Category 
III CPT codes for fractional flow reserve derived from computed 
tomography (FFRCT): CPT codes 0501T-0504T. Medicare began payment for 
CPT code 0503T (Noninvasive estimated coronary fractional flow reserve 
(FFR) derived from coronary computed tomography angiography data using 
computation fluid dynamics physiologic simulation software analysis of 
functional data to assess the severity of coronary artery disease; 
analysis of fluid dynamics and simulated maximal coronary hyperemia, 
and generation of estimated FFR model) in the hospital outpatient 
department setting under the Outpatient Prospective Payment System 
(OPPS) in CY 2018 (82 FR 59284). We typically assign contractor pricing 
for Category III codes for the PFS since they are temporary codes 
assigned to emerging technology and services. However, we made an 
exception for FFRCT services, and we have since been trying to 
understand the costs of the PE resource inputs for CPT code 0503T in 
the physician's office setting. In the CY 2021 PFS final rule (85 FR 
84630), we stated that we found FFRCT to be similar to other 
technologies that use algorithms, artificial intelligence, or other 
innovative forms of analysis to determine a course of treatment, where 
the analysis portion of the service cannot adequately be reflected 
under the PE methodology; and that our recent reviews for the overall 
cost of CPT code 0503T had shown the costs in the physician office 
setting to be similar to costs reflected in payment under the OPPS (85 
FR 84630). As such, we proposed to use the geometric mean costs under 
the OPPS as a proxy for CPT code 0503T and ultimately finalized 
national pricing for CPT code 0503T based on a valuation crosswalk to 
the technical component (TC) of CPT code 93457 in the CY 2022 PFS final 
rule (86 FR 65037-65042).
    For CY 2024, the CPT Editorial Panel approved the replacement of 
Category III codes 0501T-0504T with a single new Category I code 
(75580) to report a non-invasive estimate of coronary fractional flow 
reserve derived from augmentative software analysis of the dataset from 
a coronary computed tomography angiography. CPT code 75580 (Noninvasive 
estimate of coronary fractional flow reserve derived from augmentative 
software analysis of the data set from a coronary computed tomography 
angiography, with interpretation and report by a physician or other 
qualified health care professional) was reviewed at the January 2023 
RUC meeting and valuation recommendations were submitted to CMS. These 
recommendations include a software analysis fee for FFRCT listed as a 
supply input which accounts for the overwhelming majority of the code's 
valuation.
    We have long had concerns that the software algorithm in the 
analysis fee for CPT code 75580 is not well accounted for in our PE 
methodology; however, we recognize that practitioners are incurring 
resource costs for purchasing the FFRCT software and its ongoing use. 
This was the rationale for our previous policy to use a crosswalk that 
reflected this service's overall relative resource costs. At the same 
time, we continued to consider potentially refining and updating our PE 
methodology. The RUC recommendations include the previously mentioned 
software analysis fee for FFRCT as a supply input. However, analysis 
fees are not well accounted for in our current PE methodology. Although 
we recognize that these fees are a cost for practitioners, we have not 
traditionally recognized these analysis fees as forms of direct PE in 
our methodology. We previously stated our belief that crosswalking the 
RVUs for CPT code 0503T to a code with similar resource costs (the TC 
for CPT code 93457) allowed CMS to recognize that practitioners are 
incurring resource costs for the purchase and ongoing use of the 
software employed in CPT code 0503T, which would not typically be 
considered direct PE under our current methodology (86 FR 65038 and 
65039).

[[Page 78902]]

    Therefore, we proposed maintaining the previous valuation crosswalk 
to the technical component of CPT code 93457 for the new FFRCT code 
75580. This new Category I code is intended as a direct replacement for 
Category III code 0503T, and maintaining the current crosswalk will 
allow the geometric mean costs under the OPPS to continue serving as a 
valuation proxy. We are specifically crosswalking the technical 
component of CPT code 75580 to the technical component of CPT code 
93457; we proposed the RUC-recommended work RVU of 0.75 for the 
professional component of CPT code 75580, and the global component will 
be comprised of their sums as usual. We also noted that there was an 
error in the RUC's recommended equipment time for the Professional PACS 
Workstation (ED053), which was listed at 14.5 minutes instead of the 
correct 13.5 minutes based on the sum of the intraservice work time (11 
minutes) plus half of the preservice work time (5 divided by 2 = 2.5 
minutes).
    Comment: Many commenters stated their approval of the CMS proposal 
of the RUC's recommended work RVU of 0.75 for the professional 
component of CPT code 75580 and the proposal to maintain the crosswalk 
from CPT code 75580's predecessor code to the technical component of 
CPT code 93457 for the technical component of the procedure. Commenters 
stated that given the predominance of the cost of the analysis fee for 
CPT code 75580, it was critical that CMS utilize something other than 
the current PE methodology when establishing the physician fee schedule 
rate for the procedure. Commenters stated that CMS' proposal to 
continue to use the crosswalking methodology, that has been in place 
since CY 2022, was an appropriate alternative for the valuation of the 
technical component of CPT code 75580 and should be finalized. 
Commenters stated that the proposed crosswalk to the technical 
component of CPT code 93457 was an appropriate method to account for 
the costs physicians incur to provide FFRCT. Many commenters detailed 
the clinical benefits of FFRCT services, such as leading to a 70% 
reduction in rates of heart attack, death, or unnecessary invasive 
catheterization in one study, and urged CMS to finalize their proposed 
policies.
    Response: We appreciate the support for our proposed policies from 
the commenters.
    Comment: A commenter disagreed with the proposed crosswalk to the 
technical component of CPT code 93457 and objected to CMS using data 
from the OPPS in establishing relative values for the PFS. The 
commenter stated that any proposal to use the relativity of hospital 
charge data to determine the relativity of practice costs within a 
physician office is not consistent with statutory provisions under 
Section 4505 of the Balanced Budget Act of 1997.
    Response: We disagree with the commenter and believe that we can 
use OPPS data in certain circumstances to inform payment under the PFS. 
As we stated in the proposed rule, our recent reviews for the overall 
cost of CPT code 0503T showed the costs in the physician office setting 
to be similar to those reflected in payment under the OPPS (85 FR 
84630). As such, we proposed to use the geometric mean costs under the 
OPPS as a proxy for CPT code 0503T and ultimately finalized national 
pricing for CPT code 0503T based on a valuation crosswalk to the 
technical component (TC) of CPT code 93457 in the CY 2022 PFS final 
rule (86 FR 65037-65042). We then carried over this proposed policy to 
CPT code 75580, the direct replacement for CPT code 0503T. We believe 
this is a more accurate way to value the service due to the problems 
that this service's analysis fee poses for our PE methodology.
    Comment: A commenter disagreed with the proposed crosswalk to the 
technical component of CPT code 93457 by stating that this crosswalk 
approach was not resource-based. The commenter stated that the software 
analysis fee was the only supply input and represented a per-patient, 
single-use item, and thus was appropriately included as a direct 
supply. The commenter recommended that CMS negate the need for a 
crosswalk by accepting this software as a direct practice expense 
input.
    Response: As we stated in the proposed rule, we have long had 
concerns that the software algorithm in the analysis fee for CPT code 
75580 is not well accounted for in our PE methodology; however, we 
recognize that practitioners are incurring resource costs for 
purchasing the FFRCT software and its ongoing use. This was the 
rationale for our previous policy to use a crosswalk (86 FR 65037 
through 65042) that reflected the overall relative resource costs for 
this service while we continued to consider potentially refining and 
updating our PE methodology. The RUC recommendations included the 
previously mentioned software analysis fee for FFRCT as a supply input. 
However, analysis fees are not well accounted for in our current PE 
methodology. Although we recognize that these fees are a cost for 
practitioners, we have not traditionally recognized these analysis fees 
as forms of direct PE in our methodology. We continue to believe that 
the software analysis fee would not be considered as a form of direct 
PE under our current methodology, and therefore, we proposed to 
maintain the previous valuation crosswalk to the technical component of 
CPT code 93457 to incorporate these costs.
    Comment: Several commenters recommended that CMS separately 
identify and pay for high-cost disposable supplies. Commenters stated 
that creating separate high-cost supply codes would be a way to pay for 
the software analysis fee included in CPT code 75580.
    Response: We have received a number of prior requests from 
interested parties, including the RUC, to implement separately billable 
alpha-numeric Level II HCPCS codes to allow practitioners to be paid 
the cost of high cost disposable supplies per patient encounter instead 
of per CPT code. We stated at the time, and we continue to believe, 
that this option presents a series of potential problems that we have 
addressed previously in the context of the broader challenges regarding 
our ability to price high cost disposable supply items. (For a 
discussion of this issue, we direct the reader to our discussion in the 
CY 2011 PFS final rule with comment period (75 FR 73251)).
    After consideration of the public comments, we are finalizing our 
proposal of the RUC-recommended work RVU of 0.75 for the professional 
component of CPT code 75580. We are also finalizing our proposal to 
crosswalk the technical component of CPT code 75580 to the technical 
component of CPT code 93457, maintaining the previous crosswalk in 
place for CPT code 0503T, as well as finalizing our proposed equipment 
time for the Professional PACS Workstation (ED053), which was 
unmentioned by commenters.
(14) Ultrasound Guidance for Vascular Access (CPT Code 76937)
    To specify the insertion of a peripherally inserted central venous 
catheter (PICC), the CPT Editorial Panel decided to create two new 
codes: CPT code 36572 and CPT code 36573, and revised CPT codes 36568, 
36569 and 36584 in September of 2017. This revision of these codes 
created a scenario where these bundled services could be performed by a 
clinician that performs the procedure without imaging guidance or a 
radiologist that performs the procedure with imaging guidance. When 
this code family was surveyed again in January 2018, CPT code 76937 
(Ultrasound guidance for vascular

[[Page 78903]]

access requiring ultrasound evaluation of potential access sites, 
documentation of selected vessel patency, concurrent realtime 
ultrasound visualization of vascular needle entry, with permanent 
recording and reporting (List separately in addition to code for 
primary procedure) was identified as part of this code family. Since it 
was expected that utilization of PICC procedures would decrease once 
CPT code 76937 was bundled with these services, the specialty societies 
that perform this service proposed to review CPT code 76937 after 2 
years, once more data about these services became available. CPT code 
76937 was reviewed at the October 2022 RUC meeting for CY 2024.
    We proposed the RUC-recommended work RVU of 0.30 for CPT code 
76937. We also proposed the RUC-recommended direct PE inputs for CPT 
code 76937.
    Comment: Commenters were in support of the CMS proposal of the RUC-
recommended values for CPT code 76937.
    Response: We thank the commenters for their support.
    After consideration of the comments, we are finalizing a work RVU 
of 0.30 for CPT code 76937 as proposed. We are also finalizing the 
direct PE inputs as proposed.
(15) Neuromuscular Ultrasound (CPT Codes 76881, 76882, and 76883)
    Since their creation in 2011, CPT codes 76881 (Ultrasound, complete 
joint (ie, joint space and peri-articular soft-tissue structures), 
real-time with image documentation) and 76882 (Ultrasound, limited, 
joint or other nonvascular extremity structure(s) (e.g., joint space, 
peri-articular tendon[s], muscle[s], nerve[s], other soft-tissue 
structure[s], or soft-tissue mass[es]), real-time with image 
documentation) have been reviewed numerous times as New Technology/New 
Services by the Relativity Assessment Workgroup (RAW). In October 2016, 
the RAW reviewed these codes and agreed with the specialty societies 
that the dominant specialties providing the complete (CPT code 76881) 
versus the limited (CPT code 76882) ultrasound of extremity services 
were different than originally thought, causing variation in the 
typical PE inputs. The RAW recommended referral to the Practice Expense 
Subcommittee for review of the direct PE inputs and the CPT Editorial 
Panel to clarify the introductory language regarding the reference to 
one joint in the complete ultrasound. The PE Subcommittee reviewed the 
direct PE inputs for CPT codes 76881 and 76882 and adjusted the 
clinical staff time at the January 2017 RUC meeting, and the CPT 
Editorial Panel editorially revised CPT codes 76881 and 76882 to 
clarify the distinction between complete and limited studies and 
revised the introductory guidelines to clarify the reference to one 
joint in the complete ultrasound procedure in June 2017.
    In October 2021, the CPT Editorial Panel approved the addition of 
CPT code 76883 (Ultrasound, nerve(s) and accompanying structures 
throughout their entire anatomic course in one extremity, 
comprehensive, including real-time cine imaging with image 
documentation, per extremity) for reporting real-time, complete 
neuromuscular ultrasound of nerves and accompanying structures 
throughout their anatomic course, per extremity, and the revision of 
CPT code 76882 to add focal evaluation. CPT codes 76881 and 76882 were 
identified as part of the neuromuscular ultrasound code family with CPT 
code 76883 and surveyed for the January 2022 RUC meeting. We reviewed 
these recommendations for CY 2023 and discussed our concerns with the 
commenters' assertions regarding typical PE inputs for CPT code 76882 
in the CY 2023 PFS final rule (87 FR 69506 through 69510). 
Specifically, given the changes in dominant specialty for these CPT 
codes from 2010 to 2017, and again from 2017 to 2022, we recommended 
that the RUC and interested parties reconsider the PE inputs for each 
code based on the dominant specialty for each CPT code, based on the 
most recent year's Medicare claims data, and consideration of survey 
responses submitted to CMS in response to the CY 2023 PFS proposed 
rule.
    The PE inputs for CPT codes 76881, 76882, and 76883 were 
subsequently re-reviewed at the January 2023 RUC meeting and the RUC 
submitted refinements to the PE inputs for CPT code 76882 only. We 
proposed the RUC-recommended PE refinements for CPT code 76882 with the 
exception of the RUC-recommended 13.5 minutes for ED053 (Professional 
PACS workstation) and 23 minutes for EQ250 (ultrasound unit, portable). 
We noted that the old intraservice time of 11 minutes was used in error 
when calculating the standard equipment time for ED053. Therefore, we 
disagreed with the RUC-recommended equipment time of 13.5 minutes and 
proposed 17.5 minutes for ED053, which is calculated by using the 
standard equipment formula for ED053 established in the CY 2017 PFS 
final rule (81 FR 80182) with the updated intraservice time from the CY 
2023 PFS final rule ((0.5*5)+15 = 17.5).
    We disagreed with the RUC-recommended 23 minutes of equipment time 
for EQ250, which includes one minute of clinical labor time for CA014 
(Confirm order, protocol exam) in the highly technical equipment 
formula, as discussed beginning in the CY 2013 PFS final rule (77 FR 
69028), in error. Therefore, the correct equipment time for EQ250 using 
the highly technical equipment formula would be 22 minutes. However, 
because the Summary of Recommendations included in the RUC 
recommendations did not provide a rationale for the use of the highly 
technical equipment formula for EQ250, we proposed to maintain the 15 
minutes of equipment time for EQ250 for CPT code 78882, which 
corresponds to the interservice time for this code and maintains 
consistency with how equipment time is allotted for EQ250 across the 
three codes in this family. We referred readers to the classification 
of highly technical equipment in the CY 2014 PFS final rule (79 FR 
67639).
    The RUC did not make recommendations on the work RVUs for CPT codes 
76881, 76882, and 76883, and CMS did not propose any changes.
    Comment: Some commenters thanked CMS for proposing the RUC 
recommended direct PE inputs for CPT code 76882. One commenter agreed 
with the CMS PE refinements for CPT code 76882, including the 
refinement for EQ250.
    Response: We thank the commenters for their support.
    Comment: Some commenters expressed continued concern about the PE 
inputs for CPT code 76881, and one commenter submitted several invoices 
for ultrasound machine technology used by rheumatologists for 
neuromuscular ultrasound services. The commenter stated that the 
clinical labor, which they believed was typically a diagnostic medical 
sonographer, and the dedicated ultrasound room and high-quality 
ultrasound machines utilized by rheumatologists were not appropriately 
accounted for in CPT code 76881. Some commenters requested that CMS 
utilize the invoices and informal survey data provided in response to 
last year's CY 2023 PFS proposed rule to raise the PE values for CPT 
code 76881 to match the proposed PE values of CPT code 76882 until a 
formal workforce survey of typical rheumatology practice expenses has 
been conducted to prevent a rank order anomaly. Multiple commenters 
stated that rheumatologists' typical practice expenses are not 
accounted for in the valuation of CPT code 76881, and many offered to 
provide more resources to capture these expenses. Some commenters 
asserted that rheumatologists were not surveyed on

[[Page 78904]]

their typical practice expense and requested a similar re-review for 
CPT code 76881 that was done for CPT code 76882.
    Response: As stated in the CY 2023 PFS final rule, we appreciate 
the commenters' survey collection efforts to reflect rheumatologists' 
costs in performing neuromuscular ultrasound and the concern regarding 
the accounting of rheumatologists' typical clinical labor and equipment 
in the RUC recommendations. We encourage the commenters to coordinate 
with the RUC to provide their survey data to facilitate a 
reconsideration of PE inputs if the commenters believe certain 
specialties were not appropriately queried. Because the RUC has 
standardized procedures for PE and physician surveys, and the fact that 
the commenters' survey results differ so drastically from the January 
2022 and 2023 RUC recommendations, we encourage the RUC and other 
interested parties to consider the commenters' survey efforts. We 
encourage collaboration with the RUC PE subcommittee and the submission 
of specific invoices to support the surveys' results and robust data to 
show the typicality of these PE inputs.
    We note that the RUC submitted a letter in their January 2023 
recommendations outlining the process for re-surveying these codes. The 
RUC noted that PE recommendations were formulated at the January 2022 
meeting based on RUC database claims at the time, which showed 
Rheumatology as the highest single provider of CPT code 76881 and 
Radiology as the highest single specialty provider of CPT code 76882, 
although for both codes no single specialty has more than a plurality. 
For the January 2023 RUC meeting, there was a change in the dominant 
specialty for CPT code 76882 to Podiatry, rather than Radiology, in the 
non-facility setting; therefore, the PE recommendations were adjusted 
to reflect the more common hand-held ultrasound device, rather than the 
ultrasound room, sonographer, and PACS workstation that are typical in 
radiology practices. The RUC's letter stated that they reviewed the 
several hundred letters from rheumatologists submitted in response to 
the CY 2023 PFS proposed rule.
    In response, the American College of Radiology, American Academy of 
Neurology, American Association of Neuromuscular and Electrodiagnostic 
Medicine, American Academy of Physical Medicine and Rehabilitation, 
American College of Rheumatology, and American Podiatric Medical 
Association convened a panel that included experts familiar with these 
services and typical practice expense to reevaluate the direct practice 
expense inputs for neuromuscular ultrasound. At the time of the panel, 
rheumatology was the dominant specialty for CPT code 76881 at 26 
percent, and radiology was the dominant specialty for CPT code 76882 at 
27 percent. Because of the dominant specialty change back to radiology 
for CPT code 76882, which has been the historical standard and was 
temporarily changed to Podiatry based on COVID pandemic alterations of 
the utilization, the RUC-recommended inputs for CPT code 76882 
submitted for the January 2023 meeting reflected updated clinical 
staff, clinical activities, supplies, and equipment (PACS) utilized 
when performed by Radiology. The letter also stated that the expert 
panel carefully considered the comments submitted to CMS regarding the 
practice expense for CPT code 76881. The letter stated the following: 
``While the use of dedicated sonographers is increasing in 
Rheumatology, we did not believe it was yet the typical clinical staff 
in the non-facility setting and will re-evaluate the issue when the 
code family returns for review under the new technology process. The 
expert panel recognizes that many non-radiology specialties are 
increasingly adopting a ``picture archiving and communication system 
(PACS)'' for image storage and important patient care. However, the RUC 
has previously indicated that these are general practice expenses not 
typically allocated to a single patient/code and that only the specific 
use of the PACS workstation is acceptable under PE supplies. As many 
PACS vendors increasingly shift to a per-patient cost, the RUC may need 
to reconsider how these supplies are allocated in practice expense.''
    We also remind interested parties that we have established an 
annual process for the public nomination of potentially misvalued 
codes. This process provides an annual means for those who believe that 
values for individual services are inaccurate and should be readdressed 
through notice and comment rulemaking to bring those codes to our 
attention, as detailed in section II.C. of this final rule. As part of 
our current process, we identify potentially misvalued codes for 
review, and request recommendations from the RUC and other public 
commenters on revised work RVUs and direct PE inputs for those codes. 
While this process is available to interested parties, we remind 
commenters that the RUC plans to review the practice expense for CPT 
codes 76881, 76882, and 76883 with additional data according to their 
new technology process at a future RUC meeting.
    After consideration of the comments, we are finalizing the direct 
PE refinements as proposed for CPT codes 76881, 76882, and 76883. We 
did not propose and are not finalizing any changes to the work RVU for 
CPT codes 76881, 76882, and 76883.
(16) Intraoperative Ultrasound Services (CPT Codes 76998, 76984, 76987, 
76988, and 76989)
    In October 2018, the Relativity Assessment Workgroup (RAW) created 
a screen for CMS/Other codes with Medicare utilization of 20,000 or 
more, and CPT code 76998 (Ultrasonic guidance, intraoperative) was 
subsequently identified as part of that screen. When CPT code 76998 was 
identified in the CMS/Other screen, it was noted that many specialties 
were represented in the Medicare claims data. Specialties representing 
cardiothoracic surgery, general surgery, breast surgery, urology, 
interventional cardiology, interventional radiology and vascular 
surgery jointly submitted an action plan that the RAW reviewed in 
October 2019. Based on the variability of intraoperative ultrasound for 
each specialty with differences in the typical patient and physician 
work, it was decided that each society would submit applications for 
new code(s) as needed to carve out the work currently reported with CPT 
code 76998 until the code was no longer needed, or until it was clear 
what the final dominant use of CPT code 76998 was so that a survey 
could be conducted.
    In October 2019, the RUC referred this issue to the CPT Editorial 
Panel to clarify correct coding and accurately differentiate physician 
work, as multiple specialties currently report CPT code 76998. The CPT 
Editorial Panel addressed CPT code 76998 in 2020 and 2021 by adding 
instructional parentheticals that restrict the use of imaging guidance 
with vein ablation procedures and adding new codes that bundled imaging 
guidance for urological procedures. In May 2022, the CPT Editorial 
Panel created four new codes to report intraoperative cardiac 
ultrasound services, thus carving out most of the prior reporting of 
CPT code 76998 by cardiothoracic surgeons and cardiologists.
    After utilization was removed from CPT code 76998 for vein ablation 
procedures, most urological procedures, cardiac procedures, and intra-
abdominal procedures through instructions and/or new or revised codes, 
it was determined that the dominant use of the code would be related to 
breast surgery, allowing for

[[Page 78905]]

CPT code 76998 to be surveyed. CPT codes 76984 (Ultrasound, 
intraoperative thoracic aorta (e.g., epiaortic), diagnostic), 76987 
(Intraoperative epicardial cardiac (e.g., echocardiography) ultrasound 
for congenital heart disease, diagnostic; including placement and 
manipulation of transducer, image acquisition, interpretation and 
report), 76988 (Intraoperative epicardial cardiac (e.g., 
echocardiography) ultrasound for congenital heart disease, diagnostic; 
placement, manipulation of transducer, and image acquisition only), 
76989 (Intraoperative epicardial cardiac (e.g., echocardiography) 
ultrasound for congenital heart disease, diagnostic; interpretation and 
report only), and 76998 were surveyed by the specialty societies for 
the September 2022 RUC meeting.
    We disagreed with the RUC-recommended work RVU of 1.20 for CPT code 
76998 and proposed the total time ratio work RVU of 0.91. The RUC 
recommended a 7-minute total time decrease for CPT code 76998. We 
agreed with the RUC that the intensity of CPT code 76998 (real-time 
during an operation) is greater than the identically-timed CPT code 
76641 (Ultrasound, breast, unilateral, real time with image 
documentation, including axilla when performed; complete), which 
represents a single ultrasound session typically performed by a 
technician, whereas CPT code 76998 includes multiple, separate 
ultrasound maneuvers during a surgical procedure that require a more 
intense, immediate interpretation in order to direct resection of the 
breast tissue and ensure a thorough and complete surgical excision of 
the abnormal breast tissue. The work RVU of 0.91 for CPT code 76998 
adequately values the surgeon's 5 minutes of pre-service time, 12 
minutes of intraservice time, and 5 minutes of immediate post-service 
time more than the same 5, 12, and 5 minutes of the technician's time 
for CPT code 76641, which has a work RVU of 0.73.
    Additionally, the IWPUT of CPT code 76641 is appropriately less 
than the IWPUT of CPT code 76698, with IWPUTs of 0.0422 and 0.0572, 
respectively. We remind interested parties that we believe that, since 
the two components of work are time and intensity, absent an obvious or 
explicitly stated rationale for why the relative intensity of a given 
procedure has increased, decreases in time should be reflected in 
decreases to work RVUs. We disagreed with the RUC-recommended 
maintenance of the current work RVU for CPT code 76998 for a few 
reasons: the RUC recommendations did not advocate for a change in 
intensity, and presumably some higher-intensity cardiac procedures will 
no longer be reported using CPT code 76998, as they can now be reported 
using CPT codes 76984 through 76989. Instead, we proposed an 
appropriately lower work RVU and associated IWPUT to account for the 7-
minute decrease in total time and removal of higher-intensity cardiac 
procedures previously reported by CPT code 76998. We noted that the 
work RVU of 0.91 for CPT code 76998 is supported by the upper brackets 
of CPT codes 72125 (Computed tomography, cervical spine; without 
contrast material), 72128 (Computed tomography, thoracic spine; without 
contrast material), and 72131 (Computed tomography, lumbar spine; 
without contrast material), and a lower bracket of CPT code 76641. CPT 
codes 72125, 72128, and 72131 represent spinal computed tomography (CT) 
of the cervical, thoracic, and lumbar spine, respectively.
    We proposed the RUC-recommended work RVU of 0.60 and work times of 
5 minutes of pre-evaluation time, 10 minutes of intraservice time, and 
3 minutes of immediate postservice time for total time of 18 minutes 
for CPT code 76984. We also proposed the RUC-recommended work times for 
CPT codes 76987 and 76988 of 10 minutes of pre-evaluation time and 20 
minutes of intraservice time for both codes, and 5 and 10 minutes of 
immediate postservice time, for total times of 40 and 35 minutes, 
respectively. We proposed the RUC-recommended work times for CPT code 
76989 with the exception of the intraservice time. We proposed the 
survey median intraservice time of 15 minutes rather than the RUC-
recommended 75th percentile based on the assertion in the RUC's Summary 
of Recommendations that the cardiologist is typically in the operating 
room intraoperatively with the cardiothoracic surgeon prior to and 
after the cardiac repair. Based on this assertion, we do not believe 
the cardiologist spends the same amount of time in the operating room 
as the cardiothoracic surgeon in CPT codes 76987 and 76988. Therefore, 
we proposed 5 minutes of pre-evaluation time, 15 minutes of 
intraservice time, and 10 minutes of immediate postservice time for 
total time of 30 minutes for CPT code 76989.
    Due to the CPT code descriptor for CPT code 76987, we believe that 
the appropriate work for this service is reflected in the combined work 
of CPT codes 76988 and 76989. We noted that in the CY 2015 PFS final 
rule (79 FR 67669), we reviewed a similarly constructed family of codes 
representing interventional transesophageal echocardiography (TEE) for 
congenital cardiac anomalies in the same way by proposing and 
finalizing a work RVU for CPT code 93315 (Transesophageal 
echocardiography for congenital cardiac anomalies; including probe 
placement, image acquisition, interpretation and report) equal to the 
combined work RVUs of CPT codes 93316 (Transesophageal echocardiography 
for congenital cardiac anomalies; placement of transesophageal probe 
only) and 93317 (Transesophageal echocardiography for congenital 
cardiac anomalies; image acquisition, interpretation and report only). 
We noted that the Summary of Recommendations for CPT codes 76987 
through 76989 state that these intraoperative ultrasound services are 
expected to be very rare, as intraoperative TEE is considered the gold 
standard and can be performed for most patients instead, which could be 
reported using CPT codes 93315 through 93317. Because CPT codes 76987 
through 76989 are an alternative to CPT codes 93315 through 93317 for 
congenital cardiac anomalies when intraoperative TEE is 
contraindicated, we believe we should maintain consistency and propose 
a work RVU for CPT code 76987 that equals the combined work RVUs of CPT 
codes 76988 and 76989.
    Therefore, we disagreed with the RUC-recommended work RVUs of 1.90, 
1.20, and 1.55 for CPT codes 76987, 76988, and 76989, respectively. We 
proposed a work RVU of 1.62 for CPT code 76987 based on a crosswalk to 
CPT codes 73219 (Magnetic resonance (e.g., proton) imaging, upper 
extremity, other than joint; with contrast material(s)) and 78452 
(Myocardial perfusion imaging, tomographic (SPECT) (including 
attenuation correction, qualitative or quantitative wall motion, 
ejection fraction by first pass or gated technique, additional 
quantification, when performed); multiple studies, at rest and/or 
stress (exercise or pharmacologic) and/or redistribution and/or rest 
reinjection). We noted that this crosswalk is supported by total time 
ratios between CPT code 76987 and reference CPT codes 93312 
(Echocardiography, transesophageal, real-time with image documentation 
(2D) (with or without M-mode recording); including probe placement, 
image acquisition, interpretation and report) and 93315, which equal 
1.66 and 1.67 respectively. We also noted that this is supported by a 
total time ratio to

[[Page 78906]]

the current time and work RVU for the code that cardiothoracic surgeons 
currently use to report this service before the creation of CPT code 
76987, CPT code 76998 ((40/29)*1.20 = 1.66). Lastly, this is also 
supported by a total time ratio to the same CPT code 76998 after 
factoring in the updated total time of 22 minutes and our work RVU for 
CPT code 76998 of 0.91 ((40/22)*0.91 = 1.65). We noted that a work RVU 
of 1.62 for CPT code 76987 yields an IWPUT of 0.059, which is slightly 
higher than the IWPUTs of the intraoperative TEE CPT codes 93315 and 
93312 that represent the complete procedure, which are 0.0532 and 
0.0580, respectively.
    Similar to how CPT code 76987 is broken down into service parts by 
CPT codes 76988 and 76989 to allow for multiple providers to perform 
different parts of the whole service done by one provider (represented 
by CPT code 76987), CPT codes 93312 through 93314 and 93315 through 
93317 are broken down as well. According to the RUC Database, CPT code 
93316 represents placement of transesophageal probe only, typically 
performed by a cardiac anesthesiologist. CPT code 93313 
(Echocardiography, transesophageal, real-time with image documentation 
(2D) (with or without M-mode recording); placement of transesophageal 
probe only) also represents placement of transesophageal probe only, 
when performed by a cardiac anesthesiologist. Similarly, CPT code 76988 
represents placement and manipulation of transducer and image 
acquisition only, which is typically performed by a cardiothoracic 
surgeon according to the Summary of Recommendations.
    According to the RUC Database, CPT code 93317 represents image 
acquisition and interpretation and report only, typically done by the 
cardiologist after probe placement typically performed by the cardiac 
anesthesiologist, represented by CPT code 93316. CPT code 93314 
(Echocardiography, transesophageal, real-time with image documentation 
(2D) (with or without M-mode recording); image acquisition, 
interpretation and report only) also represents image acquisition and 
interpretation and report only, typically done by the cardiologist 
after probe placement typically performed by the anesthesiologist, 
represented by CPT code 93313. Similarly, CPT code 76989 represents 
interpretation and report only, which is typically performed by a 
cardiologist according to the Summary of Recommendations.
    Because this family is broken down into service parts in the same 
way CPT codes 93312 through 93314 and 93315 through 93317 are, we 
disagreed with the RUC's recommendation to assign work RVUs for CPT 
codes 76988 and 76989 that sum to more than the aggregate work RVU for 
CPT code 76987. Therefore, we proposed a work RVU of 1.08 for CPT code 
76988 and a work RVU of 0.54 for CPT code 76989, which sum to the 
aggregate work RVU of 1.62 for CPT code 76987. The work RVUs for CPT 
code 76988 and 76989 were calculated by taking the aggregate work RVU 
of the whole service, represented by CPT code 76987, and dividing by 
three based on the number of discernable service parts: probe placement 
and manipulation, image acquisition, and interpretation and report. 
Because CPT code 76988 represents two of the three service parts 
performed by a cardiothoracic surgeon, we allotted 2/3rds of the 
aggregated work RVU for CPT code 76987, equaling 1.08 (1.62 * \2/3\ = 
1.08). Because CPT code 76989 represents one of the three service parts 
performed by a cardiologist, we allotted 1/3rd of the aggregated work 
RVU for CPT code 76987, equaling 0.54 (1.62 * \1/3\ = 0.54). Because 
the Summary of Recommendations was unclear regarding the intensity of 
each part of the service as broken out, we invited comments on 
additional ways to break down the aggregate work RVU of CPT code 76987 
to adequately account for the cardiothoracic surgeon and cardiologist's 
time and intensity to perform CPT codes 76988 and 76989, but we believe 
that the work RVUs should sum to no more than the aggregate work RVU 
for CPT code 76987 based on similarly broken down code families that 
represent the more widely used intraoperative TEE procedures.
    The RUC did not recommend, and we did not propose any direct PE 
inputs for the five codes in the Intraoperative Ultrasound family.
    Comment: Some commenters disagreed with CMS' proposed work RVU of 
0.91 for CPT code 76998, stating that it is invalid to draw comparisons 
between the current work times and work RVUs to the newly surveyed work 
time and work RVUs as recommended by the RUC because they were 
``Harvard'' times. One commenter disagreed with the use of total time 
ratios to account for changes in time and stated that the work RVU was 
reduced by CMS for CY 1993 and 1995 without the time being adjusted, 
rendering the originally assigned times and work RVUs untethered. The 
commenter also stated that the proposed work RVU of 0.91 for CPT code 
76998 is only 1/3rd more intense than CPT code 76641, which describes a 
diagnostic ultrasound study that is typically performed by a 
technician, where the saved images are then reviewed, and an 
interpretation report is generated by a radiologist at a later time. In 
comparison, a surgeon uses an ultrasound probe periodically during the 
operation and interprets the images in real time to help direct the 
limits of surgical excision of a mass, images are saved, and a report 
is generated by the surgeon for CPT code 76998. The commenter stated 
that the intensity and complexity of CPT code 76998 (dynamic real-time 
ultrasound at operation) is significantly greater than CPT code 76641. 
The commenter also stated that CPT code 76641 represents a single 
ultrasound session typically performed by a technician, whereas CPT 
code 76998 includes multiple separate ultrasound maneuvers throughout 
an operative procedure by the surgeon, which require a more intense 
immediate interpretation in order to direct resection of the breast 
tissue to ensure a thorough and complete surgical excision of the 
abnormal breast tissue.
    Response: We agree that it is important to use the recent data 
available regarding work times, and we note that when many years have 
passed since work time has been measured, significant discrepancies can 
occur. However, we also believe that our operating assumption regarding 
the validity of the existing values as a point of comparison is 
critical to the integrity of the relative value system as currently 
constructed. The work times currently associated with codes play a very 
important role in PFS ratesetting, both as points of comparison in 
establishing work RVUs and in the allocation of indirect PE RVUs by 
specialty. If we were to operate under the assumption that previously 
recommended work times had been routinely overestimated, this would 
undermine the relativity of the work RVUs on the PFS in general, in 
light of the fact that codes are often valued based on comparisons to 
other codes with similar work times. Such an assumption would also 
undermine the validity of the allocation of indirect PE RVUs to 
physician specialties across the PFS.
    Instead, we believe that it is crucial that the code valuation 
process take place with the understanding that the existing work times 
that have been used in PFS ratesetting are accurate. We recognize that 
adjusting work RVUs for changes in time is not always a straightforward 
process and that the intensity associated with changes in time is not 
necessarily always linear, so we apply various methodologies to 
identify several potential work values for individual codes. However, 
we

[[Page 78907]]

reiterate that we believe it would be irresponsible to ignore changes 
in time based on the best data available and that we are statutorily 
obligated to consider both time and intensity in establishing work RVUs 
for PFS services. For additional information regarding the use of old 
work time values that were established many years ago and have not 
since been reviewed in our methodology, we refer readers to our 
discussion of the subject in the CY 2017 PFS final rule (81 FR 80273 
through 80274).
    We also disagree and continue to believe that the use of time 
ratios is one of several appropriate methods for identifying potential 
work RVUs for particular PFS services, particularly when the 
alternative values recommended by the RUC and other commenters do not 
account for survey information that suggests the amount of time 
involved in furnishing the service has changed significantly. We 
reiterate that, consistent with the statute, we are required to value 
the work RVU based on the relative resources involved in furnishing the 
service, which include time and intensity. In accordance with the 
statute, we believe that changes in time and intensity must be 
accounted for when developing work RVUs. When our review of recommended 
values reveals that changes in time are not accounted for in a RUC-
recommended work RVU, the obligation to account for that change when 
establishing proposed and final work RVUs remains.
    With regards to the relativity of intensity and complexity of CPT 
code 76998 (dynamic real-time ultrasound at operation) compared to CPT 
code 76641, we continue to believe that the intensity of CPT code 76998 
(real-time during an operation) is greater than the identically-timed 
CPT code 76641. The work RVU of 0.91 for CPT code 76998 adequately 
values the surgeon's 5 minutes of pre-service time, 12 minutes of 
intraservice time, and 5 minutes of immediate post-service time more 
than the same 5, 12, and 5 minutes for CPT code 76641, which has a work 
RVU of 0.73. Additionally, the IWPUT of CPT code 76641 is appropriately 
less than the IWPUT of CPT code 76698, with IWPUTs of 0.0422 and 
0.0572, respectively.
    Comment: Commenters disagreed with the comparison to intraoperative 
TEE and stated that the sum of the different components of work will 
not be the same as the combined work as it is for intraoperative TEE. 
The commenters stated that there would be time savings, as represented 
by the surveyed times, if the cardiothoracic surgeon provides the 
service alone, represented by CPT code 76987. Commenters also stated 
that CPT codes 73219 and 78452 are inappropriate comparator codes, as 
they are not intraoperative services and CPT code 78452 describes 
cardiac imaging performed on a patient before and after exercise in 
which a technologist typically handles the image acquisition. 
Commenters stated that CPT code 76987 is rarely performed and describes 
ultrasound image acquisition performed in the operating room through an 
open chest where the ultrasound probe is placed directly on the 
patient's beating heart and sterility must be maintained throughout. 
Commenters suggested that a work RVU of 1.90 was supported by 
comparison to CPT code 93317, with a work RVU of 1.84, intraservice 
time of 20 minutes, and total time of 40 minutes, which is the 
component code for the image acquisition, interpretation and report 
only of the congenital TEE codes.
    Response: We agree with commenters that the proposed work RVU does 
not adequately account for the complexity of the intraoperative 
ultrasound image acquisition performed on a beating heart with abnormal 
heart structure, and that CPT code 93317 is a better comparator code 
with a work RVU of 1.84. Therefore, we are finalizing the RUC-
recommended work RVU of 1.90 for CPT code 76987.
    Comment: Some commenters disagreed with CMS' proposed work RVU of 
1.08 for CPT code 76988. Commenters stated that CPT code 76988 
describes ultrasound image acquisition performed in the operating room 
through an open chest in a sterile field where the ultrasound probe is 
placed directly on the patient's beating heart. Commenters stated that 
the cardiologist can provide guidance to the cardiothoracic surgeon to 
ensure capture of certain views and that work by the cardiologist is 
captured in CPT code 76989. The physician work involved in placing and 
manipulating the echo probe both before surgical repair and after 
repair with various suture lines requires careful manual manipulation 
and positioning by the cardiothoracic surgeon in order to obtain 
certain views. The commenters stated that, because of the abnormal 
structure of the heart and the surgical repair, the normal external 
landmarks for probe positioning are not present adding increased 
complexity to the procedure.
    Response: We agree with commenters that the proposed work RVU does 
not adequately account for the complexity of the intraoperative 
ultrasound image acquisition performed on a beating heart with abnormal 
heart structure and are finalizing the RUC-recommended work RVU of 1.20 
for CPT code 76987.
    Comment: Some commenters disagreed that the combination of CPT 
codes 76988 and 76989 should equal the value for CPT code 76987, and 
stated that this methodology is flawed and inconsistent with how CMS 
pays for most services that are performed by multiple providers for 
which CMS provides payment that is greater than 100% to the two 
surgeons. The commenters stated that when there are co-surgeons 
(modifier 62), CMS's payment of 125 percent is split between the two 
surgeons. Similarly, when there is an assistant at surgery (modifier 
80), CMS pays the primary surgeon 100 percent and the assistant at 
surgery 16 percent. Commenters also disagreed with the proposed median 
intraservice time of 15 minutes rather than the RUC-recommended 75th 
percentile intraservice time, stating that pediatric cardiologists 
completing the survey underestimated the amount of time they spent in 
the operating room and stated that the nature of the service where the 
cardiologist is not in the operating room during the entire procedure 
but rather in the operating room prior to the repair(s), leaves and 
then comes back at the completion of the repair(s) could have resulted 
in the survey respondent's underestimation of time. Therefore, the 
commenters stated that the 75th percentile intraservice time of 20 
minutes is more appropriate for CPT code 76989.
    Response: We continue to believe that, because this family is 
broken down into service parts in the same way CPT codes 93312 through 
93314 and 93315 through 93317 are, the work RVUs for CPT codes 76988 
and 76989 should not sum to more than the aggregate work RVU for CPT 
code 76987. We did not receive comments that clarified the intensity of 
each part of the service as broken out from the aggregate work RVU of 
CPT code 76987 to adequately account for the cardiothoracic surgeon and 
cardiologist's time and intensity to perform CPT codes 76988 and 76989. 
Commenters only stated that co-surgeons and assistants at surgery are 
paid more than 100 percent and commenters reiterated that the RUC 
recommended that CPT code 76989 to be valued higher than CPT code 
76988. While this is true, these codes along with the intraoperative 
TEE codes for congenital cardiac anomalies are not structured to allow 
the billing of co-surgeons or assistants at surgery. Rather, the CPT 
Editorial Panel structured these codes to have clearly sanctioned, 
disaggregated service parts to allow for

[[Page 78908]]

multiple providers to perform different parts of the aggregate service 
represented by CPT codes 76987 and 93315.
    As stated above, CPT code 93317 represents image acquisition and 
interpretation and report only, typically done by the cardiologist 
after probe placement typically performed by the cardiac 
anesthesiologist, represented by CPT code 93316. Similarly, CPT code 
76989 represents interpretation and report only, which is typically 
performed by a cardiologist according to the Summary of 
Recommendations. We note that the services as described by the 
disaggregated component CPT codes 76988 and 76989 would likely be an 
assistant at surgery situation if the codes were structured to be 
billed this way because CPT code 76989 is described as the cardiologist 
assisting the cardiothoracic surgeon on probe placement and 
manipulation with real-time image interpretation, guidance, and 
discussion of the findings before and after the cardiac repair(s) to 
ensure accurate image acquisition and to determine if the repair(s) is 
adequate or additional procedures are needed after the cardiac repair 
is complete. In this case, where the cardiologist is acting as an 
assistant at surgery, the primary surgeon who is actually placing and 
manipulating the probe on the beating heart would be paid 100 percent 
and the assistant surgeon would be paid 16 percent. If this were the 
case, the cardiologist that performs the work described by CPT code 
76989 would be valued at 0.30 work RVUs (based on 16 percent of the 
finalized work RVU of 1.90 for CPT code 96987). Similarly, CPT code 
93315 cannot be billed with modifier 62 or 80, but rather the codes 
were structured to allow for multiple providers to perform different 
parts of the aggregate service represented by CPT code 93315 by 
cardiologists and cardiac anesthesiologists, yet the work RVUs of CPT 
codes 93317 and 93316 do not total more than the work RVU of CPT code 
93315.
    We continue to believe that the sum of the work RVUs for CPT codes 
76988 and 76989 should not be more than the aggregate work RVU of CPT 
code 76987 and disagree with the RUC that CPT code 76989 should be 
valued higher than CPT code 76988 based on the code descriptions and 
breakdown of service parts. Therefore, we are finalizing a work RVU of 
0.70 for CPT code 76989 based on the subtraction of the finalized work 
RVU of 1.20 for CPT code 76988 from finalized work RVU of 1.90 for CPT 
code 76987. We subtracted these final work RVUs from each other to 
calculate the work RVU for CPT code 76989 to maintain the relationship 
where the work RVUs for CPT codes 76988 and 76989 sum to the work RVU 
of CPT code 76987. We note that commenters did not respond to the 
request for additional information that clarified the intensity of each 
part of the service as broken out from the aggregate work RVU of CPT 
code 76987 to adequately account for the cardiothoracic surgeon and 
cardiologist's time and intensity to perform CPT codes 76988 and 76989. 
We note that this final work RVU is greater than the 0.30 work RVUs 
that the cardiologist would receive if the surgeons were able to bill 
CPT code 76987 with modifier 80, greater than the proposed work RVU of 
0.54, and greater than the work RVU of 0.63 that would result if we 
maintained the proposed methodology for calculating a work RVU for CPT 
code 76989, in which it where it was based on \1/3\ of the work RVU of 
CPT code 76987 (1.90 * \1/3\ = 0.63).
    With regards to the intraservice time for CPT code 76989, we agree 
with the commenters that it is possible that the survey respondents 
underestimated their intraservice time because they are in and out of 
the operating room throughout the procedure, and that it is typical 
that the cardiologist spends 20 minutes of intraservice time for CPT 
code 76989 rather than the proposed 15 minutes. Therefore, we are 
finalizing the RUC-recommended work times for CPT code 76989 as 
follows: 5 minutes of pre-evaluation time, 20 minutes of intraservice 
time, and 10 minutes of immediate postservice time for total time of 35 
minutes.
    After consideration of the public comments, we are finalizing the 
proposed work RVUs for CPT codes 76984 and 76998 of 0.60 and 0.91, 
respectively, the RUC-recommended work RVUs of 1.90 and 1.20 for CPT 
codes 76987 and 76988, respectively, and a work RVU of 0.70 for CPT 
code 76989.
(17) Percutaneous Coronary Interventions (CPT Code 92972)
    In September 2022, the CPT Editorial Panel created one new Category 
I CPT code for percutaneous coronary lithotripsy. Sixteen other 
percutaneous coronary intervention (PCI) codes were considered part of 
the code family but were ultimately not reviewed by the RUC. New add-on 
CPT code 92972 was reviewed by the RUC on an interim basis for CY 2024 
while the entire percutaneous coronary intervention code family was 
referred to the CPT Editorial Panel for restructuring for the CY 2025 
cycle.
    We proposed the RUC-recommended work RVU of 2.97 for CPT code 92972 
(Percutaneous transluminal coronary lithotripsy). The RUC did not 
recommend and we did not propose any direct PE inputs for this 
facility-based add-on service.
    Comment: Several commenters thanked CMS for our consideration and 
for proposing the RUC's recommended work RVU for this code.
    Response: We appreciate the support for our proposals from the 
commenters.
    After consideration of the public comments, we are finalizing the 
work RVU and lack of direct PE inputs for CPT code 92972 as proposed.
(18) Auditory Osseointegrated Device Services (CPT Codes 92622 and 
92623)
    In February 2022, the CPT Editorial Panel created CPT code 92622 
(Diagnostic analysis, programming, and verification of an auditory 
osseointegrated sound processor, any type; first 60 minutes) and 92623 
(Diagnostic analysis, programming, and verification of an auditory 
osseointegrated sound processor, any type; each additional 15 minutes 
(list separately in addition to code for primary procedure) for CY 
2024. CPT code 92623 serves as the add-on code for base CPT code 92622.
    We proposed the RUC-recommended work RVU of 1.25 for CPT code 92622 
and 0.33 for CPT code 92623. We also proposed the RUC-recommended 
direct PE inputs for both codes. Additionally, because audiologists 
provide these services, we proposed to add CPT codes 92622 and 92623 to 
the list of audiology services that can be billed with the AB modifier, 
that is personally provided by audiologists without a physician/NPP 
referral for non-acute hearing conditions--the list for CY 2023 is 
available at https://www.cms.gov/audiology-services.
    Comment: A majority of commenters supported the CMS proposal of the 
RUC-recommended values for CPT codes 92622 and 92623, as well as the 
proposal to add the AB modifier.
    Response: We thank the commenters for their support.
    Comment: One commenter disagreed with the valuation of these codes 
and stated that the RVU work value of 1.25 for CPT code 92622 is lower 
than other, less technical timed audiology codes and as a result will 
cause financial problems for audiologists to continue providing these 
procedures. This commenter urged CMS to reconsider the valuation of 
these codes.
    Response: We thank the commenter for their feedback but we continue 
to believe that the RUC-recommended

[[Page 78909]]

values for these codes are correct. The RUC's recommended work RVU was 
based on a survey of 45 audiologists and supported by two key reference 
service codes: CPT codes 92626 (Evaluation of auditory function for 
surgically implanted device(s) candidacy or postoperative status of a 
surgically implanted device(s); first hour) (work RVU = 1.40, 7 minutes 
pre-service, 60 minutes intra-service and 10 minutes post-service 
time)) and 92603 (Diagnostic analysis of cochlear implant, age 7 years 
or older; with programming) (work RVU = 2.25, 20 minutes pre-service, 
82 minutes intra-service and 20 minutes post-service time)). These 
codes are optimal comparators as both have similar intensity to the 
surveyed code and service period times that increase respectively as 
the RVU increases. These reference service codes demonstrate 
appropriate relativity within other XXX-global audiologic and hearing 
implant testing services.
    After consideration of the comments, we are finalizing the work 
RVUs and direct PE inputs for CPT codes 92622 and 92623 as proposed.
(19) Venography Services (CPT Codes 93584, 93585, 93586, 93587, and 
93588)
    In February 2022, the CPT Editorial Panel created six new CPT add-
on codes to describe Venography services that are performed during 
cardiac catheterization for congenital heart defects in the superior 
vena cava (SVC), the inferior vena cava (IVC), and in other congenital 
veins, that will be reported in conjunction with the main cardiac 
catheterization procedure codes (CPT codes 93593-93598). CPT codes 
93584 (Venography for congenital heart defect(s), including catheter 
placement, and radiological supervision and interpretation; anomalous 
or persistent superior vena cava when it exists as a second 
contralateral superior vena cava, with native drainage to heart (List 
separately in addition to code for primary procedure)) and CPT codes 
9X001 (Venography for congenital heart defect(s), including catheter 
placement, and radiological supervision and interpretation; inferior 
vena cava (List separately in addition to code for primary procedure)) 
were to replace the two more general CPT codes 75827 (Venography, 
caval, superior, with serialography, radiological supervision and 
interpretation) and 75825 (Venography, caval, inferior, with 
serialography, radiological supervision and interpretation). CPT code 
9X001 has since been rescinded, and all the remaining new add-on codes 
have been clarified to state in their descriptors that they are 
specifically for congenital heart defects.
    For CPT code 93584 (Venography for congenital heart defect(s), 
including catheter placement, and radiological supervision and 
interpretation; anomalous or persistent superior vena cava when it 
exists as a second contralateral superior vena cava, with native 
drainage to heart (List separately in addition to code for primary 
procedure)), the AMA RUC proposed a work RVU of 1.20 for 10 minutes of 
intra-service time and total time. We proposed the AMA RUC recommended 
work RVU of 1.20 with 10 minutes of intra-service time and total time 
for CPT code 93584.
    For CPT code 93585 (Venography for congenital heart defect(s), 
including catheter placement, and radiological supervision and 
interpretation; azygos/hemi-azygos venous system (List separately in 
addition to code for primary procedure)), the AMA RUC proposed a work 
RVU of 1.13 for 10 minutes of intra-service time and total time. We 
noted that this code has the same number of minutes as CPT code 93584, 
but with a lower recommended work RVU. We proposed the AMA RUC 
recommended work RVU of 1.13 with 10 minutes of intra-service time and 
total time for CPT code 93585.
    For CPT code 93586 (Venography for congenital heart defect(s), 
including catheter placement, and radiological supervision and 
interpretation; coronary sinus (List separately in addition to code for 
primary procedure)) the AMA RUC proposed a work RVU of 1.43 for 12 
minutes of intra-service time and total time. We noted that this code 
has two additional minutes than CPT code 93584 which is 20 percent more 
in physician time than the 10 minutes from CPT code 93584. We proposed 
the AMA RUC recommended work RVU of 1.43 with 12 minutes of intra-
service time and total time for CPT code 93586.
    For CPT code 93587 (Venography for congenital heart defect(s), 
including catheter placement, and radiological supervision and 
interpretation; venovenous collaterals originating at or above the 
heart (e.g., from innominate vein) (List separately in addition to code 
for primary procedure)), the AMA RUC proposed a work RVU of 2.11 for 16 
minutes of intra-service time and total time. We noted that this code 
has six additional minutes more than CPT code 93584 (10 minutes), which 
is 60 percent more physician time. Although we do not imply that 
increases in time as reflected in survey values must equate to a one-
to-one or linear increase in the valuation of work RVUs, we believe 
that since the two components of work are time and intensity, 
significant increases in time within the same code family should 
typically be reflected in increases to work RVUs. In the case of CPT 
code 93587, we believe that it would be more accurate to propose a work 
RVU of 1.92 to account for this increase in the surveyed work time as 
compared with CPT code 93584. Therefore, we proposed a work RVU of 1.92 
along with 16 minutes of intra-service time and total time for CPT code 
93587.
    For CPT code 93588 (Venography for congenital heart defect(s), 
including catheter placement, and radiological supervision and 
interpretation; venovenous collaterals originating below the heart 
(e.g., from the inferior vena cava) (List separately in addition to 
code for primary procedure)), the AMA RUC proposed a work RVU of 2.13 
for 17 minutes of intra-service time and total time. We noted that this 
code has seven additional minutes more than CPT code 93584 (10 
minutes), which is 70 percent more physician time than CPT code 93584. 
Although we do not imply that increases in time as reflected in survey 
values must equate to a one-to-one or linear increase in the valuation 
of work RVUs, we believe that since the two components of work are time 
and intensity, significant increases in time within the same code 
family should typically be reflected in increases to work RVUs. In the 
case of CPT code 93588, we believe that it would be more accurate to 
propose a work RVU of 2.04 to account for this increase in the surveyed 
work time as compared with CPT code 993584. Therefore, we proposed a 
work RVU of 2.04 along with 17 minutes of intra-service time and total 
time for CPT code 93588.
    The RUC did not recommend and we did not propose any direct PE 
inputs for the five codes in the Venography Services family.
    Comment: We received a few comments concerning these five new add-
on codes for Venography congenital heart defect(s). All commenters were 
in favor of CMS accepting the AMA RUC recommended work RVUs for CPT 
codes 93584, 93585, and 93586. All commenters were also not in favor of 
the CMS proposed work RVUs for CPT codes 93587 and 93588, and they 
urged CMS to withdraw our proposed values and accept the RUC 
recommended values. Additionally, commenters stated that CPT codes 
93584, 93585, 93586, 93587 and 93588, which were introduced for review 
as a family of congenital heart catheter add-on codes, are actually 
more of a selectively unique group of codes that are distinct from one 
another, rather than a family of codes in

[[Page 78910]]

the usual sense, and CMS had mistakenly treated them as a usual family 
of codes.
    Response: We agree with the commenters regarding the grouping of 
these congenital heart catheter add-on codes. We acknowledge that these 
codes are services that are selectively unique and distinct from one 
another, and that they are not a just family of codes that are a series 
of similar services, as in having a base code with successively 
increasing values of magnitude of similar iterations in a rank order. 
As a result, we are finalizing the AMA RUC recommended work RVUs of 
2.11 for CPT code 93587, and 2.13 for 93588. We are also finalizing the 
AMA RUC recommended work RVUs for CPT codes 93584, 93585, and 93586, as 
proposed.
(20) Post Operative Low-Level Laser Therapy (CPT Code 97037)
    In May 2022, the CPT Editorial Panel created CPT code 97037 
(Application of a modality to 1 or more areas; low-level laser therapy 
(i.e., non-thermal and non-ablative), for post operative pain 
reduction) to describe the application of low-level laser therapy for 
post operative pain reduction. The RUC did not offer a recommendation 
on CPT code 97037 and we did not realize that this code would be added 
to the CPT code set for CY 2024 until after the publication of the 
proposed rule. Although we did not receive recommendations for CPT code 
97037 and did not have the opportunity to solicit public comments on 
its valuation, we are finalizing non-covered status (Procedure Status 
``N'') for CPT code 97037 because NCD 270.6 states: The use of infrared 
and/or near-infrared light and/or heat, including monochromatic 
infrared energy, is non-covered for the treatment, including the 
symptoms such as pain arising from these conditions, of diabetic and/or 
non-diabetic peripheral sensory neuropathy, wounds and/or ulcers of the 
skin and/or subcutaneous tissues. Thus, it is noncovered by Medicare.
(21) General Behavioral Health Integration Care Management (CPT Code 
99484, and HCPCS Code G0323)
    We proposed to refine the work RVU of both CPT code 99484 and HCPCS 
code G0323, (see section II.J.1.c. of this final rule), by increasing 
the work RVU to 0.93 from the current 0.61 and increasing the work time 
to 21 minutes to match the results of the surveyed work time. For CPT 
code 99484 we proposed the direct PE inputs as recommended by the RUC 
without refinement. We also proposed the same PE inputs for HCPCS code 
G0323.
    CMS created four behavioral health integration (BHI) HCPCS G-codes 
for CY 2017. In 2018 the codes were replaced by new CPT codes. At that 
time RUC specialty societies undertook a survey, but the RUC did not 
use the survey results to establish work RVUs, and instead adopted the 
valuations we had finalized in 2017. For CY 2017 we finalized a work 
RVU of 0.61 based on a direct crosswalk from CPT code 99490 (chronic 
care management services) (81 FR 80351). We recognized that the 
services described by CPT code 99490 are distinct from those furnished 
under BHI, but we stated that until we have more information about how 
the services described by HCPCS code G0507 (replaced in 2018 by CPT 
code 99484) are typically furnished, we believed valuation based on an 
estimate of the typical resources would be most appropriate (81 FR 
80351). For CY 2022 we increased the value of CPT code 99490 from 0.61 
to 1.00 (86 FR 65118).
    In the CY 2023 PFS final rule (87 FR 69549), we finalized a new 
HCPCS code G0323 (care management services for behavioral health 
conditions, at least 20 minutes of clinical psychologist or clinical 
social worker time, per calendar month. (These services include the 
following required elements: Initial assessment or follow-up 
monitoring, including the use of applicable validated rating scales; 
behavioral health care planning in relation to behavioral/psychiatric 
health problems, including revision for patients who are not 
progressing or whose status changes; facilitating and coordinating 
treatment such as psychotherapy, coordination with and/or referral to 
physicians and practitioners who are authorized by Medicare to 
prescribe medications and furnish E/M services, counseling and/or 
psychiatric consultation; and continuity of care with a designated 
member of the care team.)) (See section II.J.1.c. of this final rule, 
for final code descriptor refinement.) We valued HCPCS code G0323 based 
on a direct crosswalk to the work values and direct PE inputs for CPT 
code 99484, because we believed the services described by HCPCS code 
G0323 mirrored those described by CPT code 99484. We noted that we may 
consider changes in how this code is valued for future rulemaking.
    We continue to be concerned about undervaluing care management 
services under the PFS given the variability of costs involved with 
these evolving models of care. The RUC has recommended revaluing CPT 
code 99484, following a survey of 63 respondents. The median survey 
work RVU was 1.30, and the median time was 21 minutes (all intra-
service). The specialty societies recommend a value of 0.93 based on a 
crosswalk to code 99202. We believe the specialty societies are in a 
good position to understand the evolving practice models. The RUC has 
recommended the 25th percentile survey work RVU of 0.85. Consistent 
with our goals of ensuring continued and consistent access to these 
crucial care management services we are finalizing to increase the work 
RVU of CPT code 99484 to 0.93. This value reflects the work RVU of CPT 
code 99202, which has a similar work time.
    We continue to believe that the services described by HCPCS code 
G0323 (section II.J.1.c. of this final rule) closely mirror those 
described by CPT code 99484. As we proposed to update the work RVU and 
one of the PE inputs for CPT code 99484, we continue to believe that a 
direct crosswalk to the work values and direct PE inputs for CPT code 
99484, is an appropriate valuation of the level, time, and intensity of 
the services under HCPCS code G0323 (section II.J.1.c. of this final 
rule). As such we proposed to value HCPCS code G0323, (section 
II.J.1.c. of this final rule), based on a direct crosswalk to the work 
values and direct PE inputs for CPT code 99484, previously in this 
section.
    We continue to believe that there is a systemic undervaluation of 
work estimates for behavioral health services. We proposed values for 
CY 2024 that we believe will more accurately value the work involved in 
delivering behavioral health services.
    Comment: Nearly all commenters were supportive of our proposal to 
increase payment for general behavioral health integration services. 
Some also expressed their appreciation for our support for multiple 
evidence-based models of integrated care, as it allows psychologists 
the flexibility required to support the behavioral health needs of the 
broader community. Some requested that we increase the payment for CPT 
code 99484 and HCPCS code G0323 to, at a minimum, account for the lower 
reimbursement rate that nonphysician MH and SUD counselors receive for 
delivering these services (75 percent of the Physician Fee Schedule) 
and ensure that such providers receive an adequate rate. Other 
commenters urged us to ensure the reimbursement rates are adequate, 
accounting for the systemic undervaluation of work for behavioral 
health services and increase where appropriate.
    Response: We thank commenters for their overwhelming support for 
our

[[Page 78911]]

proposal. We note that the statute requires that clinical social 
workers are paid 75 percent of the amount paid to clinical 
psychologists. We also note that we are refining the code descriptor 
for HCPCS code G0323 to allow two new provider types to bill HCPCS code 
G0323. We refer commenters to section II.J.1.c. of this final rule for 
discussion of these two new provider types and to section II.J.5. of 
this final rule discussion of steps we are taking to improve the 
accuracy of the valuation of behavioral health services. We are 
finalizing values for CPT code 99484 and HCPCS code G0323, as proposed.
    Comment: Some commenters requested that CMS consider creating a 
code for 20 minutes of additional care management services for 
behavioral health conditions. One commenter requested that CMS also 
increase payment for the three Collaborative Care Model behavioral 
health integration codes. Another requested that CMS also increase 
payment for Screening, Brief Intervention, and Referral to Treatment 
(SBIRT) services (HCPCS codes G0396 and G0397) to encourage greater 
integration of SUD treatment in primary care and more widespread 
screening for SUDs.
    Response: We may consider the development of a code for 20 
additional minutes of care management services for behavioral health 
conditions in future rulemaking. We note that we have a process for 
potentially misvalued codes, whereby we adjust the codes' RVUs taking 
into account recommendations provided by interested parties. On an 
annual basis prior to developing the proposed rule, we seek nominations 
from the public and from interested parties for codes that they believe 
we should consider as potentially misvalued. We invite the commenters 
to make such nominations per the process outlined in section II.C. of 
this final rule.
    Comment: One commenter encouraged us to ensure that non-Medicare 
eligible Addiction Counselors and peer support specialists be permitted 
to participate in furnishing BHI services, consistent with applicable 
requirements for auxiliary personnel.
    Response: We thank the commenter for raising the contributions that 
addiction counselors and peer support specialists might be able to make 
in the delivery of general behavioral health integration services as 
auxiliary personnel. CPT code 99484 may be billed by a physician or 
nonphysician practitioner (NPP), referred to as a qualified health care 
professional in the AMA's CPT Editorial Panel CPT[supreg] codebook, 
whose State licensure and scope of practice includes evaluation & 
management (E/M) services and who is authorized under their Medicare 
statutory benefit category to bill Medicare independently for their 
services (See FAQs about billing Medicare for BHI services, https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/Behavioral-Health-Integration-FAQs.pdf). 
Medicare Part B pays for services and supplies incident to the service 
of a physician (or other practitioner), under Sec.  410.26. This 
regulation permits payment for services and supplies furnished by the 
physician or other practitioner with an incident to benefit or 
auxiliary personnel. Auxiliary personnel must meet any applicable 
requirements to provide incident to services, including licensure, 
imposed by the State in which the services are being furnished. As 
such, a physician or NPP would be able to bill for behavioral health 
integration services furnished by addiction counselors and peer support 
specialists as auxiliary personnel under their general supervision if 
the addiction counselors and peer support specialists meet all the 
requirements under Sec.  410.26.
    We created HCPCS code G0323 specifically for clinical psychologists 
and social workers (section II.J.1.c. of this final rule), whose scope 
of practice does not include evaluation & management (E/M) services, to 
bill general behavioral health integration services. Only clinical 
psychologists have an incident to benefit enabling them to bill for 
general behavioral health integration services furnished under their 
general supervision by auxiliary personnel.
    Comment: One commenter expressed dissatisfaction with the adequacy 
of the behavioral health integration codes and on that basis stated 
there was no need to increase their payment rates at this time. On the 
other hand, the commenter did offer that over time CMS should review 
and increase payment for more mental health and substance use services 
and integrated care codes to incentivize more providers to participate 
in Medicare and support innovation.
    Response: We thank the commenter for their perspective and 
feedback. As discussed in the proposal we agree with the RUC and 
specialty societies that an increase in work RVUs is appropriate at 
this time. We are finalizing as proposed the work RVUs for both CPT 
code 99484 and HCPCS code G0323, (see section II.J.1.c. of this final 
rule), by increasing the work RVU to 0.93 from the current 0.61 and 
increasing the work time to 21 minutes to match the results of the 
surveyed work time. For CPT code 99484, we are finalizing the direct PE 
inputs as recommended by the RUC without refinement. We are also 
finalizing the same PE inputs for HCPCS code G0323.
(22) Advance Care Planning (CPT Codes 99497 and 99498)
    In January 2022, the Relativity Assessment Workgroup reviewed CPT 
codes 99497 and 99498. The Workgroup determined these advance care 
planning services should be examined given the recent changes in 
evaluation and management services. The RUC recommended that CPT codes 
99497 and 99498 be surveyed for physician work and practice expense for 
the April 2022 RUC meeting. The RUC recommended no changes in physician 
time, work RVUs, or direct PE inputs for these services for CY 2024.
    We proposed the RUC-recommended work RVU of 1.50 for CPT code 99497 
and 1.40 for CPT code 99498, which are the current values for these 
codes. We proposed the RUC-recommended direct PE inputs for these codes 
without refinement.
    Comment: Some commenters supported our proposal to value these 
services with the RUC-recommended work RVUs and direct PE inputs 
without refinement.
    Response: We appreciate the support of commenters.
    Comment: One commenter did not support our proposal and stated that 
we should instead finalize work RVUs based on the survey median values, 
stating that the fact that CPT code 99498 is valued at an interval 
between the 25th and the median work RVU is anomalous and that the 
proposed values do not reflect that primary care delivery has become 
significantly more complex for providers and patients.
    Response: As the commenter noted, the RUC survey material states, 
``When CPT code 99498 is reported, it is typically a much more 
difficult situation that requires extra time and effort beyond that 
required for the base code and usually includes the presence of family 
members. This add-on code is more intense than the first 30 minutes of 
advance care planning because the physician or qualified health care 
professional (QHP) is not just filling out forms but is working through 
contentious and difficult issues and educating the family members on 
all diagnoses to reach planning decisions.'' We believe this difference 
in intensity between the two codes is accurately reflected in the 
slightly higher intensity of CPT code 99498 that results from the RUC-
recommended values.

[[Page 78912]]

    After considering the comments, we are finalizing the RUC-
recommended work RVUs and direct PE inputs for these codes without 
refinement, as proposed.
(23) Pelvic Exam (CPT Code 99459)
    In September 2022, the CPT Editorial Panel created a new CPT code 
for reporting a pelvic exam--CPT code 99459. The specialty societies 
noted that reimbursement for the work would be captured with the 
problem-oriented E/M code billed for the visit. The CPT Editorial Panel 
agreed, thus the new code is a practice expense only code that captures 
the direct practice expenses associated with performing a pelvic exam 
in the non-facility setting. CPT code 99459 (Pelvic Exam) captures the 
4 minutes of clinical staff time associated with chaperoning a pelvic 
exam.
    We proposed the RUC-recommended direct-PE inputs for CPT code 99459 
without refinement. As a PE-only service, the RUC did not recommend and 
we did not propose a work RVU for this code.
    Comment: One commenter noted that they believe there was an error 
with Addendum B regarding the PE RVUs for CPT code 99459.
    Response: We thank the commenter for their support. We do not 
believe there is an error in Addendum B for CPT code 99459. The PE RVUs 
are listed correctly with 0.68 RVUs for non-facility and ``NA'' for 
facility, as there are no direct-PE inputs for this code in the 
facility setting.
    After consideration of the public comments, we are finalizing our 
direct PE inputs for CPT code 99459 as proposed.
(24) Hyperthermic Intraperitoneal Chemotherapy (HIPEC) (CPT Codes 96547 
and 96548)
    In September 2022, the CPT Editorial Panel created two time-based 
add-on Category I CPT codes 96547 (Intraoperative hyperthermic 
intraperitoneal chemotherapy (HIPEC) procedure, including separate 
incision(s) and closure, when performed; first 60 minutes) and 96548 
(Intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC) 
procedure, including separate incision(s) and closure, when performed; 
each additional 30 minutes). CPT codes 96547 and 96548 were surveyed 
for the January 2023 RUC meeting. While reviewing the survey data, it 
was noted by specialty societies that the instructions were not 
sufficient as the survey data reflected time estimates that exceeded 
the time specified in the new time-based code descriptors. The RUC has 
stated that the survey results for both CPT codes 96547 and 96548 are 
inaccurate and that the codes should be resurveyed for 2025. Therefore, 
the RUC recommended contractor pricing for CPT codes 96547 and 96548 
and that they be referred to the CPT Editorial Panel for revision.
    We proposed to contractor price CPT codes 96547 and 96548 for CY 
2024.
    Comment: We received comments in support of our proposed contractor 
pricing for Hyperthermic Intraperitoneal Chemotherapy (HIPEC).
    Response: We thank commenters for their support. After 
consideration of the public comments, we are finalizing contractor 
pricing for these codes as proposed.
(25) Hyperbaric Oxygen Under Pressure (HCPCS Code G0277)
    In 2015, CMS created HCPCS code G0277 (Hyperbaric oxygen under 
pressure, full body chamber, per 30 minute interval) to describe direct 
practice expense inputs associated with CPT code 99183 (Physician or 
other qualified health care professional attendance and supervision of 
hyperbaric oxygen therapy, per session) (consistent with the Medicare 
Hospital Outpatient Prospective Payment System coding mechanism). At 
the September 2022 Relativity Assessment Workgroup meeting, HCPCS code 
G0277 was identified as a high-volume growth code with Medicare 
utilization of 10,000 or more that have increased by at least 100 
percent from 2015 through 2022 and was reviewed at the January 2023 RUC 
meeting. Hyperbaric oxygen therapy is typically administered to one 
patient in one hyperbaric chamber for 2 hours. Two hours is typical, 
and all inputs are prorated for four units being performed (each 30 
minutes, totaling 2 hours). All medical supply and time inputs were 
divided into quarters.
    There was a change in the dominant specialty providing this 
service, which is now primarily performed by family medicine. There was 
also a change in clinical staff type, and it is now typical for a 
single staff person to perform all activities (RN/Respiratory 
Therapist) as opposed to two staff (an RN/LPN/MA and an RN/respiratory 
therapist). This was primarily due to a 2016 change by the National 
Board of Diving and Hyperbaric Medical Technology to no longer allow 
certified nursing assistants and certified medical assistants to be 
eligible to take the certified hyperbaric technologist examination. The 
PE Subcommittee agreed with the specialty societies to update the 
clinical staff type to reflect solely L047C RN/Respiratory Therapist. 
We agreed with the specialties that the intra-service time is more 
appropriately labeled as clinical activity CA021 (Perform procedure/
service--NOT directly related to physician work time) as opposed to 
CA018 due to the change in clinical staff type.
    We proposed to refine the clinical labor time for the CA013 
activity (Prepare room, equipment, and supplies) from 1.5 minutes to 
0.5 minutes, as well as the clinical labor time for the CA016 activity 
(Prepare, set-up and start IV, initial positioning and monitoring of 
patient) from 1 minute to 0.5 minutes to align with the 2-minute 
standard for these clinical activities. We arrived at these refinements 
by dividing the standard 2-minutes of clinical labor times for CA013 
and CA016 by four to account for all inputs being prorated for four 
units being performed for one typical 2-hour session. CA013 and CA016 
would each be 0.5 minutes per 30-minute interval, which amounts to the 
standard 2 minutes for these clinical activities when four units are 
billed for the typical 2-hour session. The RUC recommended 30 minutes 
for clinical labor activity CA021 (Perform procedure/service--Not 
directly related to physician work time (intra-service time) based on a 
flawed assumption that the current 15 minutes for CA021 accounts for 
two patients receiving treatment simultaneously. We noted that it had 
been standard for one patient to receive treatment at a time, and the 
current 15 minutes for CA021 was based on a time ratio to the CY 2015 
RUC-recommended direct PE inputs for CPT code 99183; therefore, we 
disagreed with this RUC recommendation and proposed to refine the 
recommended intra-service CA021 clinical labor time to maintain the 
current 15 minutes. This was to reflect the 2015 PFS final rule where 
``we used the RUC recommended direct PE inputs for CPT code 99183 and 
adjusted them to align with the 30-minute treatment interval'' (79 FR 
67677). Each PE input was prorated for four units of HCPS code G0277 
being provided in one typical 2-hour session. Since CPT code 99183 
(Physician or other qualified health care professional attendance and 
supervision of hyperbaric oxygen therapy, per session) was a 120-minute 
code with 60-minute intra-service time, all PE inputs in HCPCS code 
G0277 were prorated for four units being performed.
    To conform to these changes in clinical labor time, we also 
proposed to refine the equipment time for the EQ362 (HBOT air break 
breathing apparatus demand system (hoses, masks, penetrator, and demand 
valve)) and

[[Page 78913]]

EQ131 (hyperbaric chamber) equipment items from the recommended 39.75 
minutes to 23.25 minutes. This was a result of the 15-minute intra-
service time, as opposed to the RUC recommendation of 30 minutes of 
intra-service time.
    Comment: We received many public comments disagreeing with the 
proposed refinements to the intra-service time (CA021) for HCPCS code 
G0277. Many of these comments were based on a concern for patient 
safety and supervision. Commenters stated that the standard of practice 
for patient safety is attendance and availability of clinical staff for 
100 percent of the time. In case of an adverse event that could occur 
at any point in treatment, the clinical staff must be present to notify 
the physician to alter or stop the treatment. One staff member per 
patient must be available to carry out emergency procedures. Commenters 
provided many scenarios where an adverse event may require clinical 
staff attendance and availability. Due to this standard of practice, 
commenters stated that it is necessary for the clinical staff time to 
align with the code descriptor (30 minutes). The 30-minute clinical 
staff time is required because the patient is at pressure for longer 
than the 15-minute proposed time during the treatment. In a standard 2-
hour session, which would account for four units of HCPCS code G0277, 
patients are at pressure for 106-110 minutes. Having a clinical staff 
time for a total of 60-minutes would not meet the standard of practice 
in which the clinical staff is in attendance for the entire treatment. 
There were similar comments regarding the equipment times; commenters 
specified that the equipment is used the entire treatment time. 
Commenters also provided information about the rarity of multiple 
patients to receive treatment at the same time, so intra-service time 
must be 30 minutes.
    Response: We agree with the commenters and are finalizing the RUC-
recommended clinical labor time of 30 minutes for the CA021 clinical 
labor task. We acknowledge that this time is needed to meet the 
standard of practice for clinical staff supervision during the entire 
treatment to ensure patient safety and to align with the time that 
patients are at pressure. This will also affect the equipment times 
(EQ362 and EQ131), adjusting each to 38.25 minutes to align with the 
adjustment to clinical staff time. This is because clinical labor task 
CA021 is used in the formula to calculate EQ362 and EQ131, so any 
refinements to CA021 also changes those values. We are finalizing RUC 
proposed values for CA021, EQ362, and EQ131.
    Comment: Many commenters pointed out that clinical staff must be 
supervised by a physician the entire time, so clinical staff time 
should not be separate from physician work.
    Response: The change in designation of intra-service time from 
CA018 to CA021 was a RUC recommendation that CMS agreed with. We 
specify that clinical staff are supervised by physicians during the 
entirety of the treatment. Physician or QHP work is accounted for in 
CPT code 99183 (Physician or other qualified health care professional 
attendance and supervision of hyperbaric oxygen therapy), while HCPCS 
code G0277 solely accounts for practice expenses associated with 
hyperbaric oxygen therapy. The change from the CA018 to the CA021 
clinical labor task is a clerical update to reflect the fact that HCPCS 
code G0277 does not have an intraservice work time by virtue of being a 
PE-only code. We are finalizing as proposed to change the intra-service 
time from CA018 to CA021, consistent with the RUC recommendations.
    Comment: We received many public comments disagreeing with CMS' 
proposed refinements to the clinical staff time (CA013 and CA016) which 
CMS proposed at 0.5 minutes per 30-minute interval, which amounts for 
each of them to equal the standard 2 minutes for these clinical 
activities when four units are billed for the typical 2-hour session. 
Commenters stated that clinical activities must align with the same 
clinical labor values for CPT code 99183 (the code for this service 
that is associated with physician work), which exceed the 2-minute 
standard. One commenter stated that during this clinical activity time, 
clinical staff complete additional activities. Commenters specified 
that one reason for clinical activity time to be beyond the standard, 
is due to increased need for disinfecting and infection control for the 
next patient.
    Response: We note that all input values for HCPCS code G0277 do not 
align with CPT code 99183, and therefore, clinical activity times do 
not need to have the same values. We do not agree that CA013 and CA016 
exceed the 2-minute standard for those inputs. We calculated these 
times to align with these specific clinical activities (in this case 
CA013 and CA016). Each clinical activity has a separate time 
calculation; therefore, the 2 minutes total for CA013 only includes 
preparing the room, equipment, and supplies. The 2 minutes total for 
CA016 only includes preparing, setting up and starting the IV and 
initial positioning and monitoring of patient. We do not consider staff 
completing additional activities during these specified times . We note 
that we did not adjust any of the time requirements that involve post-
service time, for example cleaning rooms and equipment. The refinements 
to CA013 and CA016 that we are finalizingdo not affect the time spent 
ensuring infection control. We would also like to note that CA013 and 
CA016 are not the only aspects of pre-service for the treatment, they 
are the only ones that had refinements in this rulemaking cycle. All 
other values for pre-service time are aligned with the RUC 
recommendations. We disagree with commenters and are finalizing the 
proposed time refinements for CA013 and CA016 to align with the 
standard 2 minutes for these clinical activities.
    After consideration of the public comments, we are finalizing the 
proposed CA013 and CA016 direct PE inputs for HCPCS code G0277 and we 
are finalizing the RUC-recommended clinical labor time of 30 minutes 
for CA021 and equipment times (EQ362 and EQ131) of 38.25 minutes, as 
detailed above.
(26) Remote Interrogation Device Evaluation--Cardiovascular (HCPCS Code 
G2066, and CPT Codes 93297, and 93298)
    CPT code 93299 (Interrogation device evaluation(s), (remote) up to 
30 days; implantable cardiovascular physiologic monitor system or 
subcutaneous cardiac rhythm monitor system, remote data 
acquisitions(s), receipt of transmissions and technician review, 
technical support and distribution of results) was meant to serve as a 
catch-all for both base CPT codes 93297 and 93298, which are work-only 
codes. However, the CPT Editorial Panel determined that CPT code 93299 
was no longer necessary if CPT codes 93297 and 93298 were assigned 
direct PE inputs and therefore recommended CMS to delete CPT code 93299 
at the beginning of CY 2020 under the assumption that CPT codes 93297 
and 93298 would be assigned direct PE inputs. Since CMS did not agree 
with the recommended values, CMS decided to not allocate direct PE 
inputs for CPT codes 93297 or 93298 and instead created contractor 
priced HCPCS code G2066 for CY 2020 to ensure these services could 
still be furnished that were previously described under CPT code 93299 
(84 FR 62777 and 62778). Since the publication of the CY 2020 PFS final 
rule, HCPCS code G2066 has remained contractor priced and CPT codes 
93297 and 93298 remain as work-only codes. CMS continues to work with 
MACs and

[[Page 78914]]

interested parties to address a lot of the payment concerns surrounding 
G2066 such as discrepancies in payment between jurisdictions. However, 
interested parties have indicated that a long-term solution is needed 
from CMS in order to help establish payment stability for these 
services.
    Therefore, for CY 2024, we proposed to delete HCPCS code G2066 and 
proposed the RUC-recommended direct PE inputs for CPT codes 93297 and 
93298. Since CPT code 93298 is most commonly billed with G2066, the RUC 
recommended the same inputs for CPT code 93298 and HCPCS code G2066 in 
the event that no change would be made for HCPCS code G2066. Since CMS 
does agree with the RUC recommended values, we proposed to delete HCPCS 
code G2066 altogether and establish direct PE-inputs for CPT codes 
93297 and 93298 based on the RUC recommendations.
    The RUC did not make recommendations on, and we did not propose any 
changes to the work RVUs for CPT codes 93297 and 93298.
    Comment: One commenter disagreed with the proposal to delete HCPCS 
code G2066 and establish direct PE inputs for CPT Codes 93297 and 93298 
because they believed CMS did not establish an alternative billing 
mechanism to allow continued access to these services in the facility 
setting.
    Response: We disagree with the commenter that access to these 
services will be altered with the coding change. We note that the 
services which were previously billed under HCPCS code G2066 will now 
be billed under CPT codes 93297 and 93298. This will only change how 
the services will be reported but access to these services will remain 
the same.
    Comment: Several commenters disagreed with the CMS proposal of the 
RUC's recommended equipment times for the pacemaker follow-up system 
(incl software and hardware) (Paceart) (EQ198) for CPT codes 93297 and 
93298. The commenters stated that the RUC's PE subcommittee decided 
that the EQ198 equipment is not used when the technician is educating 
or re-educating the patient and accordingly reduced the total equipment 
minutes per service assigned to the equipment system. The commenters 
stated that this is an inaccurate assumption as the equipment must be 
operational and accessible for the technician to train the patient on 
how to use and understand the monitor, to review clinical status with 
the patient, to verify connection status and to further educate the 
patient about how to initiate transmissions when needed. The commenters 
recommended that CMS update the equipment time assigned to CPT codes 
93297 and 93298 to reflect the total clinical labor time assigned to 
these services, 33 and 69 minutes, respectively.
    Response: We disagree with the commenters and continue to agree 
with the RUC's recommendation that the EQ198 equipment would not 
typically be in use when the technician is educating or re-educating 
the patient. We agree with the commenters that the equipment time would 
be needed for tasks such as initiating transmissions with the patient 
and verifying their connection status. However, this equipment time is 
already incorporated into CPT codes 93297 and 93298 under the 4 minutes 
allocated for troubleshooting activities, and as a result we continue 
to believe that EQ198 would not typically require additional equipment 
time above what the RUC recommended.
    Comment: The same commenters stated that if CMS continued to apply 
fewer minutes of EQ198 equipment time than the total clinical labor 
time for CPT codes 93297 and 93298, then CMS needed to correct a 
clerical error in the time assigned to the equipment. The commenters 
stated that the RUC's recommendations included 4 minutes of clinical 
labor time for education/re-education tasks, however the equipment time 
assigned to these services was inadvertently reduced by 11 minutes, in 
what appeared to be a clerical error. The commenters stated that if CMS 
would not set the EQ198 equipment time equal to the total clinical 
labor time assigned to these services, then CMS must correct the 
equipment time to only remove the 4 minutes assigned to education/re-
education and finalize 29 minutes of equipment time for CPT code 93297 
and 65 minutes of equipment time for CPT code 93298.
    Response: After reviewing this information from the commenters, 
along with the RUC's recommendations for CPT codes 93297 and 93298, we 
agree that there appears to be a clerical error in the equipment 
minutes for EQ198. The RUC provided a sum of clinical labor tasks in 
its recommendations listing 33 total minutes for CPT code 93297 and 69 
total minutes for CPT code 93298. The RUC stated that it was 
recommending a removal of the 4 minutes of clinical labor time allotted 
for education/re-education tasks from the EQ198 equipment time, but 
instead recommended 22 minutes and 58 minutes respectively for the two 
codes, a decrease of 11 minutes instead of 4 minutes. This was mostly 
likely an inadvertent error since one of the other clinical labor tasks 
(Technician requested transmissions) was listed at 11 minutes. We are 
therefore finalizing an increase in the EQ198 equipment time, for both 
codes, to 29 minutes for CPT code 93297 and to 65 minutes for CPT code 
93298. These refinements should correct the errors and align with what 
the RUC presumably intended to recommend.
    After consideration of the public comments, we are finalizing our 
proposal to delete contractor priced code HCPCS code G2066 and 
establish direct PE inputs for CPT codes 93297 and 93298.
(27) Payment for Caregiver Training Services
a. Background
    In CY 2022, we received AMA RUC recommendations for a new code 
family of two codes (CPT code 96202 (Multiple-family group behavior 
management/modification training for parent(s)/guardian(s)/caregiver(s) 
of patients with a mental or physical health diagnosis, administered by 
physician or other qualified health care professional (without the 
patient present), face-to-face with multiple sets of parent(s)/
guardian(s)/caregiver(s); initial 60 minutes) and CPT code 96203 
(Multiple-family group behavior management/modification training for 
parent(s)/guardian(s)/caregiver(s) of patients with a mental or 
physical health diagnosis, administered by physician or other qualified 
health care professional (without the patient present), face-to-face 
with multiple sets of parent(s)/guardian(s)/caregiver(s); each 
additional 15 minutes (List separately in addition to code for primary 
service)) that described group caregiver training services for patient 
behavior management/modification (without the patient in attendance). 
In CY 2023 we received AMA RUC recommendations for a family of three 
new caregiver training codes (CPT code 97550 (Caregiver training in 
strategies and techniques to facilitate the patient's functional 
performance in the home or community (e.g., activities of daily living 
[ADLs], instrumental ADLs [IADLs], transfers, mobility, communication, 
swallowing, feeding, problem solving, safety practices) (without the 
patient present), face-to-face; initial 30 minutes), and add-on code, 
CPT code 97551 (each additional 15 minutes (List separately in addition 
to code for primary service) (Use 97551 in conjunction with 97550)), 
and 97552 (Group caregiver training in strategies and techniques to 
facilitate the patient's functional performance in the home or

[[Page 78915]]

community (eg, activities of daily living [ADLs], instrumental ADLs 
[IADLs], transfers, mobility, communication, swallowing, feeding, 
problem solving, safety practices) (without the patient present), face-
to-face with multiple sets of caregivers). Historically, we have taken 
the position that codes describing services furnished to other 
individuals without the patient's presence are not covered services. As 
we noted in the CY 2023 PFS final rule (87 FR 69521), we have explained 
in previous rulemaking that we read section 1862(a)(1)(A) of the Act to 
limit Medicare coverage and payment to items and services that are 
reasonable and necessary for the diagnosis and treatment of an 
individual Medicare patient's illness or injury or that improve the 
functioning of an individual Medicare patient's malformed body member. 
For example, in the CY 2013 PFS final rule (77 FR 68979), when 
discussing payment for the non-face-to-face care management services 
that are part of E/M services, we stated that Medicare does not pay for 
services furnished to parties other than the patient. We listed, as an 
example, communication with caregivers. Because the codes for caregiver 
behavior management training described services furnished exclusively 
to caregivers rather than to the individual Medicare patient, we 
indicated that we did not review the RUC-recommended valuation of these 
codes or propose to establish RVUs for these codes for purposes of PFS 
payment. Although we did not establish payment for the new caregiver 
behavior management training codes in the CY 2023 PFS final rule, we 
indicated that there could be circumstances where separate payment for 
such services may be appropriate. We stated that we would continue to 
consider the status of these and similar services in rulemaking for CY 
2024 (87 FR 69522 through 69523). We specifically requested public 
comment on how a patient may benefit in medical circumstances when a 
caregiver is trained to effectively modify the patient's behavior, how 
current Medicare policies regarding these caregiver training services 
(CTS) can impact a patient's health, and how the services described by 
these codes might currently be bundled into existing Medicare-covered 
services. (87 FR 69521). Public comments were generally in favor of CMS 
making payment for these codes, stating that there is extensive 
empirical support for training parents/guardians/caregivers in behavior 
management/modification as a component of the standard of care for the 
treatment of certain social determinants of health (SDOH) behavior 
issues and that this training promotes improved outcomes. Commenters 
also noted that there are several CPT codes paid under the PFS that 
describe services that do not include direct contact with the patient 
but are still considered integral to the patient's care, including, for 
example, separately billable care management services, 
interprofessional consultations, and caregiver-focused health risk 
assessment instrument (eg, depression inventory) for the benefit of the 
patient. In response to public comments, we acknowledged the important 
role caregivers could have in a patient's overall care.
    As indicated in the CY 2023 PFS final rule, we have continued to 
consider whether the caregiver behavior management training and similar 
caregiver training services could be considered to fall within the 
scope of services that are reasonable and necessary under section 
1862(a)(1)(A) of the Act, in alignment with the principles of the 
recent Executive Order on Increasing Access to High-Quality Care and 
Supporting Caregivers (https://www.whitehouse.gov/briefing-room/presidential-actions/2023/04/18/executive-order-on-increasing-access-to-high-quality-care-and-supporting-caregivers/), and as part of a HHS 
level review of our payment policies to identify opportunities to 
better account for patient-centered care (https://acl.gov/programs/support-caregivers/raise-family-caregiving-advisory-council), changes 
in medical practice that have led to more care coordination and team-
based care, and to promote equitable access to reasonable and necessary 
medical services. We also believed it was important for practitioners 
furnishing patient-centered care to use various effective communication 
techniques when providing patient-centered care, in alignment with 
requirements under section 1557 of the Affordable Care Act. We stated 
that we believe that, in certain circumstances, caregivers can play a 
key role in developing and carrying out the treatment plan or, as 
applicable to physical, occupational, or speech-language therapy, the 
therapy plan of care (collectively referred to in this discussion as 
the ``treatment plan'') established for the patient by the treating 
practitioner (which for purposes of this discussion could include a 
physician; NPP such as a nurse practitioner, physician assistant, 
clinical nurse specialist, clinical psychologist; or a physical 
therapist, occupational therapist, or speech-language pathologist). In 
this context, we believed Caregiver Training Services (CTS) could be 
reasonable and necessary to treat the patient's illness or injury as 
required under section 1862 (a)(1)(A) of the Act. We had the 
opportunity to consider the best approach to establishing separate 
payment for the services described by the caregiver training codes, 
especially as it relates to a practitioner treating a patient and 
expending resources to train a caregiver who is assisting or acting as 
a proxy for the patient.
    For CY 2024, we proposed to establish an active payment status for 
CPT codes 96202 and 96203 (caregiver behavior management/modification 
training services) and CPT codes 97550, 97551, and 97552 (caregiver 
training services under a therapy plan of care established by a PT, OT, 
SLP). These codes allow treating practitioners to report the training 
furnished to a caregiver, in tandem with the diagnostic and treatment 
services furnished directly to the patient, in strategies and specific 
activities to assist the patient to carry out the treatment plan. We 
believed that CTS may be reasonable and necessary when they are 
integral to a patient's overall treatment and furnished after the 
treatment plan (or therapy plan of care) is established. The CTS 
themselves need to be congruent with the treatment plan and designed to 
effectuate the desired patient outcomes. We believe this is especially 
the case in medical treatment scenarios where assistance by the 
caregiver receiving the CTS is necessary to ensure a successful 
treatment outcome for the patient--for example, when the patient cannot 
follow through with the treatment plan for themselves.
    We solicited public comment on this definition of 'caregiver' for 
purposes of CTS and were interested if there were any additional 
elements of a caregiver that we considered incorporating in the 
proposed CTS caregiver definition. We believed that our definition 
would allow for holistic patient care with those who know and 
understand the patient, their condition, and their environment. We were 
interested in and solicited comment on how the clinician and caregiver 
interactions would typically occur, including when the practitioner is 
dealing with multiple caregivers and how often these services would be 
billed, considering the established treatment plan involving caregivers 
for the typical patient.
    We proposed that payment may be made for CTS when the treating 
practitioner identified a need to involve and train one or more 
caregivers to assist the patient in carrying out a patient-centered 
treatment plan. We further proposed that because CTS are furnished 
outside the patient's presence,

[[Page 78916]]

the treating practitioner must obtain the patient's (or 
representative's) consent for the caregiver to receive the CTS. We 
further proposed that the identified need for CTS and the patient's (or 
representative's) consent for one or more specific caregivers to 
receive CTS must be documented in the patient's medical record. In the 
following discussion, we detail the specific aspects of our proposal 
and the comments received.
    Comment: Most commenters supported the proposals. Many commenters 
detailed their experiences as caregivers, while others explained how 
CTS would have benefited them in the past. Some commenters also 
expressed support for CMS' recognition of the efforts of caregivers in 
effectuating the treatment of beneficiaries.
    Response: We thank commenters for their feedback and value 
commenters sharing their experiences on how Caregiver Training Services 
could be beneficial.
    Comment: Some commenters opposed our CTS proposals and stated that 
the proposed services are currently provided by organizations better 
equipped to provide CTS, such as home health agencies, home and 
community-based services, and non-profit organizations. Some commenters 
expressed concern about the efficacy of the services if the patient is 
not required to be present, while another commenter stated that there 
was insufficient scientific evidence proving that caregiver training 
improves patient outcomes. Additionally, one commenter was worried that 
CTS would cause medical care to be provided by caregivers as opposed to 
medical providers. Overall, many commenters who opposed CTS suggested 
direct payment be made to caregivers.
    Response: The CTS codes, developed through the AMA CPT Editorial 
Panel's process, describe training services furnished by a practitioner 
to effectuate the practitioner's treatment plan to improve treatment 
outcomes for a patient. We believe there are circumstances where 
involving the caregiver in the treating practitioner's treatment plan 
through CTS would improve outcomes for the patient. We also believe 
that the treating practitioner who develops the treatment plan is best 
situated to provide CTS to inform the caregiver on how to help 
effectuate the treatment plan they develop for the patient. The 
availability of these codes and the provision of these services should 
not prevent caregivers from seeking support, education, certifications, 
or assistance from other organizations. As with other established 
coding, we expect that the treating practitioner who furnishes and 
bills for CTS to furnish services as described by the codes. 
Additionally, we note that the codes specify that the patient is not 
present during the service. We believe this is in recognition that both 
the practitioner's and the caregiver's undivided attention should be 
focused on the training that is being furnished to help the caregiver 
carry out an established treatment plan. In response to comments about 
the effects on patient eligibility to receive care under other programs 
or by medical providers, we clarify that the provision of CTS to a 
patient's caregiver does not affect patient eligibility for other 
Medicare services when reasonable and necessary. We clarify for 
commenters that under the statute, Medicare makes payments under the 
PFS only to enrolled physicians and other practitioners, not to 
caregivers. We continue to believe that CTS services have their place 
in a reasonable and necessary treatment plan for some patients and can 
serve as an important supplement to other caregiver training and other 
resources that might be available.
    Comment: The majority of commenters supported our proposal to 
require the patient's (or representative's) consent for the caregiver 
to receive CTS. One commenter stated that the patient's consent for the 
initial plan of care is sufficient, so further consent is not needed 
for CTS. One commenter suggested using the terms ``informed consent'' 
or ``supported decision making'' instead of consent. Another commenter 
requested that in cases of an Alzheimer's or dementia diagnosis, 
patient consent be obtained early in diagnosis. A few commenters 
expressed that they did not want CTS to be required for the caregiver 
to participate in. One commenter was concerned about patient privacy if 
beneficiary consent was not required.
    Response: We proposed to specifically require the patient's (or 
their representative's) consent for CTS because, unlike most services, 
the patient would not be present for the service. We believed it would 
be important to make the patient aware, out of concern for patient 
privacy, that the service is furnished outside their presence and that 
any applicable cost-sharing would be their responsibility. We do not 
believe that the general consent to receive treatment would be 
sufficient to make a patient aware of the unique circumstances under 
which CTS are furnished. For these same reasons, we continue to believe 
it is appropriate to require a specific consent for CTS. We are using 
the term ``consent'' as opposed to other recommended terms to remain 
consistent across other codes with consent requirements across the PFS. 
In cases of an Alzheimer's or dementia diagnosis, we encourage 
providers to obtain consent from the patient or their representative 
for CTS as early as possible in the diagnosis. We want to emphasize 
that CTS are not required services but services that the treating 
practitioner may choose to furnish, with a patient's consent, in 
consideration of a patient's diagnosis. If caregivers do not want to 
participate in caregiver training, they are not required to do so. We 
are finalizing, as proposed, that the patient's (or representative's) 
consent is required for the caregiver to receive CTS and that the 
consent must be documented in the patient's medical record.
    Comment: Commenters requested more guidance regarding CTS, 
including specifically asking for descriptions of training sessions, 
the requirement of post-training resources, materials, or referrals to 
social agencies to be provided to caregivers, and for CTS to be 
culturally competent (including being provided in languages other than 
English and at varying literacy levels). Commenters also requested 
caregiver assessments to assess burden, capacity, and understanding. 
Commenters also suggested that CMS require quality standards for CTS 
and suggested teaching methods. Additionally, one commenter requested 
that documentation of the caregiver's contact information be required 
in the patient's health record. Many commenters also provided input 
about the settings in which CTS are provided, suggesting that CTS could 
be furnished inside the beneficiary's home, or current residence. 
Commenters requested that CTS be provided upon discharge from 
hospitals, skilled nursing facilities, or home health outpatient 
services. One commenter requested that CTS be included in the 
definition of primary care services for purposes of beneficiary 
assignment in the Medicare Shared Savings Program.
    Commenters also requested additional coding to describe CTS 
furnished, for example, when the patient is present for part of all of 
the training, to recognize reduced time thresholds, to allow auxiliary 
personnel to perform CTS, or when training is included for additional 
tasks. Commenters also requested that CTS be added to the Medicare 
telehealth services list.
    Response: We appreciate all the information and considerations 
included in these comments, which will inform any policy development 
for CTS

[[Page 78917]]

in future rulemaking. We will not be adding these codes to the 
telehealth list at this time. Additionally, concerns not addressed in 
this proposed rule, such as quality standards, teaching methods, and 
additional requirements may be considered for future rulemaking.
    In the CY 2024 PFS proposed rule, we proposed a definition of 
``caregiver'' for purposes of CTS and discussed the circumstances under 
which patients may benefit from care involving caregivers. We proposed 
that CTS may meet the conditions for Medicare payment when the treating 
practitioner identifies a need to involve and train caregivers to 
assist the patient in carrying out a treatment plan established by the 
treating practitioner. We also proposed values for each of the CTS 
codes.
(1) Definition of a Caregiver
    In the CY 2024 PFS proposed rule, we proposed to define 
``caregiver'' for purposes of CTS. We stated that in our ongoing 
education and outreach work on the use of caregivers in assisting 
patients, we have broadly defined a caregiver as a family member, 
friend, or neighbor who provides unpaid assistance to a person with a 
chronic illness or disabling condition (https://www.cms.gov/outreach-
and-education/outreach/partnerships/
caregiver#:~:text=Caregivers%20are%20broadly%20defined%20as,chronic%20il
lness%20or%20disabling%20condition). Further, in the context of our 
proposals for CTS, we believe a caregiver is an individual who is 
assisting or acting as a proxy for a patient with an illness or 
condition of short or long-term duration (not necessarily chronic or 
disabling); involved on an episodic, daily, or occasional basis in 
managing a patient's complex health care and assistive technology 
activities at home; and helping to navigate the patient's transitions 
between care settings. For purposes of CTS, we also include a guardian 
in this definition when warranted. For CTS, when we note ``caregiver,'' 
we are also referring to guardians who for purposes of CTS, are the 
caregiver for minor children or other individuals who are not legally 
independent. In these circumstances, a caregiver is a layperson 
assisting the patient in carrying out a treatment plan that was 
established for the patient by the treating physician or practitioner 
and assisted the patient with aspects of their care, including 
interventions or other activities directly related to a treatment plan 
established for the patient to address a diagnosed illness or injury. 
In this context, caregivers would be trained by the treating 
practitioner in strategies and specific activities that improve 
symptoms, functioning, and adherence to treatment related to the 
patient's primary clinical diagnoses. Caregiver understanding and 
competence in assisting and implementing these interventions and 
activities from the treating practitioner is critical for patients with 
functional limitations resulting from various conditions.
    The following is a summary of the comments we received and our 
responses.
    Comment: Many commenters did not favor the proposal to define 
caregiver for purposes of CTS to include only unpaid individuals, 
stating that this would unfairly exclude nursing aides, direct service 
professionals, or individuals paid directly by the beneficiary.
    An overwhelming number of commenters requested that CMS use the 
definition of ``family caregiver'' that was used in the Recognize, 
Assist, Include, Support, and Engage (RAISE) Family Caregivers Act 
(Pub. L. 115-119). The definition of family caregiver in the RAISE Act 
is ``an adult family member or other individual who has a significant 
relationship with, and who provides a broad range of assistance to, an 
individual with a chronic or other health condition, disability, or 
functional limitation.'' The RAISE Family Caregivers Act directs the 
Secretary of Health and Human Services to develop a national caregiving 
strategy to recognize and support family caregivers. Commenters 
requested the RAISE definition because it is more expansive and 
provides more detail about what a caregiver is than the CMS definition.
    Commenters also requested that we remove the terms ``layperson,'' 
``proxy'', and/or ``guardian'' from our definition. One commenter 
requested that we use the term ``care partner'' as opposed to 
``caregiver.'' Additionally, we note that commenters generally 
supported our proposal that CTS could be furnished to more than one 
caregiver representing the same beneficiary, as someone could have 
multiple caregivers, or the primary caregiver could change.
    Response: We agree that the definition of caregiver matters. For 
that reason, we agree with commenters that the definition of ``family 
caregiver'' used in the RAISE Family Caregivers Act does support our 
CTS proposal as an adult family member or other individual who has a 
significant relationship with, and who provides a broad range of 
assistance to, an individual with a chronic or other health condition, 
disability, or functional limitation. We will use the RAISE definition 
and the CMS Outreach and Education definition (a family member, friend, 
or neighbor who provides unpaid assistance to a person with a chronic 
illness or disabling condition). Since the definitions do not 
contradict each other, we will adopt both definitions of caregiver.
    We note that even as we refine our definition of caregiver, we 
maintain that the caregiver population receiving these services on 
behalf of the patient should not also receive concurrent CTS under 
another Medicare benefit category or Federal program (88 FR 52323).
    After considering the public comments, we are finalizing a revised 
definition of caregiver to be ``an adult family member or other 
individual who has a significant relationship with, and who provides a 
broad range of assistance to, an individual with a chronic or other 
health condition, disability, or functional limitation'' and ``a family 
member, friend, or neighbor who provides unpaid assistance to a person 
with a chronic illness or disabling condition''.
(2) Patients Who Benefit From Care Involving Caregivers
    In the proposed rule, we discussed our expectation that a patient-
centered treatment plan should appropriately account for clinical 
circumstances where the treating practitioner believes a caregiver's 
involvement is necessary to ensure a successful outcome for the patient 
and where, as appropriate, the patient agrees to caregiver involvement. 
There may be clinical circumstances when it might be appropriate for 
the physician or practitioner to directly involve the caregiver in 
developing and carrying out a treatment plan. Such clinical cases could 
include various physical and behavioral health conditions and 
circumstances under which CTS may be reasonable and necessary to train 
a caregiver who assists in carrying out a treatment plan. Conditions 
include, but are not limited to, stroke, traumatic brain injury (TBI), 
various forms of dementia, autism spectrum disorders, individuals with 
other intellectual or cognitive disabilities, physical mobility 
limitations, or necessary use of assisted devices or mobility aids. The 
previously mentioned clinical scenarios are circumstances under which 
CTS may be reasonable and necessary to train a caregiver who assists in 
carrying out a treatment plan. For example, patients with dementia, 
autism spectrum disorder, or individuals with other intellectual or 
cognitive disabilities may

[[Page 78918]]

require assistance with challenging behaviors to carry out a treatment 
plan, patients with mobility issues may need help with safe transfers 
in the home to avoid post-operative complications, patients with 
persistent delirium may require guidance with medication management, 
patients with certain degenerative conditions or those recovering from 
stroke may need assistance with feeding or swallowing. Separate from 
medical circumstances noted previously, we also seek to avoid 
potentially duplicative payment. We would not expect the caregiver 
population receiving these services on behalf of the patient to also 
receive CTS on behalf of the patient under another Medicare benefit 
category or Federal program. Also, we note that when Medicare and 
Medicaid cover the same services for patients eligible for both 
programs, Medicare generally is the primary payer in accordance with 
section 1902(a)(25) of the Act. Based on the specificity of the coding 
for our proposal, we do not expect that CTS will neatly overlap with 
any other coverage for patients who are dually eligible for Medicare 
and Medicaid. However, we solicited public comment regarding whether 
States typically cover services similar to CTS under their Medicaid 
programs, and whether such coverage would be duplicative of the CTS 
codes. We solicited comment on this issue and whether payment is 
currently available for CTS through other Federal or other programs.
    The following is a summary of the comments we received and our 
responses.
    Comment: Many commenters suggested various physical and behavioral 
health conditions and circumstances under which CTS may be reasonable 
and necessary to train a caregiver who assists in carrying out a 
treatment plan. The examples provided include traumatic injury, use of 
mobility devices, cell therapy, stem cell transplants, cancer, ESRD, 
lymphedema, rare diseases, and/or chronic conditions.
    Additionally, many commenters detailed how these services could 
overlap with State-funded Medicaid consumer-directed programs and 
sometimes with our Innovation Center model tests. These commenters also 
noted that due to variations in Medicaid and other State programs, 
overlap in payment may be difficult to identify.
    Response: The examples we provided in the proposed rule of physical 
and behavioral health conditions for which CTS might be appropriate 
were not intended to be exhaustive. We acknowledge that there are many 
circumstances under which CTS may be reasonable and necessary to train 
a caregiver who assists in carrying out a treatment plan. Also, we do 
not believe participation in Medicaid consumer-directed programs for 
dually eligible beneficiaries, or our demonstration models would be 
duplicative of the CTS codes, given how the services are designed and 
how the consumer-directed programs work. Through the CTS codes, 
Medicare will pay the treating practitioner to train caregivers. 
Currently, this is not duplicative of the Medicaid consumer- directed 
programs due to the limited scope of the CTS. Further, when designing 
Innovation Center models, we include overlap policies, billing 
policies, and other model parameters that are specifically designed to 
avoid duplication.
(3) Reasonable and Necessary CTS
    In the CY 2024 PFS proposed rule, we proposed that CTS could be 
reasonable and necessary when furnished based on an established 
individualized, patient-centered treatment plan or therapy plan of care 
accounting for the patient's specific medical needs.
    As provided in the code descriptors, treating practitioners may 
train caregivers in a group setting with other caregivers involved in 
care for patients with similar needs for assistance to carry out a 
treatment plan. Training for all the caregivers for the patient could 
occur simultaneously, and the applicable CTS codes (CPT code 96202, 
96203, and 97552) would be billed once per beneficiary. We solicited 
comment on this issue. We also inquired about whether payment is 
currently available for CTS through other Federal or other programs. We 
considered whether CTS would be reasonable and necessary when furnished 
to caregivers in more than one single session, or to (presumably the 
same) caregivers by the same practitioner for the same patient more 
than once per year and solicited comment on this. We want to note that 
the treating physician or NPP may provide training to more than one 
caregiver for a single patient.
    The following is a summary of the comments we received and our 
responses.
    Comment: The majority of commenters stated that CTS would be 
reasonable and necessary, when furnished to (presumably the same) 
caregivers (by the same practitioner for the same patient) in more than 
one single session, more than once per year. Many commenters requested 
that payment be made per caregiver, not per beneficiary. A few 
commenters requested that CTS be limited to practitioners who have a 
longitudinal relationship with the patient.
    Response: We agree that the number of CTS sessions furnished to 
caregivers, by the same practitioner and for the same patient, may be 
based on the treatment plan, as well as changes in patient condition, 
the treatment plan, the patient's diagnosis, or the patient's 
caregivers. In other words, the medical necessity of CTS for the 
patient should determine the volume and frequency of the training. CTS 
could be considered reasonable and necessary when the treating 
practitioner determines a caregiver needs more training to ensure a 
successful patient treatment plan outcome. We require the treating 
practitioner to document the need for each occurrence of CTS in the 
medical record.
    To bill for CTS, practitioners should select the appropriate group 
code (CPT code 96202, 96203, or 97552) if more than one caregiver is 
trained at the same time, or individual code (CPT code 97550, 97551) if 
one individual caregiver is trained. If caregivers are trained in a 
group, practitioners would not bill individually for each caregiver. 
More than one caregiver trained at the same time must be billed under 
the group code, as the treating practitioner's time and effort should 
not be counted multiple times.
    After consideration of the public comments, for CY 2024, we are 
finalizing our proposal for CTS with the following clarifications: the 
volume and frequency of CTS sessions furnished to caregivers by the 
treating practitioner for the same patient may be based on the 
treatment plan, as well as changes in patient condition, the treatment 
plan, the patient's diagnosis, or the patient's caregivers.
(4) Service Coding and Valuation
    Behavior management/modification training for guardians/caregivers 
of patients with a mental or physical health diagnosis (CPT Codes 96202 
and 96203)
a. Coding
    CPT code 96202 (Multiple-family group behavior management/
modification training for parent(s)/guardian(s)/caregiver(s) of 
patients with a mental or physical health diagnosis, administered by 
physician or other qualified health care professional (without the 
patient present), face-to-face with multiple sets of parent(s)/
guardian(s)/caregiver(s); initial 60 minutes) and its add-on code, CPT 
code 96203 (Multiple-family group behavior management/modification 
training for parent(s)/guardian(s)/caregiver(s) of

[[Page 78919]]

patients with a mental or physical health diagnosis, administered by 
physician or other qualified health care professional (without the 
patient present), face-to-face with multiple sets of parent(s)/
guardian(s)/caregiver(s); each additional 15 minutes (List separately 
in addition to code for primary service)), were two new codes created 
by the CPT Editorial Panel during its February 2021 meeting. The two 
codes are to be used to report the total duration of face-to-face time 
spent by the physician or other qualified health professional providing 
group behavior management/modification training to guardians or 
caregivers of patients. Although the patient does not attend the group 
trainings, the goals and outcomes of the sessions focus on 
interventions aimed at effectuating the practitioner's treatment plan 
through addressing challenging behaviors and other behaviors that may 
pose a risk to the person, and/or others. According to the Summary of 
Recommendations (which was submitted by the AMA RUC with the valuation 
of this code), during the face-to-face service time, caregivers are 
taught how to structure the patient's environment to support and 
reinforce desired patient behaviors, to reduce the negative impacts of 
the patient's diagnosis on patient's daily life, and to develop highly 
structured technical skills to manage the patient's challenging 
behavior.
    Behavior management/modification training for guardians/caregivers 
of patients with a mental or physical health diagnosis should be 
directly relevant to the person-centered treatment plan for the patient 
in order for the services to be considered reasonable and necessary 
under the Medicare program. Each behavior should be clearly identified 
and documented in the treatment plan, and the caregiver should be 
trained in positive behavior management strategies.
b. Valuation
    The RUC recommended the survey median work value for both CPT codes 
96202 and 96203. Three specialty societies sent surveys to a random 
sample of a subset of their members. Based on survey results and after 
discussion, the RUC recommended a work RVU of 0.43 for a specific 
patient who was represented in the group session being billed for CPT 
code 96202. The RUC noted that this recommendation was based upon a 
median group size of six caregivers and includes 10 minutes pre-time, 
60 minutes intra-time, and 20 minutes post-time for a total time of 90 
minutes. For CPT code 96203, the 15-minute add on code, the RUC 
recommended a work RVU of 0.12, which was also based upon a median 
group size of six. We proposed the RUC-recommended work RVU of 0.43 for 
CPT code 96202 and the RUC-recommended work RVU of 0.12 for CPT code 
96203. We also proposed the RUC-recommended direct PE inputs for these 
codes. We proposed requiring the full 60 minutes of time to be 
performed to report CPT code 96202. The add on code, CPT code 96203, 
may be reported once 75 minutes of total time is performed.
    Finally, we note that the RUC recommendation included information 
suggesting that the RUC intends to review the valuation of these 
services again soon.
    Comment: Commenters were generally supportive of the proposed 
valuations for these codes. A few commenters suggested that higher 
valuations would more accurately reflect the time and intensity of 
services provided. These commenters expressed concerns that the 
proposed values do not reflect the significant amount of planning and 
effort required by the practitioner who furnishes these services, and 
that undervaluation of CTS could lead to underutilization or access 
issues for patients who would benefit from these services.
    Response: We believe that the RUC-recommended valuations that we 
have proposed to adopt reflect the typical inputs for the service. The 
RUC's recommendations were based on extensive surveys with 
psychologists, child and adolescent psychiatrists, and dieticians, and 
represent the best information that we have at present for these new 
codes. Additionally, the Caregiver Training Services CPT codes fall 
appropriately between the key reference services used by the RUC to 
compare the work RVU, total time, and related intensity of each 
service. We believe that this supports the recommended values as 
maintaining relativity with other similar services already listed on 
the PFS.
    After consideration of the public comments, we are finalizing our 
proposed work RVUs and direct PE inputs for CPT codes 96202 and 96203.
    Caregiver training in strategies and techniques to facilitate the 
patient's functional performance (CPT codes 97550, 97551, and 97552)
(a) Coding
    CPT codes 97550 (Caregiver training in strategies and techniques to 
facilitate the patient's functional performance in the home or 
community (e.g., activities of daily living [ADLs], instrumental ADLs 
[IADLs], transfers, mobility, communication, swallowing, feeding, 
problem solving, safety practices) (without the patient present), face-
to-face; initial 30 minutes), and add-on code, CPT code 97551 (each 
additional 15 minutes (List separately in addition to code for primary 
service) (Use 97551 in conjunction with 97550)), and 97552 (Group 
caregiver training in strategies and techniques to facilitate the 
patient's functional performance in the home or community (e.g., 
activities of daily living [ADLs], instrumental ADLs [IADLs], 
transfers, mobility, communication, swallowing, feeding, problem 
solving, safety practices) (without the patient present), face-to-face 
with multiple sets of caregivers) were new codes created by the CPT 
Editorial Panel during its October 2022 meeting. The three codes are to 
be used to report the total duration of face-to-face time spent by the 
physician or other qualified health professional providing individual 
or group training to caregivers of patients. Although the patient does 
not attend the trainings, the goals and outcomes of the sessions focus 
on interventions aimed at improving the patient's ability to 
successfully perform activities of daily living (ADL's). Activities of 
daily living generally include ambulating, feeding, dressing, personal 
hygiene, continence, and toileting.
    During the face-to-face service time, caregivers are taught by the 
treating practitioner how to facilitate the patient's activities of 
daily living, transfers, mobility, communication, and problem-solving 
to reduce the negative impacts of the patient's diagnosis on the 
patient's daily life and assist the patient in carrying out a treatment 
plan. These specific services are reasonable and necessary when 
treating practitioners identify a need to involve and train caregivers 
to assist the patient in carrying out a treatment plan. As part of an 
individualized plan of care, the caregiver is trained in skills to 
assist the patient in completing daily life activities. These trainings 
to the caregiver include the development of skills such as safe 
activity completion, problem solving, environmental adaptation, 
training in the use of equipment or assistive devices, or interventions 
focusing on motor, process, and communication skills.
(b) Valuation
    The RUC recommended work values for CPT codes 97550, 97551, and 
97552 based on the survey median values and the key reference CPT codes 
97535 and 97130. The surveyed codes fall appropriately between these 
key reference services compared to the work

[[Page 78920]]

RVU, total time, and related intensity of each service. Three specialty 
societies sent surveys to a random sample of a subset of their members. 
Based upon survey results and after discussion, the RUC recommended a 
work RVU 1.00 for CPT code 97550, a work RVU of 0.54 for 97551, and a 
work RVU of 0.23 per specific patient represented in the group service 
being billed for CPT code 97552.
    We proposed the RUC-recommended work RVU 1.00 for CPT code 97550, 
the RUC-recommended work RVU of 0.54 for CPT code 97551, and the RUC-
recommended work RVU of 0.23 per identified patient service for CPT 
code 97552. The RUC noted that the recommendation for 97552 is based on 
a median group size of five caregivers. We also proposed the RUC-
recommended direct PE inputs for these codes.
    Finally, we noted that the RUC recommendation included information 
suggesting that the RUC intends to review the valuation of these 
services again soon. We proposed to designate 97550, 97551, and 97552 
as ``sometimes therapy'' services. This means that the services 
described by these codes are always furnished under a therapy plan of 
care when provided by PTs, OTs, and SLPs; but, in cases where they are 
appropriately furnished by physicians and NPPs outside a therapy plan 
of care, that is, where the services are not integral to a therapy plan 
of care, they can be furnished under a treatment plan by physicians and 
NPPs.
    Comment: Commenters were generally supportive of the valuations of 
these codes. A few commenters expressed concerns that the proposed 
values do not reflect the significant amount of planning and effort 
required by the practitioner who furnishes these services, and that 
undervaluation of CTS could lead to underutilization or access issues 
for patients who would benefit from these services. Commenters were 
also supportive of CMS designating CPT codes 97550, 97551, and 97552 as 
``sometimes therapy'' services.
    Response: We believe that the RUC-recommended valuations that we 
proposed reflect the typical inputs for the service. The RUC's 
recommendations were based on extensive surveys with occupational 
therapists, physical therapists, and speech language pathologists, and 
represent the best information that we have at present for these new 
codes. Additionally, the Caregiver Training Services CPT codes fall 
appropriately between the key reference services used by the RUC to 
compare the work RVU, total time, and related intensity of each 
service. We believe that this supports the recommended values as 
maintaining relativity with other similar services already listed on 
the PFS. We also understand that the RUC may intend to review the 
valuation of these services again soon--we will take potential updates 
from the RUC into consideration in the future.
    After consideration of the public comments, we are finalizing our 
proposed work RVUs and direct PE inputs for CPT codes 97550, 97551, and 
97552. We are also finalizing the designation of CPT codes 97550, 
97551, and 97552 as ``sometimes therapy'' services.
(28) Services Addressing Health-Related Social Needs (Community Health 
Integration Services, Social Determinants of Health Risk Assessment, 
and Principal Illness Navigation Services)
a. Background
    In recent years, we have sought to recognize significant changes in 
health care practice and have been engaged in an ongoing, incremental 
effort to identify gaps in appropriate coding and payment for care 
management/coordination and primary care services under the PFS. See, 
for example, our CY 2013, 2015, and 2017 PFS final rules, where we 
finalized new coding to provide separate payment for transitional care 
management services, chronic care management services, and behavioral 
health care management services to improve payment accuracy to better 
recognize resources involved in care management and coordination for 
certain patient populations (77 FR 68978, 79 FR 67715 and 82 FR 53163, 
respectively). To improve payment accuracy, we are exploring ways to 
better identify and value practitioners' work when they incur 
additional time and resources helping patients with serious illnesses 
navigate the healthcare system or removing health-related social 
barriers interfering with the practitioner's ability to execute a 
medically necessary plan of care. Practitioners and their staff of 
auxiliary personnel sometimes obtain information about and help address 
social determinants of health (SDOH) that significantly impact the 
practitioner's ability to diagnose or treat a patient. Additionally, 
practitioners and their staff of auxiliary personnel sometimes help 
newly diagnosed cancer patients and other patients with similarly 
serious, high-risk illnesses navigate their care, such as helping them 
understand and implement the plan of care and locate and reach the 
right practitioners and providers to access recommended treatments and 
diagnostic services, taking into account the personal circumstances of 
each patient. Payment for these activities, to the extent they are 
reasonable and necessary for the diagnosis and treatment of the 
patient's illness or injury, is currently included in payment for other 
services such as evaluation and management (E/M) visits and some care 
management services. Medical practice has evolved to increasingly 
recognize the importance of these activities, and we believe 
practitioners are performing them more often. However, this work is not 
explicitly identified in current coding, so we believe it is 
underutilized and undervalued. Accordingly, we proposed to create new 
coding to expressly identify and value these services for PFS payment, 
and distinguish them from current care management services. We expect 
that our new codes would also support the CMS pillars \9\ for equity, 
inclusion, and access to care for the Medicare population and improve 
patient outcomes, including for underserved and low-income populations 
where there is a disparity in access to quality care. They would also 
support the White House's National Strategy on Hunger, Nutrition and 
Health, and the White House's Cancer Moonshot Initiative.\10\
---------------------------------------------------------------------------

    \9\ CMS Strategic Plan [verbar] CMS.
    \10\ White-House-National-Strategy-on-Hunger-Nutrition-and-
Health-FINAL.pdf (whitehouse.gov); Fact Sheet: President Biden 
Reignites Cancer Moonshot to End Cancer as We Know It [verbar] The 
White House https://www.whitehouse.gov/briefing-room/statements-releases/2022/02/02/fact-sheet-president-biden-reignites-cancer-moonshot-to-end-cancer-as-we-know-it/.
---------------------------------------------------------------------------

    As part of this effort, in the CY 2023 PFS final rule (87 FR 69551 
through 69551), we issued a Request for Information (RFI) related to 
Medicare Part B Payment for services involving community health workers 
(CHWs). For CY 2024, we considered how we could better recognize, 
through coding and payment policies, when members of an 
interdisciplinary team, including CHWs, are involved in treatment of 
Medicare beneficiaries. Currently, no separately enumerated statutory 
Medicare benefit category provides direct payment to CHWs for their 
services. Additionally, current HCPCS coding does not specifically 
identify services provided by CHWs, even though CHWs may facilitate 
access to healthcare through community-based services that are 
necessary to alleviate barriers to care that are interfering with a 
practitioner's ability to diagnosis or treat an illness or injury. In 
rulemaking for the CY 2023 PFS, to gain a broader perspective on

[[Page 78921]]

CHWs and how we could refine our coding and payment policies to better 
recognize their role in furnishing Medicare-covered services, we 
solicited comment through an RFI on how services involving CHWs are 
furnished in association with the specific Medicare benefits 
established by the statute.
    Commenters were supportive overall of potential, separate coding 
and payment for services involving CHWs. The public comments indicated 
that many physicians, practitioners, group practices, and other 
entities currently utilize the services of CHWs to bridge gaps in the 
continuum of their medical and behavioral healthcare furnished to 
Medicare patients. In public comments on our RFI, interested parties 
provided testimonials and evidence about the effectiveness of CHWs and 
the services they provide to patients in the community by monitoring, 
interpreting, clarifying, and supporting the plans of care that 
physicians and practitioners establish for delivering care to patients.
    In addition, in 2021, the AMA CPT Editorial Panel recognized in the 
CPT E/M Guidelines that SDOH needs can increase complexity of a 
practitioner's medical decision making (MDM) for an E/M visit and 
increase risk to the patient, when diagnosis or treatment is 
significantly limited by SDOH.\11\ Specifically, the CPT Editorial 
Panel included as an example of moderate level MDM for E/M visit coding 
and level selection, a situation where diagnosis or treatment is 
significantly limited by SDOH. This situation is listed as an example 
of moderate risk of morbidity from additional diagnostic testing or 
treatment. The CPT E/M Guidelines defined SDOH as, ``Economic and 
social conditions that influence the health of people and communities. 
Examples may include food or housing insecurity.'' \12\ We adopted 
these revised CPT guidelines for MDM in E/M visits through notice and 
comment rulemaking, effective January 1, 2021 (84 FR 62844 through 
62860, 87 FR 69587 through 69614).
---------------------------------------------------------------------------

    \11\ 2021 CPT Codebook, p. 16.
    \12\ 2021 CPT Codebook, p. 14.
---------------------------------------------------------------------------

    Physicians and NPPs are generally trained to obtain a patient's 
social and family history, in support of patient-centered care, to aid 
in diagnosis, and to better understand and help address problem(s) 
addressed in a medical visit and associated risk factors.\13\ For 
example, a practitioner who discovers that a patient's living situation 
does not permit reliable access to electricity may need to prescribe an 
inhaler rather than a power-operated nebulizer to treat asthma. Some 
practices and facilities employ social workers or other ancillary staff 
to help address SDOH needs that impact the ability to provide medically 
necessary care, such as appropriate treatment or diagnostic services 
after an office visit or discharge from a facility.
---------------------------------------------------------------------------

    \13\ See for example Patient-Centered Communication: Basic 
Skills [verbar] AAFP; https://www.aafp.org/about/policies/all/social-determinants-health-family-medicine-position-paper.html; 
https://doi.org/10.7326/M17-2441; .https://nam.edu/social-determinants-of-health-201-for-health-care-plan-do-study-act/; 
https://www.ama-assn.org/system/files/2021-05/ama-equity-strategic-plan.pdf; https://edhub.ama-assn.org/steps-forward/module/2702762. 
The Origins of the History and Physical Examination--Clinical 
Methods--NCBI Bookshelf (nih.gov) https://www.ncbi.nlm.nih.gov/books/NBK458/.
---------------------------------------------------------------------------

    Practitioners are increasingly expending resources to obtain 
information from the patient about SDOH and risks and formulate 
diagnosis and treatment plans that consider these needs. We believe 
that social workers, CHWs, and other auxiliary personnel are currently 
performing some of these activities and that the resources involved in 
these activities are not consistently appropriately reflected in 
current coding and payment policies. As such, we believe it would be 
appropriate to create codes to separately identify and more accurately 
value this work. Accordingly, we proposed new coding to describe and 
separately value three types of services that may be provided by 
auxiliary personnel incident to the billing physician or practitioner's 
professional services, and under the billing practitioner's 
supervision, when reasonable and necessary to diagnose and treat the 
patient: community health integration services, SDOH risk assessment, 
and principal illness navigation. In our proposed rule, we discussed 
the proposed codes and their valuation. We described the circumstances 
under which we believe these services may be reasonable and necessary 
for the diagnosis or treatment of illness or injury such that Medicare 
payment may be made for them.
b. Community Heath Integration (CHI) Services
    In light of the feedback we received from our RFI regarding CHWs, 
and increased recognition within the medical community of the role that 
social needs can play in patients' health (specifically, interfering 
with ability to diagnose and treat patients), we proposed to establish 
separate coding and payment for community health integration (CHI) 
services. We proposed to create two new G codes describing CHI services 
performed by certified or trained auxiliary personnel, which may 
include a CHW, incident to the professional services, and under the 
general supervision of the billing practitioner. We proposed that CHI 
services could be furnished monthly, as medically necessary, following 
an initiating E/M visit (CHI initiating visit) in which the 
practitioner identifies the presence of SDOH need(s) that significantly 
limit the practitioner's ability to diagnose or treat the problem(s) 
addressed in the visit.
    We proposed that the CHI initiating visit would be an E/M visit 
(other than a low-level E/M visit that can be performed by clinical 
staff) performed by the billing practitioner, who would also be 
furnishing the CHI services during the subsequent calendar month(s). 
The CHI initiating visit would be separately billed (if all 
requirements to do so are met), and would be a pre-requisite to billing 
for CHI services. We stated that certain types of E/M visits, such as 
inpatient/observation visits, ED visits, and SNF visits, would not 
typically serve as CHI initiating visits because the practitioners 
furnishing the E/M services in those settings would not typically be 
the ones to provide continuing care to the patient, including 
furnishing necessary CHI services in the subsequent month(s).
    The CHI initiating visit would serve as a pre-requisite to billing 
for CHI services, during which the billing practitioner would assess 
and identify SDOH needs that significantly limit the practitioner's 
ability to diagnose or treat the patient's medical condition and 
establish an appropriate treatment plan. The subsequent CHI services 
would be performed by a CHW or other auxiliary personnel incident to 
the professional services of the practitioner who bills the CHI 
initiating visit. The same practitioner would furnish and bill for both 
the CHI initiating visit and the CHI services, and CHI services must be 
furnished in accordance with the ``incident to'' regulation at Sec.  
410.26. We would not require an initiating E/M visit every month that 
CHI services are billed, but only before commencing CHI services, to 
establish the treatment plan, specify how addressing the unmet SDOH 
need(s) would help accomplish that plan, and establish the CHI services 
as incident to the billing practitioner's service. This framework is 
similar to our current requirements for billing care management 
services, such as chronic care management services. It also comports 
with our longstanding policy in the Medicare Benefit Policy Manual, 
which provides, ``where a physician supervises auxiliary personnel to 
assist them in rendering services to patients

[[Page 78922]]

and includes the charges for their services in their bills, the 
services of such personnel are considered incident to the physician's 
service if there is a physician's service rendered to which the 
services of such personnel are an incidental part. This does not mean, 
however, that to be considered incident to, each occasion of service by 
auxiliary personnel (or the furnishing of a supply) need also always be 
the occasion of the actual rendition of a personal, professional 
service by the physician. Such a service or supply could be considered 
to be incident to when furnished during a course of treatment where the 
physician performs an initial service and subsequent services of a 
frequency which reflect their active participation in and management of 
the course of treatment'' (Chapter 15, Section 60.1.B of the Medicare 
Benefit Policy Manual (Pub. 100-02), available on our website at 
https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/bp102c15.pdf (cms.gov)).
    We also solicited comment on whether we should consider any 
professional services other than an E/M visit performed by the billing 
practitioner as the prerequisite initiating visit for CHI services, 
including, for example, an annual wellness visit (AWV) that may or may 
not include the optional SDOH risk assessment. Under section 
1861(hhh)(3)(C) of the Act, the AWV can be furnished by a physician or 
practitioner or by other types of health professionals whose scope of 
practice does not include the diagnosis and treatment involved in E/M 
services, for example, a health educator. When the AWV is furnished by 
other types of health professionals, it is not necessarily furnished 
incident to the professional services of a physician or other 
practitioner. Therefore, if we allowed an AWV to be furnished by a 
health care practitioner other than a physician or practitioner to 
serve as the initiating visit for CHI services, the CHI services would 
not necessarily be furnished consistent with our proposed application 
of the ``incident to'' regulations as a condition of payment. Further, 
we believe that practitioners would normally bill an E/M visit in 
addition to the AWV when medical problems are addressed in the course 
of an AWV encounter, in accordance with our manual policy providing 
that a medically necessary E/M visit may be billed when furnished on 
the same occasion as an AWV in those circumstances (Chapter 12, Section 
30.6.1.1.H of the Medicare Claims Processing Manual (Pub, 100-04).
    The following is a summary of the comments we received and our 
responses.
    Comment: Commenters were generally supportive of our proposal to 
establish CHI services, including allowing monthly furnishing of CHI 
services, as medically necessary, following an initiating E/M visit 
(CHI initiating visit).
    Response: We thank the commenters for their feedback.
    Comment: One commenter disagreed with the proposal to create new G 
codes for CHI services and stated these codes may be duplicative of 
both work and practice expenses already accounted for in existing CPT 
codes. The commenter noted that the CPT Editorial Panel revised the E/M 
visit coding and level selection to include an example of moderate 
level medical decision making (MDM), accounting for clinical scenarios 
when SDOH significantly limits diagnosis or treatment.
    Response: We thank the commenter for noting the changes made by 
CPT. However, we believe the new G codes will describe and account for 
integrated services supported by certified or trained auxiliary 
personnel, including CHWs, who will assist the practitioner in 
connecting the patient with helpful resources. This is separate from 
the work being furnished as part of the medical decision-making in an 
E/M visit and want to reiterate that CHI services are separate and 
different from an E/M service. These new services, further described in 
the code descriptors below, consist of activities to address social 
determinants of health (SDOH) need(s) that are significantly limiting 
the practitioner's ability to diagnose or treat problem(s) addressed in 
an initiating CHI visit. These services include a person-centered 
assessment, practitioner, home-, and community-based care coordination, 
health education, building patient self-advocacy skills, health care 
access/health system navigation, facilitating and providing social and 
emotional support, and leveraging lived experience when applicable. We 
recognize that CPT recently revised its evaluation and management (E/M) 
code set to include language that pertains to diagnosis or treatment 
significantly limited by social determinants of health as an element of 
medical decision making, however the CHI services to address the SDOH 
limitations are not captured in the revised E/M codes. It is for this 
reason that we proposed new coding to account for the services that are 
not accounted for in the E/M code set. We believe the services 
described by the CHI codes will help to resolve the patient's health 
related social needs that are impacting their care and the 
practitioner's ability to properly diagnose and treat the patient.
    Comment: A few commenters requested that CMS clarify whether these 
services can be billed at safety-net clinics in academic medical 
centers. Commenters also raised concerns that academic medical centers 
and other facility-based providers could not furnish the services, 
given the reliance on incident to billing. Commenters requested that 
CMS clarify how such facilities may furnish these services to ensure 
that patients can benefit from the services regardless of where they 
receive their care.
    Response: We thank the commenters for their feedback and 
acknowledge that there are aspects of the policy that we must consider 
further for possible future rulemaking. As proposed, these services can 
only be furnished and billed by physicians and practitioners who can 
bill for services performed by auxiliary personnel incident to their 
professional services.
    Comment: Some commenters sought clarification on whether the full 
range of qualified health professionals permitted to bill E/M codes 
would also be permitted to bill HCPCS code G0019.
    Response: Our final policy requires the individual billing for the 
initiating visit to be the same as the practitioner billing for CHI. In 
order to bill for these services, practitioners must have a statutory 
benefit and be able to enroll and bill Medicare as they would for other 
services on the fee schedule and specifically be able to bill an E/M 
service that would serve as the initiating visit.
    Comment: Some commenters requested CMS allow CHWs to enroll in 
Medicare as a type of practitioner that can bill directly and be paid 
for their services, and that CBOs be able to bill Medicare directly for 
the CHI services if they have a NPI number.
    Response: There is no statutory benefit category that would allow 
CBOs to bill the PFS directly. Therefore, we are not finalizing such a 
policy.
    Comment: One commenter stated that CMS does not have the statutory 
authority to implement separate payment for CHW services as a new 
benefit category. Other commenters requested that CMS seek authority 
and funding from Congress before establishing a new Medicare social 
services benefit category.
    Response: We note that CHI services will be furnished and billed 
incident to the professional services of the billing practitioner. As 
such, only physicians and other types of practitioners that are

[[Page 78923]]

authorized by statute to enroll and bill the PFS directly will be 
included among those who can bill for CHI services. We clarify that our 
final policy will not create a new Medicare benefit category but 
instead allow CHI services to be furnished incident to the professional 
services of a billing practitioner. When diagnosis or treatment of a 
patient's medical condition is significantly limited by social 
determinants of health, we believe that these services are within the 
scope of medically necessary physicians' services, and that payment for 
them is permitted when the services are reasonable and necessary under 
section 1862(a)(1)(A) of the Act. We clarify that CHI services are 
consistent with the ``incident to physicians' services'' benefit 
category under section 1861(s)(2)(A) of the Act.
    Comment: Some commenters expressed concern with the CHI initiating 
visit being limited only to E/M visits and asserted that doing so would 
restrict access to the service as proposed. Commenters requested that 
the following services that are not E/M visits, be allowed to serve as 
an initiating visit: AWV, CPT codes 90791 (Psychiatric diagnostic 
evaluation) and 96156 ((Health behavior assessment, or re-assessment 
(i.e., health-focused clinical interview, behavioral observations, 
clinical decision making))
    Response: Regarding whether the CHI initiating visit can be an AWV, 
we solicited comment on this topic and having considered the public 
comments, we are finalizing that the AWV can be a CHI initiating visit 
when the furnishing practitioner identifies an unmet SDOH need that 
will prevent the patient from carrying out the recommended personalized 
prevention plan. We believe that, in these cases, it could be 
reasonable and necessary for the practitioner furnishing the AWV to 
furnish CHI services. There may be instances where the identification 
of SDOH needs through an SDOH risk assessment conducted with the AWV 
could identify and produce the conditions for reasonable and necessary 
CHI services, for example, when the practitioner furnishing the AWV is 
assuming ongoing ``longitudinal'' care for the patient. However, when 
the AWV is provided by a type of health care professional who does not 
have an ``incident to'' benefit for their services under the Medicare 
program, including, for example, a health educator, a registered 
dietitian, or nutrition professional, the AWV would not serve as an 
initiating visit for CHI because the furnishing professional could not 
then furnish and bill for CHI services incident to their professional 
services. Even if we allow AWV to be the initiating visit, the AWV 
would still need to be furnished by a physician or practitioner, 
consistent with the incident to rules so that services for CHI can be 
billed by a practitioner incident to their own professional services.
    We continue to believe that when an AWV involves diagnosis or 
treatment of injury or illness to the degree that would warrant 
subsequent furnishing and billing of CHI to remove barriers 
significantly limiting the treatment plan, in most cases, an E/M visit 
would be separately billed.
    While we considered adding services provided by clinical 
psychologists, specifically CPT codes 90791 and 96156 to the list of 
services that could serve as an initiating visit for CHI services based 
on feedback received from commenters, we are not including these 
services as services that can serve as an initiating visit for CHI. We 
believe that these services would be better captured under the PIN 
services discussed below and would better serve the needs being 
addressed with the PIN service elements. However, we will continue to 
analyze the uptake of CHI services and will consider these comments for 
future rulemaking.
    Comment: Commenters wanted CMS to allow emergency department E/M 
visits, inpatient/observation E/M visits, and transitional care 
management services to serve as initiating visits for CHI.
    Response: In response to the commenters, we note that inpatient/
observation visits and ED visits could not serve as CHI initiating 
visits, as conceptualized in this final rule and the proposed rule, 
because the practitioners furnishing the E/M services in those settings 
would not typically provide continuing care to the patient, including 
furnishing necessary CHI services in the subsequent month(s) following 
a potential initiating visit. Additionally, under our regulations at 
Sec.  410.26(b), Medicare payment is only made for services and 
supplies incident to the service of a physician or other practitioner 
(such as the proposed CHI services) when those services and supplies 
are furnished in a noninstitutional setting to noninstitutional 
patients (all settings other than a hospital or SNF). So, under our 
current regulations and the CHI policies that we are finalizing in this 
rule, an E/M service furnished in the ED or SNF setting would not serve 
as the initiating visit for CHI services.
    ED visits, as well as inpatient and observation visits would not be 
an initiating visit since these practitioners would not be following 
the patient longitudinally in the community or furnishing the CHI 
services.
    Response: As discussed above, ED visits would not typically serve 
as CHI initiating visits because the practitioners furnishing the E/M 
services in those settings would not typically provide continuing care 
to the patient, including furnishing necessary CHI services incident to 
their professional services in the month(s) subsequent to an ED visit. 
We agree with commenters that the E/M visit done as part of a 
Transitional Care Management (TCM) services could serve as an 
initiating visit for CHI services because it includes a high level 
office/outpatient E/M visit furnished by a physician or nonphysician 
practitioner managing the patient in the community after discharge.
    Comment: Commenters also expressed concern with our proposal to 
allow only one practitioner to furnish a CHI initiating visit and 
requested that CMS allow more than one practitioner to furnish and bill 
the CHI initiating visit and services. Additionally, a few commenters 
requested that CMS clarify whether more than one initiating visit would 
be required when a subsequent need for CHI is identified during the 
initiating visits.
    Response: We continue to be concerned that CHI services would be 
too fragmented if the patient has more than individual addressing their 
unmet SDOH need(s). Therefore, we are finalizing that only one 
practitioner will bill CHI and therefore there will only be one 
initiating visit. We acknowledge that practitioners may identify 
additional SDOH that are significantly limiting their ability to 
diagnose or treat the problem(s) address addressed in the initiating 
visit. We provide additional discussion with regard to the service 
elements below.
    After consideration of the public comments, we are finalizing our 
proposal to establish separate coding and payment for CHI services. We 
are finalizing that a CHI initiating visit can be an E/M visit (other 
than a low-level E/M visit that can be performed by clinical staff) 
performed by the billing practitioner who would also be furnishing the 
CHI services during the subsequent calendar month(s), including an E/M 
visit furnished as part of TCM, or an AWV. The CHI initiating visit 
would be separately billed (if all requirements to do so are met) and 
would be a pre-requisite to billing for CHI services.
    In the proposed rule, for purposes of assigning a supervision level 
for these ``incident to'' services, we proposed to designate CHI 
services as care management services that may be

[[Page 78924]]

furnished under the general supervision of the billing practitioner in 
accordance with Sec.  410.26(b)(5). General supervision means the 
service is furnished under the physician's (or other practitioner's) 
overall direction and control, but the physician's (or other 
practitioner's) presence is not required during the performance of the 
service (Sec.  410.26(a)(3)).
    In the proposal, we explained that the phrase or term ``problem 
addressed'' referred to the definition in the CPT E/M Guidelines that 
we adopted for E/M visits. Specifically, ``[a] problem is a disease, 
condition, illness, injury, symptom, finding, complaint, or other 
matter addressed at the encounter, with or without a diagnosis being 
established at the time of the encounter. Problem addressed [means the 
following]: A problem is addressed or managed when it is evaluated or 
treated at the encounter by the physician or other qualified healthcare 
professional reporting the service. This includes consideration of 
further testing or treatment that may not be elected by virtue of risk/
benefit analysis or patient/parent/guardian/surrogate choice. Notation 
in patient's medical record that another professional is managing the 
problem without additional assessment or care coordination documented 
does not qualify as being addressed or managed by the physician or 
other qualified healthcare professional reporting the service. Referral 
without evaluation (by history, examination, or diagnostic study[ies]) 
or consideration of treatment does not qualify as being addressed or 
managed by the physician or other qualified healthcare professional 
reporting the service. For hospital inpatient and observation care 
services, the problem addressed is the problem status on the date of 
the encounter, which may be significantly different than on admission. 
It is the problem being managed or co-managed by the reporting 
physician or other qualified healthcare professional and may not be the 
cause of admission or continued stay'' (2023 CPT Codebook, p. 6-8).
    For purposes of CHI services (and PIN services outlined later in 
this section), we proposed that SDOH means economic and social 
condition(s) that influence the health of people and communities, as 
indicated in these same CPT E/M Guidelines (2023 CPT codebook, page 
11). We proposed to adopt CPT's examples of SDOH, with additional 
examples. Specifically, we proposed that SDOH(s) may include but are 
not limited to food insecurity, transportation insecurity, housing 
insecurity, and unreliable access to public utilities, when they 
significantly limit the practitioner's ability to diagnose or treat the 
problem(s) addressed in the CHI initiating visit. Since Medicare 
payment is generally limited to items and services that are reasonable 
and necessary for the diagnosis or treatment of illness or injury, the 
focus of CHI services would need to be on addressing the particular 
SDOH need(s) that are interfering with, or presenting a barrier to, 
diagnosis or treatment of the patient's problem(s) addressed in the CHI 
initiating visit.
    We proposed the following specific codes and descriptors:
    G0019--Community health integration services performed by certified 
or trained auxiliary personnel, including a community health worker, 
under the direction of a physician or other practitioner; 60 minutes 
per calendar month, in the following activities to address social 
determinants of health (SDOH) need(s) that are significantly limiting 
ability to diagnose or treat problem(s) addressed in an initiating E/M 
visit:
     Person-centered assessment, performed to better understand 
the individualized context of the intersection between the SDOH need(s) 
and the problem(s) addressed in the initiating E/M visit.
    ++ Conducting a person-centered assessment to understand patient's 
life story, strengths, needs, goals, preferences and desired outcomes, 
including understanding cultural and linguistic factors.
    ++ Facilitating patient-driven goal-setting and establishing an 
action plan.
    ++ Providing tailored support to the patient as needed to 
accomplish the practitioner's treatment plan.
     Practitioner, Home-, and Community-Based Care 
Coordination.
    ++ Coordinating receipt of needed services from healthcare 
practitioners, providers, and facilities; and from home- and community-
based service providers, social service providers, and caregiver (if 
applicable).
    ++ Communication with practitioners, home- and community-based 
service providers, hospitals, and skilled nursing facilities (or other 
health care facilities) regarding the patient's psychosocial strengths 
and needs, functional deficits, goals, preferences, and desired 
outcomes, including cultural and linguistic factors.
    ++ Coordination of care transitions between and among health care 
practitioners and settings, including transitions involving referral to 
other clinicians; follow-up after an emergency department visit; or 
follow-up after discharges from hospitals, skilled nursing facilities 
or other health care facilities.
    ++ Facilitating access to community-based social services (e.g., 
housing, utilities, transportation, food assistance) to address the 
SDOH need(s).
     Health education--Helping the patient contextualize health 
education provided by the patient's treatment team with the patient's 
individual needs, goals, and preferences, in the context of the SDOH 
need(s), and educating the patient on how to best participate in 
medical decision-making.
     Building patient self-advocacy skills, so that the patient 
can interact with members of the health care team and related 
community-based services addressing the SDOH need(s), in ways that are 
more likely to promote personalized and effective diagnosis or 
treatment.
     Health care access/health system navigation.
    ++ Helping the patient access healthcare, including identifying 
appropriate practitioners or providers for clinical care and helping 
secure appointments with them.
     Facilitating behavioral change as necessary for meeting 
diagnosis and treatment goals, including promoting patient motivation 
to participate in care and reach person-centered diagnosis or treatment 
goals.
     Facilitating and providing social and emotional support to 
help the patient cope with the problem(s) addressed in the initiating 
visit, the SDOH need(s), and adjust daily routines to better meet 
diagnosis and treatment goals.
     Leveraging lived experience when applicable to provide 
support, mentorship, or inspiration to meet treatment goals.
    G0022--Community health integration services, each additional 30 
minutes per calendar month (List separately in addition to G0019).
    By way of example, tailored support could be provided through CHI 
services to a patient experiencing homelessness with signs of potential 
cognitive impairment and a history of frequent ED admissions for 
uncontrolled diabetes. The patient's primary care practitioner (PCP) 
learns during a clinic visit after discharge from the ED, that the 
patient has been able to reliably fill their prescriptions for diabetes 
medication, but frequently loses the medication (or access to it) while 
transitioning between homeless shelters and a local friend's home. In 
the medical record, the PCP documents SDOH need(s) of housing 
insecurity and transportation insecurity contributing to medication 
noncompliance, resulting in inadequate

[[Page 78925]]

insulin control and a recent ED visit for hypoglycemia. The PCP's 
treatment plan is daily diabetes medication, with the goal of 
maintaining hemoglobin A1c within appropriate levels. To accomplish the 
treatment plan, the PCP orders CHI services to develop an 
individualized plan for daily medication adherence/access while 
applying for local housing assistance, and also orders a follow up 
visit for cognitive impairment assessment and care planning to further 
evaluate the potential contribution of cognitive impairment. The PCP's 
auxiliary personnel provide tailored support, comprised of facilitating 
communication between the patient, local shelters, and the friend, to 
help the patient identify a single location to reliably store their 
medication while applying for local housing assistance. The auxiliary 
personnel also help the patient identify a reliable means of 
transportation daily to that location for their medication and show the 
patient how to create a daily automated phone reminder to take the 
diabetes medication. The auxiliary personnel document these activities 
(including amount of time spent) in the medical record at the PCP's 
office, along with periodic updates regarding the status of the 
patient's housing assistance application.
    To help inform whether our proposed descriptor times were 
appropriate and reflect typical service times, and whether a frequency 
limit is relevant for the add-on code, we solicited comment on the 
typical amount of time practitioners spend per month furnishing CHI 
services to address SDOH needs that pose barriers to diagnosis and 
treatment of problem(s) addressed in an E/M visit. We also solicited 
comment to better understand the typical duration of CHI services, in 
terms of the number of months for which practitioners furnish the 
services.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Most commenters supported our proposal to allow general 
supervision for CHI services. However, some commenters asked a related 
question about whether auxiliary personnel providing CHI services under 
general supervision can identify additional unmet SDOH needs to 
address. When CHI services are being furnished, sometimes a patient is 
receiving CHI services to address one unmet SDOH need, and in the 
course of auxiliary personnel providing CHI services during the month, 
the auxiliary personnel identify additional unmet SDOH need(s). These 
commenters recommended that if the auxiliary personnel are regularly 
updating the billing practitioner on CHI services they provide, we 
should not require another initiating visit in order for the auxiliary 
personnel to address the additional unmet SDOH needs.
    Response: We thank the commenters support of our proposal for 
general supervision. It would not be in the scope of practice of the 
auxiliary personnel for them to make a determination that a given SDOH 
need(s) is impacting ability of the billing practitioner to diagnose or 
treat problems addressed in an initiating visit. In addition, general 
supervision requires the CHI services to be furnished under the billing 
practitioner's direction and control. While we do not believe another 
initiating visit is necessary, the auxiliary personnel must review all 
unmet SDOH need(s) they find in order for them to be addressed by the 
billing practitioners in the CHI services.
    Comment: Some commenters also stated that general supervision could 
inadvertently lead to the consolidation and integration of CHWs and 
other auxiliary personnel currently employed by CBOs to instead be 
employed by billing practitioners, where payment may be more robust,
    Response: There is no statutory benefit that can allow CBOs to 
directly bill the PFS. In accordance with this final rule, CHI services 
must be provided incident to the professional service of a physician or 
other statutorily qualified practitioner who must bill for those 
services. Auxiliary personnel who provide these services must be under 
the supervision of the physician [or other practitioner] and the 
provided services must be reasonable and necessary for diagnosis and 
treatment of illness or injury. In the course of implementing our 
payment policy for chronic care management services, we became 
concerned about the number of care management companies that were 
contracted by the physician with potentially little oversight, clinical 
integration and communication with the billing practitioner, where the 
services might not be furnished under the direction and control of the 
billing practitioner. As discussed above, we were concerned that our 
incident to policy might not be met, which requires the billing 
practitioner to maintain active participation in and management of the 
course of treatment. We are allowing for the broadest level of 
supervision possible (general supervision) and contracting with third 
parties (such as CBOs) in accomplishing the furnishing of CHI services 
but this must be part of clinical care and treatment by the billing 
practitioner. Under our incident to regulations, we cannot prohibit 
physicians from directly hiring auxiliary personnel for furnishing CHI 
services.
    Comment: Commenters were generally supportive of assigning general 
supervision for CHI services.
    Response: We thank commenters for supporting our proposal to assign 
general supervision for the CHI codes. We believe that general 
supervision offers flexibility for the auxiliary personnel to provide 
the CHI services without the billing practitioner being physically 
present or immediately available, as would be required under direct or 
personal supervision (see Sec.  410.26).
    Comment: Another commenter recommended that the services provided 
by a CHW should be provided under the supervision of a qualified health 
professional providing care management activities, including, but not 
limited to registered nurses.
    Response: No, our regulations require supervision by the 
practitioner who bills for the services.
    Comment: Commenters were overall supportive of the valuation for 
HCPCS codes G0019 and G0022. Some commenters requested that CMS 
consider 20- or 30-minute increments for HCPCS code G0019, or other 
shorter increments, that could be billed individually, or as multiple 
units during the same encounter, with a maximum per calendar month of 
no less than 60 minutes total. One commenter also requested that HCPCS 
code G0019 be extended to 120 minutes and HCPCS code G0022 be extended 
up to 60 minutes per calendar month. A few commenters stated 30 minutes 
was sufficient, but the majority of commenters stated they spend 60 
minutes up to 120 minutes, especially during the first few months.
    Response: We asked commenters what they believe is the typical 
amount of time practitioners spend per month furnishing CHI services to 
address SDOH needs that pose barriers to diagnosis and treatment of 
problem(s) addressed. Commenters suggested a broad range of the time 
they expected to spend furnishing CHI services over a month. We are not 
finalizing a frequency limitation for the add on HCPCS code G0022 to 
allow for flexibility when practitioners do spend more than 60 minutes 
on CHI services in the month. Commenters expressed that for CHI 
services, especially during the first month, more time may be spent on 
providing services. We believe it is difficult to adequately address a

[[Page 78926]]

patient's social needs, consistent with the proposed elements of the 
CHI service, in less than an hour. As a result, we continue to believe 
that the 60 minutes of time spent by auxiliary personnel is most 
appropriate. For HCPCS code G0022, we continue to believe that 30 
minutes of time spent by auxiliary personnel is most appropriate for 
the code descriptor. Therefore, we are finalizing 60 minutes for the 
base code and 30 minutes for the add-on code with no frequency 
limitation for the add-on code as long as the time spent is reasonable 
and necessary.
    Comment: Several commenters requested that CMS include social 
workers and registered nurses in the code descriptors for HCPCS codes 
G0019 and G0022. Commenters also requested that these professionals be 
included as personnel who may conduct the initial CHI visit and oversee 
the provision of these services. Commenters also requested that CMS 
identify social workers, including a bachelor of social work (BSW), as 
eligible auxiliary workforce under CHI and PIN. Commenters expressed 
that including social workers is especially important as auxiliary 
personnel are employed by community care hubs (CCHs) and/or individual 
community-based organizations (CBOs) that may be contracting with a 
Medicare billing provider, and BSWs make up a significant part of this 
workforce. Another commenter stated that social workers provide 
services aligned with these proposed codes day in and day out across 
the country, yet they are not identified among lists of providers 
recognized for offering these proposed services.
    Response: We note that our HCPCS G-code descriptors specify that 
auxiliary personnel may provide these services under general 
supervision. These codes were specifically designed to capture services 
commonly performed by community health workers, which are a type of 
auxiliary personnel. But the codes do not limit the types of other 
health care professionals, such as registered nurses and social 
workers, that can perform CHI services (and PIN services, as we discuss 
in the next section) incident to the billing practitioner's 
professional services, so long as they meet the requirements to provide 
all elements of the service included in the code, consistent with the 
definition of auxiliary personnel at Sec.  410.26(a)(1).
    Comment: Some commenters supported our proposal to establish CHI 
services described by HCPCS code G0019 and stated the code should only 
be billed by one practitioner, to maintain longitudinal care. Other 
commenters did not agree with our proposed limitation for CHI and PIN 
services to one billing practitioner per patient per calendar month, 
and requested that we not impose such a limit. One commenter expressed 
that limiting CHI services to one practitioner per patient per month 
would impair the ability of auxiliary personnel to provide CHI services 
to the patient. Most commenters opposed our proposal that the add-on 
service, HCPCS code G0022, could be billed only once per month. Some 
commenters suggested that practitioners should be allowed to bill HCPCS 
code G0022 at least once a week. Another commenter expressed concern 
regarding frequency limits for the CHI add-on code and noted that 
spending adequate time with patients will be essential for high-quality 
CHI service provision. Another commenter requested not limiting the 
number of add-on services per month or the length of time a patient can 
continue to receive CHI or PIN services and expressed that if a patient 
needs services beyond six months, for example, a new order from the 
billing practitioner could be submitted. Several commenters recommended 
that CHI services have one in person interaction per month and 
expressed it was critical to allow the add on service (HCPCS code 
G0022) to be billed weekly.
    One commenter noted that most beneficiaries screened for SDOH had 
two to five SDOH needs and to address those identified needs, it was 
conceivable that the CHI services would occur over multiple months 
(when more than one need was identified). The commenter noted that they 
would anticipate more intensity/time spent with the patient during the 
first month, while subsequent months may not have the same intensity or 
time spent, and that time spent delivering CHI services would be 
aggregated to determine the total time spent, per calendar month. Some 
commenters asserted that they could typically spend up to 120 minutes 
providing CHI services in the first month.
    Response: We thank the commenters for their suggestions regarding 
frequency limitations for the CHI codes, specifically the add-on code, 
HCPCS code G0022. We are not finalizing to establish a frequency 
limitation for HCPCS code G0022. Considering the feedback from the 
commenters, we understand that it may be typical for practitioners and 
auxiliary staff to spend significant time supporting the activities 
described by the CHI codes during the first month. We believe as long 
as the time spent by auxiliary personnel is reasonable and necessary 
for the diagnosis and treatment of injury or illness, we should allow 
it to be billed. We agree with commenters that there could be 
situations where a patient requires more intensive CHI services over a 
month that would warrant billing more than one unit of the add-on HCPCS 
code G0022, perhaps especially in the first month and where multiple 
health related social needs impact the practitioner's ability to 
diagnose and treat the patient. We will monitor utilization in the 
claims data of the add-on code for medical necessity.
    Comment: Several commenters recommended that we create a separate 
HCPCS code for CHI services performed in a group setting. These 
commenters expressed that certain service elements such as health 
education and facilitating behavior change, may be provided to patients 
as part of a group session with other patients. The commenter expressed 
that many patients benefit from services provided to a group of similar 
patients similar challenges.
    Response: We did not propose a code describing services furnished 
to a group of patients. CHI services are highly individualized and 
focused on a person-centered assessment, performed to better understand 
the individualized context of the intersection between the SDOH need(s) 
and the problem(s) addressed in the initiating visit and subsequently 
by the CHW and/or auxiliary personnel in the community. Therefore, we 
continue to believe that the service should be tailored to address the 
individual patient's specific needs, and did not consider whether it 
would be appropriate for CHI services to be furnished in a group 
setting.
    Comment: Many commenters asked whether the new G codes for CHI 
could be excluded from budget neutrality.
    Response: We remind commenters that section 1848(c)(2)(B)(ii)(II) 
of the Act requires that increases or decreases in RVUs may not cause 
the amount of Medicare Part B expenditures for the year to differ by 
more than $20 million from what expenditures would have been in the 
absence of these changes. If this threshold is exceeded, we make 
adjustments to preserve budget neutrality. There is no statutory 
exception available for CHI services, so the expected spending 
associated with these services must be included in the CY 2024 BN 
adjustment.
    Comment: Several commenters expressed concern regarding the medical 
record documentation requirements for CHI services and requested that 
CMS clarify that services must be documented by the billing 
practitioner and not necessarily by the

[[Page 78927]]

auxiliary staff delivering the services. This arrangement would allow a 
CBO to communicate with the billing practitioner about the services 
provided (including the time spent furnishing services and the social 
needs addressed), without requiring CBOs to have the technical capacity 
to directly input documentation into medical records. Other commenters 
stated that the billing practitioner or the auxiliary personnel should 
be responsible for documenting CHI and PIN services in the Electronic 
Medical Record (EMR).
    Response: We thank the commenters for requesting clarification 
regarding documentation in the medical record, including an EMR, by the 
auxiliary personnel. We refer commenters to the finalized policies 
about medical record documentation in the CY 2020 PFS final rule (84 FR 
62681 through 62684) and our later clarifications in the CY2021 PFS 
final rule (85 FR 84594 through 84596), which state that any individual 
who is authorized under Medicare law to furnish and bill for their 
professional services, whether or not they are acting in a teaching 
role, may review and verify (sign and date) the medical record for the 
services they bill, rather than re-document notes in the medical record 
made by physicians, residents, nurses, and students (including students 
in therapy or other clinical disciplines), or other members of the 
medical team. Documentation, in the end, is the responsibility of the 
billing practitioner. CBOs may enter data following our general policy, 
as long as the biller reviews and verifies the documentation.
    After consideration of the public comments, we are finalizing our 
proposal to designate CHI services as care management services that may 
be furnished under the general supervision of the billing practitioner 
in accordance with Sec.  410.26(b)(5). We are also finalizing the 
proposed code descriptor for HCPCS code G0019, with a few minor 
changes. The final code descriptor for HCPCS code G0019, states that 
CHI services performed by certified or trained auxiliary personnel, 
including a community health worker, under the direction of a physician 
or other practitioner requires 60 minutes per calendar month to bill 
the service. We are also finalizing the valuation for HCPCS code G0019 
as proposed. We are also finalizing the proposed code descriptor and 30 
minutes per calendar month for HCPCS code G0022 as proposed. 
Additionally, we are not finalizing a frequency limitation for HCPCS 
code G0022. We will monitor utilization of the add-on HCPCS code G0022 
and may re-evaluate these policies in future rulemaking.
    With regard to changes in our final code descriptor, we are 
modifying the descriptor to reflect the policy we are finalizing in 
response to public comments received. We removed `E/M' from the code 
descriptor since we are finalizing a policy to allow an E/M service, 
including an E/M service that is part of a TCM service, and an AWV 
service to serve as the initiating visit for CHI services. 
Additionally, we are adding a service element for the SDOH risk 
assessment to describe instances when a CHW or other auxiliary 
personnel performing CHI services identifies an SDOH need that the 
furnishing practitioner did not identify and needs to apprise the 
billing practitioner of that unmet SDOH need(s) they find for the need 
to be addressed by the billing practitioners and for the billing 
practitioner to identify if that need would impact the ability of the 
billing practitioner to diagnose and treat the problem addressed in the 
initiating visit .
    We are finalizing the code descriptor for HCPCS code G0019 to read 
as follows:
    Community health integration services performed by certified or 
trained auxiliary personnel, including a community health worker, under 
the direction of a physician or other practitioner; 60 minutes per 
calendar month, in the following activities to address social 
determinants of health (SDOH) need(s) that are significantly limiting 
the ability to diagnose or treat problem(s) addressed in an initiating 
visit:
     Person-centered assessment, performed to better understand 
the individualized context of the intersection between the SDOH need(s) 
and the problem(s) addressed in the initiating visit.
    ++ Conducting a person-centered assessment to understand patient's 
life story, strengths, needs, goals, preferences and desired outcomes, 
including understanding cultural and linguistic factors and including 
unmet SDOH needs (that are not separately billed).
    ++ Facilitating patient-driven goal-setting and establishing an 
action plan.
    ++ Providing tailored support to the patient as needed to 
accomplish the practitioner's treatment plan.
     Practitioner, Home-, and Community-Based Care Coordination
    ++ Coordinating receipt of needed services from healthcare 
practitioners, providers, and facilities; and from home- and community-
based service providers, social service providers, and caregiver (if 
applicable).
    ++ Communication with practitioners, home- and community-based 
service providers, hospitals, and skilled nursing facilities (or other 
health care facilities) regarding the patient's psychosocial strengths 
and needs, functional deficits, goals, preferences, and desired 
outcomes, including cultural and linguistic factors.
    ++ Coordination of care transitions between and among health care 
practitioners and settings, including transitions involving referral to 
other clinicians; follow-up after an emergency department visit; or 
follow-up after discharges from hospitals, skilled nursing facilities 
or other health care facilities.
    ++ Facilitating access to community-based social services (e.g., 
housing, utilities, transportation, food assistance) to address the 
SDOH need(s).
     Health education--Helping the patient contextualize health 
education provided by the patient's treatment team with the patient's 
individual needs, goals, and preferences, in the context of the SDOH 
need(s), and educating the patient on how to best participate in 
medical decision-making.
     Building patient self-advocacy skills, so that the patient 
can interact with members of the health care team and related 
community-based services addressing the SDOH need(s), in ways that are 
more likely to promote personalized and effective diagnosis or 
treatment.
     Health care access/health system navigation
    ++ Helping the patient access healthcare, including identifying 
appropriate practitioners or providers for clinical care and helping 
secure appointments with them.
     Facilitating behavioral change as necessary for meeting 
diagnosis and treatment goals, including promoting patient motivation 
to participate in care and reach person-centered diagnosis or treatment 
goals.
     Facilitating and providing social and emotional support to 
help the patient cope with the problem(s) addressed in the initiating 
visit, the SDOH need(s), and adjust daily routines to better meet 
diagnosis and treatment goals.
     Leveraging lived experience when applicable to provide 
support, mentorship, or inspiration to meet treatment goals.
    The commenters did not suggest any changes to the add-on code 
descriptor so for the add-on HCPCS code G0022 we are not finalizing any 
changes and the descriptor will read as follows: HCPCS code G0022--
Community health integration services, each additional 30

[[Page 78928]]

minutes per calendar month (List separately in addition to G0019).
    In the proposed rule, we proposed that all auxiliary personnel who 
provide CHI services must be certified or trained to perform all 
included service elements and authorized to perform them under 
applicable State laws and regulations. Under Sec.  410.26(a)(1) of our 
regulations, auxiliary personnel must meet any applicable requirements 
to provide the services performed incident to the billing 
practitioner's professional services, including licensure, that are 
imposed by the State in which the services are being furnished. In 
States where there are no applicable licensure or other laws or 
regulations relating to individuals performing CHI services, we 
proposed to require auxiliary personnel providing CHI services to be 
trained to provide them. Training must include the competencies of 
patient and family communication, interpersonal and relationship-
building skills, patient and family capacity-building, service 
coordination and system navigation, patient advocacy, facilitation, 
individual and community assessment, professionalism and ethical 
conduct, and the development of an appropriate knowledge base, 
including of local community-based resources. We proposed these 
competencies because they reflect professional consensus regarding 
appropriate core competencies for CHWs, applied to this context.\14\ We 
solicited public comment on whether it would be appropriate to specify 
the number of hours of required training, as well as the training 
content and who should provide the training.
---------------------------------------------------------------------------

    \14\ https://chwtraining.org/c3-project-chw-skills/.
---------------------------------------------------------------------------

    The following is a summary of the comments we received and our 
responses.
    Comment: Most commenters generally agreed with our proposal. Some 
commenters expressed that a minimum number of training hours is needed 
to ensure basic skills and understanding related to the CHW scope of 
work. Other commenters noted that training should be development-
oriented and not be a one-time certification. Some commenters expressed 
that CHWs, and the associations that represent them, are best 
positioned to determine the appropriate training requirements to 
balance patient safety and access to care. Commenters also expressed 
that there should be flexibility in training and certification 
requirements to support the development of a diverse CHI services 
workforce.
    Several commenters noted they utilize the Community Health Worker 
Core Competency (C3) project. A few commenters agreed that training 
should not focus on clinical topics as CHWs are not trained clinicians 
or health educators. Other commenters also suggested and agreed that 
when there are no applicable licensure or State laws related to 
individuals performing CHI, services should align with the C3 Project 
competencies.
    Response: We continue to believe that our rules for all incident to 
services should apply such that applicable State rules and requirements 
must be met and that training/certification must meet any applicable 
requirements to provide the services performed incident to the billing 
practitioner's professional services, including licensure, that are 
imposed by the State.
    Comment: Some commenters disagreed with our proposal to require 
auxiliary personnel providing CHI services to be trained. These 
commenters suggested that CMS offer a legacy certification option for 
CHWs with extensive lived experience.
    Response: We thank commenters for their feedback. We do not 
understand what the commenters mean by legacy certification. We 
continue to believe that we should defer to States, as they have 
applicable standards for auxiliary personnel (as specified for all 
incident to services under Sec.  410.26). For States without a standard 
for training or certification, that we believe that we should adopt the 
professional consensus regarding appropriate core competencies for CHI 
services, applied to this context.
    Comment: While some commenters stated that requiring a specific 
number of training hours may be a deterrent for some individuals to 
actually obtain the required training, others suggested auxiliary 
personnel providing CHI services should participate in training 
programs with anywhere from 7 to 10 hours, 30 to 40 hours, and up to 
140 hours before beginning work. Other commenters recommended an annual 
training requirement of 2 to 3 hours.
    Response: We thank the commenters for their thoughts and 
suggestions on whether it would be appropriate to specify the number of 
hours of required training, as well as the training content and who 
should provide the training to be obtained by CHWs. We did not propose 
and do not plan to finalize a specific number of hours of training for 
auxiliary personnel providing CHI services.
    After consideration of the public comments, we are finalizing our 
proposal that all auxiliary personnel who provide CHI services must be 
certified or trained to perform all included service elements, and 
authorized to perform them under applicable State laws and regulations.
    For CHI services, as with all incident to services, it is the 
billing practitioner's responsibility to ensure that all payment rules 
and applicable State requirements are met including licensure, 
certification, and/or training. This does not mean that the billing 
practitioners are required to provide the licensure, certification, 
and/or training themselves, but rather that they must ensure that the 
Medicare criteria for billing and payment of CHI services are met.
    We continue to believe that the training required to provide CHI 
services must include the competencies of patient and family 
communication, interpersonal and relationship-building, patient and 
family capacity-building, service coordination and system navigation, 
patient advocacy, facilitation, individual and community assessment, 
professionalism and ethical conduct, and the development of an 
appropriate knowledge base, including of local community-based 
resources.
    Because we defer to applicable State rules, we are not requiring a 
set number of training hours or content in States that have applicable 
rules. For States that do not have applicable rules, we continue to 
believe that our proposed competencies as specified above are 
appropriate. Due to the wide range of training hours suggested by 
commenters, we are not specifying a required number of training hours 
that need to be obtained in States who do not have an applicable rule 
to specify the number of required hours.
    Comment: One commenter suggested a national certification mechanism 
and to call these personnel certified Community Health Professionals 
(CCHPs). Some commenters expressed that there should be a program-level 
accreditation that recognizes community-based organizations that are 
employing community-health workers, and pointed to accrediting bodies 
that have plans in the works for such accreditations.
    Response: We are not sure whether the commenter is recommending a 
national accreditation for CHI services, CHWs, or CBOs. PFS payment 
policy provides payment rules for services, in this case CHI services 
furnished by CHWs or other types of auxiliary personnel who may or may 
not be working in conjunction with a CBO. Above, we have finalized our 
policy for CHI services and if a national accreditation program trains 
or certifies and meets our requirements which includes applicable State 
requirements, then those auxiliary personnel would

[[Page 78929]]

meet requirements to provide CHI services (assuming all other billing 
requirements are met).
    In our proposed rule, we proposed to require that time spent 
furnishing CHI services for purposes of billing HCPCS codes G0019 and 
G0022 must be documented in the patient's medical record in its 
relationship to the SDOH need(s) they are intended to address and the 
clinical problem(s) they are intended to help resolve. The activities 
performed by the auxiliary personnel would be described in the medical 
record, just as all clinical care is documented in the medical record. 
We proposed to require the SDOH need(s) to be recorded in the patient's 
medical record, and for data standardization purposes, stated that 
practitioners would be encouraged to record the associated ICD-10 Z-
code (Z55-Z65) in the medical record and on the claim.
    Since CHI services are community-based and involve connecting the 
patient with local resources in their community, and are highly 
personalized, for example, hearing and understanding a patient's life 
story and culture, we believe that most of the elements of CHI services 
would involve direct contact between the auxiliary personnel and the 
patient, and that a substantial portion would be in-person, but 
recognized that a portion might be performed via two-way audio. We 
sought to confirm our understanding of where and how these services 
would be typically provided (for example, in-person, audio-video, two-
way audio).
    We solicited public comment regarding whether we should require 
patient consent for CHI services. For care management services that 
could generally be performed without any direct patient contact, we 
require advance patient consent to receive the services as a 
prerequisite to furnishing and billing the services, to avoid patients 
receiving bills for cost sharing that they might not be expecting to 
receive. For example, a patient might receive chronic care management 
services comprised of practitioners coordinating care with each other 
and reviewing or exchanging medical records between visits in ways that 
do not require involving the patient directly. As we have frequently 
discussed in prior rulemaking for care management services (for 
example, at 81 FR 80240), we do not have statutory authority to waive 
cost sharing for care management or other services. Rather, cost 
sharing remains applicable except as specified by statute such as for 
certain preventive services. In recent years, we have required advance 
documented patient consent to receive most care management services as 
a condition of the practitioner billing those services, to avoid a 
situation where the patient is surprised to receive a bill for the 
associated cost sharing. These consent requirements include informing 
the patient about applicable cost sharing, the right to discontinue 
services, and, where applicable, the limitation that payment is made 
for the service to only one practitioner per month. We have heard from 
interested parties over time that requiring advance patient consent is 
an administrative burden and may pose a barrier to receipt of needed 
services. We did not propose to require consent for CHI services, since 
we believe these services typically would involve direct patient 
contact, and largely be provided in-person. However, we stated that if 
we heard from public commenters that CHI services would frequently not 
involve direct contact with the patient, or could extend for periods of 
time for which the patient might not be expecting to incur cost sharing 
obligations (such as multiple months), we would consider requiring 
patient consent to receive CHI services. We solicited comment regarding 
whether we should require patient consent for CHI services. The 
following is a summary of the comments we received and our responses.
    Comment: Commenters confirmed that CHI services would most likely 
occur both in-person and virtually (via audio-video or via two-way 
audio) but noted that evidence shows that all services should include 
some in-person interaction. As a result, a few commenters requested 
that CMS provide a higher payment for services when they are delivered 
in person to incentivize these types of interactions. Additionally, one 
commenter recommended at least one in-person interaction each month, 
unless the patient is in an area designated as rural, frontier, tribal, 
or a geographically isolated territory.
    Response: We acknowledge the commenters' suggestion that CHI 
services would be available either in person, virtually, or a mix of 
both. However, we continue to believe that most of the elements of CHI 
services would involve direct contact between the auxiliary personnel 
and the patient. Thus, we do not plan to provide a higher payment for 
services when they are delivered in person, and we do not believe that 
we need to incentivize in-person interactions. We hope to engage with 
practitioners and other interested parties to inform any refinements to 
the services through future rulemaking, as our collective experience 
with these services grows.
    Comment: Most commenters stated that patient consent should be 
obtained prior to initiating services for CHI, so the beneficiary can 
be counseled on the services being provided, in addition to potential 
co-insurance and/or cost sharing requirements. A few commenters stated 
that a patient should be allowed to give their consent verbally, 
documented in the medical record, that the auxiliary personnel may 
obtain consent, or virtually. Lastly, another commenter stated that 
including the CHW in the CHI initiating visit with the practitioner as 
part of the patient care team would avoid complications with consent 
since the patient's approval would be provided during the initial 
visit. The commenters stated that, considering that a variety of 
factors may prevent a patient from returning to the clinic, it is 
imperative that the CHW is introduced during the initial visit.
    Comment: A few commenters disagreed consent should be required for 
several reasons. One commenter expressed that consent should not be 
required for CHI services because often times, patients do not 
understand CHI services at the time presented, therefore discussing 
consent would be difficult especially when there may be a lack of 
understanding or if there are literacy, language, culture and learning 
difficulties. Requiring consent is especially challenging given the 
short time spent with the practitioner, especially during long 
appointments where there are interpreter needs. Commenters generally 
agreed that if consent will be required, they ask CMS to consider 
verbal consent or consent as part of the annual consent for treatment.
    Response: Having reviewed the public comments, we are persuaded by 
the opinions of the commenters that we should require consent. CHI 
services may not necessarily be in person, could be provided over many 
months, and the patient would not necessarily expect to incur cost 
sharing.
    Comment: We received comments recommending on how consent should be 
obtained. Commenters recommended that we not require consent to 
obtained in person. Commenters stated that there may be circumstances 
where it may not be possible to obtain consent during the initiating 
visit. Commenters recommended that we not require written consent but 
rather allow the patient to provide a verbal consent.
    Response: After considering public comments we agree with 
commenters that in order to reduce administrative burden that written 
or verbal consent may be obtained as long as it is documented in the 
medical record.

[[Page 78930]]

    Comment: Several commenters asked about who would obtain consent. 
Commenters asked CMS if consent could be obtained by auxiliary 
personnel.
    Response: While we believe it would be best for the billing 
practitioner to obtain consent, we agree with the commenters that we 
should allow auxiliary personnel to obtain the consent and that is what 
we are finalizing. As part of the consent process, it must be explained 
to the patient that cost sharing will apply and that only one 
practitioner per month can bill the services. Consent only has to be 
obtained once (rather than annually) and in cases where there is a 
change in the billing practitioner, a new patient consent would be 
required.
    In summary, after consideration of public comments, we are 
finalizing that patient consent is required in advance of providing CHI 
services, but may be obtained either in writing or verbally, so long as 
the consent is documented in the patient's medical record. We are also 
finalizing that consent for CHI services may be obtained by auxiliary 
personnel and must be obtained if there is a change in the billing 
practitioner. The consent process must include explaining to the 
patient that cost sharing applies and that only one practitioner may 
furnish and bill the services in a given month.
    In the proposed rule, we proposed that a billing practitioner may 
arrange to have CHI services provided by auxiliary personnel who are 
external to, and under contract with, the practitioner or their 
practice, such as through a community-based organization (CBO) that 
employs CHWs, if all of the ``incident to'' and other requirements and 
conditions for payment of CHI services are met. Although we proposed to 
allow CHI services to be performed by auxiliary personnel under a 
contract with a third party, we stated, as we have in our regulations 
for current care management services, that there must be sufficient 
clinical integration between the third party and the billing 
practitioner in order for the services to be fully provided, and the 
connection between the patient, auxiliary personnel, and the billing 
practitioner must be maintained. As we discussed in a similar context 
for other care management services in the CY 2017 PFS final rule, if 
there was little oversight by the billing practitioner or a lack of 
clinical integration between a third party providing the services and 
the billing practitioner, we did not believe services, as we proposed 
to define them, could be fully performed; and therefore, in such cases, 
services should not be billed (see 81 FR 80249). We stated that we 
would expect the auxiliary personnel performing the CHI services to 
communicate regularly with the billing practitioner to ensure that CHI 
services are appropriately documented in the medical record, and to 
continue to involve the billing practitioner in evaluating the 
continuing need for CHI services to address the SDOH need(s) that limit 
the practitioner's ability to diagnose and treat the problem(s) 
addressed in the initiating visit.
    As noted in the CY 2023 PFS final rule (87 FR 69790) and explained 
in the CY 2023 PFS proposed rule (87 FR 46102), when we refer to 
community-based organizations, we mean public or private not-for-profit 
entities that provide specific services to the community or targeted 
populations in the community to address the health and social needs of 
those populations. They may include community-action agencies, housing 
agencies, area agencies on aging, centers for independent living, aging 
and disability resource centers or other non-profits that apply for 
grants or contract with healthcare entities to perform social services. 
As described earlier in this section, they may receive grants from 
other agencies in the U.S. Department of Health and Human Services, 
including Federal grants administered by the Administration for 
Children and Families (ACF), Administration for Community Living (ACL), 
the Centers for Disease Control and Prevention (CDC), the Substance 
Abuse and Mental Health Services Administration (SAMHSA), or State-
funded grants to provide social services. We stated that, generally, we 
believe such organizations know the populations and communities they 
serve, and may have the infrastructure or systems in place to assist 
practitioners to provide CHI services. We understood that many CBOs 
provide social services and do other work that is beyond the scope of 
CHI services, but we believed they are well-positioned to develop 
relationships with practitioners for providing reasonable and necessary 
CHI services.
    Because we were concerned about potential fragmentation that could 
occur in addressing specific SDOH, we proposed that only one 
practitioner per beneficiary per calendar month could bill for CHI 
services. This would allow the patient to have a single point of 
contact for all their CHI services during a given month.
    We proposed that the practitioner could separately bill for other 
care management services during the same month as CHI services, if time 
and effort are not counted more than once, requirements to bill the 
other care management service are met, and the services are medically 
reasonable and necessary.
    We proposed that CHI services could not be billed while the patient 
is under a home health plan of care under Medicare Part B, since we 
believed there would be significant overlap between services furnished 
under a home health plan of care and CHI services, particularly in the 
home health services referred to as ``medical social services,'' and in 
comprehensive care coordination. For example, medical social services 
can be furnished to the patient's family member or caregiver on a 
short-term basis when the home health agency (HHAs) can demonstrate 
that a brief intervention by a medical social worker is necessary to 
remove a clear and direct impediment to the effective treatment of the 
patient's medical condition or to the patient's rate of recovery. 
Additionally, the home health agency (HHA) conditions of participation 
require that HHAs coordinate all aspects of the beneficiary's care 
while under a home health plan of care, such as integrating services, 
whether provided directly or under arrangement, to assure the 
identification of patient needs and factors that could affect patient 
safety and treatment effectiveness and the coordination of care 
provided by all disciplines; and involvement of the patient, 
representative (if any), and caregiver(s), as appropriate, in the 
coordination of care activities.
    Also, we noted that when Medicare and Medicaid cover the same 
services for patients eligible for both programs, Medicare generally is 
the primary payer in accordance with section 1902(a)(25) of the Act. 
Based on the specificity of the coding for our proposal, we do not 
expect that CHI services will neatly overlap with any other coverage 
for patients who are dually eligible for Medicare and Medicaid. 
However, we solicited public comment regarding whether States typically 
cover services similar to CHI under their Medicaid programs, and 
whether such coverage would be duplicative of the CHI service codes. We 
also solicited comment on whether there are other service elements not 
included in the proposed CHI service codes that should be included, or 
are important in addressing unmet SDOH need(s) that affect the 
diagnosis or treatment of medical problems, where CMS should consider 
coding and payment in the future.
    The following is a summary of the comments we received and our 
responses.

[[Page 78931]]

    Comment: Many commenters requested that CMS reconsider the 
exclusion of home health patients and urged CMS to allow for concurrent 
billing of CHI services and skilled home health plan of care because it 
is well established that the limited social work component of a home 
health plan of care is not adequate to address complex health related 
social needs and does not include the same intensity of support that is 
outlined in the CHI services benefit. Commenters expressed that not 
allowing CHI services to be billed for patients who are receiving the 
home health benefit and have a home health plan of care could result in 
patients losing the services provided by CHWs to meet their needs 
related to social determinants of health, healthcare translation, and 
patient advocacy. Commenters noted that home health services typically 
extend for 60 days or more, and if the patient is currently receiving 
home health benefits it would put the patient in a position of choosing 
between two important services, potentially negatively impacting health 
outcomes.
    Response: We acknowledge the commenter's assertions that a home 
health plan of care is inadequate to address complex health-related 
social needs and does not include the same intensity of support that is 
outlined in the CHI services benefit. However, we believe that policy 
and payments accounted for under the home health prospective payment 
system already reflect much of the services described by the CHI codes, 
such that there would be significant overlap between CHI services and 
services furnished under a home health plan of care. Specifically, when 
a beneficiary is under a home health plan of care, medical social 
services are a covered home health service. Services of these 
professionals which may be covered include, but are not limited to: 
assessment of the social and emotional factors related to the patient's 
illness, need for care, response to treatment and adjustment to care; 
assessment of the relationship of the patient's medical and nursing 
requirements to the patient's home situation, financial resources and 
availability of community resources; appropriate action to obtain 
available community resources to assist in resolving the patient's 
problem; and counseling services that are required by the patient and 
medical social services for the patient's family member or caregiver on 
a short-term basis.
    Comment: Some commenters stated that most State Medicaid programs 
do not directly cover CHI services at this time, and the States that do 
have Medicaid billing codes for CHW services have reimbursement rates 
that are insufficient and unsustainable. Other commenters stated that 
authorizing Medicare payments for the CHI services would be 
complementary to services currently provided under Medicaid. 
Additionally, commenters stated that the Medicare proposal takes a more 
effective holistic approach to identify and remedy all social 
determinants of health impacting a beneficiary's medical condition 
compared to Medicaid.
    Response: We thank the commenters for their feedback. The CHI 
services are meant to resolve those specific concerns to facilitate the 
patient's medical care, which would distinguish CHI from other social 
services and programs that may be available through Medicaid State 
plans or other State or community programs.
    After consideration of public comments, we are finalizing as 
proposed that a billing practitioner may arrange to have CHI services 
provided by auxiliary personnel who are external to, and under contract 
with, the practitioner or their practice, such as through a community-
based organization (CBO) that employs CHWs, if all of the ``incident 
to'' and other requirements and conditions for payment of CHI services 
are met, and that there must be sufficient clinical integration between 
the third party and the billing practitioner in order for the services 
to be fully provided. We are also finalizing as proposed that CHI 
services could not be billed while the patient is under a home health 
plan of care under Medicare Part B. We want to emphasize the idea that 
CHI is covered and paid under the Medicare program when there are SDOH 
needs that are interfering with the billing clinician's diagnosis and 
treatment of the patient. These services are meant to resolve those 
specific concerns to facilitate the patient's medical care, which would 
distinguish CHI from other social services and programs that may be 
available through Medicaid State plans or other State or community 
programs.
c. CHI Services Valuation
    For HCPCS code G0019, we proposed a work RVU of 1.00 based on a 
crosswalk to CPT code 99490 (Chronic care management services with the 
following required elements: multiple (two or more) chronic conditions 
expected to last at least 12 months, or until the death of the patient, 
chronic conditions that place the patient at significant risk of death, 
acute exacerbation/decompensation, or functional decline, comprehensive 
care plan established, implemented, revised, or monitored; first 20 
minutes of clinical staff time directed by a physician or other 
qualified health care professional, per calendar month) as we believed 
these values most accurately reflected the resource costs incurred when 
the billing practitioner furnishes CHI services. CPT code 99490 has an 
intraservice time of 25 minutes and the work is of similar intensity to 
our proposed HCPCS code G0019. Therefore, we proposed a work time of 25 
minutes for HCPCS code G0019, based on this same crosswalk to CPT code 
99490. We also proposed to use this crosswalk to establish the direct 
PE inputs for HCPCS code G0019.
    For HCPCS code G0022, we proposed a crosswalk to the work RVU and 
direct PE inputs associated with CPT code 99439 (Chronic care 
management services with the following required elements: multiple (two 
or more) chronic conditions expected to last at least 12 months, or 
until the death of the patient, chronic conditions that place the 
patient at significant risk of death, acute exacerbation/
decompensation, or functional decline, comprehensive care plan 
established, implemented, revised, or monitored; each additional 20 
minutes of clinical staff time directed by a physician or other 
qualified health care professional, per calendar month (List separately 
in addition to code for primary procedure)) as we believed these values 
reflected the resource costs incurred when the billing practitioner 
furnishes CHI services. Therefore, we proposed a work RVU of 0.70 and a 
work time of 20 minutes for HCPCS code G0022.
    We received public comments on valuation. The following is a 
summary of the comments we received and our responses.
    Comment: While most commenters were generally supportive of our 
proposed crosswalks and valuations for HCPCS codes G0019 and G0022, and 
our proposed work RVU of 1.00 and a work time of 25 minutes based on a 
crosswalk to CPT code 99490 for G0019 and proposed a work RVU of 0.70 
and a work time of 20 minutes for HCPCS code G0022 based on a crosswalk 
to CPT code 99439. While some commenters agreed with HCPCS code G0019 
and the crosswalk to CPT code 99490, they disagreed with the suggested 
time for the service and suggested that every subsequent 20 minutes of 
CHI services up to 60 minutes should have a separate HCPCS code that 
has an equivalent RVU crosswalk to CPT code 99490. Then, these 
commenters would agree with the RVU for HCPCS code G0022, as long as

[[Page 78932]]

there is recognition that the first hour can be billed in 20-minute 
increments up to a total of 60 minutes.
    Additionally, several commenters noted that the chronic care 
management services codes are billed in 20-minute increments and 
questioned whether every subsequent twenty minutes of CHI, up to 60 
minutes, should have a separate HCPCS code that has an equivalent RVU 
crosswalk to CPT codes 99490 and 99439, up to 60 minutes per calendar 
month.
    Response: We thank the commenters for their feedback. It is our 
understanding that appropriately addressing patient needs that require 
CHI services would take longer than 20 minutes per month, and so to 
promote the comprehensiveness and integrity of the service elements we 
are finalizing as proposed for these services. We will monitor the 
utilization of CHI services and will consider changes over time for 
future rulemaking.
    Comment: A few commenters were not in support of the proposed 
valuations and encouraged CMS to reevaluate as there is a significant 
amount of work the CHW provides to the patient, whether for SDOH 
support or coordination of care for chronic conditions, wellness, and 
prevention, educating the patient, and building patient self-advocacy 
skills. Another commenter requested the work RVU for HCPCS code G0019 
be increased. An additional commenter suggested that the work RVU value 
of the 60-minute monthly CHI service should be equivalent to a CPT code 
99214 E/M visit and the additional 30-minutes CHI service should be 
equivalent to a CPT code 99213 E/M visit.
    Commenters recommended that CMS submit the CHI services codes and 
the PIN services codes to the RUC for their review.
    Response: We thank commenters for their feedback and recommendation 
to have these new G codes for CHI services be reviewed by the RUC. 
While the RUC does not typically review G codes created by CMS, these 
codes could be potentially reviewed in a future rule cycle if the RUC 
chooses to do so. We remind readers that the RUC is an independent 
organization not administered by CMS that typically decides which codes 
will be reviewed based on its own internal criteria.
    After consideration of public comments, we are finalizing the 
valuation of these codes as proposed. We will monitor the utilization 
of these new codes and consider any changes in possible future 
rulemaking.
d. Social Determinants of Health (SDOH)--Proposal To Establish a Stand-
Alone G Code
i. Background
    As previously discussed, there is increasing recognition within the 
health care system of the need to take SDOH into account when providing 
health care services, given that it is estimated \15\ that around 50 
percent of an individual's health is directly related to SDOH. Healthy 
People 2030 define the broad groups of SDOH as: economic stability, 
education access and quality, healthcare access and quality, 
neighborhood and built environment, and social and community context, 
which include factors like housing, food and nutrition access, and 
transportation needs. Many Federal agencies are also developing 
policies to better address the impact SDOH have on patients, in support 
of HHS's Strategic Approach to Addressing Social Determinants of Health 
to Advance Health Equity,\16\ as well as the CMS Framework for Health 
Equity.\17\
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    \15\ https://aspe.hhs.gov/sites/default/files/documents/e2b650cd64cf84aae8ff0fae7474af82/SDOH-Evidence-Review.pdf.
    \16\ https://aspe.hhs.gov/sites/default/files/documents/aabf48cbd391be21e5186eeae728ccd7/SDOH-Action-Plan-At-a-Glance.pdf.
    \17\ https://www.cms.gov/files/document/cms-framework-health-equity-2022.pdf.
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ii. SDOH Risk Assessment Code
    Over the past several years, we have worked to develop payment 
mechanisms under the PFS to improve the accuracy of valuation and 
payment for the services furnished by physicians and other health care 
professionals, especially in the context of evolving models of care. 
Section 1862(a)(1)(A) of the Act generally excludes from coverage 
services that are not reasonable and necessary for the diagnosis or 
treatment of illness or injury or to improve the functioning of a 
malformed body member. Practitioners across specialties have opined and 
recognized the importance of SDOH on the health care provided to their 
patients, including by recommending the assessment of SDOH through 
position or discussion papers,18 19 20 organizational 
strategic plans,\21\ and provider training modules.\22\ In the proposed 
rule, we outlined how the practice of medicine currently includes 
assessment of SDOH in taking patient histories, assessing patient risk, 
and informing medical decision making, diagnosis, care and treatment. 
The taking of a social history is generally performed by physicians and 
practitioners in support of patient-centered care to better understand 
and help address relevant problems that are impacting medically 
necessary care. We believe the resources involved in these activities 
are not appropriately reflected in current coding and payment policies. 
As such, we proposed to establish a code to separately identify and 
value a SDOH risk assessment that is furnished in conjunction with an 
E/M visit.
---------------------------------------------------------------------------

    \18\ https://www.aafp.org/about/policies/all/social-determinants-health-family-medicine-position-paper.html.
    \19\ https://doi.org/10.7326/M17-2441.
    \20\ https://nam.edu/social-determinants-of-health-201-for-health-care-plan-do-study-act/.
    \21\ https://www.ama-assn.org/system/files/2021-05/ama-equity-strategic-plan.pdf.
    \22\ https://edhub.ama-assn.org/steps-forward/module/2702762.
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    We proposed a new stand-alone G code, now assigned as HCPCS code 
G0136, Administration of a standardized, evidence-based Social 
Determinants of Health Risk Assessment, 5-15 minutes, not more often 
than every 6 months. SDOH risk assessment refers to a review of the 
individual's SDOH or identified social risk factors that influence the 
diagnosis and treatment of medical conditions. We proposed HCPCS code 
G0136 to identify and value the work involved in the administering a 
SDOH risk assessment as part of a comprehensive social history when 
medically reasonable and necessary in relation to an E/M visit. SDOH 
risk assessment through a standardized, evidence-based tool can more 
effectively and consistently identify unmet SDOH needs and enable 
comparisons across populations. For example, through administration of 
the SDOH risk assessment for a patient presenting for diabetes 
management, a practitioner might discover that a patient's living 
situation does not permit reliable access to electricity, impacting the 
patient's ability to keep insulin refrigerated. The practitioner may 
then prescribe a type of insulin that remains stable at room 
temperature or consider oral medication instead. In this example, the 
practitioner could furnish an SDOH risk assessment in conjunction with 
the E/M visit to gain a more thorough understanding of the patient's 
full social history and to determine whether other SDOH needs are also 
impacting medically necessary care.
    We further proposed that the SDOH risk assessment must be furnished 
by the practitioner on the same date they furnish an E/M visit, as the 
SDOH assessment would be reasonable and necessary when used to inform 
the patient's diagnosis, and treatment plan established during the 
visit. Required elements would include:

[[Page 78933]]

     Administration of a standardized, evidence-based \23\ SDOH 
risk assessment tool that has been tested and validated through 
research, and includes the domains of food insecurity, housing 
insecurity, transportation needs, and utility difficulties.
---------------------------------------------------------------------------

    \23\ https://health.gov/healthypeople/tools-action/browse-evidence-based-resources/types-evidence-based-resources.
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    ++ Billing practitioners may choose to assess for additional 
domains beyond those listed above if there are other prevalent or 
culturally salient social determinants in the community being treated 
by the practitioner.
    Possible evidence-based tools include the CMS Accountable Health 
Communities (AHC) \24\ tool, the Protocol for Responding to & Assessing 
Patients' Assets, Risks & Experiences (PRAPARE) \25\ tool, and 
instruments identified for Medicare Advantage Special Needs Population 
Health Risk Assessment.\26\
---------------------------------------------------------------------------

    \24\ https://innovation.cms.gov/files/worksheets/ahcm-screeningtool.pdf.
    \25\ https://www.nachc.org/research-and-data/prapare/.
    \26\ CMS-10825.
---------------------------------------------------------------------------

    Given the multifaceted nature of unmet SDOH needs appropriate 
follow-up is critical for mitigating the effects of the identified, 
unmet SDOH needs on a person's health. An SDOH risk assessment without 
appropriate follow-up for identified needs would serve little purpose. 
As such, CMS solicited comment on whether we should require as a 
condition of payment for SDOH risk assessment that the billing 
practitioner also have the capacity to furnish CHI, PIN, or other care 
management services, or have partnerships with community-based 
organizations (CBO) to address identified SDOH needs.
    The SDOH needs identified through the risk assessment must be 
documented in the medical record and may be documented using a set of 
ICD-10-CM codes known as ``Z codes'' \27\ (Z55-Z65) which are used to 
document SDOH data to facilitate high-quality communication between 
providers. We proposed a duration of 5-15 minutes for HCPCS code G0136 
for the administration of an SDOH risk assessment tool, billed no more 
often than once every 6 months. We proposed to limit the SDOH 
assessment service to once every six months, as we believe there are 
generally not significant, measurable changes to health outcomes 
impacted by a patient's SDOH in intervals shorter than 6 months.
---------------------------------------------------------------------------

    \27\ https://www.cms.gov/files/document/z-codes-data-highlight.pdf.
---------------------------------------------------------------------------

    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Commenters were overall supportive of our definition of 
SDOH. We received several comments requesting that CMS change the name 
to social drivers of health, drivers of health, or health-related 
social needs. Many of these commenters noted that other CMS programs 
use the term social drivers of health and requested that CMS use 
consistent naming conventions. Many commenters agreed that our proposal 
aligns with ongoing efforts to improve health equity and applauded our 
proposal for a new code. Other commenters discussed work that is 
already occurring in performing SDOH risk assessments and cited the 
benefits of adding payment in the PFS for these services, as they are 
currently under- or unpaid. Several commenters from rural and 
underserved areas noted that funding is scarce for resources like 
community-based organizations, and they were hopeful this code would 
increase funding and therefore access to such services.
    One commenter suggested that this service was duplicative as the E/
M coding structure allows practitioners to report a higher code to 
capture increased intensity services, such as when SDOH considerations 
are present. A few commenters strongly opposed the proposal, expressing 
concern that our proposal would divert dollars from medical care and 
would impose surveillance data gathering, which they considered 
intrusive on patients. A few other commenters recommended that the 
proposal should not be finalized and should be further studied before 
implementation. Another commenter recommended that we delay 
implementation until a more detailed analysis is available on the use 
of SDOH to improve patient outcomes. Several commenters recommended 
this code be exempted from budget neutrality, and a few other 
commenters suggested that CMS waive cost-sharing for this service.
    Response: We note that there are many definitions and names for 
similar assessments, and we share the desire to align naming 
conventions across programs, especially within CMS. However, we note 
that there is not yet a universally accepted term for these types of 
factors. Many definitions have slight differences in their intent or 
meaning, which complicates standardization. SDOH is defined by the 
Current Procedural Terms (CPT) coding guidelines, which is why we used 
this term in the proposal. We will consider whether there could be 
greater alignment in terminology across CMS in the future. We 
acknowledge that the E/M coding structure does allow for a higher level 
of Medical Decision-Making when taking things like SDOH into 
consideration. For this reason, we continue to believe that this code 
represents work that is currently not accounted for.
    With respect to budget neutrality, we remind commenters that 
section 1848(c)(2)(B)(ii)(II) of the Act requires that increases or 
decreases in RVUs may not cause the amount of Medicare Part B 
expenditures for the year to differ by more than $20 million from what 
expenditures would have been in the absence of these changes. If this 
threshold is exceeded, we must make adjustments to preserve budget 
neutrality. There is no statutory exception available for the SDOH risk 
assessment, so the expected spending associated with these services 
must be included in the CY 2024 BN adjustment. As we have frequently 
discussed in prior rulemaking for care management services (for 
example, at 81 FR 80240), we do not have authority to waive cost 
sharing for care management or other services except as specified in 
statute, such as for certain preventive services. Rather, cost sharing 
remains applicable for the proposed SDOH risk assessment and other care 
management services. We note that the beneficiaries likely to benefit 
the most from this risk assessment may qualify or already be enrolled 
in programs to reduce or eliminate cost sharing, such as Medicaid or 
other supplemental insurances. We do not agree with commenters who 
stated this type of information will impose surveillance data gathering 
in a way that is intrusive to patients. We acknowledge that the 
information collected as part of an SDOH risk assessment could be 
sensitive in nature, and we understand that discussing SDOH-related 
topics may be perceived as intrusive to some beneficiaries. However, as 
we discussed in the introduction, this information is already being 
collected by practitioners in medical settings, as many across the 
medical community agree that this type of information is important to 
the health care patients receive. We are not proposing new forms of 
data collection, but rather are seeking to acknowledge this work 
through payment, which was supported by other commenters.
    Comment: We received many comments related to the proposed 
requirement that SDOH risk assessment be furnished the same date as an 
E/M visit. Many commenters requested clarification on the same date 
requirement, citing operational difficulty in performing the assessment 
during the visit and requested that we

[[Page 78934]]

allow for the risk assessment to be performed 7-10 days prior to the 
appointment, given that many practitioners utilize a ``pre-check-in'' 
system via an online portal. We also received many comments discussing 
the furnishing of the SDOH risk assessment in conjunction with E/M 
visits. Some commenters requested that clinical psychologists be 
allowed to furnish SDOH risk assessment and specified that the SDOH 
risk assessment should be billable with CPT code 90791 and HBAI codes 
in addition to E/M visits, noting that patients with mental health 
conditions often have unmet social needs and may not see another health 
care practitioner routinely beyond a clinical psychologist. We received 
many comments requesting clinical social workers be added explicitly to 
the list of practitioners able to furnish SDOH risk assessments, citing 
that assessment of SDOH needs falls within their competencies and 
training. Other commenters recommended including all practitioners who 
can bill Medicare directly, such as marriage and family therapists 
(MFTs), mental health counselors (MHCs), and physical and occupational 
therapists.
    Response: We understand that many practitioners use online portals 
for the collection of demographic and insurance information prior to 
the visit for operational ease. However, we emphasize that this is a 
SDOH risk assessment, not a screening. The SDOH risk assessment is 
intended to be used when a practitioner has reason to believe there are 
unmet SDOH needs that are interfering with the practitioner's diagnosis 
and treatment of a condition or illness. As such, there are limited 
scenarios in which we envision a practitioner would know ahead of a 
visit that an SDOH risk assessment would be appropriate, such as a 
patient who has a history of unmet SDOH needs, or the patient disclosed 
such information before the visit. Examples could include the patient 
requesting an appointment at a specific time or on a specific date due 
to the limited availability of transportation to or from the visit, or 
the patient requests a refill of refrigerated medication that went bad 
when the electricity was terminated at their home. Given this, we do 
not agree with commenters that it would be typically appropriate to 
have a patient fill out an SDOH risk assessment 7-10 days in advance of 
an appointment. We understand that in limited scenarios, such as 
described above, a clinician may wish to get an SDOH risk assessment 
during pre-check-in paperwork. We are also sensitive to commenters' 
feedback about the operational difficulties in getting an SDOH risk 
assessment during an associated appointment, especially in 
circumstances discussed by the commenters where it is already part of 
the check-in process practitioners have in place. We agree with 
commenters that SDOH risk assessment is relevant to the diagnosis and 
treatment of conditions furnished by practitioners such as clinical 
psychologists for patients with behavioral health conditions. We do not 
agree with commenters that all practitioners who can bill for Medicare 
should qualify to perform the SDOH risk assessment under statute as 
reasonable and necessary, as we believe that practitioners who can bill 
E/M or similar behavioral health visits such as CPT code 90791 and HBAI 
codes are best positioned to provide follow-up and ongoing assessment 
in a longitudinal way. These codes are used by clinical psychologists 
to diagnose and treat behavioral health conditions as analogous codes 
to E/M services given State law and scope of practice. We acknowledge 
that other practitioners such as clinical social workers may benefit 
from an understanding of the patient's SDOH considerations to furnish 
their services. However, we believe that this information should be 
shared when possible or applicable with the care team by the furnishing 
practitioner of the associated E/M or behavioral health visit.
    After consideration of the public comments, we are finalizing the 
title, ``Social Determinants of Health'' (SDOH) risk assessment for 
HCPCS code G0136 as proposed. As discussed in response to public 
comments, this is to align with the language used by CPT. Given that we 
are focused on payment for physicians' services, most of which are 
billed using CPT codes, we believe that aligning our terminology with 
CPT makes the most sense. We are not finalizing the requirement that 
the SDOH risk assessment must be performed on the same date as the 
associated E/M or behavioral health visit (such as CPT code 90791 or 
HBAI codes), for the operational ease of practitioners. This is also in 
alignment with when HCPCS code G0136 is performed in conjunction with 
an AWV, as the AWV may be split over two visits (see section III.S. of 
this final rule for this discussion). We continue to believe that in 
most cases, HCPCS code G0136 would not be performed in advance of the 
associated E/M or behavioral health visit. We reiterate that the SDOH 
risk assessment code, HCPCS code G0136, when performed in conjunction 
with an E/M or behavioral health visit is not designed to be a 
screening, but rather tied to one or more known or suspected SDOH needs 
that may interfere with the practitioners' diagnosis or treatment of 
the patient.
    Regarding the types of associated visits that can be performed with 
HCPCS code G0136, our aim is to allow behavioral health practitioners 
to furnish the SDOH risk assessment in conjunction with the behavioral 
health office visits they use to diagnose and treat mental illness and 
substance use disorders. We are finalizing that in addition to an 
outpatient E/M visit (other than a level 1 visit by clinical staff) as 
proposed, SDOH risk assessment can also be furnished with CPT code 
90791 (Psychiatric diagnostic evaluation) and the Health Behavior 
Assessment and Intervention (HBAI) services, described by CPT codes 
96156, 96158, 96159, 96164, 96165, 96167, and 96168. We are also 
finalizing that HCPCS code G0136 may also be performed in conjunction 
with an Annual Wellness Visit. This is discussed in more detail in 
section III.S. of this final rule.
    Comment: We received several comments requesting clarification on 
the types of settings in which a SDOH risk assessment can occur, and 
several commenters asked whether this service could be furnished in the 
emergency department, observation unit, or during the perioperative 
period. These commenters noted that beneficiaries with unmet social 
needs are often seen more frequently in the emergency department 
setting, and these beneficiaries may lack access to primary care. Other 
commenters asked whether HCPCS code G0136 could be performed in 
conjunction with the E/M that is part of TCM. These commenters 
discussed that a patient's SDOH needs may have changed during the time 
of a hospitalization, citing examples such as new financial or housing 
instability due to being out of work for a prolonged time. Another 
commenter discussed that if a patient was going to be going home in a 
wheelchair for the first time, they may have new transportation issues 
if they do not have access to wheelchair-accessible transportation. 
Commenters also asked about the use of HCPCS code G0136 in conjunction 
with hospital discharge visits.
    Response: We thank the commenters for their feedback. We recognize 
that unmet SDOH needs may be relevant to the care received in facility 
settings such as emergency departments and observation units, and it 
may be appropriate for practitioners to adjust the treatment plan in 
these settings

[[Page 78935]]

based on known SDOH needs. When we created HCPCS code G0136, we 
envisioned it being used in outpatient office settings, in which a 
patient is interacting with a practitioner with whom they have a long-
standing care relationship. We acknowledge that patients may have long-
standing care relationships with practitioners they see in settings 
such as during the operative period, but we believe this to be 
atypical. Additionally, we are generally wary of paying for SDOH risk 
assessment upon every interaction with the health care system, since 
this could be burdensome for the patient and have less utility if the 
unmet SDOH needs are never addressed or followed up with in a 
longitudinal way. We agree with commenters that it makes sense to 
permit the use of HCPCS code G0136 in conjunction with hospital 
discharge visits. We note that this is consistent with other CMS 
policies since SDOH are present in the Hospital Inpatient Quality 
Reporting Program measures, and that SDOH have been identified as key 
factors related to safe discharge planning. Even so, our expectation is 
that patients that have identified unmet SDOH needs will continue to 
follow up as an outpatient either through TCM or E/M visits.
    We also believe that SDOH risk assessment is especially important 
during transitions in care, which was pointed out by commenters when 
asking if hospital discharges and TCM would count as an applicable 
associated visit. For TCM visits, we clarify that individuals who are 
discharged from a hospital, observation unit, or post-acute care, would 
also be able to receive the SDOH risk assessment during the TCM E/M 
visit, to ensure that SDOH needs have been taken into consideration as 
the patient transitioned back into the community. The use of HCPCS code 
G1036 in conjunction with the TCM E/M visit has the added benefit that 
it is likely that the practitioner furnishing TCM will be following the 
patient longitudinally in an outpatient setting and can assess for 
changes in unmet SDOH needs over time.
    After consideration of public comments, we are finalizing that 
HCPCS code G0136 may be furnished with hospital discharge visits, to 
remain consistent with other CMS policies promoting assessment of SDOH 
as an indicator of quality care and to promote safe discharge planning. 
We are also finalizing that HCPCS code G0136 can be billed in 
outpatient settings. We are interested in learning more about the ideal 
settings for HCPCS code G0136 as we work with interested parties about 
how HCPCS code G0136 is used, and we will continue to examine this 
issue in future rulemaking.
    Comment: Commenters were generally supportive of the proposed 
requirements for the use of a standardized, evidence-based SDOH risk 
assessment tool. Commenters generally appreciated the operational 
flexibility of CMS not requiring a specific tool, especially if they 
are already utilizing an SDOH risk assessment tool. A few commenters 
requested that CMS specify one specific tool or publish a list of 
approved tools to improve standardization and interoperability. Other 
commenters requested that CMS clarify that the list of tools is not 
exhaustive, and tools beyond those listed can be used if they meet the 
criteria. A few commenters requested that CMS only accept tools that 
meet the Office of the National Coordinator (ONC) for Health 
Information IT's interoperability standards. Others recommended that 
CMS limit to a specific list of industry-approved tools. Several 
commenters also noted that some quality standards allow for 
practitioners to combine questions from validated instruments and 
suggested CMS adopt similar standards.
    Response: We agree with commenters that interoperability and 
standardization are important, and we understand that specifying a list 
of tools or limiting to one tool would work towards those aims. As 
such, we note that in the proposed rule, we discussed that possible 
evidence-based tools include the CMS Accountable Health Communities 
tool, the Protocol for Responding to & Assessing Patients' Assets, 
Risks & Experiences (PRAPARE) tool, and instruments identified for 
Medicare Advantage Special Needs Population Health Risk Assessment. 
However, we are also interested in ensuring that practitioners are able 
to select tools and questions beyond the specified tools, that are 
relevant to the beneficiaries they serve. There is not a national 
consensus around one specific tool for the assessment of SDOH needs. 
Currently, practitioners and researchers choose the tool (or tools) 
that fit their needs, and we have no desire to limit or restrict this 
current work, so long as it meets the parameters specified in this 
rule. We remain committed to finding a balance between the benefits of 
allowing maximum operational flexibility and encouraging evidence-based 
standardization and interoperability.
    Comment: Commenters were in favor of requiring the use of a tool 
which includes the specified domains of food insecurity, housing 
insecurity, transportation needs, and utility difficulties. Several 
commenters discussed food insecurity as a foundational or key domain to 
be assessed, citing the dietary aspects to the treatment of conditions 
such as diabetes and hypertension. A few commenters expressed 
appreciation for the option to add additional domains, as relevant to 
their patient population. Several commenters also requested that the 
tool used be required to include the domain of interpersonal safety, 
citing CMS quality programs that require inclusion of interpersonal 
safety, and evidence that this is an important SDOH need. Another 
commenter recommended CMS explore including domains related to climate 
change.
    Response: We agree with commenters who discussed the importance of 
food insecurity, and we believe the inclusion of this domain is in line 
with efforts across the government to tackle food insecurity, such as 
the White House Conference and Strategy on Hunger, Nutrition, and 
Health.\28\ We agree that interpersonal safety is an important 
dimension of potential SDOH needs, and we also recognize the potential 
difficulty of collecting, storing, and acting on such sensitive 
information in a clinical setting. We note that practitioners may add 
additional domains if they believe those domains are relevant to their 
patient population, in which case they could utilize a tool that 
includes interpersonal safety.
---------------------------------------------------------------------------

    \28\ https://health.gov/our-work/nutrition-physical-activity/white-house-conference-hunger-nutrition-and-health.
---------------------------------------------------------------------------

    After consideration of public comments, we are finalizing as 
proposed, that any standardized, evidence-based SDOH risk assessment 
tool that has been tested and validated through research, may be used 
to conduct the SDOH risk assessment. The tool must include the domains 
of food insecurity, housing insecurity, transportation needs, and 
utility difficulties.
    We solicited comments regarding whether we should require as a 
condition of payment for SDOH risk assessment, that the billing 
practitioner also have the capacity to furnish CHI, PIN, or other care 
management services, or have partnerships with community-based 
organizations (CBO) to address identified SDOH needs.
    Comment: Commenters were mixed on this potential required condition 
of payment. Most commenters agreed with our assessment that follow-up 
is critical to mitigating the impacts of unmet SDOH needs. However, 
commenters differed on how CMS should potentially handle this. Many 
commenters agreed

[[Page 78936]]

that furnishing CHI, PIN, other care management services, or having 
partnerships with CBOs would address identified SDOH needs and was a 
reasonable requirement to furnish this service. Some commenters stated 
that we should only finalize this proposal with some requirement for 
follow-up. A few commenters stated that there is no need to perform an 
SDOH risk assessment if the practitioner does not have the ability to 
provide adequate follow up in place. Some commenters agreed that 
ideally, a practitioner would have an established relationship with a 
CBO, but noted that in some areas, particularly those that are rural 
and underserved, there are a limited supply of CBOs to address SDOH 
needs. Other commenters asked us to clarify if we were expecting 
practitioners to solve long-standing barriers for patients, or if we 
were focused on immediate actions that practitioners could take based 
on a positive risk assessment. A few other commenters agreed with the 
importance of follow-up but noted that this requirement is too 
burdensome for practitioners to have in place before they understand 
the SDOH needs of their patients and the communities in which their 
patients live.
    Response: We continue to believe that follow-up or referral is an 
important aspect of following up on findings from an SDOH risk 
assessment. We acknowledge that practitioners may not be ideally suited 
to solve long-standing SDOH concerns, but we also agree with commenters 
that follow up or referral after an SDOH risk assessment is an 
important element to addressing the issues that impact a patient's 
health and can help the patient connect with services and individuals 
that can address more of the patient's SDOH needs. We are clarifying 
that we are focused on SDOH risk assessment to identify issues that 
impact the practitioner's ability to diagnose and treat the patient. We 
thank the commenters for noting supply issues with CBOs in some places, 
and we understand that this will likely be an ongoing issue for some 
time, particularly in rural and underserved areas as many practitioners 
do not currently have relationships with CBOs. We are also sensitive to 
the operational needs of practitioners who do not yet have these 
resources in place, but who may wish to develop these relationships 
with the advent of this new coding. We are attempting to strike a 
balance between these two needs. We expect to monitor utilization of 
these codes, and we leave open the opportunity to reevaluate this 
decision on an ongoing basis.
    Comment: Many commenters supported the use of the ICD-10-CM codes 
known as Z codes (Z55-Z65) for documentation of SDOH data. A few 
commenters recommended CMS require the use of Z codes for 
standardization and interoperability across platforms. Other commenters 
recommended CMS mention or require the utilization of other systems for 
documenting social needs. Commenters who discussed the duration of 5-15 
minutes agreed that this seemed appropriate.
    Response: As stated previously, we understand and recognize the 
importance of data standardization and interoperability. We are 
requiring that the SDOH needs identified through the risk assessment be 
documented in the medical record, and we are actively encouraging Z-
code reporting to improve our data and understanding of how SDOH affect 
the patient populations enrolled in CMS programs. For example, recently 
CMS identified that when the Z code for homelessness was encoded during 
an inpatient admission, there is an increase in resource usage by the 
hospital, and as such, CMS underwent rulemaking to incorporate the Z 
code for homelessness as a comorbidity or complication that would 
increase the severity level in the MS-DRG \29\ system.
---------------------------------------------------------------------------

    \29\ 88 FR 58640.
---------------------------------------------------------------------------

    Comment: Many commenters discussed the proposed frequency 
limitation of once per 6 months, requesting that CMS clarify if the 
limitation was per beneficiary, or per practitioner per beneficiary. 
Many commenters noted operational difficulty if the frequency 
limitation was per beneficiary, as beneficiaries often have 
practitioners across different health systems, and interoperability 
constraints with EHRs would make it difficult to verify if the patient 
had received an SDOH risk assessment in the last 6 months. Other 
commenters noted that a new diagnosis may cause a rapid shift in SDOH 
needs, with sudden onset of mobility and transportation difficulty, or 
a disability that limited a beneficiary's ability to work. Many 
commenters discussed alternative frequency limitations, understanding 
that 6 months may be appropriate for those without previous SDOH needs, 
but more frequent risk assessment may be necessary for those with a 
history of unmet SDOH needs. Commenters also noted that the SDOH risk 
assessment would be especially salient during care transitions such as 
discharge from a facility such as a hospital or SNF, or a beneficiary 
who was seen several times in the emergency department recently.
    Response: We appreciate the commenters for their thoughtful and 
thorough comments. We agree that with new services, the appropriate 
frequency limitation is often difficult to ascertain. We also 
appreciate the operational difficulty of knowing when a beneficiary 
last received an SDOH risk assessment, given that many beneficiaries 
seek care with several practitioners or in different health systems. We 
acknowledge that SDOH needs may change quickly, especially in 
beneficiaries with a history of unmet social needs. We also agree with 
the comments discussing that care transitions are especially important 
moments for potential SDOH risk assessment and note that the 
Transitional Care Management (TCM) (CPT codes 99495 and 99496) are E/M 
visits and qualify as an associated visit. We aim to strike a balance 
between what is best for the patient and what is operationally best for 
the practitioner, as well as considering the patient's cost sharing 
responsibilities for each time HCPCS code G0136 is furnished separately 
from the AWV. We also note that if a patient requires frequent SDOH 
reassessments, this patient may benefit from CHI or PIN to manage these 
concerns on an ongoing basis. We will continue to engage with 
interested parties and may consider policy changes in future rulemaking 
cycles based on our review of claims data or feedback from interested 
parties.
    In light of comments we received in response to the proposed rule, 
we are not finalizing the requirement that the practitioner who 
furnishes the SDOH risk assessment must also have the capacity to 
furnish CHI, PIN, other care management services, or have partnerships 
with CBOs. We do expect that the practitioner furnishing an SDOH risk 
assessment would, at a minimum, refer the patient to relevant resources 
and take into account the results of the assessment in their medical 
decision making, or diagnosis and treatment plan for the visit.
    We are finalizing as proposed that any SDOH need identified during 
HCPCS code G0136 must be documented in the medical record. We are 
clarifying that we are not requiring the use of the Z code for 
documentation, though we are confirming that use of Z codes would be 
appropriate to document SDOH needs in the medical record. We encourage 
the use of Z codes across CMS programs to better understand the needs 
of our beneficiaries. We are finalizing a limitation on payment for the 
SDOH

[[Page 78937]]

risk assessment service of once every 6 months per practitioner per 
beneficiary.
iii. Valuation for SDOH Risk Assessment (HCPCS Code G0136)
    We proposed a direct crosswalk to HCPCS code G0444 (Screening for 
depression in adults, 5-15 minutes), with a work RVU of 0.18, as we 
believe this service reflects the resource costs associated when the 
billing practitioner performs HCPCS code G0136. HCPCS code G0444 has an 
intraservice time of 15 minutes, and the physician work is of similar 
intensity to our proposed HCPCS code G0136. Therefore, we proposed a 
work time of 15 minutes for HCPCS code G0136 based on this same 
crosswalk to HCPCS code G0444. We also proposed to use this crosswalk 
to establish the direct PE inputs for HCPCS code G0136.
    We believe these services would largely involve direct patient 
contact between the billing practitioner or billing practitioner's 
auxiliary personnel and the patient through in-person interactions, 
which could be conducted via telecommunications as appropriate. 
Therefore, we proposed to add this code to the Medicare Telehealth 
Services List to accommodate a scenario in which the practitioner (or 
their auxiliary personnel incident to the practitioner's services) 
completes the risk assessment in an interview format, if appropriate. 
We believe it is important that when furnishing this service, all 
communication with the patient be appropriate for the patient's 
educational, developmental, and health literacy level, and be 
culturally and linguistically appropriate. We solicited comment on 
where and how these services would be typically provided, along with 
other aspects of the SDOH assessment service.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Commenters agreed with our proposed crosswalk to HCPCS 
code G0444 for similar time, intensity, and direct PE inputs. 
Commenters were overwhelmingly supportive of our proposal to add HCPCS 
code G0136 to the Medicare Telehealth Services List. Commenters also 
supported CMS' belief that all communication with the patient be 
appropriate for the patient's educational, developmental, and health 
literacy level, and be culturally and linguistically appropriate. A few 
commenters noted that SDOH risk assessments are typically provided in 
an outpatient setting on a tablet or paper document by auxiliary 
personnel. A few commenters noted that they are performing routine SDOH 
``screening'' at standard intervals, with one commenter noting they 
screen patients at every visit. We also received a few comments 
requesting that CMS provide more clarity on the intersection between 
HCPCS code G0136 and PIN services. These commenters asked if HCPCS code 
G0136 should be used to reassess when SDOH needs are present while the 
patient is also receiving PIN services, or if SDOH reassessment can be 
counted towards time spent performing PIN services.
    Response: We appreciate the comments providing more context around 
how similar services are currently being furnished. See section II.D. 
of this rule for more comments on the addition of the SDOH risk 
assessment service, HCPCS code G0136, to the Medicare Telehealth List. 
We reiterate that HCPCS code G0136 is not intended to be a routine 
screening for SDOH at standard intervals or every visit. We agree with 
commenters that SDOH risk assessment is related to CHI and PIN 
services, and we believe that time spent performing HCPCS code G0136 
should count towards the 60 minutes per month spent in the performance 
of PIN services.
    After consideration of public comments, we are finalizing, as 
proposed, a direct crosswalk for HCPCS code G0136 to HCPCS code G0444, 
with a work RVU of 0.18, intraservice time of 15 minutes, and matching 
direct PE inputs from HCPCS code G0444 to HCPCS code G0136.
e. Principal Illness Navigation (PIN) Services
i. Background
    Experts on navigation of treatment for cancer and other high-risk, 
serious illnesses have demonstrated the benefits of navigation services 
for patients experiencing these conditions.\30\ Experts have noted the 
importance of these services for all affected patients, but especially 
those with socioeconomic disadvantages or barriers to care. Navigation 
generally means the process or activity of ascertaining one's position 
and planning and following a route; the act of directing from one place 
to another; the skill or process of plotting a route and directing; the 
act, activity, or process of finding the way to get to a place you are 
traveling. In the context of healthcare, it refers to providing 
individualized help to the patient (and caregiver, if applicable) to 
identify appropriate practitioners and providers for care needs and 
support, and access necessary care timely, especially when the 
landscape is complex and delaying care can be deadly. It is often 
referred to in the context of patients diagnosed with cancer or another 
severe, debilitating illness, and includes identifying or referring to 
appropriate supportive services. It is perhaps most critical when a 
patient is first undergoing treatment for such conditions, due to the 
extensive need to access and coordinate care from a number of different 
specialties or service-providers for different aspects of the diagnosis 
or treatment, and in some cases, related social services (for example, 
surgery, imaging and radiation therapy, chemotherapy for cancer; 
psychiatry, psychology, vocational rehabilitation for severe mental 
illness; psychiatry, psychology, vocational rehabilitation, 
rehabilitation and recovery programs for substance use disorder; 
infectious disease, neurology and immunology for human immunodeficiency 
virus (HIV)-associated neurocognitive disorders). For some conditions, 
patients are best able to engage with the healthcare system and access 
care if they have assistance from a single, dedicated individual who 
has ``lived experience'' (meaning they have personally experienced the 
same illness or condition the patient is facing). Although we currently 
make separate payment under the PFS for a number of care management and 
other services that may include aspects of navigation services, those 
care management services are focused heavily on clinical aspects of 
care rather than social aspects and are generally performed by 
auxiliary personnel who may not have lived experience or training in 
the specific illness being addressed. We sought to better understand 
whether there are gaps in coding for patient navigation services for 
treatment of serious illness, that are not already included in current 
care management services such as advance care planning services (CPT 
codes 99497-99498), chronic care management services (CPT codes 99490, 
99439, 99491, 99437, 99487 and 99489), general behavioral health 
integration care management services (CPT code 99484), home health and 
hospice supervision (HCPCS codes G0181-G0182), monthly ESRD-related 
services (CPT codes 90951-90970), principal care management services 
(CPT codes 99424-99427), psychiatric collaborative care management 
services (CPT codes 99492-99494), and transitional care management 
services (CPT codes 99495-99496). See

[[Page 78938]]

additional information on our PFS Care Management Services web page at 
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Care-Management.
---------------------------------------------------------------------------

    \30\ See for example, https://view.ons.org/3hjHjc and https://www.accc-cancer.org/docs/projects/pdf/patient-navigation-guide.
---------------------------------------------------------------------------

    For CY 2024, we proposed to better recognize through coding and 
payment policies when certified or trained auxiliary personnel under 
the direction of a billing practitioner, which may include a patient 
navigator or certified peer specialist, are involved in the patient's 
health care navigation as part of the treatment plan for a serious, 
high-risk disease expected to last at least 3 months, that places the 
patient at significant risk of hospitalization or nursing home 
placement, acute exacerbation/decompensation, functional decline, or 
death. Examples of serious, high-risk diseases for which patient 
navigation services could be reasonable and necessary could include 
cancer, chronic obstructive pulmonary disease, congestive heart 
failure, dementia, HIV/AIDS, severe mental illness, and substance use 
disorder (SUD). We proposed new coding for Principal Illness Navigation 
(PIN) services. In considering the appropriate patient population, we 
considered the patient population eligible for principal care 
management service codes (CPT codes 99424 through 99427), as well as 
clinical definitions of ``serious illness.'' For example, one peer-
review study defined ``serious illness'' as a health condition that 
carries a high risk of mortality and either negatively impacts a 
person's daily function or quality of life, or excessively strains 
their caregivers.\31\ Another study describes a serious illness as a 
health condition that carries a high risk of mortality and commonly 
affects a patient for several years.\32\ Some measure serious illness 
by the amount of urgent health care use (911 calls, emergency 
department visits, repeated hospitalizations) and polypharmacy.\33\ The 
navigation services such patients need are similar to CHI services (as 
outlined previously in this section), but SDOH need(s) may be fewer or 
not present; and there are specific service elements that are more 
relevant for the subset of patients with serious illness. Accordingly, 
we proposed for PIN services a parallel set of services to the CHI 
services, but focused on patients with a serious, high-risk illness who 
may not necessarily have SDOH needs; and adding service elements to 
describe identifying or referring the patient to appropriate supportive 
services, providing information/resources to consider participation in 
clinical research/clinical trials, and inclusion of lived experience or 
training in the specific condition being addressed.
---------------------------------------------------------------------------

    \31\ https://pubmed.ncbi.nlm.nih.gov/29125784/.
    \32\ https://www.ajmc.com/view/serious-illness-a-high-priority-for-accountable-care.
    \33\ https://www.ajmc.com/view/serious-illness-a-high-priority-for-accountable-care.
---------------------------------------------------------------------------

    Note about definitions: we are finalizing an additional subset of 
PIN codes below. For purposes of this section, where we refer to PIN, 
we mean all associated PIN codes (HCPCS codes G0023, G0024, G0140, and 
G0146). If there are items that do not apply to all, that is noted.
ii. Proposed Principal Illness Navigation (PIN) Service Definition
    We proposed that PIN services could be furnished following an 
initiating E/M visit addressing a serious high-risk condition/illness/
disease, with the following characteristics:
     One serious, high-risk condition expected to last at least 
3 months and that places the patient at significant risk of 
hospitalization, nursing home placement, acute exacerbation/
decompensation, functional decline, or death;
     The condition requires development, monitoring, or 
revision of a disease-specific care plan, and may require frequent 
adjustment in the medication or treatment regimen, or substantial 
assistance from a caregiver.
    Examples of a serious, high-risk condition/illness/disease include, 
but are not limited to, cancer, chronic obstructive pulmonary disease, 
congestive heart failure, dementia, HIV/AIDS, severe mental illness, 
and substance use disorder (SUD).
    We proposed that the PIN initiating visit would be an E/M visit 
(other than a low-level E/M visit that can be performed by clinical 
staff) performed by the billing practitioner who will also be 
furnishing the PIN services during the subsequent calendar month(s). 
The PIN initiating visit would be separately billed (if all 
requirements to do so are met) and would be a pre-requisite to billing 
for PIN services. We believe that certain types of E/M visits, such as 
inpatient/observation visits, ED visits, and SNF visits would not 
typically serve as PIN initiating visits because the practitioners 
furnishing the E/M services in those settings would not typically be 
the ones to provide continuing care to the patient, including 
furnishing necessary PIN services in the subsequent month(s).
    The PIN initiating visit would serve as a pre-requisite to billing 
for PIN services, during which the billing practitioner would identify 
the medical necessity of PIN services and establish an appropriate 
treatment plan. The subsequent PIN services would be performed by 
auxiliary personnel incident to the professional services of the 
practitioner who bills the PIN initiating visit. The same practitioner 
would furnish and bill for both the PIN initiating visit and the PIN 
services, and PIN services must be furnished in accordance with the 
``incident to'' regulation at Sec.  410.26. We would not require an 
initiating E/M visit every month that PIN services are billed, but only 
prior to commencing PIN services, to establish the treatment plan, 
specify how PIN services would help accomplish that plan, and establish 
the PIN services as incident to the billing practitioner's service. 
This framework is similar to our current requirements for billing care 
management services, such as chronic care management services. It also 
comports with our longstanding policy in the Medicare Benefit Policy 
Manual which provides, ``where a physician supervises auxiliary 
personnel to assist him/her in rendering services to patients and 
includes the charges for their services in his/her own bills, the 
services of such personnel are considered incident to the physician's 
service if there is a physician's service rendered to which the 
services of such personnel are an incidental part. This does not mean, 
however, that to be considered incident to, each occasion of service by 
auxiliary personnel (or the furnishing of a supply) need also always be 
the occasion of the actual rendition of a personal professional service 
by the physician. Such a service or supply could be considered to be 
incident to when furnished during a course of treatment where the 
physician performs an initial service and subsequent services of a 
frequency which reflect his/her active participation in and management 
of the course of treatment'' (Chapter 15, Section 60.1.B of the 
Medicare Benefit Policy Manual (Pub. 100-02), available on our website 
at https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/bp102c15.pdf.
    We also solicited comment on whether we should consider any 
professional services other than an E/M visit performed by the billing 
practitioner as the prerequisite initiating visit for PIN services, 
including, for example, an AWV that may or may not include the optional 
SDOH risk assessment. Under section 1861(hhh)(3)(C) of the Act, the AWV 
can be furnished by a physician or practitioner, or by other types of 
health professionals whose scope of practice does not include the 
diagnosis and

[[Page 78939]]

treatment involved in E/M services, for example a health educator.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Commenters overwhelmingly supported this proposed code. 
Several commenters expressed support for PIN services but requested 
that CMS exempt PIN services from budget neutrality. Many commenters 
discussed the wide range of benefits navigation services can have on a 
variety of conditions. Some commenters discussed the important health 
equity implications for such a proposal, citing research showing that 
members of historically disadvantaged communities and communities of 
color often receive lower rates of patient navigation, are often 
diagnosed with serious, high-risk illnesses like cancer at later 
stages, and have longer times between suspicion and definitive 
diagnosis for conditions like cancer. Many of these inequities are tied 
to access issues, and commenters suggested that PIN services would fill 
a critical gap in navigation services, noting that many navigation 
programs are currently grant-funded and unable to serve all patients 
that might benefit. Commenters also opined on the benefits of 
condition-specific navigation, discussing the value of navigators with 
targeted training or lived experience in the conditions for which they 
are providing navigation services.
    We received many comments requesting that CMS clarify the 
definition of a serious, high-risk condition, the expected duration of 
the illness, and whether conditions beyond those we listed are 
appropriate. Commenters stated that CMS should not limit the timeframe 
to an expected duration of 3 months, discussing that there are many 
conditions that meet all requirements listed by CMS of a serious, high-
risk condition, but that may be treated with the patient being cured or 
in remission within a 3-month period. Many commenters applauded our 
inclusion of severe mental illness and substance use disorder (SUD) as 
serious, high-risk conditions and noted that PIN services could be very 
impactful for these beneficiaries. Other commenters requested 
clarification on conditions such as chronic liver disease, chronic 
kidney disease, stroke, diabetes, and conditions with treatments that 
require stem cell transplantation.
    Response: With respect to budget neutrality, we remind commenters 
that section 1848(c)(2)(B)(ii)(II) of the Act requires that increases 
or decreases in RVUs may not cause the amount of Medicare Part B 
expenditures for the year to differ by more than $20 million from what 
expenditures would have been in the absence of these changes. If this 
threshold is exceeded, we must make adjustments to preserve budget 
neutrality. There is no statutory exception available for PIN services, 
so the expected spending associated with these services must be 
included in the CY 2024 BN adjustment.
    As we noted in the proposed rule, the definition of a serious, 
high-risk condition is dependent on clinical judgement. The list of 
conditions we provided is not exhaustive, and we will monitor 
utilization across beneficiaries and specialties to ascertain where and 
how PIN services are best utilized going forward. We agree with the 
commenters that additional conditions such as chronic liver disease, 
chronic kidney disease, stroke, and conditions that require stem cell 
transplantation could all meet the outlined definition depending on the 
specific severity of the illness in individuals with these conditions. 
We disagree with commenters who requested the inclusion of conditions 
that can be treated fully within the 3-month timeframe, as we do not 
believe a condition of this limited duration would require the extent 
of navigation services provided by PIN. We believe that an expected 3-
month period is a reasonable benchmark for the use of PIN services, as 
we envision PIN services as necessary to treat serious, high-risk 
conditions that require navigation over the course of several months.
    Comment: Many commenters recommended that CMS should not restrict 
PIN initiating visits to only E/M visits. Commenters noted that for 
many beneficiaries with severe mental illness or substance use disorder 
(SUD), a clinical psychologist may be the only health care practitioner 
they see regularly. Since clinical psychologists do not furnish E/M 
services, these beneficiaries would be unable to benefit from PIN 
services. Several commenters recommended including Behavioral Health 
Integration (BHI) and bundled office-based substance use disorder codes 
as initiating visits. Other commenters noted that inpatient/observation 
E/M visits and ED visits should count as initiating visits. Some 
commenters requested that CMS address whether TCM services would count 
as an initiating visit, further commenting that some serious, high-risk 
conditions are diagnosed in the hospital or similar setting, and PIN 
services would be beneficial upon discharge from such a facility. Many 
commenters also requested that the AWV count as an initiating visit for 
PIN. We received comments from dementia practitioners stating that the 
AWV includes a cognitive decline assessment, and positive results would 
likely prompt a practitioner to order PIN services. Commenters also 
requested clarification regarding the requirement that the initiating 
visit be completed by the practitioner who will be furnishing PIN 
services during the subsequent calendar months, with commenters 
discussing the burden of supervision for ongoing PIN services if one 
practitioner was covering for another practitioner, had the initiating 
visit for PIN, and would then transition care back to the returning 
practitioner after PIN services had started.
    Response: We appreciate the commenters' views and specific examples 
of how PIN services may be furnished. We thank the commenters for 
pointing out that clinical psychologists may be the practitioner type 
that primarily interfaces with beneficiaries with severe mental illness 
and SUD, and that they would be unable to furnish PIN given the 
proposed requirement for an E/M initiating visit. We agree with 
commenters that clinical psychologists should be able to bill PIN 
codes, especially for those with behavioral health conditions. We note 
that clinical psychologists have an incident to benefit under Sec.  
410.26, and clinical psychologists most commonly use CPT code 90791 
(Psychiatric diagnostic evaluation) and the Health Behavior Assessment 
and Intervention (HBAI) services described by CPT codes 96156, 96158, 
96159, 96164, 96165, 96167, and 96168 to diagnose and treat behavioral 
health conditions as analogous codes to E/M, based on the services 
clinical psychologists are allowed to furnish under State law and scope 
of practice. We note that the BHI codes and office-based substance use 
disorder bundled codes also describe care management services. We 
believe considering those codes as an initiating visit for PIN would be 
duplicative, as they also require an initiating visit, but that is 
specified for those services. Therefore, we believe they would not 
serve the purpose of an initiating visit, which is meant to establish 
the beneficiary's relationship with the furnishing practitioner, ensure 
the practitioner assesses the beneficiary and identifies a clinical 
need for services prior to initiating care management, and provide an 
opportunity to inform the beneficiary about the services and obtain 
beneficiary consent (if applicable).
    We agree with commenters that the E/M visit done as part of a 
Transitional Care Management (TCM) services could

[[Page 78940]]

serve as an initiating visit for PIN services because it includes a 
high-level office/outpatient E/M visit furnished by a physician or 
nonphysician practitioner managing the patient in the community after 
discharge.
    We appreciate the commenters' suggestions about including the AWV 
as a type of initiating visit, and the comments from dementia 
practitioners who discussed that the cognitive decline assessment in 
the AWV may be a flag for initiating PIN services. In these 
circumstances the personalized prevention plan services may include 
elements for further diagnosis and treatment of cognitive impairment 
and dementia, which may count as a high-risk condition in certain 
clinical scenarios based on clinical judgement. We acknowledge that an 
AWV may be provided by health care practitioners who do not have the 
authority to diagnose or treat medical conditions. To this end, we 
believe it would be inconsistent with our proposed application of the 
``incident to'' regulations, as a condition of payment, to allow an AWV 
furnished by a health care practitioner, other than a physician or 
qualified health care practitioner, to serve as the initiating visit 
for PIN services. Given that the AWV is a preventative service, there 
may be instances where the patient sees a medical professional 
(including a health educator, a registered dietitian, or nutrition 
professional, or other licensed practitioner) or a team of such medical 
professionals, working under the direct supervision of a physician 
where an SDOH need may be identified. Additionally, the Personalized 
Prevention Plan that is part of AWV may also help a patient who has 
identified in the AWV a high-risk condition(s) that meets the standard 
for PIN, and the high-risk condition may be part of the focus of the 
recommended Personalized Prevention Plan.
    There is no benefit under the PFS for facility settings in 
accordance with the ``incident to'' regulation at Sec.  410.26. Since 
PIN services are provided under incident to regulations, inpatient/
observation E/M visits and ED visits cannot serve as initiating visits 
for the purpose of PIN. We also continue to believe that the furnishing 
practitioner should have continuity from initiating visit through the 
supervision of PIN services, given the medical necessity of PIN 
services, and the formation of the appropriate treatment plan specific 
to that patient. This framework is similar to the current requirements 
for billing care management services, and the requirements for billing 
CHI services that we are finalizing in this rule. PIN services are 
furnished over the course of a month, and we note that patients do not 
stay in inpatient, observation, or ED settings for one month, making 
practitioners in this setting unable to furnish PIN services for the 
duration of the month, as required under incident to requirements.
    After consideration of public comments, we are finalizing CPT code 
90791 (Psychiatric diagnostic evaluation) and the Health Behavior 
Assessment and Intervention (HBAI) services described by CPT codes 
96156, 96158, 96159, 96164, 96165, 96167, and 96168 as initiating 
visits for PIN services, as we believe these are the most analogous 
codes to E/M codes that are utilized by clinical psychologists.
    We are also finalizing that the AWV may serve as an initiating 
visit for PIN services when the AWV is furnished by a practitioner who 
has identified in the AWV a high-risk condition(s) that would qualify 
for PIN services under this rule.
    For purposes of assigning a supervision level for payment, we 
proposed to designate PIN services as care management services that may 
be furnished under general supervision under Sec.  410.26(b)(5). 
General supervision means the service is furnished under the 
physician's (or other practitioner's) overall direction and control, 
but the physician's (or other practitioner's) presence is not required 
during the performance of the service (Sec.  410.26(a)(3)).
    We proposed the following codes for PIN services. As described 
previously, and in our proposed PIN code descriptors, the term ``SDOH 
need(s)'' means an SDOH need(s) that is identified by the billing 
practitioner as significantly limiting the practitioner's ability to 
diagnose or treat the serious, high-risk condition/illness/disease 
addressed in the initiating visit. We note that SDOH needs are not 
required for use PIN services but may be applicable. ``Addressed'' 
means the definition in the CPT E/M Guidelines that we have adopted for 
E/M visits. Specifically, ``[a] problem is a disease, condition, 
illness, injury, symptom, finding, complaint, or other matter addressed 
at the encounter, with or without a diagnosis being established at the 
time of the encounter. Problem addressed [means the following]: A 
problem is addressed or managed when it is evaluated or treated at the 
encounter by the physician or other qualified healthcare professional 
reporting the service. This includes consideration of further testing 
or treatment that may not be elected by virtue of risk/benefit analysis 
or patient/parent/guardian/surrogate choice. Notation in patient's 
medical record that another professional is managing the problem 
without additional assessment or care coordination documented does not 
qualify as being addressed or managed by the physician or other 
qualified healthcare professional reporting the service. Referral 
without evaluation (by history, examination, or diagnostic study[ies]) 
or consideration of treatment does not qualify as being addressed or 
managed by the physician or other qualified healthcare professional 
reporting the service.
    For purposes of PIN services, we proposed that SDOH means economic 
and social condition(s) that influence the health of people and 
communities, as indicated in these same CPT E/M Guidelines (2023 CPT 
codebook, page 11). We proposed to adopt CPT's examples of SDOH, with 
additional examples. Specifically, we proposed that SDOH(s) may include 
but are not limited to food insecurity, transportation insecurity, 
housing insecurity, and unreliable access to public utilities, when 
they significantly limit the practitioner's ability to diagnose or 
treat the serious, high-risk illness/condition/disease.
    G0023--Principal Illness Navigation services by certified or 
trained auxiliary personnel under the direction of a physician or other 
practitioner, including a patient navigator or certified peer 
specialist; 60 minutes per calendar month, in the following activities:
     Person-centered assessment, performed to better understand 
the individual context of the serious, high-risk condition.
    ++ Conducting a person-centered assessment to understand the 
patient's life story, strengths, needs, goals, preferences, and desired 
outcomes, including understanding cultural and linguistic factors.
    ++ Facilitating patient-driven goal setting and establishing an 
action plan.
    ++ Providing tailored support as needed to accomplish the 
practitioner's treatment plan.
     Identifying or referring patient (and caregiver or family, 
if applicable) to appropriate supportive services.
     Practitioner, Home, and Community-Based Care Coordination
    ++ Coordinating receipt of needed services from healthcare 
practitioners, providers, and facilities; home- and community-based 
service providers; and caregiver (if applicable).
    ++ Communication with practitioners, home-, and community-based 
service providers, hospitals, and skilled nursing facilities (or other 
health care facilities) regarding the patient's psychosocial strengths 
and needs,

[[Page 78941]]

functional deficits, goals, preferences, and desired outcomes, 
including cultural and linguistic factors.
    ++ Coordination of care transitions between and among health care 
practitioners and settings, including transitions involving referral to 
other clinicians; follow-up after an emergency department visit; or 
follow-up after discharges from hospitals, skilled nursing facilities 
or other health care facilities.
    ++ Facilitating access to community-based social services (e.g., 
housing, utilities, transportation, food assistance) as needed to 
address SDOH need(s).
     Health education--Helping the patient contextualize health 
education provided by the patient's treatment team with the patient's 
individual needs, goals, preferences, and SDOH need(s), and educating 
the patient (and caregiver if applicable) on how to best participate in 
medical decision-making.
     Building patient self-advocacy skills, so that the patient 
can interact with members of the health care team and related 
community-based services (as needed), in ways that are more likely to 
promote personalized and effective treatment of their condition.
     Health care access/health system navigation.
    ++ Helping the patient access healthcare, including identifying 
appropriate practitioners or providers for clinical care, and helping 
secure appointments with them.
    ++ Providing the patient with information/resources to consider 
participation in clinical trials or clinical research as applicable.
     Facilitating behavioral change as necessary for meeting 
diagnosis and treatment goals, including promoting patient motivation 
to participate in care and reach person-centered diagnosis or treatment 
goals.
     Facilitating and providing social and emotional support to 
help the patient cope with the condition, SDOH need(s), and adjust 
daily routines to better meet diagnosis and treatment goals.
     Leverage knowledge of the serious, high-risk condition 
and/or lived experience when applicable to provide support, mentorship, 
or inspiration to meet treatment goals.
    G0024--Principal Illness Navigation services, additional 30 minutes 
per calendar month (List separately in addition to G0023).
    To help inform whether our descriptor times are appropriate and 
reflect typical service times, and whether a frequency limit is 
relevant for the add-on code, we solicited comment on the typical 
amount of time practitioners spend per month furnishing PIN services. 
We also solicited comment to better understand the typical duration of 
PIN services, in terms of the number of months for which practitioners 
furnish PIN services following an initiating visit.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Commenters were very supportive of including PIN as a care 
management service that may be furnished under general supervision. 
Commenters were overwhelmingly supportive of our inclusion of patient 
navigators in the code description, with many comments focusing on the 
breadth of types of patient navigators in relation to the treatment of 
serious, high-risk conditions. These commenters were supportive of the 
required service element activities outlined in the proposal. 
Commenters were generally not in favor of limiting the frequency of the 
add-on code, and many commenters stated that navigation time spent per 
month is greatly dependent on the condition or illness for which it is 
being provided and the needs of the beneficiary being served. A few 
commenters discussed that CMS could add flexibility in for those 
patients who require a lot of navigation time per month by not limiting 
the frequency of the add-on code. Commenters working in the cancer/
oncology space estimated an average duration of 6 months of navigation, 
and commenters from the dementia care community suggested navigation of 
3-6 months duration. Comments related to the amount of time per month 
varied widely, with many commenters in general discussing the 
difficulty and burden in trying to capture every minute of service 
time.
    Response: We appreciate the varying nature of requirements for 
navigation across conditions. We strive to strike a balance, and we 
will monitor utilization and feedback from interested parties going 
forward to determine if changes need to be made. We appreciate the 
comments regarding a duration of 3-6 months across different 
conditions, as this aligns with our vision that PIN services will 
likely be needed for several months. We appreciate the difficulty named 
by commenters in estimating an ``average'' amount of time per month, as 
conditions and circumstances vary widely. We agree that the add-on code 
offers flexibility to provide more time if needed to patients, and we 
understand that if we limited the use of the add-on codes, we would be 
limiting the amount of time spent per month on navigation around an 
average that not every patient fits into.
    Comment: Several commenters suggested that HCPCS code G0023 be 
broken into 20-minute increments, with 3 increments making up the first 
code, and HCPCS code G0024 describing an additional 30 minutes. One 
commenter suggested increasing HCPCS code G0023 to 120 minutes and 
another commenter suggested that months 1 and 2 of PIN services should 
be 120 minutes, then subsequent months decreased to 60 minutes per 
month as intensity of navigation decreases after the initial diagnosis 
and treatment period. A few commenters suggested no limit on the 
duration of PIN services, while another commenter suggested that 
another initiating visit be required every 6 months. Some commenters 
suggested that a timed code was not the best for this type of service 
and suggested CMS adopt a per member per month flat fee. Lastly, 
several commenters requested clarification on whether PIN services 
could start before definitive diagnosis, noting that for some types of 
cancer, there is not a definitive diagnosis until a surgical 
intervention has been performed, but that there are many steps leading 
up to that, and current navigation programs often start with 
practitioner suspicion of such a diagnosis, for example after a 
positive screening test such as a mammogram. Commenters noted that this 
impacts the duration of expected PIN services, as it can often be a 
month or more between suspicion and definitive diagnosis. These 
commenters also cited research outlining health equity impacts, as many 
underserved communities have higher rates of late diagnosis due to 
delayed follow-up. These commenters stated that early navigation is 
currently being used to get patients, especially those in underserved 
communities, to a definitive diagnosis faster.
    Response: We understand the variability in the time that can be 
spent providing navigation services, given the diverse nature of what 
we have defined as a ``serious, high-risk illness.'' We continue to 
believe that PIN services should reflect a substantial amount of time 
spent per month in the navigation of the principal illness. We believe 
that if a patient requires less than 60 minutes per month for PIN 
services, then their needs may be best suited to other types of care 
management services. We thank the commenters for discussing the 
expected duration of PIN services in the context of how frequently the 
initiating visit should be performed. We disagree that a new initiating 
visit should be required every 6 months, but we do believe that 
requiring one every year

[[Page 78942]]

would be an appropriate middle ground between every 6 months and not 
requiring one as long as the serious, high-risk condition persists. We 
agree with commenters that the length of time between suspicion (such 
as a positive screening test) and definitive diagnosis can stretch into 
weeks for some conditions, and navigation services may be medically 
necessary to ensure full diagnosis and treatment of that condition. We 
note that our definition of a ``high risk condition'' does not exclude 
conditions without a definitive diagnosis. For example, a patient may 
have a mass in the colon identified on a CT scan of the abdomen. 
Regardless of the definitive diagnosis of the mass, presence of a 
colonic mass for that patient may be a serious high-risk condition that 
could, for example, cause obstruction and lead the patient to present 
to the emergency department, as well as be potentially indicative of an 
underlying life-threatening illness such as colon cancer. As such, a 
practitioner could exercise clinical judgement and determine that the 
mass represents a serious high-risk condition for that patient, and 
that PIN services should be furnished as part of the early treatment 
plan. Therefore, we are clarifying that a definitive diagnosis is not 
required before the practitioner makes a clinical determination that 
the patient has a serious high-risk condition.
    Comment: We received several comments about our proposals for PIN 
and the SDOH risk assessment requesting that CMS clarify the 
requirements surrounding the reassessment of unmet social needs and 
proposed frequency limitations. Commenters also noted that there was no 
defined activity within the proposed PIN elements of service to perform 
an SDOH risk assessment and sought clarification on the intersection 
between PIN and the SDOH risk assessment code.
    Response: We agree with commenters that the reassessment of known 
SDOH needs is interrelated to PIN services, especially within the 
presence of a serious, high-risk condition. We also agree that this 
reassessment should not be confined to the frequency limitations 
described for HCPCS code G0136.
    Comment: We received many comments from the peer support community 
applauding our inclusion of certified peer support specialists in the 
code descriptor for PIN services. Commenters were effusive in their 
support for the use and benefits of peer support specialists for 
beneficiaries with behavioral health conditions like severe mental 
illness and SUD. Peer support specialists also appreciated the 
inclusion of lived experience as a key element to PIN services and 
noted that this lived experience is a particular strength and benefit 
that peer support specialists bring to their patients. These commenters 
discussed the fear and mistrust that commonly exists within the medical 
community regarding behavioral health conditions, and these commenters 
noted that peer support specialists help bridge that gap, as their 
lived experience enables them to be a trusted and safe member of the 
care team. Many of these commenters stated that, while they are 
certified and trained to perform many of the activities listed in the 
code descriptor, care coordination activities fall outside the scope of 
certified peer support specialists. We required in our proposal that 
auxiliary personnel performing PIN services be certified or trained to 
perform all activities, and these commenters stated that this 
requirement would effectively exclude peer support specialists from 
performing PIN services. These commenters discussed that beneficiaries 
with severe mental illness and SUD would benefit from the significant 
set of activities described for PIN services that peer specialists are 
qualified to perform and urged CMS to create unique coding for PIN 
performed by peer support specialists, removing the requirements that 
fall outside of peer support specialist expertise.
    Several commenters discussed that, given low reimbursement rates 
throughout the health care industry for peer support services, many 
clinicians do not have experience working with peer support 
specialists, and misinformation about the role abounds. Commenters 
acknowledged that one way to include peer support specialists in HCPCS 
codes G0023 and G0024 would be to remove the requirement as proposed 
for all PIN auxiliary staff to be trained and certified in all service 
elements of PIN. However, these commenters described that peer support 
specialists are often asked to perform tasks outside of their 
competency and role. These commenters discussed the difficulty they 
face in clinical settings when the expectations placed on them by 
clinical practitioners do not align with what peer support specialists 
understand to be their scope and role on the treatment team. These 
commenters stated concern that having care management activities listed 
in the service descriptor but not required would further 
misunderstanding about the peer support specialist role and would lead 
to peer support specialists being asked to complete those tasks. 
Commenters also suggested that CMS remove the care coordination 
elements in the PIN code descriptors altogether to align these services 
with peer support competencies. We also received many comments 
recommending that CMS should align the PIN activities with SAMHSA's 
National Model Standards for Certification \34\ for peer support 
workers.
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    \34\ https://www.samhsa.gov/about-us/who-we-are/offices-centers/or/model-standards.
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    Commenters were generally aligned on the specific items they noted 
were outside of the scope of peer support specialists but differed on 
how to handle these items. Below is a list of the items in the PIN 
descriptor on which we received comment.
    One commenter recommended removing  Person-centered 
assessment, performed to better understand the individual context of 
the serious, high-risk condition. The same commenter recommended 
changing ++ Conducting a person-centered assessment to understand the 
patient's life story, strengths, needs, goals, preferences, and desired 
outcomes, including understanding cultural and linguistic factors, and 
including unmet SDOH needs (that is not separately billed) to ++ 
Conducting a person-centered interview. Most commenters recommended 
changing ++ Providing tailored support as needed to accomplish the 
practitioner's treatment plan to ++ Providing tailored support as 
needed to accomplish the person-centered goals in the practitioner's 
treatment plan, while another commenter removed this item.
    Response: We thank the commenters for their feedback. The peer 
support community has told us through public comment that they have 
issues with scope of work, and they are frequently asked to perform 
tasks outside of their scope of practice. We defer to the peer support 
community with their suggestion of changing the word assessment to 
interview to make the language more consistent with peer support 
competencies and scope of practice. We also believe it is important to 
explicitly state items to be included in the interview. We agree with 
the commenters who suggested modifying this bullet to ``person-centered 
goals'' in the treatment plan, as this is in alignment with both peer 
support values as stated by the commenters and maintains the intention 
of the descriptor.
    Comment: All commenters recommended either renaming  
Practitioner, Home, and Community-Based Care Coordination to  
Practitioner, Home, and Community-

[[Page 78943]]

Based Care Communication or removing this bullet. All commenters 
recommended removing ++ Coordinating receipt of needed services from 
healthcare practitioners, providers, and facilities; home- and 
community-based service providers; and caregiver (if applicable).
    Commenters either recommended removing this bullet or renaming ++ 
Communication with practitioners, home-, and community-based service 
providers, hospitals, and skilled nursing facilities (or other health 
care facilities) regarding the patient's psychosocial strengths and 
needs, functional deficits, goals, preferences, and desired outcomes, 
including cultural and linguistic factors to ++ Assisting the patient 
in communicating with their practitioners, home-, and community-based 
service providers, hospitals, and skilled nursing facilities (or other 
health care facilities) regarding the patient's psychosocial strengths 
and needs, functional deficits, goals, preferences, and desired 
outcomes, including cultural and linguistic factors.
    All commenters recommended removing ++ Coordination of care 
transitions between and among health care practitioners and settings, 
including transitions involving referral to other clinicians; follow-up 
after an emergency department visit; or follow-up after discharges from 
hospitals, skilled nursing facilities or other health care facilities.
    Response: We largely defer to the commenters' judgements about 
these word choices, but we agree that ``assisting the patient in 
communicating'' with practitioners is largely analogous to 
communicating on behalf of patients, and we appreciate the intention to 
leave this important facet of all navigation services in the PIN code. 
Given that all commenters were in favor of removing some bullets, we 
again defer to the peer support community.
    All commenters recommended removing  Health care access/
health system navigation.
    ++ Helping the patient access healthcare, including identifying 
appropriate practitioners or providers for clinical care, and helping 
secure appointments with them.
    ++ Providing the patient with information/resources to consider 
participation in clinical trials or clinical research as applicable.
    Response: We thank the commenters for their feedback. Given that 
commenters were unanimous in removing these items from the descriptor, 
we support removing them from the PIN-PS descriptor.
    Comment: Commenters were split on the descriptor  
Facilitating behavioral change as necessary for meeting diagnosis and 
treatment goals, including promoting patient motivation to participate 
in care and reach person-centered diagnosis or treatment goals. Some 
commenters suggested removal of this bullet, whereas others recommended 
rewriting to  Developing and proposing strategies to help meet 
person-centered treatment goals and supporting the patient in using 
chosen strategies to reach person-centered treatment goals.
    Response: We believe the inclusion of strategizing with a patient 
to help them meet their treatment goals is an important element of PIN 
services. We support the revision of this bullet to emphasize the 
person-centered approach to treatment goals and assisting the patient 
in using individualized strategies towards this aim.
    Comment: Commenters also differed on  Facilitating and 
providing social and emotional support to help the patient cope with 
the condition, SDOH need(s), and adjust daily routines to better meet 
diagnosis and treatment goals. A few commenters suggested the addition 
of person-centered to meet the diagnosis and treatment goals, whereas 
others removed everything after daily routines. One commenter 
recommended editing  Leverage knowledge of the serious, high-
risk condition and/or lived experience when applicable to provide 
support, mentorship, or inspiration to meet treatment goals to end 
after inspiration, removing mention of meeting treatment goals.
    Response: We continue to believe that the intersection of the 
diagnosis and treatment goals with the support provided to the patient 
is essential to the success of PIN services. We also support the 
revision throughout these code descriptors to emphasize the ``person-
centeredness'' of diagnosis and treatment goals.
    We are sympathetic to the nuances of the interactions between peer 
support specialists and clinicians, and we appreciate the peer support 
community for bringing these issues to our attention. We agree with the 
value and benefit of having peer support specialists as part of the 
treatment team for those with severe mental illness and SUD. We are 
clarifying that our intention in creating the PIN service elements was 
to include a navigation role for certified peer support specialists in 
the treatment of severe mental illness and SUD. We believe that it is 
important to preserve the care management elements of PIN that can be 
performed by other types of health care professionals, and which are 
important to PIN for many serious, high-risk conditions. We also 
recognize the role that peer support specialists can serve in providing 
navigation for patients with severe mental illness and SUD through PIN 
services. We thank the commenters for their efforts in specifically 
describing the items in the PIN service descriptor that they believe 
fall outside of the scope of a peer support specialist. We understand 
that, given the misalignment that can occur between clinical 
practitioners and peer support specialists regarding their role on the 
treatment team outlined in the peer support specialists' comments, it 
is important to be as specific when possible to avoid misunderstanding 
about the types of auxiliary personnel we envision performing these 
services. We believe that further defining the role of peer support 
specialists within PIN codes will help alleviate this misalignment. We 
note that the comments were generally unified around the removal or 
modification of some items, and we believe that the overall nature and 
value PIN services provide to behavioral health patients is unchanged 
from the original PIN descriptor.
    As described by the commenters, the conducting of a person-centered 
assessment or interview to understand the patient's life remains 
critical to the medical benefit of navigation for serious, high-risk 
conditions including behavioral health conditions. Discussing goal 
setting, establishing an action plan, and identifying or referring the 
patient to appropriate supportive services is important to ensuring 
behavioral health patients stay engaged in the treatment of their 
principal illness. As discussed previously, we heard from commenters 
that many patients with behavioral health conditions have unmet SDOH 
needs, and service elements such as facilitating access to community-
based social services, health education, and building patient self-
advocacy skills all help patients better understand their condition, 
contextualize their principal illness within their lives, and advocate 
for themselves both in and out of health care settings with the aim of 
improving their diagnosis and treatment of said condition.
    After consideration of public comments, we are finalizing the 
service elements, descriptors, and time per month for HCPCS codes G0023 
and G0024 generally as proposed, with the addition of ``and including 
unmet SDOH needs (that are not separately billed)'' as part of the 
person-centered assessment. This addition is in response

[[Page 78944]]

to comments made in both the HCPCS code G0136 and PIN sections 
regarding the intersection of the SDOH risk assessment code. This 
service element describes the need to reassess SDOH needs within both 
CHI and PIN and allows for time spent performing SDOH reassessment that 
is not otherwise billed to count towards CHI and PIN services. We 
clarify that this time cannot be duplicated by HCPCS code G0136 or any 
other service. Below are the final code descriptors for HCPCS codes 
G0023 and G0024.
    G0023--Principal Illness Navigation services by certified or 
trained auxiliary personnel under the direction of a physician or other 
practitioner, including a patient navigator or certified peer 
specialist; 60 minutes per calendar month, in the following activities:
     Person-centered assessment, performed to better understand 
the individual context of the serious, high-risk condition.
    ++ Conducting a person-centered assessment to understand the 
patient's life story, strengths, needs, goals, preferences, and desired 
outcomes, including understanding cultural and linguistic factors and 
including unmet SDOH needs (that are not separately billed).
    ++ Facilitating patient-driven goal setting and establishing an 
action plan.
    ++ Providing tailored support as needed to accomplish the 
practitioner's treatment plan.
     Identifying or referring patient (and caregiver or family, 
if applicable) to appropriate supportive services.
     Practitioner, Home, and Community-Based Care Coordination.
    ++ Coordinating receipt of needed services from healthcare 
practitioners, providers, and facilities; home- and community-based 
service providers; and caregiver (if applicable).
    ++ Communication with practitioners, home-, and community-based 
service providers, hospitals, and skilled nursing facilities (or other 
health care facilities) regarding the patient's psychosocial strengths 
and needs, functional deficits, goals, preferences, and desired 
outcomes, including cultural and linguistic factors.
    ++ Coordination of care transitions between and among health care 
practitioners and settings, including transitions involving referral to 
other clinicians; follow-up after an emergency department visit; or 
follow-up after discharges from hospitals, skilled nursing facilities 
or other health care facilities.
    ++ Facilitating access to community-based social services (e.g., 
housing, utilities, transportation, food assistance) as needed to 
address SDOH need(s).
     Health education--Helping the patient contextualize health 
education provided by the patient's treatment team with the patient's 
individual needs, goals, preferences, and SDOH need(s), and educating 
the patient (and caregiver if applicable) on how to best participate in 
medical decision-making.
     Building patient self-advocacy skills, so that the patient 
can interact with members of the health care team and related 
community-based services (as needed), in ways that are more likely to 
promote personalized and effective treatment of their condition.
     Health care access/health system navigation.
    ++ Helping the patient access healthcare, including identifying 
appropriate practitioners or providers for clinical care, and helping 
secure appointments with them.
    ++ Providing the patient with information/resources to consider 
participation in clinical trials or clinical research as applicable.
     Facilitating behavioral change as necessary for meeting 
diagnosis and treatment goals, including promoting patient motivation 
to participate in care and reach person-centered diagnosis or treatment 
goals.
     Facilitating and providing social and emotional support to 
help the patient cope with the condition, SDOH need(s), and adjust 
daily routines to better meet diagnosis and treatment goals.
     Leverage knowledge of the serious, high-risk condition 
and/or lived experience when applicable to provide support, mentorship, 
or inspiration to meet treatment goals.
    G0024--Principal Illness Navigation services, additional 30 minutes 
per calendar month (List separately in addition to G0023).
    For certified peer support specialists, we continue to believe the 
work provided by peer support specialists is crucial to the treatment 
of some patients with behavioral health conditions. We attempted to 
recognize this work with our proposed PIN code, but given the public 
comments we received, we are also finalizing two new codes, HCPCS code 
G0140 and HCPCS code G0146 for Principal Illness Navigation--Peer 
Support (PIN-PS). Given the nature of work typically performed by peer 
support specialists, we are limiting these codes to the treatment of 
behavioral health conditions that otherwise satisfy our definition of a 
high-risk condition(s). Patients with behavioral health conditions can 
still receive HCPCS code G0023 and HCPCS code G0024 services, so long 
as the auxiliary staff providing them is trained and certified in all 
parts of those code descriptors. We understand that behavioral health 
patients are not a monolith, and some patients may be best suited to 
traditional PIN services.
    G0140--Principal Illness Navigation--Peer Support by certified or 
trained auxiliary personnel under the direction of a physician or other 
practitioner, including a certified peer specialist; 60 minutes per 
calendar month, in the following activities:
     Person-centered interview, performed to better understand 
the individual context of the serious, high-risk condition.
    ++ Conducting a person-centered interview to understand the 
patient's life story, strengths, needs, goals, preferences, and desired 
outcomes, including understanding cultural and linguistic factors, and 
including unmet SDOH needs (that are not billed separately).
    ++ Facilitating patient-driven goal setting and establishing an 
action plan.
    ++ Providing tailored support as needed to accomplish the person-
centered goals in the practitioner's treatment plan.
     Identifying or referring patient (and caregiver or family, 
if applicable) to appropriate supportive services.
     Practitioner, Home, and Community-Based Care Communication
    ++ Assist the patient in communicating with their practitioners, 
home-, and community-based service providers, hospitals, and skilled 
nursing facilities (or other health care facilities) regarding the 
patient's psychosocial strengths and needs, goals, preferences, and 
desired outcomes, including cultural and linguistic factors.
    ++ Facilitating access to community-based social services (e.g., 
housing, utilities, transportation, food assistance) as needed to 
address SDOH need(s).
     Health education--Helping the patient contextualize health 
education provided by the patient's treatment team with the patient's 
individual needs, goals, preferences, and SDOH need(s), and educating 
the patient (and caregiver if applicable) on how to best participate in 
medical decision-making.
     Building patient self-advocacy skills, so that the patient 
can interact with members of the health care team and related 
community-based services (as needed), in ways that are more likely to 
promote personalized and effective treatment of their condition.
     Developing and proposing strategies to help meet person-
centered treatment goals and supporting the patient in

[[Page 78945]]

using chosen strategies to reach person-centered treatment goals.
     Facilitating and providing social and emotional support to 
help the patient cope with the condition, SDOH need(s), and adjust 
daily routines to better meet person-centered diagnosis and treatment 
goals.
     Leverage knowledge of the serious, high-risk condition 
and/or lived experience when applicable to provide support, mentorship, 
or inspiration to meet treatment goals.
    G0146--Principal Illness Navigation--Peer Support, additional 30 
minutes per calendar month (List separately in addition to G0140).
    We are not finalizing a frequency limitation for the services 
described by HCPCS codes G0024 or G0146, and we will monitor 
utilization of these codes going forward to ascertain the time spent 
per month per PIN service. We are not limiting the duration PIN 
services, but we are finalizing a requirement that a new initiating 
visit be conducted once per year. We proposed that all auxiliary 
personnel who provide PIN services must be certified or trained to 
provide all elements in the corresponding service and be authorized to 
perform them under applicable State law and regulations. Under Sec.  
410.26(a)(1) of our regulations, auxiliary personnel must meet any 
applicable requirements to provide incident to services, including 
licensure, imposed by the State in which the services are being 
furnished. Many States have applicable rules and certifications, and 
there are existing certification programs for navigators working in 
certain settings of care or with specified conditions, such as cancer 
navigators, diabetes navigators, cardiovascular navigators, mental 
health navigators, geriatric care navigators, pediatric navigators, 
social worker navigators, primary care navigators, general patient 
advocate navigators, and nurse navigators in ambulatory settings.\35\
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    \35\ https://resumecat.com/blog/patient-navigator-certifications.
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    For peer support specialists, approximately 48 States have 
professional certification programs for those providing services to 
patients with substance use or mental health conditions. States may 
include qualified peer support specialist in their Medicaid programs. 
In 2007, the Center for Medicaid and CHIP Services published guidance 
outlining minimum requirements for peer support specialist 
participating in Medicaid as follows: peer support specialists must be 
self-identified consumers who are in recovery from mental illness and/
or substance use disorders, supervised by a competent mental health 
professional, and complete training that provides peer support 
specialists with a basic set of competencies necessary to perform the 
peer support function, including demonstrating the ability to support 
the recovery of others from mental illness and/or substance use 
disorders and ongoing continual educational requirements.\36\ In States 
with professional certification programs, training and certification 
requirements vary, with an average of 40 and 46 hours of initial 
approved education, with almost all States requiring either a written 
or written and oral exam. A little less than half of States also 
require supervised work or volunteer hours to obtain certification.\37\
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    \36\ https://downloads.cms.gov/cmsgov/archived-downloads/smdl/downloads/smd081507a.pdf.
    \37\ https://peerrecoverynow.org/wp-content/uploads/2023-FEB-07-prcoe-comp-analysis.pdf.
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    In States that do not have applicable licensure, certification, or 
other laws or regulations governing the certification or training of 
auxiliary personnel, we proposed to require auxiliary personnel 
providing PIN services be trained to provide all service elements. 
Training must include the competencies of patient and family 
communication, interpersonal and relationship-building, patient and 
family capacity building, service coordination and systems navigation, 
patient advocacy, facilitation, individual and community assessment, 
professionalism and ethical conduct, and the development of an 
appropriate knowledge base, including specific certification or 
training on the serious, high-risk condition/illness/disease addressed 
in the initiating visit. We proposed these competencies because we 
believe they reflect professional consensus regarding appropriate core 
competencies, adjusted to this context.\38\ We solicited public comment 
on the number of hours of training to require, as well as the training 
content and who should provide the training.
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    \38\ https://view.ons.org/3hjHjc and https://www.accc-cancer.org/docs/projects/pdf/patient-navigation-guide; https://chwtraining.org/c3-project-chw-skills/; and https://peerrecoverynow.org/wp-content/uploads/Comparative-Analysis_Jan.31.2022-003.pdf; https://www.samhsa.gov/sites/default/files/national-model-standards-for-peer-support-certification.pdf?utm_source=SAMHSA&utm_campaign=4b88ba3e51-EMAIL_CAMPAIGN_2023_06_05_02_41&utm_medium=email&utm_term=0_-4b88ba3e51-%5BLIST_EMAIL_ID%5D.
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    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: We received a few comments, outside of the peer support 
specialist community, regarding training and certification for 
auxiliary personnel providing PIN service elements. One commenter 
emphasized the importance of training and/or lived experience with the 
relevant condition to the PIN services being provided, and this 
commenter suggested training for all auxiliary personnel should require 
case studies for each condition for which the auxiliary personnel will 
be providing navigation. Commenters were split on whether a standard 
amount of training hours should be required, with one commenter 
suggesting 8 hours per year, and another commenter suggesting a 
requirement of 225 hours for the initial training. Another commenter 
suggested all navigators be trained in oncology navigation, given the 
prevalence of cancer in many communities, regardless of what population 
they will primarily serve. Another commenter discussed the importance 
of providing training on how to help patients access clinical trials. 
One commenter recommended CMS require all auxiliary personnel 
performing PIN services to have a bachelor's degree. Another commenter 
recommended CMS require training in trauma-informed care, implicit 
bias, empathetic inquiry, and motivational interviewing.
    Response: We appreciate the suggestion of case studies and 
condition-specific training, as we outlined in the proposed rule. While 
we agree that PIN services are well-suited for oncology navigation, we 
disagree with the idea that all auxiliary personnel providing PIN 
services should be trained in oncology navigation, given that we expect 
PIN services to be focused on the principal illness for which PIN 
services are being furnished. We note that since we are finalizing PIN 
services as ``per condition,'' rather than the patient only being able 
to have one PIN service at a time, this crossover in navigation is 
unnecessary, as a patient receiving PIN for one condition that gets 
diagnosed with cancer would likely qualify for a second, oncology-
specific PIN navigator. Given the wide variety of suggestions we 
received from commenters regarding the number of specific hours to 
require, we believe that it is important for PIN services to allow for 
many types of auxiliary personnel to furnish PIN, making potential 
standardization of training and education requirements, such as a set 
number of hours of training, difficult.
    After consideration of public comments, we are not finalizing a 
required number of hours of training for auxiliary personnel to provide 
PIN services. We defer to State requirements

[[Page 78946]]

where applicable for all types of auxiliary personnel. For States with 
no applicable State requirements, we are finalizing as proposed that 
the training and certification for auxiliary personnel providing HCPCS 
codes G0023 and G0024 include the competencies of patient and family 
communication, interpersonal and relationship-building, patient and 
family capacity building, service coordination and systems navigation, 
patient advocacy, facilitation, individual and community assessment, 
professionalism and ethical conduct, and the development of an 
appropriate knowledge base, including specific certification or 
training on the serious, high-risk condition/illness/disease addressed 
in the initiating visit.
    Comment: Regarding certified peer support specialists, we received 
many comments regarding their training and certification requirements. 
A few commenters stated that training and certification is required at 
the State level in 49 States and that these requirements are sufficient 
for Medicaid payment by states. Several commenters requested that CMS 
not require any additional training for peer support specialists beyond 
State certification, as that would be a burden on the workforce and the 
agencies that employ them. A few commenters recommended that CMS 
mandate training alignment with the SAMHSA National Model Standards for 
the training of all peer support specialists, stating that these 
standards were developed with direct input and feedback from peer 
support workers themselves. These commenters discussed that it is 
important for those who are doing peer support work to have input into 
the training and certification standards for their profession.
    Response: We note that a 2023 review of State requirements done in 
partnership with SAMHSA cited that two States remain without current 
peer support specialist certification or licensing requirements. One of 
the remaining States is currently working on developing a 
certification.\39\ We thank the commenters for the mention of the 
National Model Standards, and we agree that we should aim to align 
across the Federal government where possible.
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    \39\ https://peerrecoverynow.org/wp-content/uploads/2023-FEB-07-prcoe-comp-analysis.pdf.
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    After consideration of public comments, for PIN-PS (HCPCS codes 
G0140 and G0146), if no applicable State requirements exist, we are 
finalizing that training must be consistent with the National Model 
Standards for Peer Support Certification published by SAMHSA. This is 
the most universally recognized standard for peer support specialists 
in the country and was developed and is maintained by SAMHSA, who has 
an expertise in this area.
    We proposed that time spent furnishing PIN services for purposes of 
billing HCPCS codes G0023-4 must be documented in the medical record in 
its relationship to the serious, high-risk illness. The activities 
performed by the auxiliary personnel, and how they are related to the 
treatment plan for the serious, high-risk condition, would be described 
in the medical record, just as all clinical care is documented in the 
medical record. We would require identified SDOH need(s), if present, 
to be recorded in the medical record, and for data standardization, 
practitioners would be encouraged to record the associated ICD-10 Z-
code (Z55-Z65) in the medical record and on the claim.
    Similar to CHI services, we believe that many of the elements of 
PIN services would involve direct contact between the auxiliary 
personnel and the patient but may not necessarily be in-person and a 
portion might be performed via two-way audio. We sought to confirm our 
understanding of where and how PIN services would be typically provided 
(for example, with or without direct patient contact, in-person, using 
audio-video, using two-way audio; and whether navigators are typically 
local to the patient).
    We solicited public comment regarding whether we should require 
patient consent for PIN services. For care management services that 
could generally be performed without any direct patient contact, we 
have required advance patient consent to receive the services as a 
prerequisite to furnishing and billing the services, to avoid patients 
receiving bills for cost sharing that they might not be expecting to 
receive. For example, a patient might receive chronic care management 
services comprised of practitioners coordinating care with each other 
and reviewing or exchanging medical records between visits, in ways 
that do not require involving the patient directly. As we have 
frequently discussed in prior rulemaking for care management services 
(for example, at 81 FR 80240), we do not have statutory authority to 
waive cost sharing for care management or other services. Rather, cost 
sharing remains applicable, except as specified by statute such as for 
certain preventive services. In recent years, we have required advance 
documented patient consent to receive most care management services as 
a condition of the practitioner billing those services, to avoid a 
situation where the patient is surprised to receive a bill for the 
associated cost sharing. These consent requirements include informing 
the patient about applicable cost sharing, the right to discontinue 
services, and, where applicable, the limitation that payment is made 
for the service to only one practitioner per month. We have heard from 
interested parties over time that requiring advance patient consent is 
an administrative burden and may unnecessarily prevent patient receipt 
of needed services. We did not propose to require consent for PIN 
services, since we believe these services typically would involve 
direct patient contact, and largely be provided in-person. However, in 
the proposed rule we stated that if we heard from public commenters 
that PIN services would frequently not involve direct contact with the 
patient, or could extend for periods of time for which the patient 
might not be expecting to incur cost sharing obligations (such as 
several months), we would consider requiring patient consent to receive 
PIN services in our final rule.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: We received many comments regarding the use of two-way 
audio or audio-video technology in the current practice of navigation 
services. One commenter noted that the time required to provide 
navigation services for each patient had dropped during the pandemic 
when most of the communication switched to two-way audio or audio-
visual. Other commenters discussed that for patients in rural areas, 
not requiring face-to-face contact in person reduced patient burden, 
given that the individuals providing navigation services may not be 
located in the exact community in which the patient live. This 
commenter noted that in rural areas, navigators often cover a large 
geographic area, but are still aware of community resources and all the 
appropriate services throughout their catchment area. Several 
commenters also discussed the importance of virtual communication for 
patients who are immunocompromised. A few commenters requested that PIN 
services be placed on the Medicare Telehealth Services List.
    Response: We note that we did not receive comments directly 
discussing the current amount of time spent each month furnishing 
navigation services in person versus the amount of time spent using 
telecommunications. We did not receive comments discussing the

[[Page 78947]]

amount of time navigators spend performing activities on behalf of the 
patient without the patient being present. We also did not receive much 
information regarding if there are elements of the navigation service 
that are best served face-to-face or pieces that are just as impactful 
if done via telecommunications technology. We agree with commenters 
generally that PIN services will likely benefit from the use of two-way 
audio or audio-visual technology as a key part of the service, but 
based on the comments received, we do not believe that we have a 
complete understanding of how technology is being used to furnish 
navigation services currently. We also acknowledge that PIN services 
(HCPCS codes G0023 and G0024) and PIN-Peer Support (HCPCS codes G0140 
and G0146) may look different when they are being furnished. For 
example, the wording on the service elements for PIN-PS is slightly 
different, discussing that the navigator in PIN-PS ``assists the 
patient in communicating'' with health care practitioners, rather than 
communicating with the practitioners on behalf of the patient through 
coordination activities. This may mean that the navigator for PIN-PS is 
in direct contact with the patient more, as they are assisting the 
patient in performing a task, rather than performing that task on 
behalf of the patient. Given these intricacies and the lack of 
specificity in the comments we received, we do not believe we can make 
a determination at this time regarding whether or not PIN services meet 
the standards of services that are inherently in-person services that 
are instead furnished using an interactive telecommunications system as 
described in Sec.  410.78(a)(3). Given these factors, we are not 
finalizing the inclusion of PIN services (HCPCS codes G0023, G0024, 
G0140, G0146) on the Medicare Telehealth Services List at this time. We 
will continue to consider this issue for potential rulemaking in the 
future.
    Comment: In response to our comment solicitation, commenters were 
overwhelmingly in favor of requiring patient consent for PIN services. 
Many commenters cited patient cost sharing obligations, discussing both 
the expected duration of PIN services over several months, as well as 
the fact that some parts of the service may be provided without the 
patient present. Several commenters encouraged CMS to require consent, 
but noted potential burdens depending on how the consent is obtained, 
especially when advance consent is required. Commenters urged CMS to 
allow verbal consent to be documented in the medical record and to 
allow auxiliary personnel to document it. One commenter that was not in 
favor of requiring consent was concerned that a patient might not have 
a clear understanding of their condition and expected course of 
treatment at the beginning of a principal illness and is likely to be 
overwhelmed with information. This commenter further clarified that 
without adequate information, as well as potentially having concerns 
regarding their financial responsibility for both their course of 
treatment and any applicable cost-sharing for PIN, would decline PIN 
services without fully understanding the costs and benefits of 
navigation.
    Response: We appreciate the commenters' thoughts about this issue. 
We acknowledge that beneficiaries are dealing with a lot at the time 
they are diagnosed with a principal illness, but we also acknowledge 
that navigation services are a key part of helping beneficiaries manage 
this difficult time. While we do not always require consent for all 
medically necessary services, we have required consent on occasion when 
services are being provided for a prolonged period of time and when 
some of the service may be performed without the patient's presence. In 
addition, the vast majority of commenters strongly supported the 
requirement of consent to provide improved patient awareness of cost-
sharing responsibilities, especially given that these navigation 
services may be expected to last several months.
    After consideration of public comments, we are finalizing that 
patient consent is required for PIN services, and that consent can be 
written or verbal, so long as it is documented in the patient's medical 
record. We believe that the commenters' feedback regarding the 
potential duration of PIN services over multiple months, in addition to 
the fact that PIN services may not be furnished with the patient 
present is convincing evidence that patients should be aware of their 
cost-sharing obligations over time for PIN services. We are finalizing 
that consent must be obtained annually and may be obtained by the 
auxiliary personnel either before or at the same time that they begin 
performing PIN services for the patient.
    We proposed that a practitioner may arrange to have PIN services 
provided by auxiliary personnel who are external to, and under contract 
with, the practitioner or their practice, such as through a community-
based organization (CBO) that employs CHWs or other auxiliary 
personnel, if all of the ``incident to'' and other requirements and 
conditions for payment of PIN services are met. Although we proposed to 
allow PIN services to be performed by auxiliary personnel under a 
contract with a third party, we clarify, as we have in our regulations 
for other care management services, that there must be sufficient 
clinical integration between the third party and the billing 
practitioner in order for the services to be fully provided, and the 
connection between the patient, auxiliary personnel, and the billing 
practitioner must be maintained. As we discussed in a similar context 
for care management services the CY 2017 PFS final rule, if there is 
little oversight by the billing practitioner or a lack of clinical 
integration between a third party providing the services and the 
billing practitioner, we do not believe PIN services, as we proposed to 
define them, could be fully performed; and therefore, in such cases, 
PIN services should not be billed (81 FR 80249). We would expect the 
auxiliary personnel performing the PIN services to communicate 
regularly with the billing practitioner to ensure that PIN services are 
appropriately documented in the medical record, and to continue to 
involve the billing practitioner in evaluating the continuing need for 
PIN services to address the serious, high-risk condition.
    In the CY 2023 PFS final rule (87 FR 69790) and as explained in the 
CY 2023 PFS proposed rule (87 FR 46102), where we refer to community-
based organizations, we mean public or private not-for-profit entities 
that provide specific services to the community or targeted populations 
in the community to address the health and social needs of those 
populations. They may include community-action agencies, housing 
agencies, area agencies on aging, centers for independent living, aging 
and disability resource centers or other non-profits that apply for 
grants or contract with healthcare entities to perform social services. 
As described earlier, they may receive grants from other agencies in 
the U.S. Department of Health and Human Services, including Federal 
grants administered by the Administration for Children and Families 
(ACF), Administration for Community Living (ACL), the Centers for 
Disease Control and Prevention (CDC), the Substance Abuse and Mental 
Health Services Administration (SAMHSA), or State-funded grants to 
provide social services. Generally, we believe such organizations know 
the populations and communities they serve and may have the 
infrastructure or systems in place to assist practitioners to provide 
PIN

[[Page 78948]]

services. We understand that many CBOs provide social services and do 
other work that is beyond the scope of PIN services, but we believe 
they are well-positioned to develop relationships with practitioners 
for providing reasonable and necessary PIN services.
    We proposed that only one practitioner per beneficiary per calendar 
month could bill for PIN services for a given serious, high-risk 
condition, because we are concerned about potential care fragmentation 
if the patient has more than one navigator for their condition during a 
given month. Our proposal would allow the patient to have a single 
point of contact for navigation of their condition.
    We proposed that the practitioner could bill separately for other 
care management services during the same month as PIN, if time and 
effort are not counted more than once, requirements to bill the other 
care management services are met, and the services are medically 
reasonable and necessary.
    Similar to CHI services discussed previously in this final rule, 
there are aspects of PIN services, or PIN services for certain 
conditions, that may be covered under a Medicaid State plan. When 
Medicare and Medicaid cover the same services for patients eligible for 
both programs, Medicare generally is the primary payer in accordance 
with section 1902(a)(25) of the Act. We sought public comment regarding 
whether States typically cover services similar to PIN under their 
Medicaid programs, and whether such coverage would be duplicative of 
the PIN service codes. We also solicited comment on whether there are 
other service elements not included in the PIN service codes that are 
part of associated care that should be included in the PIN service 
codes, or are important in navigation for high-risk conditions, where 
CMS should consider coding and payment in the future. For example, are 
there circumstances when clinical navigators, under the supervision of 
another professional, typically spend time face-to-face with patients 
that the PIN services codes, as currently described, may not fully 
account for?
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Many commenters appreciated our mention of CBOs, and these 
commenters outlined the benefits of external partnerships to increase 
the capacity of practitioners to furnish services such as PIN. A few 
commenters noted that there are geographic areas with a limited 
presence of CBOs, and they were hopeful that increased reimbursement 
opportunities through PIN would increase the supply of CBOs able to 
work in this space. A few commenters requested clarification on what 
``sufficient clinical integration'' means in this context, while a few 
other commenters discussed that CBOs often lack the funding to be 
integrated with electronic health records that may be used by 
practitioners in their area.
    Response: We reiterate that regular communication between the 
patient, auxiliary personnel, and billing practitioner is essential to 
ensure that everyone is involved in the patient's ongoing care. 
Documentation of the PIN services furnished in relation to the serious, 
high-risk condition in the medical record is required to track a 
patient's progress through the diagnosis and treatment of their 
principal illness, describe the interventions and PIN service elements 
performed, and to describe the medical necessity of PIN services to the 
principal illness. Documentation is also required to describe the 
ongoing need or changes to the treatment plan that allow for the 
cessation of PIN services; we appreciate that CBOs may not have access 
to the electronic health record in which the furnishing practitioner is 
documenting the patient's care in the medical record. To reduce 
administrative burden, we are not requiring that all auxiliary 
personnel performing PIN services must document the services in the 
medical record themselves. Rather, the billing practitioner is 
responsible for ensuring appropriate documentation of the PIN services 
provided to the patient is included in the medical record.
    Comment: Many commenters requested clarity on our proposed 
requirement that PIN services can be furnished by one practitioner per 
beneficiary per month for a serious, high-risk condition. These 
commenters asked if the limit was by practitioner, meaning 
beneficiaries could get one PIN service per practitioner or if each 
beneficiary could only get one PIN service for all conditions. 
Commenters noted that a patient may be receiving PIN for one condition 
and while receiving PIN services, get diagnosed with another illness or 
condition that also meets PIN criteria. A few commenters discussed that 
some types of navigation services, like oncology navigation, are highly 
condition-specific, and suggested that if a patient could only get PIN 
services from one practitioner for one condition per month, oncology 
navigators may not believe it within their skills and training to 
provide PIN services for other conditions. Other commenters mentioned 
that the enhanced value of navigation services in which the auxiliary 
personnel have lived experience or training specific to the serious 
high-risk condition and suggested that having the same navigators 
perform PIN services for conditions other than those in which they have 
training or lived experience would likely be detrimental to the 
treatment of those conditions. Commenters also discussed the 
operational difficulties of knowing whether the patient is receiving 
PIN services for another condition.
    Lastly, commenters were overwhelmingly in favor of our proposal to 
allow PIN services to be billed in conjunction with other care 
management codes. Commenters noted that patients who are likely to 
receive PIN may also have comorbidities that are best managed through 
care management codes, and practitioners should not have to choose 
between PIN and other care management activities.
    Response: Our intention in the proposed rule was to limit PIN 
services to one per month per beneficiary, as we were concerned about 
care fragmentation. We do not believe that having multiple navigators 
for each condition is conducive to the patient's experience, and we 
believe that the patient should generally have a single point of 
contact when navigating a principal illness. However, we understand 
that patients can have multiple principal illnesses at a time. We also 
understand that some types of navigation, such as peer support and 
oncology navigation are very condition-specific, which we continue to 
believe is a benefit of PIN services. Also, as discussed previously in 
this rule, we are not requiring auxiliary personnel furnishing PIN 
services to be versed in every principal illness for which a patient 
needs PIN services. However, we are also concerned about the 
duplication of time and effort if the same practitioner bills two kinds 
of PIN services for the same beneficiary. For example, a primary care 
physician might be providing PIN services to a patient for one serious, 
high-risk condition, and then the patient gets diagnosed with another 
high-risk condition that is also being managed by the same primary care 
physician. In this instance, the same navigator working incident to 
this primary care physician would be unable to fully perform the PIN 
service elements without duplicating time and effort, and therefore, 
the primary care physician can only provide PIN services once per month 
for this beneficiary.
    We appreciate the commenters' support for our proposal to allow PIN

[[Page 78949]]

services to be billed with other care management codes. We aimed to 
provide maximum flexibility to practitioners to choose the right type 
of service for each of their patient's needs, and we agree with 
commenters that if a patient has chronic or comorbid conditions that 
are well-managed with a care management code and is then diagnosed with 
a principal illness, it makes the most sense to provide that patient 
with care management plus PIN.
    After consideration of public comments, we are finalizing that PIN 
services can be provided more than once per practitioner per month for 
any single serious high-risk condition, to avoid duplication of PIN 
service elements when utilizing the same navigator or billing 
practitioner. We are also clarifying that PIN and PIN-PS should not be 
billed concurrently for the same serious, high-risk condition. However, 
practitioners furnishing PIN services may bill care management services 
as appropriate for managing and treating a patient's illness. We remain 
concerned about care fragmentation should patients receive multiple PIN 
services for different high-risk conditions. We believe that PIN is 
best suited for situations in which the navigator can serve as a point 
of contact for the patient. Given this, we do not expect a patient to 
require multiple PIN services for a prolonged period of time, except in 
circumstances in which a patient is receiving PIN services for highly 
specialized navigation, such as behavioral health or oncology. Lastly, 
we are finalizing, as proposed, that PIN services can be furnished in 
addition to other care management services as long as time and effort 
are not counted more than once, requirements to bill the other care 
management services are met, and the services are medically reasonable 
and necessary.
iii. PIN Services Valuation
    For HCPCS code G0023, we proposed a work RVU of 1.00 based on a 
crosswalk to CPT code 99490 (Chronic care management services with the 
following required elements: multiple (two or more) chronic conditions 
expected to last at least 12 months, or until the death of the patient, 
chronic conditions that place the patient at significant risk of death, 
acute exacerbation/decompensation, or functional decline, comprehensive 
care plan established, implemented, revised, or monitored; first 20 
minutes of clinical staff time directed by a physician or other 
qualified health care professional, per calendar month) as we believe 
these values most accurately reflect the resource costs associated when 
the billing practitioner performs PIN services. CPT code 99490 has an 
intraservice time of 25 minutes and the physician work is of similar 
intensity to our proposed HCPCS code G0023. Therefore, we proposed a 
work time of 25 minutes for HCPCS code G0023 based on this same 
crosswalk to CPT code 99490. We proposed using this crosswalk to 
establish the direct PE inputs for HCPCS code G0023.
    For HCPCS code G0024, we proposed a crosswalk to the work RVU and 
direct PE inputs associated with CPT code 99439 (Chronic care 
management services with the following required elements: multiple (two 
or more) chronic conditions expected to last at least 12 months, or 
until the death of the patient, chronic conditions that place the 
patient at significant risk of death, acute exacerbation/
decompensation, or functional decline, comprehensive care plan 
established, implemented, revised, or monitored; each additional 20 
minutes of clinical staff time directed by a physician or other 
qualified health care professional, per calendar month (List separately 
in addition to code for primary procedure)) as we believe these values 
reflect the resource costs associated with the clinician's direction of 
clinical staff who are performing the PIN services. Therefore, we 
proposed a work RVU of 0.70 and a work time of 20 minutes for HCPCS 
code G0024.
    Comment: Commenters generally supported the proposed crosswalk to 
the Chronic Care Management services and our proposed valuation. 
Commenters agreed that the RVU for HCPCS code G0023 should have a work 
RVU of 1.00 based on the crosswalk to CPT code 99490 but the RVU 
crosswalk should not be limited to the first 20 minutes of PIN services 
and each subsequent 20 minutes should have its own code. We did not 
receive any comments regarding the proposed crosswalk for HCPCS code 
G0024.
    Response: We thank the commenters for their feedback. We believe 
the commenters have misunderstood our crosswalk. While CPT code 99490 
is broken down into 20-minute blocks of time, we do not believe that 20 
minutes is sufficient per month to be spent on PIN services, as 
discussed above. We clarify that the RVU crosswalk for 60 minutes per 
month of CPT code 99490 has an intraservice time of 25 minutes, and has 
a work RVU of 1.00, so the valuation for 60 minutes per month of time 
is equal between CPT codes 99490 and G0023.
    After consideration of public comments, we are finalizing the 
crosswalks for HCPCS codes G0023 and G0024 as proposed, with HCPCS code 
G0023 being directly crosswalked with CPT code 99490 at work RVU of 
1.00, 25 minutes of intraservice time and matching direct PE inputs. We 
are also finalizing a direct crosswalk between HCPCS code G0024 and CPT 
code 99439, with a work RVU of 0.70, a work time of 20 minutes, and 
matching direct PE inputs. While we note that PIN-PS does not contain 
all descriptor elements to the original PIN service, we believe that 
the core elements of PIN are preserved in PIN-PS, and that the 
activities and service elements described in PIN-PS represent equal 
time and intensity to the PIN codes and CPT codes 99490 and 99439, 
respectively. The PIN-PS codes are targeted for specific work performed 
by auxiliary staff such as peer support specialists, and since this is 
a timed code, we believe that 60 minutes of time spent per month by 
auxiliary staff, including 25 minutes of intraservice time for the 
physician or billing practitioner is unchanged, even if the code 
descriptors vary slightly. Therefore, we are finalizing the crosswalk 
to CPT code 99490 for HCPCS code G0140 and CPT code 99439 for HCPCS 
code G0146.
(29) Maternity Services (CPT Codes 59400, 59410, 59425, 59426, 59430, 
59510, 59515, 59610, 59614, 59618, 59622)
    In the CY 2021 PFS final rule with comment period (85 FR 84554 and 
84555), we finalized our proposal to revalue the bundled maternity 
codes used to bill for delivery, antepartum, and postpartum maternity 
care services to account for increases in the values of office/
outpatient E/M services. These codes are all designated with a unique 
global period indicator ``MMM.'' There are 11 MMM codes that include E/
M visits as part of their valuation.
    For CY 2024, we proposed to update the work RVUs and work times of 
these MMM codes to reflect any relevant E/M updates associated with 
their global periods that were finalized in CY 2023. Table 13 contains 
a list of these codes and the proposed work RVUs for CY 2024. MMM codes 
are unique within the PFS in that they are the only global codes that 
provide a single payment for almost 12 months of services, which 
include a relatively large number of E/M visits performed along with 
delivery services and imaging; and were valued using a building-block 
methodology as opposed to the magnitude estimation method.

[[Page 78950]]

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    Comment: Several commenters stated that they supported CMS' 
proposal to update the maternity codes to account for the increases in 
the office and hospital visits bundled into their global period and 
agreed that the work RVU increases were correct. However, the 
commenters stated that the total work times incorporating both the 
increases in office visits and hospital visits into the global periods 
for these maternity services were not correct; the commenters 
recommended that CMS fix this technical error when calculating the time 
increases in the global periods for the maternity services and 
submitted a spreadsheet detailing the correct work times.
    Response: We appreciate the support for our proposed policies from 
the commenters, as well as alerting us to this potential technical 
error in the updated work times for the maternity services codes. After 
reviewing the additional information provided by the commenters, we 
discovered that the incorrect work time values for the maternity 
services codes were used in calculating the payment rates due to a 
technical error. We will correct these codes with their updated work 
times for the final rule.
    After consideration of the public comments, we are finalizing our 
proposal to update the work RVUs and work times of these MMM codes to 
reflect any relevant E/M updates associated with their global periods 
that were finalized in CY 2023, as detailed in Table 13.
BILLING CODE 4120-01-P

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BILLING CODE 4120-01-C

F. Evaluation and Management (E/M) Visits

1. Background
    Over the past several years, we have engaged in a multi-year effort 
with the American Medical Association (AMA) and other interested 
parties to update coding and payment for evaluation and management (E/
M) visits, so that they better reflect the current practice of 
medicine, are less administratively complex, and are paid more 
accurately under the PFS. This work is critical to improve payment 
accuracy and help reduce practitioner burnout.
    E/M visits comprise approximately 40 percent of all allowed charges 
under the PFS. The office/outpatient (O/O) E/M visits comprise 
approximately half of these allowed charges (approximately 20 percent 
of total PFS allowed charges), and Other E/M visits (such as inpatient/
observation visits, nursing facility visits and home/residence visits) 
comprise the other half (approximately 20 percent of total PFS allowed 
charges). As we have discussed in prior rules, within the E/M services 
represented in these percentages, there is wide variation in the volume 
and level of E/M visits billed by different specialties (84 FR 62844). 
According to Medicare claims data, E/M visits are furnished by nearly 
all specialties but represent a greater share of total allowed services 
for physicians and other practitioners who do not routinely furnish 
procedural interventions or diagnostic tests. Accordingly, our policies 
for revaluation of E/M visits have a significant impact on relative 
resource valuation under the PFS, which could potentially impact 
patient care more broadly.
    In this section of our final rule, we continue our work to address 
two outstanding issues in E/M visit payment: implementing separate 
payment for the O/O E/M visit complexity add-on code for separate 
payment, and our definition of split (or shared) visits, which we 
delayed last year.
    For CY 2018, we solicited public comment regarding how we could 
comprehensively reform the E/M documentation guidelines to reduce 
administrative and clinical burden, improve payment accuracy, and 
better align E/M coding and documentation with the current practice of 
medicine (82 FR 34078 and 34079, 82 FR 53163). We believed that the 
documentation requirements for history and physical exam were 
particularly outdated clinically and that medical decision making (MDM) 
and time were the more significant factors in distinguishing visit 
levels (82 FR 53164). Public commenters recommended a transparent, 
iterative, and perhaps transitional approach, and some commenters 
suggested that CMS and the AMA should also undertake revision and 
revaluation of the E/M visit code set itself, in addition to updating 
the documentation guidelines (82 FR 53165). Having reviewed the public 
comments, we noted they illustrated how difficult it is to utilize or 
rely upon such a relatively small set of codes to describe and pay for 
the work of a wide range of physicians and practitioners in many vastly 
different clinical contexts; that E/M documentation guidelines were not 
simply a matter of administrative burden, but were also clinically 
outdated and intimately related to the definition and description of E/
M work as well as valuation; and that there were different opinions on 
potential redefinition and revaluation of the E/M code set depending on 
practitioner specialty, and the type of

[[Page 78969]]

work dominating the specialty (for example, primary care, so-called 
``cognitive'' specialty work, or global procedures that have E/M visits 
bundled in rather than separately performed and documented) (82 FR 
53165). We stated that we would continue working on these issues with 
interested parties in future years.
    Because we agreed with commenters that we should take an 
incremental approach to these issues, the following year we proposed 
changes largely limited to the O/O E/M visit code family (83 FR 59628). 
In our CY 2019 PFS final rule, we finalized documentation changes, some 
of which took effect in CY 2019 (83 FR 59628 through 59535), while 
others (notably choice of MDM or time for supporting documentation) 
would be effective in CY 2021 in conjunction with finalized coding and 
payment changes for O/O E/M visits (83 FR 59636 through 59645). The 
coding and payment changes included a single payment rate for levels 2 
through 4 O/O E/M visits (retaining separate payment for level 5 visits 
to account for the most complex patients and visits); two HCPCS add-on 
codes to provide separate, additional payments for the resource costs 
involved in furnishing certain types of O/O E/M visit care, 
specifically visit complexity inherently associated with primary care 
and non-procedural specialty care; and a third HCPCS code for O/O E/M 
visits taking extended amounts of time (83 FR 59638).
    In January and February 2019, we held listening sessions, and we 
learned that the AMA was convening an E/M Workgroup to develop an 
alternative solution to some of these issues (84 FR 40673). The AMA 
revised and resurveyed the O/O E/M visit code family (see 84 FR 62844 
through 62847). Effective January 1, 2021, the CPT Editorial Panel 
redefined the codes for O/O E/M visits such that the furnishing 
practitioner may select the level of visit to bill based either on the 
amount of practitioner time spent performing the visit or the level of 
medical decision-making (MDM) involved. The CPT Editorial Panel 
redefined MDM in the CPT E/M Guidelines, which are an accompanying set 
of CPT interpretive guidelines delineating different levels of MDM and 
various other reporting parameters. Additionally, history of present 
illness (History) and a physical exam were no longer used to select the 
O/O E/M visit level. These service elements were updated to remove 
reliance on clinically outdated parameters to contribute to the 
selection of visit level, such as number of body systems reviewed, and 
to require a medically appropriate history and exam instead. Also, 
effective January 1, 2021, the CPT Editorial Panel revised the O/O E/M 
visit descriptor times. Previously, the CPT code descriptors included 
typical service times, but they were revised to specify new time ranges 
that must be furnished in order to select a given visit level using 
time. The AMA RUC resurveyed the O/O E/M visit CPT codes, and provided 
us with revaluation recommendations that we then addressed in our CY 
2020 PFS proposed rule, a year in advance of when the revised codes 
would take effect in CY 2021 (84 FR 40675 through 40678).
    In our CY 2020 PFS final rule, we generally adopted the revised O/O 
E/M code set and the related changes in the CPT E/M Guidelines, 
including the revised approach to visit level selection and 
documentation, for payment purposes under the PFS effective January 1, 
2021 (84 FR 62844 through 62859). While we accepted the revised CPT 
codes and approach for the O/O E/M visits, we finalized Medicare-
specific coding for prolonged O/O service codes, because we were 
concerned that the CPT codes were administratively complex, and their 
use would have impacted our ability to tell how much total time was 
spent with the patient and could have resulted in inappropriately 
inflated payment (84 FR 62849 through 62850, and 85 FR 84572 through 
84575).
    In our CY 2020 PFS final rule, we generally accepted the RUC 
recommendations, which reflected increased service times (84 FR 62851 
through 62854). This resulted in increased values for the O/O E/M visit 
codes beginning in CY 2021. However, since we believed these increased 
valuations still did not account for the resources involved in 
furnishing certain kinds of care included in the O/O E/M visit code 
set, in the CY 2021 PFS final rule, we retained our add-on codes for 
visit complexity inherently associated with primary care and non-
procedural specialty care, though we refined and consolidated them into 
a single code, a HCPCS add-on code G2211 (O/O E/M visit complexity) 
that can be reported in conjunction with O/O E/M visits to better 
account for additional resources associated with primary care, or 
similarly ongoing medical care related to a patient's single, serious 
condition, or complex condition (84 FR 62854 through 62856, 85 FR 
84571). (Hereafter in this rule, we refer to this code as the O/O E/M 
visit complexity add-on).
    After we issued the CY 2021 PFS final rule, section 113 of Division 
CC of the Consolidated Appropriations Act, 2021 (Pub. L. 116-260, 
December 27, 2020) (CAA, 2021) imposed a moratorium on Medicare payment 
for this service by prohibiting CMS from making payment under the PFS 
for services described by HCPCS code G2211 (or any successor or 
substantially similar code) before January 1, 2024. Accordingly, the O/
O E/M visit complexity add-on code can be reported, but it is currently 
assigned a bundled payment status indicator. See our fact sheet 
available at Physician Fee Schedule (PFS) Payment for Office/Outpatient 
Evaluation and Management (E/M) Visits--Fact Sheet \40\ (cms.gov).
---------------------------------------------------------------------------

    \40\ https://www.cms.gov/files/document/physician-fee-schedule-pfs-payment-officeoutpatient-evaluation-and-management-em-visits-fact-sheet.pdf.
---------------------------------------------------------------------------

    In the CY 2022 PFS final rule, we established revised payment rules 
for split (or shared) visits (86 FR 65150 through 65159). The following 
year the CPT Editorial Panel defined a split (or shared) visit for the 
first time in the CPT E/M Guidelines for 2023. However, we did not 
adopt the CPT definition as it did not conform with our established 
final policy or address which practitioner should report a shared 
visit.
    For CY 2023, the CPT Editorial Panel also revised the rest of the 
E/M visit code families (except critical care services) to match the 
general framework of the O/O E/M visits, including inpatient and 
observation visits, emergency department (ED) visits, nursing facility 
visits, domiciliary or rest home visits, home visits, and cognitive 
impairment assessment. We referred to these other E/M visit code 
families as ``Other E/M'' visits or CPT codes, as relevant. Effective 
January 1, 2023, the CPT Editorial Panel redefined the Other E/M visits 
so that they parallel the O/O E/M visits, where visit level is selected 
based on the amount of practitioner time spent with the patient or the 
level of MDM as redefined in the CPT E/M Guidelines. As for the O/O E/M 
visits, a medically appropriate history and/or physical exam is a 
required element of the services but no longer impacts the Other E/M 
visit level. The CPT Editorial Panel also revised the service times 
within the descriptors, the associated CPT prolonged service codes, and 
the CPT E/M Guidelines for the Other E/M CPT codes. The CPT Editorial 
Panel also consolidated many of the Other E/M CPT codes, with inpatient 
and observation visits combined into a single code set and home and 
domiciliary visits combined into a single code set. The CPT Editorial 
Panel created one new CPT code for prolonged inpatient services by 
physicians and other qualified healthcare professionals on the date of

[[Page 78970]]

the E/M visit. Finally, the RUC resurveyed the Other E/M visits and 
associated prolonged service codes and provided revaluation 
recommendations to CMS.
    We addressed these changes to the Other E/M visit families in the 
CY 2023 PFS final rule (87 FR 69586 through 69616). In that final rule, 
we adopted the revised CPT codes and descriptors for Other E/M visits, 
except for prolonged services for which we finalized Medicare-specific 
coding. We also adopted the CPT E/M Guidelines for levels of MDM as 
revised for 2023. Regarding valuation, we adopted most of the RUC-
recommended values for Other E/M visits, increasing their relative 
valuation in aggregate. However, we believe that certain types of O/O 
E/M visits remain undervalued, given the moratorium on separate payment 
for the O/O E/M visit complexity add-on (87 FR 69588). We expressed 
concern about assumptions made in the RUC recommendations for Other E/M 
visits that patient needs were inherently more complex, or work was 
more intense for E/M visits furnished in non-office settings (for 
example, inpatient, ED, and home settings) when compared to the office 
settings (87 FR 69587 through 69588). We stated that this direct 
comparison between Other E/M visits and the O/O E/M visit codes may not 
be appropriate or accurate, and laid out reasons why practitioners in 
office settings may expend more resources than practitioners in 
institutional and other settings. We noted that the survey times for O/
O E/M visits increased significantly when resurveyed (85 FR 50123), 
while times for Other E/M visits generally decreased significantly or 
remained the same when resurveyed, despite the level of MDM remaining 
constant (87 FR 69598, 69605). To the extent we adopted the RUC-
recommended values for Other E/M visits beginning in CY 2023, we 
expressed that we did not agree that the RUC-recommended relative 
values for E/M visits fully accounted for the complexity of certain 
kinds of visits, especially for those in the office setting, nor do 
they fully reflect appropriate relative values, since separate payment 
is not yet made for the O/O E/M visit complexity add-on (87 FR 69588).
    During the CAA, 2021 moratorium on separate payment for the O/O E/M 
visit complexity add-on, interested parties have continued to engage 
CMS about the appropriate valuation of O/O E/M visits relative to other 
PFS services, including through public comments on the proposed 
revaluation of Other E/M visits (87 FR 70218), as well as in meetings 
and letters submitted to CMS outside of the rulemaking process. 
Anticipating the end of the CAA, 2021 moratorium, interested parties, 
including the AMA, several medical associations, and others, recently 
approached CMS outside of the rulemaking process with recommendations 
regarding implementation and potential refinements to the service 
beginning in 2024 to ensure the appropriate relative valuation of O/O 
E/M visits. Interested parties have also continued to approach CMS and 
the CPT Editorial Panel with questions and recommendations about 
payment rules for split (or shared) visits.
2. Office/Outpatient (O/O) E/M Visit Complexity Add-On Implementation
a. Background
    As discussed above, in the CY 2021 PFS final rule, CMS refined the 
O/O E/M visit complexity add-on code, GPC1X (which was replaced by 
HCPCS code G2211), to describe intensity and complexity inherent to O/O 
E/M visits associated with medical care services that serve as the 
continuing focal point for all needed health care services and/or with 
medical care services that are part of ongoing care related to a 
patient's single, serious, or complex condition. (85 FR 84569 through 
84571). While we adopted the AMA RUC recommendations for the revised O/
O E/M CPT visit codes, those values did not fully account for the 
resource costs associated with primary care and other longitudinal care 
of complex patients. Under our final policy, which was delayed by the 
CAA, 2021 before it was implemented, the O/O E/M visit complexity add-
on code could be reported with all O/O E/M visit levels. We disagreed 
with comments suggesting that billing of the O/O E/M visit complexity 
add-on code should be restricted to higher level office/outpatient E/M 
visits; and responded that, given the wide variety of visit types 
billable with the office/outpatient E/M visit code set, we did not 
believe that the value associated with the typical visit accounts for 
the additional resources associated with primary care or ongoing care 
related to a patient's single, serious, or complex chronic condition, 
regardless of the visit level. The full descriptor for the O/O E/M 
visit complexity add-on code, as refined in the CY 2021 PFS final rule, 
is HCPCS code G2211 (Visit complexity inherent to evaluation and 
management associated with medical care services that serve as the 
continuing focal point for all needed health care services and/or with 
medical care services that are part of ongoing care related to a 
patient's single, serious condition or a complex condition. (Add-on 
code, list separately in addition to office/outpatient evaluation and 
management visit, new or established)) (85 FR 84571) We also estimated 
that the O/O E/M visit complexity add-on service would be reported by 
specialties that rely on office/outpatient E/M visits to report the 
majority of their services and would be billed in addition to those E/M 
visits. While we did not explicitly prohibit billing the O/O E/M visit 
complexity add-on in conjunction with visits that are reported with 
various modifiers, and did not exclude those from our utilization 
estimates, we stated we did not expect the add-on service to be 
reported for visits billed with a payment modifier, for example, to 
identify a separately billable E/M visit in conjunction with a minor 
procedure (85 FR 84571 through 84572). We stated that visits reported 
with payment modifiers are likely to involve resources distinct from 
the stand-alone O/O E/M visits for primary care and other longitudinal 
care of complex patients, and that we may consider this issue in future 
rulemaking. We further stated that we do not expect the O/O E/M visit 
complexity add-on code to be reported when the O/O E/M visit is 
reported with payment modifiers such as modifier -25 which describes 
separately billed visits on the same day as another visit or procedure 
(see our fact sheet, identifying additional modifiers, available at 
Physician Fee Schedule (PFS) Payment for Office/Outpatient Evaluation 
and Management (E/M) Visits--Fact Sheet (cms.gov)).
    Interested parties have continued to express uncertainty about when 
reporting the O/O E/M visit complexity add-on service would be 
appropriate. Some interested parties have expressed larger concerns 
about potential reductions to the PFS CF or redistributive impacts 
among specialties if we were to implement the O/O E/M visit complexity 
add-on code. In the CY 2021 PFS final rule, we clarified and refined 
the service definition to alleviate some of these concerns and revised 
our utilization estimates (85 FR 84572). Conversely, some interested 
parties, specifically practitioners who rely on office/outpatient E/M 
visits to report the majority of their services, who could use the add-
on code to better reflect the resources they use to furnish complex 
longitudinal services, expressed continued support for our policy. We 
reiterated our belief that the O/O E/M visit complexity add-on reflects 
the time, intensity, and PE resources involved when practitioners 
furnish the

[[Page 78971]]

kinds of O/O E/M office visit services that enable them to build 
longitudinal relationships with all patients (that is, not only those 
patients who have a chronic condition or single high-risk disease) and 
to address the majority of a patient's health care needs with 
consistency and continuity over longer periods of time. In response to 
comments, we also made further refinements to the HCPCS code descriptor 
to clarify that the code applies to a serious condition rather than any 
single condition. We also acknowledged concerns that given the request 
by some medical societies for additional time to educate their members 
about the appropriate use of the O/O E/M visit complexity add-on code, 
ongoing implementation of the revisions to the O/O E/M visit code set, 
electronic health records integration, and the persistence of the 
COVID-19 pandemic, practitioners that rely on O/O E/M visits to report 
the majority of their services are not likely to report the complexity 
add-on code with every office visit. However, we disagreed with 
commenters who thought the O/O E/M visit complexity add-on code would 
be billed with only 10 to 25 percent of O/O E/M services. Because we 
had not implemented any additional policies that restricted the billing 
of this code, we estimated that the add-on code would be billed with 90 
percent of O/O E/M visits billed by certain physician specialties 
(roughly 58 percent of all office/outpatient E/M visits).
b. O/O E/M Visit Complexity Add-On HCPCS Code G2211
    Interested parties have continued to engage with us and provide 
recommendations for implementing the O/O E/M visit complexity add-on. 
Some commenters recommended that CMS delay the implementation of HCPCS 
add-on code G2211, citing concerns about the expected budget neutrality 
adjustment necessitated by implementing the O/O E/M visit complexity 
add-on and redistributive impact on PFS payment (85 FR 84572). Many 
commenters who rely upon O/O E/M visits to report most of their 
services continued to support HCPCS add-on code G2211 (85 FR 84570) and 
have recommended that we speedily implement it. Some commenters also 
suggested ways to clarify the intended use of the O/O E/M visit 
complexity add-on code, which could reduce redistributive impacts. 
Finally, as noted above, the values we established for the revised O/O 
E/M CPT codes in the CY 2021 PFS final rule were finalized in concert 
with a policy that would have provided separate payment for the new 
add-on code G2211 (87 FR 69588). To the extent we adopted the RUC-
recommended values for Other E/M visits beginning in CY 2023, we 
expressed that we did not agree that the RUC-recommended relative 
values for E/M visits fully reflected appropriate relative values, 
since separate payment is not yet made for HCPCS code G2211.
    The CAA, 2021 moratorium on Medicare payment under the PFS for 
HCPCS code G2211 will end on December 31, 2023. We proposed to change 
the status of HCPCS code G2211 to make it separately payable by 
assigning it an ``active'' status indicator, effective January 1, 2024. 
After considering the feedback from interested parties, both through 
the CY 2021 PFS rulemaking process and during the moratorium, we also 
proposed several policy refinements (with respect to HCPCS code G2211). 
We stated in the CY 2021 PFS final rule that we would not expect HCPCS 
add-on code G2211 to be reported when the O/O E/M service is reported 
with a payment modifier, such as the modifier-25, which denotes a 
separately billable E/M service by the same practitioner furnished on 
the same day of a procedure or other service (85 FR 84572). We continue 
to believe that separately identifiable O/O E/M visits occurring on the 
same day as minor procedures (such as zero-day global procedures) have 
resources that are sufficiently distinct from the costs associated with 
furnishing stand-alone O/O E/M visits to warrant different payment (85 
FR 84572). As such we proposed that the O/O E/M visit complexity add-on 
code, HCPCS code G2211, would not be payable when the O/O E/M visit is 
reported with payment modifier-25.
    Interested parties have also requested that we reconsider our 
previous utilization assumptions. In the CY 2021 PFS final rule, we had 
assumed that specialties that rely on O/O E/M visit codes to report the 
majority of their services would be most likely to report the O/O E/M 
visit complexity add-on code and that they would report the add-on code 
with every O/O E/M visit they report. We acknowledged commenters' 
concerns that, given the request by some medical societies to educate 
their members about appropriate use, and ongoing implementation of the 
revisions to the office/outpatient E/M visit code set and electronic 
health records integration, practitioners that rely on office/
outpatient E/M visits to report the majority of their services would 
not be likely to report HCPCS code G2211 with every O/O E/M visit they 
report (85 FR 84572).
    Interested parties have presented persuasive reasons that such 
practitioners would not be likely to report HCPCS code G2211 with every 
O/O E/M visit they report. They reasoned that many practitioners 
delivering care in settings specifically designed to address acute 
healthcare needs, without coordination or follow-up, will regularly 
have encounters with patients that are not part of continuous care.
    Furthermore, in contrast to situations where the patient's overall, 
ongoing care is being managed, monitored, and/or observed by a 
specialist for a particular disease condition, we continue to believe 
that there are many visits with new or established patients where the 
O/O E/M visit complexity add-on code would not be appropriately 
reported, such as when the care furnished during the O/O E/M visit is 
provided by a professional whose relationship with the patient is of a 
discrete, routine, or time-limited nature; such as, but not limited to, 
a mole removal or referral to a physician for removal of a mole; for 
treatment of a simple virus; for counseling related to seasonal 
allergies, initial onset gastroesophageal reflux disease; treatment for 
a fracture; and where comorbidities are either not present or not 
addressed, and/or when the billing practitioner has not taken 
responsibility for ongoing medical care for that particular patient 
with consistency and continuity over time, or does not plan to take 
responsibility for subsequent, ongoing medical care for that particular 
patient with consistency and continuity over time (85 FR 84570 and 
84571).
    These considerations taken together with our proposal that the O/O 
E/M visit complexity add-on code, HCPCS code G2211, would not be 
payable when the O/O E/M visit is reported with payment modifier-25 
have informed our revised utilization assumptions. Considering the 
comments received by interested parties, and the reasons discussed 
above, we now estimate that HCPCS code G2211 will be billed with 38 
percent of all O/O E/M visits initially. We calculated these revised 
utilization assumptions by considering the uptake of new codes in prior 
years and the O/O E/M billing patterns of all specialties. 
Specifically, we took into account the likelihood that primary care 
specialties will have a higher utilization of the add-on code than 
other specialties, surgical specialties will have the lowest 
utilization since they are less likely to establish longitudinal care 
relationships with patients, and other specialists are more likely to 
have

[[Page 78972]]

longitudinal care relationships than surgical specialties but less 
likely than primary care specialists. We also revised our estimates by 
excluding (1) claims from practitioners participating in CMS capitated 
models and (2) claims for established patient visits performed by 
certain specialties that are unlikely to have a longitudinal care 
relationship with a beneficiary. We also accounted for the number of 
visits billed that were furnished as consults or to obtain a second 
clinical opinion and excluded these types of visits from our estimates. 
We estimated that HCPCS code G2211 could be billed with 54 percent of 
all O/O E/M visits when fully adopted. This fully adopted estimate was 
informed by considering the uptake of new codes after several years. We 
sought comment on these utilization assumptions and the application of 
this proposed policy for CY 2024.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: MedPAC appreciated our continued focus on ensuring that 
primary care clinicians and other clinicians who primarily furnish E/M 
services are accurately and appropriately paid. MedPAC also stated that 
longstanding misvaluations in the fee schedule that have had a 
detrimental impact on accurate primary care valuation, focusing on the 
overvaluation of non-E/M services.
    However, MedPAC did not support the agency's proposed approach to 
establish payment for the add-on code because, in their view (similar 
to some other commenters), there continues to be too much ambiguity 
regarding the code's use and the resource costs it is intended to 
reflect. MedPAC and other commenters expressed concern that without 
further clarification, the code would likely be misused and could 
potentially duplicate payments for other services. MedPAC noted that 
CMS had added several services that describe services related to the 
provision of longitudinal, comprehensive care, including care 
management or other non-face-to-face services (for example, chronic 
care management (CCM), principal care management (PCM), responding to 
patient portal messages, and remote patient monitoring (RPM)). 
Similarly, many commenters also questioned how the proposed complexity 
add-on code would reflect additional work intensity resulting from 
concurrently addressing multiple health complaints in a single visit, 
additional clinical staff time or supplies expended during a visit, or 
additional non-face-to-face activities associated with furnishing 
comprehensive, longitudinal care. Some commenters went further to 
assert that the code is duplicative and stated that the selection of 
visit level by medical decision making (MDM) and/or total time on the 
date of the encounter is flexible enough to address patient visit 
complexity requiring unusual resources.
    Response: We appreciate the concerns raised by MedPAC and the other 
commenters. We strongly agree with MedPAC and others who state it is 
important to clarify what specific additional resources this code would 
better account for compared to the current available coding and 
associated valuations, including of care management services, prolonged 
services, and other non-face-to-face services. As proposed, the 
inherent complexity code would address what we believe are longstanding 
issues with coding and valuation of O/O E/M services that do not fully 
distinguish and account for resource costs for primary care and other 
longitudinal care for complex patients, but specifically for visits 
associated with longitudinal, non-procedural care when compared to work 
RVUs for procedural services and visits furnished in association with 
procedural-based care. We believe that because E/M visit codes are 
intended to be used very broadly, the complexity of services required 
to provide this type of care is not fully incorporated as part of the 
valuation of the work RVUs when the E/M code itself is used as the 
primary way to report the work of the professional. In other words, 
while many medical professionals rely on procedural codes with work 
RVUs that account--appropriately--for their particular expertise and 
the intensity associated with their overall costs in furnishing care, 
the expertise of those who rely predominantly on E/M services to report 
their services is left relatively underrecognized within the previous 
and current E/M coding and valuation structure. This is because E/M 
valuation is broad-based and the same E/M visit codes are routinely 
reported both alone and with many different procedural codes. We 
believe that this specific gap in appropriate valuation and coding is 
in addition to, and not overlapping with, the gaps in coding and 
valuation that led to the creation of care management coding, remote 
patient monitoring, etc. As we understand them, these latter codes 
describe services furnished and resource costs incurred in addition to 
the intensity and professional work within the visits themselves. 
Consequently, we do not believe the inherent complexity code would be 
duplicative of care management services since the inherent complexity 
better recognizes the professional work within the visit, while the 
care management codes recognize services that happen outside of the 
visit. This applies, of course, when the inherent complexity code is 
appropriately reported as a way to characterize E/M visits associated 
with medical care services that serve as the continuing focal point for 
all needed health care services and/or with medical care services that 
are part of ongoing care related to a patient's single, serious 
condition or a complex condition.
    We recognize that many commenters, especially those concerned with 
budget neutrality-based payment reductions should the proposal be 
finalized and implemented, disagree with our assertion that there is 
historical (and ongoing) underrecognition in coding and valuation of 
resources involved in primary and nonprocedural care are an inherent 
part of the coding and valuation system. Instead, we understand that 
they view the current disparities in overall payment amount as 
appropriately reflective of different resource costs in professional 
work between procedural care and primary and non-procedural care.
    In contrast, MedPAC acknowledges the disparity as a significant 
problem but recommends the issue should be addressed outside of the 
assignment of RVUs and code definitions for primary care. We appreciate 
the commenters' perspectives and recognize that other payment 
mechanisms could be utilized (perhaps even less controversially) to 
address these problems, especially through the kinds of changes MedPAC 
has recommended to Congress. However, we believe that we have the 
obligation to value services as accurately as possible within the 
structure of the resource-based relative value system, and that until 
changes to coding and valuation are made to specifically address the 
underrecognition of the complexity inherent to these kinds of visits 
(either through this rule or another mechanism), the RVUs on the PFS 
would otherwise perpetuate the systemic undervaluation of primary and 
longitudinal, non-procedural care.
    Comment: Other commenters supported the proposal and agreed that 
the O/O E/M visit complexity add-on code better accounts for the 
additional time, intensity, and practice expense inherent to 
longitudinal care. These commenters offered that the PCM codes account 
for care management and coordination over time as opposed to the 
additional complexity and resources

[[Page 78973]]

involved in furnishing an office/outpatient E/M visit. They added that 
primary care physicians may provide care management and coordination 
services for a condition first addressed in an office/outpatient E/M 
visit that will not last as long as three months or would not 
reasonably be expected to result in a risk of hospitalization. These 
commenters highlighted COVID-19 cases, for instance, as clinical 
circumstances that generally do not last three months but may require 
significant acute management, care coordination, and follow-up within a 
given month, particularly for patients with comorbidities. They further 
stated that alternatively, physicians, qualified health practitioners, 
or their staff may provide care coordination and management services 
for a condition that does meet these conditions, and the time may not 
reach the required 30-minute interval. Thus, care coordination for a 
month that includes 20 minutes of consulting with other physicians and 
modifying medications to address an acute exacerbation of hypertension 
would not meet the requirements for billing PCM. Despite the inability 
to bill for these services, ongoing coordination and medication 
management is a standard part of comprehensive primary care. The 
commenters stated that the distinctions and limitations of TCM, CCM, 
and CCCM are similar with specific time thresholds. With respect to 
prolonged services codes, these commenters noted that primary care 
physicians often provide complex office visits without requiring 
additional time given that their training enables them to address a 
significant number of diagnoses, risk factors, and symptoms in a short 
time. Commenters added further that when prolonged services codes are 
billed, they are not valued to include the additional intensity 
inherent to primary care.
    The commenters stated that the complexity inherent in primary care 
includes evaluating how each condition and resulting treatment, new 
symptom or challenge, unmet social needs, and recommended preventive 
services interact and impact a person's overall wellbeing. The visits 
involve balancing clinical guidelines and recommendations from a 
multitude of sources including the United States Preventive Services 
Task Force, the AAFP, the American College of Physicians or the 
American Academy of Pediatrics (depending on the patient's age), the 
American Psychiatric Association, the American College of Obstetricians 
and Gynecologists (when relevant), the Advisory Committee on 
Immunization Practices, and other evidence such as that published by 
the CDC. They added that the primary care visit also involves 
evaluating biochemical processes and drug interactions across several 
medications, noting the extensive time counseling patients about new 
and upcoming vaccines, like those for COVID-19 or respiratory syncytial 
virus. The visit further involves the evaluation of lab and imaging 
results sent by various care team members, reports from home health 
aides or nurses, and immunization registries. They added that primary 
care physicians and practitioners evaluate the persons' understanding 
of their diseases and treatments and discuss behaviors or habits that 
could impact their well-being. In the same encounter, primary care 
practitioners provide several preventive screenings, including for 
cancer, behavioral health, and substance use disorders. They provide 
counseling and brief referrals based on the results of those 
screenings, including help connecting patients to facilities providing 
mammograms, colonoscopies, or behavioral health diagnoses. The 
commenters asserted that most Medicare beneficiaries struggle to afford 
their health care services and medications, so many primary care 
physicians spend time on pharmacy discount websites alongside their 
patients to help them get lower prices on their medications. The 
commenters also stated that most orders for new screening or diagnostic 
tests will require prior authorization for patients with primary or 
secondary insurance through a plan administered by a health insurance 
company. All of these findings and processes require documentation in 
the medical record and updates to other health team members, such as an 
endocrinologist, cardiologist, or psychiatrist. Commenters offered 
clinical examples from primary care physicians.
    Response: We appreciate the support from these commenters. After 
consideration of public comments, we are finalizing changing the status 
of HCPCS code G2211 to make it separately payable by assigning it an 
``active'' status indicator, effective January 1, 2024, as proposed. In 
addition, in consideration of the many comments we received, we 
recognize that we should clarify when this code can be used. 
Specifically, this add-on code is intended to characterize the base 
service (that is, O/O E/M visits) based on the kind of care being 
furnished (medical care services that serve as the continuing focal 
point for all needed health care services and/or with medical care 
services that are part of ongoing care related to a patient's single, 
serious, or complex condition) to better account for the inherent 
complexity of these visits that would otherwise be unaccounted for. We 
note that the application of the add-on code is not based on the 
characteristics of particular patients (even though the rationale for 
valuing the code is based on recognizing the typical complexity of 
patient needs) but rather the relationship between the patient and the 
practitioner. We agree with commenters who have pointed out that O/O E/
M visit levels, care management codes, and prolonged service codes are 
intended to account for additional minutes of time or complexities for 
individual patients. This code should be used when furnishing O/O E/M 
visit associated with medical care services that serve as the 
continuing focal point for all needed health care services and/or with 
medical care services that are part of ongoing care related to a 
patient's single, serious condition or a complex condition.
    We clarify that it is the relationship between the patient and the 
practitioner that is the determining factor of when the add-on code 
should be billed. First, the ``continuing focal point for all needed 
health care services'' describes a relationship between the patient and 
the practitioner, when the practitioner is the continuing focal point 
for all health care services that the patient needs. For example, a 
patient has a primary care practitioner that is the continuing focal 
point for all health care services, and the patient sees this 
practitioner to be evaluated for sinus congestion. The inherent 
complexity that this code (G2211) captures is not in the clinical 
condition itself--sinus congestion--but rather the cognitive load of 
the continued responsibility of being the focal point for all needed 
services for this patient. There is previously unrecognized but 
important cognitive effort of utilizing the longitudinal relationship 
itself in the diagnosis and treatment plan and weighing the factors 
that affect a longitudinal doctor patient relationship. In this 
example, the primary care practitioner could recommend conservative 
treatment or prescription of antibiotics. If the practitioner 
recommends conservative treatment and no new prescriptions, some 
patients may think that the doctor is not taking the patient's concerns 
seriously and it could erode the trust placed in that practitioner. In 
turn, an eroded primary care practitioner/patient relationship may make 
it less likely that the patient would follow that

[[Page 78974]]

practitioner's advice on a needed vaccination at the next visit. The 
primary care practitioner must decide--what course of action and choice 
of words in the visit itself, would lead to the best health outcome in 
this single visit, while simultaneously building up an effective, 
trusting longitudinal relationship with this patient for all of their 
primary health care needs. Weighing these various factors, even for a 
seemingly simple condition like sinus congestion, makes the entire 
interaction inherently complex, and it is this complexity in the 
relationship between the doctor and patient that this code captures.
    The second part of the add-on code also describes a relationship 
between the practitioner and patient, but for specific types of 
conditions. The add-on code describes ``medical care services that are 
part of ongoing care related to a patient's single, serious condition 
or a complex condition.'' Again, the ``ongoing care'' describes a 
longitudinal relationship between the practitioner and the patient. In 
comparison to the previous example, though, this is specifically in 
reference to a single, serious condition or a complex condition. For 
example, a patient with HIV has an office visit with their infectious 
disease physician, who is part of ongoing care. The patient with HIV 
admits to the infectious disease physician that there have been several 
missed doses of HIV medication in the last month. The infectious 
disease physician has to weigh their response during the visit--the 
intonation in their voice, the choice of words--to not only communicate 
clearly that it is important to not miss doses of HIV medication, but 
also to create a sense of safety for the patient in sharing information 
like this in the future. If the interaction goes poorly, it could erode 
the sense of trust built up over time, and the patient may be less 
likely to share their medication adherence shortcomings in the future. 
If the patient isn't forthright about their medication adherence, it 
may lead to the infectious disease physician switching HIV medicines to 
another with greater side effects, even when there was no issue with 
the original medication. It is because the infectious disease physician 
is part of ongoing care, and has to weigh these types of factors, that 
the E/M visit becomes inherently more complex and the practitioner 
bills this code (G2211). Even though the infectious disease doctor may 
not be the focal point for all services, such as in the previous 
example, HIV is a single, serious condition, and/or a complex 
condition, and so as long as the relationship between the infectious 
disease physician and patient is ongoing, this E/M visit could be 
billed with the add-on.
    We appreciate the clarifying questions raised by commenters on the 
appropriate usage of this add-on code. We will continue to engage with 
interested parties on the use of this code and will consider developing 
additional educational materials as needed.
    Comment: Another commenter who supported our proposal offered 
clinical scenarios they thought were excellent examples of the 
complexity of care this code was intended to address:
    Example A: A patient with sickle cell disease (SCD) visits the 
clinic to see her hematologist and has clearly deteriorated 
cognitively. The physician needs to understand if this is dementia or 
SCD-related. Most of the time during the patient's visit is spent 
ordering neurocognitive testing fand consulting with psychiatry.
    Example B: A patient with SCD needs to be prescribed oxycontin for 
their chronic pain. The provider also spends time during the patient's 
visit managing other medications and then seeking the appropriate pre-
approval and prior authorization for oxycontin.
    Response: We thank the commenter for providing these clinical 
scenarios. However, the most important information used to determine 
whether or not the add-on code could be billed is missing: the 
relationship between the practitioner and the patient. If the 
practitioner is the focal point for all needed services, such as a 
primary care practitioner, this add-on code could be billed in these 
examples. Or, if the practitioner is part of ongoing care for sickle 
cell disease (a single, serious and complex condition) then the add-on 
code could be billed. Otherwise, this add-on code could not be billed. 
Again, this add-on code captures the inherent complexity of the visit 
that is derived from the longitudinal nature of the practitioner and 
patient relationship.
    We also note unequivocally that this code is not restricted to 
medical professionals based on particular specialties. Instead, it 
should be used by medical professionals, regardless of specialty, with 
O/O E/M visits (other than those reported with the -25 modifier) for 
care that serves as the continuing focal point for all needed health 
care services and/or with medical care services that are part of 
ongoing care related to a patient's single, serious condition or a 
complex condition. We reiterate that when physicians and other 
practitioners provide care that serves as the continuing focal point 
for all needed healthcare services, they should report the inherent 
complexity add-on code along with all reasonable and necessary O/O E/M 
visits (not reported with the -25 modifier).
    Comment: We received many comments on our proposal to not make 
payment for HCPCS G2211 when the underlying O/O E/M visit had been 
reported with modifier -25. Many commenters were supportive. Some 
commenters opposed our proposal excluding payment when there were 
underlying visits with modifier -25 because they believed some 
preventive services would be rescheduled to a later date. One of these 
commenters suggested that a more appropriate mechanism for addressing 
any distinction between a stand-alone O/O E/M service and one at which 
a physician elects to also perform a minor procedure is the National 
Correct Coding Initiative (NCCI) edits that could be revised to bundle 
code G2211 to codes for minor surgical procedures that are commonly 
performed in the primary care or other non-procedural specialty care 
setting. She further suggested a better option could be the creation of 
HCPCS codes that are not add-on codes but rather adequately valued 
codes representing visits for longitudinal care for all of a patient's 
health care needs and/or ongoing care related to a patient's single, 
serious, or complex condition which she believed might represent a 
significant reduction in the burden of the add-on code assignment, 
audit/overpayment risk, and stress until in her view a better health 
care system design can be established for delivering and funding these 
services.
    Several commenters echoing the concern for preventive services 
requested that the annual wellness visit be excepted from the policy. 
Another commenter stated that modifier -25 is often used in cases where 
clinicians are treating complex patients since these patients are 
likely to receive multiple services on the same day. They stated that 
excluding these cases therefore may be counter to the ultimate goal of 
appropriately valuing complex O/O E/M services.
    Another commenter wrote that patients often travel long distances 
to receive care at their facilities requiring multiple visits with 
different specialists for a variety of medical management and 
interventions on the same day to treat a variety of disease co-
morbidities related to their cancer care. They stated it would be 
appropriate for their primary treating physician to bill the G2211 add-
on code for the on-going coordination effort related to these complex 
treatment plans regardless of the multiple visits occurring on the

[[Page 78975]]

same day. Another commenter stated that urologists frequently manage 
multiple chronic conditions simultaneously and that certain diagnostic 
procedures are commonly performed as part of the ongoing management of 
a patient with chronic genitourinary disease. They recommended that CMS 
consider permitting the use of modifier -25 in those situations where 
the surgical code is associated with a 0-day global period and where 
the sites of service are any of the O/O settings. They also suggested 
that specific CPT codes 52000 and 51741 be exempt from our policy to 
not pay the inherent complexity add-on when modifier -25 is reported on 
the base O/O E/M code so that urologists could continue to perform 
these tests and be appropriately paid for providing longitudinal care 
for the multiple chronic conditions the manage simultaneously.
    Response: We thank commenters for raising these concerns and 
offering suggestions on how we might refine the policy. First, we are 
clarifying that modifier -25 is reported in instances where the 
physician or practitioner billing the O/O E/M is the same one who is 
billing the significant separately identifiable procedure or other 
service on the same day. Commenters seemed to incorrectly suggest 
modifier -25 was reported with an O/O E/M visit if the patient had a 
visit or procedure with another physician or another practitioner on 
the same day as the physician or practitioner billing the O/O E/M 
visit. With respect to the concern that a physician or practitioner 
would not perform a preventive service on the same day as an O/O E/M 
visit merely to avoid our policy to not pay G2211 when the O/O E/M 
visit is reported with modifier -25, we intend to monitor the 
utilization of this code and continue engagement with interested 
parties as this policy is implemented. With respect to the suggestion 
for a new set of parallel codes for the kind of care captured by 
inherent complexity add-on code we believe such a set of codes could 
increase administrative burden with minimal benefit gained and 
unnecessarily delay reactivation of the complexity add-on code and 
payment. Similarly, we believe relying on NCCI edits to single out 
unbundled procedures or services with which G2211 should not be billed 
would also increase administrative burden and delay reactivation. 
Finally, for future rulemaking and as discussed in the next section, we 
remain open to considering additional iterations in coding and 
valuation within the PFS that would meet the same goals regarding the 
appropriate valuation of these services.
    Comment: Many commenters expressed concerns or disagreed with our 
utilization estimates for G2211. Many commenters were appreciative that 
we have revised our utilization estimates resulting in a smaller 
negative impact on the budget neutrality conversion factor. However, 
most commenters urged to further refine these assumptions to prevent 
reductions in the conversion factor that they noted might, in fact, not 
be warranted by actual usage. They suggested that there continues to be 
a lack of clarity surrounding the appropriate circumstances for 
reporting the inherent complexity add-on code and that combined with 
potential implications for patient cost-sharing, health care 
practitioners would experience ambiguity toward billing the code, which 
could result in our having overestimated utilization. Many other 
commenters asked that we align utilization estimates with the actual 
first year utilization of care management codes for transitional care 
management (TCM) and chronic care management (CCM). Some commenters 
asked us to make mid-year adjustments to the conversion factor if in 
our monitoring we find that we overestimated utilization of the code.
    Response: We have considered the suggested factors but do not 
believe those care management codes are an apt comparison for G2211 
utilization, given several limitations in their code descriptors and 
other requirements which are not applicable to the inherent complexity 
add-on code. We also believe that the documentation requirements 
specific to the care management codes may have contributed to the 
slower uptake in utilization than was estimated for the first year. 
Additionally, we believe the additional clarifications we are making in 
this final rule about when it is appropriate to bill the inherent 
complexity add on code will give practitioners increased confidence to 
bill the inherent complexity add-on code appropriately. Finally, we 
note that we make budget neutrality calculations on a prospective 
annual basis and would not be able to make mid-year retrospective 
adjustments to the conversion factor as was suggested by some 
commenters. CMS uses claims data for the services as they become 
available in subsequent years, to inform budget neutrality adjustments 
that would apply for a given year.
c. Request for Comment About Evaluating E/M Services More Regularly and 
Comprehensively
    Over the last several years, we have received suggestions/
recommendations outside of the rulemaking process that CMS consider 
using a different approach for valuing services that rely on research 
and data other than the AMA RUC's specialty-specific valuation 
recommendations. These commenters have highlighted that the evolving 
practice of medicine looks significantly different than it did when the 
resource-based relative value scale (RBRVS) was established three 
decades ago. Disease prevention and health promotion have grown in 
practice, and patient expectations are higher for managing 
hypertension, diabetes, and hypercholesterolemia. Additionally, more 
pharmaceuticals and new biologics have expanded therapeutic options for 
non-procedural care. Commenters have suggested convening expert panels 
that might review pertinent research and recommend resource 
recalibrations to update relative values under the PFS. The commenters 
suggested that such independent assessments could support CMS and the 
broader health delivery and health finance community in addressing 
growing distortions in resource allocations under the PFS for certain 
types of services, including evaluation and management visits and other 
non-procedural/non-surgical services.
    For many years, CMS has worked to address coding and payment 
deficiencies, explicitly focusing on instances where resources are not 
well accounted for in the inputs for certain services, including where 
significant differences in relative resources involved in furnishing 
care are not reflected in the coding distinctions, or where too-
specific coding makes valuation at appropriate intervals impractical. 
As we continue ongoing work to establish resource-based relative units 
for PFS services, we have sought and still seek public comment about 
the potential range of approaches CMS could take to improve the 
accuracy of valuing services. We continue to be interested in how we 
might improve the accuracy of valuation for services, and sought 
information about how we might evaluate E/M services with greater 
specificity, more regularly and comprehensively in the proposed rule.
    As we consider how CMS can potentially move forward with reforms to 
the way we establish values for E/M and other services, we specifically 
sought comment in the proposed rule

[[Page 78976]]

from the public on the following questions:
    a. Do the existing E/M HCPCS codes accurately define the full range 
of E/M services with appropriate gradations for intensity of services?
    b. Are the methods used by the RUC and CMS appropriate to 
accurately value E/M and other HCPCS codes?
    c. Are the current Non-E/M HCPCS codes accurately defined?
    d. Are the methods used by the RUC and CMS appropriate to 
accurately value the non-E/M codes?
    e. What are the consequences if services described by HCPCS codes 
are not accurately defined?
    f. What are the consequences if services described by HCPCS codes 
are not accurately valued?
    g. Should CMS consider valuation changes to other codes similar to 
the approach in section II.J.5. of this rule?
    In the proposed rule, we stated that we are particularly interested 
in ways CMS could improve processes and methodologies. We requested 
that commenters provide specific recommendations on improving data 
collection and making better evidence-based and more accurate payments 
for E/M and other services. We expressed particular interest in ways 
that we can make more timely improvements to our methodologies to 
reflect changes in the Medicare population, treatment guidelines, and 
new technologies that represent standards of care. We also asked for 
recommendations to ensure that data collection from and documentation 
requirements for physician practices are as least burdensome as 
possible while maintaining strong program integrity requirements. 
Finally, we also expressed interest in whether commenters believe that 
the current AMA RUC is the entity that is best positioned to provide 
recommendations to CMS on resource inputs for work and PE valuations, 
as well as how to establish values for E/M and other physicians' 
services; or if another independent entity would better serve CMS and 
interested parties in providing these recommendations.
    We received public comments on some or all of these questions from 
more than 50 commenters. The following is a summary of the comments we 
received and our responses.
    Comment: In response to a., ``Do the existing E/M HCPCS codes 
accurately define the full range of E/M services with appropriate 
gradations for intensity of services?'' some commenters responded that 
recent revisions of the E/M services were extensive and specifically 
addressed the granularity of services by allowing for gradation in 
reporting through allowing use of medical decision making or time on 
the date of the encounter (straightforward, low, moderate, and high), 
further enhanced by the development of coding for prolonged services. 
They believe the prolonged services codes, non-face-to-face services 
codes, clinical staff services codes, screening codes, care management 
codes, and HCPCS Category II codes reported for the evaluation and 
management of a patient allow for reporting of many nuanced 
interactions with a patient both on the day of encounter and between 
encounters. They expressed concern that HCPCS codes that CMS has added 
have created an unbundled component coding system with significant 
overlap of codes billable for the evaluation and management of Medicare 
beneficiaries and believe that while E/M and care management services 
have a sufficient gradation of intensity of work, they do not 
comprehensively define typical work, resulting in duplicative payment 
that CMS has not audited.
    Other commenters believed that the acuity between higher-level E/M 
codes is often quite steep and inconsistent with the differential 
between lower-level codes. They believed that rapid implementation of 
G2211 is necessary in accounting for this higher acuity and complexity. 
Similarly, another commenter stated that O/O E/M encounters represent a 
broad and diverse range of diagnoses and that the full set of E/M codes 
is relatively small, given the wide variety of encounters they are 
meant to describe. They added that CPT is better at describing discrete 
procedures than E/M services, especially E/M services that represent 
continuous, comprehensive primary care. Another commenter stated that 
the RUC tends to value codes primarily based on the physical skill 
involved and that cognitive services (that is, critical thinking 
involved in data gathering and analysis, planning, management, decision 
making, and exercising judgment in ambiguous or uncertain situations) 
are routinely undervalued. Another commenter suggested that many 
primary care activities are not accounted for under fee-for-service 
(FFS) payment. They stated that over the past decade, CMS has expanded 
the range of E/M services separately billable under the PFS but are 
concerned this piecemeal, code-by-code approach within the PFS may 
never fully account for the resources used to furnish primary care. 
They do not see the PFS as it is currently configured to be a platform 
allowing Medicare to pay for a broad range of elements defining primary 
care. Another commenter stated that the current high-level O/O E/M 
service codes do not distinguish between managing a few concurrent 
conditions, many concurrent conditions, and a single highly intense 
condition effectively. They further asserted that the original 
gradations within the outpatient and inpatient E/M service code 
families were not based on clinical evidence but rather Medicare 
payment data, which was likely distorted, and there has been no attempt 
to address these gradations. Another commenter stated they did not 
believe that the current outpatient and other E/M service codes reflect 
the work and resources required to deliver non-procedural and 
cognitively intense care to Medicare beneficiaries. They stated that 
the most recent revisions of E/M service code definitions and 
valuations have not remedied the original problems and failed to 
capture the intensity of E/M care, particularly the care provided to 
Medicare beneficiaries with one or more complex comorbid conditions.
    Response: We appreciate commenters' assertion that the current E/M 
coding structure does not adequately capture certain types of primary 
care. Our established policy for the complexity add-on code, as 
finalized in the CY 2019 PFS final rule and proposed with modifications 
for CY 2024, is rooted in our long-standing assessment that there are 
certain complexities inherent in furnishing some kinds of E/M visits 
that the current E/M coding and visit levels do not fully recognize, 
similar to what the commenters have highlighted. We continue to believe 
about how best to address this issue within the framework of the PFS 
and welcome ongoing dialogue with all interested parties.
    Comment: In response to b. ``Are the methods used by the RUC and 
CMS appropriate to accurately value E/M and other HCPCS codes?'' many 
commenters responded that they believed the methods used by the RUC and 
CMS are appropriate to value E/M and other HCPCS codes. They stated 
that standard packages for pre-service time, post-service time, 
practice expense direct input benchmarks, and pre-service clinical 
staff time packages were implemented, allowing for enhanced relativity 
and comparison among all services. They relayed that the median number 
of RUC survey respondents in recent years is 70, with surveys for high-
volume services having more than 100 physician respondents. They added 
that the recent office visit RUC survey yielded the highest number of 
responses in the history of the RUC process, with 1,700 physicians 
completing the survey.

[[Page 78977]]

They stated that the survey was the concerted effort of 51 specialty 
societies and other healthcare professional organizations that 
represented 95 percent of Medicare claims for E/M office visits. They 
further added that the RUC incorporates extant data when possible, such 
as data from the Society of Thoracic Surgeons, American College of 
Cardiology, and National Surgical Quality Improvement Program (NSQIP). 
These commenters requested that CMS make one methodological improvement 
to restore the Refinement Panel process, serving as an appeal process 
for those commenting on CMS's proposed relative values. Another 
commenter expressed concern that unlike the RUC's process, which they 
stated is based on statistics, CMS's methods to assign values to E/M 
and other HCPCS codes, especially G-codes, are opaque and not 
scientifically sound. They stated in doing so, CMS undermines the 
relative nature of the PFS. Another commenter explained that to 
identify potentially misvalued services, the RUC identifies, maintains, 
and reviews a list of new services and services that use new 
technology, develops objective screens based on defined criteria, and 
examines all services in which utilization estimates are more than 
expected.
    In their comment letter to the proposed rule, MedPAC highlighted 
their long-standing problems with the data and processes used to set 
different services' RVUs, which they concluded have led to certain 
services (for example, procedures, imaging, and tests) becoming 
overvalued relative to other services (for example, E/M services). They 
believe CMS relies heavily on RUC recommendations when setting RVUs, 
even though most of the RUC's members have a financial stake in setting 
payment rates, about which researchers have expressed RUC transparency 
and objectivity concerns. MedPAC further stated that as far back as 
2006, they recommended that CMS augment the RUC with a standing panel 
of experts that could help the agency identify overvalued services and 
review recommendations from the RUC. They also recited some of their 
other past recommendations. They added that, in their view, a wide 
range of codes should be reviewed using new data and analyses, 
beginning with the 10- and 90-day global surgical codes. They noted 
that because of the evidence of the substantial overvaluation of 10- 
and 90-day surgical global codes, they have continued to support CMS's 
prior proposal to convert all 10- and 90-day global surgical codes to 
lower-priced 0-day global codes and allow practitioners to separately 
bill for postoperative visits on a FFS basis (that is, outside of the 
global package). Some commenters shared this view about global surgical 
codes, whereas others took an opposite view in response to the 
questions below.
    Other commenters stated that the methods used by the RUC and CMS do 
not lead to accurate valuation and that the problems lie with the 
nature of E/M services and the PFS's budget neutrality adjustment. They 
stated that the resources used in furnishing the work portion of E/M 
services are primarily a function of the time the clinician spends with 
the patient and, therefore, are not amenable to efficiency gains and 
that the valuation process is not responsive to efficiency gains, 
leading to passive devaluation of E/M services under the constraints of 
budget neutrality. They recommend a robust process, supported by an 
expert advisory panel, to review misvalued services, which would focus 
on replacing magnitude estimation with a building block approach to 
valuation. Other commenters stated that they believed there were 
several methodologic issues in the RBRVS initial work done by Bill 
Hsiao and Peter Braun, some of which were identified by the original 
investigators, undermining its ongoing value. They stated that 
clinically significant factors, such as the expertise needed to manage 
specific complex clinical conditions or multiple simultaneous clinical 
conditions, are not currently recognized. They stated low response 
rates and small sample sizes for the RUC surveys distinguished this 
feature from the original methodology employed by Hsiao et al., whose 
validity depended critically on robust sample sizes. These commenters 
suggested additional data sources could result in more robust 
recommendations and recommend that CMS invest resources in other 
supplemental sources of information, especially physician time, rather 
than relying almost exclusively on the RUC. Another commenter stated 
that the current survey methodology has several limitations that impact 
both E/M and non-E/M services, including low response rates, an 
inability to determine if the responses received are accurate 
reflections of real-world clinical practice and substantial variations 
in modern-day clinical practice for the same HCPCS code across 
different specialties. They added that more direct methodologies might 
be more costly and burdensome. Still, they would reflect the actual 
time and effort inherent to a particular HCPCS code more accurately. 
They believe that time and motion studies could be used to determine 
the required resources for RBRVS. Another commenter stated that it is 
more difficult to quantify the physician work involved in E/M services 
than for more specific procedural service vignettes in the RUC survey 
process, given that the survey focuses on the ``typical'' patient and 
distributes surveys based on vignettes for E/M services that are much 
less specific. They added that the input of the primary care 
specialties that provide the most complex E/M services and do so most 
commonly is undervalued when these broad E/M vignettes are surveyed 
across more than 50 specialty societies, many of which do relatively 
few and much more straight-forward E/M visits than primary care.
    Another commenter stated that fundamental problems with the 
outpatient and other E/M codes would not be solved by the existing 
processes employed by the Current Procedural Terminology (CPT)[supreg] 
Editorial Panel and the American Medical Association (AMA) RUC. They 
stated there is an expertise bias on the RUC toward procedural care 
based on the panel's composition influencing how services are valued. 
They posited that a significant portion of the value of E/M and other 
non-procedural services lies in the physicians' skills and expertise in 
diagnosing and managing complex conditions, coordinating care, 
considering the patient's overall health and well-being, and making 
treatment decisions that consider various factors beyond just the face-
to-face interaction between the physician and patient, which is harder 
to quantify in a survey.
    Response: We appreciate the perspectives shared by commenters and 
recognize that there are opportunities to improve how all services are 
valued and better account for resource variation for different types of 
care under the PFS. Our policy for the complexity add-on code reflects 
several years of consideration and engagement with interested parties 
to address these long-standing issues. However, we view our 
implementation of the inherent complexity add-on code as an improvement 
in valuation and coding compared to the status quo, not necessarily an 
end in itself. We welcome engagement on this broader issue of 
recognizing costs for specific services as we have described, including 
through our usual review of coding and recommendations for PFS services 
from the AMA editorial panel, RUC, and other interested parties.
    Comment: In response to c., ``Are the current Non-E/M HCPCS codes 
accurately defined?'' some commenters responded, yes, the current non-
E/M

[[Page 78978]]

HCPCS codes are accurately defined through the CPT Editorial Process 
and called the process a respected method that is best suited to 
preserve accurately defined medical codes. They added that not only are 
HCPCS level I CPT codes generated and accurately defined, but the 
reporting guidelines and instructional parentheticals are also 
established to ensure proper usage and reporting of such codes. These 
commenters stated that, in contrast, descriptors for HCPCS level II 
codes developed by CMS through an application process twice per year or 
as C-codes and G-codes are often ill-defined because CMS does not 
differentiate them from existing HCPCS level I CPT codes, resulting in 
reporting confusion. Other commenters stated that the PFS has 
experienced a proliferation of non-E/M codes whose fine-tuning of time 
and intensity to distinguish minor variations in resource costs creates 
a false sense of accuracy because empirical times are subject to 
unavoidable measurement error and intensity estimations should be 
limited to a few clearly-defined intervals.
    Response: We thank the commenters for their feedback. We recognize 
the role that certain interested parties play in establishing the HCPCS 
level I coding that healthcare practitioners use to bill for the 
services they furnish and note that we routinely rely on the CPT coding 
process as a critical part of our process for recognizing and paying 
for such services under the PFS. We also acknowledge that in some 
circumstances, when we must act to address beneficiary access or 
practitioner payment issues, we can establish HCPCS level II coding, 
and we do so in the public interest, reflecting our consideration of 
appropriate coding and provider administrative burden. We also 
recognize that there are intrinsic limitations in the level of 
specificity in time and intensity as reflected in the RBRVS, regardless 
of the origin of the service definition in coding or how many survey 
responses are considered in the valuation process.
    Comment: In response to d., ``Are the methods used by the RUC and 
CMS appropriate to accurately value the non-E/M codes?'' commenters 
stated that it is important that all services be examined via the same 
resource-based relative value scale methodology to ensure fairness, 
consistency, and relativity. Another commenter stated that CMS has 
often discounted intensity and over-relied on time as a measure of 
value. They characterized intensity as based on requisite education and 
training, dealing with complex patient cases that are physically 
challenging during treatment with a risk of unexpected intraoperative 
complications. They stated that managing these patients requires 
considerable mental effort and judgment, with the procedure's outcome 
more dependent on the surgeon's skill than the time necessary to 
accomplish it. Other commenters believed that the process used by CMS 
is typically a calculation made by a nonphysician practitioner (NPP) 
using math without physician validation. They stated that a glaring 
example of CMS inaccurately valuing non-E/M codes is the failure to 
incorporate the RUC-recommended work and time incremental increases for 
the revised office/outpatient visit E/M codes into global codes. They 
noted that CMS did finalize adjustments for other bundled services, 
such as maternity codes, in the CY 2021 PFS. They implored CMS to 
follow precedent and correct this issue. They also believed that recent 
decisions had been incorrectly made solely on time, without adequate 
consideration of the intensity involved, and that time should not be 
the deciding factor in code valuation. Some commenters stated that the 
methods used by the RUC are appropriate to value E/M and non-E/M codes. 
They believed the underlying RBRVS methodology remains relevant today 
and that the RUC valuation process continues to improve with the 
development of numerous standards/policies/conventions to improve 
relativity and ensure consistency. They remarked that standard packages 
for pre-service time, post-service time, practice expense direct input 
benchmarks, and pre-service clinical staff time packages have been 
implemented, allowing for enhanced relativity and comparison among all 
services. Another commenter voiced frustration at what they 
characterize as a lack of rationale provided for CMS' decisions when 
they differ from RUC recommendations. They stated that it is difficult 
to respond when CMS' rationale is only a ``belief'' that a crosswalk to 
another code is better than the RUC recommendation or the data from the 
survey. They added that, without additional substantive rationale, just 
because a CPT code has the same intra-service or total time, does not 
mean another code should share its exact physician work RVU. They and 
other commenters urged CMS to consider restoring the Refinement Panel 
process that served as an appeals process for those commenting on CMS 
proposed relative values.
    Other commenters stated that there is ample evidence that many non-
E/M services are overvalued due to time over-estimations and payment 
for bundled post-operative visits that rarely occur. Additionally, they 
stated that unlike under the original Harvard study methodology, on 
which the RUC magnitude estimation process relies, RUC survey 
respondents are likely aware that a higher rating of time and work 
directly leads to a higher work RVU for the rated procedure. They added 
that this problem is illustrated in the CMS proposed rule section on 
the valuation of specific codes where estimates and work RVUs, 
originating with whom they termed self-interested participants in the 
process, are evaluated at the statistical median, whereas others, out 
of a concern about inadequate data, are evaluated at the 25th 
percentile. They stated that choosing statistics this way does not 
overcome the problem of inadequate data and invites conflicts of 
interest. Furthermore, they stated that many survey respondents have 
not performed the service in question, as there is no requirement for 
it, calling into question the validity of their assessments. They 
recommended: (1) Moving the estimation of work from subjective 
magnitude estimation to analysis relying primarily on a measured-time-
data-informed building block approach; (2) Routinely and periodically 
observing and collecting measured, actual-time data for work (and 
direct PE) from a rotating panel of practices and other healthcare 
providers; and (3) Adoption of a criterion for the misvalued codes 
initiative to identify codes within BETOS families that have aberrant 
intensity values, what the RUC has termed ``rank order anomalies.'' 
They recommended that accurate data collection, particularly for code-
specific time data from practices, should be central to this review. 
Another commenter, taking a similar approach, suggested that CMS 
develop an agency-based independent process parallel to the RUC for 
service valuation. They envisioned this parallel process would take a 
fundamentally different approach to valuation that would use empirical 
data and the building block approach to value services. CMS might use 
the RUC estimates to determine valuation in selected situations. They 
posited that a CMS process would not be bound by the inherent 
distortions in representation between cognitively intense and 
procedural specialties currently found in the RUC.
    Response: We thank the commenters for their feedback on this 
specific question. We share the same concerns about effectively valuing 
and accounting

[[Page 78979]]

for resources involved in furnishing in the services paid under the 
PFS, especially when considering codes of dissimilar structures. We 
recognize that there are varying perspectives on how to best reflect 
the inputs for services paid under the PFS, which is why we are 
engaging in this dialogue and asking these questions. As part of our 
obligation to maintain the PFS and ensure access to services for 
Medicare beneficiaries, we thoroughly review and consider available 
information, including recommendations and supporting information from 
the RUC, the Health Care Professionals Advisory Committee (HCPAC), 
public commenters, medical literature, Medicare claims data, 
comparative databases, comparison with other codes within the PFS, as 
well as consultation with other physicians and healthcare professionals 
within CMS and the Federal Government as part of our process for 
establishing valuations. In response to the comments expressing concern 
about our valuation review process, we note that our approach does 
consider the expertise supporting the RUC process. We primarily use the 
RUC-recommended values as a starting reference for services under 
review and then apply one of these several methodologies, which we have 
discussed in detail in past rules to account for adjustments to 
specific inputs that we believe were not otherwise reflected in the 
RUC-recommended value. We note our current process of proposing the 
majority of code values in a proposed rule, allowing the public to 
comment on those proposed values, and then finalizing those values in a 
final rule offers greater transparency and accountability than the 
refinement panels which we established to assist us in reviewing the 
public comments on CPT codes with interim final work RVUs. Our process 
also offers greater transparency and accountability than the refinement 
panels in balancing the interests of the specialty societies who 
commented on the work RVUs with the budgetary and redistributive 
effects that could occur if we accepted extensive increases in work 
RVUs across a broad range of services. Further, we have established an 
annual process for the public nomination of potentially misvalued 
codes, which allows those who believe that values for individual 
services are inaccurate and should be readdressed through notice and 
comment rulemaking, including possibly through the RUC process, to 
bring those codes to our attention. We disagree with the comments 
asserting that we discount intensity entirely and rely on time alone as 
a measure of value for certain services, though we acknowledge 
commenters for particular codes have sometimes urged us to give more 
weight to assertions regarding greater relative intensity, much like 
some interested parties have urged us to consider intensity as 
reflected in survey data overall. Following our statutory authority, we 
have consistently considered revisions to valuations based on the 
relative resources involved in furnishing the service, which include 
time and intensity. We have always stated in past discussions on this 
issue that we believe that changes in time and intensity must be 
accounted for when developing work RVUs. Thus, when our review of 
recommended values reveals that changes in time are not accounted for 
in a RUC-recommended work RVU, the obligation to account for that 
change when establishing proposed and final work RVUs remains. If we 
were to disregard intensity altogether, the work RVUs for all services 
would be developed based solely on time values, and that is not the 
case, as indicated by the many services that share the same time values 
but have different work RVUs. For example, among the codes reviewed in 
this CY 2024 PFS final rule, CPT codes 76987, 97550, and 99497 all 
share the same total work time of 40 minutes. However, these codes had 
very different proposed work RVUs of 1.62, 1.00 and 1.50, respectively. 
These examples demonstrate that we do not value services purely based 
on work time; instead, we incorporate time as one of multiple factors 
in our review process, and we anticipate continuing to engage in 
constructive dialogue with the community regarding the appropriate 
weighing of time and intensity in establishing work RVUs.
    Comment: In response to e., ``What are the consequences if services 
described by HCPCS codes are not accurately defined?'' some commenters 
stated that the RUC's Relativity Assessment Workgroup (RAW) process 
helps to identify a lack of clarity or the need for change in 
descriptions due to changing technology. They believed that CMS's 
differing coding methodologies for reporting prolonged services deepen 
the administrative burden for healthcare professionals and increase the 
potential for improper coding. Many commenters expressed that it is 
imperative that physicians have one set of clear codes and guidelines 
to report medical procedures and services and that if other HCPCS level 
II codes are created that are not accurately defined, it could lead to 
improper reporting of medical services to Medicare and other insurers. 
Another commenter stated that inappropriate utilization, particularly 
if no health benefit is obtained for the patient or population, can 
lead to high healthcare costs. Another commenter stated that when HCPCS 
codes are poorly defined, clinicians and other healthcare professionals 
may be challenged with when and how to confidently adopt HCPCS codes in 
their clinical practice, which can lead clinicians, other healthcare 
professionals, and their administrative staff to inadvertently misuse 
or misapply a HCPCS code, leaving them vulnerable to program integrity 
audits.
    Response: We recognize the role that certain interested parties 
play in establishing HCPCS level I coding that healthcare practitioners 
use to bill for the services they furnish and note that we routinely 
rely on the CPT coding process as a critical part of our process for 
recognizing and paying for services under the PFS. We also acknowledge 
that in some circumstances, when we must act to address beneficiary 
access or practitioner payment issues, we establish HCPCS level II 
coding, and we do so in the public interest, reflecting our 
consideration of Medicare policy goals, appropriate coding, and 
healthcare provider administrative burden.
    Comment: In response to f., ``What are the consequences if services 
described by HCPCS codes are not accurately valued?'' some commenters 
stated that the intent of the RBRVS is to ensure that the payment of 
one service is relative to the payment of another when accounting for 
the resources consumed in the provision of the service. They 
furthermore stated that if the relativity of one service is 
undervalued, physicians may not be able to sustain the practice of 
providing that service in an office setting. Likewise, a significant 
overvaluation of a service may provide a financial incentive to perform 
the service. They added that the RUC created the RAW to develop 
objective and fair screens to identify potentially misvalued services 
and address these issues. Another commenter stated that there may be 
services described by multiple overlapping codes, likely resulting in 
duplicative billing and overpayments for a single service. They urged 
CMS to research and audit utilization of the over 150 CPT codes and 
HCPCS G-codes for reporting unbundled, finite pieces of E/M services 
for which they stated a potential for overpayment may result in fraud, 
waste, and abuse under the Medicare program.
    MedPAC commented that when subsets of services are overvalued, it

[[Page 78980]]

causes the gap between the compensation of different clinical 
specialties to be more significant than it otherwise would be. They 
reported that in 2021, the median compensation for surgical specialties 
was $441,000, well above the $264,000 that primary care physicians 
earned. They added that this large compensation gap makes careers as 
primary care providers less financially attractive than careers as 
specialists and may be a factor in why the supply of primary care 
physicians in the U.S. has been declining in recent years. Other 
commenters expressed similar views, citing MedPAC and a National 
Academies of Science, Engineering, and Medicine (NASEM) 2021 consensus 
report that concluded that the current approach to FFS valuation has 
``resulted in systematically devaluing primary care services relative 
to other services and its population health benefit . . .''
    Response: We agree that there may be distortions in the PFS that 
result from disparities in coding and valuation, which is at the core 
of the issue we have highlighted and are working to address by 
implementing the inherent complexity add-on code as discussed above.
    Comment: In response to g., ``Should CMS consider valuation changes 
to other codes similar to the approach in section II.J.5. of this 
rule?'' some commenters stated that CMS should not consider valuation 
changes like the approach in section II.J.5. of the CY 2024 PFS 
proposed rule. They remarked that the calculation proposed for the 
increase in behavioral health services is not resource-based and could 
potentially distort the RBRVS. They added that section 6102 of the 
Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-239) that 
created the RBRVS requires that the relative values are based on 
resource costs. They stated that CMS should not use arbitrary 
calculations to adjust specific services performed by one specialty to 
tackle issues outside of the scope of the RBRVS payment system and that 
access and shortage issues should be addressed through legislative 
solutions and funded by Congress.
    Response: We do not agree that recognizing distortions in valuation 
and accounting for them within the RBRVS departs from basing valuation 
on resources. Instead, we believe that deliberate failure to account 
for systemic distortions in the methodologies, once recognized, would 
violate resource-based valuation. We look forward to continued 
engagement with interested parties so that more comprehensive and 
consensus-based solutions to address these distortions within the 
ratesetting methodologies can be implemented. We received public 
comments in response to our requests, following the items a. through 
g., for recommendations on a series of specific topics: improving data 
collection and making better evidence-based and more accurate payments 
for E/M and other services; making more timely improvements to our 
methodologies to reflect changes in the Medicare population, treatment 
guidelines, and new technologies that represent standards of care; 
ensuring that data collection from and documentation requirements for 
physician practices are as least burdensome as possible while 
maintaining strong program integrity requirements; and finally whether 
commenters believe that the current AMA RUC is the entity that is best 
positioned to provide--recommendations to CMS on resource inputs for 
work and PE valuations, as well as how to establish values for E/M and 
other physicians' services, or if another independent entity would 
better serve CMS and interested parties in providing these 
recommendations.
    Comment: In response to the interest we expressed in hearing 
potential ways that we could improve processes and methodologies, and 
our request that commenters provide specific recommendations on ways 
that we can improve data collection and make better evidence-based and 
more accurate payments for E/M and other services, some commenters 
stated that the RUC is continuously improving its processes to ensure 
it best utilizes reliable, extant data., as noted above, in response to 
``b.'' Another commenter stated that while the RUC can recommend 
relative work RVUs and direct PE details, because adjustments for 
inflation have not been applied to such services via statute, CMS 
cannot pay providers at the appropriate rate for the work and PE 
measured. They stated that to make more accurate, evidence-based 
payment for E/M and other services, Congress must adjust the factors 
that impact reimbursement rates under the PFS, and they urged CMS to 
support such Congressional efforts. They also encouraged CMS to 
consider examining electronic health record (EHR) data as a credible 
source for provider work, not only for global codes but also for 
services provided by PCPs over a 30-to-90-day period to ensure there is 
no overlap in work. They added that services reported over the 10-day 
global period for E/M office visits should also be reviewed for 
duplicative work and that because many services can be reported using 
time, a time modifier could enhance the ability for EHR and other 
program integrity audits to identify overlapping services provided in 
person or via telehealth.
    Another commenter recommended that CMS consider using a 
supplemental independent panel of experts to provide recommendations on 
evidence-based and accurate valuation of services under the PFS. They 
stated that a more formalized process for submitting data to CMS 
(including publicizing how, where, and by when to submit available 
data) could also be helpful to stakeholders who are not as regularly 
engaged with the staff who draft the PFS proposed and final rules to 
share any data they do have access to.
    We also received public comments in response to our particular 
interest in recommendations on making more timely improvements to our 
methodologies to reflect changes in the Medicare population, treatment 
guidelines, and new technologies that represent standards of care.
    Response: We appreciate the commenters' concerns and acknowledge 
that there are changes in treatment standards and new technologies that 
should be recognized better in the PFS. Moreover, we realize that 
aspects of the PFS methodology need to be revised to better account for 
these changes. Over the last several years, we have engaged in research 
to identify viable approaches to updating the data inputs we use to 
better set payment rates to reflect these changes. We thank the 
commenters for their thoughts, as your engagement is crucial to our 
ongoing efforts to understand critical variables in any attempt to 
reform the PFS, including identifying alternate data sources (like 
EHRs) to support the refinement of data inputs or, more broadly, 
identifying how to proceed within our existing statutory authority or 
when congressional may be required to facilitate necessary fundamental 
changes to calculating physician payment rates.
    Comment: Many commenters suggested that CMS may improve 
methodologies by improving access to Medicare and Medicaid data. They 
added that disseminating Medicare utilization data earlier would be 
particularly helpful to immediately understand if the utilization of a 
service is as anticipated. They suggested that the first quarter of 
Medicare claims data should be available by July 1st of each year, and 
a full year of claims data should be available by April each year (for 
example, 2023 data should be publicly available by April 2024). They

[[Page 78981]]

requested that CMS share recent Medicaid data and investigate 
mechanisms to collect and share Medicare Advantage encounter 
information.
    One commenter stated that the RUC identifies, maintains, and 
reviews a list of new services and services that use new technology, 
develops objective screens to identify potentially misvalued services, 
and examines all services in which utilization estimates are more than 
expected. They stated that since its inception in 2006, the RAW and CMS 
have identified over 2,700 services through over 20 screening criteria 
for further review by the RUC. Another commenter stated that due to a 
lack of transparency, they do not know what methodologies CMS employs 
to be able to provide recommendations on more timely improvements for 
HCPCS G-codes. They stated that from their perspective, CMS often 
reacted to stakeholder requests by creating G-codes--sometimes for 
services that do not need to be urgently reportable--and often based 
them on new technology that has not reached sufficient evidence for 
support.
    Response: We appreciate the commenters' concerns and acknowledge 
that there are changes in treatment standards and new technologies that 
could be recognized better within the PFS. We thank the commenters for 
their thoughts, as their engagement is crucial to our ongoing efforts 
to understand critical variables in any attempt to reform the PFS, 
including identifying alternate data sources (like EHRs) to support the 
refinement of data inputs or, more broadly, identifying how to proceed 
within our existing statutory authority or when congressional action 
may be required to facilitate necessary fundamental changes to 
calculating physician payment rates.
    We also received public comments in response to our interest in 
recommending that data collection and documentation requirements for 
physician practices are as least burdensome as possible while 
maintaining strong program integrity requirements.
    Comment: Some commenters supported addressing the significant 
administrative burden plaguing physicians and other healthcare 
professionals. They added that physicians and other healthcare 
professionals have limited time and other resources to participate in 
data collection efforts. Another commenter stated documentation should 
be utilized for clinical purposes and should not burden physicians to 
satisfy administrative or billing requirements. They noted that 
supporting the national medical specialties and other health care 
professional organizations is imperative in obtaining adequate data on 
the resources required to provide services. Another commenter believed 
that modifiers (for example, a modifier when an E/M service is reported 
using time) would be very useful to assist with program integrity 
audits. They thought CMS should collect data (for example, service 
times, the number and types of services reported on any day by a given 
provider) from EHR vendors to evaluate billing patterns better. They 
believed that without this information from EHRs regarding times and 
visits, in some scenarios, patients may not receive the care they 
expect and deserve.
    Response: We appreciate commenters' interests and will consider 
them both for future rulemaking and as part of ongoing efforts to 
improve transparency.
    Finally, we also received public comments in response to our 
interest in whether commenters believe that the current AMA RUC is the 
entity that is best positioned to provide--recommendations to CMS on 
resource inputs for work and PE valuations, as well as how to establish 
values for E/M and other physicians' services; or if another 
independent entity would better serve CMS and interested parties in 
providing these recommendations.
    Comment: Many commenters objected to the question and noted that 
any individual or entity, including the RUC, has a constitutional right 
to provide recommendations to CMS on resource inputs for work and 
practice expense valuation. One commenter stated that it is when CMS 
deviates from the RUC process, such as with creating the add-on code 
and providing no evidence of its time or relative intensity, that the 
entire RUC process' legitimacy becomes threatened, positing that if 
medical societies perceived that CMS would ignore their good-faith 
participation in a consensus-based process, there would be even more 
efforts to seek legislative action, thereby resulting in an even more 
inconsistent system. Several commenters stated that the RUC 
recommendations to CMS are based on extensive granular data to describe 
physician time, work relativity, and PE resources associated with 
providing procedures and other services. They stated that CMS is not 
required to accept RUC recommendations and that they will continue to 
support and advocate for the RUC process in maintaining Medicare 
relative values. Other commenters stated they played a significant role 
in valuing new or revised services within their specialty, supported 
the work of the AMA CPT[supreg] Editorial Panel to revise the entire E/
M code set, with those revised services then valued by the AMA RUC, and 
believed that the processes used by the RUC provided an avenue for 
physician input that helped to maintain an appropriate resource-based 
payment system. They and other commenters noted that the RUC is best 
suited for valuing physician services. Another commenter expanded upon 
this view and noted that the AMA CPT Editorial Panel and the RUC are 
the best-situated entities to provide input to CMS on values, 
documentation, and coding as a part of the annual PFS rulemaking cycle, 
including for E/M services. They stated the physician experts who 
provided input at all stages of defining codes and valuing services as 
part of the CPT and RUC continuum provided the essential clinical 
knowledge needed to conduct these functions. They stated it also 
involved members from across the medical community, not just the 
specialty that delivers the service under review, to serve as a 
sounding board and safety net in defining and valuing codes. This 
commenter expressed concern that CMS attempted to marginalize the input 
of CPT and RUC and another entity may serve as a mechanism to reverse-
engineer some other policy goal beyond providing medical expertise 
about the resources and work that are provided when furnishing a well-
defined set of services. They and other commenters noted that CMS is 
not bound by the recommendations of the RUC and posited that any 
stakeholder is free to establish the infrastructure to generate 
detailed, data-driven recommendations for the valuation of services. 
They also noted that CMS continues to consider RUC recommendations 
precisely because the RUC provides the best available information and 
offers an unmatched coherent, data-driven rationale to its 
recommendations. Another commenter stated that there is no need for 
another independent entity to provide recommendations regarding the 
valuation for services that are reported on the PFS. They noted the RUC 
process for valuing services is fair and balanced, as experts across 
all specialties engage in deeply informed discussions and must come to 
a consensus (a two-thirds vote) to approve any recommendations. They 
stated that having all major specialties at the table, within the 
budget neutrality confines of the PFS, ensured that any changes are 
evidence-based and justifiable. Another commenter believed CMS should 
defer to the RUC process, especially when CMS does not have the 
appropriate specialty representation to make

[[Page 78982]]

informed decisions about the RUC recommendations. They further opined 
that CMS should communicate with the RUC and work to alter the process 
requirements so all interested parties can work together on a desired 
outcome.
    In contrast, several commenters offered strong support and thoughts 
in response to CMS's request for information. These commenters opined 
that CMS should not view the RUC as the sole source of knowledge and 
expertise to ensure that physician services are valued appropriately. 
They encouraged CMS to invest in additional adjunctive sources to 
ensure its recommendations are well-informed, balanced, and reflective 
of the evolving healthcare environment. One commenter supported CMS in 
considering another independent entity, including pharmacists and other 
clinical staff, that would serve CMS in providing recommendations on 
resource inputs for work and practice expense (PE) valuations and to 
more accurately establish values for E/M and other physician services 
that better reflect modern-day team-based health care delivery and the 
actual services provided by pharmacists and other clinical staff to 
provide E/M services. Other commenters greatly appreciated CMS posing 
this question, as they did not believe that the AMA RUC is the entity 
best positioned to provide recommendations to CMS on resource inputs 
for work and PE valuations and how to establish values for E/M and 
other physicians' services. They stated that the valuations established 
during this process no longer represent the valuation of services for 
`physicians' but all healthcare providers who bill Medicare, advanced 
practice nurses, physician assistants, limited license practitioners, 
and allied health professionals. They noted the valuation process 
relegated them to be represented by the Health Care Professionals 
Advisory Committee (HCPAC), which only has one seat on the RUC. These 
commenters asserted that there are inherent conflicts in the valuation 
process, which led to a historical undervaluation of E/M services, a 
foundational aspect of the primary care system. They also raised 
concerns about the data from surveys conducted by specialty societies 
having low response rates and total number of responses, which they 
claim raises questions about the representativeness of the results. 
They added that the lack of public accessibility of this information is 
not addressed by CMS's fee schedule notice and comment process, as the 
fee schedule itself is often used the valuations determined by the RUC 
as the basis for CMS's rationale. They requested CMS develop an 
equitable, accessible, and accurate valuation process reflective of the 
modern healthcare system, ensuring that nurse practitioners and other 
providers directly billing Medicare can participate in the entirety of 
the valuation process, which must be transparent and accessible for 
all. Another commenter echoed concerns that there are structural flaws 
with the RUC that undermine the accuracy of its recommendations, 
including inherent conflicts of interest among RUC members and a 
reliance on surveys from medical societies that lead to overvaluation 
of certain specialty services. They also stated that current CMS 
processes for valuing services lack external validation and do not 
leverage a diverse, evolving data set, which would be more accurate and 
comprehensive. They suggested that CMS supplement the RUC's 
recommendations with additional research and external data, positioning 
CMS to more actively lead the determination of relative values, with 
consultation from the RUC, consistent with expert recommendations. They 
recommended implementing accurate and ongoing data collection to 
independently validate RVUs, establish an empirical source of 
information on time and costs associated with services, and establish 
an expert advisory panel within CMS to provide crucial advice on 
improving valuation processes and ensure independence and transparency. 
Another commenter asserted that from the very first implementation of 
the PFS based on the RBRVS, there has been no CMS agency-level 
commitment to ensure that both the definition and valuation of 
physicians' services are based on the best evidence possible, that the 
determination of relativity has internal checks and balances, and that 
the entire process is publicly accountable. They and other commenters 
suggested that an expert panel will be best equipped to ensure these 
services are evaluated regularly, limiting the significant 
redistributive effects associated with major valuation and policy 
changes, as we recently saw when the outpatient E/M codes were 
revalued. They stated that a regular, independent assessment of 
available data and the resulting data-driven policy recommendations 
would stabilize an irregular process, significantly contributing to the 
declining primary care workforce.
    Another commenter urged CMS to initiate the expert panel as part of 
the CY 2024 PFS final rule. They stated that the transition to more 
accurate, evidence-based, and accountable processes for defining 
services within the PFS and their relative pricing is long overdue and 
that the work to address the many distortions within the PFS should 
begin as quickly as possible.
    Response: We recognize that there are varying perspectives on how 
to best reflect the inputs for services paid under the PFS. We 
appreciate the depth of consideration different interested parties have 
offered in their comments, and we will consider all the public comments 
regarding the potential range of approaches CMS could take to improve 
the accuracy of valuing services and how we might evaluate E/M services 
with greater specificity, more regularly, and comprehensively for 
future rulemaking.
3. Split (or Shared) Visits
    The split (or shared) ``substantive portion'' policy for services 
furnished in facility settings was reflected in subregulatory guidance 
until it was withdrawn in May 2021 in response to a petition under the, 
since rescinded, Good Guidance regulation (see 87 FR 44002 (February 
25, 2022). In the CY 2022 PFS final rule (86 FR 65150 through 65159), 
we finalized a policy for evaluation and management (E/M) visits 
furnished in a facility setting to allow payment to a physician for a 
split (or shared) visit (including prolonged visits), where a physician 
and NPP in the same group practice provide the service together (not 
necessarily concurrently) and the billing physician personally performs 
a substantive portion of the visit. Commenters generally supported our 
CY 2022 proposals; however, there were divided comments regarding our 
proposed definition of ``substantive portion.'' Some commenters 
preferred the use of medical decision making (MDM) or one of the three 
key visit components as opposed to time for purposes of defining the 
``substantive portion'' of the service.
a. Background
    A split (or shared) visit refers to an E/M visit performed by both 
a physician and an NPP in the same group practice. In the non-facility 
(for example, office) setting, the rules for ``incident to'' billing 
apply under this circumstance. However, ``incident to'' services are 
not available for services furnished in a facility setting. 
Longstanding CMS policy has been that, for split (or shared) visits in 
the facility (for example, hospital) setting, the physician can bill 
for the services if they perform a substantive portion of the 
encounter.

[[Page 78983]]

Otherwise, the NPP would bill for the service. Section 1833(a)(1)(N) of 
the Act specifies that payment is made for services furnished and 
billed by a physician at 100 percent of the PFS rate, while under 
section 1833(a)(1)(O)(i) of the Act, certain NPPs are paid for the 
services they furnish and bill for at a reduced PFS rate (for example, 
85 percent of the PFS rate).
    We defined ``substantive portion'' in the CY 2022 PFS final rule 
(86 FR 65152 through 65156) and provided for billing of split (or 
shared) visits in certain settings (86 FR 65156 through 65157) and for 
certain patient types (new and established) (86 FR 65156). After 
consideration of the public comments on the CY 2022 PFS proposed rule, 
we finalized a phased-in approach to this policy (86 FR 65153). For CY 
2022, we finalized the definition of ``substantive portion'' as one of 
the following: either one of the three key E/M elements (that is, 
history, exam, or MDM) or more than half of total time. We also stated 
that we would delay the full implementation of the definition of 
``substantive portion'' as more than half of total time until CY 2023 
(86 FR 65152 and 65153).
    Additionally, in the CY 2022 PFS final rule (86 FR 65158 through 
65159), we finalized our proposal to create a payment modifier 
(modifier FS), to describe split (or shared) visits (see 86 FR 65158 
through 65159 for this discussion). Over time, implementing and using 
this modifier will better enable us to quantify split (or shared) 
visits and better understand the billing patterns of practitioners that 
typically furnish them. Such information is helpful to CMS for program 
integrity purposes and may also inform us on whether we need to clarify 
or further revise the policy for these services in future rulemaking. 
We have roughly one year's worth of claims data from the time we 
implemented the modifier as part of our ongoing engagement with 
interested parties. We have continued to hear concerns about our intent 
to implement our policy to use more than half of the total time to 
define the ``substantive portion'' of a split or shared visit, and have 
received requests to continue to recognize MDM as the ``substantive 
portion.'' Many of these concerns specifically reference disruptions to 
current team-based practice patterns, and the potential for significant 
adjustments to the practice's internal processes or information systems 
to allow for tracking visits based on time, rather than MDM. With these 
concerns in mind, in the CY 2023 PFS final rule (87 FR 69614 through 
69616), we finalized a policy to delay implementation of our definition 
of substantive portion as more than half of the total practitioner time 
until January 1, 2024.
    After much consideration, we proposed to delay the implementation 
of our definition of the ``substantive portion'' as more than half of 
the total time through at least December 31, 2024, for the same reasons 
outlined in the CY 2023 PFS final rule (87 FR 69614 through 69616). We 
proposed maintaining the current definition of `substantive portion' 
for CY 2024, which allows using any of the three key components 
(history, exam, or MDM) or more than half of the total time spent to 
determine who bills the visit. We stated that the additional delay 
would allow interested parties to have another opportunity to comment 
on this policy and would give CMS time to consider more recent feedback 
and evaluate whether there is a need for additional rulemaking on this 
aspect of our policy. We expressed interest in how facilities currently 
implement our split (or shared) services policy in their workflows and 
how facilities now account for billing practitioners' services that are 
performed split (or shared). We expressed interest in better accounting 
for the billing practitioner's services in team-based care clinical 
scenarios. We recognized that the AMA CPT Editorial Panel was 
considering revisions to aspects of split or shared visits for CY 2024 
that may impact our policies, but those changes had not been finalized 
before our proposed rule was published. We stated we would review the 
AMA CPT Editorial Panel's changes to split or shared visits when and if 
available before the final rule and in the context of our policy 
proposal. We indicated that we would consider any changes that are made 
by CPT and their relationship to our previously finalized policies and 
whether a further implementation delay beyond CY 2024 or revision of 
the definition of ``substantive portion'' is warranted.
    We proposed to amend Sec.  415.140 to delay implementation of the 
definition of ``substantive portion'' as more than half of the total 
time through CY 2024 in the interim while we continued to analyze and 
collect information from interested parties and commenters as to 
whether we should permanently modify our current definition. We 
proposed that the current definition of ``substantive portion'' would 
apply for visits other than critical care visits furnished such that 
substantive portion means either one of the three key components 
(history, exam, or MDM) or more than half of the total time spent by 
the physician and NPP performing the split (or shared) visit for 
services furnished through the end of CY 2024.
    We received public comments related to our proposal to delay the 
implementation of the definition of substantive portion, as more than 
half of the time spent by the physician and NPP through at least 
December 31, 2024.
    Below is a summary of the comments we received and our responses.
    Comment: Most commenters supported at least our proposed additional 
year delay in the implementation of time being used as the substantive 
portion. Additionally, one commenter expressed support for the overall 
goal of this policy, which is to require transparency.
    Response: We thank commenters for their feedback.
    Comment: While many commenters supported the delay, several asked 
that our permanent policy add the option to use time or MDM to 
determine who has furnished the substantive portion of the service, 
which is broadly consistent with the new set of E/M codes. Many 
commenters who supported using MDM stated that basing the policy solely 
on time could result in administrative burden and a possible disruption 
to team-based care. One commenter also noted that MDM would allow for 
the physician and NPP to decide which of them will bill for the 
services based on who furnished the substantive portion of the visit 
and assignment of the billing provider.
    Other commenters stated that the physician should always bill for 
the shared visits because their level of expertise and efficiency was 
medically necessary, regardless of who spent more time with the 
patient. One commenter noted that if CMS is concerned that facility-
based practices will take advantage of the E/M code changes that no 
longer utilize the examination elements in code selection, CMS could 
still require face-to-face care by the physician to bill for the shared 
visit as a simplified way to determine and audit when the physician 
level of expertise was necessary and when an independent visit without 
the physician was more appropriate.
    Response: These comments were consistent with the public comments 
that we received and addressed in our CY 2023 PFS final rule (87 FR 
69614 through 87 FR 69616). We define a split (or shared) visit as an 
E/M visit in the facility setting that is performed in part by both a 
physician and an NPP who are in the same group practice, in accordance 
with applicable laws and regulations. We note that the policy is not 
about whether the physician's expertise is ``necessary'' for the visit 
but

[[Page 78984]]

rather whether the physician or the NPP should bill for the service 
when each of them are performing part of an E/M visit.
    Comment: Several commenters expressed that the policy to define 
``substantive portion'' as more than half of the total time should 
never be fully implemented, other commenters asked CMS to permanently 
delay the implementation of this policy, while others urged CMS to 
withdraw the ``substantive portion'' policy altogether or continue the 
current policy to allow use of the three key components or time to 
determine who bills for the visit.
    Response: We continue to believe that application of a substantive 
portion policy is appropriate for purposes of determining which 
clinician should bill for split (or shared) services as the higher PFS 
payment rate should apply only when a physician performs the 
substantive portion of the visit. Otherwise, the visit should be billed 
by the NPP who performs the substantive portion of the visit.
    Comment: A couple of commenters expressed that this policy is 
troublesome for rural healthcare providers where the NPPs provide most 
of the care, and the practitioners receive less payment for split (or 
shared) visits as compared to physicians. The commenter stated this 
`substantive portion' policy of more than half of total time by the 
physician and NPP performing the split (or shared) visit) would 
disenfranchise rural beneficiaries and providers. A few commenters 
urged CMS to withdraw the ``substantive portion'' policy and continue 
using its current history, exam, or medical decision-making policy and 
do not believe that ``over half'' is an appropriate definition of 
``substantive portion'' for the purpose of paying for split/shared 
services.
    Response: We appreciate the commenters' concerns and will continue 
to consider the potential impact of our policy on rural or health 
professional shortage areas for future rulemaking.
    Comment: A few commenters expressed general concerns with the 
proposed delay in implementing our revised definition of ``substantive 
portion'' for split (or shared) services. Specifically, commenters 
stated that each year CMS proposes a delay, the facilities and 
practices spend time and resources preparing for potential changes that 
never come to fruition. To mitigate this burden, commenters urged CMS 
to finalize the current rules for split (or shared) visits.
    Response: We note that we previously delayed finalizing the split 
(or shared) policy to consider additional feedback from interested 
parties, especially regarding administrative burden on professionals 
and concerns about the policy potentially deterring appropriate team-
based care. Commenters continue to echo those same concerns with 
requests that we continue to recognize MDM as the ``substantive 
portion.'' We also acknowledge the commenters concerns surrounding the 
time and resources spent to prepare for changes in their practice 
patterns.
    Comment: Several commenters noted that the AMA CPT Editorial Panel 
was in the process of strengthening their guidance for reporting split 
(or shared) visits using MDM, and this information would be included in 
the 2024 CPT publication. Other commenters asked CMS to adopt the new 
CPT guidance for split/shared visits and to delay its application until 
January 1, 2025. One commenter expressed that having two definitions of 
`substantive portion' will create confusion, and stated that it is 
important for physicians to stick with one set of guidelines in 
reporting services.
    Response: Over the past 2 years, CPT has reviewed and revised its 
guidelines involving E/M visits, including split (or shared) services. 
CMS has been concurrently reviewing those additions, revisions, and 
changes made by CPT, and addressing and incorporating them as 
appropriate for Medicare billing through our rulemaking process to 
provide greater alignment between the CPT E/M Guidelines and PFS 
billing rules for E/M services, including the split (or shared) visits.
    We note that the CPT Editorial Panel recently issued its revised 
guidelines for ``split or shared visits'' for CY 2024. Specifically, 
the Editorial Panel changed the definition of a '' split or shared 
visit'' to refer to the substantive portion of a service as either more 
than half of the total time spent by the physician and NPP performing 
the split (or shared) visit or a substantive part of the medical 
decision making, and to indicate that these guidelines should be 
applied to determine whether the physician or NPP may bill for the 
service. For CY 2024, the CPT E/M Guidelines for billing split or 
shared services now state that ``physician(s) and other QHP(s) may act 
as a team in providing care for the patient, working together during a 
single E/M service. The split or shared visits guidelines are applied 
to determine which professional may report the service. If the 
physician or other QHP performs a substantive portion of the encounter, 
the physician or other QHP may report the service. If code selection is 
based on total time on the date of the encounter, the service is 
reported by the professional who spent the majority of the face-to-face 
or non-face-to-face time performing the service. For the purpose of 
reporting E/M services within the context of team-based care, 
performance of a substantive part of the MDM requires that the 
physician(s) or other QHP(s) made or approved the management plan for 
the number and complexity of problems addressed at the encounter and 
takes responsibility for that plan with its inherent risk of 
complications and/or morbidity or mortality of patient management. By 
doing so, a physician or other QHP has performed two of the three 
elements used in the selection of the code level based on MDM. If the 
amount and/or complexity of data to be reviewed and analyzed is used by 
the physician or other QHP to determine the reported code level, 
assessing an independent historian's narrative and the ordering or 
review of tests or documents do not have to be personally performed by 
the physician or other QHP, because the relevant items would be 
considered in formulating the management plan. Independent 
interpretation of tests and discussion of management plan or test 
interpretation must be personally performed by the physician or other 
QHP if these are used to determine the reported code level by the 
physician or other QHP'' (2024 CPT Codebook, pg. 6). We remind our 
readers that for CY 2023, the CPT E/M Guidelines define a shared or 
split visit as a visit in which a physician and other qualified health 
care professional(s) (QHP) both provide the face-to-face and non-face-
to-face work related to the visit. In past discussions in rulemaking on 
this issue, we stated that MDM was not easily attributed to a single 
physician or NPP when the work is shared because MDM is not necessarily 
quantifiable and could vary depending on patient characteristics (for 
example, risk), in contrast to time, which we believe is a more precise 
factor than MDM to use as a basis for deciding which practitioner 
performs the ``substantive portion of the visit.'' However, given these 
recent changes in the CPT Guidelines for split (or shared) visits and 
our interest in reducing coding and billing administrative burden on 
health professionals through continued alignment with revised 
overarching guidelines for E/M visits, we are reconsidering our policy 
for defining `substantive portion' as it applies to split or shared 
visits.
    After reviewing the revisions made by the AMA CPT Editorial Panel 
that were included in the 2024 CPT codebook

[[Page 78985]]

publication, specifically the Evaluation and Management (E/M) Services 
Guidelines language surrounding ``substantive portion'' for split (or 
shared) services, and in light of public comments on our policies, we 
agree that we should align our definition of substantive portion with 
the CPT E/M guidelines for this service. Although we continue to 
believe there can be instances where MDM is not easily attributed to a 
single physician or NPP when the work is shared, we expect that whoever 
performs the MDM and subsequently bills the visit would appropriately 
document the MDM in the medical record to support billing of the visit. 
Generally, commenters were in support of CMS delaying for an additional 
year the requirement to use total time to determine which practitioner 
performs the substantive portion of the service. However, we also heard 
concerns about CMS implementing this definition of substantive portion 
at all, with many requests that we also recognize MDM as the 
substantive portion of the visit. In consideration of the changes made 
by the CPT Editorial Panel, we are revising our definition of 
``substantive portion'' of a split (or shared) visit to reflect the 
revisions to the CPT E/M guidelines. Specifically, for CY 2024, for 
purposes of Medicare billing for split (or shared) services, the 
definition of ``substantive portion'' means more than half of the total 
time spent by the physician and NPP performing the split (or shared) 
visit, or a substantive part of the medical decision making as defined 
by CPT. We continue to note that for critical care visits which do not 
use MDM, ``substantive portion'' continues to mean more than half of 
the total time spent by the physician and NPP performing the split (or 
shared) visit (42 CFR 415.140). In summary, we are finalizing a policy 
that reflects a revised definition of ``substantive portion'' of a 
split (or shared) visit to reflect the revisions to the CPT E/M 
guidelines, such that for Medicare billing purposes, the ``substantive 
portion'' means more than half of the total time spent by the physician 
and NPP performing the split (or shared) visit, or a substantive part 
of the medical decision making except concerning critical care visits 
which do not use MDM and only use time, ``substantive portion'' 
continues to mean more than half of the total time spent by the 
physician and NPP performing the split (or shared) visit. We will 
revise our regulations at 42 CFR 415.140 to reflect this change for 
split (or shared) visits. We note that we are finalizing this policy 
for CY 2024, in part, to avoid the administrative burden, as described 
by commenters, that would otherwise be present for facilities and 
practices that spend time and resources preparing for potential policy 
changes that are delayed year after year. If warranted, we would 
address any subsequent change in policy through notice and comment 
rulemaking.

G. Geographic Practice Cost Indices (GPCIs)

1. Background
    Section 1848(e)(1)(A) of the Act requires CMS to develop separate 
Geographic Practice Cost Indices (GPCIs) to measure relative cost 
differences among localities compared to the national average for each 
of the three fee schedule components (that is, work, practice expense 
(PE), and malpractice (MP)). Section 1848(e)(1)(E) of the Act provides 
for a 1.0 floor for the work GPCIs for the purposes of payment for 
services furnished on or after January 1, 2004, and before January 1, 
2024. Congress recently extended the 1.0 work GPCI floor only through 
December 31, 2023, in division CC, section 101 of the Consolidated 
Appropriations Act, 2021 (Pub. L. 116-260, enacted December 27, 2020). 
Therefore, the CY 2024 work GPCIs and summarized GAFs do not reflect 
the 1.0 work floor. See Addenda D and E to this final rule for the CY 
2024 GPCIs and summarized GAFs. These Addenda are available on the CMS 
website under the supporting documents section of the CY 2024 PFS final 
rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
2. Review of the California Fee Schedule Areas Used for Payment for CY 
2024
    Section 220(h) of the Protecting Access to Medicare Act (PAMA) 
(Pub. L. 113-93, April 1, 2014) added a new section 1848(e)(6) to the 
Act that modified the fee schedule areas used for payment purposes in 
California beginning in CY 2017. Prior to CY 2017, the fee schedule 
areas used for payment in California were based on the revised locality 
structure that was implemented in 1997 as previously discussed. 
Beginning in CY 2017, section 1848(e)(6)(A)(i) of the Act required that 
the fee schedule areas used for payment in California must be 
Metropolitan Statistical Areas (MSAs) as defined by the Office of 
Management and Budget (OMB) as of December 31 of the previous year; and 
section 1848(e)(6)(A)(ii) of the Act required that all areas not 
located in an MSA must be treated as a single rest-of-State fee 
schedule area. The resulting modifications to California's locality 
structure increased its number of fee schedule areas from 9 under the 
previous locality structure to 27 under the MSA-based locality 
structure; although for the purposes of payment, the actual number of 
fee schedule areas under the MSA-based locality structure is 32. We 
refer readers to the CY 2017 PFS final rule (81 FR 80267) for a 
detailed discussion of this operational decision.
    Section 1848(e)(6)(D) of the Act defined transition areas as the 
counties in fee schedule areas for 2013 that were in the rest-of-State 
locality, and locality 3, which was comprised of Marin, Napa, and 
Solano counties. Section 1848(e)(6)(B) of the Act specified that the 
GPCI values used for payment in a transition area are to be phased in 
over 6 years, from 2017 through 2022, using a weighted sum of the GPCIs 
calculated under the new MSA-based locality structure and the GPCIs 
calculated under the PFS locality structure that was in place prior to 
CY 2017. That is, the GPCI values applicable for these areas during 
this transition period were a blend of what the GPCI values would have 
been for California under the locality structure that was in place 
prior to CY 2017, and what the GPCI values would be for California 
under the MSA-based locality structure. For example, in CY 2020, which 
represented the fourth year of the transition period, the applicable 
GPCI values for counties that were previously in the rest-of-State 
locality or locality 3 and are now in MSAs were a blend of \2/3\ of the 
GPCI value calculated for the year under the MSA-based locality 
structure, and \1/3\ of the GPCI value calculated for the year under 
the locality structure that was in place prior to CY 2017. The 
proportions continued to shift by \1/6\ in each subsequent year so 
that, by CY 2021, the applicable GPCI values for counties within 
transition areas were a blend of \5/6\ of the GPCI value for the year 
under the MSA-based locality structure, and \1/6\ of the GPCI value for 
the year under the locality structure that was in place prior to CY 
2017. Beginning in CY 2022, the applicable GPCI values for counties in 
transition areas were the values calculated solely under the new MSA-
based locality structure; therefore, the phase-in for transition areas 
is complete. Additionally, section 1848(e)(6)(C) of the Act establishes 
a hold harmless requirement for transition areas beginning with CY 
2017; whereby, the applicable GPCI values for a year under the new MSA-
based locality structure may not be less than what they would

[[Page 78986]]

have been for the year under the locality structure that was in place 
prior to CY 2017. There are 58 counties in California, 50 of which were 
in transition areas as defined in section 1848(e)(6)(D) of the Act. The 
eight counties that were not within transition areas are: Orange; Los 
Angeles; Alameda; Contra Costa; San Francisco; San Mateo; Santa Clara; 
and Ventura counties. We noted that while the phase-in for transition 
areas is no longer applicable, the hold harmless requirement is not 
time-limited, and therefore, is still in effect.
    For the purposes of calculating budget neutrality and consistent 
with the PFS budget neutrality requirements as specified under section 
1848(c)(2)(B)(ii)(II) of the Act, in the CY 2017 PFS final rule (81 FR 
80266), we finalized the policy to start by calculating the national 
GPCIs as if the fee schedule areas that were in place prior to CY 2017 
are still applicable nationwide; then, for the purposes of payment in 
California, we override the GPCI values with the values that are 
applicable for California consistent with the requirements of section 
1848(e)(6) of the Act. This approach to applying the hold harmless 
requirement is consistent with the implementation of the GPCI floor 
provisions that have previously been implemented--that is, as an after-
the-fact adjustment that is made for purposes of payment after both the 
GPCIs and PFS budget neutrality have already been calculated.
    Additionally, section 1848(e)(1)(C) of the Act requires that, if 
more than 1 year has elapsed since the date of the last GPCI 
adjustment, the adjustment to be applied in the first year of the next 
adjustment shall be \1/2\ of the adjustment that otherwise would be 
made. For a comprehensive discussion of this provision, transition 
areas, and operational considerations, we refer readers to the CY 2017 
PFS final rule (81 FR 80265 through 80268).
a. Refinement to Number of Unique Fee Schedule Areas in California for 
CY 2024
    In the CY 2020 final rule (84 FR 62622), a commenter indicated that 
some of the distinct fee schedule areas that were used during the 
period between CY 2017 and CY 2018 are no longer necessary. 
Specifically, with regard to the Los Angeles-Long Beach-Anaheim MSA, 
which contains 2 counties (across two unique locality numbers, 18 and 
26) that are not transition areas, we acknowledge that we only needed 
more than one unique locality number for that MSA for payment purposes 
in CY 2017, which was the first year of the implementation of the MSA-
based payment locality structure. Neither of the counties in the Los 
Angeles-Long Beach-Anaheim MSA (Orange County and Los Angeles County) 
are transition areas under section 1848(e)(6)(D) of the Act. Therefore, 
the counties were not subject to the aforementioned GPCI value 
incremental phase-in (which is no longer applicable) or the hold-
harmless provision at section 1848(e)(6)(C) of the Act. Similarly, the 
San Francisco-Oakland-Berkeley MSA contains four counties--San 
Francisco, San Mateo, Alameda, and Contra Costa counties--across three 
unique locality numbers, 05, 06, and 07. These counties are not 
transition areas and will receive the same GPCI values, for payment 
purposes, going forward. In response to the comment, we acknowledged 
that we did not propose any changes to the number of fee schedule areas 
in California, but would consider the feasibility of a technical 
refinement to consolidate into fewer unique locality numbers; and if we 
determined that consolidation was operationally feasible, we would 
propose the technical refinement in future rulemaking. This refinement 
would ultimately change the number of distinct fee schedule areas for 
payment purposes in California from 32 to 29. In the CY 2023 PFS 
proposed rule (87 FR 46008), we proposed to identify the Los Angeles-
Long Beach-Anaheim MSA, containing Orange County and Los Angeles 
County, by one unique locality number, 18, as opposed to two, thus 
retiring locality number 26, as it is no longer needed. Similarly, we 
proposed to identify the San Francisco-Oakland-Berkeley MSA containing 
San Francisco, San Mateo, Alameda, and Contra Costa counties by one 
unique locality number, 05, as opposed to three, thus retiring locality 
numbers 06 and 07, as they are no longer needed. Additionally, we noted 
that we would modify the MSA names as follows: the San Francisco-
Oakland-Berkeley (San Francisco Cnty) locality (locality 05) would 
become San Francisco-Oakland-Berkeley (San Francisco/San Mateo/Alameda/
Contra Costa Cnty), and Los Angeles-Long Beach-Anaheim (Los Angeles 
Cnty) locality (locality 18) would become Los Angeles-Long Beach-
Anaheim (Los Angeles/Orange Cnty). We noted that because Marin County 
is in a transition area and subject to the hold harmless provision at 
section 1848(e)(6)(C) of the Act, we needed to retain a unique locality 
number for San Francisco-Oakland-Berkeley (Marin Cnty), locality 52. 
Based on support from commenters in the CY 2023 PFS final rule (87 FR 
69621), we finalized to identify the Los Angeles-Long Beach-Anaheim 
MSA, containing Orange County and Los Angeles County, by one unique 
locality number, 18, and the San Francisco-Oakland-Berkeley MSA 
containing San Francisco, San Mateo, Alameda, and Contra Costa counties 
by one unique locality number, 05, as proposed. We noted that, while we 
believed these changes were appropriate to consolidate fee schedules 
areas that are no longer operationally necessary, we were unable to 
operationalize these changes for CY 2023 due to timing constraints 
relating to the actions and coordination with the various systems 
maintainers required to effectuate changes to claims processing (87 FR 
69621). Therefore, for CY 2023, there were no changes to the existing 
locality numbers 05, 06, 08, 18, or 26. We noted in the CY 2023 PFS 
final rule that we would operationalize these finalized changes for CY 
2024. We reiterate here that we are operationalizing these locality 
number changes for CY 2024 via instruction to the MACs, and therefore, 
locality numbers 06, 07, and 26 will no longer be used for the PFS 
starting January 1, 2024. We note that these changes, when 
operationalized, do not have any payment implications under the PFS 
because these counties are not transition areas and will receive the 
same GPCI values, for PFS payment purposes, going forward.
    The following is a summary of the public comments received on the 
CY 2024 GPCIs and our responses:
    Comment: We received several comments that were outside the scope 
of the proposed rule, and some are reiterations from last year's GPCI 
update.
    Response: We appreciate the feedback from commenters. We note that 
we responded to these comments in the CY 2023 PFS final rule (87 FR 
69630 through 69634) and will not be summarizing or responding to them 
in this final rule. Also, it is important to note that although the 
comments did not relate to any proposals for CY 2024, we will take them 
into consideration for potential future rulemaking.
    Comment: One commenter encouraged CMS to consider the potential 
effects of the COVID-19 pandemic on the malpractice GPCIs. The 
commenter asked that CMS withdraw the MP component update from the CY 
2023 PFS final rule and reinstate the prior MP component in the CY 2024 
PFS final rule.
    Response: We appreciate the feedback from the commenter. We did not 
make any proposals associated with the MP

[[Page 78987]]

GPCI or MP RVUs, but will take these comments into consideration for 
potential future rulemaking. We encourage commenters to submit comments 
on the next proposed MP GPCI and MP RVU update which is anticipated for 
CY 2026.
    Comment: Some commenters highlighted the expiration of the work 
GPCI floor of 1.0 on December 31, 2023, and expressed concern with the 
CY 2024 work GPCIs that are calculated without the work GPCI floor in 
place. Commenters asked that CMS consider a two- or three-year phase in 
of the work GPCI floor expiration and recalculate the CY 2024 work 
GPCIs based on a transition period if the statutory floor is allowed to 
expire. Some commenters asked that CMS implement a permanent policy to 
set a work GPCI floor so statutory extensions would no longer be 
necessary. Some of the commenters stated an objection to any changes 
that could have a negative impact on rural areas, such as the 
expiration of the work GPCI floor.
    Response: We appreciate the commenters' feedback. The 1.0 work GPCI 
floor is required by statute and set to expire on December 31, 2023. We 
do not have the authority to extend the 1.0 work GPCI floor beyond 
December 31, 2023, or to establish a permanent policy to establish the 
1.0 work GPCI floor. We note that 34 States have statewide payment 
localities, which means that the same geographic adjustment applies to 
PFS payments throughout the State without any differential between 
rural and urban areas.
    Comment: One commenter stated that there is a lack of transparency 
into the GPCI data and methodology used to derive the GPCIs. The 
commenter stated that they cannot accurately validate CMS' GPCI 
calculations because there is little transparency and access to the 
data and methods used. The commenter stated that CMS provided these 
data prior to 2020 and that they used it to reproduce and validate the 
CMS methodology for calculating the GPCIs each year.
    Response: We direct the commenter to the step-by-step instructions 
provided in the final report entitled, ``Final Report for the CY 2023 
Update of GPCIs and MP RVUs for the Medicare PFS,'' which is available 
on our website located under the supporting documents section for the 
CY 2023 PFS final rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html. We also refer readers 
to Table 4.A.1: Summary of Elements Required for GPCI Calculation in 
the final report, and the discussion in the CY 2023 PFS final rule (87 
FR 69621) for the data sources used for the work GPCI and each 
component of the practice expense GPCIs noted in the CY 2023 PFS final 
rule, we discussed the years and timeframes of data used from each 
source and provided web links to the publicly-available data sources 
used in the CY 2023 GPCI update. Consistent with the information 
provided for previous GPCI updates, we also provided the methodological 
parameters, as well as an overview of how we develop each GPCI 
component in the final report. We also note that there is detailed 
information about the budget neutrality adjustment and statutory floors 
that are applied after the budget neutrality adjustment in the note, 
``CY 2023 GPCI Update Note_County_Data,'' on our website, also located 
under the supporting documents section for the CY 2023 PFS final rule 
at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
    We remind the commenter that, in response to commenters' concerns 
expressed in rulemaking for the CY 2020 GPCI update, we added more 
detailed descriptions of the steps in the final report entitled, 
``Final Report for the CY 2020 Update of GPCIs and MP RVUs for the 
Medicare Phys Fee Sched_v19Feb2020,'' which is available on the CMS 
website under the downloads section of the CY 2020 PFS final rule at 
https://www.cms.gov/Medicare/Medicare-Fee-forService-Payment/PhysicianFeeSched/index.html, to assist interested parties in 
navigating these data. Additionally, as part of our ongoing commitment 
to transparency, we post the county-level data that we use to develop 
the proposed GPCIs, which allows interested parties to further examine 
and replicate our GPCI methodology. This file is available on the CMS 
website on our website under the Downloads section, titled ``CY 2023 
Proposed Rule GPCI County-Level Data File.''
    We did not receive any comments about the announcement in the CY 
2024 PFS proposed rule of our planned operationalization of the changes 
to the California localities that we finalized in the CY 2023 PFS final 
rule beginning for CY 2024. Therefore, we are proceeding with 
implementation as planned for CY 2024. We note that these changes to 
California localities, when operationalized, do not have any payment 
implications under the PFS. The final CY 2024 GPCIs and summarized GAFs 
in Addenda D and E to this final rule reflect the California locality 
changes, and locality numbers 06, 07, and 26 are not present in these 
Addenda for CY 2024.

H. Payment for Skin Substitutes

1. Background
    In the CY 2023 PFS proposed rule, CMS outlined several objectives 
related to refining skin substitute policies under Medicare, including: 
(1) ensuring a consistent payment approach for skin substitute products 
across the physician office and hospital outpatient department setting; 
(2) ensuring that appropriate HCPCS codes describe skin substitute 
products; (3) using a uniform benefit category across products within 
the physician office setting, regardless of whether the product is 
synthetic or comprised of human or animal-based material, to 
incorporate more consistent payment methodologies; and (4) maintaining 
clarity for interested parties on CMS skin substitutes policies and 
procedures. When considering potential changes to policies involving 
skin substitutes, we noted that we believe it would be appropriate to 
take a phased approach over multiple rulemaking cycles to examine how 
we could appropriately incorporate skin substitutes as supplies under 
the PFS ratesetting methodology. Generally, we determine the direct PE 
for a specific service by adding the costs of the direct resources 
(that is, the clinical staff, medical supplies, and medical equipment) 
typically involved with furnishing that service. For a detailed 
explanation of the direct PE methodology, including examples, we 
referred readers to the 5-year review of work RVUs under the PFS and 
proposed changes to the PE methodology CY 2007 PFS proposed notice (71 
FR 37242) and the CY 2007 PFS final rule with comment period (71 FR 
69629).
    Similar to the way we assess costs for other incident to supplies, 
our approach to identifying appropriate PE direct costs for skin 
substitute products may include: reviewing various sources for price 
information, including performing market research, reviewing invoices 
submitted by interested parties, or reviewing cost information on 
Medicare claims. Further, we would assess how the incident to supplies 
are billed or represented while also considering the service with which 
it is typically furnished. For example, if the supply is billed 
separately, with the base service, or usually bundled and incident to 
the base service. Also, we would consider whether there are different 
supply costs or other meaningful stratifications (for example, a unit 
of measure or product type) that should be accounted for as we develop 
direct PE costs, considering how the base service is furnished.
    We solicited comments on these approaches under our PFS ratesetting

[[Page 78988]]

methodology as potential methods to establish appropriate payment for 
skin substitute products under the PFS.
    We received public comments on these potential approaches. The 
following is a summary of the comments we received and our responses.
    Comment: The majority of commenters were in support of our efforts 
to achieve a consistent payment approach for skin substitute products 
across different settings of care. Additionally, many commenters stated 
that they appreciated the opportunity to further engage with CMS on 
skin substitute policies through the CMS Skin Substitutes Town Hall in 
January of 2023.
    Response: We thank commenters for their support and for their 
participation in the CMS Skin Substitutes Town Hall, which was held 
virtually on January 18, 2023. More information regarding the CMS Skin 
Substitutes Town Hall such as links to recording and transcripts is 
available at https://www.cms.gov/medicare/payment/fee-schedules/
physician/skin-
substitutes#:~:text=The%20CMS%20Skin%20Substitutes%20Town,Physician%20Fe
e%20Schedule%20(PFS).
    Comment: Many commenters opposed the idea of packaging and paying 
for skin substitutes as supplies and recommended that CMS retain 
separate coding and payment for these products. The commenters did not 
view skin substitutes as supplies because the products are affixed to a 
wound, and their function is similar to a drug or biologic.
    Response: CMS recognizes there are numerous factors to consider 
when establishing a consistent payment approach for all skin substitute 
products. Additionally, CMS will take into consideration concerns 
raised by interested parties to help inform how we might best achieve 
an appropriate payment approach for future rulemaking.
    Comment: Many commenters opposed to treating skin substitute 
products as supplies recommended that CMS instead assign HCPCS Q codes 
to all skin substitute products and pay for all skin substitute 
products using the ASP+6% payment methodology. Some commenters 
expressed their support for separate payment under the ASP +6% payment 
methodology by citing an OIG report (OEI-BL-23-00010) that highlighted 
significant cost savings for Part B payment amounts if ASP data were to 
be reported by all skin substitute manufacturers. More information 
regarding this OIG report is available at https://oig.hhs.gov/oei/reports/OEI-BL-23-00010.asp.
    Response: We appreciate the feedback from commenters. We maintain 
our commitment to establishing a consistent payment approach for all 
skin substitute products.
    Comment: A few commenters noted that most skin substitute products 
in the physician office setting meet the statutory definition of a 
biological product and question whether this move is legal under the 
mandatory payment laws for drugs and biologicals. Another commenter 
noted that CMS must support the reversal of prior policy under the 
Administrative Procedure Act.
    Response: The CY 2024 PFS proposed rule includes no proposals for 
skin substitute polices. Instead, CMS solicited comments from 
interested parties to help us consider an approach to pricing these 
products as supplies.
    Comment: Some commenters noted that CMS did not provide enough 
information on these different pricing approaches in order to 
meaningfully comment.
    Response: We remind commenters that, in response to concerns 
expressed by commenters in CY 2023 PFS rulemaking, we included more 
information in the CY 2024 PFS proposed rule on how CMS could 
incorporate skin substitutes as a supply under the PFS and solicited 
comments on the different approaches we could consider. Additionally, 
we refrained from making any proposal for CY 2024 to allow more 
opportunities for us to receive and consider feedback from interested 
parties, including through the Skin Substitutes Town Hall and the CY 
2024 PFS proposed rule.
    Comment: A few commenters noted that as CMS reviews skin substitute 
policies, the terminology should not be changed to ``wound care 
management products'' and that skin substitutes is the appropriate 
term. Additionally, one commenter suggested creating a new taxonomy 
code for wound care specialists to acknowledge the providers delivering 
this specific type of enhanced care. Lastly, one commenter recommended 
that CMS require the physician applying the product to the wound cover 
the entire wound surface area in order to receive payment for the 
application procedure.
    Response: We appreciate the commenters' feedback.
2. Sources of Price Information
    We have refined specific PE data inputs in recent years, using 
market research and publicly available data (for example, market 
research on medical supply and equipment items and BLS data to update 
clinical labor wages) to update the direct PE data inputs used in the 
PFS ratesetting process. Historically, the PFS uses a variety of 
sources to help inform payment for specific services that are then used 
to establish direct PE inputs. Direct PE inputs may derive from 
assessing the current value of products on the market, which may be 
achieved by utilizing Average Sales Price (ASP) data or Wholesale 
Acquisition Cost data (WAC). Since some manufacturers self-report ASP/
WAC data at the end of every quarter, this may help to inform CMS of 
the current market value of these products.
    We also review submitted invoices, which reflect the specific cost 
of products that practitioners are paying manufacturers for these 
products. We noted in the CY 2011 PFS final rule (75 FR 73205) that we 
update supply and equipment prices through an invoice submission 
process. In this process, we consider the invoice information and 
incorporate it into our direct costs database if the submitted pricing 
data indicates the typical market price of the supply or equipment 
item.
    While performing market research and the invoice submission process 
are different methods to derive pricing for specific products, 
reviewing cost information on Medicare claims may also help us identify 
the variability in product costs. For example, assessing detailed cost 
information on claims with skin substitute products could inform how 
these products are priced and allow us to consider how the skin 
substitutes are typically furnished and where these services are 
performed. This information would enable us to refine our payment 
policies for these products across different care settings.
    We solicited comment on the cost-gathering approaches we described 
in order to inform how we would establish direct PE inputs for skin 
substitute products and appropriately develop payment rates for 
physicians' services that involve furnishing skin substitute products. 
The following is a summary of the comments we received and our 
responses.
    Comment: A few commenters noted that if CMS were to consider skin 
substitute products as direct PE inputs, then ASP data would be the 
best estimate of cost.
    Response: We appreciate this feedback from commenters.
    Comment: Some commenters mentioned that to capture supplies in the 
PE RVU methodology, CMS must consider the following: the single use 
supply item, unit of measurement, per unit price, and the quantity of 
the

[[Page 78989]]

specified item. These commenters also believe the PE methodology relies 
on evaluation of a `typical service' for a single-use supply item, but 
because skin substitute products may change based on patient-specific 
factors and can vary by application code, commenters state that no 
single skin substitute product stands out as ``typical.'' Additionally, 
one commenter noted that claims data show variations in the number of 
product units reported per claim and the per unit payments for 
products.
    Response: We thank these commenters for their feedback and will 
take this information into consideration.
3. Approaches to Billing
    We acknowledged that there are various approaches that we could use 
to identify and establish direct cost inputs for the skin substitute 
products. We are also considering how to account for these products' 
variability and resource costs, especially as new products increasingly 
become available.
    Similar to the way different sources of information can influence 
cost information for supplies, specifically considering variables such 
as different units of measurement, product type, product composition, 
or in what clinical circumstances the product is used, for example, 
would help us appropriately reflect costs in payment for the services 
that include the specific supply. We believe this to be pertinent to 
any proposal to pay for skin substitute products. For instance, 
grouping the direct costs for particular skin substitute products based 
on the typically associated application procedure could help us 
systematically incorporate the resource costs involved for different 
product billing scenarios. This approach can be seen in the Outpatient 
Prospective Payment System (OPPS), where a high-cost/low-cost system is 
used for skin substitute products billed with a specific procedure code 
based on their cost grouping.
    Alternatively, when services and products are not performed 
frequently enough to be grouped, retaining separate procedure coding 
can help inform specificity and granularity for coding and payment of 
these services. Specifically, we could create separate procedure coding 
for specific product types, which could be billed with the appropriate 
skin substitute application services. We would account for cost 
variability for the different products (that is, establishing 
individual or group direct cost profiles and allocating direct cost 
inputs based on these groupings) under any combination of approaches 
discussed above. We could also review the unit of measurement for 
billed products, as available in our internal data or received in 
submissions, and create direct cost groupings for the products based on 
the reviewed/billed units of measurement. We could also establish 
direct cost inputs by employing our standard `crosswalk' method using 
information from interested parties. Specifically, we would derive PE 
inputs by reviewing similarly resourced services to establish RVUs for 
a service that includes the cost of the skin substitute products and 
other information to account for the physician's work in furnishing the 
skin substitute product. We would employ this method to establish 
payment for individual services that include specific skin substitute 
products or services that describe cost groupings of similarly priced 
skin substitute products. As we have discussed in prior rulemaking, we 
believe that the nature of the PFS relative value system is such that 
all services are appropriately subject to comparisons to one another. 
There is a long history of using crosswalk codes for this kind of 
valuation under the PFS, which is generally established through notice 
and comment rulemaking.
    We solicited comment on how these methods may help reflect the 
resource costs involved with skin substitute products as furnished with 
different skin application procedures. The following is a summary of 
the comments we received and our responses.
    Comment: The majority of commenters were concerned with the idea of 
incorporating skin substitute products into the PE as they believe this 
would exert pressure on all other PE RVUs, resulting in cuts to other 
areas of physician reimbursement due to budget neutrality. Commenters 
raised this concern to highlight that packaging skin substitute 
products in an office setting could lead to decreased patient access. 
One commenter suggested that if CMS were to incorporate skin substitute 
products in direct PE, we should ensure that it does not result in 
budget neutrality reductions.
    Response: As stated in the CY 2024 PFS proposed rule, our goal is 
to achieve a consistent payment approach for skin substitute products 
that does not negatively impact beneficiary access. We recognize the 
budget neutrality concerns from interested parties and note that 
commenters raised similar concerns in the CY 2022 PFS final rule when 
we finalized the implementation of the clinical labor pricing update. 
In response, we noted that the PFS is a resource-based relative value 
payment system that necessarily relies on accuracy in the pricing of 
resource inputs. We also noted that for many services that involve 
proportionally more clinical labor, payment rates were reduced as a 
result of the prior market-based supply and equipment pricing update, 
and payment rates will increase with the clinical labor pricing update, 
due to the same PFS budget neutrality requirements (86 FR 65025 through 
65027). Therefore, any changes to the RVU does not necessarily result 
in negative consequences for other areas of physician reimbursement.
    Comment: A few comments suggested that CMS should include 
additional Part B funding to account for the change in methodology, as 
well as work with the AMA CPT Editorial Panel/RVS Update Committee to 
address potential changes. A few commenters also recommended that CMS 
mirror the existing OPPS reimbursement methodology for skin 
substitutes, where payment is based on a high cost/lost cost model.
    Response: We thank these commenters for their suggestions.
    Comment: Some commenters offered alternative suggestions such as to 
pay for high-cost disposable supplies priced at more than $500 using 
appropriate HCPCS codes, where pricing of these supplies is based on a 
transparent process that is annually reviewed and updated. 
Additionally, one commenter recommended that CMS replace application 
HCPCS codes 15271-15278 with newer, temporary codes to describe the 
more complex wound procedures and offer revisions to the sizing 
increments, for example: G5271-G5XXX Application of cellular and/or 
tissue-based product graft to trunk, arms, legs; G5275-G 5XXX 
Application of cellular and/or tissue-based product graft to face, 
scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/
or multiple digits.
    Response: We thank these commenters for these suggestions.
    Comment: Some commenters also stated that in order for interested 
parties to meaningfully comment on the different pricing methodologies 
for skin substitute products, CMS should: (1) explain specific direct 
inputs CMS proposes to incorporate into each HCPCS code that may 
include a skin substitute as a supply (HCPCS 15271-15278 or replacement 
codes if established); (2) provide information on estimates of proposed 
rates; (3) describe the valuation of the application procedure code and 
any redistribution effects on other PFS services with PE RVUs; and (4) 
provide the impact that the proposal will have on vulnerable 
populations.
    Response: We did not propose any policies for skin substitutes in 
the CY

[[Page 78990]]

2024 PFS proposed rule, so did not include specific proposed direct 
resource inputs or pricing information, or any impact analysis.
    We will consider the suggestions and concerns raised by commenters 
to help inform future rulemaking. We will also continue our dialogue 
with interested parties,with our continued goal to achieve a consistent 
payment approach for skin substitute products across different sites of 
service.

I. Supervision of Outpatient Therapy Services, KX Modifier Thresholds, 
Diabetes Self-Management Training (DSMT) Services by Registered 
Dietitians and Nutrition Professionals, and DSMT Telehealth Services

1. Supervision of Outpatient Therapy Services in Private Practices
(a) Remote Therapeutic Monitoring for Physical Therapists and 
Occupational Therapists in Private Practice
    In the CY 2023 PFS final rule, we finalized new policies allowing 
Medicare payment for remote therapeutic monitoring (RTM) services, 
including allowing RTM services to be furnished under general 
supervision (87 FR 69649). RTM refers to the use of a device to monitor 
a patient's health or response to treatment using non-physiological 
data (please see a more detailed list of RTM services at section II.D. 
of this proposed rule). The current regulations, however, at Sec. Sec.  
410.59(a)(3)(ii) and 410.60(a)(3)(ii) specify that all occupational and 
physical therapy services are performed by, or under the direct 
supervision of, the occupational or physical therapist, respectively, 
in private practice. These regulations make it difficult for physical 
therapists in private practice (PTPPs) and occupational therapists in 
private practice (OTPPs) to bill for the RTM services performed by the 
physical therapist assistants (PTAs) and occupational therapy 
assistants (OTAs) they are supervising since the PTPP or OTPP must 
remain immediately available when providing direct supervision of PTAs 
and OTAs (even though we noted in the CY 2022 PFS final rule that PTPPs 
and OTPPs were intended to be among the primary billers of RTM services 
(86 FR 65116)). We designated the RTM codes as ``sometimes therapy'' 
codes (originally in the CY 2022 PFS final rule (86 FR 65116)), meaning 
that these services may be furnished outside a therapy plan of care 
when they are performed by physicians and certain NPPs where their 
State practice includes the provision of physical therapy, occupational 
therapy, and/or speech-language pathology services. Because we did not 
propose revisions to Sec. Sec.  410.59 and 410.60 last year for OTPPs 
and PTPPs, we proposed to establish an RTM-specific general supervision 
policy at Sec. Sec.  410.59(a)(3)(ii) and (c)(2) and 410.60(a)(3)(ii) 
and (c)(2) to allow OTPPs and PTPPs to provide general supervision only 
for RTM services furnished by their OTAs and PTAs, respectively.
    We also noted that Medicare requires each therapist in private 
practice to meet the requirements specified in our current regulations 
at Sec. Sec.  410.59(c) and 410.60(c) to qualify under Medicare as a 
supplier of outpatient occupational therapy or physical therapy 
services. Given that occupational therapists (OTs) and physical 
therapists (PTs) who are not enrolled and working as employees of OTPPs 
or PTPPs do not meet these requirements, we believe they should 
continue to function under direct supervision of the OTPP or PTPP. This 
is consistent with the Medicare Benefit Policy Manual, Pub. 100-02, 
Chapter 15, section 230.4.B, which states that in private practice, 
OTPPs and PTPPs must provide direct supervision of all services, 
including those furnished by OTs and PTs who are not yet enrolled in 
Medicare (even if they meet the other requirements for occupational 
therapists and physical therapists at 42 CFR part 484). As such, we 
proposed to retain the OTPP and PTPP direct supervision requirement for 
unenrolled PTs or OTs by clarifying that the RTM general supervision 
regulation at Sec. Sec.  410.59(c)(2) and 410.60(c)(2) applies only to 
the OTA and PTA and does not include the unenrolled OT or PT. We 
solicited comment on this specific proposal as we want to know more 
about how this policy is now functioning with OTs and PTs who are not 
enrolled and our proposal to maintain this longstanding policy for 
direct supervision.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Many commenters supported our proposal to allow PTs and 
OTs in private practice to provide general supervision for RTM 
services. Many commenters urged us to finalize our proposal.
    Response: We appreciate the support for our proposed policy from 
the commenters.
    Comment: Some commenters reported that the current direct 
supervision requirement makes it challenging to use PTAs or OTAs to 
deliver RTM services and stated that allowing general supervision of 
PTAs and OTAs in private practice settings provides a safe way for 
patients to receive RTM services.
    Response: We appreciate the support for our proposed policy from 
the commenters.
    Comment: Some commenters noted that our proposal aligns with the 
general supervision policy we finalized beginning in CY 2023 for RTM 
services furnished by physicians and other practitioners, while a few 
commenters noted that we did not propose to allow general supervision 
of PTAs and OTAs last year.
    Response: We thank the commenters for their views and clarify that 
instead of the four proposed G-codes, two of which would encompass PTs, 
OTs, and SLPs in private practice, we finalized an alternate RTM 
general supervision policy to begin January 1, 2023. As such, we had 
not proposed a regulatory change for PTAs and OTAs employed in private 
practices of PTs and OTs.
    Comment: One commenter supported our proposal to retain the OTPP 
and PTPP direct supervision requirement for unenrolled PTs or OTs. We 
did not receive any responses to our comment solicitation about how 
this policy now functions with OTs and PTs who are not enrolled.
    Response: We appreciate the support for our proposed policy from 
the commenter.
    After consideration of public comments, we are finalizing our 
proposal for RTM services to allow general supervision of OTAs and PTAs 
by OTs and PTs in private practice; and finalizing the proposal to 
continue the requirement for direct supervision of unenrolled PTs and 
OTs, including for RTM services. We are also finalizing the amendments 
to the corresponding regulation text at Sec. Sec.  410.59 and 410.60 as 
proposed.
    We believe this proposal will increase access to these remotely 
provided services performed by PTAs and OTAs under the general 
supervision furnished by PTPPs and OTPPs, and aligns the regulatory 
text at Sec. Sec.  410.59 and 410.60 with the general supervision 
policy that we finalized for RTM services in the CY 2023 PFS final 
rule.
(b) General Supervision for PTs and OTs in Private Practice Comment 
Solicitation
    Sections 1861(p) and 1861(g) (by cross-reference to section 
1861(p)) of the Act describe outpatient physical therapy and 
occupational therapy services furnished to individuals by physical and 
occupational therapists meeting licensing and other standards 
prescribed by the Secretary, including conditions relating to the 
health and safety of

[[Page 78991]]

individuals who are furnished services on an outpatient basis. The 
second sentence of section 1861(p) of the Act describes outpatient 
therapy services that are provided to an individual by a physical 
therapist or occupational therapist (in their office or in such 
individual's home) who meets licensing and other standards prescribed 
by the Secretary in regulations and differentiates the therapists that 
furnish these outpatient therapy services from those working for an 
institutional provider of therapy services. In regulations, we have 
specifically addressed these therapists, previously referred to as 
PTPPs and OTPPs, since 1999 (63 FR 58868 through 58870). Because we 
wanted to create consistent requirements for therapists and therapy 
assistants, we clarified in the CY 2005 PFS final rule with comment 
period (69 FR 66236, 66351 through 66354) that the personnel 
qualifications applicable to home health agencies (HHAs) in 42 CFR part 
484 are applicable to all outpatient physical therapy, occupational 
therapy, and speech-language pathology services. Also, in the CY 2005 
PFS final rule, we cross-referenced the qualifications for OTs and 
their OTAs and PTs and their PTAs for all occupational therapy and 
physical therapy services, respectively, including those who work in 
private practices, to 42 CFR part 484 by adding a basic rule at 
Sec. Sec.  410.59(a) and 410.60(a), respectively. Under Medicare Part 
B, outpatient therapy services are generally covered when reasonable 
and necessary and when provided by PTs and OTs meeting the 
qualifications set forth at 42 CFR part 484. Services provided by 
qualified therapy assistants, including PTAs and OTAs, may also be 
covered by Medicare when furnished under the specified level of 
therapist supervision that is required for the setting in which the 
services are provided (institutions, and private practice therapist 
offices and patient homes).
    In accordance with various regulations, the minimum level of 
supervision for services performed by PTAs and OTAs by PTs and OTs 
working in institutional settings is a general level of supervision 
(see Table A in the Report to Congress titled Standards for Supervision 
of PTAs and the Effects of Eliminating the Personal PTA Supervision 
Requirement on the Financial Caps for Medicare Therapy Services at 
https://www.cms.gov/Medicare/Billing/TherapyServices/Downloads/61004ptartc.pdf). For example, 42 CFR 485.713 specifies that when an 
OTA or PTA provides services at a location that is off the premises of 
a clinic, rehabilitation agency, or public health agency, those 
services are supervised by a qualified occupational or physical 
therapist who makes an on-site supervisory visit at least once every 30 
days. We noted that the Medicare Benefit Policy Manual, Pub. 100-02, 
chapter 8, section 30.2.1 defines skilled nursing and/or skilled 
rehabilitation services as those services, furnished pursuant to 
physician orders, that, among other requirements, ``must be provided 
directly by or under the general supervision of these skilled nursing 
or skilled rehabilitation personnel to assure the safety of the patient 
and to achieve the medically desired result.'' The same manual 
provision notes that in the SNF setting, skilled nursing or skilled 
rehabilitation personnel include PTs, OTs, and SLPs. However, since 
2005 in the private practice setting, we have required direct 
supervision for physical and occupational therapy services furnished by 
PTAs and OTAs, requiring an OTPP or PTPP to be immediately available to 
furnish assistance and direction throughout the performance of the 
procedure(s). We finalized this direct supervision policy in the CY 
2005 PFS final rule (69 FR 66354 through 66356)--changing it from 
personal supervision, which required the OTPP or PTPP to be in the same 
room as the therapy assistant when they were providing the therapy 
services. Under the current regulations Sec. Sec.  410.59(c)(2) and 
410.60(c)(2), all services not performed personally by the OTPP or 
PTPP, respectively, must be performed under the direct supervision of 
the therapist by employees of the practice. Subsequently, in the CY 
2008 PFS final rule (72 FR 66328 through 66332), we updated the 
qualification standards at 42 CFR part 484 for OTs, OTAs, PTs, PTAs, 
along with those for speech-language pathologists (SLPs).
    Over the last several years, interested parties have requested that 
we revise our direct supervision policy for PTPPs and OTPPs to align 
with the general supervision policy for physical and occupational 
therapists working in Medicare institutional providers that provide 
therapy services (for example, outpatient hospitals, rehabilitation 
agencies, SNFs and CORFs), to allow for the general supervision of 
their therapy assistants. Additionally, the interested parties have 
informed us that all-but-one State allows for general supervision of 
OTAs and at least 44 States allow for the general supervision of PTAs, 
via their respective State laws and policies.
    We were considering whether to revise the current direct 
supervision policy for PTPPs and OTPPs of their PTAs and OTAs, to 
general supervision for all physical therapy and occupational therapy 
services furnished in these private practices, and solicited comments 
from the public that we may consider for possible future rulemaking. We 
were particularly interested in receiving comments regarding the 
possibility of changing the PTA and OTA supervision policy from direct 
supervision to general supervision in the private practice setting, and 
whether a general supervision policy could have implications for 
situations or conditions raised below:
     Because we want to ensure quality of care for therapy 
patients, could the general supervision policy raise safety concerns 
for therapy patients if the PT or OT is not immediately available to 
assist if needed? Do State laws and policies allow a PTA or OTA to 
practice without a therapist in a therapy office or in a patient's 
home?
     Could any safety concerns be addressed by limiting the 
types of services permitted under a general supervision policy?
     Would a general supervision policy be enhanced with a 
periodic visit by the PT or OT to provide services to the patient? If 
so, what number of visits or time period should we consider?
     Would a general supervision policy potentially cause a 
change in utilization? Would such a change in the supervision policy 
cause a difference in hiring actions by the PT or OT with respect to 
therapy assistants?
    Interested parties have been requesting that CMS reconsider its 
supervision policies for occupational therapy or physical therapy 
services, and in light of experiences during the PHE for COVID-19, we 
may consider proposing a general supervision policy for all services 
furnished by OTAs and PTAs employed by a PTPP or OTPP in the future 
after reviewing the comments and supporting data in response to this 
comment solicitation. Therefore, we solicited public comment, along 
with supporting data, about the questions and concerns we highlighted 
above, for our consideration for possible future rulemaking. We were 
further interested in public comment regarding changing Sec. Sec.  
410.59(a)(3)(ii), 410.59(c)(2), 410.60(a)(3)(ii), and 410.60(c)(2) to 
allow for general supervision of OTAs and PTAs by the OTPP and PTPP, 
respectively, when furnishing therapy services. Additionally, we 
solicited public comment for our consideration for possible future 
rulemaking regarding any appropriate exceptions to allowing general 
supervision in the furnishing of therapy services.

[[Page 78992]]

    We received public comments on this comment solicitation. The 
following is a summary of the comments we received.
    Comment: Many commenters stated they supported general supervision 
of PTAs and OTAs in the private practice setting, as it would align 
with the supervision requirement of all other Medicare therapy settings 
and nearly all state practice acts for physical and occupational 
therapy. Other commenters stated that making the supervision 
requirement consistent across outpatient settings will reduce 
administrative burden and confusion and ease compliance for therapy 
services providers who work and manage staff in more than one type of 
setting.
    Collectively, many commenters suggested that changing the Medicare 
minimum required supervision level in private practice from direct to 
general, for example, would: (a) increase access to therapy services 
for more patients, especially those in rural and underserved 
communities; (b) allow therapists and therapy assistants to work 
different or overlapping schedules to accommodate patient availability; 
(c) optimize resource allocation with more flexibility in scheduling 
time off for PTs/OTs when PTAs/OTAs are scheduled to work with Medicare 
patients; (d) remove the additional labor costs of onsite therapist 
staff during delivery of services by therapy assistants, and (e) 
eliminate the possibility of disruptions in patient care when the 
supervising therapist steps out of the practice office, even for a 
short period of time, as the therapy assistant must stop working, the 
commenter states that these disruptions can result in patient setbacks, 
delayed visits, and greater costs to Medicare.
    Many commenters responded to our question as to whether a change to 
general supervision would raise safety concerns for therapy patients. 
Collectively, commenters did not believe there would be safety concerns 
with the change to general supervision; and many commenters also 
pointed out that they are unaware of safety concerns arising in the 
other Medicare settings where general supervision policies have been in 
place for many years, even though acuity levels were suggested by 
several commenters to be higher in SNFs and HHAs. Several other 
commenters stated that they were not aware of any safety concerns 
during the time PTAs/OTAs were treating patients while the PT/OT was 
off-site utilizing the direct virtual supervision flexibility through 
real-time audio and video technology during the COVID-19 PHE. One 
commenter also stated that they believe the existing structure of 
guidance from the House of Delegates of the American Physical Therapy 
Association, Medicare, and State law authorities on the PT-PTA 
relationship is sufficient to ensure patient safety under a general 
supervision policy.
    Several commenters reported that State licensure practice acts 
include supervision policies for all settings, including when PTAs and 
OTAs treat patients in therapy offices or in patients' homes. Two 
commenters referred us to the Federation of State Boards of Physical 
Therapy for a comprehensive list of State supervision laws but listed 
out some of the latest trends in states' supervision requirements, 
including, for example--44 States require general supervision in all 
settings, New York and the District of Columbia are the only 
jurisdictions that require on-site supervision of PTAs in all settings, 
and five States expressly require a PT to be on-site when a PTA 
provides in-home care. These commenters noted that States are 
responsibly regulating supervision levels and that where a State has 
considered off-site supervision or in-home care as appropriate, CMS 
should not require additional standards.
    Two commenters stated that Medicare regulations already limit the 
types of services permitted to be performed by PTAs and OTAs, for all 
settings not just private practice, that is, they may not provide 
evaluation services, make clinical judgments or decisions, or take 
responsibility for the service. One commenter stated that many States 
have added additional restrictions for PTAs and believes that State 
licensure and scope of practice requirements for PTAs determine what 
services can be safely provided by PTAs to patients, in and off the 
premises of each health care setting.
    Commenters also noted that Medicare already requires the PT and OT 
to ``actively'' treat the patient at least once every 10 treatment 
days, per the progress note requirement. In addition, one commenter 
stated that many States also mandate that PTs provide periodic 
reevaluations or on-site or in-room supervisory visits of PTAs more 
frequently than Medicare does. Since Medicare and State laws already 
require periodic visits by the PT, one commenter asserted that 
additional requirements by CMS are not necessary.
    In responding to our question as to whether a general supervision 
policy would cause a change in utilization of therapy services, 
Commenters mentioned a report by Dobson DaVanzo that they, along with 
several other rehabilitation organizations, commissioned to evaluate 
the financial impact of various provisions included in the Stabilizing 
Medicare Access to Rehabilitation and Therapy (SMART) Act, (H.R. 5536) 
in the 117 Congress.\41\ As one issue, the report sought to predict 
whether the change to general supervision in the private practice 
setting would increase therapy utilization generally and whether a 
change in utilization of PTAs/OTAs versus PTs/OTs will occur, as part 
of the legislation. Using the report's data, the commenters stated that 
by making the supervision policy change--which they indicate replaces 
utilization of therapists with therapy assistants--Medicare could save 
up to $271.3 million (in 2021 dollars) over a 10-year period from 2022 
to 2031. They stated this savings is due to the payment differential, 
the 15 percent reduction of the PFS amount--for services furnished in 
whole or in part by PTAs and OTAs that went into effect in CY 2022 per 
section 1834(v) of the Act.
---------------------------------------------------------------------------

    \41\ Dobson DaVanzo & Associates LLC. Impact on Medicare 
Spending of the Stabilizing Medicare Access to Rehabilitation and 
Therapy Act Assumptions and Methodology Final Technical Report Data, 
2022.
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    Response: CMS will take these comments into consideration for 
possible future rulemaking.
    After consideration of public comments in response to our comment 
solicitation for general supervision of PTAS and OTAs by PTs and OTs in 
private practice, we will take these comments into consideration for 
possible future rulemaking.
    Additionally, we received public comments on issues that are 
considered out-of-scope of the proposals in this rule. As a result, CMS 
did not summarize or respond to those comments.
2. KX Modifier Thresholds
    Formerly referred to as the therapy cap amounts, the KX modifier 
thresholds were established through section 50202 of the Bipartisan 
Budget Act (BBA) of 2018 (Pub. L. 115-123, February 9, 2018). These 
per-beneficiary amounts under section 1833(g) of the Act (as amended by 
section 4541 of the Balanced Budget Act of 1997) (Pub. L. 105-33, 
August 5, 1997) are updated each year based on the percentage increase 
in the Medicare Economic Index (MEI). In the CY 2023 PFS final rule (87 
FR 69688 through 69710), we rebased and revised the MEI to a 2017 base 
year. Specifically, these amounts are calculated by updating the 
previous year's amount by the percentage increase in the MEI for the 
upcoming calendar year and rounding to the nearest $10.00. Thus, for CY 
2024, we proposed to increase the CY 2023 KX

[[Page 78993]]

modifier threshold amount by the most recent forecast of the 2017-based 
MEI. For CY 2024, the proposed growth rate of the 2017-based MEI is 
estimated to be 4.5 percent, based on the IHS Global, Inc. (IGI) first 
quarter 2023 forecast with historical data through the fourth quarter 
of 2022.\42\ Multiplying the CY 2023 KX modifier threshold amount of 
$2,230 by the proposed CY 2024 percentage increase in the MEI of 4.5 
percent ($2,230 x 1.045), and rounding to the nearest $10.00 results in 
a proposed CY 2024 KX modifier threshold amount of $2,330 for physical 
therapy and speech-language pathology services combined and $2,330 for 
occupational therapy services. We also proposed that if more recent 
data subsequently became available (for example, a more recent estimate 
of the CY 2024 2017-based MEI percentage increase), we would use such 
data, if appropriate, to determine the final CY 2024 MEI percentage 
increase and would apply that more recent MEI percentage increase to 
formulate the CY 2024 KX modifier threshold amounts in the CY 2024 PFS 
final rule. We received a more recent estimate of the CY 2024 2017-
based MEI percentage increase of 4.6 percent which is greater than the 
MEI of 4.5 percent used for determining the proposed $2,330 each for 
the CY 2024 KX modifier threshold amounts; however, the MEI of 4.6 
percent was not enough to formulate a change to the proposed KX 
modifier threshold amounts for CY 2024. Therefore, we are finalizing 
the CY 2024 KX modifier threshold amounts of $2,330 for physical 
therapy and speech-language pathology services combined and $2,330 for 
occupational therapy services as proposed. Section 1833(g)(7)(B) of the 
Act describes the targeted medical review (MR) process for services of 
physical therapy, speech-language pathology, and occupational therapy 
services. The threshold for targeted MR is $3,000 through CY 2027. 
Effective beginning with CY 2028, the MR threshold levels would be 
annually updated by the percentage increase in the MEI, per section 
1833(g)(7)(B) of the Act. Consequently, for CY 2024, the MR threshold 
is $3,000 for physical therapy and speech-language pathology services 
combined and $3,000 for occupational therapy services. Section 
1833(g)(5)(E) of the Act states that CMS shall identify and conduct 
targeted medical review using factors that may include the following:
---------------------------------------------------------------------------

    \42\ IGI is a nationally recognized economic and financial 
forecasting firm with which we contract to forecast the components 
of the MEI and other CMS market baskets.
---------------------------------------------------------------------------

    (1) The therapy provider has had a high claims denial percentage 
for therapy services under this part or is less compliant with 
applicable requirements under this title.
    (2) The therapy provider has a pattern of billing for therapy 
services under this part that is aberrant compared to peers or 
otherwise has questionable billing practices for such services, such as 
billing medically unlikely units of services in a day.
    (3) The therapy provider is newly enrolled under this title or has 
not previously furnished therapy services under this part.
    (4) The services are furnished to treat a type of medical 
condition.
    (5) The therapy provider is part of a group that includes another 
therapy provider identified using the factors described previously in 
this section.
    We track each beneficiary's incurred expenses for therapy services 
annually and count them towards the KX modifier and MR thresholds by 
applying the PFS rate for each service less any applicable MPPR amount 
for services of CMS-designated ``always therapy'' services (see the CY 
2011 PFS final rule at 75 FR 73236). We also track therapy services 
furnished by critical access hospitals (CAHs), applying the same PFS-
rate accrual process, even though they are not paid for their therapy 
services under the PFS and may be paid on a cost basis (effective 
January 1, 2014) (see the CY 2014 PFS final rule at 78 FR 74406 through 
74410).
    When the beneficiary's incurred expenses for the year for 
outpatient therapy services exceeds one or both of the KX modifier 
thresholds, therapy suppliers and providers use the KX modifier on 
claims for subsequent medically necessary services. Through the use of 
the KX modifier, the therapist and therapy provider attest that the 
services above the KX modifier thresholds are reasonable and necessary 
and that documentation of the medical necessity for the services is in 
the beneficiary's medical record. Claims for outpatient therapy 
services exceeding the KX modifier thresholds without the KX modifier 
included are denied. (See the CY 2023 PFS final rule at 87 FR 69650 
through 69651))
    Comment: One commenter supported the change in the KX modifier 
threshold amounts for CY 2024, and thanked us for the confirmation.
    Response: We appreciate the supportive remarks from the commenter.
    Using the updated MEI of 4.6 in determining the CY 2024 KX modifier 
amounts, we are finalizing the CY 2024 KX modifier threshold amounts as 
proposed: $2,330 for physical therapy and speech-language pathology 
services combined and $2,330 for occupational therapy services.
3. Diabetes Self-Management Training (DSMT) Services Furnished by 
Registered Dietitians (RDs) and Nutrition Professionals
    During the CY 2022 PFS rulemaking, we adopted a regulation at Sec.  
410.72(d) that requires the services that RDs and nutrition 
professionals furnish to beneficiaries to be directly performed by 
them. This is based on the MNT regulations at subpart G, Sec. Sec.  
410.130--410.134. When developing this policy, we were only referring 
to MNT services. These MNT services are distinct from the DSMT services 
that RDs or nutrition professionals may furnish when they are or 
represent an accredited DSMT entity.
    We note that the RD or nutrition professional, when named in or a 
sponsor of an accredited DSMT entity, may act as the DSMT certified 
provider, which is defined at section 1861(qq) of the Act as a 
physician or other individual or entity to which Medicare makes payment 
for other services. RDs and nutrition professionals may qualify as DSMT 
certified providers within the meaning of the statute since they 
provide and bill for MNT services. This is reinforced in our sub-
regulatory manual provisions (Pub. 100-02, Chapter 15, section 300.2), 
which specifies that DSMT certified providers may bill and be paid for 
the entire DSMT program and further clarifies that the RD or nutrition 
professional is eligible to bill on behalf of an entire DSMT program 
(or entity) on or after January 1, 2002, after obtaining a Medicare 
provider number. In addition, section 1861(qq) of the Act requires that 
DSMT certified providers meet quality standards established by the 
Secretary, except that the physician or other individual or entity 
shall be deemed to have met such standards if the physician or other 
individual or entity meets applicable standards originally established 
by the National Diabetes Advisory Board and subsequently revised by 
organizations who participated in the establishment of standards by 
such Board. DSMT entities are required to meet the National Standards 
for Diabetes Self-management Education Programs (NSDSMEP) set of 
quality standards at Sec.  410.144(b). DSMT entities are also required 
to be recognized or accredited by CMS Accreditation Organizations 
(AOs). There are currently two national DSMT AOs--the American Diabetes

[[Page 78994]]

Association (ADA) or the Association of Diabetes Care & Education 
Specialists (ADCES) (Medicare Program Integrity Manual, Pub. 100-08, 
chapter 10, section 10.2.4.B). The ADA and ADCES also review and 
approve the credentials of DSMT program instructors.
    Interested parties have alerted us that the wording of Sec.  
410.72(d) has caused confusion for DSMT entities/suppliers and Part B 
Medicare Administrative Contractors (MACs) about whether RD or 
nutrition professionals must personally provide DSMT services. To 
alleviate any confusion, we believe a clarification is needed to 
distinguish between when a RD or nutritional professional is personally 
providing MNT services, in accordance with the MNT regulations, and 
when they are acting as or on behalf of an accredited DSMT entity and 
billing for DSMT services that may be provided by a group of other 
professionals working under an accredited DSMT entity, for example, 
registered nurses (RNs), pharmacists, or RDs other than the sponsoring 
RD. Under the NSDSMEP quality standards, the RD, RN, or pharmacist is 
permitted to provide the educational DSMT services on a solo basis, 
that is without a multi-disciplinary team; however, only the RD or 
nutrition professional, when enrolled as a Medicare supplier, in these 
accredited DSMT entities is authorized by section 1861(qq)(2)(A) of the 
Act to bill Medicare on behalf of the entire DSMT entity as the DSMT 
certified provider.
    Consequently, we proposed to amend the regulation at Sec.  
410.72(d) to clarify that a RD or nutrition professional must 
personally perform MNT services. Additionally, we proposed to clarify 
that a RD or nutrition professional may bill for, or on behalf of, the 
entire DSMT entity as the DSMT certified provider regardless of which 
professional furnishes the actual education services. We proposed to 
clarify Sec.  410.72(d) to provide that, except for DSMT services 
furnished as, or on behalf of, an accredited DSMT entity, registered 
dietitians and nutrition professionals can be paid for their 
professional MNT services only when the services have been directly 
performed by them.
    We received public comments on this proposal. The following is a 
summary of the comments we received and our responses.
    Comment: Many commenters stated their support for the proposal to 
clarify and revise Sec.  410.72(d) for the enrolled RD or nutrition 
professional, when acting as the DSMT certified provider, may bill for, 
or on behalf of, the entire DSMT entity, regardless of which 
professional personally delivers each aspect of the services. Some 
commenters also supported the proposed regulatory text. One of these 
commenters appreciated that the revised text would provide clarity when 
Registered Dietitian Nutritionists (RDNs) bill for DSMT services to 
make sure they are complying with regulatory guidelines. Although two 
commenters recommended that in addition to mentioning RNs and 
pharmacists as additional professionals for whom the RD may bill for in 
DSMT that we include paraprofessionals in the examples as a means of 
aligning our proposal with the accreditation requirements. The 
commenters reasoned that ADCES and ADA Accreditation requirements 
include the use the paraprofessionals to deliver elements of the DSMT 
under the supervision of the RD, noting that many of the trained 
professionals have lived experience with diabetes.
    Response: We thank the commenters for their comments and 
suggestions. We purposely limited the professionals we named in the 
proposed clarification of our policy to DSMT team members that the 
National Standards quality standards recognizes to provide services 
independently, without the supervision of the RD, RN, or pharmacist. 
This way, by naming the RD, RN, and pharmacist, it would encompass the 
paraprofessionals or other individuals who are being supervised in 
accredited ADA or ADCES DSMT entities.
    After consideration of public comments, we are finalizing our 
proposal to revise Sec.  410.72(d) to clarify that RDs and nutrition 
professionals can bill as or on behalf of a DSMT entity regardless of 
which professional furnished the actual services, but that they must 
directly provide the MNT services they bill for.
4. DSMT Telehealth Issues
(a) Distant Site Practitioners
    Since 2006, RDs and nutrition professionals have been recognized as 
distant site practitioners for purposes of Medicare telehealth services 
under section 1834(m)(4)(E) of the Act. Section 1834(m)(4)(E) of the 
Act specifies that the practitioners listed at section 1842(b)(18)(C) 
of the Act, which include RDs and nutrition professionals as of 2006, 
can serve as distant site practitioners for Medicare telehealth 
services. Our regulations and sub-regulatory policies for Medicare 
telehealth services do not address scenarios involving the furnishing 
of DSMT services via telehealth when the actual services are personally 
furnished by individuals who provide them, for example, RNs, 
pharmacists, or other multidisciplinary team members, who are not 
recognized as telehealth distant site practitioners under the statutory 
definition. In keeping with the NSDSMEP quality standards, an RD is 
often part of a DSMT entity, and when they are, they can be considered 
a ``certified provider'' when they are enrolled in Medicare and intend 
to bill for the DSMT services, in accordance with the statutory 
provision at section 1861(qq)(2)(A) of the Act, which defines certified 
providers as physicians, or other individuals or entities designated by 
the Secretary, that, in addition to providing DSMT services, provides 
other items or services for which Medicare payment may be made. As we 
noted previously in this section of the final rule, there may be other 
RDs among the group or team of professionals, along with RNs and/or 
pharmacists, that are performing DSMT services in addition to the 
sponsoring or billing RD or nutrition professional functioning as the 
certified provider. Additionally, our Medicare Benefit Policy Manual, 
Pub. 100-02, Chapter 15, section 300.2 clarifies that these certified 
providers, including RDs or nutrition professionals, may bill for 
services of the DSMT entity. Since we allow RDs and other DSMT 
certified providers to bill on behalf of the DSMT entity when other 
professionals personally furnish the service in face-to-face 
encounters, we believe that this should also be our policy when DSMT is 
furnished as a Medicare telehealth service. To increase access to DSMT 
telehealth services, we proposed to codify billing rules for DSMT 
services furnished as Medicare telehealth services at Sec.  
410.78(b)(2)(x) to allow distant site practitioners who can 
appropriately report DSMT services furnished in person by the DSMT 
entity, such as RDs and nutrition professionals, physicians, nurse 
practitioners (NPs), physician assistants (PAs), and clinical nurse 
specialists (CNSs), to also report DSMT services furnished via 
telehealth by the DSMT entity, including when the services are 
performed by others as part of the DSMT entity. This revision to our 
regulation will preserve access to DSMT services via telehealth for 
Medicare beneficiaries in cases where the DSMT service is provided in 
accordance with the NSDSMEP quality standards. We note that DSMT 
services are on the Medicare Telehealth Services List, and are subject 
to the requirements and conditions of payment under section 1834(m) of 
the Act and Sec.  410.78 of our regulations, including originating site

[[Page 78995]]

and geographic location requirements, when they are in effect. See 
section II.D. for a discussion of Medicare telehealth policies.
(b) Telehealth Injection Training for Insulin-Dependent Beneficiaries
    Currently, our manual instruction for Payment for Diabetes Self-
Management Training (DSMT) in the Medicare Claims Processing Manual, 
Pub. 100-04, chapter 12, section 190.3.6, requires 1 hour of the 10-
hour DSMT benefit's initial training and 1 hour of the 2-hour follow-up 
annual training to be furnished in-person to allow for effective 
injection training when injection training is applicable for insulin-
dependent beneficiaries. This policy was clarified for 2019 to specify 
that in-person training only applies to a beneficiary for whom the 
injection training was applicable via CMS Transmittal 4173, available 
at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R4173CP.pdf.
    We believe that, with the expansion of the use of telehealth during 
the PHE for COVID-19, there have been significant changes in clinical 
standards, guidelines, and best practices regarding services furnished 
using interactive telecommunications technology, including for 
injection training for insulin-dependent patients. We do not want our 
policies to prevent injection training via telehealth when clinically 
appropriate. Consequently, we proposed to revise our policy at Sec.  
410.78(e) to allow the 1 hour of in-person training (for initial and/or 
follow-up training), when required for insulin-dependent beneficiaries, 
to be provided via telehealth. If finalized, we anticipate revising the 
Medicare Claims Processing Manual, Pub. 100-04, chapter 12, section 
190.3.6 to reflect that flexibility.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Nearly half of the commenters submitting comments 
regarding our proposal for distant site practitioners expressed 
concerns about our proposed regulatory text for Sec.  410.78(b)(2)(x) 
and the term distant site practitioner, not including outpatient 
hospitals, that bill on a UB-04 claim form using their NPI rather than 
a personal provider NPI, and pharmacies that enroll as suppliers of 
DSMT services. The commenters requested we include the term ``approved 
entity'' in the regulatory text and change the term ``report'' to 
``bill for.'' Most of these commenters supported modifying the 
regulatory text to read as follows: Any distant site practitioner or 
approved entity who/that can bill for diabetes self-management training 
services may do so on behalf of others who personally furnish the 
services as part of the DSMT entity. One commenter stated ADA and ADCES 
accreditation data indicates that more than 1,200--or approximately 56 
percent--of all accredited DSMT programs, operate out of the outpatient 
hospital setting. Similarly, more than 200--or approximately 11 
percent--of all accredited DSMT programs are located within pharmacies, 
making up two-thirds of all DSMT programs. Five commenters expressed 
their support for including services for DSMT and MNT services 
furnished remotely by staff in outpatient hospitals to patients in 
their homes under section 1834(m) of the Act for payment of telehealth 
services see the provision in the Telehealth section at II.D. titled 
Payment for Outpatient Therapy Services, Diabetes Self-Management 
Training, and Medical Nutrition Therapy When Furnished by Institutional 
Staff to Beneficiaries in Their Homes Through Communication Technology. 
Another commenter asked that CMS clearly restate that accredited and 
recognized DSMT programs are eligible to bill Medicare Part B directly 
for DSMT services and may furnish and bill for DSMT services provided 
via telehealth, regardless of the provider type (RNs, pharmacists, 
registered dietitians, etc.) furnishing the service.
    Response: Given that the pharmacy and outpatient hospital are 
recognized as certified providers of DSMT services per section 1861(qq) 
of the Act, they are recognized to bill for DSMT services they provide 
in-person, regardless of which professional furnishes the services. For 
purposes of telehealth, though, the current statute is clear at section 
1834(m)(4)(E) of the Act, that only physicians and nonphysician 
practitioners listed at section 1842(b)(18)(C) of the Act qualify as 
distant site practitioners, so that area of Medicare law that does not 
include hospitals or pharmacies. However, we agree that the term ``bill 
for'' is more appropriate than ``report'' and will modify our proposed 
regulation text to reflect this change. We also want to clarify that 
CMS did not state that ``accredited and recognized DSMT programs are 
eligible to bill Medicare Part B directly for DSMT services and may 
furnish and bill for DSMT services provided via telehealth, regardless 
of the provider type (RNs, pharmacists, registered dietitians, etc.) 
furnishing the service'' since DSMT programs must qualify as a 
certified provider in accordance with the statute before they can bill 
for DSMT services. However, to the extent that the DSMT program 
qualifies as a certified provider of DSMT services and is a distant 
site practitioner specified in section 1834(m)(4) of the Act, that 
distant site physician or practitioner may bill for DSMT services 
furnished via telehealth and may do so on behalf of others who 
personally furnish the services as part of the DSMT entity.
    Comment: Regarding our proposal on insulin injection-training to 
eliminate the regulatory prohibition on providing the full hours of 
DSMT via telehealth when clinically appropriate, all commenters were 
supportive. Although, a few commenters expressed concern about the 
definition of distant site practitioner that does not include all the 
DSMT multidisciplinary-team members that furnish injection-training in 
addition to RDs, including RNs and pharmacists. These commenters urged 
CMS to amend the proposed regulation text so as not to preclude certain 
practitioners from providing this important service via telehealth.
    Response: We thank the many commenters for their support. Please 
refer to the previous response regarding distant site practitioners for 
DSMT furnished as Medicare telehealth services.
    After consideration of public comments, we are doing the following: 
(a) finalizing our proposal on insulin injection-training that will 
allow the full initial 10-hours, or annual 2 hours, of DSMT services 
for insulin-dependent diabetics, via telehealth, when clinically 
appropriate, and we will reflect this change in our Medicare Claims 
Processing Manual, chapter 12, section 190.3. 6--Payment for Diabetes 
Self-Management Training (DSMT) as a Telehealth Service through our 
change management system; and, (b) finalizing our proposed regulatory 
text with a modification that replaces the term ``report'' with ``bill 
for'' so that the new text for Sec.  410.78(b)(2)(x) will provide that 
any distant site practitioner who can appropriately bill for diabetes 
self-management training services may do so on behalf of others who 
personally furnish the services as part of the DSMT entity.

J. Advancing Access to Behavioral Health Services

1. Implementation of Section 4121(a) of the Consolidated Appropriations 
Act, 2023
a. Statutory Amendments
    Section 4121(a) of Division FF, Title IV, Subtitle C of the 
Consolidated

[[Page 78996]]

Appropriations Act, 2023 (CAA, 2023) (Pub. L. 117-328, December 29, 
2022), Coverage of Marriage and Family Therapist Services and Mental 
Health Counselor Services under Part B of the Medicare Program, 
provides for Medicare coverage of and payment for the services of 
mental health care professionals who meet the qualifications for 
marriage and family therapists (MFTs) and mental health counselors 
(MHCs) when billed by these professionals.
    Specifically, section 4121(a)(1) of the CAA, 2023 amended section 
1861(s)(2) of the Act by adding a new benefit category under Medicare 
Part B in new subparagraph (II) to include marriage and family 
therapist services (as defined in an added section 1861(lll)(1) of the 
Act) and mental health counselor services (as defined in an added 
section 1861(lll)(3) of the Act).
    Section 4121(a)(2) of the CAA, 2023 added a new subsection (lll) to 
section 1861 of the Act, which defines marriage and family therapist 
services, marriage and family therapist (MFT), mental health counselor 
services, and mental health counselor (MHC). Section 1861(lll)(1) of 
the Act defines ``marriage and family therapist services'' as services 
furnished by an MFT for the diagnosis and treatment of mental illnesses 
(other than services furnished to an inpatient of a hospital), which 
the MFT is legally authorized to perform under State law (or the State 
regulatory mechanism provided by State law) of the State in which such 
services are furnished, as would otherwise be covered if furnished by a 
physician or as an incident to a physician's professional service. 
Section 1861(lll)(2) of the Act defines the term MFT to mean an 
individual who:
     Possesses a master's or doctor's degree which qualifies 
for licensure or certification as a MFT pursuant to State law of the 
State in which such individual furnishes marriage and family therapist 
services;
     Is licensed or certified as a MFT by the State in which 
such individual furnishes such services;
     After obtaining such degree has performed at least 2 years 
of clinical supervised experience in marriage and family therapy; and
     Meets such other requirements as specified by the 
Secretary.
    Section 1861(lll)(3) of the Act defines ``mental health counselor 
services'' as services furnished by a mental health counselor (MHC) for 
the diagnosis and treatment of mental illnesses (other than services 
furnished to an inpatient of a hospital), which the MHC is legally 
authorized to perform under State law (or the State regulatory 
mechanism provided by the State law) of the State in which such 
services are furnished, as would otherwise be covered if furnished by a 
physician or as incident to a physician's professional service. Section 
1861(lll)(4) of the Act defining MHC as an individual who:
     Possesses a master's or doctor's degree which qualifies 
for licensure or certification as a mental health counselor, clinical 
professional counselor, or professional counselor under State law of 
the State in which such individual furnishes MHC services;
     Is licensed or certified as a mental health counselor, 
clinical professional counselor, or professional counselor by the State 
in which the services are furnished;
     After obtaining such degree has performed at least 2 years 
of clinical supervised experience in mental health counseling; and
     Meets such other requirements as specified by the 
Secretary.
    Section 4121(a)(3) of the CAA, 2023 amended section 1833(a)(1) of 
the Act to add a new subparagraph (FF), which provides that, with 
respect to MFT services and MHC services under section 1861(s)(2)(II) 
of the Act, the amounts paid shall be 80 percent of the lesser of the 
actual charge for the services or 75 percent of the amount determined 
for payment of a psychologist under subparagraph (L).
    Section 1888(e)(2)(A)(ii) of the Act, as amended by section 
4121(a)(4) of the CAA, 2023, excludes MFT and MHC services from 
consolidated billing requirements under the skilled nursing facility 
(SNF) prospective payment system. For further discussion about this 
exclusion of MFT and MHC services from SNF consolidated billing, see 
discussion in the FY 2024 SNF Prospective Payment System (PPS) proposed 
rule (88 FR 21316).\43\ Section 4121(a)(5) of the CAA, 2023 amended 
section 1842(b)(18)(C) of the Act to add MFTs and MHCs to the list of 
practitioners whose services can only be paid by Medicare on an 
assignment-related basis. MFTs, MHCs, and other practitioners described 
in section 1842(b)(18)(C) of the Act may not bill (or collect any 
amount from) the beneficiary or another person for any services for 
which Medicare makes payment, except for deductible and coinsurance 
amounts applicable under Part B. More information on assignment of 
claims can be found in the Medicare Claims Processing Manual, Pub. 100-
04, Chapter 1, Section 30.3.1.
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    \43\ https://www.govinfo.gov/content/pkg/FR-2023-04-10/pdf/2023-07137.pdf.
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    We also noted that section 1861(aa)(1)(B) of the Act was amended by 
section 4121(b)(1) of the CAA, 2023 to add services furnished by MFTs 
and MHCs to the definition of rural health clinic services. See section 
III.B. of this final rule for discussion related to MFT and MHC 
services furnished in RHCs and FQHCs.
    Additionally, section 1861(dd)(2)(B)(i)(III) of the Act was amended 
by 4121(b)(2) of the CAA, 2023 to require a hospice program to have an 
interdisciplinary team that includes at least one social worker, MFT or 
MHC. For further discussion about this amended requirement for hospice 
program interdisciplinary teams, see section III.O. of this final rule.
b. Proposed Changes to Regulations
    Consistent with the changes to the statute described above, we 
proposed to create two new regulation sections at Sec.  410.53 and 
Sec.  410.54 to codify the coverage provisions for MFTs and MHCs, 
respectively.
    Specifically, we proposed to define a marriage and family therapist 
at Sec.  410.53 as an individual who:
     Possesses a master's or doctor's degree which qualifies 
for licensure or certification as a marriage and family therapist 
pursuant to State law of the State in which such individual furnishes 
the services defined as marriage and family therapist services;
     After obtaining such degree, has performed at least 2 
years or 3,000 hours of post master's degree clinical supervised 
experience in marriage and family therapy in an appropriate setting 
such as a hospital, SNF, private practice, or clinic; and
     Is licensed or certified as a marriage and family 
therapist by the State in which the services are performed.
    We noted that we are aware that there may be some States that 
require a number of hours of clinical supervised experience for MFT 
licensure that may be inconsistent with the statutory requirement in 
section 1861(s)(2) of the Act that requires at least 2 years of 
clinical supervised experience. We believe it could be possible for an 
MFT to have completed the required number of clinical supervised hours 
required for licensure in their State, but to have accomplished this in 
less than two years. Therefore, we proposed a requirement for MFTs to 
have performed at least 2 years or 3,000 hours of post master's degree 
clinical supervised experience, if consistent with State licensure 
requirements. We stated in the proposed rule that we

[[Page 78997]]

believe that 3,000 hours is roughly equivalent to the statutory 
requirement to have performed 2 years of clinical supervised experience 
and note that the regulatory requirements for clinical social workers 
(CSWs) at Sec.  410.73(a)(3)(ii) allow 2 years or 3,000 hours of 
supervised experience. Additionally, the statutory benefit category for 
both MFTs and CSWs is defined as services for the diagnosis and 
treatment of mental illnesses. As such, we believe it would be 
appropriate to provide similar flexibility in the required amount of 
clinical supervised experience for MFTs and CSWs. We stated in the 
proposed rule that we were also interested in public comments regarding 
States that have a supervised clinical hour requirement for MFT 
licensure that is less than 2 years.
    We proposed to define ``Marriage and family therapist services'' at 
Sec.  410.53(b)(1) as services furnished by a marriage and family 
therapist for the diagnosis and treatment of mental illnesses (other 
than services furnished to an inpatient of a hospital), which the 
marriage and family therapist is legally authorized to perform under 
State law (or the State regulatory mechanism provided by State law) of 
the State in which such services are furnished. We also proposed at 
Sec.  410.53(b)(1) that the services must be of a type that would be 
covered if they were furnished by a physician or as an incident to a 
physician's professional service and must meet the requirements of this 
section.
    Lastly, we proposed at Sec.  410.53(b)(2) that the following 
services do not fall under the Medicare Part B benefit category for MFT 
services:
     Services furnished by a marriage and family therapist to 
an inpatient of a Medicare-participating hospital.
    Similarly, we proposed to define a mental health counselor at Sec.  
410.54 as an individual who:
     Possesses a master's or doctor's degree which qualifies 
for licensure or certification as a mental health counselor, clinical 
professional counselor, or professional counselor under the State law 
of the State in which such individual furnishes the services defined as 
mental health counselor services;
     After obtaining such a degree, has performed at least 2 
years or 3,000 hours of post master's degree clinical supervised 
experience in mental health counseling in an appropriate setting such 
as a hospital, SNF, private practice, or clinic; and
     Is licensed or certified as a mental health counselor, 
clinical professional counselor, or professional counselor by the State 
in which the services are performed. As previously explained for MFTs, 
and for the same reasons, we proposed a requirement for MHCs to have 
performed at least 2 years or 3,000 hours of post master's degree 
clinical supervised experience, if consistent with State licensure 
requirements. We believe that 3,000 hours is roughly equivalent to the 
statutory requirement to have performed 2 years of clinical supervised 
experience and note that the regulatory requirements for clinical 
social workers at Sec.  410.73(a)(3)(ii) allows 2 years or 3,000 hours. 
The MHC statutory benefit category authorizes MHCs to furnish services 
for the diagnosis and treatment of mental illnesses as it does for 
CSWs. We stated in the proposed rule that we were also interested in 
public comments regarding States that have a supervised clinical hour 
requirement for MHC licensure that is less than 2 years.
    We proposed to define ``mental health counselor services'' at Sec.  
410.54(b)(1) as services furnished by a mental health counselor (as 
defined in paragraph (a) of this section) for the diagnosis and 
treatment of mental illnesses (other than services furnished to an 
inpatient of a hospital), which the mental health counselor is legally 
authorized to perform under State law (or the State regulatory 
mechanism provided by State law) of the State in which such services 
are furnished. We also proposed at Sec.  410.54(b)(1) that the services 
must be of a type that would be covered if they were furnished by a 
physician or as an incident to a physician's professional service.
    We proposed at Sec.  410.54(b)(2) that the following services do 
not fall under the Medicare Part B benefit category for MHC services:
     Services furnished by a mental health counselor to an 
inpatient of a Medicare-participating hospital.
    We proposed to amend Sec.  410.10 to add marriage and family 
therapist services and mental health counselor services to the list of 
included medical and other health services. We also proposed to amend 
Sec.  410.150 to add marriage and family therapists and mental health 
counselors, to the list of individuals or entities to whom payment is 
made.
    Currently, Sec.  410.32(a)(2) lists the health care practitioners 
that may order diagnostic tests. Since this list currently includes 
CSWs and clinical psychologists (CPs), who are also authorized by 
statute to furnish services for the diagnosis and treatment of mental 
illnesses, we proposed to amend Sec.  410.32(a)(2) to add MFTs and MHCs 
to the list of practitioners who may order diagnostic tests, as for the 
other non-physician practitioners, to the extent that the MFT or MHC is 
legally authorized to perform the service under State law (or the State 
regulatory mechanism provided by State law) of the State in which such 
services are furnished.
    We also proposed to codify in a new Sec.  414.53 the payment 
amounts authorized under section 1833(a)(1)(FF) for MFT and MHC 
services. Additionally, we proposed to codify at Sec.  414.53 the 
payment amount for clinical social worker (CSW) services as authorized 
under section 1833(a)(1)(FF) of the Act. As we reviewed our regulations 
to implement section 4121 of the CAA, 2023, we found that the payment 
amounts for CSWs are not yet codified under regulations. Specifically, 
we proposed to add that the payment amount for CSW, MFT, and MHC 
services is 80 percent of the lesser of the actual charge for the 
services or 75 percent of the amount determined for clinical 
psychologist services under the PFS.
    We also proposed to add MFTs and MHCs to the list of practitioners 
who are eligible to furnish Medicare telehealth services at the distant 
site. See section II.D. of this final rule for a discussion of this 
proposal.
    Additionally, we proposed to allow Addiction Counselors who meet 
all of the applicable requirements (possess a master's or doctor's 
degree which qualifies for licensure or certification as a mental 
health counselor; after obtaining such degree have performed at least 2 
years (or, as proposed, 3,000 hours) of clinical supervised experience 
in mental health counseling; and licensed or certified as a MHC, 
clinical professional counselor, or professional counselor by the State 
in which the services are furnished) to enroll in Medicare as MHCs. 
That is, under this proposal, Addiction Counselors will be considered 
Mental Health Counselors and will be eligible to enroll and bill 
Medicare for MHC services if they meet these requirements. We 
understand there is variation in the terminology used for licensure 
across States for MHCs and MFTs and sought information pertaining to 
other types of professionals who may meet the applicable requirements 
for enrollment as mental health counselors. We noted that in past 
rulemaking, we have discussed the term `mental health' to be inclusive 
of diagnosis and treatment of substance use disorders. For example, in 
the CY 2022 PFS final rule (86 FR 65061), we stated that SUD services 
are considered mental health services for the purposes of the expanded 
definition

[[Page 78998]]

of ``interactive telecommunications system.'' We proposed to apply that 
same interpretation for purposes of the mental health services included 
in the definition of MFT, MHC, and to clarify that the same 
interpretation applies for CSW, and CP services.
c. Coding Updates To Allow MFT and MHC Billing
    In light of the new statutory benefits for MFTs and MHCs authorized 
by section 4121(a) of the CAA, 2023, we have considered whether updates 
to certain HCPCS codes are required in order to allow MFTs and MHCs to 
bill for the services described by those HCPCS codes. In the CY 2023 
PFS final rule, we finalized new coding and payment for General 
Behavioral Health Integration services performed by CPs or CSWs to 
account for monthly care integration where the mental health services 
furnished by a CP or CSW serve as the focal point of care integration. 
In light of the new coverage under Medicare for MFT and MHC services 
for the diagnosis and treatment of mental illness, we proposed to 
revise the code descriptor for HCPCS code G0323 in order to allow MFTs 
and MHCs, as well as CPs and CSWs, to be able to bill for this monthly 
care integration service. We noted that MFTs and MHCs, like CSWs, are 
authorized by statute for the diagnosis and treatment of mental 
illnesses (other than services furnished to an inpatient of a 
hospital), which the MFT or MHC is legally authorized to perform under 
State law (or the State regulatory mechanism provided by State law) of 
the State in which such services are furnished, as would otherwise be 
covered if furnished by a physician or as an incident to a physician's 
professional service. The code descriptor for HCPCS code G0323 is: Care 
management services for behavioral health conditions, at least 20 
minutes of clinical psychologist, clinical social worker, mental health 
counselor, or marriage and family therapist time, per calendar month. 
(These services include the following required elements: Initial 
assessment or follow-up monitoring, including the use of applicable 
validated rating scales; behavioral health care planning in relation to 
behavioral/psychiatric health problems, including revision for patients 
who are not progressing or whose status changes; facilitating and 
coordinating treatment such as psychotherapy, coordination with and/or 
referral to physicians and practitioners who are authorized by Medicare 
to prescribe medications and furnish E/M services, counseling and/or 
psychiatric consultation; and continuity of care with a designated 
member of the care team.)
    Lastly, we noted that consistent with the changes to valuation of 
CPT code 99484 in the Valuation of Specific Codes section (section 
II.E. of this final rule), which describes General BHI and is the 
crosswalk code used for valuation of HCPCS code G0323, we also proposed 
conforming updates to the valuation for work and PE inputs for HCPCS 
code G0323. See section II.E. of this final rule for further discussion 
of changes to the valuation for HCPCS code G0323.
    We welcomed comments regarding any other HCPCS codes that may 
require updating to allow MFTs and MHCs to bill for the services 
described in the HCPCS code descriptor.
    We received many public comments on these proposals to implement 
section 4121 of the CAA, 2023. The following is a summary of the 
comments we received and our responses.
    Comment: Many commenters expressed broad support for our proposals 
to implement section 4121 of the CAA, 2023, and expressed appreciation 
that CMS is working to expand access to behavioral health services by 
allowing for qualified professionals to provide this vital care while 
others noted that the increased workforce would help to address 
shortages and needs in their communities.
    Response: We thank the commenters for their support of our 
proposals to implement section 4121 of the CAA, 2023.
    Comment: Many commenters expressed support for our proposal to 
allow either 2 years or 3,000 hours of clinical supervised experience. 
Several commenters provided detailed feedback regarding the amount of 
required clinical supervised experience for state licensure for MFTs 
and MHCs across States. A few commenters noted a small number of States 
that allow for licensure with less than 2 years and fewer than 3,000 
hours. They stated that although most licensed and practicing MFTs and 
MHCs would meet the clinical supervised experience requirement as 
proposed, some would not and noted that those who obtained their 
supervised experience in a community mental health setting are more 
likely to accumulate the required number of hours of experience in less 
than 2 years. The commenters noted that some States differentiate 
between direct client contact versus other clinical activities and that 
some States require a specified number of direct contact hours. One 
commenter encouraged CMS to allow applicants who may not have performed 
at least 2 years or 3,000 hours of post master's degree clinical 
supervised experience before becoming licensed, but who instead 
provided an equivalent number of direct client contact hours to meet 
the supervised experience requirements and specified that they believed 
that 1,000 hours would be roughly equivalent to the proposed 2 years or 
3,000 hours of clinical supervised experience. Other commenters 
expressed concern that ambiguity and discrepancies may exist in 
implementation across states as some states allow supervised clinical 
experience to count toward licensure requirements prior to completing 
their degree, and some states do not provide for clinical supervised 
experience requirements for licensure, and that licensure requirements 
can vary between clinicians with a master's or a doctoral degree. Some 
commenters requested that CMS allow for clinical supervised experience 
earned post-licensure to count toward the required amount for Medicare 
enrollment. A few commenters noted that ``clinical supervised 
experience'' was not defined and recommended that CMS be robust in its 
consideration of what constitutes such experience. Additionally, some 
commenters pointed out that California licensing laws for MFTs and MHCs 
consider some supervised clinical experience obtained during the 
progression toward academic degrees as supervised experience required 
for licensure and noted that while practicing MHCs and MFTs would 
generally meet the clinical supervised experience requirement as 
proposed, some individuals would not necessarily do so if CMS requires 
that all required supervised clinical experience occur following the 
granting of the academic degree. Some commenters also expressed that 
MFTs and MHCs who have been in practice for an extended period of time 
may have difficulty providing documentation of clinical supervised 
experience that occurred years or even decades ago. Some commenters 
requested that CMS consider accepting an attestation as evidence of 
having met the requirement for clinical supervised experience and 
others made a similar request for MFTs and MHCs who have not graduated 
within the last 5 years.
    Response: We note that sections 1861(lll)(2) and1861(lll)(4) of the 
Act require that an MFT or MHC, after obtaining such degree has 
performed at least 2 years of clinical supervised experience in 
marriage and family therapy or mental health counseling. However, we 
wish to clarify that clinical

[[Page 78999]]

supervised experience earned after earning the required degree and 
licensure can count toward the required amount of clinical supervised 
experience for Medicare enrollment purposes. Regarding comments 
pertaining to States that differentiate between direct client contact 
versus other clinical activities and States that require a specified 
number of direct contact hours, we note that a total of 2 years or 
3,000 hours of clinical supervised experience is required and we defer 
to State law and licensure requirements regarding specifics related to 
how many of these hours must be direct client contact. Similarly, 
regarding commenters' requests for CMS to define the term ``clinical 
supervised experience,'' we did not propose, and are not finalizing a 
definition of this term, but rather, defer to State law and licensure 
requirements regarding the nature of the 2 years or 3,000 hours of 
clinical supervised experience.
    We thank the commenters for bringing the issue pertaining to 
clinical supervised experience for MFTs or MHCs in certain states, 
including California, to our attention. We note that sections 
1861(lll)(2) and1861(lll)(4) of the Act require that an MFT or MHC, 
after obtaining such degree has performed at least 2 years of clinical 
supervised experience in marriage and family therapy or mental health 
counseling. As such, any clinical supervised experience would need to 
have occurred after obtaining the applicable master's or doctor's 
degree which qualifies for licensure or certification as a MFT pursuant 
to State law of the State in which such individual furnishes marriage 
and family therapist services, or the applicable master's or doctor's 
degree which qualifies for licensure or certification as a mental 
health counselor, clinical professional counselor, or professional 
counselor under State law of the State in which such individual 
furnishes MHC services, in order to count toward the required 2 years 
or 3,000 hours of clinical supervised experience. However, as noted 
above, clinical supervised experience earned after an individual 
obtains their licensure can count toward the required amount of 
clinical supervised experience for Medicare enrollment purposes.
    Lastly, we note that the amount of clinical supervised experience 
required to be licensed as an MFT or MHC in certain states is the same 
as the required amount of clinical supervised experience that we are 
finalizing for Medicare enrollment purposes in this final rule (a total 
of 3,000 hours or 2 years). In a situation where an MFT or MHC is 
licensed in a state that requires a total of 3,000 hours or 2 years of 
clinical supervised experience after the completion of their degree as 
a requirement to be licensed as an MFT or MHC, no additional action is 
necessary for Medicare enrollment purposes and the Medicare 
Administrative Contractor (MAC) will validate the individual's license 
and clinical supervised experience during application processing.
    Comment: Some commenters expressed concern regarding the statutory 
requirement that MFTs and MHCs be paid at 75 percent of the fee 
schedule rate and stated that the proposed regulations would prevent 
MFTs and MHCs from delivering services to hospital inpatients. A few 
commenters suggested that CMS consider add-on codes to more 
appropriately value the work, time, and effort of these practitioners, 
while others recommended that CMS consider further adjustments to the 
valuation of services used to treat mental health and SUDs under the 
PFS.
    Response: The statutory benefit category for MFTs and MHCs does not 
prohibit MFTs and MHCs from delivering services to hospital inpatients. 
Rather, payment for MFT and MHC services furnished to hospital 
inpatients will be paid under the hospital inpatient prospective 
payment system as ``hospital inpatient services,'' consistent with 
section 1861(b) of the Act, instead of being paid as ``MFT or MHC 
services'' that are paid under the PFS. Additionally, the PFS payment 
amounts for MFT services and MHC services at 75 percent of the payment 
amount for a clinical psychologist is established in section 
1833(a)(1)(FF) of the Act, which provides that, with respect to MFT 
services and MHC services under section 1861(s)(2)(II) of the Act, the 
amounts paid shall be 80 percent of the lesser of the actual charge for 
the services or 75 percent of the amount determined for payment of a 
psychologist. We did not consider changing the valuation of services 
furnished by MFTs and MHCs in the proposed rule, but we welcome 
additional information for our consideration in the future.
    Comment: Many commenters expressed support for our proposal to 
allow addiction counselors who meet all the applicable requirements of 
a MHC to enroll in Medicare as MHCs and bill Medicare for MHC services, 
noting that if finalized, this proposal will increase access to needed 
care for Medicare beneficiaries with SUDs. Several commenters requested 
for CMS to explicitly codify this inclusion at Sec.  410.54 to ensure 
that these practitioners and Medicare beneficiaries are aware of this 
policy. Several commenters noted that in the Medicaid Managed Care 
Access Proposed Rule, when amending its regulations to specify MH and 
SUD instead of behavioral health, CMS stated, ``It is important to use 
clear, unambiguous terms in regulatory text.'' As such, the commenters 
noted they believe it was necessary for CMS to include ``addiction 
counselor or alcohol and drug counselor'' at Sec. Sec.  410.54(a)(1) 
and (3); ``addiction counseling'' at Sec.  410.54(a)(2); and 
``substance use disorders'' at Sec.  410.54(b)(1) in the final rule. 
Other commenters similarly recommended that CMS develop new guidelines 
(both regulatory and subregulatory) that use the phrase ``mental 
health'' or ``addiction'' services, rather than the more global 
``behavioral health,'' noting that this is especially important for 
States in which addiction counselors and mental health counselors have 
distinct roles.
    Response: We are finalizing our proposal to allow addiction 
counselors who meet all the applicable requirements of a MHC to enroll 
in Medicare as MHCs and bill Medicare for MHC services. We understand 
that some States certify addiction counselors with a Bachelor's degree; 
however, these individuals would not meet the education requirements 
for MHCs in the Medicare context. For Medicare purposes, an individual 
must possess a master's or doctor's degree to meet the definition of an 
MHC as defined at section 1861(lll)(4)(A) of the Act and Sec.  410.54, 
which we are finalizing in this rule. While we are not finalizing 
changes to the regulation text at Sec.  410.54 to refence addiction 
counselors, we note that for Medicare purposes, alcohol and drug 
counselors who furnish addiction counseling services for the diagnosis 
and treatment of mental illnesses, including substance use disorders, 
can enroll in Medicare and bill as MHCs, to the extent that they meet 
all of the statutory requirements regarding education, clinical 
supervised experience, and licensure. We are finalizing Sec.  410.54 as 
proposed, and we refer readers to the discussion in our proposed rule 
on this topic (88 FR 52363).
    Comment: One commenter noted that the requirements for MFTs and 
MHCs are not equivalent to the training that physicians must complete, 
noting that physicians complete 4 years of medical school plus 3 to 7 
years of residency, including 10,000-16,000 hours of clinical training. 
The commenter stated

[[Page 79000]]

that MFTs and MHCs are an essential part of a physician led patient 
care team; however, they believe that they lack the requisite medical 
education, medication management training, and clinical training that 
is critical for the diagnosis and treatment of certain mental 
illnesses. As such, though commenters applauded CMS for requiring 
adherence to State law, they requested that the definitions of MFTs and 
MHCs have a specific additional reference to the requirement that they 
must adhere to State scope of practice requirements. The commenter also 
stated that the MFT or MHC should be licensed in the State in which the 
patient is receiving care, as well as the State in which the 
practitioner is located, to ensure that the patient has clear access to 
remedies should malpractice occur, especially with the increased use of 
telehealth in this space.
    Response: We note that for Medicare telehealth services, 42 CFR 
410.78(b)(1) requires that the distant site practitioner be ``licensed 
to furnish the [telehealth] service under State law.'' Therefore, any 
MHCs and MFTs who enroll in Medicare and furnish services would need to 
be licensed to furnish the service under State law. Additionally, we 
note that sections 1861(lll)(1) and (3) of the Act authorize MFTs and 
MHCs to furnish services for the diagnosis and treatment of mental 
illnesses which the MFT or MHC is legally authorized to perform under 
State law. We require that physicians and any practitioner who 
furnishes services under the Medicare program does so in accordance 
with their scope of practice. Therefore, MFTs and MHCs who furnish 
services under the Medicare program will also be required to adhere to 
the scope of practice in their respective State.
    Comment: Several commenters requested clarification regarding 
variation in terminology used across States. Some commenters encouraged 
CMS to clarify that practitioners who meet the applicable requirements 
but are licensed by their State under a different title can also bill 
for these services and be recognized by Medicare for purposes of this 
policy. Other commenters recommended that CMS use the term Mental 
Health Professional (MHP) instead of Mental Health Counselor to be more 
inclusive of the types of professionals who may meet the applicable 
requirements for enrollment as a master's level mental health 
practitioner. They specifically requested that CMS recognize licensed 
psychological practitioners (Kentucky), licensed clinical 
psychotherapists (Kansas), licensed psychological associates (Texas), 
psychologist-masters (Vermont), and psychologists (West Virginia) as 
MHCs, or preferably as MHPs. Other commenters noted that Michigan has a 
licensure category for Licensed Professional Counselors (LPCs) and 
California uses the credential title Licensed Professional Clinical 
Counselor (LPCC) to describe the same or similar practitioner and noted 
that recognizing LPCs, LPCCs, and other functionally similar 
practitioners as MHCs for purposes of Medicare enrollment would 
increase access to these services. Another commenter advocated for 
psychologist associates or psychological associates to be included as 
mental health counselors. A few commenters expressed concern that the 
definitions of an MHC and MFT under the statute could open the door for 
master's level behavioral health professionals, who are not 
professional counselors, to qualify for Medicare reimbursement ``as 
counselors.'' The commenters stated that while they understand that it 
is not within CMS' authority to influence State occupational licensure 
requirements and the agency is beholden to the statute as passed by 
Congress, they are concerned with a growing trend of non-professional 
counselors, such as ``masters level psychologists,'' being granted the 
privilege to practice as counselors in some States.
    Response: We note that while section 1861(lll)(4) of the Act uses 
the term ``mental health counselor,'' the statute defines this term as 
a clinical professional counselor or a professional counselor. Section 
1861(lll)(4)(A) of the Act defines the term mental health counselor as 
an individual who possesses a master's or doctor's degree which 
qualifies for licensure or certification as a mental health counselor, 
clinical professional counselor, or professional counselor under the 
State law of the State in which such individual furnishes MHC services. 
Additionally, we proposed that addiction counselors who meet all 
applicable requirements for MHCs could enroll in Medicare as MHCs. In 
response to the comments received on the variation in nomenclature used 
across States for mental health counselors, we wish to make clear that 
individuals who meet all of the applicable statutory and regulatory 
qualifications for the mental health counselor benefit category for 
education and clinical supervised experience, but are licensed or 
certified by their State under a different title to furnish mental 
health counseling, are eligible to enroll in Medicare under the Part B 
``mental health counselor'' statutory benefit category.
    Comment: Commenters expressed support for our proposal to revise 
the code descriptor for HCPCS code G0323 to allow MFTs and MHCs, as 
well as CPs and CSWs, to be able to bill for this monthly care 
integration service.
    Response: We are finalizing our proposal to update the code 
descriptor for HCPCS code G0323, as proposed. The updated code 
descriptor for HCPCS code G0323 is: Care management services for 
behavioral health conditions, at least 20 minutes of clinical 
psychologist, clinical social worker, mental health counselor, or 
marriage and family therapist time, per calendar month. (These services 
include the following required elements: Initial assessment or follow-
up monitoring, including the use of applicable validated rating scales; 
behavioral health care planning in relation to behavioral/psychiatric 
health problems, including revision for patients who are not 
progressing or whose status changes; facilitating and coordinating 
treatment such as psychotherapy, coordination with and/or referral to 
physicians and practitioners who are authorized by Medicare to 
prescribe medications and furnish E/M services, counseling and/or 
psychiatric consultation; and continuity of care with a designated 
member of the care team.)
    Comment: One commenter urged CMS to update the code descriptors for 
all other HCPCS codes that are utilized by current Medicare behavioral 
health practitioners and requested that MFTs and MHCs be allowed to 
bill for services described in HCPCS code G0409 (Social work and 
psychological services, directly relating to and/or furthering the 
patient's rehabilitation goals, each 15 minutes, face-to-face; 
individual (services provided by a CORF-qualified social worker or 
psychologist in a CORF) pertaining to services directly relating to 
and/or furthering a patient's rehabilitation goals. The commenter also 
encouraged CMS to ensure that MFTs and MHCs are able to provide 
services and bill for them using applicable HCPCS codes even if the 
code descriptors do not address the provider types eligible to bill for 
these services, such as the two new G-codes for psychotherapy for 
crisis services, GPFC1 and GPFC2.
    Response: As to MFTs and MHCs providing services and billing for 
them using applicable HCPCS codes even if the code descriptors do not 
address the provider types eligible to bill for these services, we note 
that most HCPCS codes do not specify in the code descriptor which 
practitioners may

[[Page 79001]]

furnish the service described, so CMS need not change code descriptors 
for most codes describing services for the diagnosis and treatment of 
mental illnesses in order for MFTs and MHCs to bill for them. As 
specified in sections 1861(lll)(1) and (3) of the Act, MFT services and 
MHC services include any services that are furnished by the MFT or MHC 
for the diagnosis and treatment of mental illnesses, that they are 
legally authorized to furnish under State law. Regarding the comment 
about HCPCS code G0409, which describes services provided by a CORF-
qualified social worker or psychologist in a CORF, we thank the 
commenters for bringing this to our attention and note that this is 
something we may take into consideration for future rulemaking.
    Comment: Several commenters urged CMS to use its authority to 
develop additional codes for substance use counseling that could be 
delivered by addiction counselors in office-based and community 
settings, similar to the services developed for community health 
workers, patient navigators, and peer support specialists in the 
proposed rule, and the services identified in the opioid treatment 
program regulations. A few commenters also suggested coding for 
psychoeducation activities for patients with SUD. Some commenters also 
urged CMS to work with Congress to authorize Medicare to cover 
addiction counselors who do not have master's degrees but have the 
appropriate training and supervision to deliver reasonable and 
necessary substance use disorder counseling services to Medicare 
beneficiaries. The commenters noted that allowing these additional 
substance use disorder counselors to serve Medicare beneficiaries, as 
many already do for Medicaid enrollees, aligns with CMS's objective to 
expand the workforce capacity to improve access to substance use 
disorder prevention, treatment, and recovery services, as outlined in 
its Behavioral Health Strategy.
    Response: We thank the commenters for this feedback and the 
detailed suggestions about potential coding for substance use 
counseling and psychoeducation activities. We may consider this for 
future rulemaking. We thank the commenters for information regarding 
other types of professionals who furnish services for the treatment of 
SUDs, but who do not have a master's degree. We will keep this in mind 
as we consider ways to improve access to SUD treatment in the future. 
We note that the Medicare statute specifies the types of health care 
professionals that can enroll and bill the program directly for their 
services, and the services of the various recognized health care 
professionals are also defined in the statute. However, if a health 
care professional does not meet the statutory and regulatory 
requirements to enroll in Medicare, and bill and receive Medicare 
payment directly, they can instead explore whether they may work with a 
physician or other practitioner who is enrolled in the Medicare program 
to provide services incident to the billing practitioner's professional 
services in accordance with our regulation at Sec.  410.26. This is a 
way in which individuals who do not meet the requirements to enroll in 
Medicare as MFTs or MHC, for example, addiction counselors and other 
professionals who do not have a master's or doctor's degree, may be 
able to participate in care furnished to Medicare beneficiaries.
    Comment: Several commenters requested that CMS amend the 
regulations at 42 CFR 419.22 to add the services of MFTs and MHCs to 
the list of Medicare Part B services that are not paid for under the 
Hospital Outpatient Prospective Payment System (OPPS) (except when 
packaged as part of a bundled payment) in order to clarify that MHC and 
MFT services are excluded from payment under the OPPS. The commenters 
stated that the regulation at Sec.  419.22 lists those services that 
are authorized by Medicare statute to be paid under other payment 
systems outside of the OPPS, such as the PFS, the Skilled Nursing 
Facility Prospective Payment System (SNF PPS) and, the End-Stage Renal 
Disease (ESRD) composite rate.
    Response: We thank the commenters for bringing this to our 
attention. We proposed a number of changes to our regulations (88 FR 
52361 through 52364) to implement the amendments made by section 4121 
of CAA, 2023. Generally, these amendments added MFTs and MHCs as types 
of non-physician practitioners who can enroll in Medicare and bill 
independently for their professional services to diagnose and treat 
mental illnesses, and specified that payment is made for these services 
at 80 percent of the lesser of the actual charges for the services or 
75 percent of the amount determined under the PFS for services of a 
clinical psychologist (CP). In proposing to implement section 4121 of 
CAA, 2023, we inadvertently did not address whether MFT and MHC 
services are excluded from payment under the hospital OPPS. Services 
paid under fee schedules or other payment systems, including the 
professional services of physicians and nonphysician practitioners, are 
not paid under the OPPS (see 69 FR 65685). The regulation at Sec.  
419.22 lists the hospital services excluded from payment under the 
OPPS, and includes among them the services of qualified psychologists, 
as defined in section 1861(ii) of the Act. Because MHC and MFT services 
are professional services of nonphysician practitioners for which 
payment is made under the PFS at 75 percent of the amount of payment 
for services of a psychologist, we believe that in implementing the 
amendments to the Act made by section 4121 of the CAA, 2023, we must 
also exclude these services from payment under the OPPS, effective 
January 1, 2024. Accordingly, we anticipate amending the regulation at 
Sec.  419.22 to add the services of MFTs as defined in section 
1861(lll)(1) of the Act and the services of MHCs as defined in section 
1861(lll)(3) of the Act to the list of hospital services excluded from 
payment under the OPPS, at new paragraphs (w) and (x), respectively. 
These amendments to the regulation text will be addressed in the CY 
2024 OPPS final rule which is expected to be issued on or around the 
same time as this final rule.
    Comment: A few commenters requested that CMS update the definition 
of ``practitioner'' in the regulation text to enable MFTs and MHCs to 
opt out of the Medicare program and make use of private contracts with 
Medicare beneficiaries.
    Response: We thank the commenter for bringing this to our 
attention. As noted above, we proposed a number of changes to our 
regulations (88 FR 52361 through 52364) to implement the amendments 
made by section 4121 of CAA, 2023. Generally, these amendments added 
MFTs and MHCs as types of non-physician practitioners who can enroll in 
Medicare and bill independently for their professional services to 
diagnose and treat mental illnesses, and specified that payment is made 
for these services at 80 percent of the lesser of the actual charges 
for the services or 75 percent of the amount determined under the PFS 
for services of a clinical psychologist (CP). In proposing to implement 
section 4121 of CAA, 2023, we inadvertently did not address the section 
of the regulation text pertaining to opting out of the Medicare 
program. We believe that in implementing the amendments to the Act made 
by section 4121 of the CAA, 2023, we must make a conforming change to 
Sec.  405.400, which defines ``practitioner'' for opt-out purposes, to 
include MFTs and MHCs in the definition of ``practitioner,'' consistent 
with other practitioners listed in the regulation text who as 
authorized to furnish services for the diagnosis and

[[Page 79002]]

treatment of mental illnesses, such as clinical psychologists and 
clinical social workers. Accordingly, we are amending the regulation at 
Sec.  405.400 to revise the definition of ``practitioner'' to include a 
marriage and family therapist and mental health counselor.
    Comment: A few commenters requested that Sec.  410.27, which 
permits certain hospital services to be furnished incident to a 
physician or nonphysician practitioner's service, be updated to expand 
the definition of ``nonphysician practitioner'' to include MFTs and 
MHCs.
    Response: We thank the commenters for bringing this to our 
attention. As noted above, we proposed a number of changes to our 
regulations (88 FR 52361 through 52364) to implement the amendments 
made by section 4121 of CAA, 2023. Generally, these amendments added 
MFTs and MHCs as types of non-physician practitioners who can enroll in 
Medicare and bill independently for their professional services to 
diagnose and treat mental illnesses, and specified that payment is made 
for these services at 80 percent of the lesser of the actual charges 
for the services or 75 percent of the amount determined under the PFS 
for services of a clinical psychologist (CP). In proposing to implement 
section 4121 of CAA, 2023, we inadvertently did not address the section 
of the regulation text pertaining to therapeutic outpatient hospital or 
CAH services and supplies incident to a physician's or nonphysician 
practitioner's service. We believe that in implementing the amendments 
to the Act made by section 4121 of the CAA, 2023, we must make a 
conforming change to Sec.  410.27 to recognize MFTs and MHCs as a type 
of nonphysician practitioner. Accordingly, we are amending the 
regulation at Sec.  410.27 to revise the definition of ``nonphysician 
practitioner'' to include MFTs and MHCs. This amendment to the 
regulation text at Sec.  410.27 will be addressed in the CY 2024 OPPS 
final rule.
    Comment: A few commenters stated that the regulatory exception to 
the physician self-referral law for assistance to compensate a 
nonphysician practitioner at Sec.  411.357(x), defines ``nonphysician 
practitioner'' at Sec.  411.357(x)(3) to include certain types of 
mental health practitioners, but the definition does not include 
marriage and family therapists or mental health counselors. The 
commenter asked that CMS expand the definition of ``non-physician 
practitioners'' to include marriage and family therapists and mental 
health counselors, which would permit a hospital to provide assistance 
to a physician to compensate such practitioners.
    Response: The proposed rule focused on implementing the new benefit 
category for MFT and MHC services that permits them to enroll and bill 
independently under the Medicare program. The proposed rule addressed 
certain enrollment, billing and payment policies for MFTs and MHCs and 
the services they furnish, but did not address physician self-referral 
policies. We did not propose any changes to Sec.  411.357(x) or any 
other physician self-referral regulation in the proposed rule. The 
change the commenter suggested falls outside the scope of the proposed 
rule. We thank the commenter for bringing this point to our attention 
and will take it into consideration for possible future rulemaking.
    Comment: We received other comments that were outside the scope of 
the proposed rule.
    Response: While we are not responding to comments that were outside 
the scope of the proposed rule in this final rule, we will take them 
into consideration for possible future rulemaking.
    After consideration of the public comments, we are finalizing our 
proposals to implement section 4121 of the CAA, with some 
clarifications and modifications, as described above. In this final 
rule, we are clarifying that to the extent that addiction counselors 
and alcohol and drug counselors who furnish services for the diagnosis 
and treatment of mental illnesses, including substance use disorders, 
can meet all of the statutory and regulatory requirements regarding 
education, clinical supervised experience, and State licensure for 
MHCs, such counselors can enroll in Medicare as MHCs. We are also 
finalizing a clarification that individuals who meet the statutory and 
regulatory requirements for education and clinical supervised 
experience for MHCs, but are licensed to furnish mental health 
counseling in their State under a title other than mental health 
counselor, clinical professional counselor, or professional counselor, 
are eligible to enroll in Medicare as MHCs. We are also finalizing an 
amendment to Sec.  405.400 to include MFTs and MHCs as practitioners 
who may opt out of Medicare; and will address amendments to Sec. Sec.  
419.22 and 410.27 in the CY 2024 OPPS final rule. We believe these 
policies to implement section 4121 of the CAA, 2023 will advance health 
equity by providing increased access to behavioral health services for 
Medicare beneficiaries.
d. Medicare Enrollment of MFTs and MHCs
    Individuals who meet the applicable requirements as described in 
detail above in this section, and as finalized in this rule, will need 
to enroll in Medicare as MFTs and MHCs in order to submit claims for 
MFT services or MHC services, respectively, furnished to Medicare 
beneficiaries. Under Sec.  424.510, a provider or supplier must 
complete, sign, and submit to the relevant MAC the appropriate Form 
CMS-855 (OMB Control No. 0938-0685) application in order to enroll in 
the Medicare program and obtain Medicare billing privileges. The Form 
CMS-855, which can be submitted via paper or electronically through the 
internet-based Provider Enrollment, Chain, and Ownership System (PECOS) 
process (SORN: 09-70-0532; 104 Provider Enrollment, Chain, and 
Ownership System), captures information about the provider or supplier 
that is needed for CMS or its MACs to determine whether the provider or 
supplier meets all Medicare requirements. We proposed, and are 
finalizing, that the MFT and MHC supplier types, like most nonphysician 
practitioner types, be subject to limited-risk screening under Sec.  
424.518.
    Individuals who meet the MFT or MHC requirements in Sec. Sec.  
410.53 and 410.54 as finalized, would enroll in Medicare via the Form 
CMS-855I application (Medicare Enrollment Application--Physicians and 
Non-Physician Practitioners; OMB No. 0938-1355) and could begin 
submitting their enrollment applications after the publication of the 
CY 2024 PFS final rule. However, as the new benefit categories 
authorized by section 4121(a) of the CAA, 2023, do not take effect 
until January 1, 2024, MFT or MHC claims for MFT or MHC services 
furnished to Medicare beneficiaries with dates of service prior to 
January 1, 2024, will not be payable under Medicare Part B. MFTs and 
MHCs can visit https://www.cms.gov/medicare/provider-enrollment-and-certification for basic information on the provider enrollment process.
2. Implementation of Section 4123 of the CAA, 2023
    Section 4123(a)(1) of the CAA, 2023, Improving Mobile Crisis Care 
in Medicare, amended section 1848 of the Act by adding a new paragraph 
(b)(12) regarding payment for psychotherapy for crisis services 
furnished in an applicable site of service. New subparagraph (A) of 
section 1848(b)(12) of the Act requires the Secretary to

[[Page 79003]]

establish new HCPCS codes under the PFS for services described in 
subparagraph (B) that are furnished on or after January 1, 2024. 
Subparagraph (B) of section 1848(b)(12) of the Act describes these 
services as psychotherapy for crisis services that are furnished in an 
applicable site of service. Section 1848(b)(12)(C) of the Act specifies 
that the payment amount for these psychotherapy for crisis services 
shall be equal to 150 percent of the fee schedule amount for non-
facility sites of service for each year for the services identified (as 
of January 1, 2022) by HCPCS codes 90839 (Psychotherapy for crisis; 
first 60 minutes) and 90840 (Psychotherapy for crisis; each additional 
30 minutes (List separately in addition to code for primary service)), 
and any succeeding codes.
    For purposes of this provision, subparagraph (D)(i) of new section 
1848(b)(12) of the Act defines an applicable site of service as a site 
of service other than a site where the facility rate under the PFS 
applies and other than an office setting, while subparagraph (D)(ii) 
requires that the code descriptors for these new psychotherapy for 
crisis services be the same as the services identified (as of January 
1, 2022) by HCPCS codes 90838 and 90840, and any succeeding codes, 
except that the new codes shall be limited to services furnished in an 
applicable site of service.
    Therefore, consistent with the requirements described in new 
paragraph (12) of section 1848(b) of the Act, we proposed to create two 
new G-codes describing psychotherapy for crisis services furnished in 
any place of service at which the non-facility rate for psychotherapy 
for crisis services applies, other than the office setting: HCPCS codes 
GPFC1 and GPFC2.
    To identify the places of service that are assigned the non-
facility rate, Sec.  414.22(b)(5)(i) states that there are usually two 
levels of PE RVUs that correspond to each code paid under the PFS: 
facility PE RVUs and non-facility PE RVUs. Under Sec.  
414.22(b)(5)(i)(A), the facility PE RVUs apply to services furnished in 
a hospital, skilled nursing facility, community mental health center, 
hospice, ambulatory surgical center, or wholly owned or wholly operated 
entity providing preadmission services under Sec.  412.2(c)(5), or for 
services furnished via telehealth under Sec.  410.78 (though we note 
that special rules relating to the PHE for COVID-19 currently apply, 
and we include proposals regarding the place of service for telehealth 
services in section II.D. of this final rule). Under Sec.  
414.22(b)(5)(i)(B), the non-facility rate is paid in all other 
settings, including a physician's office, the patient's home, a nursing 
facility, or a comprehensive outpatient rehabilitation facility. We 
provided the full list of places of service that are assigned a non-
facility rate on the CMS website at https://www.cms.gov/Medicare/Coding/place-of-service-codes. We proposed that the two new G-codes 
describing psychotherapy for crisis services can be billed when the 
services are furnished in any non-facility place of service other than 
the physician's office setting. We also noted that in the CY 2022 PFS 
final rule (86 FR 65059), in our discussion of Medicare telehealth 
services where the patient's home is a permissible originating site for 
services furnished for diagnosis, evaluation, or treatment of a mental 
health disorder, we indicated that we define the term ``home'' broadly 
to include temporary lodging, such as hotels and homeless shelters (86 
FR 65059). We clarified that, for circumstances where the patient, for 
privacy or other personal reasons, chooses to travel a short distance 
from the exact home location during a telehealth service, that would 
qualify as the patient's home. For purposes of implementing section 
1848(b)(12) of the Act, we proposed to use the same broad definition of 
the patient's home for purposes of these proposed G-codes describing 
psychotherapy for crisis services.
    The new G-codes and their descriptors are:
     GPFC1 (Psychotherapy for crisis furnished in an applicable 
site of service (any place of service at which the non-facility rate 
for psychotherapy for crisis services applies, other than the office 
setting); first 60 minutes); and
     GPFC2 (Psychotherapy for crisis furnished in an applicable 
site of service (any place of service at which the non-facility rate 
for psychotherapy for crisis services applies, other than the office 
setting); each additional 30 minutes (List separately in addition to 
code for primary service)).
    As required by section 1848(b)(12)(C) of the Act, we proposed to 
establish a fee schedule amount for these two new G-codes that is 150 
percent of the current PFS non-facility RVUs for CPT codes 90839 
(Psychotherapy for crisis; first 60 minutes) and 90840 (Psychotherapy 
for crisis; each additional 30 minutes (List separately in addition to 
code for primary service)), respectively. Specifically, we proposed to 
calculate the work, PE, and MP RVUs for HCPCS codes GPFC1 and GPFC2 by 
multiplying the work, PE, and MP RVUs for CPT codes 90839 and 90840, 
respectively, by 1.5.
    We noted that section 4123(a)(2) of the CAA, 2023 amends section 
1848(c)(2)(B)(iv) of the Act to include a waiver of budget neutrality 
providing that paragraph (b)(12) shall not be taken into account in 
applying PFS budget neutrality requirements under section 
1848(c)(2)(B)(ii)(II) of the Act for 2024. Accordingly, we proposed to 
exclude expected expenditures for HCPCS codes GPFC1 and GPFC2 from the 
budget neutrality calculation for CY 2024 PFS ratesetting.
    Additionally, section 4123(d) of the CAA, 2023 requires that the 
Secretary use existing communication mechanisms to provide education 
and outreach to providers of services, physicians, and practitioners 
with respect to the ability of auxiliary personnel, including peer 
support specialists, to participate, consistent with applicable 
requirements for auxiliary personnel, in the furnishing of 
psychotherapy for crisis services billed under the PFS under section 
1848 of the Act, behavioral health integration services, as well as 
other services that can be furnished to a Medicare beneficiary 
experiencing a mental or behavioral crisis. We understand that there 
are varying definitions of the term ``peer support specialist.'' The 
Substance Abuse and Mental Health Services Administration (SAMHSA) 
defines a ``peer support specialist'' as a person who uses their lived 
experience of recovery from mental illness and/or addiction, plus 
skills learned in formal training, to deliver services to promote 
recovery and resiliency. The essential principles of peer support 
include shared personal experience and empathy, a focus on individual 
strengths, and supporting individuals as they work toward recovery 
pursuant to a person-centered plan of care. However, for Medicare 
payment purposes, we noted that the term auxiliary personnel is defined 
at Sec.  410.26(a)(1) as any individual who is acting under the 
supervision of a physician (or other practitioner), regardless of 
whether the individual is an employee, leased employee, or independent 
contractor of the physician (or other practitioner) or of the same 
entity that employs or contracts with the physician (or other 
practitioner), has not been excluded from the Medicare, Medicaid, and 
all other Federally funded health care programs by the Office of 
Inspector General or had his or her Medicare enrollment revoked, and 
meets any applicable requirements to provide incident to services, 
including licensure, imposed by the State in

[[Page 79004]]

which the services are being furnished. We do not include definitions 
of any specific types of personnel who could be included under the 
definition of auxiliary personnel in our regulations and did not 
propose to do so in the proposed rule. We anticipate conducting this 
outreach and education through existing communications mechanisms as 
required by the CAA, 2023.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Many commenters supported the proposals to implement 
section 4123 of the CAA, 2023. Some commenters noted that individuals 
who are in crisis should be able to access services wherever they are 
in need and commended CMS for enabling this flexibility through 
proposals included in the proposed rule. Other commenters stated that 
in light of the implementation of the 988-crisis system, it is 
particularly important to increase access to behavioral health services 
that can respond to a crisis in homes and communities and avoid law 
enforcement involvement.
    Response: We thank the commenters for their support of our 
proposals to implement section 4124 of the CAA, 2023.
    Comment: We received several comments on the proposal related to 
peer support specialists. Many commenters stated that psychotherapy is 
not within the scope of practice for peer support specialists. They 
stated that peer support specialists do provide engagement services, 
including education, support, and sharing lived experience to 
facilitate an individual participating in crisis psychotherapy 
effectively. The commenters described that peer support specialists are 
analogous to emergency medical technicians (EMTs) who are not medical 
clinicians but are specially trained to respond in emergency 
situations. Other commenters encouraged CMS to provide guidance and 
support that meaningfully encourages incorporation of peer support 
services, such as by training clinic staff on the value and role of 
peer services and ensuring that peer services are utilized in alignment 
with state scopes of practice for peers. One commenter requested that 
CMS update the regulatory definition of auxiliary personnel to 
specifically state that this includes, but is not limited to, peer 
support specialists and suggested using language from SAMHSA's national 
model standards.
    Response: We thank the commenters for highlighting that furnishing 
psychotherapy is not within the scope of practice for peer support 
specialists. We did not make any proposals specific to peer support 
specialists as it pertains to section 4123 of the CAA, 2023. The CAA 
requires CMS to provide education and outreach to peer support 
specialists, to the extent that they can serve as auxiliary personnel, 
regarding psychotherapy for crisis services. Additionally, we wish to 
clarify that peer support specialists participating in the furnishing 
of any service as auxiliary personnel, including psychotherapy for 
crisis, must operate within their scope of the role of peer support 
specialists and meet any applicable requirements to provide incident to 
services, including licensure, imposed by the State in which the 
services are being furnished. We also note that we did not propose to 
specify any particular types of personnel in our regulatory definition 
of auxiliary personnel; the definition at Sec.  410.26 currently 
references ``any individual,'' and we do not believe greater 
specificity is warranted at this time.
    Comment: A few commenters urged CMS to consider paying for the 
existing code billed under Medicaid in many states, HCPCS code H2011 
(crisis intervention service per 15 minutes), and to do so at rates 
that cover the cost of care, noting that there are limitations to the 
psychotherapy for crisis codes in that they require the services be 
provided by a licensed practitioner that can bill Medicare 
independently. Some of the commenters stated that much of this type of 
crisis work is done by a multidisciplinary team that does not always 
include someone who can independently bill under the Medicare program. 
They stated that the existing coding described by CPT codes 90839 and 
90840, and the newly proposed codes which are based on the existing CPT 
codes, have the potential to create a barrier to care since they do not 
describe or include the resource costs of team-based care. Other 
commenters noted that SAMHSA's National Guidelines for Behavioral 
Health Crisis include mobile crisis teams as an essential component of 
a crisis system and specify that, to fully align with best practice 
guidelines, teams must ``incorporate peers within the mobile crisis 
team'' and requested that CMS create a pathway for peer support 
specialists to be reimbursed when they work with clinicians on mobile 
crisis teams. Other commenters recommended CMS create a code for 
``Crisis Psychotherapy with engagement services'' and increase the 
payment by 40 percent with a modifier to indicate when the service is 
furnished by a two-person mobile crisis team. Other commenters 
requested adjustments for services furnished in rural areas, as well as 
additional payment for mileage, and some suggested that utilizing a 
Prospective Payment System (PPS) may be a more appropriate model for 
furnishing mobile crisis services. A few commenters requested that CMS 
consider whether it would be more appropriate to utilize a methodology 
similar to what it uses for establishing EMS/ambulance base rates and 
some commenters recommended that CMS consider expanding data collection 
and the testing of new payment and service delivery models for EMS 
providers to supplement mobile crisis response teams. Other commenters 
recommended that CMS create an add-on code for Mobile Crisis Services 
to bill up to two additional 30-minute blocks after the first 60 
minutes of mobile crisis care, similar to the way HCPCS code 90839 
(Psychotherapy for crisis, first hour) can be billed as the primary 
code with HCPCS code 90840 (Psychotherapy for crisis, each additional 
30 mins). Some commenters noted that after 2 hours of Mobile Crisis 
Services, the patient should be transferred to the appropriate level of 
care.
    Response: We note that the proposals for CY 2024 were specific to 
implementing section 4123 of the CAA, which focuses on payment for 
psychotherapy for crisis services furnished in an applicable site of 
service and specified that the payment amount for these psychotherapy 
for crisis services shall be equal to 150 percent of the fee schedule 
amount for non-facility sites of service for each year for the services 
identified (as of January 1, 2022) by HCPCS codes 90839 (Psychotherapy 
for crisis; first 60 minutes) and 90840 (Psychotherapy for crisis; each 
additional 30 minutes (List separately in addition to code for primary 
service)), and any succeeding codes. However, regarding requests that 
CMS consider paying for other types of crisis care that is more 
comprehensive or team-based, we agree with commenters regarding the 
importance of beneficiary access to crisis services and we may consider 
this feedback for future rulemaking. Regarding the comment about an 
add-on code, we note that the proposed G codes are based on CPT codes 
90839 (Psychotherapy for crisis, first hour) and 90840 (Psychotherapy 
for crisis, each additional 30 mins), and therefore, HCPCS codes GPFC1 
and GPFC2 do allow for billing an add-on code for each

[[Page 79005]]

additional 30 minutes beyond the first hour.
    Comment: A few commenters requested that CMS clarify that 
``applicable sites of service'' includes services administered outside 
of a clinical setting by a mobile crisis response team, and in a crisis 
stabilization unit.
    Response: In the CY 2024 PFS proposed rule (88 FR 52364), we 
proposed that the two new G-codes describing psychotherapy for crisis 
services can be billed when the services are furnished in any non-
facility place of service other than the physician's office setting. We 
noted that the full list of places of service that are assigned a non-
facility rate can be found on the CMS website at https://www.cms.gov/Medicare/Coding/place-of-service-codes.
    Comment: One commenter requested that we clarify whether a co-pay 
would be applicable for these the newly proposed codes and noted that 
collecting a co-pay in this context would be difficult unless crisis 
psychotherapy is provided to a beneficiary with an existing 
professional relationship with the provider(s) furnishing the service.
    Response: We note that the Part B coinsurance would apply for the 
new psychotherapy for crisis services, as mandated for Part B services 
by section 1833(a)(1) of the Act.
    After consideration of public comments, we are finalizing our 
proposals to implement section 4123 of the CAA, 2023, as proposed. 
Specifically, we are finalizing two new G-codes to describe 
psychotherapy for crisis furnished in an applicable site of service 
(any place of service at which the non-facility rate for psychotherapy 
for crisis services applies, other than the office setting) and 
establishing a fee schedule amount for these two new G-codes that is 
150 percent of the current PFS non-facility RVUs for CPT codes 90839 
(Psychotherapy for crisis; first 60 minutes) and 90840 (Psychotherapy 
for crisis; each additional 30 minutes (List separately in addition to 
code for primary service)), respectively. As required by section 
1848(b)(12)(C) of the Act, we proposed, and are finalizing, to 
establish a fee schedule amount for these two new G-codes that is 150 
percent of the current PFS non-facility RVUs for CPT codes 90839 
(Psychotherapy for crisis; first 60 minutes) and 90840 (Psychotherapy 
for crisis; each additional 30 minutes (List separately in addition to 
code for primary service)), respectively.
    We note that the codes GPFC1 and GPFC2 were placeholder codes and 
that the final code numbers will be G0017 and G0018. The new G-codes 
and their descriptors are:
     G0017 (Psychotherapy for crisis furnished in an applicable 
site of service (any place of service at which the non-facility rate 
for psychotherapy for crisis services applies, other than the office 
setting); first 60 minutes); and
     G0018 (Psychotherapy for crisis furnished in an applicable 
site of service (any place of service at which the non-facility rate 
for psychotherapy for crisis services applies, other than the office 
setting); each additional 30 minutes (List separately in addition to 
code for primary service)).
3. Implementation of Section 4124 of the Consolidated Appropriations 
Act, 2023 (CAA, 2023)
    Section 4124 of the CAA, 2023, Ensuring Adequate Coverage of 
Outpatient Mental Health Services under the Medicare Program, 
establishes Medicare coverage and payment for intensive outpatient 
services for individuals with mental health needs when furnished by 
hospital outpatient departments, community mental health centers, RHCs, 
and FQHCs, effective January 1, 2024. Please see the discussion of our 
implementation of section 4124 in the CY 2024 Outpatient Prospective 
Payment System (OPPS) final rule, section VIII. Payment for Partial 
Hospitalization and Intensive Outpatient Services.
4. Health Behavior Assessment and Intervention (HBAI) Services
    The current Health and Behavior Assessment and Intervention codes 
(CPT codes 96156, 96158, 96159, 96164, 96165, 96167, 96168, 96170, and 
96171) were created by the CPT Editorial Panel during its September 
2018 meeting. The CPT Editorial Panel deleted the six previous HBAI CPT 
codes and replaced them with nine new CPT codes. As discussed in the CY 
2023 PFS final rule (87 FR 69541), the HBAI range of CPT codes are 
intended to be used for psychological assessment and treatment, when 
the primary diagnosis is a medical condition. A health behavior 
assessment under these HBAI services is conducted through health-
focused clinical interviews, behavioral observation and clinical 
decision-making and includes evaluation of the person's responses to 
disease, illness or injury, outlook, coping strategies, motivation, and 
adherence to medical treatment. HBAI services are provided 
individually, to a group (two or more patients), and/or to the family, 
with or without the patient present, and include promotion of 
functional improvement, minimization of psychological and/or 
psychosocial barriers to recovery, and management of and improved 
coping with medical conditions. The HBAI codes apply to services that 
address psychological, behavioral, emotional, cognitive, and 
interpersonal factors in the treatment/management of people diagnosed 
with physical health issues. According to the CPT prefatory language in 
the CPT 2023 Professional Edition, the patient's primary diagnosis is 
physical in nature and the focus of the assessment and intervention is 
on factors complicating medical conditions and treatments. The HBAI 
codes capture services related to physical health, such as adherence to 
medical treatment, symptom management, health-promoting behaviors, 
health related risky behaviors, and adjustment to physical illness.
    In light of the new benefit categories authorized by section 
4121(a)(2) of the CAA, 2023, which authorize MFTs and MHCs to furnish 
services for the diagnosis and treatment of mental illness, this 
prompted us to consider whether MFTs and MHCs could furnish and bill 
for HBAI services. Additionally, we re-examined whether CSWs could 
furnish and bill these HBAI codes given that their statutory benefit 
category also authorizes them to furnish services for the diagnosis and 
treatment of mental illnesses. We noted that prior to the passage of 
the CAA, 2023, which authorized benefit categories for MFTs and MHCs, 
there was previously a National Coverage Determination (NCD) that 
stated, the CPT codes 96156, 96158, 96159, 96164, 96165, 96167 and 
96168 may be used only by a Clinical Psychologist (CP), (Specialty Code 
68). However, we noted that this NCD was retired on December 8, 
2022.\44\
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    \44\ https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=57754&ver=12&=.
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    Like CPs, who can currently bill Medicare for HBAI services, CSWs, 
MFTs, and MHCs have the education and training to address psychosocial 
barriers to meet the needs of patients with physical health conditions. 
In accordance with State law and scope of practice, CSWs, MFTs, and 
MHCs can assess, diagnose, and treat psychological and/or psychosocial 
behaviors associated with physical health conditions. Interested 
parties have informed us that like CSWs, MHCs and MFTs can play a key 
role in a multidisciplinary team approach that leads to successful 
outcomes in patient care, including offering integrated care within 
hospitals and medical practices where patients are diagnosed with

[[Page 79006]]

physical health conditions. For example, mental health professionals 
such as MHCs and MFTs facilitate ``behavioral management and 
reinforcement, guided problem-solving, supporting patients in setting 
realistic and attainable goals, and teaching relaxation strategies for 
managing diabetes-related stressors.'' \45\ In this role, mental health 
professionals such as CSWs, MHCs, and MFTs help patients manage mental 
health symptoms associated with a physical health condition. Moreover, 
according to the National Cancer Institute at the National Institutes 
of Health, mental health professionals can also provide emotional and 
social support to assist cancer patients in reducing ``levels of 
depression, anxiety, and disease and treatment-related symptoms among 
patients.'' \46\ Therefore, we proposed to allow the HBAI services 
described by CPT codes 96156, 96158, 96159, 96164, 96165, 96167, and 
96168, and any successor codes, to be billed by CSWs, MFTs, and MHCs, 
in addition to CPs. We noted that in order for payment to be made under 
Medicare for HBAI services furnished to a beneficiary, the HBAI 
services must be reasonable and necessary for the diagnosis or 
treatment of illness or injury or to improve the functioning of a 
malformed body member, in accordance with section 1862(a)(1)(A) of the 
Act.
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    \45\ Powell PW, Hilliard ME, Anderson BJ (2014). Motivational 
interviewing to promote adherence behaviors in pediatric type 1 
diabetes. Curr Diab Rep. 2014;14(10):531. 10.1007/sll892-014-0531-z.
    \46\ National Cancer Institute at the National Institutes of 
Health, (nd). ``Stress and Cancer'' https://www.cancer.gov/about-cancer/coping/feelings/stress-fact-sheet.
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    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: All commenters supported our proposal to allow HBAI 
services and any successor codes, to be billed by CSWs, MFTs, and MHCs, 
in addition to CPs. One commenter requested that we allow HBAI services 
to be billed by occupational therapists during the mental health 
workforce shortage.
    Response: We appreciate the support expressed in the comments. HBAI 
services have historically not been designated as therapy services, 
therefore occupational therapists cannot furnish these services. As 
such, we are not recognizing these codes as therapy services at this 
time.
    After consideration of public comments, we are finalizing our 
proposal to allow the HBAI services described by CPT codes 96156, 
96158, 96159, 96164, 96165, 96167, and 96168, and any successor codes, 
to be billed by CSWs, MFTs, and MHCs, in addition to CPs.
5. Adjustments to Payment for Timed Behavioral Health Services
    There is an ongoing behavioral health crisis in the United States, 
which has been exacerbated by the COVID-19 pandemic, the overdose 
crisis,\47\ and worsening behavioral healthcare workforce 
shortages.\48\ Public comments received in response to the CY 2023 PFS 
proposed rule described practices that furnish treatment for behavioral 
health conditions experiencing difficulty recruiting and retaining 
behavioral health clinicians and expressed concern that people are 
experiencing unprecedented delays in receiving medically necessary 
services across care settings. Commenters described workforce shortages 
nationwide that, combined with increasing demand for behavioral health 
care services, have limited Medicare beneficiary access to these vital 
services. Prior to the pandemic, the Health Resources and Services 
Administration (HRSA) projected shortages of seven selected types of 
behavioral health providers by 2025.\49\ As of March 31, 2023, HRSA 
designated more than 6,635 health professional shortage areas for 
mental health, with more than one-third of Americans living in these 
shortage designations.\50\ Additionally, according to SAMHSA's guide on 
Addressing Burnout in the Behavioral Health Workforce Through 
Organizational Strategies, staffing shortages, and high turnover rates 
place enormous demands on the workforce, jeopardizing the provision of 
care, especially to underserved individuals.\51\ The behavioral health 
workforce experiences high levels of work-related stress, relatively 
low salaries, and full caseloads; these combined factors place 
individuals working in the behavioral health field at high risk for 
experiencing burnout.\52\ Over 50 percent of behavioral health 
providers report experiencing burnout symptoms. The rate of burnout 
will likely increase, given the continued growth in the number of 
people seeking behavioral health care, behavioral health staffing, and 
retention challenges.\53\
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    \47\ https://www.kff.org/coronavirus-covid-19/issue-brief/the-implications-of-covid-19-for-mental-health-and-substance-use/.
    \48\ https://bhw.hrsa.gov/sites/default/files/bureau-health-workforce/data-research/behavioral-health-2013-2025.pdf.
    \49\ https://bhw.hrsa.gov/sites/default/files/bureau-health-workforce/data-research/behavioral-health-2013-2025.pdf.
    \50\ Health Resources and Services Administration, Health 
Workforce Shortage Areas, https://data.hrsa.gov/topics/health-workforce/shortage-areas.
    \51\ https://bhw.hrsa.gov/sites/default/files/bureau-health-workforce/data-research/bh-workforce-projections-fact-sheet.pdf.
    \52\ Kelly, R.J., Hearld, L.R. Burnout and Leadership Style in 
Behavioral Health Care: a Literature Review. J Behav Health Serv Res 
47, 581-600 (2020). https://doi.org/10.1007/s11414-019-09679-z.
    \53\ https://store.samhsa.gov/sites/default/files/SAMHSA_Digital_Download/pep22-06-02-005.pdf.
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    In CY 2023 PFS rulemaking, we sought comment on how we can best 
help ensure beneficiary access to behavioral health services, including 
any potential adjustments to the PFS ratesetting methodology, for 
example, any adjustments to systematically address the impact on 
behavioral health services paid under the PFS. We described that as 
part of our review of our payment policies and systems, we understand 
that the PFS ratesetting methodology and application of budget 
neutrality may impact certain services more significantly than others 
based on factors such as how frequently codes are revalued and the 
ratio of physician work to PE. In the CY 2018 PFS final rule (82 FR 
52999), we discussed feedback we received from some interested parties 
suggesting that, for codes with very low direct PE inputs, our 
methodology for allocating indirect PE does not produce a differential 
between facility and nonfacility PE RVUs that accurately reflects the 
relative indirect costs involved in furnishing services in non-facility 
settings. We stated that primary therapy and counseling services 
available to Medicare beneficiaries for the treatment of behavioral 
health conditions, including substance use disorders, are among the 
services most affected by our methodology. For example, we stated at 
the time that, for the most commonly reported psychotherapy service 
(CPT code 90834), the difference between the nonfacility and facility 
PE RVUs was only 0.02 RVUs, which seemed unlikely to represent the 
difference in relative PE resource costs in terms of administrative 
labor, office expense, and all other expenses incurred by the billing 
practitioner for 45 minutes of psychotherapy services when furnished in 
the office setting versus the facility setting. We agreed with these 
interested parties that the site of service differential for these 
services produced by our PE methodology seems unlikely to reflect the 
relative resource costs for the practitioners furnishing these services 
in nonfacility settings. For example, we believe the 0.02 RVUs, which 
translated at the time to approximately $0.72, was unlikely to

[[Page 79007]]

reflect the relative administrative labor, office rent, and other 
overhead involved in furnishing the 45-minute psychotherapy service in 
a nonfacility setting. Consequently, we modified our PE methodology to 
establish a minimum nonfacility PE RVU for certain outlier codes with 
very low direct PE inputs as compared to work RVUs, most of which are 
primarily furnished by behavioral health professionals. We finalized a 
policy to implement only one quarter of the minimum value for 
nonfacility indirect PE for the identified outlier codes over a 4-year 
transition period, beginning with CY 2018. We stated that we recognized 
that this change in the PE methodology could significantly impact the 
allocation of indirect PE RVUs across all PFS services (82 FR 53000).
    In light of increasing patient needs for behavioral health services 
and continued workforce shortages, we have been examining a number of 
dynamics in our processes for developing values for behavioral health 
services under the PFS. We continue to consider approaches to ensuring 
that the relative values we establish for these services accurately 
reflect the resources involved in furnishing them, especially since any 
potential systemic undervaluation could serve as an economic deterrent 
to furnishing these kinds of services and be a contributing factor to 
the workforce shortage.
    Interested parties have long raised concerns regarding the 
valuation of services that primarily involve person-to-person 
interactions with beneficiaries, particularly those services that are 
comprised of conversational interactions rather than physical 
interactions, because these services require minimal equipment and 
supplies compared to other services, and therefore, valuation is based 
almost entirely on the practitioner's work. Because the physician/
practitioner work RVU is developed based on the time and intensity of 
the service, the issues regarding the valuation of these types of 
services are particularly pronounced for services that are billed in 
time units (like psychotherapy codes) that directly reflect the 
practitioner time inputs used in developing work RVUs, compared to 
other services that are not billed in time units in which work RVUs are 
based on estimates of typical time, usually based on survey data. For 
example, a 2016 report by the Urban Institute entitled Collecting 
Empirical Physician Time Data \54\ (the Urban Institute report) 
reviewed empirical time estimates for 60 services paid under the PFS 
with relative values developed based on time estimates derived from 
survey data (as opposed to actual reported time). The Urban Institute 
report suggested that there may be systemic overestimations of times 
for these services within the PFS, which would lead to overvaluation of 
these services and, by implication, undervaluation of other services.
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    \54\ https://www.urban.org/sites/default/files/publication/87771/2001123-collecting-empirical-physician-time-data-piloting-approach-for-validating-work-relative-value-units_0.pdf.
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    The dynamic described by the Urban Institute report can lead to 
systemic undervaluation for some kinds of time-based codes for several, 
interrelated reasons. First, overestimates of time for some kinds of 
codes compared to other kinds of codes results in ``implied intensity'' 
(that is the ratio of work RVU/per minute, sometimes referred to by the 
AMA RUC as intra-service work per unit of time, or IWPUT) that is 
artificially low. This is important since we understand that the 
implied intensity is used as part of the AMA RUC review of survey data 
to contextualize the credibility of data and the resulting recommended 
work RVUs compared to codes with similar times. CMS' review of the RUC 
recommendations similarly utilizes implied intensity as important 
contextual information in order to assess the relative values assigned 
to particular services.
    The second reason this dynamic could result in potential 
undervaluation of certain services is that time-based codes that 
describe one-on-one time with the patient are highly unlikely to become 
more efficient over multiple years. In contrast, surgical procedures 
tend to become more efficient over the years as they become more 
common, professionals gain more experience with them, improved 
technology is deployed, and other general operational improvements are 
implemented. Meanwhile, 45 minutes of psychotherapy remains static in 
terms of efficiency since, by definition, it requires 45 minutes of 
time, personally spent by the billing professional, one-on-one with the 
patient. Moreover, even if there were efficiencies that reduced the 
time required to furnish therapy services, the services would then be 
reported with time-based codes with lower total values. Additionally, 
in contrast to services such as procedures that utilize clinical staff, 
no part of the one-on-one therapy service can be performed by clinical 
staff working with the billing professional. This means that any 
overestimations in the initial estimates of time used to established 
work times and values, as discussed previously, are likely compounded 
over time as there are gains in efficiencies for some services in terms 
of time, clinical staff delegation, and improved technology, but no 
such gains for other services.
    For many professionals who provide a heterogenous range of services 
paid under the PFS, this phenomenon may not have a significant overall 
impact on their Medicare PFS payments. However, this phenomenon would 
have an outsized impact on Medicare PFS payments for professionals who 
predominantly furnish services involving person-to-person interactions 
with patients that are reported and valued in time-based units. It 
would not be logical to assume that the marketplace ignores this 
dynamic, since the opportunity for increased revenue generation through 
efficiency for timed, one-on-one services is limited as compared to 
services for which there are multiple avenues to gain efficiencies.
    We also recognized that, while this underlying valuation dynamic 
may create distortion of increasing magnitude over time, the quickly 
changing needs of Medicare beneficiaries relative to behavioral health 
also likely contribute to systemic distortion. This is especially the 
case as beneficiaries rely on behavioral health professionals for 
ongoing care of chronic and acute mental health needs. In other words, 
at the same time that the intensity of the work involved in furnishing 
services to Medicare beneficiaries increases, the work RVUs assigned to 
these services may be initially undervalued relative to other services 
that are valued based on potentially inflated time data, and therefore, 
may not accurately reflect the current relative resource costs 
associated with these services.
    One approach to curb the impact of this dynamic would be to conduct 
more frequent revaluations of these kinds of services, including timed 
psychotherapy services. However, our current valuation process relies 
primarily, as noted, on times reported through survey data of 
professionals who furnish these services and assessment by the RUC of 
those survey data. We believe that survey results from the 
professionals that currently provide behavioral health services, 
including physicians, psychologists, and social workers could reflect 
the increased intensity of the work due to changes in the complexity of 
care for beneficiaries, but would be unlikely to address any relative 
undervaluation of work estimates. We are interested in working with the 
broader community, including the AMA RUC, to address these specific 
concerns over the long term.

[[Page 79008]]

    However, given the emerging need for access to behavioral health 
care and the continuing difficulties in behavioral health workforce 
capacity, we believe it would be appropriate to take immediate steps to 
improve the accuracy of the valuation of these services until we can 
develop systemic solutions to longstanding process limitations. 
Consequently, we proposed to address the immediate need for improvement 
in valuation for timed psychotherapy services in such a way that 
considers the policy we initially finalized in the CY 2020 PFS final 
rule (84 FR 62856) in order to address valuation distortions for 
primary and longitudinal care through implementation of an add-on code 
for office/outpatient E/M services that involve inherent complexity, 
and which we proposed to reestablish in this rule. Our implementation 
of that policy is discussed in section II.F. of this final rule. Like 
E/M visits that are furnished for primary and longitudinal care, we 
believe that the psychotherapy codes similarly describe treatment that 
is ongoing or longitudinal, and therefore, we believe it is appropriate 
to address the need for improvement in valuation for timed 
psychotherapy services based on the valuation for the inherent 
complexity add-on code for office/outpatient E/M services.
    We proposed to apply an adjustment to the work RVUs for the 
psychotherapy codes payable under the PFS. We proposed to base this 
adjustment on the difference in total work RVUs for office/outpatient 
E/M visit codes (CPT codes 99202 through 99205 and 99211 through 99215) 
billed with the proposed inherent complexity add-on code (HCPCS code 
G2211) compared to the total work RVUs for visits that are not billed 
with the inherent complexity add-on code. This resulted in an 
approximate upward adjustment of 19.1 percent for work RVUs for these 
services, comparable to the relative difference in office/outpatient 
visits that are also systemically undervalued absent such an 
adjustment, which we proposed to implement over a 4-year transition. In 
making significant adjustments to RVUs in past rulemaking, we have 
implemented such changes using a 4-year transition, noting that a 
transition period allows for a more gradual adjustment for affected 
practitioners. We proposed to apply this adjustment to the following 
time-based psychotherapy codes that describe one-on-one time with the 
patient that are significantly unlikely to become more efficient over 
multiple years: CPT code 90832 (Psychotherapy, 30 minutes with 
patient); CPT code 90834 (Psychotherapy, 45 minutes with patient); CPT 
code 90837 (Psychotherapy, 60 minutes with patient); 90839 
(Psychotherapy for crisis; first 60 minutes); CPT code 90840 
(Psychotherapy for crisis; each additional 30 minutes (List separately 
in addition to code for primary service); CPT code 90845 
(Psychoanalysis); 90846 (Family psychotherapy (without the patient 
present), 50 minutes); CPT code 90847 (Family psychotherapy (conjoint 
psychotherapy) (with patient present), 50 minutes); CPT code 90849 
(Multiple-family group psychotherapy); CPT code 90853 (Group 
psychotherapy (other than of a multiple-family group) and newly 
proposed HCPCS codes GPFC1 and GPFC2 ((Psychotherapy for crisis 
furnished in an applicable site of service (any place of service at 
which the non-facility rate for psychotherapy for crisis services 
applies, other than the office setting). We did not propose to include 
CPT codes 90833, 90836, and 90838 in this list of codes for which we 
would make the adjustment because these are add-on codes for 
psychotherapy that is performed with an E/M visit and under our 
proposal described at section II.F. of this final rule, E/M codes will 
be eligible to be billed with HCPCS code G2211. Therefore, the 
psychotherapy codes that are performed with an E/M visit will already 
be eligible for an adjustment to account for the resources costs 
involved in furnishing longitudinal care. We stated we believe that 
implementing an adjustment to the work RVUs for psychotherapy services 
concurrent with implementation of HCPCS code G2211 will help address 
distortions that may occur within our valuation process that may 
otherwise result in understated estimates of the relative resources 
involved in furnishing psychotherapy services. We recognized that many 
other services share some similarities with these psychotherapy 
services. For example, there are other services that are reported in 
time units. Likewise, there are other codes that primarily describe 
conversational interactions between medical professionals and 
beneficiaries. However, we believe that these services are unique 
because neither technology nor clinical staff can be utilized to 
increase efficiency, and because these services represent the 
significant majority of services furnished by certain types of 
professionals. We stated that if finalized, the implementation of this 
proposal for CY 2024, concurrent with the proposal to implement the 
inherent complexity add-on code, if finalized, would also mitigate any 
negative impact in valuation for psychotherapy services based on 
redistributive impacts if we were to finalize only the inherent 
complexity add-on code for E/M visits without proposing and finalizing 
any adjustments for psychotherapy. We welcomed comments on this 
proposal, including and especially how the PFS valuation processes for 
these services and other services with similar characteristics can be 
improved in the future in order to mitigate the kinds of distortions 
previously described.
    Additionally, as noted above in this section, in the CY 2018 PFS 
final rule (82 FR 52999), we identified a set of outlier codes for 
which we believed it would be appropriate to establish a minimum 
nonfacility indirect PE RVU that would be a better reflection of the 
resources involved in furnishing these services. For each of the 
outlier codes, we compared the ratio between indirect PE RVUs and work 
RVUs that result from the application of the standard methodology to 
the ratio for a marker code, which was CPT code 99213. The finalized 
change in the methodology then increased the allocation of indirect PE 
RVUs to the outlier codes to at least one quarter of the difference 
between the two ratios. We stated we believed this approach reflected a 
reasonable minimum allocation of indirect PE RVUs, but that we did not 
have empirical data that would be useful in establishing a more precise 
number. We finalized implementation of one quarter of the minimum value 
for nonfacility indirect PE for the identified outlier codes. We stated 
that we recognized that this change in the PE methodology could have a 
significant impact on the allocation of indirect PE RVUs across all PFS 
services and finalized that we would implement this change over a 4-
year transition, beginning in CY 2018 and ending in CY 2021. We 
welcomed comments on whether we should consider further adjustments to 
the nonfacility indirect PE for the identified outlier codes. 
Specifically, we requested comment on whether this minimum value 
adjustment to the indirect PE for certain services sufficiently 
accounted for the resources involved in furnishing these services, or 
whether we should consider further adjustments, such as applying 50 
percent of the calculated minimum value for nonfacility indirect PE 
values for these services, and whether we should consider implementing 
further changes using a similar 4-year transition.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.

[[Page 79009]]

    Comment: Many commenters supported the proposed increase, and 
expressed appreciation that CMS recognized the limitations associated 
with the valuation of time-based services that must be performed 
directly by the clinician that offers no opportunity to become more 
efficient over time. Some commenters stated that the proposed changes 
will help close the access gap to behavioral health services by 
expanding the behavioral health workforce and paying more accurately 
for behavioral health services.
    Response: We thank the commenters for their support of this 
proposal.
    Comment: Many commenters requested that CMS also increase the 
values for other similar services. Some commenters stated they believe 
that the increase should also be applied to the psychotherapy codes 
that are billed as an add-on to an E/M visit (CPT codes 90833, 90836, 
and 90838), noting that not doing so would further exacerbate the lack 
of pay-parity and result in rank order anomalies. The commenters also 
stated that if finalized, this policy would have the unintended 
consequence of devaluing the work of psychiatrists when compared to 
psychologists, social workers, and other mental health professionals, 
thereby further discouraging psychiatrist participation in Medicare, 
while also reducing access for patients to what has been shown to be 
one of the most effective treatments, combined psychotherapy and 
medication management. These commenters also referenced our statement 
in the CY 2012 PFS rule final rule that, ``. . .we believe that the 
work involved in furnishing the psychotherapy add-on CPT codes is very 
similar to the work of furnishing the stand-alone psychotherapy CPT 
codes'' and that the work itself is the same regardless of the 
professional degree held by the clinician, with the same constraints 
due to the time-based nature of the codes and the fact that the 
clinician, and not their clinical staff, must provide the care. Many 
commenters requested that the increase also be applied to the HBAI 
services, as well as the psychological and neuropsychological testing 
services.
    Response: We thank the commenters for this feedback. After 
consideration of the comments received, we are finalizing the 19.1 
percent increase to the work RVUs for the standalone psychotherapy 
codes, transitioned over the course of 4 years, as proposed. 
Additionally, we are finalizing to apply the same increase to the work 
RVUs for the psychotherapy codes that are billed as an add-on to an E/M 
visit (CPT codes 90833, 90836, and 90838), as we agree with the 
commenters and our statement in past rulemaking that the work involved 
in furnishing the psychotherapy add-on CPT codes is very similar to the 
work of furnishing the stand-alone psychotherapy CPT codes, and 
therefore, agree that it is appropriate to apply the increase to the 
psychotherapy codes billed as an add-on to E/M visit in addition to the 
standalone psychotherapy codes. We do not wish to discourage 
psychiatrist participation in Medicare and believe that applying this 
increase to the work RVUs for all of the psychotherapy codes, whether 
billed with an E/M visit or as a standalone service, will avoid the 
relativity issues the commenters raised. In addition to finalizing the 
increase to the work RVUs for the standalone psychotherapy codes and 
the psychotherapy codes that are billed as an add-on to an E/M visit, 
we are also finalizing the proposed increase to the work RVUs of the 
codes describing HBAI services (CPT codes 96156, 96158, 96159, 96164, 
96165, 96167, and 96168), as we believe that these codes are similar to 
the psychotherapy services in that these codes are also timed services 
and are generally provided person-to-person without support from 
clinical staff. Regarding the request to apply the proposed increase to 
the work RVUs of the codes describing psychological and 
neuropsychological testing services, we believe psychological and 
neuropsychological testing services are distinct from psychotherapy and 
HBAI services with regard to the nature of the work in that they are 
not necessarily timed services that are provided without assistance 
from clinical staff, and therefore, do not fit the same criteria as the 
services addressed in the proposed rule. We welcome additional feedback 
on the valuation of the psychological and neuropsychological testing 
services, and we may consider updates to the valuation of these 
services in future rulemaking.
    Comment: The RUC acknowledged the emerging need for access to 
behavioral health care and the continuing difficulties in behavioral 
health workforce capacity, but stated they did not believe that a 
systematic percentage increase to the psychotherapy services would 
appropriately address this issue and would negatively exacerbate the 
relativity to other services paid under the PFS. They stated that 
distortions and rank order anomalies would result if finalized as 
proposed. For example, they noted that if these increases are 
implemented for CPT code 90837 (Psychotherapy, 60 minutes with 
patient), the fully transitioned work RVU in 2028 will be higher than 
the work RVU for CPT code 90838 (Psychotherapy, 60 minutes with patient 
when performed with an evaluation and management service), when 
reported with a CPT code 99213 office visit.
    Response: We welcome RUC review and recommendations on the 
valuation for these services, however, we reiterate our concerns 
described in the proposed rule that survey results from the 
professionals that currently provide behavioral health services, 
including physicians, psychologists, and social workers, could reflect 
the increased intensity of the work due to changes in the complexity of 
care for beneficiaries, but would be unlikely to address any relative 
undervaluation of work estimates due to the longstanding systematic 
undervaluation of this type of work. Additionally, as noted above, we 
are finalizing to apply the 19.1 percent increase to the work RVUs for 
the psychotherapy codes that are billed as an add-on to an E/M visit 
(CPT codes 90833, 90836, and 90838), transitioned over the course of 4 
years, in order to avoid any rank order anomalies within the 
psychotherapy code family.
    Comment: A few commenters suggested that as an alternative to the 
proposed increase, CMS create a separate G-code for psychiatry services 
with an RVU equivalent to the RVU for HCPCS code G2211 that could be 
used by qualified mental health professionals (that is, psychologists 
and social workers) as an add-on to stand-alone psychotherapy, similar 
to the way the CPT code 90785 (Interactive Complexity) is used.
    Response: While an add-on G-code could serve to address the issues 
we cited in the proposed rule, we believe that building the proposed 
increase into the valuation of these services would more directly 
address the systematic undervaluation of these services. Unlike HCPCS 
code G2211 and CPT code 90785, which are meant to be billed only in 
certain specified circumstances, we believe that the issues we describe 
in the proposed rule apply the psychotherapy services uniformly.
    Comment: A few commenters expressed concern that the proposed 
increase is insufficient, especially recognizing that many of the 
practitioners who bill these codes, including Clinical Social Workers, 
and as of January 1, 2024, Marriage and Family Therapists and Mental 
Health Counselors, are only reimbursed at 75 percent of the PFS rate. 
The commenters recommended that CMS consider

[[Page 79010]]

further adjustments to the ratesetting methodology, pending legislative 
change. The commenters noted that a more substantial increase would 
further the goal of bringing more mental health and SUD practitioners 
into the Medicare program. One commenter recommended that CMS consider 
ways to either mitigate the impact of behavioral health payment 
increases on other services by spreading budget neutrality adjustment 
over longer time horizons, or suggested that Congress should 
appropriate additional, permanent funding for behavioral health 
services within the PFS.
    Response: We will continue to evaluate how we can ensure that these 
services are valued accurately, but we believe that the final increase 
of 19.1 percent to the work RVUs for psychotherapy services and 
psychotherapy codes that are billed as an add-on to an E/M visit (CPT 
codes 90833, 90836, and 90838) is sufficient. We based this adjustment 
on the valuation for the inherent complexity add-on code that will be 
used with office/outpatient E/M services to address valuation 
distortions for primary and longitudinal care, and since the 
psychotherapy codes similarly describe treatment that is ongoing or 
longitudinal, we believe that it is appropriate to address the need for 
improvement in valuation for timed psychotherapy services based on the 
valuation for the inherent complexity add-on code for office/outpatient 
E/M services.
    Regarding ways to mitigate the impact of these increases on other 
services, we note that we are implementing these changes over a 4-year 
transition, as we have done when making significant adjustments to RVUs 
in past rulemaking. We believe that this transition period will allow 
for a more gradual budget neutrality adjustment for affected 
practitioners. Regarding practitioners such as CSWs, MFTs, and MHCs 
being paid at 75 percent of the PFS rate for services of a clinical 
psychologist, we note that this is a requirement specified in section 
1833(a)(1)(FF) of the Act.
    Comment: Some commenters supported finalizing the proposal but 
recommended that CMS view the adjustment as a temporary stopgap and 
consider long-term solutions to code valuation moving forward. Another 
commenter urged CMS to implement RVU accuracy assessments annually, or 
at least more frequently.
    Response: We reiterate that we are interested in working with the 
broader community, including the AMA RUC, to address these specific 
concerns regarding valuation and RVU accuracy over the long term.
    Comment: One commenter stated that the market rate for out-of-
network mental health care far exceeds Medicare rates and suggested 
that CMS should conduct a review and issue a report comparing out-of-
network billing rates to Medicare rates and determine if the current 
code valuation process reflects the market. The commenter went on to 
suggest that accordingly, CMS should make changes to the RUC/RVU system 
so it more closely values behavioral healthcare at market rates. The 
commenter also noted that CMS should recognize that it has historically 
undervalued these rates for decades and it will take time and 
incentives to grow the workforce.
    Response: We thank the commenter for this feedback. We note that we 
are trying to address potential historical undervaluation of certain 
mental health services in this rule. We will continue to evaluate how 
we can make sure that these services are valued accurately and may 
consider these comments regarding market rates for future rulemaking.
    After consideration of the public comments, we are finalizing our 
proposal to apply an upward adjustment of 19.1 percent to the work RVUs 
for the standalone psychotherapy services, in addition to the 
psychotherapy codes that are billed as an add-on to an E/M visit (CPT 
codes 90833, 90836, and 90838) and the codes describing HBAI services 
(CPT codes 96156, 96158, 96159, 96164, 96165, 96167, and 96168), and we 
are finalizing our proposal to implement this adjustment over a 4-year 
transition.
6. Updates to the Payment Rate for the PFS Substance Use Disorder (SUD) 
Bundle (HCPCS Codes G2086-G2088)
    In the CY 2023 PFS final rule (87 FR 69772 through 69774), we 
finalized a modification to the payment rate for the non-drug component 
of the bundled payment for episodes of care under the Opioid Treatment 
Program (OTP) benefit to base the rate for individual therapy on a 
crosswalk to CPT code 90834 (Psychotherapy, 45 minutes with patient), 
which reflects a 45-minute psychotherapy session, instead of a 
crosswalk to CPT code 90832 (Psychotherapy, 30 minutes with patient), 
as was our current policy at the time. We received public comments 
urging us to consider adopting this modification for other bundled 
payments for SUD under the PFS, such as the bundled rate for office-
based SUD treatment, to reflect the complexity of treating these 
patients and ensure that there is consistent and sufficient access to 
counseling for SUD across settings of treatment. The commenters noted 
that some patients who are prescribed buprenorphine in non-OTP settings 
will have similarly complex care needs requiring more intensive 
therapeutic care, and that by recognizing the appropriate complexity 
and intensity of the services in setting the rates, CMS can incentivize 
more office-based practices to offer these services and build out the 
treatment teams that deliver this care.
    In the CY 2020 PFS final rule (84 FR 62673 through 62677), we 
finalized the establishment of bundled payments for the overall 
treatment of OUD, including management, care coordination, 
psychotherapy, and counseling activities. We stated that for the 
purposes of valuation of HCPCS codes G2086 (Office-based treatment for 
a substance use disorder, including development of the treatment plan, 
care coordination, individual therapy and group therapy and counseling; 
at least 70 minutes in the first calendar month) and G2087 (Office-
based treatment for a substance use disorder, including care 
coordination, individual therapy and group therapy and counseling; at 
least 60 minutes in a subsequent calendar month), we assumed two 
individual psychotherapy sessions per month and four group 
psychotherapy sessions per month, and noted that we understand that the 
number of therapy and counseling sessions furnished per month will vary 
among patients and also fluctuate over time based on the individual 
patient's needs. We were persuaded by the public comments received in 
response to the CY 2023 PFS proposed rule requesting that these codes 
be priced consistent with the crosswalk codes used to value the bundled 
payments made for OUD treatment services furnished at OTPs, as 
beneficiaries receiving buprenorphine in settings outside of OTPs may 
have similarly complex care needs as compared to beneficiaries 
receiving OUD treatment services at OTPs. In order to update the 
valuation for HCPCS codes G2086 and G2087, we proposed to increase the 
current payment rate to reflect two individual psychotherapy sessions 
per month, based on a crosswalk to the work RVUs assigned to CPT code 
90834 (Psychotherapy, 45 minutes with patient), rather than CPT code 
90832 (Psychotherapy, 30 minutes with patient). The current work RVU 
assigned to CPT code 90834 is 2.24, compared to the work RVU assigned 
to CPT code 90832, which is 1.70, which results in a difference of 0.54 
work RVUs. Because the bundled payments

[[Page 79011]]

described by HCPCS codes G2086 and G2087 include two individual 
psychotherapy sessions per month, we proposed to add 1.08 RVUs to the 
work value assigned to HCPCS codes G2086 and G2087, which results in a 
new work RVU of 8.14 for HCPCS code G2086 and 7.97 for HCPCS code 
G2087. We noted that as described above, we also proposed to update the 
work RVUs assigned to CPT code 90834. We noted in the proposed rule 
that if our proposal to update the work RVUs for the standalone 
psychotherapy codes were finalized, CPT code 90834 would be assigned a 
work RVU of 2.35. We stated that in that case, our update to HCPCS 
codes G2086 and G2087 would also reflect the updated work RVUs for 
90834 and would result in a work RVU of 8.36 for HCPCS code G2086 and a 
work RVU of 8.19 for HCPCS code G2087.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Many commenters expressed support for this proposal. 
Commenters stated that they agreed that the proposed increase more 
accurately reflects the cost, time, and effort of delivering these 
services. Commenters stated that by making the proposed adjustment, CMS 
will help to increase access to office-based SUD treatment and meet 
beneficiaries where they are and noted that the proposed increased 
payment rate will also enable more auxiliary personnel to participate 
in interdisciplinary teams, further ensuring that beneficiaries have 
the full range of services and supports they need. Some commenters 
stated that the proposed payment increase will help ensure that the 
complex care needs of patients receiving in-office treatment for SUDs 
are addressed and that the complexity of delivering office-based SUD 
treatment is accurately reflected.
    Other commenters expressed support for actions to facilitate access 
to substance use disorder treatment, including medications for Opioid 
Use Disorder, like buprenorphine, noting that the U.S. is in the midst 
of a drug overdose epidemic and that according to the Centers for 
Disease Control and Prevention, 106,699 people died from a drug 
overdose in 2021, a 14 percent increase from 2020.\55\ The commenters 
described that in-office treatment for SUDs can also enable patients to 
receive care for co-occurring conditions.
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    \55\ https://www.cdc.gov/drugoverdose/deaths/index.html.
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    Response: We thank the commenters for their support of this 
proposal. We agree that the proposed increase more accurately reflects 
the cost, time, and effort of delivering office-based SUD services. We 
aim to ensure that beneficiaries have access to the full range of 
services needed, especially in light of the drug overdose epidemic 
referenced in the comments. After consideration of the public comments, 
we are finalizing as proposed to increase the payment rate for HCPCS 
codes G2086 and G2087 to reflect two individual psychotherapy sessions 
per month, based on a crosswalk to the work RVUs assigned to CPT code 
90834 (Psychotherapy, 45 minutes with patient), rather than CPT code 
90832 (Psychotherapy, 30 minutes with patient).
7. Comment Solicitation on Expanding Access to Behavioral Health 
Services
    In recent years, we have made efforts to undertake rulemaking and 
establish policies to expand access to behavioral health services, 
consistent with the CMS Behavioral Health Strategy, which aims to 
strengthen quality and equity in behavioral health care; improve access 
to substance use disorders prevention, treatment, and recovery 
services; ensure effective pain treatment and management; improve 
mental health care and services; and utilize data for effective actions 
and impact.\56\ We continue to be interested in hearing feedback 
regarding ways we can continue to expand access to behavioral health 
services. For example, we welcomed feedback regarding ways to increase 
access to behavioral health integration (BHI) services, including the 
psychiatric collaborative care model; whether we could consider new 
coding to allow interprofessional consultation to be billed by 
practitioners who are authorized by statute for the diagnosis and 
treatment of mental illness; intensive outpatient (IOP) services 
furnished in settings other than those addressed in the CY 2024 OPPS 
proposed rule; and how to increase psychiatrist participation in 
Medicare given their low rate of participation relative to other 
physician specialties. Additionally, we solicited comment on whether 
there is a need for potential separate coding and payment for 
interventions initiated or furnished in the emergency department or 
other crisis setting for patients with suicidality or at risk of 
suicide, such as safety planning interventions and/or telephonic post-
discharge follow-up contacts after an emergency department visit or 
crisis encounter, or whether existing payment mechanisms are sufficient 
to support furnishing such interventions when indicated.
---------------------------------------------------------------------------

    \56\ https://www.cms.gov/cms-behavioral-health-strategy.
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    We welcomed comments from the public on these topics as well as any 
other ways we might consider expanding access to behavioral health 
services for Medicare beneficiaries.
    We received public comments in response to these comment 
solicitations. The following is a summary of the comments we received 
and our responses.
    Comment: We received many detailed comments on these topics. 
Commenters provided feedback regarding potential ways to expand 
implementation of the psychiatric collaborative care model (CoCM) and 
suggestions to support technical assistance and increased payments for 
CoCM.
    In response to our comment solicitation regarding whether there is 
a need for potential separate coding and payment for interventions 
initiated or furnished in the emergency department or other crisis 
setting for patients with suicidality or at risk of suicide, such as 
safety planning interventions and/or telephonic post-discharge follow-
up contacts after an emergency department visit or crisis encounter, 
several commenters encouraged CMS to enable wider implementation under 
Medicare of the Safety Planning Intervention (SPI) and the Post-
Discharge Telephonic Follow-up Contacts Intervention (FCI) and 
expressed that the current payment mechanisms are not sufficient, 
noting that the lack of adequate payment mechanisms and suitable 
billing codes for these interventions are barriers that are essential 
to address. The commenters noted that EDs are not the only care setting 
where there is need and opportunity to enhance suicide prevention, but 
that elevated suicide risk is particularly prevalent among ED patients. 
One commenter noted that a designated code for SPI would make it 
significantly easier to document that SPI was furnished, including in 
quality reporting and value-based payment programs. Commenters also 
cited that multiple trials have found FCI to reduce improve outcomes 
and specifically, to reduce suicide attempts and deaths, but noted that 
despite the effectiveness of these interventions, they are 
underutilized.
    Regarding settings of care where IOP services are furnished, 
commenters described that IOP services are most commonly delivered in 
freestanding community-based SUD treatment facilities and suggested 
that CMS create coding that would enable IOP to be delivered in these 
settings.

[[Page 79012]]

    Commenters also suggested a variety of ways to improve psychiatrist 
participation in Medicare and many cited low and disparate 
reimbursement rates as a significant barrier.
    Response: We thank the commenters for the many detailed comments 
received on these topics and note that we may consider this input for 
potential policy proposals through future rulemaking.
8. Request for Information on Digital Therapies, Such as, but not 
Limited to, Digital Cognitive Behavioral Therapy
    The widespread adoption and use of software technologies, 
including, but not limited to digital therapeutics, is creating new 
ways to treat patients. In recent years, the Food and Drug 
Administration (FDA) has reviewed and cleared several mobile medical 
applications (``apps'') that have been shown to demonstrate a 
reasonable assurance of safety and effectiveness for addressing a 
variety of health conditions including sleep disorders disturbances and 
substance use disorders. These breakthrough devices include apps for 
depression and anxiety. Our understanding is that these mobile medical 
apps generally require a prescription or referral from a clinician and 
are used for specific medical purposes rather than general wellness and 
education.
    As technologies have evolved, we have sought public comment and 
expanded Medicare payment under Part B for use of technologies in 
remote monitoring of treatment and physical health. Beginning in 2018, 
CMS began making separate payment for the services described by CPT 
code 99091, which paid for collection and interpretation of physiologic 
data digitally stored and/or transmitted to the practitioner. Beginning 
in 2019, we began paying for additional new remote physiologic 
monitoring (RPM) codes.
    We have continued to improve and expand payment for remote 
treatment and monitoring in subsequent years. In 2022, we began paying 
for a new class of CPT codes (98975, 98980, and 98981) for Remote 
Therapeutic Monitoring (RTM) in addition to RPM, which enabled 
reimbursement of monitoring of non-physiologic data, to help ensure 
Medicare beneficiaries have access to these services. RTM is currently 
limited to monitoring respiratory system status, musculoskeletal 
status, and therapy adherence, or therapy response (87 FR 69647). 
However, we continue to add, clarify, and refine payment for RTM codes.
    In the CY 2023 PFS final rule (87 FR 69645), we finalized a new RTM 
code for supply of a device for cognitive behavioral therapy monitoring 
(CPT Code 989X6 Remote therapeutic monitoring (e.g., therapy adherence, 
therapy response); device(s) supply with scheduled (e.g., daily)) 
recording(s) and/or programmed alert(s) transmission to monitor 
cognitive behavior therapy, each 30 days). In that rule, we noted 
specialty societies indicated the technologies for this service are 
still evolving, and as a result, there were no invoices for devices 
specific to the cognitive behavioral therapy monitoring services 
described by the code that could be shared. We accepted the RUC 
recommendation to contractor price CPT code 989X6, a PE-only device 
code. We stated we would work with Medicare Administrative Contractors 
(MACs) to better understand the devices and device costs they encounter 
as they review claims for payment for the new cognitive behavioral 
monitoring code.
    For both RPM and RTM codes, the device used must meet the FDA 
definition of a device as described in section 201(h) of the Federal 
Food, Drug and Cosmetic Act (FFDCA). As we continue to gather 
information on how remote monitoring services are used in clinical 
practice and experience with coding and payment policies for these 
codes, we requested information on the following areas to improve our 
understanding of the opportunities and challenges related to our 
coverage and payment policies, as well as claims processing, as we 
consider the need for further practitioner education, program 
instructions, and guidance, or potential future rulemaking regarding 
these services.
     How do practitioners determine which patients might be 
best served by digital therapeutics? How do practitioners monitor the 
effectiveness of prescribed interventions, such as, but not limited to, 
for their patients on an ongoing basis once the intervention has begun?
     We sought comment and real-life examples where digital 
cognitive behavioral therapy or other digital enabled therapy services 
are used by clinicians, and how the technology is imbedded in various 
practice models. For example, how is the patient evaluated and/or how 
is the treating clinician involved in the services received when the 
patient participates in digital cognitive behavioral therapy?
     What standards have interested parties developed or 
consulted to ensure the physical safety and privacy of beneficiaries 
utilizing digital cognitive behavioral therapy (CBT) and/or other 
digital therapeutics for behavioral health?
     What are effective models for distribution/delivery of 
digital therapeutics, such as prescription digital mental health 
therapy products to patients? What best practices exist to ensure that 
patients have the necessary support and training to use applications 
effectively?
     What practitioners and auxiliary staff are involved in 
furnishing RPM and RTM services, including training patients on its 
use, and to what extent is additional training or supervision of 
auxiliary staff necessary to provide an appropriate for and/or 
recommended standard of care in the delivery of these services?
     How are data that are collected by the technology 
maintained for recordkeeping and care coordination?
     What information exists about how an episode of care 
should be defined, particularly in circumstances when a patient may 
receive concurrent RTM or digital CBT services from two different 
clinicians engaged in separate episodes of care?
     We noted in previous rulemaking that even when multiple 
medical devices are provided to a patient, the services associated with 
all the medical devices can be billed by only one practitioner, only 
once per patient, per 30-day period, and only when at least 16 days of 
data have been collected. We sought information on the type and 
frequency of circumstances that involve multiple medical devices and 
multiple clinicians. How might allowing multiple, concurrent RTM 
services for an individual beneficiary affect access to health care, 
patient out-of-pocket costs, the quality of care, health equity, and 
program integrity?
     Do interested parties believe digital CBT could be billed 
using the existing remote therapeutic monitoring codes described by CPT 
codes 98975, 98980, and 98981? What impediments may exist to using 
these codes for digital CBT?
     In the past, commenters generally supported the concept of 
a generic RTM device code, and offered a wide variety of possible use 
cases, including where FDA approved devices and devices that have gone 
through other premarket pathways exist for the purpose of monitoring 
various conditions that do not meet the current scope of the existing 
RTM codes.
    ++ What are the advantages and disadvantages of a generic RTM 
device code, versus specific RTM codes?
    ++ Would generic device codes undermine or stall progress toward a 
wider set of specific codes that would provide less ambiguity on 
reimbursement?

[[Page 79013]]

    ++ How might generic RTM codes for supply of a device be valued 
given the broad array of pricing models?
     What scientific and clinical evidence of effectiveness 
should CMS consider when determining whether digital therapeutics for 
behavioral health are reasonable and necessary?
     What aspects of digital therapeutics for behavioral health 
should CMS consider when determining whether it fits into a Medicare 
benefit category, and which category should be used?
     If CMS determines the services fit within an existing 
Medicare benefit category or if other coverage requirements are met, 
what aspects of delivering digital cognitive based therapy services 
should be considered when determining potential Medicare payment? Under 
current practice models, are these products used as incident-to 
supplies or are they used independent of a patient visit with a 
practitioner? If used independently of a clinic visit, does a 
practitioner issue an order for the services?
     Are there barriers to digital CBT reaching underserved 
populations, and would a supervision requirement impact access to 
digital CBT for underserved populations?
     What strategies, if any, within the digital therapeutics 
for behavioral health support disadvantaged/hard to reach populations 
in advancing equity in health care services?
     What are some potential considerations for protecting the 
privacy and confidentiality of the patient population in digital 
therapeutics, including compliance with State behavioral health privacy 
requirements?
    We received public comments in response to our request for 
information on Digital Therapies, such as, but not limited to, digital 
Cognitive Behavioral Therapy. The following is a summary of the 
comments we received and our responses.
    Comment: We received many detailed comments in response to our 
Request for Information on digital therapies, such as, but not limited 
to, digital Cognitive Behavioral Therapy. Some commenters stated that 
CMS has existing authority to pay for two types of digital 
therapeutics: those that meet the definitions of durable medical 
equipment (DME) and those that are used incident to a physician 
service, assuming other relevant criteria are met. The commenters 
suggested that CMS should continue to use their authority to code and 
pay for digital therapeutics that are cleared by the FDA consistent 
with other prescription medical devices that fall under these existing 
benefit categories, and that are reasonable and necessary for the 
treatment of illness or injury. Additionally, the commenters stated 
that regarding coding and payment under the PFS for digital 
therapeutics that are furnished incident-to a physician's service, they 
noted that there are new coding proposals shown in the public agenda 
for the September 2023 CPT Editorial Panel meeting to allow for 
reporting of digital CBT (dCBT) and remote therapeutic treatment and 
other digital therapeutics as incident-to services. These commenters 
stated that such coding would provide an appropriate mechanism to 
facilitate coverage when furnished incident-to a healthcare 
practitioner's service and stated that if such coding is not adopted, 
they would encourage CMS to use its authority to adopt such coding 
under the HCPCS system where CMS would establish a separate set of G-
codes to account for when digital therapeutic devices are acquired by a 
Medicare enrolled practitioner, and that practitioner then furnishes 
that device to a patient and manages their treatment.
    Response: We thank the commenters for their detailed feedback on 
this topic. In the CY 2023 PFS final rule (87 FR 69645 through 69649), 
we accepted the RUC's recommendation to contractor price CPT code 
98978, a PE-only code that describes provision of a monitoring device 
for CBT and noted that we would work with our Medicare Administrative 
Contractors (MACs) to better understand the kinds of devices and device 
costs they are encountering as they review claims for payment for the 
services described by this code. Additionally, we note that the 
existing codes described by CPT codes 98978, 98980, and 98981 allow for 
the billing of remote therapeutic monitoring services, including 
monitoring patient adherence and therapy response for use with 
cognitive behavioral therapy. In response to the commenters' statement 
that there are new coding proposals shown in the public agenda for the 
September 2023 CPT Editorial Panel meeting to allow for reporting of 
digital CBT (dCBT) and remote therapeutic treatment and other digital 
therapeutics as incident-to services, we note that we routinely rely on 
the CPT coding process as a critical part of how services, including 
those involving emerging technologies, that might be paid under the PFS 
are understood and provided by medical professionals. While we do not 
always rely on CPT exclusively, we look forward to reviewing any 
forthcoming codes and potential recommendations for the valuation of 
such codes through our standard annual processes. Additionally, we 
continue to be interested in any feedback from interested parties on 
this topic, including feedback from interested parties about any 
potential codes that we would review under those processes and 
considerations we might need to take into account for future rulemaking 
to improve the accuracy of coding and payment under the Medicare PFS. 
For example, we welcome nominations for potentially misvalued codes and 
refer to the public nomination process outlined in section II.C. of 
this final rule, which can be used to help us identify codes that 
should be prioritized for review through the RUC process as well as 
resource costs involved in furnishing reasonable and necessary care to 
Medicare beneficiaries that are not accurately reflected under existing 
coding and payment policies. In some specific cases, of course, we have 
identified the need to develop G-codes as part of proposals to improve 
accuracy of payment for services paid under the PFS.
    In response to the comments regarding DME, we note that for a 
digital therapeutic item to be designated as DME it must meet the 
Medicare definition of DME. DME is defined in section 1861(n) of the 
Act and Medicare regulations at 42 CFR 414.202, and means equipment 
furnished by a supplier or a home health agency that meets the 
following conditions: (1) Can withstand repeated use; (2) Effective 
with respect to items classified as DME after January 1, 2012, has an 
expected life of at least 3 years; (3) Is primarily and customarily 
used to serve a medical purpose; (4) Generally is not useful to an 
individual in the absence of an illness or injury; and (5) Is 
appropriate for use in the home. All five of these conditions must be 
met in order for equipment to be classified as DME.

K. Provisions on Medicare Parts A and B Payment for Dental Services 
Inextricably Linked to Specific Covered Services

1. Medicare Payment for Dental Services
a. Overview
    Section 1862(a)(12) of the Act generally precludes payment under 
Medicare Parts A or B for any expenses incurred for services in 
connection with the care, treatment, filling, removal, or replacement 
of teeth or structures directly supporting teeth. (Collectively here, 
we will refer to ``the care, treatment, filling, removal, or 
replacement of teeth or structures directly supporting teeth'' as 
``dental services.'') In the CY 2023 PFS final rule

[[Page 79014]]

(87 FR 69663 through 69688), we identified certain clinical scenarios 
where payment is permitted under both Medicare Parts A and B for 
certain dental services in circumstances where the services are not 
considered to be in connection with dental services within the meaning 
of section 1862(a)(12) of the Act.
    The regulation at Sec.  411.15(i)(3)(i) includes examples of 
services for which payment can be made under Medicare Parts A and B for 
dental services, furnished in an inpatient or outpatient setting, that 
are inextricably linked to, and substantially related to the clinical 
success of, certain other covered services (hereafter in this section, 
``inextricably linked to other covered services'').
    Recognizing that there may be other instances where covered 
services necessary to diagnose and treat the individual's underlying 
medical condition and clinical status may require the performance of 
certain dental services, in the CY 2024 PFS proposed rule we proposed 
to codify other instances where dental services are inextricably linked 
to other covered services such that they are not in connection with 
dental services within the meaning of section 1862(a)(12) of the Act 
(88 FR 52371 through 52384). At the same time, we continue to recognize 
that there are dental services that are not, or currently not evidenced 
to be, inextricably linked to other covered services. In these 
instances, we continue to believe that Medicare payment is precluded by 
section 1862(a)(12) of the Act, except when, due to the patient's 
underlying medical condition and clinical status or the severity of the 
dental procedure, hospitalization is required; and that in those 
instances, the Medicare Part A exception provided under section 
1862(a)(12) of the Act will apply.
    In the CY 2023 PFS final rule (87 FR 69682, 69685, 69687), we also 
established a process for the public to submit additional dental 
services that may be inextricably linked to other covered services for 
our consideration and review and finalized a policy to permit payment 
for certain dental services, such as dental examinations and necessary 
treatment, prior to or contemporaneously with the treatment of head and 
neck cancers, beginning in CY 2024. The process for the public to 
submit comments is discussed below.
    In the CY 2024 PFS proposed rule, we proposed to codify in section 
Sec.  411.15(i)(3)(i)(A) additional policies to permit payment for 
certain dental services that are inextricably linked to other covered 
services. We also proposed to make non-substantive technical changes to 
improve the clarity of the regulation text (88 FR 52740).
b. Other Medical Services for Which Dental Services May Be Inextricably 
Linked
    In the CY 2023 PFS final rule, we discussed whether we should 
specify that payment can be made under Medicare Parts A and B for 
certain dental services prior to the initiation of immunosuppressant 
therapy, joint replacement procedures, or other surgical procedures. We 
stated that we remain committed to exploring the inextricable link 
between dental and covered services associated with immunosuppressant 
therapy, joint replacement surgeries, and other surgical procedures and 
that we welcomed continued engagement with the public to review the 
clinical evidence to determine whether certain dental services were 
inextricably linked to other covered services (87 FR 69668 and 69680 
through 69686).
    We partnered with researchers at the Agency for Healthcare Research 
and Quality (AHRQ) to consider the relationship between dental services 
and specific covered services and reviewed available clinical evidence 
regarding the relationship between dental services and medical services 
in the treatment of cancer using chemotherapeutic agents, which may 
lead to more clinically severe infections and often involve 
immunosuppression in patients.57 58 The AHRQ report \59\ 
regarding dental services and the link between medical services is 
available at https://effectivehealthcare.ahrq.gov/sites/default/files/related_files/rapid-response-chemotherapy-dental.pdf. For example, it 
is generally understood that many chemotherapeutic agents used in the 
treatment of cancer target rapidly proliferating cells (which include 
those cells found in healthy tissue, like the oral mucosa). This 
targeting of rapidly reproducing cells in the oral mucosa can lead to 
the development of oral mucositis, which can negatively affect 
individuals with periodontitis and other dental conditions more 
severely, especially when exposed to higher doses/duration of 
chemotherapy.\60\ Another example of a dental-related issue resulting 
from covered services that are immunosuppressive in nature is 
medication-related osteonecrosis of the jaw (MRONJ). MRONJ may occur as 
an adverse effect when patients with cancer receive specific covered 
services, such as high-dose antiresorptive and/or antiangiogenic drug 
therapy (for example, high doses of bisphosphonates or drugs like 
denosumab used to treat osteoporosis) or bone-modifying therapy in 
conjunction with their chemotherapy regimen. Patients with existing 
dental disease are most at risk for developing MRONJ secondary to bone-
modifying therapy. MRONJ complicates the cancer treatment and can 
reduce survival rates up to 3 years post-treatment.\61\ Dental services 
to identify and treat oral complications/comorbidities prior to and, 
sometimes, throughout chemotherapy treatment have been associated with 
improved outcomes for the patient receiving medical services in the 
treatment of cancer.\62\ Further, AHRQ noted that there is abundant 
worldwide experience and related standards of care in the management of 
patients whose medical conditions require chemotherapy regimens that 
induce immunosuppression and that this experience has led to an 
understanding of how improved dental care potentially can reduce the 
incidence of serious infections and improve overall patient outcomes.
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    \57\ Immunosuppression describes an impairment of the cells of a 
patient's immune system and a reduction in their ability to fight 
infections and other diseases.
    \58\ National Cancer Institute. NCI Dictionary of Cancer Terms. 
2019. Available at https://www.cancer.gov/publications/dictionaries/cancer-terms.
    \59\ Hickam DH, Gordon CJ, Armstrong CE, Coen MJ, Paynter R, 
Helfand M. The Efficacy of Dental Services for Reducing Adverse 
Events in Those Receiving Chemotherapy for Cancer. Rapid Response. 
(Prepared by the Scientific Resource Center under Contract No. 
75Q80122C00002.) AHRQ Publication No. 23-EHC021. Rockville, MD: 
Agency for Healthcare Research and Quality; June 2023. DOI: https://doi.org/10.23970/AHRQEPCRAPIDDENTALCANCER.
    \60\ Poulopoulos A, Papadopoulos P, Andreadis D. Chemotherapy: 
oral side effects and dental interventions -a review of the 
literature. Stomatological Disease and Science. 2017; 1:35-49. 
http://dx.doi.org/10.20517/2573-0002.2017.03.
    \61\ Corraini, P., Heide-J[oslash]rgensen, U., Schi[oslash]dt, 
M., N[oslash]rholt, S. E., Acquavella, J., S[oslash]rensen, H. T., & 
Ehrenstein, V. (2017). Osteonecrosis of the jaw and survival of 
patients with cancer: a nationwide cohort study in Denmark. Cancer 
medicine, 6(10), 2271-2277. https://doi.org/10.1002/cam4.1173.
    \62\ Poulopoulos A, Papadopoulos P, Andreadis D. Chemotherapy: 
oral side effects and dental interventions -a review of the 
literature. Stomatological Disease and Science. 2017; 1:35-49. 
http://dx.doi.org/10.20517/2573-0002.2017.03.
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    The AHRQ examined the effects of dental care prior to treatment on 
the success of medical services for patients receiving chemotherapy 
regimens (primary medical service) in the treatment of cancer (primary 
medical illness). As part of this analysis, AHRQ identified 26 primary 
research studies, seven systematic reviews, and five practice 
guidelines that outline the benefits and harms of pre-treatment dental 
services and their effects on cancer chemotherapy regimens. The

[[Page 79015]]

studies were selected using specific inclusion criteria: a sample of 
patients beginning cancer treatment within 2 months; targeted dental 
services occurring prior to cancer treatment; outcomes data, such as 
rates of serious adverse events, quality of life, cancer relapse rates, 
mortality, or adherence to cancer treatment; and a minimum sample size 
of 10 patients.
    The 26 primary research studies identified by AHRQ included 
prospective cohort studies, retrospective cohort studies, randomized 
controlled trials, and registry-based studies. From this group of 
studies, AHRQ found evidence to support that dental evaluation/
treatment prior to cancer treatment led to decreased incidence and/or 
less severity of serious oral infections and complications (such as, 
oral mucositis and osteonecrosis) with the covered services, as well as 
requiring fewer emergency treatments.63 64 There was further 
evidence found in systematic reviews that showed a possible increased 
incidence of oral mucositis when dental treatment is not administered 
at least 2-3 weeks prior to initiation of cancer treatment, further 
complicating the totality of services a patient received to treat their 
cancer.\65\ They note that treatment of a broad range of malignancies 
often requires the use of chemotherapeutic agents that suppress the 
body's production of white blood cells, thereby impairing the body's 
ability to resist serious (often life-threatening) bacterial and fungal 
infections, and that the route of entry of these offending bacteria can 
be the mouth. AHRQ also analyzed several clinical practice guidelines 
that supported a dental evaluation/treatment before initiating 
chemotherapy so that any oral complications could be mitigated prior to 
initiating care to treat the cancer.66 67 68
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    \63\ Watson EE, Metcalfe JE, Kreher MR, et al. Screening for 
Dental Infections Achieves 6-Fold Reduction in Dental Emergencies 
During Induction Chemotherapy for Acute Myeloid Leukemia. JCO Oncol 
Pract. 2020 11;16(11):e1397-e405. doi: https://dx.doi.org/10.1200/OP.20.00107. PMID: 32609586.
    \64\ Owosho AA, Liang STY, Sax AZ, et al. Medication-related 
osteonecrosis of the jaw: An update on the memorial sloan kettering 
cancer center experience and the role of premedication dental 
evaluation in prevention. Oral Surg Oral Med Oral Pathol Oral 
Radiol. 2018 May;125(5):440-5. doi: https://dx.doi.org/10.1016/j.oooo.2018.02.003. PMID: 29580668.
    \65\ Mazzetti T, Sergio da Silva Santos P, Spindola Antunes H, 
et al. Required time for pre-oncological dental management--A rapid 
review of the literature. Oral Oncol. 2022 11;134:106116. doi: 
https://dx.doi.org/10.1016/j.oraloncology.2022.106116. PMID: 
36115328.
    \66\ Elad S, Cheng KKF, Lalla RV, et al. MASCC/ISOO clinical 
practice guidelines for the management of mucositis secondary to 
cancer therapy. Cancer. 2020 Oct 1;126(19):4423-31. doi: https://dx.doi.org/10.1002/cncr.33100. PMID: 32786044.
    \67\ Yarom N, Shapiro CL, Peterson DE, et al. Medication-Related 
Osteonecrosis of the Jaw: MASCC/ISOO/ASCO Clinical Practice 
Guideline. J Clin Oncol. 2019 Sep 1;37(25):2270-90. doi: https://dx.doi.org/10.1200/JCO.19.01186. PMID: 31329513.
    \68\ Butterworth C, McCaul L, Barclay C. Restorative dentistry 
and oral rehabilitation: United Kingdom National Multidisciplinary 
Guidelines. J Laryngol Otol. 2016 May;130(S2):S41-S4. PMID: 
27841112.
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c. Submissions Received Through Public Submission Process
    In the CY 2023 PFS final rule, we stated that we believed there may 
be additional clinical scenarios we have not yet identified under which 
Medicare payment could be made for certain dental services on the basis 
that dental services are inextricably linked to other covered services 
(87 FR 69686). In order to ensure we are appropriately considering 
other potential clinical scenarios that may involve such dental 
services, we finalized an annual public process, including notice and 
comment rulemaking, whereby interested parties can submit 
recommendations for other clinical scenarios for potential inclusion on 
the list of dental services for which payment can be made under Sec.  
411.15(i)(3)(i).
    Through this process, we stated that we would review clinical 
evidence to assess whether there is an inextricable link between 
certain dental and covered services because the standard of care for 
that medical service is such that one would not proceed with the 
medical procedure or service without performing the dental service(s) 
because the covered services would or could be significantly and 
materially compromised absent the provision of the inextricably-linked 
dental services, or where dental services are a clinical prerequisite 
to proceeding with the primary medical procedure and/or treatment (87 
FR 69685). We also stated that, section 1862(a)(12) of the Act does not 
apply only when dental services are inextricably linked to other 
covered services, such that the standard of care for that medical 
service would be compromised or require the dental services to be 
performed in conjunction with the covered services (87 FR 69666). As 
such, we requested that documentation accompanying recommendations 
should include medical evidence to support that certain dental services 
are inextricably linked to other covered services. Specifically, we 
requested that the medical evidence should:
    (1) Provide support that the provision of certain dental services 
leads to improved healing, improved quality of surgery outcomes, and 
the reduced likelihood of readmission and/or surgical revisions because 
an infection has interfered with the integration of the medical implant 
and/or interfered with the medical implant to the skeletal structure;
    (2) Be clinically meaningful and demonstrate that the dental 
services result in a material difference in terms of the clinical 
outcomes and success of the procedure such that the dental services are 
inextricably linked to other covered services; and
    (3) Be compelling to support that certain dental services would 
result in clinically significant improvements in quality and safety 
outcomes (for example, fewer revisions, fewer readmissions, more rapid 
healing, quicker discharge, and quicker rehabilitation for the patient) 
(87 FR 69686).
    We stated that interested parties should submit medical evidence to 
support, for the recommended clinical scenario, the inextricable link 
between certain dental services and other covered services by providing 
any of the following:
    (1) Relevant peer-reviewed medical literature and research/studies 
regarding the medical scenarios requiring medically necessary dental 
care;
    (2) Evidence of clinical guidelines or generally accepted standards 
of care for the suggested clinical scenario;
    (3) Other ancillary services that may be integral to the covered 
services; and/or
    (4) Other supporting documentation to justify the inclusion of the 
proposed medical clinical scenario requiring dental services (87 FR 
69686, 69687).
    We stated that we intended to use the PFS annual rulemaking process 
to discuss public submissions when considering whether the recommended 
dental services associated with certain clinical scenarios should be 
considered outside the scope of the general preclusion on payment for 
dental services under section 1862(a)(12) of the Act because they are 
inextricably linked to other covered services. We believe that public 
feedback is important, especially when considering Medicare payment for 
dental services that may benefit the clinical outcomes for certain 
covered services. We believe that using our annual notice and comment 
rulemaking process to discuss submitted recommendations will allow the 
public to comment and submit further medical evidence to assist us in 
evaluating whether certain dental services furnished in certain 
clinical scenarios would meet the standard to permit

[[Page 79016]]

Medicare payment for the dental services. Under the public process 
established in the CY 2023 PFS final rule, recommendations received by 
February 10th of a calendar year would be reviewed for consideration 
and potential inclusion within the PFS proposed rule for the subsequent 
calendar year. The deadline for submissions for potential consideration 
for CY 2024 rulemaking was February 10, 2023. We received eight 
submissions from various organizations on or before February 10, 2023. 
We received one submission after the deadline that presented 
nominations for covered services that have already been addressed by 
this payment policy.
    Submissions included recommendations for payment under Medicare 
Parts A and B of dental services prior to covered services associated 
with the treatment of cancer (chemotherapy, chimeric antigen receptor 
(CAR) T-cell therapy, bone-modifying agents or antiresorptive therapy), 
total joint arthroplasty, all cardiovascular procedures, diabetes 
treatment, treatment for sickle-cell anemia and hemophilia, and 
systemic autoimmune diseases. Additionally, many submissions 
recommended that CMS refine certain terminology surrounding previously 
finalized policies, specifically around whether payment can be made for 
dental services furnished during and after the performance of certain 
covered services.
    Several submissions recommended that Medicare make payment under 
Parts A and B for dental services prior to covered services associated 
with the treatment of patients with leukemia and lymphoma, as well as 
other cancers. Most submitting organizations stated that, by examining 
and addressing the oral health of the patient prior to the initiation 
of chemotherapy in the treatment of cancer, with or without radiation, 
oral complications could be appropriately addressed or prevented that 
would improve the clinical success of the overall cancer treatment. 
Submissions also recommended Medicare payment under Parts A and B for 
dental services before, during, and after CAR T-cell therapy and other 
lymphodepleting covered services (lymphodepleting therapy involves a 
short course of chemotherapy that targets T-cells, preconditioning the 
body prior to enhance treatments like CAR T-cell therapy). These 
submissions stressed the need to detect and monitor dental issues early 
to avoid the increased risk of related infections and complications.
    Most submissions stated that medication-related osteonecrosis of 
the jaw (MRONJ) is a serious complication of antiresorptive and/or 
antiangiogenic drug therapy used to help manage the treatment of 
cancer. Several recommended that Medicare make payment under Parts A 
and B for dental services for patients where high-dose bisphosphonate 
therapy for cancers is indicated, such as blood and solid tumor cancers 
and metastatic cancers associated with the risk of osteonecrosis of the 
jaw. These submissions recommended payment of dental services prior to 
and during antiresorptive therapy or prior to, during, and after the 
use of bone-modifying drugs. One provided references that support the 
provision of dental services to prevent, or as part of treatment for 
MRONJ. Another submission stated that the risk of MRONJ is 
significantly greater in patients receiving antiresorptive therapy in 
connection with cancer treatment compared to patients receiving 
antiresorptive therapy for osteoporosis.\69\ However, the submitter 
stated that the combination of poly-pharmaceutical management of cancer 
patients and related immunosuppression are risk factors for MRONJ 
without exposure to antiresorptive agents and that it would be 
difficult to identify a single medication as the etiologic agent for 
MRONJ in case reports or mini-case series. The submitter stated that 
prevention of MRONJ would be the clinical gold standard.
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    \69\ We note that antiresorptive therapy for cancer is the 
parenteral administration of bisphosphonates and denosumab, also 
called osteoclast inhibitors, for the purpose of reducing the 
frequency of skeletal complications (for example, fractures) in 
patients with multiple myeloma and in those with bone metastases 
from solid tumors. Per FDA label, they are administered parenterally 
and in doses that exceed those typically used for patients with 
osteoporosis. (Only two bisphosphonates, pamidronate and zoledronic 
acid, and the single monoclonal antibody, denosumab, have the cancer 
indication).
    Antiresorptive therapy for osteoporosis is typically for the 
postmenopausal female patient, for the purpose of reducing the risk 
of skeletal fracture (for example, vertebral, hip) in those patients 
who have a high fracture risk. They are typically dosed orally, at 
dosages that have significant supportive efficacy and safety data. 
Parenteral administration of bisphosphonates is available for 
osteoporosis for patients that are unable to take an oral 
preparation, at significantly lower dosages.
    For example, the dosage difference for zoledronic acid between 
the two indications would be as follows: cancer (for example, 
multiple myeloma, bone metastases) at 4 mg IV every 3 to 4 weeks 
compared with osteoporosis at 5 mg every 12 months.
---------------------------------------------------------------------------

    One submission also recommended that Medicare make payment under 
Parts A and B for dental services prior to all cardiovascular 
procedures. In their view, the provision of dental services to reduce 
the risk of perioperative and postoperative infection and complications 
is critical to ensure optimal surgical outcomes for all patients 
requiring invasive and/or interventional cardiac procedures. They cited 
a literature review supporting the need for screening and treatment for 
oral/dental infections before cardiac surgery. This submission did not 
recommend dental services prior to a specific cardiovascular procedure; 
rather, it recommended dental services prior to all cardiovascular 
procedures. The literature review they cited (which we discuss in 
section II.K.3. of this final rule) noted that there was a mixture of 
medical literature to support the performance of dental services prior 
to all cardiac procedures in part because such cardiovascular 
procedures are more urgent or emergent than elective.
    One submission recommended that Medicare make payment under 
Medicare Parts A and B for dental services prior to joint replacement 
surgeries, specifically total knee and hip arthroplasty. The submitting 
organization stated that providing dental services prior to or 
contemporaneously with joint replacement surgeries may result in more 
rapid healing and quicker rehabilitation, especially if a known dental 
infection could be addressed and potentially prevent surgical and 
rehabilitation complications for the patient. However, the submission 
acknowledged that there is no consensus on whether performing dental 
services prior to joint replacement surgeries improves the clinical 
outcomes of the medical service or whether it is typical in practice to 
furnish dental services before joint replacement procedures.
    Other submissions recommended Medicare make payment for dental 
services for patients diagnosed with a specific condition(s), such as 
patients with poorly controlled diabetes mellitus or individuals living 
with sickle cell disease (SCD) or hemophilia.
    Submissions also recommended Medicare payment for dental services 
for persons affected by systemic autoimmune disease. They argued that 
dental services are essential for medical treatment for individuals at 
much higher risk of advanced dental decay, dental loss, and/or gum 
disease. They stated that reducing oral infection of the mucosa, teeth, 
and gums; oral inflammation; and tooth loss through consistent oral 
management reduces the systemic impact that these dental conditions 
have on a patient's systemic autoimmune disease. One submission stated 
that oral health disparities

[[Page 79017]]

disproportionately affect members of racial or ethnic minority groups, 
which they offered is most pronounced in populations aged 65 and older. 
Another presented their proposal to bridge the gap in health equity and 
to improve the health outcomes for those ages 65 and older living with 
autoimmune diseases.
    We thanked all those who submitted recommendations for clinical 
scenarios for which they believe Medicare payment for dental services 
will be consistent with the policies we codified and clarified in the 
CY 2023 PFS final rule at Sec.  411.15(i)(3)(i), under which Medicare 
payment may be made for dental services when they are inextricably 
linked to, and substantially related and integral to the clinical 
success of, certain covered medical services (hereafter in this 
section, ``inextricably linked to other covered services''). We 
continued to encourage interested parties to engage with us regularly 
and to submit recommendations for our consideration of additional 
clinical scenarios where dental services may be inextricably linked to 
other covered services. As stated earlier, interested parties should 
provide evidence to support or refute that at least one of the three 
criteria listed above for submissions is met. Furthermore, submissions 
should focus on the inextricably linked relationship between dental 
services and other medical services necessary to diagnose and treat the 
individual's underlying medical condition and clinical status, and 
whether it is not clinically advisable to move forward with the primary 
medical service without performing certain dental services. We remind 
readers once again that, to be considered for purposes of CY 2025 PFS 
rulemaking, submissions through our public process for recommendations 
on payment for dental services should be received by February 10, 2024, 
via email at [email protected]. Interested 
parties should include the words ``dental recommendations for CY 2025 
review'' in the subject line of their email submission to facilitate 
processing. We continue to stress to submitters that recommendations 
must include at least one of the types of evidence listed earlier when 
submitting documentation to support the inextricable link between 
specified dental services and other covered services. We further note 
that we may also consider recommendations that are submitted as public 
comments during the comment period following the publication of the PFS 
proposed rule.
2. Additions to Current Policies Permitting Payment for Dental Services 
Inextricably Linked to Other Covered Services
    Under our current policy, we have identified several clinical 
scenarios where dental services are inextricably linked to other 
covered services that is covered by Medicare, such that Medicare 
payment for the dental services is not precluded by section 1862(a)(12) 
of the Act. After further review of current medical practice, and 
through internal and external consultations and consideration of the 
submissions received through the public process established in the CY 
2023 PFS final rule (87 FR 69669), we believe there are additional 
circumstances that are clinically similar to the scenarios we codified 
in our regulation at Sec.  411.15(i)(3)(i) as examples of clinical 
scenarios under which Medicare payment may be made for certain dental 
services because they are inextricably linked to other covered medical 
services.
    As described in the CY 2024 PFS proposed rule, in the case of the 
proposed primary-covered services, we believe that dental services are 
inextricably linked to, and substantially related and integral to the 
clinical success of, the proposed covered services because such dental 
services serve to mitigate the substantial risk to the success of the 
medical services, due to the occurrence and severity of complications 
caused by the primary medical services, including infection (88 FR 
52374 through 52380). Additionally, section 1862(a)(12) of the Act does 
not apply only when dental services are inextricably linked to, and 
substantially related and integral to the clinical success of, certain 
other covered services, such that the standard of care for that medical 
service would be compromised or require the dental services to be 
performed in conjunction with the covered services or if the dental 
services are considered to be a critical clinical precondition to 
proceeding with the primary medical procedure and/or treatment. As 
such, we believed the certain dental services are not in connection 
with the care, treatment, filling, removal, or replacement of teeth or 
structures directly supporting teeth, but instead are inextricably 
linked to, and substantially related and integral to the clinical 
success of, the following medical services, and we proposed that the 
statutory dental exclusion would not apply:
    (1) Chemotherapy when used in the treatment of cancer;
    (2) CAR T-Cell therapy, when used in the treatment of cancer; and
    (3) Administration of high-dose bone-modifying agents 
(antiresorptive therapy) when used in the treatment of cancer.
    As such, we proposed to revise our regulation at Sec.  
411.15(i)(3)(i)(A) by adding to the list of clinical scenarios in which 
Medicare Part A and B payment is permitted for dental or oral 
examinations performed as part of a comprehensive workup prior to, and 
medically necessary diagnostic and treatment services to eliminate an 
oral or dental infection prior to, or contemporaneously with, the 
following Medicare-covered services: chemotherapy, chimeric antigen 
receptor (CAR) T-cell therapy, and the administration of high-dose 
bone-modifying agents (antiresorptive therapy) when used in the 
treatment of cancer.
a. Dental Services Inextricably Linked to Chemotherapy Services When 
Used in the Treatment of Cancer
    In the CY 2024 PFS proposed rule, we discussed clinical practice 
guidelines, recommendations provided by the public, and our analyses of 
the studies and research available regarding the connection between 
dental services and the clinical success of chemotherapy services. We 
stated that there is an inextricable link between certain dental and 
chemotherapy services when used in the treatment of cancer because the 
standard of care is such that one would not proceed with the medical 
procedure or service without performing the dental service(s) because 
the covered medical services would or could be significantly and 
materially compromised absent the provision of the inextricably-linked 
dental services and that dental services are a clinical prerequisite to 
proceeding with the chemotherapy services when used in the treatment of 
cancer (88 FR 52377). Chemotherapy services, when used in the treatment 
of cancer, cause immunosuppression which may lead to significant oral 
complications and adverse events, including the possibility of an oral 
or dental infection, which in turn leads to serious and imminent risks 
to the success of the primary medical procedures and treatments. The 
complications, including possible infection, may prevent the ability to 
both initiate and proceed with the primary, covered medical service 
(that is, lead to delays in treatment and/or cause inability of the 
patient to complete the course of treatment, thereby potentially 
reducing the effectiveness of the therapy) such that the standard of 
care would be to not

[[Page 79018]]

proceed with the covered medical procedure until a dental or oral exam 
is performed to address the oral complications and/or clear the patient 
of an oral or dental infection. In the case of chemotherapy services 
when used in the treatment of cancer, dental services serve to mitigate 
the likelihood of occurrence and severity of complications caused by 
the primary medical services, including infection, and consequently the 
dental services facilitate the successful completion of the prescribed 
course of treatment. Therefore, we believed the dental services are 
integral and inextricably linked to the chemotherapy when used in the 
treatment of cancer, and the statutory dental exclusion under section 
1862(a)(12) of the Act would not apply.
    We proposed to add this clinical scenario to the examples of 
clinical scenarios under which payment can be made for certain dental 
services in our regulation at Sec.  411.15(i)(3)(i)(A). Specifically, 
we proposed to amend the regulation to include dental or oral 
examination performed as part of a comprehensive workup in either the 
inpatient or outpatient setting prior to Medicare-covered chemotherapy 
when used in the treatment of cancer; and, medically necessary 
diagnostic and treatment services to eliminate an oral or dental 
infection prior to, or contemporaneously with chemotherapy when used in 
the treatment of cancer. We solicited comments on all aspects of this 
proposal.
    Additionally, we noted that we proposed that payment is permitted 
for dental services that are inextricably linked to chemotherapy used 
in the treatment of cancer with or without the use of other therapy 
types, including radiation therapy in the treatment of cancer. That is, 
this provision is not meant to be limited to cases where chemotherapy 
in the treatment of cancer is provided without the use of other 
therapies. We solicited comment on this aspect of the proposal.
    As discussed in section II.K.2. of this final rule, we received 
submissions through the public process and comments on the CY 2023 PFS 
proposed rule requesting that Medicare payment should be permitted 
under Parts A and B for dental services when medical services that 
cause immunosuppression are being provided to treat a variety of 
medical conditions.
    Commenters asserted that immunocompromised patients are at an 
increased risk of serious infection that can lead to severe conditions 
(87 FR 69683). We stated that we agreed with commenters that 
individuals who are immunocompromised may be prone to serious 
infection, and that we will continue to consider feedback and the 
clinical literature provided by interested parties to determine whether 
there are other clinical scenarios, such as the initiation of 
immunosuppressive therapies, where Medicare payment should not be 
excluded for dental services under section 1862(a)(12) of the Act, 
because the services are inextricably linked to other covered services.
    In the CY 2023 PFS final rule (87 FR 69681) and as discussed in 
section II.K.2. of this final rule, we stated that we were finalizing a 
policy for CY 2024 that Medicare Parts A and B payment may be made for 
dental or oral examination performed as part of a comprehensive workup 
in either the inpatient or outpatient setting, as well as medically 
necessary diagnostic and treatment services to eliminate an oral or 
dental infection, prior to or contemporaneously with Medicare-covered 
treatments for head and neck cancer. We stated that removing infections 
in the oral cavity is necessary to prepare patients for treatment and 
is inextricably linked to the clinical success of treatment for cancers 
of the head and neck. There is significant and abundant worldwide 
experience and research regarding the care of patients whose medical 
conditions require chemotherapy regimens that induce acute 
immunosuppression.70 71 The treatment of a broad range of 
malignancies often requires chemotherapeutic agents that, in turn, 
suppress the body's production of white blood cells, thereby impairing 
the body's ability to resist serious (potentially life-threatening) 
infections. The route of entry of the offending pathogens can be the 
mouth.72 73 74 Therefore, individuals receiving chemotherapy 
treatment for cancer who become immunosuppressed may be more 
susceptible to infection and other adverse events with serious 
consequences for the patient. We understand that medical services used 
in cancer treatment, such as chemotherapy, induce immunosuppression. As 
such, we believe that cancer patients being treated with chemotherapy 
represent an acutely impacted, immunocompromised patient population due 
to the nature of the effects of such chemotherapy treatment. If dental 
or oral infections are left undetected or untreated in these patients, 
serious complications may occur, negatively impacting the clinical 
success of the medical services and outcomes for the patients. 
Moreover, the immunosuppression induced by the chemotherapy medical 
services in cancer treatment increases the likelihood and intensity of 
complications for the patient that could potentially jeopardize or 
impact the ability to complete the totality of the treatment across a 
normal course of treatment.75 76 If an oral or dental 
infection is not properly diagnosed and treated prior to and/or during 
the chemotherapy in the treatment of cancer, which suppresses the 
immune system, there may be an increased risk for local and systemic 
infections from odontogenic sources. Furthermore, the successful 
completion of that treatment could be compromised. Additionally, if 
such an infection is not treated, then there is an increased likelihood 
of morbidity and mortality resulting from the spreading of the local 
infection to sepsis.77 78
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    \70\ Spijkervet FKL, Schuurhuis JM, Stokman MA, et al. Should 
oral foci of infection be removed before the onset of radiotherapy 
or chemotherapy? Oral Dis. 2021 Jan;27(1):7-13. doi: https://dx.doi.org/10.1111/odi.13329. PMID: 32166855.
    \71\ Hanna N, Einhorn LH. Testicular cancer: a reflection on 50 
years of discovery. J Clin Oncol. 2014 Oct 1;32(28):3085-92. doi: 
https://dx.doi.org/10.1200/JCO.2014.56.0896. PMID: 25024068.
    \72\ Mirowski GW, Bettencourt JD, Hood AF. Oral infections in 
the immunocompromised host. Semin Cutan Med Surg. 1997 
Dec;16(4):249-56. doi: https://dx.doi.org/10.1016/s1085-5629(97)80013-2. PMID: 9421215.
    \73\ Greenberg MS, Cohen SG, McKitrick JC, et al. The oral flor 
as a source of septicemia in patients with acute leukemia. Oral Surg 
Oral Med Oral Pathol. 1982 Jan;53(1):32-6. PMID: 6948251.
    \74\ King A, Irvine S, McFadyen A, et al. Do we overtreat 
patients with presumed neutropenic sepsis? Postgrad Med J. 2022 
Nov;98(1165):825-9. doi: https://dx.doi.org/10.1136/postgradmedj-2021-140675. PMID: 34611037.
    \75\ Spijkervet FKL, Schuurhuis JM, Stokman MA, et al. Should 
oral foci of infection be removed before the onset of radiotherapy 
or chemotherapy? Oral Dis. 2021 Jan;27(1):7-13. doi: https://dx.doi.org/10.1111/odi.13329. PMID: 32166855.
    \76\ Hanna N, Einhorn LH. Testicular cancer: a reflection on 50 
years of discovery. J Clin Oncol. 2014 Oct 1;32(28):3085-92. doi: 
https://dx.doi.org/10.1200/JCO.2014.56.0896. PMID: 25024068.
    \77\ Ruescher TJ, Sodeifi A, Scrivani SJ, Kaban LB, Sonis ST. 
The impact of mucositis on alpha-hemolytic streptococcal infection 
in patients undergoing autologous bone marrow transplantation for 
hematologic malignancies. Cancer 1998;82(11):2275-2281. [PubMed: 
9610710].
    \78\ Vera-Llonch M, Oster G, Ford CM, Lu J, Sonis S. Oral 
mucositis and outcomes of allogeneic hematopoietic stem-cell 
transplantation in patients with hematologic malignancies. Support 
Care Cancer May;2007 15(5):491-496. [PubMed: 17139495].
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    Individuals undergoing chemotherapy services used in the treatment 
of cancer who become immunosuppressed by the treatment may also 
experience oral mucositis, which often facilitates the entry of oral 
bacteria into the body, potentially increasing the risk of infection 
for the patient and compromising the chemotherapy

[[Page 79019]]

regimen. The risk of mucositis and potential complications to the 
clinical success of medical services for cancer treatment is similar to 
the risk for patients receiving Hematopoietic Stem Cell Transplants 
(HSCT) and bone marrow transplants,79 80 for which we 
finalized payment for certain dental services prior to these medical 
services (87 FR 69677). These potential complications, resulting from 
the combined immunosuppression and mucositis caused by the chemotherapy 
services, present a risk to the patient and the success of the medical 
chemotherapy regimen unless mitigated by the provision of dental 
services. Additionally, as described previously, evidence found in 
systematic reviews showed a possible increased incidence of oral 
mucositis when dental treatment is not administered at least 2-3 weeks 
prior to initiation of cancer treatment, further complicating the 
totality of services a patient received to treat their cancer.\81\
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    \79\ Vera-Llonch M, Oster G, Ford CM, Lu J, Sonis S. Oral 
mucositis and outcomes of allogeneic hematopoietic stem-cell 
transplantation in patients with hematologic malignancies. Support 
Care Cancer May, 2007 15(5):491-496. [PubMed: 17139495].
    \80\ Ruescher TJ, Sodeifi A, Scrivani SJ, Kaban LB, Sonis ST. 
The impact of mucositis on alpha-hemolytic streptococcal infection 
in patients undergoing autologous bone marrow transplantation for 
hematologic malignancies. Cancer 1998;82(11):2275-2281. [PubMed: 
9610710].
    \81\ Mazzetti T, Sergio da Silva Santos P, Spindola Antunes H, 
et al. Required time for pre-oncological dental management--A rapid 
review of the literature. Oral Oncol. 2022 11;134:106116. doi: 
https://dx.doi.org/10.1016/j.oraloncology.2022.106116. PMID: 
36115328.
---------------------------------------------------------------------------

    Moreover, as described in section II.K.2. of this final rule, 
dental services to identify and treat oral complications/comorbidities 
prior to and, sometimes, throughout chemotherapy treatment have been 
associated with improved outcomes for the patient receiving medical 
services in the treatment of cancer.\82\ Additionally, as discussed in 
section II.K.2. of this final rule, research studies support that 
dental evaluation/treatment prior to cancer treatment led to decreased 
incidence and/or less severity of serious oral infections and 
complications (such as, oral mucositis and osteonecrosis) with the 
medical services, as well as requiring fewer emergency 
treatments.83 84
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    \82\ Poulopoulos A, Papadopoulos P, Andreadis D. Chemotherapy: 
oral side effects and dental interventions--a review of the 
literature. Stomatological Disease and Science. 2017; 1:35-49. 
http://dx.doi.org/10.20517/2573-0002.2017.03.
    \83\ Watson EE, Metcalfe JE, Kreher MR, et al. Screening for 
Dental Infections Achieves 6-Fold Reduction in Dental Emergencies 
During Induction Chemotherapy for Acute Myeloid Leukemia. JCO Oncol 
Pract. 2020 11;16(11):e1397-e405. doi: https://dx.doi.org/10.1200/OP.20.00107. PMID: 32609586.
    \84\ Owosho AA, Liang STY, Sax AZ, et al. Medication-related 
osteonecrosis of the jaw: An update on the memorial sloan kettering 
cancer center experience and the role of premedication dental 
evaluation in prevention. Oral Surg Oral Med Oral Pathol Oral 
Radiol. 2018 May;125(5):440-5. doi: https://dx.doi.org/10.1016/j.oooo.2018.02.003. PMID: 29580668.
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    Consequently, we believe that the evidence supports that the 
standard of care is such that one would not proceed with the 
chemotherapy when used in the treatment of cancer without performing 
the dental services because the covered services would or could be 
significantly and materially compromised, such that clinical outcomes 
of the chemotherapy treatment could be compromised absent the provision 
of the inextricably linked dental services.
    As described in the CY 2023 PFS final rule (87 FR 69685), we noted 
that evidence to support the linkage between the dental and covered 
services could include information demonstrating that the standard of 
care would be to not proceed with the covered medical procedure until a 
dental or oral exam is performed to clear the patient of an oral or 
dental infection; or, in instances where a known oral or dental 
infection is present, the standard is such that the medical 
professional would not proceed with the medical service until the 
patient received the necessary treatment to eradicate the infection. 
Our review of relevant clinical practice guidelines demonstrated that 
multiple professional societies recommend the performance of dental 
services prior to the initiation of or during 
chemotherapy.85 86 For instance, the United Kingdom 
published a guideline for dental evaluation and treatment before and 
after treatments for head and neck cancer (5th edition of the UK Multi-
Disciplinary Guidelines for Head and Neck Cancer), based on guidance 
from the National Institute for Health and Care Excellence (NICE) and 
expert recommendations: ``Preventive oral care must be delivered to 
patients whose cancer treatment will affect the oral cavity, jaws, 
salivary glands and oral accessibility.'' \87\ Additionally, as 
described in the CY 2023 PFS final rule (87 FR 69680), several 
commenters provided data regarding the treatment of head and neck 
cancer that illustrated that conditions such as oral mucositis or 
osteonecrosis of the jaw that occur during the treatment may compromise 
the clinical success of the primary medical service (chemotherapy for 
the treatment of head and neck cancer), potentially leading to multiple 
hospitalizations, including systemic infections or fatal sepsis, if 
dental infections remained untreated.
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    \85\ Butterworth C, McCaul L, Barclay C. Restorative dentistry 
and oral rehabilitation: United Kingdom National Multidisciplinary 
Guidelines. J Laryngol Otol. 2016 May;130(S2):S41-S4. PMID: 
27841112.
    \86\ American Academy of Pediatric Dentistry. Dental management 
of pediatric patients receiving immunosuppressive therapy and/or 
head and neck radiation. The Reference Manual of Pediatric 
Dentistry. Chicago, Ill.; 2022:507-16.
    \87\ Butterworth C, McCaul L, Barclay C. Restorative dentistry 
and oral rehabilitation: United Kingdom National Multidisciplinary 
Guidelines. J Laryngol Otol. 2016 May;130(S2):S41-S4. PMID: 
27841112.
---------------------------------------------------------------------------

    We believe chemotherapy used in the treatment of cancer causes 
acute immunosuppression, causing significant oral complications and 
adverse events, including the possibility of an oral or dental 
infection, which in turn may lead to serious and imminent risks to the 
success of the primary medical procedures and treatments. These 
treatment-induced complications, including possible infection, prevent 
the ability to proceed with the primary, covered medical service (that 
is, lead to delays in treatment and/or cause the inability of the 
patient to complete the course of treatment, thereby potentially 
reducing the effectiveness of the therapy) and the standard of care 
would be to not proceed with the covered medical procedure until a 
dental or oral exam is performed to address the oral complications and/
or clear the patient of an oral or dental infection. In the case of the 
Medicare covered chemotherapy, when used in the treatment of cancer, 
dental services serve to mitigate the likelihood of occurrence and 
severity of complications caused by the primary medical services, 
including infection, and consequently, the dental services facilitate 
the successful completion of the prescribed course of treatment, and 
therefore, the dental services are integral and inextricably linked to 
these medical services, and the statutory dental exclusion would not 
apply.
    We believe that proceeding without a dental or oral exam and 
necessary diagnosis and treatment of any presenting infection of the 
mouth prior to chemotherapy when used in the treatment of cancer could 
lead to systemic infection or sepsis, as well as other complications 
for the patient. We also believe that an oral or dental infection could 
present substantial risk to the success of chemotherapy when used in 
the treatment of cancer, such that the standard of care would be to not 
proceed with the procedure when there is a known oral or dental 
infection present. We believe dental services furnished to identify, 
diagnose, and treat oral or dental infections prior to and medically 
necessary diagnostic and

[[Page 79020]]

treatment services to eliminate an oral or dental infection prior to, 
or contemporaneously with chemotherapy when used in the treatment of 
cancer are not in connection with the care, treatment, filling, 
removal, or replacement of teeth or structures directly supporting 
teeth, but instead are inextricably linked to these other covered 
services.
    In the CY 2024 PFS proposed rule, we also solicited comment on 
whether we should consider radiation therapy in the treatment of cancer 
more broadly (not in conjunction with chemotherapy, and not in relation 
to head and neck cancer treatment) as medical services that may be 
inextricably linked to dental services (88 FR 52377). We stated that we 
do not believe that radiation therapy alone necessarily leads to the 
same level of treatment-induced immunosuppression as for cancer 
patients receiving chemotherapy since radiation specifically targets 
malignant cells and has more targeted and localized effects on the body 
as compared to system-wide immunosuppression effects of chemotherapy 
for cancer treatment. However, we solicited comment on whether dental 
services prior to radiation therapy in the treatment of cancer, when 
furnished without chemotherapy, such as second line therapy for 
metastasized cancer in the head and neck, would be inextricably linked 
to the radiation therapy services, and therefore, payable under 
Medicare Parts A and B.
    We received public comments on this proposal. The following is a 
summary of the comments we received and our responses.
    Comment: Commenters supported the proposal that Medicare Parts A 
and B payment may be made for dental services, such as dental or oral 
examination performed as part of a comprehensive workup prior to, and 
medically necessary diagnostic and treatment services to eliminate an 
oral or dental infection prior to, or contemporaneously with Medicare-
covered chemotherapy when used in the treatment of cancer and urged CMS 
to finalize this policy as proposed. Commenters included individuals, 
patient advocacy organizations, hospitals and hospital associations, 
medical and dental associations representing several different 
specialties and specialty societies, health centers, and health 
insurance companies, among others. Many commenters expressed the view 
that payment for dental services in the proposed additional 
circumstances could improve patient outcomes and quality of life and 
reduce Medicare expenditures overall by avoiding the need to cover 
medical complications arising from untreated dental conditions. 
Commenters also stated that they believe that these updates will have a 
direct and meaningful impact on the lives of many Medicare 
beneficiaries. Many commenters also stated that they believe that these 
revisions would serve to promote health equity and increase access to 
medically necessary services for vulnerable members of the Medicare 
population. The commenters asserted that underserved populations 
generally do not have access to the necessary oral health services 
required for successful outcomes and will help address persistent 
inequities in cancer outcomes. Commenters also stated that they 
believed payment for dental services in these circumstances may ensure 
that poor oral health in these circumstances does not further 
complicate the treatment of these covered medical conditions, may 
generate cost savings for vulnerable patients, and may also help with 
their candidacy for further interventions such as allogeneic stem cell 
transplant.
    Commenters stated that standard of care in many cancer centers 
includes a comprehensive oral exam prior to starting therapy.\88\ 
Commenters also noted that the National Cancer Institute recommends 
that cancer patients receiving high-dose chemotherapy, stem cell 
transplants, or radiation therapy should have an oral care plan in 
place before treatment begins to mitigate the risk of oral 
complications \89\ that administering chemotherapy before providing 
dental treatment when an identifiable oral or dental infection is 
present does not align with the established standard of care. 
Commenters also supported the proposed clarification that payment may 
be made for dental and oral health treatments and ancillary services 
prior to or during cancer treatment regardless of the cancer's primary 
or metastatic status, site of origin, or initial treatment modality. 
Several commenters expressed support and appreciation for proposing to 
permit Medicare payment for dental services in scenarios where patients 
are receiving chemotherapy as a single modality, regardless of whether 
chemotherapy is used in combination with other cancer therapies. 
Commenters noted that if the policy were to only apply in cases where 
chemotherapy is the only treatment, they were concerned that such an 
application of the policy would increase health disparities between 
cancer treatments.
---------------------------------------------------------------------------

    \88\ Yong CW, Robinson A, Hong C. Dental Evaluation Prior to 
Cancer Therapy. Front Oral Health. 2022 Apr 18;3:876941. doi: 
10.3389/froh.2022.876941. PMID: 35510226; PMCID: PMC9058061.
    \89\ https://www.cancer.gov/about-cancer/treatment/side-effects/mouth-throat/oral-complications-hp-pdq.
---------------------------------------------------------------------------

    Response: We agree with commenters that there is evidence to 
support that certain dental services serve to mitigate the substantial 
risk to the clinical success of the medical services due to the 
severity of complications that can be caused by the dental infection. 
We also agree that administering chemotherapy before providing dental 
treatment when an identifiable oral or dental infection is present does 
not align with the established standard of care, and that the dental 
services are considered to be an essential clinical requirement before 
moving forward with the primary medical procedure.
    We further agree with commenters that Medicare payment for dental 
services should not be limited to cases where chemotherapy in the 
treatment of cancer is provided without the use of other therapies, as 
chemotherapy services when used in the treatment of cancer, either as a 
single modality or in conjunction with other therapy types, can cause 
immunosuppression which may lead to significant oral complications and 
adverse events, including the possibility of an oral or dental 
infection, which in turn lead to serious and imminent risks to the 
success of the primary medical procedures and treatments. The 
complications, including possible infection, may prevent the ability to 
both initiate and proceed with the primary, covered medical service 
(that is, lead to delays in treatment and/or cause inability of the 
patient to complete the course of treatment, thereby potentially 
reducing effectiveness of the therapy) such that the standard of care 
would be to not proceed with the covered medical procedure until a 
dental or oral exam is performed to address the oral complications and/
or clear the patient of an oral or dental infection. In the case of 
chemotherapy services when used in the treatment of cancer, dental 
services serve to mitigate the likelihood of occurrence and severity of 
complications caused by the primary medical services, including 
infection, and consequently, the dental services facilitate the 
successful completion of the prescribed course of treatment. As such, 
we believe the dental services are integral and inextricably linked to 
the chemotherapy when used in the treatment of cancer, and the 
statutory dental exclusion under section 1862(a)(12) of the Act would 
not apply

[[Page 79021]]

and are finalizing this aspect of the proposal.
    Comment: Several commenters requested that Medicare provide payment 
for dental and oral examinations performed as part of a comprehensive 
workup for Medicare beneficiaries with cancer prior to the 
administration of single modality radiation therapy, outside of usage 
in the treatment of head and neck cancer. Commenters suggested that 
radiation, although usually not systemic, also has a powerful cytotoxic 
effect, though commenters noted that radiation may have a less damaging 
impact on the immune system because it is not systemic and does not 
cause immunosuppression. Commenters stated that radiation does have to 
travel through areas of healthy cells to treat the tumor, so healthy 
cells through which the radiation travels and nearby cells can be 
affected. Commenters also stated that the radiation may directly damage 
the immune system, the skeletal system, or bone marrow, causing 
neutropenia. Commenters stated that, for example, radiation near the 
axilla following treatment of a solid breast cancer tumor, can damage 
lymph nodes which are part of the immune system, leading to risk of 
infection in the arm and lymphedema.
    Commenters further suggested that patients with a diagnosis of 
leukemia, lymphoma, or multiple myeloma scheduled for a stem cell or, 
bone marrow transplant receive total body radiation (TBI) prior to the 
transplant (conditioning process), which then causes neutropenia and 
related immunosuppression. The commenters noted that because the 
radiation conditioning process kills stem cells, patients are 
temporarily unable to replace the neutrophils that fight infection, 
potentially leaving the patients at higher risk for oral and systemic 
infections such as dental infections.
    Response: We appreciate the suggestion that single modality 
radiation therapy should be included in the list of covered medical 
services. However, we do not believe that the evidence submitted by 
commenters is sufficient to demonstrate an inextricable linkage between 
dental services and the success of single modality radiation therapy 
during the treatment of certain cancers (other than head and neck 
cancer). In cases of single modality radiation (other than when 
utilized for treatment of head and neck cancer), we are not convinced 
that the radiation treatment necessary to treat the individual's 
underlying medical condition requires the performance of certain dental 
services and that those dental services would serve to mitigate the 
substantial risk to the success of the medical services, due to the 
occurrence and severity of complications caused by the primary medical 
services. While single modality radiation may create medical 
complications for the patient, we do not believe that dental services 
would serve to mitigate the substantial risk to the success of the 
radiation or is an essential clinical requirement before moving forward 
with the primary medical procedure, and therefore, that an inextricable 
linkage between the covered medical services and the provision of 
dental services can be established. However, we note that in instances, 
for example, where patients with a diagnosis of leukemia, lymphoma, or 
multiple myeloma scheduled for a stem cell or, bone marrow transplant 
receiving total body radiation (TBI) prior to the transplant 
(conditioning process) pretreatment for transplantation, Medicare Parts 
A and B payment may be made for dental services, such as dental or oral 
examination performed as part of a comprehensive workup prior to, and 
medically necessary diagnostic and treatment services to eliminate an 
oral or dental infection prior to, or contemporaneously with, an organ 
transplant, including hematopoietic stem cell transplant, are currently 
included in the examples listed at Sec.  411.15(i)(3)(i).
    However, we continue to encourage additional public discussions and 
engagement on issues relating to Medicare payment for certain dental 
services that do not fall within the exclusion under section 
1862(a)(12) of the Act through the finalized public process as 
described in section described in section II.K.1.c. above in this final 
rule and welcome additional public submissions regarding single 
modality radiation. We continue to seek medical evidence that certain 
dental services are so integral to medically necessary services that 
they are not in connection with the care, treatment, filling, removal, 
or replacement of teeth or structures directly supporting teeth within 
the meaning of section 1862(a)(12) of the Act and that such dental 
services are inextricably linked to other covered services.
    Moreover, we note that MACs retain the flexibility to determine on 
a claim-by-claim basis whether a patient's circumstances do or do not 
fit within the terms of the preclusion or exception specified in 
section 1862(a)(12) of the Act and Sec.  411.15(i)(3). We further note 
that the finalized policies outlined in this section of the final rule 
would not prevent a MAC from making a determination that payment can be 
made for dental services in accordance with the regulation at Sec.  
411.15(i)(3)(i) in other circumstances not specifically addressed 
within this final rule and the finalized amendments to that regulation.
    After consideration of the public comments, clinical practice 
guidelines, recommendations provided by the public, and our analyses of 
the studies and research, we are finalizing amendments to our 
regulation at Sec.  411.15(i)(3)(i) to add chemotherapy in the 
treatment of cancer as an additional example of a clinical scenario 
under which payment can be made under Medicare Parts A and B, under the 
applicable payment system, for certain dental services that occur 
within the inpatient hospital and outpatient setting, as clinically 
appropriate. We are finalizing, with modifications, an amendment to 
Sec.  411.15(i)(3)(i) to add dental or oral examination performed as 
part of a comprehensive workup prior to, and medically necessary 
diagnostic and treatment services to eliminate an oral or dental 
infection prior to, or contemporaneously with, chemotherapy in the 
treatment of cancer to the list of examples of dental services that are 
not subject to the exclusion under section 1862(a)(12) of the Act and 
for which payment can be made under Medicare Parts A and B for dental 
services.
b. Dental Services Inextricably Linked to CAR T-Cell Therapy, When Used 
in the Treatment of Cancer
    After consideration of clinical practice guidelines, 
recommendations provided by the public, and our analyses of the studies 
and research available regarding the connection between dental services 
and the clinical success of CAR T-cell therapy, in the CY 2024 PFS 
proposed rule we proposed that dental services to diagnose and treat 
infection prior to CAR T-cell therapy are inextricably linked to the 
clinical success of CAR T-cell therapy, and that these services also 
represent a clinically analogous scenario to dental services for which 
Medicare payment under Parts A and B is currently permitted when 
furnished in the inpatient or outpatient setting, such as prior to 
organ transplant, cardiac valve replacement, or valvuloplasty 
procedures (88 FR 52377 to 52379). We stated that we believe there is 
an inextricable link between dental and CAR T-cell therapy when used in 
the treatment of cancer because the standard of care is such that one 
would not proceed with the medical procedure or service without 
performing the dental service because the covered medical

[[Page 79022]]

services would or could be significantly and materially compromised 
absent the provision of the inextricably-linked dental services and 
that dental services are a clinical prerequisite to proceeding with the 
CAR T-cell therapy when used in the treatment of cancer.
    We believe that proceeding without a dental or oral exam and 
necessary diagnosis and treatment of any presenting infection of the 
mouth prior to (CAR) T-cell therapy when used in the treatment of 
cancer could lead to systemic infection or sepsis, as well as other 
complications for the patient. We also believe that an oral or dental 
infection could present a substantial risk to the success of the (CAR) 
T-cell therapy when used in the treatment of cancer, such that the 
standard of care would be to not proceed with the procedure when there 
is a known oral or dental infection present. We believe dental services 
furnished to identify, diagnose, and treat oral or dental infections 
prior to and medically necessary diagnostic and treatment services to 
eliminate an oral or dental infection prior to, or contemporaneously 
with (CAR) T-cell therapy when used in the treatment of cancer are not 
in connection with the care, treatment, filling, removal, or 
replacement of teeth or structures directly supporting teeth, but 
instead are inextricably linked to these other covered medical 
services. As such, in the CY 2024 PFS proposed rule, we proposed to add 
this clinical scenario to the examples of clinical scenarios under 
which payment can be made for certain dental services in our regulation 
at Sec.  411.15(i)(3)(i)(A) (88 FR 52379). Specifically, we proposed to 
amend the regulation to include a dental or oral examination performed 
as part of a comprehensive workup in either the inpatient or outpatient 
setting prior to Medicare-covered CAR T-cell therapy when used in the 
treatment of cancer; and medically necessary diagnostic and treatment 
services to eliminate an oral or dental infection prior to, or 
contemporaneously with, CAR T-cell therapy when used in the treatment 
of cancer. We solicited comments on all aspects of this proposal.
    We also solicited comment on whether we should add as an example of 
dental services for which payment may be made under Medicare Parts A 
and B other types of lymphodepleting medical services used for cancer 
treatment, in addition to those used in conjunction with CAR T-cell 
therapy for cancer treatment. Commenters submitting through the public 
process for consideration in CY 2024 rulemaking specifically stated 
that CAR T-Cell therapies constituted lymphodepleting therapies, and we 
believe there may be other immunotherapies that may have a similar 
lymphodepletion component, but we received no specific information 
regarding such therapies. Evidence submitted by the public through the 
finalized public submission process indicates that treatment-induced 
immunosuppression may also occur with lymphodepleting medical services, 
and that complications caused by the treatment-induced 
immunosuppression, including possible infection, may prevent the 
ability to proceed with the primary, covered medical service (that is, 
lead to delays in treatment and/or cause inability of the patient to 
complete the course of treatment, thereby potentially reducing the 
effectiveness of the therapy) and the standard of care would be to not 
proceed with the covered medical procedure until a dental or oral exam 
is performed to address the oral complications and/or clear the patient 
of an oral or dental infection. However, we requested comment on what 
specific medical services also involve lymphodepletion and should be 
considered in addition to CAR T-cell therapy. We also requested 
additional information regarding how dental infections/conditions might 
impact those specific services. We noted that if we receive compelling 
clinical evidence, we may finalize in the CY 2024 PFS final rule 
additional clinical scenarios, such as dental services prior to other 
types of specific lymphodepleting medical services where the treatment 
may induce immunosuppression for patients with cancer and the standard 
of care would be to not proceed with the medical services without 
having first complete the dental services, where payment could be made 
under Medicare Part A or Part B. We solicited comment on whether there 
is a significant quality of care detriment if certain dental services 
are not provided prior to these other types of lymphodepleting medical 
services, and if so, we requested a description of that systematic 
evidence. We received public comments on this proposal. The following 
is a summary of the comments we received and our responses.
    Comment: Commenters supported the proposal that Medicare Parts A 
and B payment may be made for dental services, such as dental or oral 
examination performed as part of a comprehensive workup prior to, and 
medically necessary diagnostic and treatment services to eliminate an 
oral or dental infection prior to, or contemporaneously with Medicare-
covered CAR-T cell therapies when used in the treatment of cancer and 
urged CMS to finalize this policy as proposed. Commenters included 
individuals, patient advocacy organizations, hospitals and hospital 
associations, medical and dental associations representing several 
different specialties and specialty societies, health centers, and 
health insurance companies, among others.
    Many commenters expressed that payment for dental services in the 
proposed additional circumstances could improve patient outcomes and 
quality of life and reduce Medicare expenditures overall by avoiding 
the need to cover medical complications arising from untreated dental 
conditions. Commenters also stated that they believe that these updates 
will have a direct and meaningful impact on the lives of many of 
Medicare beneficiaries. Many commenters also stated that they believe 
that these revisions would serve to promote health equity and increase 
access to medically necessary services for vulnerable members of the 
Medicare population. The commenters asserted that underserved 
populations generally do not have access to the necessary oral health 
services required for successful outcomes and will help address 
persistent inequities in cancer outcomes. Commenters also stated that 
they believed payment for dental services in these circumstances may 
ensure that poor oral health in these circumstances does not further 
complicate the treatment of these covered medical conditions, may 
generate cost savings for vulnerable patients, and may also help with 
their candidacy for further interventions such as allogeneic stem cell 
transplant.
    Commenters stated that standard care in many cancer centers 
includes a comprehensive oral exam, which is a requirement prior to 
starting CAR T-cell therapy. Commenters noted that proceeding with CAR 
T-cell prior to dental treatment services when a known oral or dental 
infection is present is not the accepted standard of care, as the 
presence of the infection could jeopardize the outcome of the 
treatment. Commenters further stated that CAR T-cell medical services 
cause a patient to be immunosuppressed, such that an untreated oral or 
dental infection could complicate or compromise the clinical outcome of 
the CAR T-cell medical service. For those reasons, the commenters 
supported CMS' proposal and urged finalization of the proposed policy.

[[Page 79023]]

    Response: We agree with commenters that there is evidence to 
support that dental services serve to mitigate the substantial risk to 
the success of the medical services due to the severity of 
complications caused by the primary medical services, including 
increased risk of infection and potential sepsis. We also agree that 
the standard of care for chemotherapy, when used in the treatment of 
cancer, would be compromised absent the provision of certain dental 
services and that the dental services are considered to be an essential 
clinical requirement before moving forward with the primary medical 
procedure.
    Additionally, we agree with commenters that CAR T-cell therapy 
causes immunosuppression, which may lead to significant oral 
complications and adverse events, including the possibility of an oral 
or dental infection, which in turn leads to serious and imminent risks 
to the success of the primary medical procedures and treatments. The 
complications, including possible infection, may prevent the ability to 
both initiate and proceed with the primary, covered medical service 
(that is, lead to delays in treatment and/or cause inability of the 
patient to complete the course of treatment, thereby potentially 
reducing effectiveness of the therapy) such that the standard of care 
would be to not proceed with the covered medical procedure until a 
dental or oral exam is performed to address the oral complications and/
or clear the patient of an oral or dental infection. In the case of CAR 
T-cell therapy services when used in the treatment of cancer, dental 
services serve to mitigate the likelihood of occurrence and severity of 
complications caused by the primary medical services, including 
infection, and consequently the dental services facilitate the 
successful completion of the prescribed course of treatment. Therefore, 
we believe that the dental services that are inextricably linked to, 
and substantially related and integral to the clinical success of, CAR 
T-cell in the treatment of cancer are not subject to the exclusion 
under section 1862(a)(12) of the Act and that payment can be made under 
Medicare Parts A and B, under the applicable payment system, for such 
dental services that occur within the inpatient hospital and outpatient 
setting, as clinically appropriate. We are finalizing, with 
modifications, an amendment to Sec.  411.15(i)(3)(i) to add dental or 
oral examination performed as part of a comprehensive workup prior to, 
and medically necessary diagnostic and treatment services to eliminate 
an oral or dental infection prior to, or contemporaneously with CAR T-
cell therapy in the treatment of cancer to the list of examples of 
services that are not subject to the exclusion under section 
1862(a)(12) of the Act and for which payment can be made under Medicare 
Parts A and B. We are finalizing this aspect of the proposal.
    Comment: A few commenters provided feedback and requested that CMS 
evaluate whether dental services may be inextricably linked to the 
clinical success of other immunotherapies that may have a similar 
lymphodepleting component as CAR T-cell therapies. However, the 
commenters noted that at this time they were unable to supply medical 
or clinical evidence to support this potential addition to this policy. 
The commenters encouraged CMS to continue to consider whether dental 
services may be inextricably linked to the clinical success of other 
immunotherapies that may have a similar lymphodepleting component as 
CAR T-cell therapies. One commenter submitted research related to the 
usage of rituximab as a first-line treatment for non-Hodgkin's lymphoma 
and discussed the impacts the advent of rituximab had on treatment 
outcomes for patients with diffuse large B cell lymphoma (DLBCL) 
compared with the pre-rituximab era.\90\
---------------------------------------------------------------------------

    \90\ Mohammed R, Milne A, Kayani K, Ojha U. How the discovery of 
rituximab impacted the treatment of B-cell non-Hodgkin's lymphomas. 
J Blood Med. 2019 Feb 27;10:71-84. doi: 10.2147/JBM.S190784. PMID: 
30881167; PMCID: PMC6398399.
---------------------------------------------------------------------------

    Response: We thank the commenters for their suggestion and 
submission of studies related to the connection between the clinical 
success of other immunotherapies that may have a lymphodepleting 
component and the provision of dental services. While the clinical 
trials appeared to show a positive impact of rituximab on survival 
outcomes when treating aggressive B-cell lymphomas, the research did 
not provide concrete evidence regarding the connection between the 
provision of dental or oral services and outcomes for immunotherapies 
such as Rituximab. We continue to welcome further evidence on the 
impact of dental services on clinical scenarios involving monoclonal 
antibodies. Additionally, while some commenters noted that there is 
limited evidence to establish that dental services may be inextricably 
linked to the clinical success of other lymphodepleting therapies, we 
will continue to consider this and other suggestions as we consider 
potential future rulemaking through research of clinical studies and 
related materials. We reiterate that as described in section II.K.1.c. 
of this final rule, documentation submitted for the purposes of this 
payment policy should include medical evidence to support that certain 
dental services are inextricably linked to other covered services. 
Materials submitted should demonstrate that dental services are so 
integral to other medically necessary services that they are not in 
connection with the care, treatment, filling, removal, or replacement 
of teeth or structures directly supporting teeth within the meaning of 
section 1862(a)(12) of the Act but rather that such dental services are 
inextricably linked to other covered services, and therefore, are 
instead substantially related and integral to that primary medical 
service. Details regarding the public submission process are available 
in the CY 2023 PFS final rule (87 FR 69669 through 69670).
    Moreover, we reiterate that MACs have the flexibility to determine 
on a claim-by-claim basis whether certain dental services for 
beneficiaries receiving other immunotherapies that may involve a 
lymphodepleting component are subject to the exclusion on payment for 
dental services under section 1862(a)(12) of the Act and Sec.  
411.15(i). We further note that the finalized policies outlined in this 
section of this final rule would not prevent a MAC from determining on 
a case-by-case basis that payment can be made for certain dental 
services in other circumstances not specifically addressed within this 
final rule and Sec.  411.15(i)(3)(i), including as that regulation is 
amended by this final rule.
c. Dental Services Inextricably Linked to Administration of High-Dose 
Bone-Modifying Agents (Antiresorptive Therapy) When Used in the 
Treatment of Cancer
    In the CY 2024 PFS proposed rule, after consideration of clinical 
practice guidelines, recommendations provided by the public, and our 
analyses of the studies and research available regarding the connection 
between dental services and the clinical success of the administration 
of high-dose bone-modifying agents (antiresorptive therapy) when used 
in the treatment of cancer, we proposed to add this clinical scenario 
to the examples of clinical scenarios under which payment can be made 
for certain dental services in our regulation at Sec.  
411.15(i)(3)(i)(A) (88 FR 52379). We stated that we believe that there 
is an inextricable link between dental and administration of high-dose 
bone-modifying agents (antiresorptive

[[Page 79024]]

therapy) when used in the treatment of cancer because the standard of 
care is such that one would not proceed with the medical procedure or 
service without performing the dental service because the covered 
medical services would or could be significantly and materially 
compromised absent the provision of the inextricably-linked dental 
services and that dental services are a clinical prerequisite to 
proceeding with the administration of high-dose bone-modifying agents 
(antiresorptive therapy) when used in the treatment of cancer. 
Specifically, we proposed to amend the regulation to include dental or 
oral examination performed as part of a comprehensive workup in either 
the inpatient or outpatient setting prior to Medicare-covered the 
administration of Medicare-covered high-dose bone-modifying agents 
(antiresorptive therapy), when used in the treatment of cancer; and 
medically necessary diagnostic and treatment services to eliminate an 
oral or dental infection prior to, or contemporaneously with, 
administration of high-dose bone-modifying agents (antiresorptive 
therapy), when used in the treatment of cancer. We solicited comments 
on all aspects of this proposal.
    We note that in the CY 2023 PFS final rule (87 FR 70225) and now 
codified in our regulation at Sec.  411.15(i)(3)(i), we finalized that 
for dental services that are inextricably linked to, and substantially 
related and integral to the clinical success of, a certain covered 
medical service, payment may be made under Medicare Parts A and B for 
services when furnished in either the inpatient or outpatient setting; 
therefore, we proposed that these provisions would apply to the 
proposed amendments to regulation at Sec.  411.15(i)(3)(i) to allow for 
payment under Medicare Parts A and Part B in either the inpatient or 
outpatient setting. We further proposed that payment under the 
applicable payment system could also be made for services that are 
ancillary to these dental services, such as x-rays, administration of 
anesthesia, and use of the operating room as described in our 
regulation at Sec.  411.15(i)(3)(ii).
    We received public comments on this proposal. The following is a 
summary of the comments we received and our responses.
    Comment: Commenters supported Medicare payment for dental services, 
such as dental or oral examination performed as part of a comprehensive 
workup prior to, and medically necessary diagnostic and treatment 
services to eliminate an oral or dental infection prior to, or 
contemporaneously with the administration of high-dose bone-modifying 
agents (antiresorptive therapy) when used in the treatment of cancer. 
Commenters included individuals, patient advocacy organizations, 
hospitals and hospital associations, medical and dental associations 
representing several different specialties and specialty societies, 
health centers, and health insurance companies, among others. Many 
commenters expressed the view that payment for dental services in the 
proposed additional circumstances could improve patient outcomes and 
quality of life and reduce Medicare expenditures overall by avoiding 
the need to cover medical complications arising from untreated dental 
conditions. Commenters also stated that they believe that these updates 
will have a direct and meaningful impact on the lives of many of 
Medicare beneficiaries. Many commenters also stated that they believe 
that these revisions would serve to promote health equity and increase 
access to medically necessary services for vulnerable members of the 
Medicare population. The commenters asserted that underserved 
populations generally do not have access to the necessary oral health 
services required for successful outcomes and will help address 
persistent inequities in cancer outcomes. Commenters also stated that 
they believed payment for dental services in these circumstances may 
ensure that poor oral health in these circumstances does not further 
complicate the treatment of these covered medical conditions and may 
generate cost savings for vulnerable patients.
    Commenters recommended that Medicare provide payment for dental 
exams and related preventative services before initiating bone directed 
therapy using bisphosphonates and denosumab and urged CMS to finalize 
this policy as proposed. Commenters noted that there is no effective 
treatment for bisphosphonate-induced osteonecrosis, but preventative 
dental exams and management decrease risk of osteonecrosis of the jaw 
in cancer patients receiving these therapies, which can in turn 
jeopardize the successful completion of the treatment for cancer. 
Commenters stated that research shows that osteonecrosis of the jaw is 
a preventable condition, and that care coordination and preventative 
services can result in improved outcomes and in lower incidence of 
osteonecrosis of the jaw for cancer patients receiving bisphosphonate 
therapy. Commenters expressed appreciation for the inclusion of 
clinical guidelines as the rationale for coverage in the proposed rule, 
which state that cancer patients should receive an oral care assessment 
(including a comprehensive dental, periodontal, and oral radiographic 
exam, when feasible) prior to initiating the administration of high-
dose bone modifying agents (antiresorptive therapy) when used in the 
treatment of cancer to reduce complications and manage modifiable risk 
factors. Commenters stated that the dental-related complication to 
certain immunosuppressive cancer treatments, such as high-dose 
antiresorptive and/or antiangiogenic drug therapy can be serious, 
particularly medication-related osteonecrosis of the jaw (MRONJ), which 
can complicate cancer treatment and lead to reduced survival rates 
post-treatment. Commenters noted that patients with existing dental 
disease pose the greatest risk for developing MRONJ secondary to bone-
modifying therapy and recommended that the dental infection be 
addressed prior to the start of care, so as to facilitate the 
successful completion of the treatment. Commenters further stated that 
from a clinical standpoint, prevention of MRONJ is the gold standard 
and emphasized the importance of a multidisciplinary, coordinated 
approach that includes pretreatment dental management in minimizing the 
risk of MRONJ and supported CMS's proposal to expand Medicare coverage 
and payment for dental examinations prior to, as well as diagnostic and 
treatment services to eliminate an oral or dental infection prior to or 
at the same time as, the administration of high-dose bone modifying 
agents.
    Response: We agree with commenters that there is evidence to 
support that dental services serve to mitigate the substantial risk to 
the success of the medical services due to the severity of 
complications caused by the primary medical services as well as 
minimize the risk of infection and therefore the dental services are so 
integral to other medically necessary services that they are not in 
connection with the care, treatment, filling, removal, or replacement 
of teeth or structures directly supporting teeth within the meaning of 
section 1862(a)(12) of the Act. Rather, such dental services are 
inextricably linked to the clinical success of the medical service and 
are substantially related and integral to the covered medical service 
of administration of high-dose bone modifying agents in the treatment 
of cancer. As such, we are finalizing our proposal that Medicare Part A 
and Part B payment can be made for certain

[[Page 79025]]

dental services such as dental or oral examination performed as part of 
a comprehensive workup prior to, and medically necessary diagnostic and 
treatment services to eliminate an oral or dental infection prior to, 
or contemporaneously with, the administration of high-dose bone-
modifying agents (antiresorptive therapy) when used in the treatment of 
cancer. We believe that the standard of care for that medical service 
would be compromised absent the provision of dental services, and that 
the dental services are considered to be an essential clinical 
requirement before moving forward with the primary medical procedure.
    Comment: A few commenters asked that we clarify the term ``high-
dose'' bisphosphonate therapy and provide guidance regarding what this 
phrase means so as to minimize potential confusion with respect to this 
policy.
    Response: For the purposes of Medicare payment for dental services 
inextricably linked to other covered services, the term ``high-dose'' 
bisphosphonate therapy refers to the usage of bisphosphonate therapy 
when used in the treatment of cancer. In general, for patients 
undergoing treatment for cancer, currently, intravenous formulations 
have FDA label indication for patients with multiple myeloma or bone 
metastases from solid tumors. We believe that the particular dosage may 
be adjusted for various clinical situations, so setting a defined high-
dose dosage at a particular level may inadvertently exclude certain 
patient populations (such as renal-impaired patients who are receiving 
a particular dose). We also recognize that there may also be variation 
in dosage interval for the bisphosphonates varying between three, four, 
and perhaps twelve weeks of therapy. As such, we believe that ``high-
dose'' bisphosphonate therapy to which dental care may be inextricably 
linked would be defined as intravenous bisphosphonate therapy for the 
treatment of multiple myeloma and bone metastases of solid tumors. For 
example, ICD-10 codes for related conditions could include those that 
reflect multiple myeloma and bone metastases from a primary solid tumor 
(for example, breast, prostate), such as C90 Multiple myeloma and 
malignant plasma cell neoplasms, C90.0 Multiple myeloma, C90.00 
Multiple myeloma not having achieved remission, C90.01 Multiple myeloma 
in remission, C90.02 Multiple myeloma in relapse, C79.5 Secondary 
malignant neoplasm of bone and bone marrow, C79.51 Secondary malignant 
neoplasm of bone or C79.52 Secondary malignant neoplasm of bone marrow.
    From the evidence provided and reviewed, we note there are FDA 
approved defined intravenous dosages and intervals (with adjustment for 
renal impairment) for the use of some bisphosphonates for metastatic 
bone lesions and multiple myeloma, and we would not expect that oral 
regimens of these or other bisphosphonates would be commonly prescribed 
for these purposes.91 92 However, other dosage forms, when 
used for these purposes, possibly in an off-label manner, could be 
considered by the MACs on a case-by-case basis. Additionally, we would 
be open to reviewing evidence in the future of other applicable dosage 
forms. Currently, oral regimens have indications for osteoporosis and 
Paget's disease, which are not included in the list of clinical 
examples at Sec.  411.15(i).
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    \91\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021113s008lbl.pdf.
    \92\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021223s028lbl.pdf.
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    After consideration of the public comments, clinical practice 
guidelines, recommendations provided by the public, and our analyses of 
the studies and research, we are finalizing amendments to our 
regulation at Sec.  411.15(i)(3)(i) to provide that dental services 
that are inextricably linked to, and substantially related and integral 
to the clinical success of, the administration of high-dose bone-
modifying agents (antiresorptive therapy) in the treatment of cancer 
are not subject to the exclusion under section 1862(a)(12) of the Act; 
and that payment can be made under Medicare Parts A and B, under the 
applicable payment system, for such dental services that occur within 
the inpatient hospital and outpatient setting, as clinically 
appropriate. We are also finalizing an amendment to Sec.  
411.15(i)(3)(i) to add dental or oral examination performed as part of 
a comprehensive workup prior to, and medically necessary diagnostic and 
treatment services to eliminate an oral or dental infection prior to, 
or contemporaneously with the administration of high-dose bone-
modifying agents (antiresorptive therapy) in the treatment of cancer to 
the list of examples of services that are not subject to the exclusion 
under section 1862(a)(12) of the Act and for which payment can be made 
under Medicare Parts A and B.
d. Amendments to Regulations Regarding Dental Services Inextricably 
Linked to Treatment for Head and Neck Cancer
    In the CY 2024 PFS proposed rule, we proposed to clarify and codify 
that Medicare Parts A and B payment may be made for dental or oral 
examination performed as part of a comprehensive workup in either the 
inpatient or outpatient setting, as well as for the medically necessary 
diagnostic and treatment services to eliminate an oral or dental 
infection prior to the initiation of, or during, treatments for head 
and neck cancer, whether primary or metastatic, regardless of site of 
origin, and regardless of initial modality of treatment (88 FR 52380).
    Specifically, we proposed to amend our regulation at Sec.  
411.15(i)(3)(i)(A) to allow for payment under Medicare Parts A and Part 
B for:
    (1) Dental or oral examination in either the inpatient or 
outpatient setting prior to the initiation of, or during, Medicare-
covered treatments for head and neck cancer; and
    (2) Medically necessary diagnostic and treatment services to 
eliminate an oral or dental infection in either the inpatient or 
outpatient setting prior to the initiation of, or during, Medicare-
covered treatments for head and neck cancer.
    We received public comments on this proposal. The following is a 
summary of the comments we received and our responses.
    Comment: Commenters supported Medicare payment for dental services, 
such as dental or oral examination performed as part of a comprehensive 
workup prior to, and medically necessary diagnostic and treatment 
services to eliminate an oral or dental infection prior to, or 
contemporaneously with treatments for head and neck cancers. Commenters 
included individuals, patient advocacy organizations, hospitals and 
hospital associations, medical and dental associations representing 
several different specialties and specialty societies, health centers, 
and health insurance companies, among others. Many commenters expressed 
the view that payment for dental services in the proposed additional 
circumstances could improve patient outcomes and quality of life and 
reduce Medicare expenditures overall by avoiding the need to cover 
medical complications arising from untreated dental conditions. 
Commenters also stated that they believe that these updates will have a 
direct and meaningful impact on the lives of many of Medicare

[[Page 79026]]

beneficiaries. Many commenters also stated that they believe that these 
revisions would serve to promote health equity and increase access to 
medically necessary services for vulnerable members of the Medicare 
population. The commenters asserted that underserved populations 
generally do not have access to the necessary oral health services 
required for successful outcomes and will help address persistent 
inequities in cancer outcomes. Commenters also stated that they 
believed payment for dental services in these circumstances may ensure 
that poor oral health in these circumstances does not further 
complicate the treatment of these covered medical conditions and may 
generate cost savings for vulnerable patients.
    Commenters described that treatment for head and neck cancer 
generally refers to a group of cancers that originate in or metastasize 
to various areas of the head and neck, with the mucosal surfaces of the 
oral cavity, pharynx and larynx being most common and stated that these 
cancers are often grouped together because they share common risk 
factors, symptoms, and treatment approaches.
    Commenters noted, particularly for patients undergoing radiation 
therapy for any head and neck cancer, the importance of thorough 
initial dental evaluation, including dental x-rays, with special 
attention to any teeth that may require timely procedures, such as root 
canals and extractions, prior to radiation therapy. The commenters 
stated that cleaning and preparation work for radiation therapy is 
critical to the clinical success of radiation therapy. Commenters 
provided evidence that described the connection between the provision 
of dental services prior to, during, and after the treatment for head 
and neck cancer and the reduction of risk of complications that may 
jeopardize the success of the treatments and simultaneously result in 
improved outcomes for the patient.
    Response: We thank the commenters for their support. We agree that 
head and neck cancer generally refers to a group of cancers that 
originate in or metastasize to areas of the head and neck, which could 
include the mucosal surfaces of the oral cavity, pharynx and larynx and 
acknowledge that these cancers are often grouped together because they 
share common risk factors, symptoms, and treatment approaches. We also 
agree that the medical services necessary to diagnose and treat the 
underlying head and neck cancer may require the performance of certain 
dental services, which in turn serve to mitigate the substantial risk 
to the success of the medical services because of the risk of infection 
and of the occurrence and severity of complications that are caused by 
the primary medical services. Additionally, we agree that the standard 
of care for treatment for head and neck cancer would be compromised 
absent the performance of certain dental services, and that dental 
services are considered to be an essential clinical requirement before 
moving forward with the primary medical procedure. As such, we are 
finalizing our proposal that Medicare Part A and Part B payment can be 
made for certain dental services when furnished prior to or 
contemporaneously with the treatment of head and neck cancer.
    Comment: Several commenters requested that Medicare payment be 
permitted for patients undergoing single modality radiation therapy for 
any head and neck cancer, as the commenters note that it is important 
that those patients receive a thorough initial dental evaluation, 
including dental x-rays, with special attention to any teeth that may 
require timely procedures, such as root canals and extractions, prior 
to radiation therapy. Commenters provided evidence and stated that 
cleaning and preparation work for radiation therapy is also critical to 
the clinical success of radiation therapy, including the preparation of 
a fluoride carrier to protect teeth in an ongoing fashion. Commenters 
supplied research and further stated that due to the chronic dental 
side effects of head and neck radiotherapy and the risk of 
osteoradionecrosis with dental extractions after treatment, curative 
treatment for the underlying cancer may be delayed until dental care 
can be completed and that those delays would be eliminated if dental 
care could be addressed prior to the initiation of radiation treatment. 
Commenters also noted that in some radiation oncology treatments, masks 
utilized for treatment must fit on patients' faces correctly when 
receiving radiology and suggested that if the mask fits improperly due 
to issues related to dental care, treatment for the underly cancer is 
delayed until dental care can be completed. Commenters asserted that 
dental care to address these issues would facilitate the successful 
completion of the radiology treatment for head and neck cancer.
    Response: We agree that in the case of head and neck cancers, 
single modality radiation therapy uniquely impacts the dental and oral 
tissues such that the provision of certain dental services before or 
during the single modality treatment are linked to improved outcomes, 
including the reduction of the risk of infection. As such, we are 
finalizing our proposal that Medicare Part A and Part B payment can be 
made for certain dental services furnished before or during single 
modality radiation therapy when used in the treatment of head and neck 
cancer even when used as the single treatment modality and not in 
combination with any other therapy types.
    Comment: Many commenters requested that Medicare payment be 
permitted after direct treatment is completed for patients undergoing 
treatment for head and neck cancer. The commenters suggested that 
dental evaluations to identify, address, and rectify potential oral 
complications are necessary to ensure the success of the treatments and 
to improve quality outcomes for the patient in the period after the 
direct treatment for head and neck cancer. Commenters supplied clinical 
studies and research that demonstrate that the side effects encountered 
by patients undergoing treatment, such as radiotherapy, chemotherapy or 
combination treatment with concurrent systemic agents, for head and 
neck cancers, can include, but are not limited to: infection, 
mucositis, hyposalivation, dysphagia, osteoradionecrosis, and 
radiation-related caries.93 94 95 96 97 98 99

[[Page 79027]]

Commenters noted that these oral toxicities may be acute (developing 
during active treatment) or late onset (manifesting several months 
after treatment is complete) with some latent complications of 
radiotherapy linked to permanent tissue damage, as well as damage to 
bony structures, tissues, and salivary glands. Commenters noted that 
current data show approximately 30 percent of head and neck cancer 
patients develop radiation caries within 12 months following completion 
of radiotherapy.\100\
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    \93\ National Cancer Institute. Head and Neck Cancers. Updated 
May 25, 2021. Available at https://www.cancer.gov/types/head-and-neck/head-neck-fact-sheet Accessed August 8, 2023.
    \94\ Pisani, P., Airoldi, M., Allais, A., Aluffi Valletti, P., 
Battista, M., Benazzo, M., Briatore, R., Cacciola, S., Cocuzza, S., 
Colombo, A., Conti, B., Costanzo, A., Della Vecchia, L., Denaro, N., 
Fantozzi, C., Galizia, D., Garzaro, M., Genta, I., Iasi, G. A., 
Krengli, M., Landolfo, V., Lanza, G.V., Magnano, M., Mancuso, M., 
Maroldi, R., Masini, L., Merlano, M.C., Piemonte, M., Pisani, S., 
Prina-Mello, A., Prioglio, L., Rugiu, M.G., Scasso, F., Serra, A., 
Valente, G., Zannetti, M., and Zigliani, A. (2020). Metastatic 
disease in head & neck oncology. Acta Otorhinolaryngologica 
Italica,40(SUPPL. 1), S1-S86. https://doi.org/10.14639/0392-100X-suppl.1-40-2020.
    \95\ Pisani, P., Airoldi, M., Allais, A., Aluffi Valletti, P., 
Battista, M., Benazzo, M., Briatore, R., Cacciola, S., Cocuzza, S., 
Colombo, A., Conti, B., Costanzo, A., Della Vecchia, L., Denaro, N., 
Fantozzi, C., Galizia, D., Garzaro, M., Genta, I., Iasi, G. A., 
Krengli, M., Landolfo, V., Lanza, G.V., Magnano, M., Mancuso, M., 
Maroldi, R., Masini, L., Merlano, M.C., Piemonte, M., Pisani, S., 
Prina-Mello, A., Prioglio, L., Rugiu, M.G., Scasso, F., Serra, A., 
Valente, G., Zannetti, M., and Zigliani, A. (2020). Metastatic 
disease in head & neck oncology. Acta Otorhinolaryngologica 
Italica,40(SUPPL. 1), S1-S86. https://doi.org/10.14639/0392-100X-suppl.1402020.
    \96\ Epstein, J.B., Thariat, J., Bensadoun, R.J., Barasch, A., 
Murphy, B.A., Kolnick, L., Popplewell, L. and Maghami, E. (2021). 
Oral complications of cancer and cancer therapy. CA: Cancer Journal 
for Clinicians, 62(6). 400-422. https://doi.org/10.3322/caac.21157.
    \97\ Palmier N.R., Ribeiro, A.C.P, Fonseca, J.M., Salvajoli, 
J.C., Vargas, P.A., Lopes, M.A., Brandao, T.B. and Santos-Silva, 
A.R. (2017). Radiation-related caries assessment through the 
International Caries Detection and Assessment System and the Post-
Radiation Dental Index. Oral Surgery Oral Medicine Oral Pathology 
Oral Radiology, 124(6), 542-7. https://doi.org/10.1016/j.oooo.2017.08.019.
    \98\ National Institute for Dental and Craniofacial Research. 
(2009). Oral Complications of Dental Treatment: What the Dental Team 
Can Do (NIH Publication No. 09-4372). National Institutes of Health. 
2023. https://www.nidcr.nih.gov/sites/default/files/2017-09/oral-complications-cancerdental-team.pdf. Accessed August 11, 2023.
    \99\ PDQ[supreg] Supportive and Palliative Care Editorial Board. 
PDQ Oral Complications of Chemotherapy and Head/Neck Radiation. 
Bethesda, MD: National Cancer Institute. Updated October 21, 2022. 
Available at https://www.cancer.gov/about-cancer/treatment/side-effects/mouth-throat/oralcomplications-hp-pdq. Accessed August 11, 
2023. [PMID: 26389320].
    \100\ Pedroso, C.M., Miglioratti, C.A., Epstein, J.B., Ribeiro, 
A.C.P., Brandao, T.B., Lopes, M.A., Fernando de Goes, M. and Santos-
Silva, A.R. (2022). Over 300 radiation caries papers: Reflections 
from the rearview mirror. Frontiers in Oral Health, 3. https://doi.org/10.3389/froh.2022.961594.
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    Commenters also stated that the oral health of cancer patients 
undergoing radiation therapy in the treatment of head and neck cancer 
are uniquely impacted by the primary medical services intended to treat 
the underlying cancer. Commenters stated that patients undergoing 
radiotherapy experience an overall deterioration of dental and 
periodontal health, as well as chronic effects of radiotherapy, such as 
mucosal pain and recurrent infection, salivary gland dysfunction, and 
osteoradionecrosis, all of which are caused by the primary treatments 
for cancer. Commenters noted that these oral complications caused by 
the treatment for head and neck cancer can be either acute or chronic 
and can manifest within months of the final treatments and potentially 
persist through the end of life. Commenters stated that managing oral 
complications of head and neck cancer therapy can be very costly and 
create a financial burden for patients, offering that ongoing treatment 
for complications caused by treatment can range from approximately 
$4,000-$35,000 for osteoradionecrosis and between $5,000-$30,000 for 
management of oral mucositis in cancer patients undergoing 
radiotherapy, stating that some researchers attribute this high cost 
both to the resource-intensive settings in which management of oral 
complications typically takes place and the complex needs of cancer 
patients including enteral and parenteral feedings, febrile 
neutropenia, and frequency of hospitalizations.101 102
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    \101\ Sroussi, H.Y., Epstein, J.B., Bensdoun, R.J., Saunders, 
D.P., Lalla, R.V., Migliorati, C.A., Heaivilin, N. and Zumsteg, Z.S. 
(2017). Common oral complications of head and neck cancer radiation 
therapy: mucositis, infections, saliva change, fibrosis, sensory 
dysfunctions, dental caries, periodontal disease, and 
osteoradionecrosis. Cancer Medicine,6(12). 298-2931. https://doi.org/10.1002/cam4.1221.
    \102\ Elting, L.S. and Chang, Y.C. (2019). Costs or oral 
complications of cancer therapies: Estimates and a blueprint for 
future study. Journal of the National Cancer Institute 
Monographs,2019(53). https://doi.org/10.1093/jncimonographs/lgz010.
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    Additional commenters stated that, in general, medical standards of 
cancer care include routine follow-up, supplemental, or secondary 
treatments for symptom management and long-term management of overall 
health for head and neck cancer patients, and that oral and dental care 
should be incorporated into clinical cancer care protocols for pre-, 
intra- and post-treatment, especially for diagnoses or therapies known 
to cause oral complications. The commenters asserted that access to 
medically necessary dental services post-radiation positively impact 
patient quality of life and mitigate some of the resource-intensive 
treatment of advanced oral sequelae of head and neck cancer and its 
treatment. These commenters requested that CMS expand Medicare payment 
to include medically necessary dental services occurring 
postradiotherapy for beneficiaries with a diagnosis of head and neck 
cancer.
    Several commenters asked CMS to adopt a definition of ``during'' or 
``contemporaneously with'' in the treatment of head and neck cancer 
that recognizes the patient-specific clinical decisions that occur in 
this specific patient population. The commenters suggested that the 
definition of ``during'' or ``contemporaneously with'' for head and 
neck cancer should encompass a clinically recognized recovery phase for 
targeted head and neck cancer treatment, which the commenters noted 
they believe would advance the goals of the Medicare program without 
violating the statutory dental exclusion.
    Response: We appreciate the commenters' thoughtful and evidence-
based feedback regarding the link between medically necessary 
diagnostic and treatment services for head and neck cancer and the 
unique circumstances surrounding the ongoing oral complications that 
following treatment for head and neck cancer. While we did not propose 
to add to our regulation that Medicare Parts A and B payment is 
permitted for medically necessary diagnostic and treatment services to 
address dental or oral complications after radiation, chemotherapy, 
and/or surgery when used in the treatment of head and neck cancer, we 
are persuaded by evidence provided by commenters that treatment for 
head and neck cancer uniquely causes additional significant and acute 
(developing during active treatment) dental and/or oral complications 
for the patient, including increased risk of infection even after the 
direct treatment for head and neck cancer has ended. The research 
submitted by commenters indicates that radiation therapy causes an 
increased occurrence of caries, mucositis, osteoradionecrosis, and 
other severe complications. Commenters provided persuasive arguments, 
clinical guidelines, and research to substantiate that the provision of 
dental services with the treatment for head and neck cancer leads to 
improved healing and improved quality outcomes for the treatments, 
including the reduction of incidence of infection, and without the 
provision of dental services, the final outcome of the treatment for 
head and neck cancer may be jeopardized. We are also convinced that the 
standard of care for the treatments for head and neck cancer would be 
compromised absent the provision of dental services to address the oral 
complications caused by the primary treatment. Additionally, we are 
convinced by the evidence submitted by commenters that the provision of 
certain dental services after direct treatments for head and neck 
cancers supports that certain dental services would result in 
clinically significant improvements in quality and safety outcomes for 
the patient.
    The research submitted by commenters demonstrates varying post-
treatment dental needs for individuals receiving treatment for head and 
neck cancer (HNC), stemming from the acute (developing during active 
treatment) and chronic complications caused by the treatment for the 
HNC. For example, mucositis may be caused by either radiation therapy 
or chemotherapy. According to the National Cancer Institute, mucositis 
caused by chemotherapy will heal by itself, usually within 2 to 4 weeks 
if there is no infection. Mucositis caused by radiation therapy usually 
lasts 6 to 8 weeks, depending on the duration of

[[Page 79028]]

treatment.\103\ Additionally, complications such as dropped head 
syndrome (DHS) can occur from 3 months to 30 years after radiation 
therapy for HNC patients.\104\ Current research highlights the long-
term dental service needs for individuals treated for HNC. Patients who 
underwent radiation therapy reported oral complications and challenges 
within six months after treatment, such as dry mouth, sticky saliva, 
difficulty swallowing solid foods, and changes in taste.\105\ A 
systematic review revealed that certain treatment-related issues 
persisted beyond 12 months, including dry mouth, sticky saliva, 
difficulties with social eating, fatigue, and physical 
functioning,\106\ all of which may benefit from ongoing monitoring and 
dental support in the first year following treatment and beyond. 
Moreover, access to expert oral healthcare is critical for both HNC 
patients and survivors, as issues related to mobility and sensory 
disturbances can persist permanently.\107\ A systematic review 
indicated that dental caries occurs in approximately 29 percent of 
post-radiotherapy HNC patients. Furthermore, the risk of developing 
dental caries within two years of head and neck radiotherapy is 
approximately 37 percent; studies with a higher proportion of patients 
treated with chemotherapy, in addition to radiotherapy, had an 
increased incidence of dental caries.\108\ Based on the evidence 
provided by commenters, we believe that most oral complications may 
arise within 24 months of the completion of direct treatment. However, 
we recognize that some oral complications may persist beyond such a 
window. We continue to seek feedback from the public and interested 
parties on our continued interest in understanding how the timing of 
medical treatment and oral health care might illustrate an inextricable 
linkage.
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    \103\ PDQ[supreg] Supportive and Palliative Care Editorial 
Board. PDQ Oral Complications of Chemotherapy and Head/Neck 
Radiation. Bethesda, MD: National Cancer Institute. Updated <04/26/
2019>. Available at https://www.cancer.gov/about-cancer/treatment/side-effects/mouth-throat/oral-complications-pdq. Accessed 10/12/
2023. [PMID: 26389169]
    \104\ Brook I. Late side effects of radiation treatment for head 
and neck cancer. Radiat Oncol J. 2020 Jun;38(2):84-92. doi: 10.3857/
roj.2020.00213. Epub 2020 Jun 25. PMID: 33012151; PMCID: PMC7533405.
    \105\ Lalla RV, Treister N, Sollecito T, Schmidt B, Patton LL, 
Mohammadi K, Hodges JS, Brennan MT; OraRad Study Group. Oral 
complications at 6 months after radiation therapy for head and neck 
cancer. Oral Dis. 2017 Nov;23(8):1134-1143. doi: 10.1111/odi.12710. 
Epub 2017 Aug 3. PMID: 28675770; PMCID: PMC6218933.
    \106\ So WK, Chan RJ, Chan DN, Hughes BG, Chair SY, Choi KC, 
Chan CW. Quality-of-life among head and neck cancer survivors at one 
year after treatment--a systematic review. Eur J Cancer. 2012 
Oct;48(15):2391-408. doi: 10.1016/j.ejca.2012.04.005. Epub 2012 May 
12. PMID: 22579456.
    \107\ Sroussi HY, Epstein JB, Bensadoun RJ, Saunders DP, Lalla 
RV, Migliorati CA, Heaivilin N, Zumsteg ZS. Common oral 
complications of head and neck cancer radiation therapy: mucositis, 
infections, saliva change, fibrosis, sensory dysfunctions, dental 
caries, periodontal disease, and osteoradionecrosis. Cancer Med. 
2017 Dec;6(12):2918-2931. doi: 10.1002/cam4.1221. Epub 2017 Oct 25. 
PMID: 29071801; PMCID: PMC5727249.
    \108\ Moore C, McLister C, Cardwell C, O'Neill C, Donnelly M, 
McKenna G. Dental caries following radiotherapy for head and neck 
cancer: A systematic review. Oral Oncol. 2020 Jan;100:104484. doi: 
10.1016/j.oraloncology.2019.104484. Epub 2019 Nov 28. PMID: 
31786391.
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    For example, we believe that dental services may be warranted in 
the case of a patient with locoregionally advanced head and neck 
cancers treated with surgery followed by radiation therapy, or 
definitive radiation therapy, with or without adjuvant chemotherapy, 
and the oral cavity is within the radiation treatment field. We 
considered the clinical scenario of a 75-year-old patient who is a non-
smoker, that presents with a single enlarged 2 cm level 2 [upper 
lateral neck] right lymph node. The ensuing work-up discovers human 
papilloma virus (HPV) positive squamous cell carcinoma in the neck node 
with a right base of tongue primary tumor. The patient has intact 
dentition. The patient is treated with definitive chemoradiation for 
both the primary tumor and the regional metastatic neck disease. The 
patient is followed regularly by the dentist during and after treatment 
to assist with management of the oral mucositis and xerostomia [dry 
mouth] and to monitor the dentition. The oral services provided after 
the direct treatment for head and neck cancer serve to address any 
complications that may arise from the primary treatment itself. In this 
scenario, we believe that Medicare Parts A and B payment may be made 
for dental services inextricably linked to the treatment for head and 
neck cancer, such as dental or oral examination to monitor for oral and 
dental complications such as oral mucositis and xerostomia, as well as 
evaluate for changes in dentition and identification and the 
elimination of an oral or dental infection. We note that additional 
dental services, such as a dental implant or crown, may not be 
considered immediately necessary to address oral complications caused 
by the treatment for head and neck cancer. Therefore, we believe that 
such additional services would not be inextricably linked to, and 
substantially related and integral to, the clinical success of, the 
treatment for head and neck cancer. As such, no Medicare payment would 
be made for the additional services that are not immediately necessary 
prior to addressing the oral complications caused by the treatments for 
head and neck cancer.
    We also considered another case in which a 65-year-old patient, who 
is a long-term smoker, presents with multiple level 2 and 3 [upper and 
mid lateral neck] enlarged left lymph nodes. The ensuing work-up 
discovers human papilloma virus (HPV) negative squamous cell carcinoma 
in the neck nodes, but no defined primary origin of tumor, and no 
distant metastases. The patient has generally poor dentition and 
undergoes extraction of several vulnerable teeth by an oral surgeon 
prior to beginning the cancer treatment. The patient is treated with a 
left modified radical neck dissection [surgery to remove the cancerous 
lymph nodes in the neck with some of the surrounding tissue] followed 
by radiation therapy to the neck and the aerodigestive mucosa [nose, 
mouth and throat lining] from the nasopharynx [back of the nose] to the 
larynx [voice box]. The patient declined adjuvant chemotherapy. The 
patient is followed by the dentist during and after treatment to assist 
with management of the oral mucositis and xerostomia [dry mouth] and to 
monitor the remaining dentition. Again, the oral services provided 
after the direct treatment for head and neck cancer serve to address 
the unique oral complications that were a result of the primary 
treatment itself. In this scenario, we believe that Medicare Parts A 
and B payment may be made for dental services inextricably linked to 
the treatment for head and neck cancer, such as medically necessary 
diagnostic and treatment services to eliminate an oral or dental 
infection prior to the initiation of treatment, and, after direct 
treatment, dental or oral examination to monitor for oral and dental 
complications such as oral mucositis and xerostomia, as well as 
evaluate for changes in dentition and identification and the 
elimination of an oral or dental infection resulting from the treatment 
for head and neck cancers. We note that additional dental services, 
such as a dental implant or crown, may not be considered immediately 
necessary to address oral complications caused by the treatment for 
head and neck cancer. Therefore, we believe that such additional 
services would not be inextricably linked to, and substantially related 
and integral to the clinical success of, the treatment for head and 
neck cancer. As such, no Medicare

[[Page 79029]]

payment would be made for the additional services that are not 
immediately necessary prior to address the oral complications caused by 
the treatments for head and neck cancer.
    As described by evidence submitted by the commenters, the treatment 
of head and neck cancer causes oral complications caused by the primary 
medical treatment itself and increases the risk of infection after the 
direct treatment. Treatments for head and neck cancers are demonstrated 
to cause infection, caries, mucositis, and osteoradionecrosis, among 
other complications and jeopardize successful outcomes for the 
treatments. We are convinced that the provision of dental services in 
the context of treatments for head and neck cancers for the 
complications of the medical treatment is inextricably linked to the 
primary medical treatment. This is not only because such services lead 
to improved healing and improved quality outcomes, and because without 
the provision of dental services, the final outcome of the treatment 
for head and neck cancer may be jeopardized, but especially because the 
treatment itself is the direct cause of the acute oral/dental 
complications requiring the dental intervention. As demonstrated by 
evidence submitted by commenters, these complications may occur after 
some passage of time following the primary medical treatment. In other 
words, the treatment of head and neck cancer directly causes the oral 
complications, which may emerge after the treatment is completed. 
Treatments for head and neck cancers may cause infection, caries, 
mucositis, and osteoradionecrosis, among other complications, that may 
occur over months post-treatment. Based on persuasive information 
presented by commenters, we believe addressing and rectifying these 
direct consequences of the primary medical treatment for head and neck 
cancer aligns with the standard of care for treatment of head and neck 
cancers, would result in improved clinical outcomes for the patient, 
and is inextricably linked to the treatment.
    Therefore, we believe that there is a direct connection between the 
primary treatment and the dental and oral complications caused by the 
treatment for head and neck cancer itself, including those that occur 
after the direct treatments for cancer. As such, we believe that these 
dental services should be considered not subject to the general 
preclusion on payment for dental services under section 1862(a)(12) of 
the Act because they are inextricably linked to, and substantially 
related and integral to the clinical success of, the treatment for head 
and neck cancer, because the dental services serve to mitigate the 
substantial risk to the success of the medical services due to the 
severity of complications caused by the primary medical services and 
the standard of care for the medical service would be compromised. 
Consequently, we are clarifying that for the purposes of treatment for 
head and neck cancer, treatment may include dental services required in 
the period following direct treatment for the head and neck cancer.
Final Action Statement
    As described in the sections above, we are revising Sec.  
411.15(i)(3)(i) to add to the list of clinical scenarios under which 
Medicare Part A and B payment is permitted for dental or oral 
examinations performed as part of a comprehensive workup prior to, and 
medically necessary diagnostic and treatment services to eliminate an 
oral or dental infection prior to, or contemporaneously with, the 
following Medicare-covered services: chemotherapy, chimeric antigen 
receptor (CAR) T-cell therapy, and the administration of high-dose 
bone-modifying agents (antiresorptive therapy) when used in the 
treatment of cancer. We are also adding a new Sec.  411.15(i)(3)(i)(E) 
to permit Part A and B payment for dental or oral examination performed 
as part of a comprehensive workup prior to, medically necessary 
diagnostic and treatment services to eliminate an oral or dental 
infection prior to, or contemporaneously with, and medically necessary 
diagnostic and treatment services to address dental or oral 
complications after, radiation, chemotherapy, and/or surgery when used 
in the treatment of head and neck cancer. The policies we are 
finalizing take into account commenters' feedback and information 
provided in clinical literature, such as peer reviewed publications or 
clinical guidelines supported by clinical evidence, supporting the 
inextricable link between dental services and certain covered medical 
services. We anticipate making conforming changes to the Medicare 
Benefit Policy Manual (IOM Pub. 100-02) to reflect the final changes. 
Additionally, we intend to issue educational and outreach materials to 
inform billing and payment for any policies finalized in the final 
rule. Moreover, we believe that the process we finalized for CY 2023, 
as described above in section II.K.1.c. of this final rule, to engage 
with interested parties and review their recommendations regarding the 
inextricable link between dental services and certain covered medical 
services will continue to serve the need expressed by commenters for 
continued engagement on these issues. Additionally, we intend to 
continue to engage in discussions with the public on a wide spectrum of 
issues relating to Medicare payment for certain dental services that do 
not fall within the preclusion or exclusion under section 1862(a)(12) 
of the Act and related topics. We also continue to partner with 
researchers at the Agency for Healthcare Research and Quality (AHRQ) 
and other entities to consider and study the relationship between 
dental services and specific covered medical services, to review 
available clinical evidence regarding the relationship between dental 
services and specific covered medical services, and to identify other 
potential instances in which dental services are inextricably linked to 
other covered services. Furthermore, we remain open to adjusting and 
revising these finalized policies through future rulemaking and/or 
additional guidance as necessary. We appreciate the thoughtful 
questions raised by commenters and remain committed to continued 
engagement.
3. Dental Services Integral to Covered Cardiac Interventions
    In the CY 2023 PFS final rule, we finalized a policy to permit 
payment for dental or oral examination performed as part of a 
comprehensive workup in either the inpatient or outpatient setting 
prior to Medicare-covered cardiac valve replacement or valvuloplasty 
procedures; and medically necessary diagnostic and treatment services 
to eliminate an oral or dental infection prior to, or contemporaneously 
with, the cardiac valve replacement or valvuloplasty procedure (87 FR 
69675).
    We recognized that, without a dental or oral exam and necessary 
diagnosis and treatment of any presenting infection of the mouth prior 
to a cardiac valve replacement or valvuloplasty procedure, an 
undetected, non-eradicated oral or dental infection could lead to 
bacteria seeding the valves and the surrounding cardiac muscle tissues 
involved with the surgical site and conceivably leading to systemic 
infection or sepsis, all of which increase the likelihood of 
unnecessary and preventable acute and chronic complications for the 
patient (87 FR 69667).\109\ Specifically, we noted that the replaced 
valve is also at risk of being a seeding source for future 
endocarditis.

[[Page 79030]]

Endocarditis can carry a high risk of mortality for these patients and 
eliminating an infection prior to or contemporaneously with the 
procedure would be important for preventing future endocarditis related 
to the new valve (87 FR 69678).
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    \109\ Knox, K.W., & Hunter, N. (1991). The role of oral bacteria 
in the pathogenesis of infective endocarditis. Australian dental 
journal, 36(4), 286-292. https://doi.org/10.1111/j.1834-7819.1991.tb00724.x.
---------------------------------------------------------------------------

    We also concluded that an oral or dental infection could present a 
substantial risk to the success of organ transplants, such that the 
standard of care would be to not proceed with the procedure when there 
is a known oral or dental infection present. We stated that we believe 
dental services furnished to identify, diagnose, and treat oral or 
dental infections prior to organ transplant, cardiac valve replacement, 
or valvuloplasty procedures are not in connection with the care, 
treatment, filling, removal, or replacement of teeth or structures 
directly supporting teeth, but instead are inextricably linked to these 
other covered medical services (89 FR 69667).
    We encouraged the public to use the public submission process 
finalized in the CY 2023 PFS final rule to identify additional clinical 
scenarios and related medical evidence to support an inextricable link 
between specified dental services and other covered medical services.
    Through the submission process, an interested party has encouraged 
CMS to consider extending Medicare payment to include dental services 
to eliminate infection prior to all cardiovascular procedures, as the 
mitigation of risks of perioperative and postoperative infection and 
complications is critical to ensure optimal surgical outcomes for all 
patients requiring invasive and/or interventional cardiac procedures. 
This submission noted that the current standard of care does not 
conclusively require dental evaluation, diagnosis, or treatment 
services prior to certain cardiac procedures, perhaps in part because 
such cardiac procedures are often performed on a more urgent or 
emergent basis where there is not an opportunity to consider the 
possible presence of dental infection. Moreover, the submission noted 
that much of the scientific literature is inconclusive as to whether 
pre-operative dental treatments impact postoperative surgical outcomes 
in cardiovascular surgery, including cardiac valve procedures.\110\ A 
systematic literature review by Cotti et al. found that, based upon 
expert opinion, there is general agreement on the need for screening 
and treatment of oral/dental infections in patients who are to undergo 
cardiac surgery (although no standardized clinical guidelines or 
protocols exist to outline the screening process, in terms of either 
dental treatment options and/or timing of such procedures in relation 
to the planned cardiac intervention).\111\ The authors convened an 
expert panel from six Italian scientific societies (including 
cardiologists, cardiac surgeons, and dental specialists) to establish a 
consensus on early screening and resolution of dental or periodontal 
infections prior to cardiac surgery, that they intended would result in 
a standardized protocol for evaluating oral infections and dental 
treatments for cardiac patients to be used in the interventional 
preparation phase by both dental and cardiac teams.\112\ The authors 
noted, however, the lack of scientific evidence on the risk-to-benefit 
ratio for perioperative dental treatment in patients undergoing 
cardiovascular surgery.
---------------------------------------------------------------------------

    \110\ Lockhart, P.B., DeLong, H.R., Lipman, R.D., Estrich, C.G., 
Araujo, M.W.B. and Carrasco-Labra, A. (2019). Effect of dental 
treatment before cardiac valve surgery: Systematic review and meta-
analysis. Journal of the American Dental Association,150(9). 739-
747. https://doi.org/10.1016/j.adaj.2019.04.024.
    \111\ Cotti, E., Cairo, F., Bassareo, P.P., Fonzar, F., Venturi, 
M., Landi, L., Parolari, A., Franco, V., Fabiani, C., Barili, F., Di 
Lenarda, A., Gulizia, M., Borzi, M., Campus, G., Musumeci, F., and 
Mercuro, G. (2019). Perioperative dental screening and treatment in 
patients undergoing cardiothoracic surgery and interventional 
cardiovascular procedures. A consensus report based on RAND/UCLA 
methodology. International Endodontic Journal,53. 186-199. https://doi.org/10.1111/iej.13166.
    \112\ Ibid.
---------------------------------------------------------------------------

    We believe, after further review of current medical practice, 
through consultations with interested parties (including commenters on 
last year's final rule and those commenting on current topics) and our 
medical officers, and through evidence submitted through the public 
submission process we established in the CY 2023 PFS final rule, that 
there may be additional circumstances that are clinically similar to 
examples we codified in our regulation at Sec.  411.15(i)(3)(i) where 
Medicare payment for dental services could be made under other clinical 
circumstances where the dental services are inextricably linked to a 
covered cardiac medical service(s).
    To gain further understanding of any potential relationship between 
dental services and specific covered cardiac medical services, we again 
partnered with researchers at the AHRQ to review available clinical 
evidence regarding the relationship between dental services and covered 
cardiac medical services, including implantation of ventricular assist 
devices, artificial pacemakers, implantable defibrillators, synthetic 
vascular grafts and patches, and coronary and vascular stents. This 
AHRQ report \113\ is available at https://effectivehealthcare.ahrq.gov/sites/default/files/related_files/rapid-response-cardio-dental.pdf.
---------------------------------------------------------------------------

    \113\ Hickam DH, Gordon CJ, Armstrong CE, Paynter R. The 
Efficacy of Dental Services for Reducing Adverse Events in Those 
Undergoing Insertion of Implantable Cardiovascular Devices. Rapid 
Response. (Prepared by the Scientific Resource Center under Contract 
No. 75Q80122C00002.) AHRQ Publication No. 23-EHC020. Rockville, MD: 
Agency for Healthcare Research and Quality; June 2023. DOI: https://doi.org/10.23970/AHRQEPCRAPIDDENTALCARDIO.
---------------------------------------------------------------------------

    As stated in their report, the available evidence does not permit 
conclusions regarding the effect of pre-treatment dental care for 
preventing downstream infections related to any of these devices. They 
noted that professional society guidelines endorse the provision of 
patient education on routine oral hygiene practices but have not 
recommended other pre-treatment dental care prior to insertion of these 
devices. They also noted that professional society guidelines recommend 
ongoing routine dental examinations for some patients treated with 
cardiovascular devices.
    Nonetheless we solicited comment to identify additional cardiac 
interventions (that is, specific medical services) where the risk of 
infection posed to beneficiaries is similar to that associated with 
cardiac valve replacement or valvuloplasty. We note that, in order to 
consider whether certain dental services are inextricably linked to 
other covered services, we need to identify specific medical services 
for which there is clinical evidence that certain dental services are 
so integral to the clinical success that they are inextricably linked 
to other covered service(s). We encourage interested parties to use the 
public submission process to submit recommendations and relevant 
clinical evidence for establishing this connection. In section II.K. of 
this final rule, we have described the various types of documentation 
to support recommendations through this process. We considered, and 
solicited comment on, whether the following cardiac interventions are 
examples of specific medical services for which dental services are 
inextricably linked to clinical success: implantation of electronic 
devices in the heart, such as pacemakers, cardioverter defibrillators, 
and monitors. We also considered, and solicited comment on, whether the 
following procedures would be considered examples of specific medical 
services for which dental services are inextricably linked to their 
clinical success: the placement of intracardiac or

[[Page 79031]]

intravascular foreign material, such as a stent or for hemodialysis, or 
for a vascular access graft, whereas you would not proceed with the 
medical service without having first completed a dental evaluation and/
or treatment as determined necessary. We solicited comment on whether 
preoperative and perioperative dental services are inextricably linked 
to any other covered cardiac interventions as supported by clinical 
evidence.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Some commenters urged us to permit payment for dental 
screenings and, when clinically justified, medically necessary dental 
treatment that a patient may need in order to undergo, or to avoid 
complicating or compromising certain covered cardiac procedures, that 
is, pacemaker insertion or replacement, insertion or replacement of 
implantable cardioverter defibrillator, transcatheter aortic valve 
replacement, aortic valve surgical procedure, mitral valve replacement, 
endovascular stent repair or replacement, cardiac assist procedures, 
and other cardiac valve procedures. These commenters asserted that a 
large number of epidemiological investigations describe an association 
between periodontal disease (PD) and cardiovascular diseases (CVD). 
They reasoned that as CVD is clearly influenced by inflammation, and as 
treatment of PD would reduce both oral and systemic inflammation, it is 
logical to assume that treatment of PD would reduce overall 
inflammatory burden and hence the risk of CVD. As such they drew a 
parallel with our payment policy finalized last year for cardiac valve 
replacement and valvuloplasty where they stated the risk of infection 
posed to beneficiaries is similar. Other commenters stated that dental 
services should be covered for interventional cardiovascular 
procedures, another for device closure of intracardiac defects and 
stent implants, other commenters stated generally that dental services 
should be covered for cardiovascular disease patients, one commenter 
wrote to say they were not opposed to coverage of dental services to 
find and eradicate infection prior to the additional cardiac procedures 
about which we requested information.
    Response: As we described above, based on clinical evidence for 
cardiac valve replacement and valvuloplasty, we believed that without a 
dental or oral exam and necessary diagnosis and treatment of any 
presenting infection of the mouth prior to or contemporaneous with the 
procedure, an undetected, non-eradicated oral or dental infection could 
lead to bacteria seeding the valves and the surrounding cardiac muscle 
tissues involved with the surgical site and conceivably leading to 
systemic infection or sepsis, all of which increase the likelihood of 
unnecessary and preventable acute and chronic complications for the 
patient. Commenters did not assert an inextricable linkage between 
dental services and any covered cardiovascular service. They did cite 
studies for the proposition that CVD and stroke are influenced by 
inflammation and that as treatment of periodontal disease would reduce 
both oral and systemic inflammation, then it is logical to assume that 
treatment of periodontal disease would reduce overall inflammatory 
burden and hence the risk of cardiovascular disease and ischemic 
stroke. One study cited suggested that there may be associations 
between periodontal disease and cardiovascular issues.\114\ Another 
study cited found that periodontitis treatment can improve surrogate 
measurements of cardiovascular health.\115\ Commenters did not offer 
clinical evidence to support that dentally sourced infections can cause 
serious complications at the site of intracardiac or intravascular 
stents and devices, or that dental services to eradicate such dentally 
sourced infections is so integral to clinical success of the 
intracardiac or intravascular stents and devices that they are 
inextricably linked.
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    \114\ Peruzzi M, Covi K, Saccucci M, Pingitore A, Saade W, 
Sciarra L, Cristalli MP, Miraldi F, Frati G, Cavarretta E. Current 
knowledge on the association between cardiovascular and periodontal 
disease: an umbrella review. Minerva Cardiol Angiol. 2022 Mar 25. 
doi: 10.23736/S2724-5683.22.06022-7. Epub ahead of print. PMID: 
35332749.
    \115\ Sanz M, Del Castillo AM, Jepsen S, Gonzalez-Juanatey JR, 
D'Aiuto F, Bouchard P, Chapple I, Dietrich T, Gotsman I, Graziani F, 
Herrera D, Loos B, Madianos P, Michel JB, Perel P, Pieske B, Shapira 
L, Shechter M, Tonetti M, Vlachopoulos C, Wimmer G. Periodontitis 
and Cardiovascular Diseases. Consensus Report. Glob Heart. 2020 Feb 
3;15(1):1. doi: 10.5334/gh.400. PMID: 32489774; PMCID: PMC7218770.
---------------------------------------------------------------------------

    Comment: One commenter stated that most clinical guidelines do not 
recommend prophylactic dental procedures before undergoing subsequent 
cardiovascular procedures or device implantations. In contrast, the 
commenter continued, other guidelines counsel the value of optimal oral 
health hygiene and antibiotic prophylaxis to avoid infective 
endocarditis in patients with congenital heart disease and/or prior 
prosthetic valve implant. They summarized that current evidence might 
not support a role for pre-treatment dental care for preventing 
downstream infections related to the implantation of ventricular assist 
devices, artificial pacemakers, implantable cardioverter 
defibrillators, synthetic grafts, and patches, or coronary and vascular 
stents. However, the commenters noted that as evidence and guidelines 
continue to evolve--especially as increasing emphasis is placed on both 
health equity and high-quality outcomes that conserve scarce health 
care resources--it may prove appropriate for CMS to determine dental 
services are inextricably linked to certain cardiovascular therapies in 
the future.
    Response: We will continue to monitor the evolution of guidelines 
and the production of evidence showing specific cardiovascular services 
for which dental services are inextricably linked to their clinical 
success.
    Comment: Another commenter stated that they do not believe that 
dental evaluation and treatment are absolutely necessary prior to 
performing stents and vascular access grafts for hemodialysis. They 
relayed that clinicians report that while completing dental care before 
such a procedure is a laudable goal, they would proceed with placing 
the stent or graft without having this completed and do not believe 
dental services are inextricably linked to the procedures.
    Response: We thank the commenter for their perspective and sharing 
of clinical insight. After consideration of public comments, we are not 
expanding the examples in the regulation at Sec.  411.14(i)(3)(i) to 
include additional cardiac procedures at this time but will continue to 
consider public submissions through the public process discussed above 
in section II.K.1.c. of the final rule, of specific medical services in 
the future. Submissions should include clinical evidence that certain 
dental services are so integral to their clinical success that the 
standard of care for that cardiovascular intervention would be 
compromised or require the dental services to be performed in 
conjunction with the covered cardiovascular intervention services.
4. Request for Comment on Dental Services Integral to Specific Covered 
Services To Treat Sickle Cell Disease (SCD) and Hemophilia
Payment for Dental Services for Individuals Living With SCD
    Interested parties using the public submission process we finalized 
in the CY 2023 PFS final rule urged us to propose to provide that 
payment can be made for dental services for individuals living with 
SCD.
    These submissions provided information and references supporting

[[Page 79032]]

prevention of dental infection among individuals with SCD to reduce 
need for more extensive procedures that may result in bleeding 
complications and require hospitalization. They also provided 
information detailing increased dental caries and periodontal disease 
in people with SCD,\116\ many of whom lose a number of teeth, which 
greatly limits nutrition, general well-being, and overall quality of 
life.
---------------------------------------------------------------------------

    \116\ Kakkar M, Holderle K, ShethM, Arany S, Schiff L, Planerova 
A. Orofacial Manifestation and Dental Management of Sickle Cell 
Disease: A Scoping Review. Anemia. 2021 Oct22; 2021:5556708. Doi: 
10.1155/2021/5556708. PMID: 34721900; PMCID: PMC8556080.
---------------------------------------------------------------------------

    We note that the decisions we make through the public submissions 
and the rulemaking process regarding whether payment is permitted for 
certain dental services are not in terms of a coverage decision. 
Rather, we are considering whether payment can be made for certain 
dental services in a particular clinical scenario because, in 
accordance with Sec.  411.15(i)(3)(i), the dental services would be 
``inextricably linked to, and substantially related and integral to the 
clinical success of a certain covered medical service'' such that they 
are not subject to the statutory preclusion on payment for most dental 
services under section 1862(a)(12). If we determine that certain dental 
services provided in a specific clinical scenario do meet the criterion 
in Sec.  411.15(i)(3)(i), then payment can be made for the dental 
services.
    We solicited comment on whether certain dental services are 
inextricably linked to other covered services used in the treatment of 
SCD, such as, but not limited to, hydroxyurea therapy. We solicited 
comment identifying such covered services for SCD and whether an 
inextricable link is supported by clinical evidence as described in 
section II.K.1.c. of this final rule.
    We received public comments on these requests for comment. The 
following is a summary of the comments we received and our responses.
    Comment: Several commenters supported coverage for dental services 
as inextricably linked to covered services used in the treatment of 
SCD, such as, but not limited to, hydroxyurea therapy. The commenters 
also recommended that we extend coverage for dental services to 
patients living with SCD or hemophilia for 2024. Other commenters urged 
us to add SCD as a covered indication for treatment of dental services 
that are integral to the outcomes for Medicare beneficiaries with SCD.
    Another commenter urged us to expand coverage and payment of dental 
services for individuals with SCD presenting with pain crises in the 
jaw, mouth, or face and in the case of a dental abscess stated that 
better access to dental services will help to improve quality of life 
for individuals with SCD and reduce overall costs to the healthcare 
system by allowing for more appropriate treatment options and a 
reduction in length of hospital stay. This commenter provided 
references.117 118 119 120 121 One commenter questioned the 
clinical basis for adding SCD, and hemophilia, as predicates for 
medically necessary dental benefits since there are relatively few 
cases of SCD and hemophilia in the Medicare population.
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    \117\ Basati MS. Sickle cell disease and pulpal necrosis: a 
review of the literature for the primary care dentist. Prim Dent J. 
2014 Feb;3(1):76-9. doi:10.1308/205016814812135922.
    \118\ Chekroun M, Ch[eacute]rifi H, Fournier B, Gaultier F, 
Sitbon IY, Ferr[eacute] FC, Gogly B. Oral manifestations of sickle 
cell disease. Br Dent J. 2019 Jan 11;226(1):27-31. doi: 10.1038/
sj.bdj.2019.4.
    \119\ Hsu LL, Fan-Hsu J. Evidence-based dental management in the 
new era of sickle cell disease: A scoping review. J Am Dent Assoc. 
2020 Sep;151(9):668-677.e9. doi: 10.1016/j.adaj.2020.05.023.
    \120\ Bedrouni M, Touma L, Sauv[eacute] C, Botez S, 
Souli[egrave]res D, Fort[eacute] S. Numb Chin Syndrome in Sickle 
Cell Disease: A Systematic Review and Recommendations for 
Investigation and Management. Diagnostics (Basel). 2022 Nov 
24;12(12):2933. doi:10.3390/diagnostics12122933.
    \121\ Mestoudjian P, Steichen O, Stankovic K, Lecomte I, Lionnet 
F. Sickle cell disease, a benign cause of numb chin syndrome. Am J 
Med. 2008 Oct;121(10):e1. doi: 10.1016/j.amjmed.2008.05.028.
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    Response: We thank commenters for their feedback. After 
consideration of public comments, we are not expanding the examples 
under Sec.  411.15(i)(3)(i) to include additional covered medical 
services for SCD or hemophilia at this time but will continue to 
consider public submissions through the public process discussed above 
at section II.K.1.c. of the final rule, of specific medical services in 
the future. The information commenters provided did not support finding 
that dental services are inextricably linked to a covered medical 
service for SCD or that the standard of SCD care would be compromised 
or require dental services to be performed in conjunction with 
hydroxyurea therapy or other treatment for SCD. One reference cited 
concluded in part that good access to oral health care might be as 
important for SCD as it is for diabetes mellitus, but more research is 
needed.\122\ In order for us to find that dental services are 
inextricably linked to, and substantially related and integral to the 
clinical success of hydroxyurea therapy or other treatments for SCD, we 
would need clinical evidence to demonstrate that the standard of care 
would be not to proceed with the other covered services without 
providing the dental services in conjunction with the hydroxyurea 
therapy or other treatment for SCD. We welcome additional public 
submissions by the February 10 deadline for consideration in PFS 
rulemaking for CY 2025. Submissions should include medical evidence and 
supporting literature addressing why dental services are inextricably 
linked to hydroxyurea therapy or other covered treatment for SCD. 
Specifically, we request that the medical evidence should support the 
inextricable link between certain dental services and other covered 
services by providing any of the following:
---------------------------------------------------------------------------

    \122\ Hsu LL, Fan-Hsu J. Evidence-based dental management in the 
new era of sickle cell disease: A scoping review. J Am Dent Assoc. 
2020 Sep;151(9):668-677.e9. doi: 10.1016/j.adaj.2020.05.023.
---------------------------------------------------------------------------

    (1) Relevant peer-reviewed medical literature and research/studies 
regarding the medical scenarios requiring medically necessary dental 
care;
    (2) Evidence of clinical guidelines or generally accepted standards 
of care for the suggested clinical scenario; and/or
    (3) Other supporting documentation to justify the inclusion of the 
proposed medical clinical scenario requiring dental services (87 FR 
69686, 69687).
Payment for Dental Services for Individuals Living With Hemophilia
    Interested parties also urged us to propose a policy to permit 
payment for dental services for individuals living with hemophilia. 
They noted that periodic dental care reduces the risks of dental 
complications requiring haemostatic therapy (such as tooth extractions 
that may require clotting factor treatment) or oral surgeries requiring 
clotting factor replacement therapy.123 124 125
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    \123\ Raso S, Napolitano M, Sirocchi D, Siragusa S, Hermans C. 
The important impact of dental care on haemostatic treatment burden 
in patients with mild haemophilia. Haemophilia. 2022 Nov;28(6):996-
999. doi: 10.1111/hae.14626. Epub 2022 Jul 25. PMID: 35879819.
    \124\ Srivastava A, Santagostino E, Dougall A, Kitchen S, 
Sutherland M, Pipe SW, Carcao M, Mahlangu J, Ragni MV, Windyga J, 
Llin[aacute]s A, Goddard NJ, Mohan R, Poonnoose PM, Feldman BM, 
Lewis SZ, van den Berg HM, Pierce GF; WFH Guidelines for the 
Management of Hemophilia panelists and co-authors. WFH Guidelines 
for the Management of Hemophilia, 3rd edition. Haemophilia. 2020 
Aug;26 Suppl 6:1-158. doi: 10.1111/hae.14046. Epub 2020 Aug 3. 
Erratum in: Haemophilia. 2021 Jul;27(4):699. PMID: 32744769.
    \125\ Peisker A, Raschke GF, Schultze-Mosgau S. Management of 
dental extraction in patients with Haemophilia A and B: a report of 
58 extractions. Med Oral Patol Oral Cir Bucal. 2014 Jan 1;19(1):e55-
60. doi: 10.4317/medoral.19191. PMID: 24121912; PMCID: PMC3909433.
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    We noted that many submitters, using the public submission process 
we

[[Page 79033]]

finalized in the CY 2023 PFS final rule, stated that good dental and 
oral health benefits a patient's overall health generally. Several 
commenters on the CY 2023 PFS proposed rule also expressed that good 
oral hygiene, along with routine dental services, contributes to better 
outcomes for patients. We recognized in the CY 2023 PFS final rule in 
response to those comments that there is a great deal of evidence 
suggesting that dental health is generally an important component of 
overall health; however, we are interested in comments on whether 
certain dental services are considered so integral to the primary 
covered services that the necessary dental interventions are 
inextricably linked to, and substantially related and integral to 
clinical success of, the primary covered services such that they are 
not subject to the statutory preclusion on Medicare payment for dental 
services under section 1862(a)(12) of the Act.
    We received public comments on these requests for comment. The 
following is a summary of the comments we received and our responses.
    Comment: One commenter urged us to permit payment under Medicare 
Part A and Part B for preventive dental services for individuals with 
hemophilia. They noted that Hemophilia Treatment Centers (HTCs) are a 
federally supported network of care, and that the Centers for Disease 
Control and Prevention (CDC) lists dentists as a specialist who should 
be available by referral by an HTC and find it appropriate that the 
Medicare would provide coverage and payment for these services. They 
also reference World Federation of Hemophilia (WFH) Guidelines for the 
Management of Hemophilia. These guidelines provide that maintaining 
good oral health and preventing dental problems is greatly important in 
the prevention of oral diseases and conditions such as gingivitis, 
dental caries, and periodontal diseases which may cause serious gum 
bleeding, especially in those with severe/moderate hemophilia, and to 
avoid the need for major dental surgery. They noted they will submit 
additional comments by the February 10, deadline with information and 
supporting literature for why dental services are needed for bleeding 
disorders beyond hemophilia. Another commenter agreed that periodic 
dental care reduces the risks of dental complications requiring 
haemostatic therapy (such as tooth extractions that may require 
clotting factor treatment) or oral surgeries requiring clotting factor 
replacement therapy. Other commenters urged that we consider finalizing 
payment for hemophilia as one of the clinical scenarios for which 
medically necessary dental care could be covered.
    Response: In the case of dental services for individuals living 
with hemophilia, we would need to identify one or more specific 
clinical scenarios where there is clinical evidence that certain dental 
services are so integral to the clinical success of the medical 
services to manage or treat hemophilia or complications resulting from 
the condition that they are inextricably linked to the other covered 
service(s). We thank the commenters for their perspectives, and while 
we agree that maintaining good oral health and preventing dental 
problems is greatly important in the prevention of oral diseases that 
can lead to serious gum bleeding, which is particularly problematic for 
individuals with hemophilia, we are seeking specific evidence 
supporting specific medical services for which dental services are 
inextricably linked to their clinical success. We welcome additional 
submissions by the February 10, deadline with information and clinical 
evidence, discussed above at section II.K.1.c. of this final rule, 
supporting the conclusion that certain dental services are integral and 
inextricably linked to other covered services related to hemophilia and 
any other bleeding disorders.
5. Request for Comment Regarding Dental Services Possibly Inextricably 
Linked to Other Medicare-Covered Services
    Commenters, submitters, and other interested parties have urged us 
to consider the importance of access to oral health care for people 
with chronic auto-immune conditions and other chronic disease 
conditions, such as, but not limited to, diabetes. They have also 
suggested that we consider making payment for dental services 
associated with other conditions such as chronic kidney disease and end 
stage renal disease, and procedures such as joint replacement, and 
services such as inpatient substance use disorder treatment and long-
term use of immunosuppressants for the treatment of colitis, Crohn's, 
lupus, multiple sclerosis, rheumatoid arthritis, and Sj[ouml]gren's 
disease. After consideration of public comments, we are not expanding 
the examples under Sec.  411.15(i)(3)(i) to include dental services 
associated with additional covered medical services related to the 
conditions and procedures suggested in comments. We understand and 
appreciate the interest in such requests. However, the information 
generally provided by commenters did not establish an inextricable link 
between dental services and a covered medical service such that dental 
services would not be in connection with the care, treatment, filling, 
removal, or replacement of the teeth or structures supporting the 
teeth. Because the Medicare statute generally prohibits payment for 
dental services, payment may be made in limited situations such as when 
the dental services are inextricably linked to, and substantially 
related and integral to the clinical success of certain other covered 
services as provided by our regulations at Sec.  411.15(i)(3), or under 
the exceptions provided by section 1862(a)(12) of the Act and codified 
at Sec.  411.15(i)(2). We urge interested parties to consider the 
circumstances under which dental services are inextricably linked to 
other covered services (not diagnoses) used to treat patients with 
auto-immune conditions or other chronic conditions and support their 
submissions with clinical evidence or other documentation as described 
in section II.K.1.c. of this final rule. Details regarding the public 
submission process are available in the CY 2023 PFS final rule (87 FR 
69669 through 69670).
    As summarized above in section II.K.1.c. of this final rule, 
through the public submission process we finalized in the CY 2023 PFS 
final rule, interested parties should submit medical evidence to 
support an inextricable link between certain dental services and 
covered services by providing any of the following:
    (1) Relevant peer-reviewed medical literature and research/studies 
regarding the medical scenarios requiring medically necessary dental 
care;
    (2) Evidence of clinical guidelines or generally accepted standards 
of care for the suggested clinical scenario;
    (3) Other ancillary services that may be integral to the covered 
services; and/or
    (4) Other supporting documentation to justify the inclusion of the 
proposed medical clinical scenario requiring dental services.
    As discussed previously in section II.K.1.c. of this final rule, in 
order to consider whether certain dental services are inextricably 
linked to the clinical success of other covered services, we need to 
identify specific medical services for which there is medical evidence 
that certain dental services are so integral to the clinical success 
that they are inextricably linked to the covered service. The medical 
evidence should support that in the case of surgery, the provision of 
certain dental services leads to improved healing, improved quality of 
surgery, and the

[[Page 79034]]

reduced likelihood of readmission and/or surgical revisions, because an 
infection has interfered with the integration of the medical implant 
and/or interfered with the medical implant to the skeletal structure. 
Medical evidence should be clinically meaningful and demonstrate that 
the dental services result in a material difference in terms of the 
clinical outcomes and success of the primary medical procedure such 
that the dental services are inextricably linked to, and substantially 
related and integral to, the clinical success of the covered services. 
Medical evidence should support that the dental services would result 
in clinically significant improvements in quality and safety outcomes 
(for example, fewer revisions, fewer readmissions, more rapid healing, 
quicker discharge, and quicker rehabilitation for the patient), or, 
medical evidence should demonstrate that the standard of care would be 
to not proceed with the covered medical procedure until a dental or 
oral exam is performed to address the oral complications and/or clear 
the patient of an oral or dental infection.
    Comment: Some commenters recited the sequelae and the oral 
manifestations of diabetes mellitus. They relayed that for patients 
with diabetes mellitus and periodontitis, the provision of preventive 
dental care/conservative periodontal treatment leads to a statistically 
and clinically significant reduction in glycated hemoglobin (HbA1c), a 
key measure of metabolic control, and an established risk marker for 
clinical complications of diabetes mellitus. The commenters also stated 
that conservative periodontal treatment is associated with improved 
health outcomes and reduced healthcare costs. They stated preventive 
and restorative dental care fosters a healthy diet that is key to 
diabetes treatment. They shared that they are in the process of 
exploring specific diabetes-related covered services for which the 
provision of inextricably linked dental care is associated with 
improved outcomes and reduced cost and intend to submit their findings 
by February 10, 2024, in nominations through the public process we have 
established.
    Response: We thank the commenters for the information they have 
submitted and welcome submissions of further information through the 
public process we have established. Based on the information we 
received from commenters who indicated that they are still in the 
process of exploring specific diabetes-related covered services for 
which the provision of inextricably linked dental care associated with 
improved outcomes, we are not adding an additional example in Sec.  
411.15(i) related to covered medical services for diabetes at this 
time. We would consider information about specific diabetes-related 
covered services we receive under the public process by February 10, 
2024, for CY 2025 rulemaking.
    Comment: One commenter stated that our interpretation of section 
1862(a)(12) of the Act is too restrictive to meaningfully expand 
coverage to those with systemic autoimmune diseases. Nevertheless, they 
stated that they were encouraged by our commitment to continue 
exploring the inextricable link between dental and covered services 
associated with immunosuppressant therapy. The commenters stated that 
because dental caries and periodontal diseases are bacterial 
infections, they can seed complications such as sepsis, dissecting 
facial space abscesses, Ludwig's angina, and cellulitis -especially 
when individuals are immunocompromised. They reported that physicians 
across the medical specialties involved in treating colitis, Crohn's, 
lupus, multiple sclerosis, rheumatoid arthritis, and Sj[ouml]gren's 
disease have acknowledged that dental treatment to resolve dental 
infections can be integral to improving outcomes among patients 
requiring long-term use of immunosuppressive medications. The 
commenters supported us in continuing to study the relationship between 
dental care and medical services that cause immunosuppression in 
patients and urge us to adopt a more expansive view of our authorities. 
Other commenters wrote that while dental services are not inextricably 
linked to the successful treatment of severe chronic obstructive 
pulmonary disease (COPD), uncontrolled diabetes, epilepsy, Sjogren's 
disease, lupus, rheumatoid arthritis, chronic kidney disease, Ludwig's 
angina (and similar space infections), and/or retroperitoneal fibrosis 
in every case, for many Medicare beneficiaries, oral pathologies must 
be addressed when they are clinically determined to be a causal or 
highly exacerbating factor in the progression and treatment of their 
medical conditions.
    Response: We thank the commenters for their support, perspectives, 
and recommendations. We agree that additional information would be 
necessary to demonstrate that dental services are inextricably linked 
to covered services for autoimmune diseases and other chronic diseases 
before we could add those clinical scenarios as examples in Sec.  
411.15(i)(3)(i). We note that finalized policies do not prevent a MAC 
from determining on a case-by-case basis that payment can be made for 
certain dental services in other circumstances not specifically 
addressed within Sec.  411.15(i)(3)(i), as amended by this final rule. 
We will continue to engage with interested parties on ways to improve 
care for Medicare beneficiaries with autoimmune diseases.
    Comment: Other commenters stated that oral health services are 
inextricably linked to the success of inpatient treatment for substance 
use disorders. Other commenters supported the coverage of dental 
services for joint replacement surgeries to lessen the infection risk. 
Other commenters supported the coverage of annual dental examinations, 
and treatment as clinically indicated, for individuals with chronic 
kidney disease and end-stage renal disease. They stated that chronic 
immunosuppression increases the risk of dental infections leading to 
potentially deadly complications including bloodstream infections, 
peritoneal dialysis-associated peritonitis, and the exacerbation of 
chronic cardiovascular conditions. They also stated that when 
established by patient-specific medical and dental parameters, dental 
services can be unquestionably integral to the outcome of covered 
medical procedures.
    Response: We thank the commenters for the information they 
submitted about joint replacement surgeries, chronic kidney disease, 
end-stage renal disease, and inpatient treatment for substance use 
disorders. However, commenters did not provide medical evidence to 
support an inextricable link between certain dental services and 
covered medical services for these conditions or medical services. 
After consideration of public comments, we are not expanding the 
examples under Sec.  411.15(i)(3)(i) to include dental services 
associated with additional covered medical services for the conditions 
and treatment suggested by commenters and would welcome submissions of 
medical evidence through the public process we have established.
    Comment: Another commenter requested that we consider covering 
dental services when linked to significant facial trauma, for example, 
from a vehicle accident, presuming Medicare coverage instead of vehicle 
liability coverage.
    Response: In the CY 2023 PFS final rule (87 FR 69663 through 
69664), we clarified that the statute includes an exception to allow 
payment to be made under Medicare Part A for inpatient hospital 
services in connection with the

[[Page 79035]]

provision of dental services if the individual, because of their 
underlying medical condition and clinical status or because of the 
severity of the dental procedure, requires hospitalization in 
connection with the provision of such services. Our regulation at Sec.  
411.15(i)(2) similarly excludes payment for dental services except for 
inpatient hospital services in connection with dental services when 
hospitalization is required because of: (i) the individual's underlying 
medical condition and clinical status; or (ii) the severity of the 
dental procedure. It is possible that dental services for patients with 
facial trauma could fall within this exception, depending on the 
severity of the dental procedures. It is also possible that a jaw 
fracture or dislocation resulting from the scenario would be within the 
example in the regulation at Sec.  411.15(i)(3)(i)(C) permitting 
payment under Parts A and B for certain dental services. The MAC could 
make a determination that payment is permitted for certain dental 
services that are inextricably linked to the clinical success of the 
services to treat the facial trauma. We note that this is a clinical 
scenario where there is wide variability in the nature of traumatic 
facial injury, so evidence is not likely to demonstrate that dental 
services are routinely inextricably linked to services to treat facial 
trauma.
    Comment: One commenter stated that they oppose the inclusion of 
dental benefits into Medicare specifying that CMS does not possess 
legislative authority for the expansion of dental applications relating 
to chronic disease conditions. They believed that ``this type of 
proposal is unconscionable in our current regulatory and federal 
budgetary environment,'' as it would have ``significant financial costs 
for the federal government and the American public'', citing the 
federal budget deficit, announced on August 8, 2023, in the 
Congressional Budget Office, Monthly Budget Review: July 2023.
    Response: We thank the commenter for their comments. In the CY 2023 
final rule (87 FR 69404, 69664) we explained that if a dental service 
is performed as incident to and as an integral part of a covered 
procedure or service performed by a dentist, the total service 
performed by the dentist is covered, and payment can be made under 
Medicare Parts A and B as appropriate. This policy is based on the idea 
that some dental services that would ordinarily be excluded by statute 
from payment are inextricably linked to, and substantially related and 
integral to the clinical success of, certain other covered medical 
services. We believe that when that is the case those dental services 
are not in connection with dental services within the meaning of 
section 1862(a)(12) of the Act, but are instead inextricably linked to, 
and substantially related and integral to the clinical success of, 
certain other covered medical services. As such, we finalized our 
interpretation of the statute under section 1862(a)(12) of the Act to 
permit Medicare payment under Parts A and B for dental services where 
the dental service is inextricably linked to, and substantially related 
and integral to the clinical success of, certain other covered medical 
services and allowed payment to be made, regardless of whether the 
services are furnished in an inpatient or outpatient setting. Under 
these circumstances, we finalized that the exclusion under section 
1862(a)(12) of the Act would not apply, because the service is not in 
connection with the care, treatment, filling, removal, or replacement 
of the teeth or structures supporting the teeth, but instead is 
inextricably linked to, and substantially related and integral to the 
clinical success of, certain other covered medical services.
6. Implementation of Payment for Dental Services Inextricably Linked to 
Other Specific Covered Services
    We continue to consider improvements to our payment policies for 
dental services as finalized in the CY 2023 PFS final rule (87 FR 69663 
through 69688). As such, we indicated that we were interested in 
receiving comments from interested parties on our proposed rule on ways 
to continue to implement these payment policies. Additionally, we 
wanted to clarify the policies we finalized in the CY 2023 PFS final 
rule. Therefore, we requested comments on several policies related to 
the implementation of policies for dental services for which Medicare 
payment can be made.
    In the CY 2023 PFS final rule, we clarified and codified our policy 
on payment for dental services and added in Sec.  411.15(i)(3)(i) of 
our regulation examples of circumstances where payment can be made for 
certain dental services, including a dental exam and services to 
diagnose and eliminate an oral or dental infection prior to organ 
transplant, cardiac valve replacement, or valvuloplasty procedures (87 
FR 69664 through 69667).
    We provided as examples of dental services that could be furnished 
to eradicate infection services such as, but not limited to, diagnostic 
services, evaluations and exams (for example, CDT codes payable with 
D0120, D0140 or D0150), extractions (for example, CDT codes payable 
with D7140, D7210), restorations (removal of the infection from tooth/
actual structure, such as filling procedures--for example, CDT codes 
payable with D2000-2999), periodontal therapy (removal of the infection 
that is surrounding the tooth, such as scaling and root planing--for 
example, CDT codes payable with D4000-4999, more specifically D4341, 
D4342, D4335 and D4910), or endodontic therapy (removal of infection 
from the inside of the tooth and surrounding structures, such as root 
canal--for example, CDT codes payable with D3000-3999). However, we 
continued to believe that additional dental services, such as a dental 
implant or crown, may not be considered immediately necessary to 
eliminate or eradicate the infection or its source. Therefore, we 
reiterated that such additional services would not be inextricably 
linked to the specific covered services. As such, no Medicare payment 
is made for the additional services that are not immediately necessary 
to eliminate or eradicate the infection. We further clarified that we 
did not propose in CY 2023, nor did we propose in CY 2024, to adjust 
any payment policy for services involving the preparation for or 
placement of dentures, and maintained that these services are not 
payable under Medicare Parts A and B. We also reiterated our policy, as 
finalized in the CY 2023 PFS final rule, that Medicare could make 
payment for dental services occurring over multiple visits as 
clinically appropriate. We refer readers to 87 FR 69678 for a 
comprehensive discussion of this policy.
    We continue to recognize that many Medicare beneficiaries have 
separate or supplemental dental coverage, such as through a Medigap 
plan, another private insurance plan offering commercial dental 
coverage, or for those individuals dually eligible for Medicare and 
Medicaid, through a state Medicaid program. As a result, we solicited 
comment on the coordination of multiple dental benefits that Medicare 
beneficiaries may have, whether and if so, how other plans currently 
cover and pay for dental services, and what type of guidance CMS should 
provide about the dental payment policies we have established and their 
relationship to other separate or supplemental dental coverages.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Many commenters stated CMS should issue clear guidance on 
the type of dental payment policies we have established and how that 
relates to any

[[Page 79036]]

supplemental dental coverage in order to ensure access to oral and 
dental health care. Some commenters also noted it would be helpful to 
have more information on how Medicaid, Medicare Advantage, and other 
plans interact with Medicare coverage to coordinate dental services.
    Response: We appreciate the commenters' thoughtful feedback and 
questions regarding the operational aspects of this proposal, 
specifically regarding supplemental dental coverage and coordination of 
benefits, and we agree that these are necessary topics to address. We 
acknowledge the need to address and clarify certain operational issues, 
and we are working to address these issues and provide education and 
guidance. We will continue to work with our MACs and encourage 
continued feedback from interested parties to help identify concerns or 
questions regarding the submission and processing of dental claims in 
order to assist with the coordination of benefits amongst dentists and 
issuers. We also plan to provide guidance and engage in further 
rulemaking, as necessary, as operational strategies and plans are 
refined and implemented. We appreciate the questions raised by 
commenters and plan to take them into consideration as we continue to 
advance operational issues relating to this policy, and make any 
necessary changes or refinements.
    Comment: Most commenters recommended that CMS develop educational 
and outreach materials regarding billing and claims for any payment 
policies we finalize. Additionally, some commenters stated that 
dentists and transplant providers are interested in obtaining a roadmap 
on matters related to submitting claims, expecting reimbursement, and 
referring patients to local Medicare-participating dentists.
    Response: We appreciate the questions raised by commenters and plan 
to take them into consideration as we continue to refine operational 
issues relating to this policy and make any necessary refinements. We 
have started to create educational materials, including information 
regarding enrollment, through products such as Change Request 13190, 
Educational Instructions for the Implementation of the Medicare Payment 
Provisions for Dental Services as Finalized in the Calendar Year (CY) 
2023 Physician Fee Schedule (PFS) Final Rule, available at https://www.cms.gov/files/document/r12047bp.pdf and have provided content as 
well as information regarding dental claims form (837D) via the CMS 
website at https://www.cms.gov/medicare/coverage/dental. We encourage 
MACs to utilize information provided in the CR to develop their own 
educational and billing materials. We intend to make additional 
modifications to our informational and guidance materials, including 
the Medicare Claims Processing Manual, and create educational materials 
to reflect refinements to payment policy for dental services, as well 
as describe updates to operational and implementation aspects of this 
policy. We appreciate the ongoing interest and engagement from 
interested parties on all aspects of this policy.
    We also solicited comment on approaches utilized by other health 
plans to mitigate issues with third party payment, including when 
Medicare is secondary payer and when coordinating with state Medicaid 
programs. In addition, we noted there is an informal practice whereby 
dental professionals may submit a dental claim to Medicare for the 
purposes of producing a denial so that Medicaid or another third-party 
payer can make primary payment.
    Given the complexity of dental professionals submitting claims for 
purposes of denial, we solicited comment on the impact of third-party 
payers, including state Medicaid programs, requiring a Medicare denial 
as a prerequisite for adjudication of primary payment for dental 
services that are not inextricably linked to another specific covered 
service. In these cases where the dental services are not inextricably 
linked to another specific covered service, dental professionals must 
include the appropriate HCPCS modifier on the respective dental claim 
form, which serves as a certification that the professionals believe 
that Medicare should not pay the claim.
    We also solicited comment regarding an informal process on claims 
denials for the purposes of supporting payment by other payers is 
currently achieved in practice when using the dental claim form 837D. 
We note that the submission of a claim without one or more of the HCPCS 
modifier(s) meant to produce a denial shows belief by the enrolled 
billing practitioner that Medicare, not another payer, should be the 
primary payer in accordance with all applicable payment policies. As 
such, submission of a claim for dental services without such a modifier 
would mean that the billing practitioner believes the dental service is 
inextricably linked to another Medicare-covered service, or that 
payment for the service is otherwise permitted under our regulation at 
Sec.  411.15(i).
    We solicited comment on the practices of other payers related to 
submission of claims in order to generate a denial and how these 
practices impact claim submission and claim adjudication with third 
party payers, including state Medicaid programs.
    Additionally, we solicited comment on types of guidance, such as 
best practices or criteria, that are needed for purposes of 
coordinating payment for dental services under the policies specified 
in the rule.
    The following is a summary of the comments we received and our 
responses.
    Comment: Many commenters stated that CMS should provide clear 
guidance for when Medicare is a primary or secondary payer. 
Additionally, these commenters stated that they believe that Medicare 
coverage of medically necessary dental services should be in addition 
to any third-party dental plans.
    Response: We appreciate the feedback from commenters as we work 
towards coordinating efforts with any third-party payers, including 
state Medicaid programs.
    Comment: Many commenters supported CMS pursuing the adoption of the 
837D dental claim form and believe implementing this form will provide 
efficiency when processing dental claims. However, one commenter did 
not support the idea of adopting the dental claim form because the 
commenter stated they believe both the dental claim form and medical 
claim form are significantly different and that the dental claim form 
does not allow for modifiers, which would provide a barrier when 
determining which services qualify as Medicare basic benefit. Instead, 
this commenter suggested creating two new modifiers to make a 
distinction for inextricable linkage, for example, one modifier that 
attests to a particular dental service being inextricably linked and a 
second modifier that attests to a particular dental service not 
inextricably linked.
    Response: We continue to work to address issues raised by 
commenters, including questions related to claims processing and 
efforts to accommodate the dental claim form within our claims 
processing systems, effective 2024. As efforts advance to address the 
implementation and functionality of claims processing systems for the 
dental claim form, we intend to provide appropriate guidance and 
education to interested parties. Additionally, we continue to explore 
options for addressing the need to identify claims confirming 
inextricable linkage between the covered medical and dental services. 
These options include utilizing a HCPCS, CPT, or CDT modifier that may

[[Page 79037]]

allow dentists to attest to a particular dental service being 
inextricably linked and/or a second HCPCS, CPT, CDT modifier to attest 
that a particular dental service is not inextricably linked. We believe 
that the possible implementation and usage of distinct modifiers or 
codes for the purposes of confirming inextricable linkage will better 
enable us to quantify dental services and better understand the billing 
patterns of practitioners that typically furnish them. This information 
is helpful to CMS for program integrity purposes and may also inform us 
on whether we need to revise the policies for these services in future 
rulemaking. We intend to provide additional guidance and education 
around the possible usage of situationally appropriate HCPCS, CPT, and 
CDT modifiers that may be utilized in order to document inextricable 
linkage in claims processing. Additionally, we note that we intend to 
make conforming changes to the Internet Only Manual (IOM) Publication 
100-04, Medicare Claims Processing Manual, to reflect any modifications 
to the guidance on the submission of claims for the purpose of denials 
from CMS so third-party payers can pay as primary and intend to provide 
education regarding these operational aspects of this policy.
    Comment: Some commenters stated they oppose the informal practice 
of dental professionals submitting a dental claim to Medicare to 
produce a denial because they believe that it creates an administrative 
burden for health care providers. These commenters noted it also causes 
significant delays with reimbursement and can be confusing to patients 
as well. A few commenters questioned the legality and validity of the 
practice of submitting claims to elicit a denial. Many commenters 
highlighted that the current version of the American Dental Association 
dental claim form has no box for HCPCS modifiers and the commenters are 
not aware of any medical carriers that currently accept the 837D dental 
claim form. These commenters stated that the CMS-1500 form is typically 
used when a medical denial is needed for a dental service. However, a 
few commenters supported the possibility of using HCPCS modifiers on 
the 837D dental claim form for the purpose of Medicare denial and 
coordination benefits.
    Response: We note that dentists may continue submitting claims 
using the 837P and 837I claims types with existing Healthcare Common 
Procedure Coding System (HCPCS) modifiers when third-party payers need 
a Medicare claim denial. We continue to explore options for addressing 
the need to submit a dental claim to Medicare for the purpose of 
obtaining a denial so that another carrier or third-party payer may 
issue primary payment via the 837D dental claims format. In addition, 
we will take into consideration the potential usage of situationally 
appropriate modifiers or other codes that may be utilized in making 
clear that claims have been submitted expressly for the purpose of 
eliciting a denial. Additionally, we note that we will make conforming 
changes to the Internet Only Manual (IOM) Publication 100-04, Medicare 
Claims Processing Manual, to reflect any modifications to the guidance 
on the submission of claims for the purpose of denials from CMS so 
third-party payers can pay as primary, including the 837D dental claim 
format and provide education to the public regarding these efforts.
    As described in the CY 2023 PFS final rule (87 FR 69663 through 
69688), Medicare payment under Parts A and B may be made for dental 
services that are inextricably linked to other covered services. We 
believe the dental services and the other covered services would most 
often be furnished by different professionals and that in order for the 
dental services to be inextricably linked to other covered services 
such that Medicare payment can be made, there must be coordination 
between these professionals. This coordination should occur between the 
practitioners furnishing the dental and covered services regardless of 
whether both individuals are affiliated with or employed by the same 
entity. This coordination can occur in various forms, such as, but not 
limited to, a referral or exchange of information between the 
practitioners furnishing the dental and covered services. Additionally, 
any evidence of coordination between the professionals furnishing the 
primary medical service and dental services should be documented. If 
there is no evidence to support the exchange of information, or 
integration, between the professionals furnishing the primary medical 
service and the dental services, then there would not be an 
inextricable link between the dental and other covered services within 
the meaning of our regulation at Sec.  411.15(i)(3)(i). As such, 
Medicare payment for the dental services would be excluded under 
section 1862(a)(12) of the Act (though payment for the dental services 
might be available through supplemental health or dental coverage). 
Additionally, we sought information regarding the potential impact of 
these payment policies in settings other than inpatient and outpatient 
facilities, such as Federally qualified health centers (FQHCs), rural 
health clinics (RHCs), etc. We understand that some Medicare 
beneficiaries may access dental services in these settings and seek to 
understand what, if any, impact may potentially occur within the 
context of this payment policy.
    As stated in the CY 2023 PFS final rule, we note that to be 
eligible to bill and receive direct payment for professional services 
under Medicare Part B, a dentist must be enrolled in Medicare and meet 
all other requirements for billing under the PFS. Alternatively, a 
dentist not enrolled in Medicare could perform services incident to the 
professional services of a Medicare enrolled physician or other 
practitioner. In that case, the services would need to meet the 
requirements for incident to services under Sec.  410.26, including the 
appropriate level of supervision, and payment would be made to the 
enrolled physician or practitioner who would bill for the services (87 
FR 69673). In the CY 2023 PFS final rule (87 FR 69687), we finalized 
that we would continue to contractor price the dental services for 
which payment is made under Sec.  411.15(i). We will maintain this 
policy and continue to contractor price the dental services for which 
payment is made under Sec.  411.15(i) for CY 2024. Additionally, in the 
CY 2023 PFS final rule, we agreed with the suggestions made by 
commenters that there may be publicly available data sources that could 
aid MACs in determining these payment rates in order to account for 
geographic variation. We solicited comment on what specific information 
could help inform appropriate payment for these dental services (87 FR 
69679).
    The following is a summary of the comments we received and our 
responses.
    Comment: Majority of commenters supported the idea that 
coordination between medical and dental professionals must be properly 
documented. However, one commenter mentioned that requiring MACs to 
document coordination is difficult since any coordination will vary 
between different MACs. Therefore, these MACs requested that CMS to 
provide guidance that ensures compliance with the coordination 
requirement will be clear and simple. A few commenters requested 
clarification on how practitioners should demonstrate the exchange of 
information between medical and dental professionals to support 
Medicare payment for dental services as inextricably linked to other 
covered services and suggested the potential usage of existing CDT or 
CPT

[[Page 79038]]

codes or modifiers as a mechanism to establish the inextricable link 
between the dental and covered medical service.
    Response: We appreciate the commenters' feedback regarding 
documentation of the coordination and exchange of information between 
the medical and dental professionals. In the CY 2023 PFS final rule, we 
stated that we would make payment when a doctor of dental medicine or 
dental surgery (referred to as a dentist) furnishes dental services 
that are an integral part of the covered primary procedure or service 
furnished by another physician, or nonphysician practitioner, treating 
the primary medical illness. However, we explained that if there is no 
exchange of information, or integration, between the medical 
professional (physician or other non-physician practitioner) about the 
primary medical service and the dentist regarding the dental services, 
then there would not be an inextricable link between the dental and 
covered medical service within the meaning of our regulation at Sec.  
411.15(i)(3) (88 FR 69673). We continue to investigate operational 
mechanisms to demonstrate that the exchange of information between the 
Medicare enrolled medical and dental professional, such as the usage of 
the CPT or CDT modifiers or codes, including the KX HCPCS modifier, the 
CDT code D9311 (consultations with a medical health care professional), 
CPT code for interprofessional consultation (such as CPT 99452), or 
other modifiers/codes. As these operational aspects are implemented, we 
intend to provide educational materials regarding documentation of the 
exchange of information, or integration, between the medical 
professional (physician or other non-physician practitioner) in regard 
to the primary medical service and the dentist in regard to the dental 
services.
    Comment: One commenter opposed the requirement that only dentists 
enrolled in Medicare are eligible to receive direct payment from Part B 
because the commenter stated they believe this would limit Medicare 
beneficiary access to medically necessary dental benefits.
    Response: As explained in the CY 2023 PFS final rule, dentists not 
enrolled in Medicare may provide services incident-to the professional 
services of a Medicare enrolled physician or other practitioner who 
would bill for the services as long as the requirements under Sec.  
410.26 for incident-to services are met (87 FR 69673). Additionally, 
dentists not enrolled in Medicare must coordinate payment with the 
Medicare enrolled physician or other practitioner to receive payment 
from Medicare.
    Comment: Many commenters expressed their support for our current 
policy to contractor price dental services and believe using claims 
data will help inform appropriate payment for these services. However, 
a few commenters were opposed to contractor pricing of dental services 
and instead recommended that we should price the CDT codes in PFS RVU 
files to ensure consistent payment for each code while still accounting 
for geographic resource cost variations through the application of the 
PFS GPCIs. Additionally, several commenters expressed concerns 
regarding existing constraints on PFS funds due to the significant 
amount of other physician services currently included in the PE RVU 
Methodology. Therefore, these commenters noted that they believe that 
any expansion of Medicare to include dental services should be paid 
through a separate program independent of the physician fee schedule.
    Response: We continue to believe that MACs are appropriately 
situated to establish contractor prices for these services, given that 
the MACs currently establish contractor pricing for the dental services 
for which payment is currently made. We believe it is appropriate to 
continue contractor pricing for dental services for which payment is 
made in the additional clinical scenario examples we are finalizing in 
this final rule, until we have additional pricing data that could 
enable national pricing. We encourage MACs to continue to engage with 
interested parties by providing information on how they price these 
services. As such, we will continue to contractor price these services 
based on the applicable payment system for services furnished. We 
intend to continue engaging with interested parties regarding 
establishing national payment rates for these applicable dental 
services. Regarding the comment that Medicare payment for dental 
services should be made through a separate program independent of the 
PFS, we appreciate the commenters' feedback and note that we have 
clarified our interpretation of section 1862(a)(12) of the Act, and 
subsequently codified certain aspects of our current Medicare PFS 
payment policies for dental services. Additionally, while we recognize 
that the impact of access to these services to individual beneficiaries 
may be very significant, we still do not anticipate a significant 
impact in the context of overall spending and utilization under the 
PFS. We intend to closely study the trends in utilization and payment 
for these services and make refinements to the payment policy as needed 
in future rulemaking.
    Comment: Many commenters requested that we provide payment for 
inextricably linked dental services in the FQHC setting. Commenters 
stated that it is critical that CMS consider FQHCs' unique Medicare 
payment structure and that CMS ensure that policy changes for FQHCs are 
analogous to any changes made under the PFS. Commenters noted that many 
FQHCs provide dental services on-site, and health center patients could 
benefit from the payment policies for dental services inextricably 
linked to other covered services and suggested that the FQHC billing 
codes should be edited in tandem. Commenters further noted that 
``physicians' services'' component of the Medicare FQHC benefit 
includes services furnished by dentists. Several commenters urged that 
the list of billable visit codes modified in the proposed rule be 
included in the dental bundle for FQHCs or otherwise added to the list 
of codes that may be billed in the FQHC setting and also requested that 
any expansion in codes recognized under the PFS for dental-related 
services also be applied to FQHCs.
    Response: We appreciate the thoughtful feedback from commenters. We 
note that we intend to continue to refine the policy's operational 
aspects to ensure that the updates to this PFS payment policy are 
implemented in various applicable settings, including FQHCs. We 
acknowledge that the updates to the PFS payment policies for the 
purposes of this policy may be appropriate in other settings that 
provide PFS physician services, and we intend to make necessary 
modifications to operational procedures to reflect the expansion of 
this PFS payment policy, including potential updates to billable code 
lists and other relevant policies in the FQHC setting. We also note 
that we intend to provide additional guidance and education around the 
possible usage of situationally appropriate HCPCS or other modifiers or 
other CPT and/or CDT codes that may be utilized on FQHC claims in order 
to document inextricable linkage in claims processing or to elicit a 
denial for the purposes of payment by another payor, including 
Medicaid. We continue to seek engagement with interested parties on the 
appropriate application of this payment policy in other settings and 
encourage the public to continue to provide additional information 
regarding settings that may require special consideration in the 
context of this payment policy.

[[Page 79039]]

    In the CY 2023 PFS final rule (87 FR 69682), we stated that we 
would update our payment files so that these dental services could be 
billed appropriately under the applicable payment system for services 
furnished in the inpatient or outpatient setting. We have revised the 
HCPCS and PFS payment and coding files to include payment indicators 
for Current Dental Terminology (CDT) codes, such as bilateralism, 
multiple procedures, and other indicators that are included in the 
files (posted at our website at https://www.cms.gov/medicare/medicare-fee-for-service-payment/physicianfeesched/pfs-relative-value-files) for 
CDT codes. We solicited comment on whether payment indicators, as 
outlined in the PFS RVU files, appropriately align with existing dental 
billing and coding conventions or whether edits are necessary.
    Although we proposed to continue contractor pricing services billed 
using CDT codes, we solicited comment on whether the current payment 
indicators included for these CDT codes follow existing dental billing 
conventions, for example, for payment adjustment for multiple 
procedures, and whether there is a need for additional guidance 
regarding the submission of claims for services for which payment is 
permitted under the regulation at Sec.  411.15(i)(3). In the CY 2023 
PFS final rule (87 FR 69679), we acknowledged the need to address and 
clarify certain operational issues, and we are continuing to work to 
address these operational issues, including efforts to adopt the dental 
claim form. These efforts include continuing to work with our MACs and 
encouraging continued feedback from interested parties to help identify 
concerns or questions regarding submitting and processing dental 
claims.
    Finally, to promote the correct coding and processing of Medicare 
claims, we solicited comment on whether additional specialty codes 
besides specialty codes, specialty 19 (oral surgery--dentists only) or 
specialty 85 (maxillofacial surgery), should be considered for use in 
Medicare.
    We also solicited comment on whether these specialty codes may 
impact the coordination of benefits with a third-party payer.
    Finally, we acknowledged that issues could occur related to the 
coordination of benefits for dual eligible beneficiaries, for example, 
beneficiaries with hemophilia, and we solicited comment on how to best 
coordinate a potential payment policy in this area with respect to 
state Medicaid plans or private insurance.
    We also solicited comment on other coordination of benefits issues, 
or implementation topics that would be helpful for CMS to address in 
relation to continuing to implement these PFS payment policies, and we 
received public comments. The following is a summary of the comments we 
received and our responses.
    Comment: Many commenters stated that multiple procedure reductions 
and payment indicators should be removed from the PFS payment files 
because they do not align with existing dental billing and coding 
conventions.
    Response: We note that the multi-procedure payment reductions are a 
standard payment indicator used for any service priced on the PFS 
payment file. However, given feedback from interested parties, CMS has 
recently removed multi-procedure payment reductions payment indicators 
for dental services (described by current dental terminology(T) codes 
in the July 2023 release of the PFS RVU files. Additionally, we will 
continue to study and refine the payment files for dental services, 
including the applicability of other payment indicators. We also intend 
to identify appropriate modifications to the dental services code set 
on the PFS payment files to better align with clinical practice and 
implement edits in the practitioner claims processing systems to 
reflect that codes for some procedures would not likely be appropriate 
for usage in situations where medical services are inextricably linked 
dental services, such as procedures that are solely cosmetic in nature. 
We will also update appropriate Medicare payment data files to ensure 
that covered dental services can be billed and paid based on the 
applicable payment system for services furnished. For more information 
regarding dental codes that are available for payment under Medicare, 
we refer readers to the PFS RVU Files posted on our website at https://www.cms.gov/medicare/medicare-fee-for-service-payment/physicianfeesched/pfs-relative-value-files.
    As we consider refinements to the payment file in the context of 
how dentists furnish these services, we would be interested in 
obtaining information regarding certain dental codes that would not be 
covered in the context of the policies we describe. This information, 
as well as additional comments or considerations, can be submitted 
through the public submissions process described in section II.K.1.c. 
of this rule.
    Comment: A few commenters supported CMS creating new dental 
specialty codes for use by dentists enrolling in the Medicare program 
to promote the correct coding and processing of Medicare claims for 
dental services.
    Response: We appreciate the commenters' suggestion that CMS create 
new dental specialty codes to advance accurate coding and claims 
processing. We note that CMS issued guidance on August 31, 2023 via 
Change Request 13323, New Dental Specialty Codes for Medicare, 
announcing new dental specialty codes that dentists may use beginning 
on January 2, 2024. These new specialty codes include: E3--Dental 
Anesthesiology, E4--Dental Public Health, E5--Endodontics, E6--Oral and 
Maxillofacial Pathology, E7--Oral and Maxillofacial Radiology, E9--Oral 
Medicine, F1--Orofacial Pain, F2--Orthodontics and Dentofacial 
Orthopedics, F3--Pediatric Dentistry, F4--Periodontics, F5--
Prosthodontics. More details regarding this change request are 
available at https://www.cms.gov/files/document/r12231cp.pdf.
    We thank the public for their comments regarding the implementation 
considerations for these dental policies, and we will continue to work 
with MACs and other interested parties to address issues raised by the 
commenters. We continue to encourage feedback from interested parties 
to help identify concerns or questions regarding submission and 
processing of dental claims and other operational and implementation 
concerns. We plan to provide guidance and engage in further rulemaking, 
as necessary, as operational strategies and plans are refined and 
implemented. We will also monitor service utilization to identify any 
concerns about consistency of claims processing and adequacy of access 
across the country. We appreciate the questions raised by commenters 
and plan to take them into consideration as we continue to refine 
operational issues relating to this policy and make any necessary 
refinements.
    In conclusion, after consideration of the public comments, clinical 
practice guidelines, recommendations provided by the public, and our 
analyses of the studies and research, we are finalizing additions to 
our regulation at Sec.  411.15(i)(3)(i) to add dental or oral 
examination performed as part of a comprehensive workup prior to, and 
medically necessary diagnostic and treatment services to eliminate an 
oral or dental infection prior to, or contemporaneously with 
chemotherapy, chimeric antigen receptor (CAR) T-cell therapy, and the 
administration of high-dose bone-modifying agents (antiresorptive 
therapy) in the treatment

[[Page 79040]]

of cancer to the list of examples of services that are not subject to 
the exclusion under section 1862(a)(12) of the Act and for which 
payment can be made under Medicare Parts A and B. We are also 
finalizing, with modifications, the addition of Sec.  
411.15(i)(3)(i)(E) to add dental or oral examination performed as part 
of a comprehensive workup prior to, medically necessary diagnostic and 
treatment services to eliminate an oral or dental infection prior to, 
or contemporaneously with, and medically necessary diagnostic and 
treatment services to address dental or oral complications after, 
treatment of head and neck cancer using radiation, chemotherapy, 
surgery, or any combination of these, to the list of examples of 
clinical scenarios that are not subject to the exclusion under section 
1862(a)(12) of the Act and for which payment can be made under Medicare 
Parts A and B.
    Additionally, we reiterate that MACs have the flexibility to 
determine on a claim-by-claim basis whether a patient's circumstances 
do or do not fit within the terms of the preclusion or exception 
specified in section 1862(a)(12) of the Act and Sec.  411.15(i). We 
further note that the finalized policies outlined in this section of 
this final rule would not prevent a MAC from making a determination 
that payment can be made for dental services in other circumstances not 
specifically addressed within this final rule and the finalized 
amendments to Sec.  411.15(i). We remind readers once again that, to be 
considered for purposes of CY 2025 PFS rulemaking, submissions through 
our public process for recommendations on payment for dental services 
should be received by February 10, 2024, via email at 
[email protected]. Interested parties should 
include the words ``dental recommendations for CY 2025 review'' in the 
subject line of their email submission to facilitate processing. We 
continue to stress to submitters that recommendations must include at 
least one of the types of evidence listed earlier when submitting 
documentation to support the inextricable link between specified dental 
services and other covered services. We further note that we may also 
consider recommendations that are submitted as public comments during 
the comment period following the publication of the PFS proposed rule.

III. Other Provisions of the Proposed Rule

A. Drugs and Biological Products Paid Under Medicare Part B

1. Provisions From the Inflation Reduction Act Relating to Drugs and 
Biologicals Payable Under Medicare Part B (Sec. Sec.  410.152, 414.902, 
414.904, 489.30)
    Drugs and biologicals (for the purposes of the discussion in this 
section III.A., ``drugs'') payable under Medicare Part B fall into 
three general categories: those furnished incident to a physician's 
service (hereinafter referred to as ``incident to'') (section 
1861(s)(2) of the Act), those administered via a covered item of 
durable medical equipment (DME) (section 1861(n) of the Act), and 
others as specified by statute (for example, certain vaccines described 
in sections 1861(s)(10)(A) and (B) of the Act). Payment amounts for 
most drugs separately payable under Medicare Part B are determined 
using the methodology in section 1847A of the Act, and in many cases, 
payment is based on the average sales price (ASP) plus a statutorily 
mandated 6 percent add-on.
    The Inflation Reduction Act (Pub. L. 117-169, August 16, 2022) 
(hereinafter referred to as ``IRA'') contains several provisions that 
affect payment limits or beneficiary out-of-pocket costs for certain 
drugs payable under Part B. Among those provisions, two affect payment 
limits for biosimilar biological products (hereinafter referred to as 
``biosimilars''):
     Section 11402 of the IRA amends the payment limit for new 
biosimilars furnished on or after July 1, 2024 during the initial 
period when ASP data is not available. We proposed to codify this 
provision in regulation.
     Section 11403 of the IRA increased the payment limit for 
certain biosimilars with an ASP that is not more than the ASP of the 
reference biological for a period of 5 years. We implemented section 
11403 of the IRA under program instruction,126 127 as 
permitted under section 1847A(c)(5)(C) of the Act. We proposed 
conforming changes to regulatory text to reflect these provisions.
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    \126\ https://www.cms.gov/files/document/r11496cp.pdf.
    \127\ https://www.cms.gov/medicare/medicare-fee-for-service-part-b-drugs/mcrpartbdrugavgsalesprice.
---------------------------------------------------------------------------

    In addition, two provisions (among others in the IRA) make 
statutory changes that affect beneficiary out-of-pocket costs for 
certain drugs payable under Medicare Part B:
     Section 11101 of the IRA requires that beneficiary 
coinsurance for a Part B rebatable drug is to be based on the 
inflation-adjusted payment amount if the Medicare payment amount for a 
calendar quarter exceeds the inflation-adjusted payment amount, 
beginning on April 1, 2023. We issued initial guidance implementing 
this provision, as permitted under section 1847A(c)(5)(C) of the Act, 
on February 9, 2023.\128\ We proposed conforming changes to regulatory 
text.
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    \128\ https://www.cms.gov/files/document/medicare-part-b-inflation-rebate-program-initial-guidance.pdf.
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     Section 11407 of the IRA provides that for insulin 
furnished through an item of DME on or after July 1, 2023, the 
deductible is waived and coinsurance is limited to $35 for a month's 
supply of insulin furnished through a covered item of DME. We have 
implemented this provision under program instruction for 2023, as 
permitted under section 11407(c) of the IRA.\129\ We proposed to codify 
this provision in a manner that is consistent with the program 
instruction for 2023.
---------------------------------------------------------------------------

    \129\ https://www.congress.gov/bill/117th-congress/house-bill/5376/text.
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a. Payment for Drugs Under Medicare Part B During an Initial Period
    In the CY 2024 PFS proposed rule (88 FR 52385), we explained that 
section 1847A of the Act provides for certain circumstances in which 
the payment limit of a drug is based on its wholesale acquisition cost 
(WAC). For a single source drug or biological (as defined in section 
1847A(c)(6)(D) of the Act), the Medicare payment could be determined 
based on WAC under the methodology specified in section 1847A(b)(4) of 
the Act and described at Sec.  414.904(d)(1), which requires that 
payment limits for such drugs are determined using the lesser of ASP 
plus 6 percent or WAC plus 6 percent. Typically, the ASP-based payment 
limit is the lesser of the two. Under section 1847A(c) of the Act, 
payments for new drugs during an initial period for which ASP data is 
not sufficiently available are based on WAC or the Medicare Part B drug 
payment methodology in effect on November 1, 2003. Historically, WAC-
based payment under section 1847A(c)(4) of the Act was up to 106 
percent of WAC, but in the CY 2019 PFS final rule (83 FR 59661 through 
59666), we adopted a policy of paying up to 103 percent of WAC in this 
instance. Subsequently, section 6 of the Sustaining Excellence in 
Medicaid Act of 2019 (Pub. L. 116-39, enacted August 6, 2019), amended 
section 1847A(c)(4) of the Act to specify, effective January 1, 2019, a 
payment limit not to exceed

[[Page 79041]]

103 percent of the WAC or based on the Part B drug payment methodology 
in effect on November 1, 2003 during an initial period when ASP data is 
not sufficiently available. There were no regulatory changes at that 
time. Therefore, we proposed to amend Sec.  414.904(e)(4) to reflect 
this statutory change.
    In the CY 2024 PFS proposed rule (88 FR 52385), we explained that 
more recently, section 11402 of the IRA amended section 1847A(c)(4) of 
the Act by adding subparagraph (B), which limits the payment amount for 
biosimilars during the initial period described in section 
1847A(c)(4)(A) of the Act. The provision requires that for new 
biosimilars furnished on or after July 1, 2024, during the initial 
period when ASP data is not sufficiently available, the payment limit 
for the biosimilar is the lesser of (1) an amount not to exceed 103 
percent of the WAC of the biosimilar or the Medicare Part B drug 
payment methodology in effect on November 1, 2003, or (2) 106 percent 
of the lesser of the WAC or ASP of the reference biological, or in the 
case of a selected drug during a price applicability period, 106 
percent of the maximum fair price of the reference biological.
    We proposed to codify these changes to section 1847A(c)(4) of the 
Act at Sec.  414.904. Specifically, we proposed to revise paragraph 
(e)(4) at Sec.  414.904 by adding paragraphs (e)(4)(i)(A) and (B) to 
conform the regulatory text for WAC-based payment limits before January 
1, 2019 and for such payment limits on or after January 1, 2019 with 
the requirements established in section 6 of the Sustaining Excellence 
in Medicaid Act of 2019. We also proposed to add paragraphs (A) and (B) 
to Sec.  414.904(e)(4)(ii) to codify the payment limit for new 
biosimilars furnished on or after July 1, 2024 during the initial 
period as required by section 1847A(c)(4)(B) of the Act.
    We received public comments on these proposals. The following is a 
summary of the comments we received regarding implementation of the IRA 
provisions in general and our responses.
    Comment: Several commenters expressed general support for proposed 
regulatory changes that will reduce out-of-pocket costs for 
prescription drugs.
    Response: We thank the commenters for their support.
    Comment: Two commenters expressed support for CMS's ongoing efforts 
to implement the IRA by codifying provisions relating to Medicare Part 
B payments for certain biosimilar products, and one commenter stated 
that they support the proposal as a straightforward implementation of 
the statute. One commenter stated that these changes will help support 
the availability and use of biosimilar products and ensure that 
Medicare beneficiaries benefit from the savings that were intended by 
the passage of the new law.
    Response: We thank these commenters for their support.
    Comment: One commenter expressed concern about the financial impact 
the implementation of the IRA's provisions related to the payment of 
drugs will have on physician practices and requested we consider taking 
steps to offset revenue losses.
    Response: We appreciate the commenter's concern. In limited 
circumstances, the implementation of the new lesser-than methodology 
for the add-on payment for biosimilar products established under 
section 11402 of the IRA may reduce provider payments, but this 
reduction lasts only during the period of marketing before ASP data is 
available. The temporary add-on payment for certain biosimilars with an 
ASP that is not more than the ASP of the reference biological 
established under section 11403 of the IRA, on the other hand, 
increases payments to providers.
    The following is a summary of the comments we received regarding 
implementation of section 11402 of the IRA and our responses.
    Comment: Regarding payment for drugs under Part B during an initial 
period, one commenter stated that based on the statutory language in 
section 11402 of the IRA that CMS proposes to implement, it appears 
that CMS has the authority to eliminate the 3 percent add-on payment 
for new drugs paid based on WAC. Therefore, the commenter urged the 
Secretary to reduce the payment rate for new drugs lacking ASP data 
from 103 percent to 100 percent of WAC. Because WAC is generally a 
higher price than ASP and does not reflect discounts, eliminating the 
WAC add-on would reduce excess payments, increase affordability for 
beneficiaries and taxpayers, and improve financial incentives. The 
commenter noted that in its June 2023 report to Congress,\130\ the 
Medicare Payment Advisory Commission (MedPAC) recommended eliminating 
add-on payments for drugs lacking ASP data that are paid based on WAC 
to improve Medicare's Part B drug payment system.
---------------------------------------------------------------------------

    \130\ Medicare Payment Advisory Commission. 2023. Report to the 
Congress: Medicare and the health care delivery system. Washington, 
DC: MedPAC.
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    Response: We thank commenters for these policy suggestions, and we 
may consider these policies in future rulemaking. We note that under 
the proposed policy, Medicare Administrative Contractors (MACs) are not 
required to pay an amount equal to 103 percent of the WAC. In the 
common circumstance that a WAC-based payment limit is not published on 
the ASP Drug Pricing File during the initial period, MACs will be given 
instruction to price drugs during the initial period in a manner 
consistent with these provisions, including language stating that the 
WAC-based payment limit under these policies is not to exceed 103 
percent of the WAC. These instructions would not preclude MACs from 
making payments that are less than 103 percent of the WAC, but rather 
set a ceiling payment limit amount.
    Comment: One commenter requested that we clarify whether and how 
CMS determines Medicare payment and patient cost-sharing responsibility 
for covered drugs assigned a temporary, unspecified billing and payment 
code. The commenter suggested having temporary HCPCS codes to 
facilitate drug payment during the initial period.
    Response: Generally, new drugs in the initial period for which ASP 
data is not sufficiently available are not included on the ASP Drug 
Pricing File or the Not Otherwise Classified (NOC) Pricing File. 
Policies regarding WAC-based pricing during the initial period were 
finalized in the 2019 PFS final rule (83 FR 59661 through 59666) as 
discussed above in this section. These policies are currently reflected 
in section 20.1.3, Chapter 17 of the Medicare Claims Processing 
Manual,\131\ which provides instruction for MACs to price new drugs and 
biologicals that are not included on the ASP Drug Pricing File or NOC 
Pricing File. The manual currently states that, for claims with dates 
of service on or after January 1, 2019, the add-on percentage is up to 
3 percent for WAC-based payments determined by MACs for new drugs 
before an ASP-based payment limit is available. Similarly, Chapter 17 
of the Medicare Claims Processing Manual will be updated following the 
publication of this final rule to reflect policies finalized in this 
final rule regarding payment in the initial period for new drugs. In 
these circumstances, when the drug is billed using a NOC code, the MAC 
will instruct the provider on how to submit a claim using a NOC code 
and will determine the payment amount consistent with CMS policies. 
Therefore, we disagree that a temporary

[[Page 79042]]

billing and payment code is necessary to facilitate these payments.
---------------------------------------------------------------------------

    \131\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c17.pdf, accessed September 20, 2023.
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    Comment: One commenter encouraged CMS to conduct additional 
outreach to providers so that they can better understand the 
reimbursement policy for biosimilars.
    Response: The Medicare Claims Processing Manual is typically 
updated with finalized policies following the publication of a final 
rule. Near the time this CY 2024 PFS final rule is issued, these 
updates will be accompanied by other CMS communications, such as an MLN 
Matters[supreg] article, to the provider community.
    Comment: One commenter requested CMS clarify how the payment limits 
for new biosimilars as amended by section 11402 of the IRA will be 
implemented should legal challenges prevent or delay implementation of 
the drug price negotiation program, specifically regarding the maximum 
fair price (MFP) and encouraged CMS to provide education to providers 
regarding the potential impacts of this policy for reimbursement 
purposes, given changes related to the MFP.
    Response: This comment is outside of the scope of the proposals for 
payment of drugs and biologicals during the initial period. While we 
appreciate the commenter's request, we cannot speak to future legal 
matters, nor can we give future policy guidance with respect to these 
matters.
    After consideration of public comments, we are finalizing as 
proposed that we will codify requirements established in section 6 of 
the Sustaining Excellence in Medicaid Act of 2019 and section 11402 of 
the IRA. Specifically, we are revising paragraph (e)(4) at Sec.  
414.904 by adding paragraphs (e)(4)(i)(A) and (B) to conform the 
regulatory text for WAC-based payment limits before January 1, 2019 and 
for such payment limits on or after January 1, 2019 to the requirement 
that the payment amount for a drug (except as provided in paragraph 
(e)(4)(ii)) is an amount not to exceed 103 percent of the wholesale 
acquisition cost or based on the Medicare Part B drug payment 
methodologies in effect on November 1, 2003. We are also finalizing as 
proposed the addition of paragraphs (A) and (B) to Sec.  
414.904(e)(4)(ii) to codify the payment limit for new biosimilars 
furnished on or after July 1, 2024, during the initial period as 
required by section 1847A(c)(4)(B) of the Act.
b. Temporary Increase in Medicare Part B Payment for Certain Biosimilar 
Biological Products
    In the CY 2024 PFS proposed rule (88 FR 52385 through 52386), we 
stated that, consistent with section 1847A(b)(8) of the Act, the 
Medicare Part B payment limit for a biosimilar is its ASP plus 6 
percent of the reference biological product's ASP. We noted that in the 
CY 2016 PFS final rule (80 FR 71096 through 71101), we clarified that 
the payment limit for a biosimilar biological product is based on the 
ASP of all National Drug Codes (NDCs) assigned to the biosimilar 
biological products included within the same billing and payment code 
and amended Sec.  [thinsp]414.904(j) to reflect this policy. We also 
noted that in the CY 2018 PFS final rule (82 FR 53182 through 53186), 
we finalized a policy to separately assign individual biosimilar 
biological products to separate billing and payment codes and pay for 
biosimilar biological products accordingly. However, we did not change 
the regulation text at Sec.  414.904(j) at that time.
    In the CY 2024 PFS proposed rule, we explained that section 11403 
of the IRA amended section 1847A(b)(8) of the Act by establishing a 
temporary payment limit increase for qualifying biosimilar biological 
products furnished during the applicable 5-year period. Section 
1847A(b)(8)(B)(iii) of the Act defines a ``qualifying biosimilar 
biological product'' (hereinafter referred to as a ``qualifying 
biosimilar'') as a biosimilar biological product (as described in 
section 1847A(b)(1)(C) of the Act) with an ASP (as described in section 
1847A(b)(8)(A)(i) of the Act) less than the ASP of the reference 
biological for a calendar quarter during the applicable 5-year period. 
Section 11403 of the IRA requires that a qualifying biosimilar be paid 
at ASP plus 8 percent of the reference biological's ASP rather than 6 
percent during the applicable 5-year period. Section 
1847A(b)(8)(B)(ii)(I) of the Act defines the applicable 5-year period 
for a qualifying biosimilar for which payment has been made under 
section 1847A(b)(8) of the Act (that is, payment of ASP plus 6 percent 
of the reference product's ASP) as of September 30, 2022, as the 5-year 
period beginning on October 1, 2022. For a qualifying biosimilar for 
which payment is first made under section 1847A(b)(8) of the Act during 
the period beginning October 1, 2022, and ending December 31, 2027, the 
statute defines the applicable 5-year period as the 5-year period 
beginning on the first day of such calendar quarter of such 
payment.\132\
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    \132\ In accordance with these provisions, the ASP Drug Pricing 
File reflects the temporary increased payment limit for qualifying 
biosimilars beginning with the October 2022 file available at 
https://www.cms.gov/medicare/medicare-fee-for-service-part-b-drugs/mcrpartbdrugavgsalesprice.
---------------------------------------------------------------------------

    In the CY 2024 PFS proposed rule, we proposed to add definitions of 
``applicable 5-year period'' and ``qualifying biosimilar biological 
product'' at Sec.  414.902 to reflect the definitions in statute. In 
addition, we proposed to make conforming changes to regulatory text to 
reflect the requirements mandated under section 1847A(b)(8)(B) of the 
Act for the temporary payment limit increase for qualifying biosimilar 
biological products at Sec.  414.904 (j) by adding paragraphs (j)(1) 
and (2).
    We received public comments on our proposals related to the 
temporary increase in Medicare Part B payment for certain biosimilar 
biological products. The following is a summary of the comments we 
received and our responses.
    Comment: Two commenters supported CMS's ongoing efforts to 
implement the IRA by codifying provisions relating to Medicare Part B 
payments for certain biosimilar drugs. One commenter stated that these 
changes will help support the availability and use of biosimilar 
products and ensure that Medicare beneficiaries benefit from the 
savings that were intended by the passage of the new law.
    Response: We thank these commenters for their support.
    Comment: One commenter encouraged CMS to conduct additional 
outreach to providers so that they can better understand the 
reimbursement policy for biosimilars.
    Response: We appreciate the commenter's recommendations related to 
outreach and education. CMS has included information on our website 
related to section 11403 \133\ and following the publication of this 
final rule, the Medicare Claims Processing Manual will be updated with 
the finalized policies regarding payment of biosimilars. These updates 
will be accompanied by other CMS communications, such as an MLN 
Matters[supreg] article, to the provider community. Overall, CMS shares 
the commenter's interest in ensuring providers have the educational

[[Page 79043]]

resources needed to understand payment policies.
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    \133\ https://www.cms.gov/medicare/payment/fee-for-service-providers/part-b-drugs/average-drug-sales-price/asp-reporting#WhatstheTemporaryIncreaseinPaymentforBiosimilarBiologicals.

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    After consideration of public comments, we are finalizing as 
proposed the definitions of ``applicable 5-year period'' and 
``qualifying biosimilar biological product'' at Sec.  414.902 to 
reflect the definitions in statute. In addition, we are finalizing as 
proposed making conforming changes to regulatory text to reflect the 
requirements mandated under section 1847A(b)(8)(B) of the Act for the 
temporary payment limit increase for qualifying biosimilar biological 
products at Sec.  414.904(j) by adding paragraphs (j)(1) and (2).
c. Inflation-Adjusted Beneficiary Coinsurance and Medicare Payment for 
Medicare Part B Rebatable Drugs
    As discussed in the CY 2024 PFS proposed rule (88 FR 52386), 
section 11101(a) of the IRA amended section 1847A of the Act by adding 
a new subsection (i), which requires the payment of rebates into the 
Supplementary Medical Insurance Trust Fund for Part B rebatable drugs 
if the payment limit amount exceeds the inflation-adjusted payment 
amount, which is calculated as set forth in section 1847A(i)(3)(C) of 
the Act. The provisions of section 11101 of the IRA are currently being 
implemented through program instruction, as directed under section 
1847A(c)(5)(C) of the Act. As such, we issued guidance for the 
computation of inflation-adjusted beneficiary coinsurance under section 
1874A(i)(5) of the Act and amounts paid under section 1833(a)(1)(EE) of 
the Act on February 9, 2023.134 135 For additional 
information regarding implementation of section 11101 of the IRA, 
please see the inflation rebates resources page at https://www.cms.gov/inflation-reduction-act-and-medicare/inflation-rebates-medicare.
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    \134\ https://www.cms.gov/files/document/medicare-part-b-inflation-rebate-program-initial-guidance.pdf.
    \135\ In addition, beginning with the April 2023 ASP Drug 
Pricing file, the file includes the coinsurance percentage for each 
drug and specifies ``inflation-adjusted coinsurance'' in the 
``Notes'' column if the coinsurance for a drug is less than 20 
percent of the Medicare Part B payment amount. Drug pricing files 
are available at https://www.cms.gov/medicare/medicare-fee-for-service-part-b-drugs/mcrpartbdrugavgsalesprice.
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    Section 1847A(i)(5) of the Act requires that for Part B rebatable 
drugs, as defined in section 1847A(i)(2)(A) of the Act, furnished on or 
after April 1, 2023, in quarters in which the amount specified in 
section 1847A(i)(3)(A)(ii)(I) of the Act (or, in the case of selected 
drugs described under section 1192(c) of the Act, the amount specified 
in section 1847A(b)(1)(B) of the Act), exceeds the inflation-adjusted 
payment amount determined in accordance with section 1847A(i)(3)(C) of 
the Act, the coinsurance will be 20 percent of the inflation-adjusted 
payment amount for such quarter (hereafter, the inflation-adjusted 
coinsurance amount). This inflation-adjusted coinsurance amount is 
applied as a percent, as determined by the Secretary, to the payment 
amount that would otherwise apply for such calendar quarter in 
accordance with section 1847A(b)(1)(B) or (C) of the Act, as 
applicable, including in the case of a selected drug. We proposed to 
codify the coinsurance amount for Part B rebatable drugs as required by 
section 1847A(i)(5) of the Act in Sec.  489.30, specifically by adding 
a new paragraph (b)(6).
    Section 11101(b) of the IRA amended section 1833(a)(1) of the Act 
by adding a new subparagraph (EE), which requires that if the payment 
amount described in section 1847A(i)(3)(A)(ii)(I) of the Act (or, in 
the case of a selected drug, the payment amount described in section 
1847A(b)(1)(B) of the Act) exceeds the inflation-adjusted payment 
amount of a Part B rebatable drug, the Part B payment will, subject to 
the deductible and sequestration, equal the difference between such 
payment amount and the inflation-adjusted coinsurance amount. In the 
proposed rule, we proposed to codify the Medicare payment for Part B 
rebatable drugs in Sec.  410.152, specifically by adding new paragraph 
(m).
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Several commenters expressed support for our proposed 
codification of section 11101 of the IRA, including one that cited that 
it would reduce Medicare beneficiaries' out-of-pocket costs.
    Response: We thank the commenters for their support.
    Comment: One commenter pointed out that we inverted text in the 
preamble of the proposed rule at 88 FR 52386 describing the amendment 
section 11101(b) of the IRA made to section 1833(a)(1) of the Act and 
identified a typographical error in the text of proposed new paragraph 
(b)(6) at 42 CFR 489.30.
    Response: We thank the commenter for identifying our errors in the 
preamble and proposed regulatory text. We are correcting both errors in 
this final rule.
    Comment: One commenter requested that we clarify whether a 
reduction or waiver of an inflation rebate due to shortage would affect 
the reduced beneficiary coinsurance for that drug. The commenter stated 
that the section relating to the reduction or waiver of the rebate for 
shortages and severe supply chain disruptions, section 1847A(i)(3)(G) 
of the Act, makes no cross-references to the application of the 
inflation-adjusted beneficiary coinsurance, which is implemented in 
section 1847A(i)(5) of the Act.
    Another commenter advocated against of the inclusion of Medicare 
Advantage units in the calculation of Part B drug inflation rebates. 
The commenter stated the statutory definition of a Part B rebatable 
drug in section 1847A(i)(2)(A) of the Act precludes counting payments 
for drugs under Part C.
    Response: We note that since we did not make any proposals in this 
rulemaking related to the calculation of the inflation-adjusted payment 
amount described in section 1847A(i)(3)(C) of the Act, the calculation 
of the rebate amount in section 1847(i)(3)(A) of the Act, or the 
reduction or waiver for shortages and severe supply chain disruptions 
described in section 1847A(i)(3)(G) of the Act, these comments are out 
of scope. We note that these issues were addressed in the Medicare Part 
B Drug Inflation Rebates Paid by Manufacturers: Initial Memorandum, 
Implementation of Section 1847A(i) of the Social Security Act, and 
Solicitation of Comments dated February 9, 2023 (the ``initial Part B 
inflation rebate guidance''), and we gave interested parties the 
opportunity to comment on the initial Part B inflation rebate guidance. 
We will consider the comments we received in response to the initial 
Part B inflation rebate guidance when developing future guidance on the 
Medicare Prescription Drug Inflation Rebate Program.
    After consideration of public comments, we are finalizing the 
codification of the coinsurance amount and the Medicare payment for 
Part B rebatable drugs at Sec.  489.30 and Sec.  410.152, respectively, 
as proposed, except insofar as correcting the typographical error in 
new paragraph (b)(6) at Sec.  489.30.
d. Limitations on Monthly Coinsurance and Adjustments to Supplier 
Payment Under Medicare Part B for Insulin Furnished Through Durable 
Medical Equipment
    In the CY 2024 PFS proposed rule (88 FR 52386), we stated that 
drugs furnished through a covered item of DME are covered under 
Medicare Part B as provided in sections 1861(n) and (s)(6) of the Act. 
Insulin administered through covered DME, such as a durable

[[Page 79044]]

insulin pump, is covered under this benefit. As required by section 
1842(o)(1)(C) and (D) of the Act, effective January 1, 2017, infusion 
drugs furnished through DME, including insulin, are paid under section 
1847A of the Act (see 82 FR 53180 through 53181), which is typically 
ASP plus 6 percent. Prior to July 1, 2023, beneficiaries are 
responsible for coinsurance of 20 percent of the payment amount of such 
insulin, subject to the Part B deductible.
    In the CY 2024 PFS proposed rule we explained that section 11407 of 
the IRA made three changes to the way beneficiaries pay for insulin 
furnished through covered DME. First, section 11407(a) of the IRA 
amended section 1833(b) of the Act to waive the Part B deductible for 
insulin furnished through covered DME on or after July 1, 2023. Second, 
section 11407(b)(2) of the IRA amended section 1833(a) of the Act to 
establish a limit of $35 on the beneficiary coinsurance amount for a 
month's supply of such insulin furnished on or after July 1, 2023. This 
statutory change means that the beneficiary coinsurance responsibility, 
which is limited to $35 for a month's supply of insulin, could equal 
less than 20 percent if the Part B payment amount of a month's supply 
of insulin is greater than $175. Third, section 11407(b)(2) of the IRA 
also added a new sentence to section 1833(a) of the Act to require the 
Secretary to increase to the Medicare Part B payment to above 80 
percent in the case the coinsurance amount for insulin furnished 
through covered DME equals less than 20 percent of the payment amount 
to pay for the full difference between the payment amount and 
coinsurance. The adjustment specified in paragraph (b)(2) ensures the 
supplier is not responsible for the reduction in the beneficiary 
coinsurance amount.
    The above provisions were implemented through program 
instruction,\136\ as required by section 11407(c) of the IRA, for CY 
2023. Section 80 in Chapter 17 \137\ and section 140 in Chapter 20 
\138\ of the Medicare Claims Processing Manual will be updated to 
reflect these changes, effective July 1, 2023. To operationalize this 
provision, we stated that the $35 coinsurance limit applies to the 
duration of the calendar month in which the date of service occurs. As 
stated in the section 110.5, Chapter 15 of the Medicare Benefit Policy 
Manual,\139\ the date of service on the claim must be the date that the 
beneficiary or authorized representative receives the insulin or, for 
mail order, the date the insulin is shipped. A new $35 coinsurance 
limit for a month's supply applies to each calendar month. It follows 
that, as stated in the program instruction, when a 3-month supply (that 
is, the amount of such insulin that is required for treatment for up to 
3 calendar months) is billed for insulin furnished through covered DME, 
a coinsurance limit of $105 would apply for that 3-calendar month 
period ($35 coinsurance limit for each month's supply of insulin). The 
program instruction also states that the MACs will ensure that 
coinsurance does not exceed $35 for a 1-month supply or $105 for a 3-
month supply for claims billing insulin administered through covered 
DME.
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    \136\ https://www.cms.gov/files/document/r11917cp.pdf.
    \137\ https://www.cms.gov/regulations-and-guidance/guidance/
manuals/downloads/clm104c17.pdf.
    \138\ https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/clm104c20_dmemay23_r2.pdf.
    \139\ https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/bp102c15.pdf.
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    In the CY 2024 PFS proposed rule, we proposed to codify these 
elements (that are currently in program instruction) for CY 2024 and 
future years in regulation text, because section 11407(c) of the IRA 
states that only implementation for CY 2023 may be through program 
instruction or other forms of guidance. Specifically, we proposed to 
codify the new statutory monthly coinsurance limits of $35 for a 1-
month supply and $105 for a 3-month supply at Sec.  [thinsp]489.30 by 
adding paragraph (b)(7) and the adjustment to the supplier payment at 
Sec.  410.152 by adding paragraph (n). In addition, we proposed to 
codify at Sec.  [thinsp]489.30 that the $35 coinsurance limit for a 
month's supply of insulin furnished through covered DME will apply to 
the duration of the calendar month in which the date of service (or 
services) occurs. In other words, the $35 coinsurance limit will apply 
for a month's supply of insulin each calendar month. Similarly, we 
proposed to codify that the $105 coinsurance limit for 3 months' supply 
of insulin furnished through covered DME will apply to the duration of 
the calendar month in which the date of service (or services) occurs 
and the 2 following calendar months.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: One commenter expressed support for our proposed 
regulatory codification of section 11407 of the IRA.
    Response: We thank the commenter for their support.
    Comment: One commenter requested clarification that compounded 
insulin is exempt from the Part B insulin coinsurance limitation 
consistent with how compounded insulin is treated for purposes of the 
Medicare Part D Coverage Gap Discount Program (CGDC) and the 
Manufacturer Discount Program. The commenter requested that we clarify 
that several forms of compounded insulin are exempt from the 
coinsurance limitation, including insulin transferred from vials to a 
cartridge for insertion into a pump, pre-drawn syringes for patients 
who cannot prepare their own medication, insulin drips, and insulin 
added to total parenteral nutrition (TPN) or intradialytic parenteral 
nutrition (IDPN).
    Response: We thank the commenter for their question. Products that 
the commenter refers to as ``compounded insulin'' that are furnished 
through a covered item of DME are subject to the monthly coinsurance 
limitation. The coinsurance limitation of $35 for a month's supply 
would apply to insulin that is transferred from vials into a cartridge 
for insertion into an insulin pump given that the pump is a covered 
item of DME. However, insulin that is not administered through a 
covered item of DME and is instead administered through, for example, 
pre-drawn syringes, would not be subject to the monthly coinsurance 
limitation. For information on the applicability of the coinsurance 
limitation to insulin administered through syringes, see the Part D 
Inflation Reduction Act (IRA) Cost Sharing Maximum Reports for Part D 
Sponsors memorandum \140\ and Frequently Asked Questions about Medicare 
Insulin Cost-Sharing Changes in the Prescription Drug Law.\141\
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    \140\ https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/IRA_Cost_Sharing_Maximum_Reports_508_G.pdf.
    \141\ https://www.cms.gov/files/document/frequently-asked-questions-medicare-part-d-insulin-benefit.pdf.
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    We note that intravenous (IV) insulin drips are not commonly 
administered in physician offices and coverage for outpatient IV 
insulin therapy (OIVIT) was rescinded in 2010 for claims with dates of 
service on and after December 23, 2009, pursuant to Change Request 
6775,\142\ after CMS determined from a review of evidence that OIVIT 
does not improve health outcomes in Medicare beneficiaries. Typically, 
IV insulin drips would not occur in a patient's home because of the 
inability for a patient or

[[Page 79045]]

a patient's caregiver to safely supervise the administration. 
Therefore, we do not anticipate administration of IV insulin drips 
outside of a hospital setting under close monitoring, not covered under 
DME. Regarding parenteral nutrition, we note that parenteral nutrition 
is covered under the Medicare Part B benefit for prosthetic devices. 
Insulin that is not administered through a covered item of DME and is 
instead administered through, for example, a prosthetic device, would 
not be subject to the monthly coinsurance limitation.
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    \142\ https://www.cms.gov/regulations-and-guidance/guidance/transmittals/downloads/r1930cp.pdf.
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    After consideration of public comments, we are finalizing as 
proposed the new paragraph (b)(7) at Sec.  [thinsp]489.30 for the 
limitations on monthly coinsurance for insulin furnished through a 
covered item of DME. We are also finalizing as proposed the new 
paragraph (n) at Sec.  410.152 for the adjustment to the supplier 
payment under Medicare Part B.
e. Indexing the Part B Deductible to Inflation
    Prior to the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (MMA) (Pub. L. 108-173), the Part B 
deductible was set in statute. After setting the 2005 deductible amount 
at $110.00, section 629 of the MMA (amending section 1833(b) of the 
Act) required that the Part B deductible be indexed beginning in 2006. 
The inflation factor to be used each year is the annual percentage 
increase in the Part B actuarial rate for enrollees aged 65 and over. 
Specifically, the 2024 Part B deductible is calculated by multiplying 
the 2023 deductible by the ratio of the 2024 aged actuarial rate to the 
2023 aged actuarial rate. The amount determined under this formula is 
then rounded to the nearest $1.00. Although Sec.  410.160 was amended 
to reflect the statutory change, we did not make the corresponding 
revision in Sec.  489.30. Earlier in this section, we finalized 
additional changes to the regulatory text for allowable charges under 
Part B for rebatable drugs and insulin furnished on or after July 1, 
2023, through an item of durable medical equipment covered under 
section 1861(n) of the Act in Sec.  489.30(b)(6) and (7), respectively. 
Therefore, we are finalizing the revision to Sec.  489.30(b)(1) to 
conform the regulatory text for the Part B deductible with the 
statutory change made by section 629 of the MMA and the IRA provisions 
that make statutory changes that affect beneficiary out-of-pocket costs 
for certain drugs payable under Medicare Part B.
2. Request for Information (RFI): Drugs and Biologicals Which Are Not 
Usually Self-Administered by the Patient, and Complex Drug 
Administration Coding
    Section 1861(s)(2)(A) of the Act allows Medicare to pay for 
services and supplies, including drugs and biologicals (hereafter, 
drugs) that are not usually self-administered by the patient, which are 
furnished as ``incident to'' a physician's professional service. 
Section 112 of the Benefits, Improvements & Protection Act of 2000 
(BIPA) (Pub. L. 106-554, December 21, 2000) amended the above-
referenced sections 1861(s)(2)(A) and 1861(s)(2)(B) of the Act, which 
formerly referred to drugs ``which cannot be self-administered,'' to 
read, ``which are not usually self-administered.'' Drugs that are 
``usually self-administered'' are thus statutorily excluded from 
coverage and payment under Part B under the ``incident to'' benefit.
    We have provided definitions and other guidance for MACs regarding 
determinations on drugs that are ``not usually self-administered by the 
patient'' in Chapter 15, Section 50.2 of the Medicare Benefit Policy 
Manual.\143\ Chapter 15 also describes the evidentiary criteria that 
MACs should use in determining whether a drug is usually self-
administered. The guidance directs MACs to publish a description of the 
process they use to make that determination, and to publish a list of 
the drugs that are subject to the self-administered exclusion on their 
website.\144\ The guidance also requires that this list include the 
data and rationale that led to the determinations. This list is 
referred to as the ``self-administered drug (SAD) list,'' and each MAC 
maintains their own version of the list, which is applicable to that 
MAC's area of jurisdiction. While the lists are often similar between 
MACs, they are not identical. Drugs that are put on a SAD list are 
excluded from Part B coverage, but in those situations, they are almost 
always covered by Medicare Part D prescription drug coverage. For 
several years, interested parties have requested that we update and 
clarify this SAD list guidance. These parties believe that the current 
guidance may not adequately address circumstances posed by newly 
approved drugs.
---------------------------------------------------------------------------

    \143\ Ibid.
    \144\ https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/bp102c15.pdf.
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    In a similar vein, we have received concerns from interested 
parties that non-chemotherapeutic complex drug administration payment 
has become increasingly inadequate due to existing coding and Medicare 
billing guidelines that do not accurately reflect the resources used to 
furnish these infusion services. Interested parties have asserted that 
these infusion services are similar to complex and clinically intensive 
Chemotherapy and Other Highly Complex Biological Agent Administration 
(``Chemotherapy Administration'') services that are billed using CPT 
code series 96401-96549, as opposed to Therapeutic, Prophylactic, and 
Diagnostic Injections and Infusion services billed using CPT code 
series 96360-96379. We note that we discuss our policies for these 
services in Pub. 100-04 Medicare Claims Processing Manual, Chapter 12, 
Section 30.5D.\145\
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    \145\ https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/clm104c12.pdf.
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    In the CY 2024 PFS proposed rule (88 FR 52387), we solicited 
comments on the above two policy areas, since they both involve Part B 
drug payment policies that have been impacted by new developments in 
the field. In an effort to promote coding and payment consistency and 
patient access to infusion services, we solicited comments and 
information from interested parties regarding the relevant resources 
involved, as well as inputs and payment guidelines and/or 
considerations, that could be used in determining appropriate coding 
and payment for complex non-chemotherapeutic drug administration. We 
solicited comments on whether or not we should revise our policy 
guidelines as discussed to better reflect how these specific infusion 
services are furnished and should be billed.
    We also solicited comments regarding our policies on the exclusion 
of coverage for certain drugs under Part B which are usually self-
administered by the patient. Specifically, we solicited comments 
regarding our policies for the following items:
     Definitions of the following terms, as referenced in this 
section:
    ++ ``Administered.''
    ++ ``Self-Administered.''
    ++ ``Usually.''
    ++ ``By the patient.''
     The process for determining which drugs are classified as 
those ``not usually self-administered by the patient.''
     The process for issuing decisions on which drugs are 
classified as those ``not usually self-administered by the patient,'' 
and the process for issuing any changes to those classifications.
     The relevant resources involved, as well as inputs and 
payment guidelines and/or considerations, that could be

[[Page 79046]]

used in determining appropriate coding and payment for complex non-
chemotherapeutic drug administration.
     Whether or not CMS should revise policy guidelines to 
better reflect how complex non-chemotherapeutic drug administration 
infusion services are furnished and billed.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: We received many comments regarding our policies on self-
administered drugs. The comments addressed several critical issues in 
this space, including appeals, FDA labeling, and accommodating patients 
who are under caregivers' care and/or patients who do not have the 
ability self-administer drugs. Commenters provided robust feedback on 
the self-administered drug issues listed above, and on related issues 
as well.
    Response: We thank commenters for their attention to these policies 
and for sharing our desire to improve health equity and healthcare 
access for Medicare enrollees. We plan to consider all comments, and we 
look forward to continued discussions with interested parties as we 
work towards potentially developing changes to these policies in future 
rulemaking.
    Comment: We received a number of comments in response to our 
Request for Information (RFI) regarding appropriate reimbursement for 
non-chemotherapeutic complex drug administration coding. Commenters 
urged CMS to provide additional guidance clarifying the conditions 
under which infusion drugs can be considered complex and may be 
appropriately reported using the chemotherapy administration CPT codes 
96401-96549. Commenters expressed concern with the MAC guidance 
currently in effect for complex drug administration services. 
Commenters asserted that the current reimbursement rates and billing 
considerations for non-chemotherapeutic complex infusion services 
provided by the MACs are inconsistent, inadequate, and in conflict with 
CMS billing policies.
    Response: We appreciate commenters' concerns regarding the complex 
drug administration payment policy. Our current guidance regarding 
coding rules for chemotherapy administration and nonchemotherapy 
injections and infusion services, as documented in 100-4 Chapter 12, 
section 30.5 of our internet Only Manual (IOM), outlines the categories 
under which payment is made for both types of injections and infusions 
and the considerations for determining what drugs may be considered 
chemotherapy under Medicare.\146\ There, we state that ``Chemotherapy 
administration codes (CPT codes 96401-96549) apply to parenteral 
administration of non-radionuclide anti-neoplastic drugs; and also, to 
anti-neoplastic agents provided for treatment of noncancer diagnoses 
(for example, cyclophosphamide for auto-immune conditions) or to 
substances such as monoclonal antibody agents, and other biologic 
response modifiers.'' We also provide examples of specific drugs, 
including monoclonal antibody drugs, but we also clarify that the 
examples discussed do not represent an exhaustive list of drugs that 
may be administered using complex administration services. We further 
state that ``A/B MACs (B) may provide additional guidance as to which 
drugs may be considered to be chemotherapy drugs under Medicare.''
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    \146\ https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/clm104c12.pdf.
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    We acknowledge the commenters' position that the clinical work and 
expense for some complex drug infusion services are not adequately 
accounted for as currently reimbursed by Medicare. However, we note 
that Medicare payment for the chemotherapy administration CPT code 
series (96401-96549) accounts for clinical staff and supply costs as 
part of physician practice expenses for the administration service. The 
practice expense costs include preservice preparation activities, 
intra-service constant monitoring, and post-service period activities 
performed by registered nurses or oncology-certified nurses. The supply 
items also include equipment such as a biohazard hood. Medicare payment 
for the therapeutic, prophylactic, and diagnostic injections and 
infusion CPT code series (96360-96379) also accounts for clinical staff 
activities and supply equipment as part of the practice expense for the 
administration service with less clinical staff service time and fewer 
equipment items. However, we understand and acknowledge the constantly 
evolving practice of medicine and advancements in complex drug 
administration that may need to be considered relative to our existing 
payment policies. We are interested in future discussions with 
interested parties to work towards developing policies that accurately 
account for the costs involved in complex drug administration services.
3. Requiring Manufacturers of Certain Single-Dose Container or Single-
Use Package Drugs To Provide Refunds With Respect To Discarded Amounts 
(Sec. Sec.  [thinsp]414.902 and 414.940)
a. Background
    Section 90004 of the Infrastructure Investment and Jobs Act (Pub. 
L. 117-58, November 15, 2021) (hereinafter is referred to as ``the 
Infrastructure Act'') amended section 1847A of the Act to redesignate 
subsection (h) as subsection (i) and insert a new subsection (h), which 
requires manufacturers to provide a refund to CMS for certain discarded 
amounts from a refundable single-dose container or single-use package 
drug (hereafter referred to as ``refundable drug''). The refund amount 
is the amount of discarded drug that exceeds an applicable percentage, 
which is required to be at least 10 percent, of total charges for the 
drug in a given calendar quarter.
    In the CY 2023 PFS final rule (87 FR 69710 through 69734), we 
adopted many policies to implement section 90004 of the Infrastructure 
Act. We finalized the requirement that billing providers and suppliers 
report the JW modifier for all separately payable drugs with discarded 
drug amounts from single use vials or single use packages payable under 
Part B, beginning January 1, 2023. We also finalized the requirement 
that billing providers and suppliers report the JZ modifier for all 
such drugs with no discarded amounts beginning no later than July 1, 
2023, and we stated that we would begin claims edits for both the JW 
and JZ modifiers beginning October 1, 2023 (87 FR 69718 through 69719). 
Subsequent to the issuance of the CY 2023 PFS final rule, CMS published 
the JW Modifier and JZ Modifier Policy Frequently Asked Questions (FAQ) 
document \147\ addressing the correct use of these modifiers. We 
adopted a definition of ``refundable single-dose container or single-
use package drug'' at Sec.  414.902, which also specifies exclusions 
from this definition (87 FR 69724). These three exclusions are: 
radiopharmaceutical or imaging agents, certain drugs requiring 
filtration, and drugs approved by FDA on or after November 15, 2021, 
and for which payment has been made under Part B for fewer than 18 
months. Regarding reports to manufacturers, we specified that we would 
send reports (including information described in section 1847A(h)(1) of 
the Act) for each

[[Page 79047]]

calendar quarter on an annual basis to all manufacturers of refundable 
drugs (87 FR 69726). We finalized how the refund amount will be 
calculated at Sec.  [thinsp]414.940 (87 FR 69731). Regarding drugs with 
unique circumstances for which we can increase the applicable 
percentage otherwise applicable for determining the refund, we adopted 
an increased applicable percentage of 35 percent for drugs 
reconstituted with a hydrogel and with variable dosing based on 
patient-specific characteristics (87 FR 69731). Lastly, we adopted a 
dispute resolution process through which manufacturers can challenge 
refund calculations, and we established enforcement provisions 
(including manufacturer audits, provider audits, and civil money 
penalties required by statute) (87 FR 69732 through 69734).
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    \147\ https://www.cms.gov/medicare/medicare-fee-for-service-payment/hospitaloutpatientpps/downloads/jw-modifier-faqs.pdf.
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    As noted in the CY 2023 PFS final rule (87 FR 69711), sections 
11101 and 11102 of the Inflation Reduction Act (Pub. L. 117-169, August 
16, 2022) (IRA) established new requirements under which manufacturers 
must pay inflation rebates if they raise their prices for certain Part 
B and Part D drugs faster than the rate of inflation. Drug 
manufacturers are required to pay rebates to Medicare if prices for 
certain Part B drugs increase faster than the rate of inflation for 
quarters beginning with the first quarter of 2023; drug manufacturers 
are required to pay rebates to Medicare if prices for certain Part D 
drugs increase faster than the rate of inflation over 12-month periods, 
starting with the 12-month period that began October 1, 2022.
    We explained that we believe implementation of the Part B and Part 
D inflation rebate programs established under the IRA should be 
considered together with the operational implications of the discarded 
drug refunds, because the refunds and rebates both require CMS to 
accept from drug manufacturers payments that must be deposited into the 
Federal Supplementary Medical Insurance (SMI) Trust Fund.
    Therefore, to align the operation of these programs and minimize 
burden, we declined to finalize some aspects of the invoicing and 
collection of discarded drug refunds. Specifically, we declined to 
finalize the timing of the initial reports and which quarters' 
information will be included in each report. We also declined to 
finalize specific dates by which manufacturer refund obligations are 
due and those associated with the dispute resolution process, as those 
are scheduled in tandem with the reporting dates. Lastly, we stated our 
intent to address these aspects in future rulemaking.
    In the CY 2024 PFS proposed rule (88 FR 52388 through 52395), we 
proposed the date of the initial report to manufacturers, the date for 
subsequent reports, method of calculating refunds for discarded amounts 
in lagged claims data, method of calculating refunds when there are 
multiple manufacturers for a refundable drug, increased applicable 
percentages for certain drugs with unique circumstances, and a future 
application process by which manufacturers may apply for an increased 
applicable percentage for a drug, which would precede proposals to 
increase applicable percentages in rulemaking. We also proposed 
modification to the JW and JZ modifier policy for drugs payable under 
Part B from single-dose containers that are furnished by a supplier who 
is not administering the drug.
b. Provision of Information to Manufacturers
    In the CY 2023 PFS final rule (87 FR 69724 through 69726), we 
discussed our proposals related to meeting the requirements under 
section 1847A(h)(1) of the Act related to the timing and contents of 
the report to manufacturers, including what types of information to 
include, which quarters' data we would include in the initial report, 
the amount of lagged claims data we would include, whether to send 
reports quarterly or annually, and the definition of a manufacturer. 
However, we explained that due to the enactment of the IRA and our 
efforts to align the operations of the refunds with the inflation 
rebate programs and minimize burden, we did not finalize certain 
aspects of the discarded drug refund provision. Specifically, we did 
not finalize the date that we would send the first report to 
manufacturers or which quarters' information would be included in each 
report.
    Although we did not finalize the noted aspects related to timing, 
we adopted regulations at Sec.  414.940(a)(3) providing that we will 
send reports to manufacturers on an annual basis and indicated in the 
preamble text that reports will contain discard information (described 
in section 1847A(h)(1)(A) of the Act) for each calendar quarter (87 FR 
69724 through 69726). We also finalized that we would send reports to 
all manufacturers of refundable drugs. In addition, in response to 
commenters suggesting that we provide manufacturers an opportunity to 
engage with us on discard amount data in the first year of this 
provision's implementation, we stated that we would issue, no later 
than December 31, 2023, a preliminary report on estimated discarded 
amounts based on available claims data from the first two quarters of 
CY 2023.
    In the CY 2024 PFS proposed rule (88 FR 52388 through 52389), we 
discussed implementing the discarded drug refund in a timely manner. We 
proposed to issue the initial refund report to manufacturers, to 
include all calendar quarters for 2023, no later than December 31, 
2024. (Note that this report, which we refer to as the ``initial refund 
report'' in this final rule, will be separate and distinct from the 
preliminary report that we will issue by December 31, 2023, which will 
include estimated discarded amounts based on available claims data for 
the first 2 quarters of CY 2023.)
    With respect to subsequent annual reports, that is, reports for 
quarters in CY 2024 and thereafter, we stated our intent to align 
delivery of the refund reports with the delivery of Part B and Part D 
inflation rebate reports to the extent practicable. We noted that in 
the initial guidance for Part B inflation rebates,\148\ it states that 
inflation rebate reports will be sent on a quarterly basis, each no 
later than 6 months after the end of the calendar quarter as required 
in section 1847A(i)(1)(A) of the Act. We also noted that the guidance 
states, consistent with section 1847A(i)(1)(C) of the Act, that we may 
delay reporting Part B inflation rebate information for calendar 
quarters in CY 2023 and CY 2024 until not later than September 30, 
2025.\149\
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    \148\ https://www.cms.gov/files/document/medicare-part-b-inflation-rebate-program-initial-guidance.pdf.
    \149\ https://www.cms.gov/files/document/medicare-part-b-inflation-rebate-program-initial-guidance.pdf.
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    To align these reports, we proposed that, other than for the 
initial refund report, (which we are finalizing that we will issue no 
later than December 31, 2024, as described in section III.A.3.b of this 
final rule), we would send annual refund reports for discarded drug 
refunds for the 4 quarters of a calendar year at or around the time we 
plan to send Part B inflation rebate reports for the first quarter of 
the following year. Thus, for example, we would send the second refund 
report for the calendar quarters in 2024 when we plan to send the 
inflation rebate report for Q1 2025, which is required to be sent no 
later than September 30, 2025, as required in section 1847A(i)(1)(C) of 
the Act. We note that the timeframe for Part B inflation rebate reports 
has not yet been finalized; the final timing will be addressed in the 
revised Part B inflation rebate guidance.

[[Page 79048]]

    We noted in the CY 2023 PFS final rule (87 FR 69725), because 
providers and suppliers have a 12-month period to submit Medicare Part 
B claims, including claims for drugs payable under Part B, there can be 
a lag between the date of service when a drug is administered and when 
the claim is submitted and adjudicated. Therefore, there is a lag in 
available JW modifier data for any given date of service quarter. We 
provided our evaluation of July 2010 Medicare Part B claims in the 
Physician/Supplier-Carrier setting that showed 91.68, 96.84, and 98.32, 
and 99.13 percent of claims were final at 3, 6, 9, and 12 months, 
respectively, following the date of service. At 24 and 48 months after 
the date of service, 99.83 and 100 percent of the claims, respectively, 
were final.
    In the CY 2024 PFS proposed rule, we explained that based on our 
evaluation of the 2010 claims data, a small percentage of lagged claims 
data from a calendar quarter likely would not be available when the 
quarter is first included on a report, and therefore we proposed that 
annual reports (subsequent to the initial report) include lagged claims 
data (that is, true-up information) for quarters from 2 calendar years 
prior. In other words, we proposed that each report would include 
information for 8 calendar quarters: 4 quarters from the previous 
calendar year (hereafter, referred to as new refund quarters) and 4 
quarters from 2 calendar years prior (hereafter, referred to as updated 
refund quarters). See Table 20, which shows which refund quarters will 
be in each refund report. We proposed all reports (except the initial 
refund report) would include the following information for updated 
refund quarters to address lagged claims data:
     The updated total number of units of the billing and 
payment code of such drug, if any, that were discarded during such 
updated refund quarter, as determined using a mechanism such as the JW 
modifier used as of the date of enactment of this subsection (or any 
such successor modifier that includes such data as determined 
appropriate by the Secretary).
     The updated refund amount that the manufacturer is liable 
for with respect to such updated quarter that was not previously 
accounted for in the prior year's report.
    For example, as discussed above, the second annual report (sent no 
later than September 30, 2025) would include: (1) the total number of 
units of the billing and payment code of such drug, if any, that were 
discarded during new refund quarters (all calendar quarters in 2024), 
(2) the refund amount for which the manufacturer is liable under 
section 1847A(h)(3) of the Act for all calendar quarters in 2024, (3) 
the updated total number of units of the billing and payment code of 
such drug, if any, that were discarded during the updated refund 
quarters (all calendar quarters in 2023), and (4) the refund amount 
that the manufacturer is liable for or the amount CMS owes the 
manufacturer under section 1847A(h)(3) of the Act for all calendar 
quarters in 2023 that were not accounted for in the previous year's 
report.
[GRAPHIC] [TIFF OMITTED] TR16NO23.041

    We proposed to define ``new refund quarter'' and ``updated refund 
quarter'' at Sec.  414.902 and to revise Sec.  414.940(a)(1)(iii) to 
reflect the inclusion of lagged data in reports subsequent to the 
initial refund report. We solicited comments on these proposals (88 FR 
52389). See section III.A.3.d. of this final rule for the discussion 
regarding calculation of refund amounts and for updated refund 
quarters.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Several commenters expressed support for the proposal to 
align timing of discarded drug refund reports, beginning with the 
second refund report, with inflation rebate reports.
    Response: We thank the commenters for their support.
    Comment: Two commenters opposed inclusion of more than one quarter 
of lagged claims data for which manufacturers would be liable. One 
commenter stated that since manufacturers are not responsible for 
delays in claims submission, they should not bear the burden of refunds 
on lagged claims. The other commenter stated that limiting lagged data 
to one quarter would provide a better balance of administrative burden 
and the accuracy of discarded amount assessments.
    Response: We thank the commenters for their feedback. We disagree 
that discarded amounts of refundable drugs for claims properly 
submitted to Medicare contractors should not be considered for the 
calculation of discarded drug refund obligations. Under 42 CFR 424.44, 
providers and suppliers generally have one calendar year after the date 
of service to submit claims, and the process by which contractors 
review and finalize claims can sometimes take several additional 
months.\150\ To accurately determine the number of discarded units in a 
given quarter, the reconciliation of discard amounts for each quarter 
one year after discard amount information is initially reported 
provides an operational process that more accurately determines 
discarded amounts and refunds for each quarter as compared to the 
accuracy of such information if updated refund quarters were not 
included in the reports.
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    \150\ https://www.ecfr.gov/current/title-42/section-424.44.

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[[Page 79049]]

    After considering the comments, we are finalizing the definitions 
of ``new refund quarter'' and ``updated refund quarter'' at Sec.  
[thinsp]414.902, as proposed. We are also finalizing the inclusion of 
four updated refund quarters (one calendar year) in reports subsequent 
to the initial refund report at Sec.  [thinsp]414.940(a)(1)(iii) as 
proposed. With respect to timing of refund reports, we reiterate our 
intent to provide refund reports as follows:
     As discussed in the 2023 PFS final rule at 87 FR 69726, we 
intend to send a preliminary refund report to manufacturers no later 
than December 31, 2023 to provide estimated discarded amounts based on 
available claims data from the first 2 quarters of CY 2023;
     We intend to send the initial refund report to 
manufacturers not later than December 31, 2024, which will contain 
information for all calendar quarters of 2023; and
     For subsequent years, we intend to send annual refund 
reports for discarded drug refunds for the 4 quarters from the previous 
calendar year (new refund quarters) and 4 quarters from 2 calendar 
years prior (updated refund quarters) prior to or around the time we 
plan to send Part B inflation rebate reports for the first quarter of 
the following year (not later than September 30).
c. Manufacturer Provision of Refund
    In the CY 2023 PFS final rule (87 FR 69726 through 69727) we 
adopted Sec.  414.940(b), which requires manufacturers to pay refunds 
in 12-month intervals in a form and manner specified by CMS. In the CY 
2023 PFS final rule (87 FR 69727), we also discussed our proposal for 
the timing of both the initial refund report and manufacturers' 
corresponding refund obligations. That is, we proposed to issue reports 
to manufacturers by October 1 and require refund obligations to be paid 
by December 31, except in circumstances where a dispute is pending. 
Regulations at Sec.  414.940(b)(2) specify that in the case that a 
disputed report results in a refund amount due, that amount must be 
paid no later than 30 days after resolution of the dispute.
    However, we did not finalize the deadlines by which manufacturer 
refund obligations are due and those associated with the dispute 
resolution process in the CY 2023 PFS final rule, because those 
deadlines correspond with the dates of the annual refund reports, which 
we declined to finalize in order to align the operation of the 
discarded drug refunds with the inflation rebate programs. In the CY 
2023 PFS final rule (87 FR 69727), we stated our intent to revisit the 
process and timeline for manufacturers' provisions of refunds in future 
rulemaking.
    In the CY 2024 PFS proposed rule (88 FR 52389), we proposed to 
issue the initial refund report to manufacturers no later than December 
31, 2024. As discussed above, we are finalizing this policy. We 
explained that a payment deadline that is 2 calendar months after the 
issuance of the report may provide adequate time for manufacturers to 
review the reports and submit a dispute if needed prior to the refund 
payment deadline. Accordingly, we proposed to require that the refund 
amounts specified in the initial refund report be paid no later than 
February 28, 2025, except in circumstances where a report is under 
dispute.
    We also noted the proposal regarding issuance of the second annual 
refund report to manufacturers be no later than September 30, 2025, and 
once annually thereafter no later than September 30 for every year 
thereafter. We contemplated this deadline along with our belief that a 
payment deadline that is 2 calendar months after the issuance of the 
report provides adequate time for manufacturers to review the reports 
and submit a dispute if needed prior to the refund payment deadline. 
Accordingly, we proposed to require manufacturers to pay refunds 
specified in each report (beginning with the second report) no later 
than December 31 of the year in which the report is sent, except in 
circumstances where a report is under dispute. In cases in which a 
manufacturer disputes a report, we proposed that beginning with the 
initial refund report, any manufacturer liability determined upon the 
resolution of the dispute would be due by the above stated due date or 
30 days following the resolution, whichever is later. We proposed to 
revise Sec.  414.940(b)(1) and (2) to reflect these dates.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Two commenters expressed support for the payment timeline 
of liabilities for circumstances in which there is no dispute, as well 
as circumstances where there is a dispute with the extended deadline.
    Response: We thank the commenters for their support.
    Comment: One commenter stated that CMS's implementation of section 
1847A(h) of the Act violates the due process principle of fair notice 
because it attaches new legal consequences to decisions made in 
compliance with applicable laws and regulations, such as the 
determination of vial sizes, prior to enactment of the Infrastructure 
Act. The commenter asserted their belief that neither Congress nor 
agencies may impose retroactive penalties unless there is express 
legislative authorization, which they stated does not appear in the 
statutory provision for the discarded drug refund policy.
    Response: Legislative recommendations for Congress are outside of 
the scope of this rulemaking. As these policies affect refunds that 
will be paid in the future after the promulgation of the rule, we 
disagree that our proposed implementation of section 1847A(h) of the 
Act violates the due process principle of fair notice. There are no 
retroactive effects on payments that have already been made.
    After consideration of public comments, we are finalizing revisions 
to Sec.  414.940(b)(1) as proposed. That is, refund amounts specified 
in the initial refund report for calendar quarters in CY 2023 must be 
paid no later than February 28, 2025, and for calendar quarters in each 
subsequent calendar year, no later than December 31 of the year in 
which the report is sent, except in circumstances where a report is 
under dispute. Regarding cases in which a manufacturer disputes a 
refund report, we are finalizing revisions to Sec.  414.940(b)(2) as 
proposed to reflect that any refund amounts determined upon the 
resolution of the dispute will be due by the due date specified in 
Sec.  414.940(b)(1) or 30 days following the resolution, whichever is 
later.
d. Refund Amount
(1) Calculation of Refund Amounts for Updated Quarters
    In the CY 2024 PFS proposed rule (88 FR 52389 through 52390) we 
explained how we would calculate the refund amount for updated quarters 
since we need to contemplate lagged claims data in all reports other 
than the initial refund report. That is, we proposed that such 
additional lagged JW modifier data, if any, will be used to calculate 
revisions to the manufacturer refund amount. Specifically, we proposed 
to calculate the refund with updated data in the same manner as was 
finalized in the 2023 PFS final rule (87 FR 69727) and subtract the 
refund amount that already paid for such refundable drug for such 
quarter to determine the updated quarter refund amount. We proposed 
that the refund amount owed by a manufacturer, with respect to a 
refundable drug assigned to a billing and payment code for an updated 
refund quarter is the amount equal to the estimated amount (if any) by 
which:
     The product of:

[[Page 79050]]

    ++ The total number of units of the billing and payment code for 
such drug that were discarded during such quarter; and
    ++ The amount of payment determined for such drug or biological 
under section 1847A(b)(1)(B) or (C) of the Act, as applicable, for such 
quarter.
     Exceeds the difference of:
    ++ An amount equal to the applicable percentage of the estimated 
total allowed charges for such a drug (less the amount paid for 
packaged drugs) during the quarter; and
    ++ The refund amount previously paid for such refundable drug for 
the given quarter.
    We proposed that if the resulting refund calculation for an updated 
quarter is a negative number, then it will be netted out of the any 
refund owed for other updated quarters or new quarters.
    We proposed to revise Sec.  [thinsp]414.940 by adding new 
paragraphs (c)(2) and (3) to reflect the proposed method of calculation 
of revisions to the refund amount owed for quarters in the year that is 
2 calendar years prior.
    We received one public comment on these proposals. The following is 
a summary of the comment we received and our response.
    Comment: One commenter expressed support for our proposal to use 
the same refund calculation methodology for new and updated quarters' 
claims data. The commenter stated the use of a consistent methodology 
will provide manufacturers predictability.
    Response: We appreciate the commenter's feedback.
    After consideration of public comments, we are finalizing revision 
of Sec.  [thinsp]414.940 by adding paragraphs (c)(2) and (3), as 
proposed, to reflect the method of calculation of revisions to the 
refund amount owed for quarters in the year that is 2 calendar years 
prior. That is, we will calculate the refund with updated data in the 
same manner as described above and subtract the refund amount already 
paid for such refundable drug, for such quarter, to determine the 
updated quarter refund amount owed by the manufacturer.
(2) Calculation of Refund for a Drug When There are Multiple 
Manufacturers
    In the CY 2023 PFS final rule (87 FR 69727 through 69731), 
consistent with section 1847A(h)(3) of the Act, we adopted regulations 
at Sec.  414.940(c) specifying the manner in which the refund amount 
will be calculated with respect to a refundable drug of a manufacturer 
assigned to a billing and payment code for a calendar quarter beginning 
on or after January 1, 2023. The refund for which the manufacturer is 
liable is the amount equal to the estimated amount (if any) by which:
     The product of:
    ++ The total number of units of the billing and payment code for 
such drug that were discarded during such quarter; and
    ++ The amount of payment determined for such drug or biological 
under section 1847A(b)(1)(B) or (C) of the Act, as applicable, for such 
quarter;
     Exceeds an amount equal to the applicable percentage of 
the estimated total allowed charges for such a drug (less the amount 
paid for packaged drugs) during the quarter.
    In the CY 2023 PFS final rule, we proposed a policy to estimate the 
total allowed charges during the quarter by multiplying the drug's 
payment amount for the quarter by the total number of units of the 
billing and payment code of such drug that were subject to JW modifier 
reporting including those for which the JZ modifier would be required 
if no units were discarded. As specified in section 1847A(h)(1)(C) of 
the Act, the total number of units of the billing and payment code of a 
refundable drug furnished during a calendar quarter for purposes of 
subparagraph (A)(i), and the determination of the estimated total 
allowed charges for the drug in the quarter for purposes of paragraph 
(3)(A)(ii), exclude such units that are packaged into the payment 
amount for an item or service and are not separately payable.
    In the CY 2024 PFS proposed rule (88 FR 52390 through 52391) we 
discussed situations where single source drugs or biologicals have 
multiple manufacturers. We explained that because refundable drugs are 
single source drugs or biologicals, they typically will have one 
manufacturer. However, a refundable drug could have more than one 
manufacturer, for example, in the circumstance where a refundable drug 
is produced by one manufacturer, and also by one or more 
manufacturer(s) that is a repackager or relabeler. Multiple 
manufacturers of a refundable drug could also occur in the case of one 
or more authorized generic products that are marketed under the same 
FDA-approval as the original FDA applicant. In such cases, the National 
Drug Codes (NDCs) for the drug typically are assigned to the same 
billing and payment code, and each manufacturer is responsible for 
reporting ASP data to CMS, which includes sales volume.
    In the CY 2023 PFS final rule (87 FR 69724 through 69726), we 
stated that we would identify the manufacturer responsible for the 
provision of refunds by the labeler code of the refundable drug. 
Therefore, in the CY 2024 PFS proposed rule, we discussed our proposal 
to establish a method for apportioning billing units of a refundable 
drug sold during a calendar quarter in situations where there are 
multiple manufacturers of a refundable drug. When calculating the 
refund amount owed by manufacturers for a refundable drug that has more 
than one manufacturer, we proposed to identify such refundable drugs 
using the ASP sales data reported for the calendar quarter for which a 
refund amount is calculated. Furthermore, we proposed to apportion 
financial responsibility for the refund amount among each manufacturer 
in the following manner: by dividing the sum of the individual 
manufacturer's billing units sold during the refund quarter for all the 
manufacturer's NDCs assigned to the billing and payment code (as 
reported in the ASP data submissions), by the sum of all manufacturers' 
billing units sold during the refund quarter for all NDCs of the 
refundable drug assigned to the billing and payment code (as reported 
in the ASP data submissions).
    We explained that this calculation approach is consistent with the 
approach for apportioning inflation rebate obligations discussed in 
section 50.13 of the Medicare Part B Drug Inflation Rebates Paid by 
Manufacturers: Initial Memorandum, Implementation of Section 1847A(i) 
of the Social Security Act, and Solicitation of Comments,\151\ released 
on February 9, 2023.
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    \151\ https://www.cms.gov/files/document/medicare-part-b-inflation-rebate-program-initial-guidance.pdf.
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    In addition, we proposed to apportion the discarded drug refund 
when there is more than one manufacturer for a refundable drug, using 
the proportion of billing unit sales, expressed as a percentage, 
attributed to each NDC (at the NDC-11 level) assigned to the billing 
and payment code for such refund quarter. The number of billing unit 
sales for each NDC would be the reported number of NDCs sold (as 
submitted in the ASP report to CMS each quarter) multiplied by the 
billing units per package for such NDC. We proposed that the refund 
amount attributed to such NDCs for which the manufacturer is liable 
would be the amount equal to the estimated amount (if any) by which:
     The product of:
    ++ The total number of units of the billing and payment code for 
such drug that were discarded during such quarter;

[[Page 79051]]

    ++ The percentage of billing unit sales of the applicable code 
attributed to the NDC; and
    ++ The amount of payment determined for such drug or biological 
under section 1847A(b)(1)(B) or (C) of the Act, as applicable, for such 
quarter;
     Exceeds an amount equal to the product of:
    ++ The applicable percentage of the estimated total allowed charges 
for such a drug (less the amount paid for packaged drugs) during the 
quarter; and
    ++ The percentage of billing unit sales of the applicable code 
attributed to the NDC.
    For example, if a billing and payment code for a refundable drug 
includes three NDCs, each from a different manufacturer as shown in 
Table 21, there were 3,000 units discarded during the refund quarter 
out of 21,000 total billing units of a billing and payment code 
administered, the payment limit amount for the refundable drug was 
$50.00 per billing unit, the applicable percentage was 10 percent, and 
the estimated total allowed charges for the refundable drug during the 
refund quarter was $1.05 million, the proposed calculation for the 
refund amount owed by Manufacturer 1, which reported 23.81% of billing 
unit sales for the billing and payment code for the refund quarter, 
would be as follows: (3,000)(23.81%)($50)-(21,000)(10%)(23.81%)($50) = 
refund amount of $10,714.50.
[GRAPHIC] [TIFF OMITTED] TR16NO23.042

    Using this example and following the proposed calculation, the 
report to manufacturers, discussed above in section III.A.3.b of this 
final rule, would include: (1) the total number units of the billing 
and payment code of such drug attributed to the manufacturer's NDC 
assigned to the billing and payment code of the refundable drug that 
were discarded during such quarter, if any; and (2) the refund amount 
for which the manufacturer of that NDC is liable under section 
1847A(h)(3) of the Act. We proposed that this method of calculation 
apply beginning with calendar quarters in CY 2023 included in the 
initial refund report, which, as described in section III.A.3.b in this 
final rule, we are finalizing be sent no later than December 31, 2024. 
We proposed that this method of calculation will be done for new refund 
quarters and updated refund quarters.
    We proposed to revise Sec.  [thinsp]414.940 by adding a new 
paragraph (c)(4) to reflect the above proposed method of calculation of 
the refund amount attributed to a NDC when there are multiple 
manufacturers.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Two commenters expressed support of the proposed 
methodology for calculating the refund for drugs with multiple 
manufacturers.
    Response: We thank the commenters for their support.
    Comment: Two commenters opposed the proposed methodology because 
they claim that the calculation could result in a manufacturer owing a 
discarded drug refund even if the amounts discarded from the 
manufacturer's refundable drugs did not exceed the applicable 
percentage. One commenter urged CMS to ensure that Part B claims data 
correctly indicate the specific products prescribed and administered to 
patients. Commenters stated that each manufacturer's refund liability 
should only be determined based on that manufacturer's product. The 
commenters also stated that the statute precludes our methodology, as 
it states that ``a refund . . . [shall be] equal to the amount 
specified in paragraph (3) for such drug for such quarter.'' The 
commenters state that the discarded drug refund should be calculated at 
the NDC-11 level if a refund is due for a refundable drug when there 
are multiple manufacturers of such drug. One commenter states that the 
plain language of section 1847A(h) of the Act requires CMS to implement 
a process that precisely identifies refund liability based on each 
manufacturer's refundable drug. In such a case, CMS should develop a 
process to require reporting of NDC-11s on the CMS-1500 and 837P claim 
forms and reject as incomplete any forms without required NDC-11s. 
Another commenter urged CMS to assure that refund reports are accurate 
with respect to manufacturers that owe them.
    Response: We thank commenters for their input. In considering the 
issues raised by commenters about manufacturers owing refunds that they 
assert should be the responsibility of other manufacturers, we 
considered the proposed methodology for calculating the refund using 
actual data. To that end, we identified 12 refundable drugs with 
multiple manufacturers and found that in a vast majority of these 
cases, each manufacturer is packaging the product in the same sized 
container(s). We found one instance where a repackager manufactures two 
of the four package sizes available from the other manufacturer of the 
refundable drug, but the repackager did not produce any product sizes 
that were not also produced by the other manufacturer.
    Based on this analysis showing that the available product size(s) 
are typically the same or very similar between manufacturers (when 
there is more than one manufacturer for a refundable drug), it is 
unlikely that the discarded amounts from such package sizes would be 
significantly different. In addition, we do not have data that certain 
NDCs of a refundable drug from one manufacturer would be furnished to 
Medicare beneficiaries more often than another manufacturer when such a 
drug has more than one manufacturer. Therefore, we are not convinced 
that the proposed methodology for calculating the refund would result 
in one manufacturer owing any significant amount of refund that would 
have been owed by the other manufacturer because we expect discarded 
amounts to be the same in nearly all instances in which a product is 
used from the same size containers (with same labeled amount of drug) 
regardless of who is

[[Page 79052]]

manufacturing the product. For example, we would expect a vial 
containing 1 mg of a drug to have, on average, the same discarded 
amount as another vial containing 1 mg of the same drug (under the same 
approval, such as an NDA or BLA), even if it is from a different 
manufacturer. As this policy is operationalized, CMS will monitor 
report information for refundable drugs with multiple manufacturers. We 
welcome input and data from manufacturers and may address this issue 
further in future rulemaking, if appropriate.
    We thank the commenter for suggesting the requirement that NDC-11 
should be required on claims forms to facilitate accurate calculation 
of the refund, however, this is out of the scope of this proposal.
    After reviewing public comments, we are finalizing the revision to 
Sec.  [thinsp]414.940 by adding (c)(4), as proposed, to reflect the 
method of calculation of the refund amount attributed to a NDC when 
there are multiple manufacturers of a refundable drug. We clarify that 
the sales quarter of the ASP data used for this method of calculation 
will align with the dates of service for a new refund quarter or 
updated refund quarter. For example, calculation of refunds for the 
first calendar quarter of 2023 will use ASP data that reflect sales 
from that quarter. This data is reflected in the July ASP Drug Pricing 
File because of the two-quarter lag between the sales quarter and when 
that data is reflected in the ASP Drug Pricing File.
(3) Increased Applicable Percentage for Drugs With Unique Circumstances
    Section 1847A(h)(3)(B)(ii) of the Act provides that, in the case of 
a refundable drug that has unique circumstances involving similar loss 
of product as that described in section 1847A(h)(8)(B)(ii) of the Act, 
the Secretary may increase the applicable percentage otherwise 
applicable as determined appropriate by the Secretary. In the CY 2023 
PFS final rule (87 FR 69727 through 69731), we adopted an increased 
applicable percentage of 35 percent for drugs reconstituted with a 
hydrogel and with variable dosing based on patient-specific 
characteristics (Sec.  414.490(d)(1)). We have identified only one 
drug, Jelmyto[supreg] (mitomycin for pyelocalyceal solution), with such 
unique circumstances. We stated in that final rule that we recognize 
that there are drug products that may indeed have other unique 
circumstances, and that an increased applicable percentage for these 
products would have to be determined through future notice and comment 
rulemaking, as required by the statutory provision. We stated that we 
planned to collect additional information about drugs that may have 
unique circumstances along with potential increased applicable 
percentages that might be appropriate for such drugs, and to collect 
additional information about a process to identify unique circumstances 
based on manufacturer input. We explained that we would revisit 
additional increased applicable percentages for drugs that have unique 
circumstances, and a process to identify such circumstances, through 
future notice and comment rulemaking. To that end, we hosted a town 
hall meeting on February 1, 2023 to discuss what criteria would be 
appropriate to determine whether a refundable drug has unique 
circumstances, and whether a categorical approach (that is, unique 
circumstances that apply to more than one drug), drug-by-drug approach, 
or a hybrid of these two approaches should be used for determining 
drugs for which an increased applicable percentage is appropriate.
    In the CY 2024 PFS proposed rule (88 FR 52391 through 52395) we 
explained that after considering input from interested parties provided 
at the town hall and in subsequent meetings, we proposed a hybrid 
approach to determining when it is appropriate to increase the 
applicable percentage for a drug with unique circumstances. First, we 
proposed two unique circumstances along with proposed increased 
applicable percentages and, secondly, we proposed an application 
process so manufacturers may request that CMS consider whether an 
increased applicable percentage would be appropriate for a particular 
drug in light of its unique circumstances (and if an increased 
applicable percentage is considered appropriate it would then be 
proposed in future notice-and-comment rulemaking).
    We noted that we discussed in the CY 2023 PFS final rule and 
further at the town hall, the many requests from interested parties for 
CMS to increase applicable percentages (defined at Sec.  
[thinsp]414.940(c)(3) as 10 percent, except where an increased 
applicable percentage is applied in paragraph (d) of that section) for 
drugs packaged with small vial fill amounts or low-volume products 
(generally, those with a fill amount less than 1 mL). These parties 
stated that, for certain drugs, the small volume of drug contained in 
the vial (as identified on the package or FDA labeling) often 
represents the minimum volume necessary to safely and effectively 
prepare and administer the prescribed dose. Certain labeled amounts 
that are unused and discarded include amounts remaining in the syringe 
hub, amounts remaining in the syringe that are not part of the 
prescribed dose, amounts left in the vial that cannot be removed (such 
as drug adhering to the side of the vial or pooling around the vial 
stopper), and amounts left in the vial when it contains enough drug for 
two administration attempts.
    We agreed that such drugs have unique circumstances, because 
certain FDA-labeled amounts on the vial or package are unused and 
discarded after administration of the labeled dose and these amounts 
are not available to be administered. The unique circumstances 
described for such drugs are similar to loss of product from filtration 
described in section 1847A(h)(8)(B)(ii) of the Act because in both 
circumstances, such amounts lost are amounts that are not part of the 
recommended dose and are not available to be administered to the 
patient (one being loss due to labeled amounts remaining in the filter 
and the other due to labeled amounts remaining in other areas such as 
the vial or syringe).
    Since not all drugs with small fill volumes have certain labeled 
amounts that are unused and discarded, we believed more specific 
criteria are required to identify certain drugs with unique 
circumstances in this case. For example, if a drug is available as 0.8 
mL in a prefilled syringe, the total volume in the presentation is 
small, however, the entire labeled amount in the syringe may be 
administered to the patient as part of a labeled dose; the unique 
circumstances described above only occur when the volume of the labeled 
dose that is withdrawn from a vial or container is very small and there 
is a labeled amount that is unused and discarded and not available for 
administration (based on drugs currently available in the market, we 
have observed this to occur with doses contained within less than 0.4 
mL). Therefore, we proposed an increased applicable percentage for 
drugs with a ``low volume dose.'' We considered a low volume dose to be 
a dose of a drug for which the volume removed from the vial containing 
the labeled dose does not exceed 0.4 mL (which is about 8 drops of 
liquid). We proposed to revise Sec.  414.902 and define a low volume 
dose to be a labeled dose (based on FDA-approved labeling) that is 
contained within no more than 0.4 mL when removed from the vial or 
container. For example, if a labeled dose is 4 mg and a vial contains a 
suspension with a concentration of 40 mg/mL, the labeled

[[Page 79053]]

dose will be contained in 0.1 mL, which will not exceed 0.4 mL and 
will, therefore, be considered a low volume dose. We proposed that this 
definition of low volume dose apply even if the drug is further diluted 
after removal from the vial and prior to administration because, even 
if the dose is further diluted, a dose withdrawn from the vial and 
diluted would still have the same physical constraints as a dose that 
was not diluted, and those constraints would necessitate the loss of 
product as described in the previous paragraph. In addition, we 
proposed that for a drug to meet these unique circumstances, all 
labeled doses of the drug would be low volume doses. We explained, as 
proposed, this definition would not affect the determination of units 
as defined at section 1847A(b)(2)(B) of the Act and codified at Sec.  
414.802, and we note that the statutory definition of unit is exclusive 
of any diluent without reference to volume measures pertaining to 
liquids. We also explained that the proposed definition of low volume 
dose would only be applied for the determination of whether a higher 
applicable percentage is warranted for a drug.
    We proposed a two-tiered increased applicable percentage for drugs 
with low volume doses, because the percentage that is unused and 
discarded for these drugs decreases as the volume of the dose 
increases. We proposed that, for drugs with labeled doses contained 
within 0.1 mL or less when removed from the vial or container, the 
applicable percentage be increased to 90 percent. We proposed 90 
percent applicable percentage for this tier because certain drugs with 
low volume doses of 0.1 mL or less have up to 90 percent of the labeled 
amount that is unused and discarded and not part of the labeled dose 
available to be administered.152 153 We explained that we 
did not propose to add an additional 10 percent to this number as we 
did in the case of hydrogel, as discussed in the CY 2023 final rule 
(see 87 FR 69729), because, generally, we do not believe it would be 
appropriate for any product to have an applicable percentage of 100 
percent. Such an applicable percentage would, in effect, exclude drugs 
from the refund liability altogether. We believe it would be 
inappropriate to effectively expand the list of exclusions described in 
section 1847A(h)(8)(B) of the Act by proposing an increased applicable 
percentage of 100 percent to drugs not expressly excluded in statute. 
However, we considered whether some additional percentage might be 
appropriate in this case. We solicited comment on whether an additional 
percentage above 90 percent (but less than 100 percent) is warranted 
for drugs with low volume doses of 0.1 mL or less.
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    \152\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211950Orig1s000correctedlbl.pdf.
    \153\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022223,022048lbl.pdf.
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    As we discussed in the CY 2024 PFS proposed rule (88 FR 52392), in 
the second tier of the low volume dose unique circumstances, we 
proposed that for drugs with labeled doses contained within 0.11-0.4 
mL, the applicable percentage be increased to 45 percent. Certain drugs 
currently marketed that fall into this category have up to 35.6 percent 
of the labeled amount that is unused and discarded and not part of the 
labeled dose to be administered. In the same manner as the applicable 
percentage for the hydrogel finalized in the CY 2023 PFS final rule, we 
proposed to add the discarded amount percentage to the applicable 
percentage of 10 percent that is used for drugs without unique 
circumstances (that is, 35.6 percent plus 10 percent), and we proposed 
to round that number to an applicable percentage of 45 percent for this 
tier.
    In summary, we proposed to increase the applicable percentages for 
drugs with a low volume dose (a dose of a drug for which the volume 
removed from the vial or container containing the labeled dose does not 
exceed 0.4 mL). Specifically, we proposed that:
     Refundable drugs with labeled doses that are contained 
within 0.1 mL or less when removed from the vial or container have an 
increased applicable percentage of 90 percent and;
     Refundable drugs with labeled doses that are contained 
within 0.11-0.4 mL when removed from the vial or container have an 
increased applicable percentage of 45 percent.
    To date, we have identified certain drugs that would meet the 
proposed criteria for such unique circumstances and would have a 
proposed increased applicable percentage of 90 percent, including 
Triesence[supreg] (triamcinolone acetonide injection, suspension) and 
Xipere[supreg] (triamcinolone acetonide injection, suspension), along 
with some other ophthalmic drugs with such low volume doses that do not 
include all of the target fill volume in the labeled amount (that is, 
those that are labeled such that the low volume dose is equal to the 
labeled amount). We also noted that, although SusvimoTM 
(ranibizumab injection, solution) would qualify for the proposed 90 
percent applicable percentage, it is excluded from the definition of 
refundable drug due to filtration requirements as discussed in the CY 
2023 PFS final rule (87 FR 69723 through 69724). To date, we have 
identified certain drugs that would meet the proposed criteria for such 
unique circumstances and would have a proposed increased applicable 
percentage of 45 percent, including Xiaflex[supreg] (collagenase 
clostridium histolyticum) and Kimmtrak[supreg] (tebentafusp injection, 
solution, concentrate).
    In the CY 2023 PFS proposed rule (88 FR 52392 through 52393), we 
discussed that the second proposed unique circumstances is for orphan 
drugs administered to a low volume of unique beneficiaries, which we 
proposed to be fewer than 100 unique Medicare fee-for-service 
beneficiaries per calendar year (hereafter referred to as rarely 
utilized orphan drugs); we proposed an increased applicable percentage 
of 26 percent for drugs with these unique circumstances. We explained 
that there is a higher probability that the percentage of discarded 
amounts for rarely utilized orphan drugs may not have a normal 
statistical distribution from quarter to quarter, which could 
disproportionately affect manufacturers of such drugs by resulting in 
highly variable refund amounts as compared with the variability of 
drugs administered to a higher number of beneficiaries. This is 
evidenced by our analysis of quarterly discarded drug data reported 
using the JW modifier of 30 refundable drugs identified in the 2021 
Medicare Part B Discarded Drug Units data with greater than 10 percent 
units discarded,\154\ three of which were orphan drugs furnished to a 
patient population of less than 100 unique fee-for-service Medicare 
beneficiaries in CY 2021: J9262 (omacetaxine mepesuccinate); J9269 
(tagraxofusp-erzs); and J0223 (givosiran). For these drugs identified 
in the 2021 Medicare Part B Discarded Drug Units data, we analyzed JW 
modifier data for quarters in 2021 and 2022, which showed that the 
average standard deviation of the percentage of units discarded across 
quarters for the rarely utilized orphan drugs is 6.21 percent, compared 
with an average standard deviation for all other refundable drugs (with 
a percentage of discarded units over 10 percent in 2021) of 2.35 
percent. In other words, the standard deviation from the mean discarded 
drug percentage for rarely utilized orphan drugs is 2.64 times greater 
than that of the group of refundable drugs with larger patient 
populations and claims volume. In

[[Page 79054]]

addition, of the three aforementioned drugs, the most public data is 
associated with J9262, which shows that the percent discarded units for 
J9262 was 23.65 percent, 19.96 percent, and 30.98 percent in 2019, 
2020, and 2021, respectively. Because of this substantial statistical 
variation from quarter to quarter for such drugs, we believe it would 
be difficult to optimize the presentation of the drug to consistently 
minimize the discarded amounts to less than 10 percent given the small 
number of patients receiving the drug. We considered the higher 
percentage of unused and discarded amounts from such drugs as 
unavoidable loss due to both the low volume of unique beneficiaries 
receiving the drug contributing statistically higher variability in 
discarded amounts. Also, due to the low numbers of patients available 
to study for rare disease, it may be more difficult to determine the 
most efficient vial size for the patient population who receive the 
drug post-marketing. We stated this is similar to the loss of product 
due to filtration described in section 1847A(8)(B)(ii) of the Act 
because the loss is unavoidable in both circumstances. In the case of 
filtration described in statute, the loss is unavoidable because 
certain amounts of product will be left within the filter and 
unavailable for administration; in the case of rarely utilized orphan 
drugs, the loss is unavoidable because of the variability of potential 
doses (and low number of patients receiving the drug) leading to an 
inability to develop a package size that will result in a consistent 
average percentage of discarded units (as evidenced in the analysis 
above in this section). In contrast, drugs administered to a larger 
number of beneficiaries per year have a more consistent average 
percentage discarded from quarter to quarter, as evidenced by the lower 
standard deviation in our analysis, and we believe manufacturers are 
able to develop availability of the drug accordingly to minimize 
discarded amounts.
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    \154\ https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug/medicare-part-b-discarded-drug-units.
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    We proposed that unique circumstances of rarely utilized orphan 
drugs have the following characteristics: (1) a drug designated under 
section 526 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as a 
drug for a rare disease or condition; and (2) that is furnished to 
fewer than 100 unique Medicare fee-for-service beneficiaries per 
calendar year. We proposed that the number of beneficiaries receiving 
such drug in the calendar year would correspond with the refund 
quarter. For example, for refund quarters in 2023, we would use the 
number of beneficiaries receiving the drug in the 2023 calendar year to 
determine if the unique circumstances and increased applicable 
percentage would apply. Data of number of beneficiaries would be 
analyzed at the same time as the JW modifier data for the given 
calendar quarters. To meet these unique circumstances, we proposed that 
the drug be designated an orphan-drug under section 526 of the FD&C Act 
for a rare disease or condition (or diseases or conditions) and be 
approved by the FDA only for a designated rare disease or condition (or 
diseases or conditions). That is, all FDA-labeled indications for the 
drug must be orphan indications, and if the drug has one or more 
indications that are for conditions that are not designated by the FDA 
to be a rare disease or condition, the drug would not be considered to 
have unique circumstances of rarely utilized orphan drugs. In addition, 
we proposed that the drug would meet these unique circumstances and 
that the increased applicable percentage would apply for as long as the 
drug meets these conditions, even after any orphan drug exclusivity end 
date.
    The increased applicable percentage of 26 percent that we proposed 
is appropriate because the standard deviation from the mean discarded 
drug percentage for rarely utilized orphan drugs is 2.64 times greater 
than that of the larger group of refundable drugs, and multiplying the 
applicable percentage referenced in paragraph (h)(3)(B)(i)(II) by how 
many times greater the variance is (in other words, 10 percent times 
2.64) equals 26.4 percent, which we proposed to round to the nearest 
percentage.
    We proposed that we will identify drugs that have unique 
circumstances of low volume doses and rarely utilized orphan drugs in 
the report sent to manufacturers and apply the proposed increased 
applicable percentages based on these unique circumstances proposals. 
If a manufacturer believes that the incorrect applicable percentage was 
applied to the refund calculation, the manufacturer may submit a 
dispute regarding the calculation by submitting an error report (see 
Sec.  [thinsp]414.940(e)).
    We proposed to codify these applicable percentages at Sec.  
[thinsp]414.940(d). Specifically, we proposed to add applicable 
percentages for low volume doses by creating new paragraphs (d)(3) and 
(4); and we proposed to add applicable percentage for orphan drugs 
administered to fewer than 100 unique beneficiaries per calendar year 
in new paragraph (d)(5). We proposed that these applicable percentages 
apply beginning with the initial refund report that we proposed to be 
sent no later than December 31, 2024.
    We solicited comments on the proposed unique circumstances. 
Specifically, we solicited comment on the proposed volume (mL) tiers 
for drugs with low volume doses along with the proposed increased 
applicable percentages and whether an additional percentage above 90 
percent (but less than 100 percent) is warranted for drugs with low 
volume doses of 0.1 mL or less. We also solicited comment on the 
increased applicable percentage of 26 percent for rarely utilized 
orphan drugs.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Several commenters supported the proposed unique 
circumstances and increased applicable percentages. One commenter 
expressed general support for the expansion of the scope of drugs that 
may be considered to have unique circumstances and be considered for an 
increased applicable percentage.
    Several commenters expressed support for the proposed unique 
circumstances and increased applicable percentage for small volume 
drugs, some specifically supporting the increase applicable percentage 
of 90 percent for drugs with low volume doses of 0.1 mL or less and 
others specifically supporting the increased applicable percentage of 
45 percent for drugs with low volume doses of 0.11--0.4 mL. One 
commenter stated that low volume dose drugs are particularly 
susceptible to having unusable product that remains after the product 
is administered. This commenter also expressed support of the tiered 
increased applicable percentage and agreed that the percentage of 
unusable amounts decreases as product volume increases. Another 
commenter added that without an increased applicable percentage for 
small volume drugs, as proposed, the discarded drug refund policy would 
lead to underdosing of anti-vascular endothelial growth factor (anti-
VEGF) therapies used to treat age-related macular degeneration (AMD), 
diabetic retinopathy, and other vision-threatening retinal diseases. 
One commenter expressed support for the clarification that 
SusvimoTM (ranibizumab injection for intravitreal use via 
ocular implant) would have a proposed applicable percentage of 90 
percent if it were not already excluded due to filtration requirements.
    Several commenters support the proposed increased applicable 
percentage for rarely utilized orphan

[[Page 79055]]

drugs. Other commenters stated they generally support the proposal 
regarding orphan drugs and the increased flexibility of the proposal. 
Two commenters expressed support for the proposed increased applicable 
percentage of 26 percent and agree that rarely utilized orphan drugs 
possibly have high discarded amounts due to limited manufacturing 
capability.
    Response: We thank these commenters for their support of these 
proposals.
    Comment: One commenter stated that drug low volume doses with 0.1 
mL or less should have an increased applicable percentage of 100 
percent, which would effectively exempt such drugs from liability for 
any discarded drug refund. The commenter stated, to the extent that the 
purpose of this provision is to encourage manufacturers to adopt 
packaging that is appropriately sized to the dose, drugs with low 
volume doses of 0.1 mL or less have already met the objective to 
minimize discarded amounts. Another commenter requested an increased 
applicable percentage of 100 percent for drugs with a volume of 1 mL or 
less. This commenter stated that discarded drug modifiers add 
administrative burden for intravitreal, single-use drugs.
    Response: As discussed above in this section, we do not believe it 
would be appropriate for any product to have an applicable percentage 
of 100 percent. Such an applicable percentage would, in effect, exclude 
drugs from the refund liability altogether. We believe it would be 
inappropriate to effectively expand the list of exclusions described in 
section 1847A(h)(8)(B) of the Act by proposing an increased applicable 
percentage of 100 percent to drugs not excluded in statute. With regard 
to the burden of the JW and JZ modifiers, we stated in the CY 2023 PFS 
final rule (87 FR 69724) that even if a drug is excluded from the 
definition of refundable drug (and not subject to refunds), for 
example, multiple source drugs, claims for such drugs furnished from a 
single-dose container are still required to use the JW and JZ modifiers 
in accordance with the policy. Therefore, even if CMS were to increase 
the applicable percentage of a drug to 100 percent, the drug would 
still be subject to the JW and JZ modifier policy and the increased 
applicable percentage would not relieve administrative burden.
    Comment: Several commenters requested CMS clarify how we determined 
the 100-beneficiary cutoff for rarely utilized orphan drugs and an 
increased applicable percentage of 26 percent for drugs with these 
unique circumstances. One commenter stated that the qualifying criteria 
for rarely utilized orphan drugs is flawed and lacking details. Another 
commenter stated that the rationale used for establishing unique 
circumstances for rarely utilized orphan drugs could be applied to 
orphan drugs that treat more than 100 Medicare fee-for-service 
beneficiaries. One commenter noted that our initial proposal was 
limited to the 30 drugs that had discarded drug amounts exceeding 10 
percent in each of 2019, 2020 and 2021. One commenter explained that 
the ten billing and payment codes for drugs with less than 100 
beneficiaries are primarily prescribed to treat diseases for patients 
under the age of 65. Further, the commenter pointed out two of the 
three rarely utilized orphan drugs referenced in the proposed rule had 
a majority of patients who were non-elderly in their studies.
    Three commenters asked that CMS consider increasing the less than 
100-beneficiary cutoff for a drug to qualify for the unique 
circumstance. One commenter requested that we increase the beneficiary 
threshold to 500 beneficiaries a year while another commenter suggested 
increasing the threshold to 1,000 beneficiaries. One commenter supports 
a more holistic orphan disease unique circumstances and thresholds in 
line with current definitions of rare and ultra-rare diseases.
    Some commenters ask that we consider if an increase that is higher 
than the proposed 26 percent in the applicable percentage for rarely 
utilized orphan drugs may be necessary. One commenter suggested CMS 
exempt orphan drugs with a single indication from discarded drug refund 
liability. The commenter explained that in 2022, these drugs accounted 
for 1 percent of total Medicare FFS, an amount that doesn't justify the 
high proportion of the total discarded refund liabilities that will be 
imposed on orphan drugmakers. This commenter also proposed that, 
alternatively, CMS could increase the applicable percentage to 35 
percent (along with a beneficiary increase to 1,000 beneficiaries as 
described above in this section).
    Response: For unique circumstances of rarely utilized orphan drugs, 
the 100-beneficiary threshold was a result of an analysis of quarterly 
discarded drug data from 2021 and 2022. We explained in the proposed 
rule that this analysis showed that there is a higher probability that 
the percentage of discarded amounts for rarely utilized orphan drugs 
may not have a normal statistical distribution from quarter to quarter, 
which could disproportionately affect manufacturers of such drugs by 
resulting in highly variable refund amounts as compared with the 
variability of drugs administered to a higher number of beneficiaries. 
The increased variability of the percentage of discarded amounts from 
quarter to quarter was not observed for orphan drugs administered to 
more than 100 unique beneficiaries per year. We explained that the 
average standard deviation of the percentage of units discarded across 
quarters for rarely utilized orphan drugs is 6.21 percent, compared 
with an average standard deviation for all other refundable drugs (with 
a percentage of discarded units over 10 percent in 2021) of 2.35 
percent.
    The justification for the unique circumstances in rarely utilized 
orphan drugs hinges on the variability of percentage of discarded 
amounts from quarter to quarter (not the actual percentage discarded 
itself). The threshold of 100 beneficiaries per year for the unique 
circumstances of rarely utilized orphan drugs is supported by this 
sharp decrease in variability of discarded percentages when the drug is 
administered to more than 100 unique beneficiaries. Such variability 
from quarter to quarter is not observed when the number of 
beneficiaries receiving the drug exceeds 100 per year. For example, the 
percentage of discarded amounts for available quarters through the end 
of CY 2022 for Elzonris[supreg] (tagraxofusp-erzs), which was 
administered to 19 unique beneficiaries in 2021, ranges from a low of 
6.55 percent to a high of 34.52 percent per quarter (a spread of 27.97 
percent). In contrast, the percentage of discarded amounts for 
Folotyn[supreg] (pralatrexate), which was administered to 155 unique 
beneficiaries in 2021, ranges from a low of 9.04 percent to a high of 
14.87 percent per quarter (spread of 5.83 percent). We evaluated 
several other orphan drugs furnished to more than 100 beneficiaries and 
all had low variability of the percentage discarded from quarter to 
quarter.
    The statutory provision requires that unique circumstances be 
similar to the loss of product due to filtration described in section 
1847A(8)(B)(ii) of the Act. We stated in the proposed rule that rarely 
utilized orphan drugs have unique circumstances similar to filtration 
described in section 1847A(8)(B)(ii) of the Act because the loss is 
unavoidable in both circumstances. We stated that in the case of rarely 
utilized orphan drugs, the loss is unavoidable because of the 
variability of potential doses (and low number of patients receiving 
the drug)

[[Page 79056]]

leading to an inability to develop a package size that will result in a 
consistent average percentage of discarded units. We are not convinced 
by commenters that an alternative threshold of 500 or 1,000 
beneficiaries more closely ties the unique circumstances to filtration 
described in section 1847A(8)(B)(ii) of the Act.
    For justification of increased applicable percentage of 26 percent, 
we explained in the proposed rule that the standard deviation from the 
mean discarded drug percentage for rarely utilized orphan drugs is 2.64 
times greater than that of the group of refundable drugs with larger 
patient populations and claims volume. We multiplied the mean discarded 
drug percentage by the applicable percentage of drugs without unique 
circumstances (that is, 10 percent) to arrive at an increased 
applicable percentage of 26 percent. Commenters did not provide 
additional justification for their suggestions for an alternative 
increased applicable percentage, and we are not convinced by these 
comments that an alternative increased applicable percentage different 
the proposed of 26 percent is appropriate for these unique 
circumstances.
    Comment: One commenter stated that there is a risk that basing 
eligibility for being considered a rarely utilized orphan drug on a 
single year could create unwarranted volatility as to whether the 
unique circumstances apply in any given calendar year. The commenter 
requested that the 100-beneficiary cutoff for the qualification of a 
drug to be considered to have unique circumstances of a rarely utilized 
orphan drug be determined using a 3-year rolling average.
    Response: We agree with the commenter that a 3-year rolling average 
is reasonable to determine eligibility for having the unique 
circumstances of rarely utilized orphan drugs along with the increased 
applicable percentage for these unique circumstances because this would 
prevent volatility for determining whether these unique circumstances 
apply to an orphan drug that is nearing the 100-beneficiary threshold. 
Therefore, in this final rule, we are finalizing a modification to our 
proposal such that for the purposes of determining whether a drug is a 
rarely utilized orphan drug for which the applicable percentage would 
be 26 percent, the drug will have met the condition of being furnished 
to fewer than 100 unique Medicare fee-for-service beneficiaries per 
calendar year if it meets one of the two conditions below:
    (1) the number of unique beneficiaries to whom the drug is 
furnished is less than 100 during the calendar year in which the refund 
quarter occurs; or
    (2) the average number of unique beneficiaries per year for the 
calendar year in which the refund quarter occurs and the 2 previous 
calendar years (3-year average) is less than 100. In the case that a 
drug for which at least 2 but less than 3 years of data available, we 
will calculate the average to determine whether the 100-beneficiary 
threshold is met.
    Comment: One commenter asked that we allow manufacturers to provide 
feedback for potential future amendments to the criteria for these 
unique circumstances for orphan drugs. The commenter stated that there 
are manufacturers of orphan drugs with low patient volume that have 
similar circumstances to those of the three rarely utilized orphan 
drugs identified in the proposed rule. Specifically, the commenter 
stated that manufacturers of other orphan drugs have difficulty 
financially justifying creation of new vial sizes. One commenter 
requested that we continue to periodically reassess whether the 100 
unique beneficiary threshold is appropriate as new rare disease 
therapies are developed.
    Response: We welcome additional engagement on future policy 
development regarding unique circumstances of rarely utilized orphan 
drugs and their associated increased applicable percentage. We plan to 
continue monitoring JW and JZ modifier data and variability of the 
percentage discarded from quarter to quarter for orphan drugs to inform 
potential future policy development.
    Comment: One commenter recommended that CMS clarify how we 
determine whether a particular drug is a low volume dose. The commenter 
stated that clinicians administering drugs may not know the precise 
amount of product contained in the vial or other container, in part 
because the FDA label often does not indicate such amount. Therefore, 
the commenter urged CMS not to depend on the clinician's own 
interpretation to determine if a drug has a low volume dose. Instead, 
the commenter suggested that CMS should maintain a list of drug 
products with low-volume doses, and CMS should allow manufacturers to 
submit information to CMS--including information not contained in the 
FDA label, when necessary--to demonstrate that the low-volume threshold 
is met. Another commenter requested we establish a process for 
manufacturers to request and receive confirmation before a calendar 
year begins whether their product has unique circumstances with an 
increased applicable percentage. The commenter stated that such a 
process would give manufacturers necessary notice whether a product was 
considered to have unique circumstances.
    Response: We agree with commenters that CMS should communicate 
which drugs have been identified as meeting criteria for low volume 
dose unique circumstances. In the proposed rule, we stated that we 
would consider a low volume dose to be a dose of a drug for which the 
volume removed from the vial containing the labeled dose does not 
exceed 0.4 mL. In addition, we proposed that for a drug to meet these 
unique circumstances, all labeled doses of the drug must be low volume 
doses. Although all the necessary information is available in the FDA-
approved labeling to determine if a drug has a low volume dose, we 
agree that this information may not be explicitly stated in FDA-
approved labeling, and we agree that maintaining a list of drugs 
identified as having low volume doses will help provide clear 
communication of which drugs have these unique circumstances. 
Therefore, we intend to publish a list of drugs CMS has identified as 
having low volume doses and will have an increased applicable 
percentage no later than December 31, 2023, and intend to update the 
list no later than December 31 of each subsequent year. This would 
allow adequate time for manufacturers to evaluate the list prior to the 
deadline of February 1 for the application process for increased 
applicable percentage.
    Similarly, we considered providing similar advance notice for 
rarely utilized orphan drug unique circumstances. However, the number 
of beneficiaries receiving the drug in the calendar year in which the 
refund quarter occurs (or the 3-year or 2-year average as discussed 
above in this section) will not be known until data is analyzed for the 
report. To provide information in advance, CMS intends to communicate a 
list of drugs that would have met conditions for having unique 
circumstances of rarely utilized orphan drugs for CY 2022 no later than 
December 31, 2023. This list would be provided as informational only 
and may not necessarily reflect the same list of drugs that have unique 
circumstances of rarely utilized orphan drugs when the data is analyzed 
for the initial refund report. Each year, CMS will update the list of 
drugs that have unique circumstances of rarely utilized orphan drugs 
with those that met such conditions on the previous year's report. For 
example, CMS will provide the list

[[Page 79057]]

of drugs with such unique circumstances for the initial report 
(containing calendar quarters in 2023) no later than December 31, 2024.
    Finally, in the proposed rule, we stated that we will identify 
drugs that have unique circumstances of low volume doses and rarely 
utilized orphan drugs in the report sent to manufacturers and apply the 
increased applicable percentages based on these unique circumstances. 
If a manufacturer believes that the incorrect applicable percentage was 
applied to the refund calculation, the manufacturer may submit a 
dispute regarding the calculation by submitting an error report (see 
Sec.  414.940(e)).
    After consideration of public comments, we are finalizing revisions 
to Sec.  414.902 to add the definition ``low volume dose'' and Sec.  
414.940(d) to add the increased applicable percentage of 90 percent for 
drugs with a low volume dose contained within 0.1 mL or less and 45 
percent for a drug with a low volume dose contained within 0.11 mL up 
to 0.4 mL, as proposed. We also are finalizing as proposed at Sec.  
414.940(d) the increased applicable percentage of 26 percent for a drug 
designated an orphan drug under section 526 of the FD&C Act for a rare 
disease or condition (or diseases or conditions), approved by the FDA 
only for one or more indications within such designated rare disease or 
condition (or diseases or conditions) and furnished to fewer than 100 
unique beneficiaries per calendar year. We are adding that an average 
of fewer than 100 beneficiaries per calendar year for the most recent 3 
years (or 2 years, in certain circumstances) as discussed above in this 
section would be considered to have such unique circumstances.
(4) Application Process for Increased Applicable Percentages
    In the CY 2024 PFS proposed rule (88 FR 52393 through 52395), we 
discussed our proposal to establish an application process through 
which manufacturers may request that we consider an individual drug to 
have unique circumstances for which an increased applicable percentage 
is appropriate. We explained that manufacturers could benefit from a 
formal process through which they can provide information, including 
that which may not be publicly available, and therefore, not known to 
us, in order to request an increase in their refundable drug's 
applicable percentage and provide justification for why the drug has 
unique circumstances for which such an increase is appropriate, 
including in the case of a drug with an applicable percentage that has 
already been increased by virtue of its unique circumstances.
    We proposed that, to request CMS consider increasing the applicable 
percentage of a particular refundable drug, a manufacturer must submit 
the following: (1) a written request that a drug be considered for an 
increased applicable percentage based on its unique circumstances; (2) 
FDA-approved labeling for the drug; (3) justification for the 
consideration of an increased applicable percentage based on such 
unique circumstances; and (4) justification for the requested increase 
in the applicable percentage. Such justification could include 
documents, such as (but not limited to) a minimum vial fill volume 
study or a dose preparation study. We proposed that in evaluating 
requests for increased applicable percentages, we would review the 
documentation referenced above for evidence that amounts of drug 
identified in the FDA-approved package or labeling has similar loss of 
product as that described in paragraph section 1847A(8)(B)(ii) of the 
Act.
    We stated that section 1847(h)(3)(B)(ii) of the Act requires that 
any increase to applicable percentages for refundable drugs is to be 
made through notice-and-comment rulemaking. Therefore, we proposed that 
applications for individual applicable percentage increases be 
submitted in a form and manner specified by CMS by February 1 of the 
calendar year prior to the year the increased applicable percentage 
would apply (for example, applications for increased applicable 
percentages effective January 1, 2025, will be due to CMS by February 
1, 2024). We proposed to discuss our analyses of applications in the 
PFS rulemaking immediately following the application period, and to 
communicate in the rule whether we consider the drug to have unique 
circumstances that warrant an increased applicable percentage. We would 
include proposals, if any, for increased applicable percentages, along 
with a summary of any applications for which we determined not to 
propose an increase in the applicable percentage. We proposed to codify 
this application process for increased applicable percentages in new 
paragraph Sec.  414.940(e).
    We stated that we do not consider the following to be unique 
circumstances warranting an increased applicable percentage at this 
time: weight-based doses, body surface area (BSA)-based doses, varying 
surface area of a wound, loading doses, escalation or titration doses, 
tapering doses, and dose adjustments for toxicity because we believe 
manufacturers can optimize the availability of products for these 
circumstances to limit the percentage of discarded units for a drug, 
unlike the circumstances of manufacturers of drugs that require 
filtration during the preparation process, as described in section 
1847A(h)(8)(B)(ii) of the Act. FDA draft guidance, titled ``Optimizing 
the Dosage of Human Prescriptions Drugs and Biological Products for the 
Treatment of Oncologic Diseases'',\155\ states: ``Various dose 
strengths should be available to allow multiple dosages to be evaluated 
in clinical trials. Perceived difficulty in manufacturing multiple dose 
strengths is an insufficient rationale for not comparing multiple 
dosages in clinical trials.'' Although optimization of dosage and 
available product formulations most often occurs prior to marketing a 
drug, we also observed several instances where the drug formulation 
availability has been changed and subsequently resulted in a decreased 
percentage of discarded amounts. For example, Kyprolis[supreg] 
(carfilzomib), which is cross-walked to the billing and payment code 
J9047, was available in only one 60-mg single-dose vial size when first 
approved in 2012.\156\ Subsequently, a second 30-mg vial size was 
approved in 2016,\157\ and a third 10-mg vial size was approved in June 
of 2018.\158\ We observed in discarded drug data, based on the JW 
modifier, that the percentage of discarded units for J9047 was 14.27, 
12.68, 5.95, 4, and 3.09 percent in 2017, 2018, 2019, 2020, and 2021, 
respectively. There is a sharp drop in the percent of discarded units 
after 2018, which correlates with the introduction of the 10-mg vial. 
The labeled dose of Kyprolis[supreg] is based on the patient's BSA, 
there is a dose escalation, there are two different dosage schedules 
(once weekly and twice weekly) each with differing doses, there are 
dosage modifications for toxicity that involve dose reductions, and 
there is a dose reduction for patients with hepatic impairment. With 
these dose variations taken into consideration, the available vial 
sizes of the drug allow for the percentage of discarded units to remain 
well below 10

[[Page 79058]]

percent after the introduction of the third vial size.
---------------------------------------------------------------------------

    \155\ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/optimizing-dosage-human-prescription-drugs-and-biological-products-treatment-oncologic-diseases.
    \156\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202714lbl.pdf.
    \157\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202714s012lbl.pdf.
    \158\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202714s019lbl.pdf.
---------------------------------------------------------------------------

    In addition, we observed that, based on the 2021 discarded drug 
data,\159\ as the number of available package sizes increases, the 
percent discarded decreases (see Table 22). This example is indicative 
of ways in which manufacturers can optimize package sizes to reduce the 
percentage of discarded units in the circumstances listed above.
---------------------------------------------------------------------------

    \159\ https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug/medicare-part-b-discarded-drug-units.
[GRAPHIC] [TIFF OMITTED] TR16NO23.043

    We solicited comments from interested parties on the application 
process for increased applicable percentage. Specifically, we solicited 
comment on what factors we should use in a framework for considering 
these applications, what factors we should use to assess appropriate 
increases to applicable percentages, and what types of additional or 
alternative documentation may help us analyze justifications for 
increased applicable percentages.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Several commenters expressed approval of the proposed 
application process for increased applicable percentage, with several 
adding that the process, if finalized, would provide manufacturers 
transparency and predictability. One commenter specifically expressed 
support for the proposal to use minimum vial fill studies or dose 
preparation studies in CMS' evaluation of whether an increased 
applicable percentage is appropriate for a refundable drug because such 
studies examine whether a product contains a greater amount than is 
necessary to accurately and consistently deliver the labeled 
therapeutic dose. One commenter expressed support for CMS' engagement 
with manufacturers in the development of the application process.
    Response: We thank the commenters for their support.
    Comment: Several commenters requested CMS maintain flexibility in 
our approach to reviewing applications for increased applicable 
percentage and work closely with the medical community as new 
therapeutics and packaging practices develop. One commenter added that 
dialogue between CMS and interested parties is important because novel 
treatments may be ill-suited to the policy design of the discarded drug 
refund program. One commenter requested that CMS conduct outreach to 
manufacturers to ensure they are aware of the application process. One 
commenter requested additional flexibility in the application process 
by allowing manufacturers to request unique circumstance consideration 
more frequently than once a year and outside the annual rulemaking 
process.
    Response: We thank the commenters for their feedback. We agree that 
working with the medical community and other interested parties is 
important to the implementation of the discarded drug refund program. 
As the discarded drug refund policy develops, we will continue to rely 
on feedback from the provider and manufacturer communities. Public 
input gathered in the CY 2023 PFS rulemaking process, the Discarded 
Drug Refund Policy Town Hall we hosted on February 1, 2023, and 
meetings with interested parties provided the basis of the two proposed 
unique circumstances and the framework for the application process for 
increased applicable percentages. We plan to issue additional guidance 
and communications to providers and suppliers prior to the application 
window for increased applicable percentages taking effect in CY 2025.
    Comment: One commenter expressed concern that the February 1 
deadline for supporting documentation would create a significant lag 
for consideration and approval of an increased applicable percentage if 
a drug is approved on or after the deadline. The commenter requested 
that companies whose drugs are nearing approval prior to the deadline 
be allowed a fixed supplemental period to submit the FDA-approved label 
after the deadline. The commenter cited precedent for this with new 
technology add-on payments (NTAP) applications and the prior annual 
Healthcare Common Procedure Coding System (HCPCS) coding process before 
it was transitioned to a quarterly process.
    Response: We appreciate the commenter's feedback. We are persuaded 
by the commenter's suggestion that manufacturers whose products have 
not yet been approved by the FDA should have additional flexibility in 
completing their application submissions in anticipation of approval 
prior to the calendar year following the application deadline. To 
strike a balance between providing maximum flexibility to manufacturers 
seeking consideration for increased applicable percentages and the 
necessity that manufacturers possess sufficient information about the 
dosing and packaging of their product to explain and provide evidence 
for an unavoidable loss of product that meets the criterion for an 
increased applicable percentage, we will allow manufacturers to submit 
applications for increased applicable percentage prior to FDA approval 
if the product's application for FDA approval has been accepted by the 
FDA for review and such documentation of FDA acceptance can be provided 
to CMS at the time of application for increased applicable percentage 
prior to the application deadline. Similar to the NTAP

[[Page 79059]]

submission requirements for technologies that are not already FDA-
market authorized during the NTAP application period, we will require 
manufacturers of drugs that are not FDA-approved to provide 
documentation to demonstrate that an application has been accepted for 
review by the FDA (for example, a filing letter) at the time of 
submission of its application for an increased applicable percentage to 
CMS. We believe it is important that applicants applying for an 
increased applicable percentage have an accepted application for FDA 
review of the product because it increases the likelihood they have 
sufficiently studied issues related to vial size optimization and 
minimization of unavoidable drug loss and reduces the risk of using 
resources to review applications for drugs that will not be sold in the 
calendar year for which we are considering applicable percentage 
increases. Additionally, we believe documentation of FDA acceptance of 
review, such as a filing letter, will provide the clearest and most 
effective means of documenting that the applicant has submitted a 
complete request to FDA and therefore we intend to require one such 
document by February 1 for drugs that are not yet approved. Under the 
final policy, drugs that do not yet have FDA approval at the time of 
application for an increased applicable percentage will have three 
deadlines for their application:
     February 1 for all required documentation other than the 
FDA-approved label, including documentation of FDA acceptance of the 
product's application for review;
     August 1 for FDA approval; and
     September 1 for applicants to notify CMS of the product's 
FDA approval and submit the approved label.
    Therefore, we are modifying our proposed policy and finalizing a 
policy that applicants must submit the following by February 1 of the 
calendar year prior to the year the increased applicable percentage 
would apply: (1) a written request that a drug be considered for an 
increased applicable percentage based on its unique circumstances; (2) 
FDA-approved labeling for the drug, or, if the drug is not yet 
approved, documentation of the FDA acceptance of the application for 
review; (3) justification for the consideration of an increased 
applicable percentage based on such unique circumstances; and (4) 
justification for the requested increase in the applicable percentage. 
We are also finalizing that a manufacturer that does not have FDA 
approval for its product by February 1 must receive FDA approval by 
August 1 and submit the FDA-approved label to CMS by September 1 for 
its application to be complete and eligible for consideration for an 
increased applicable percentage based on unique circumstances. This 
additional 6-month window for FDA marketing authorization is similar to 
the extended deadline CMS currently allows applicants for NTAP that 
have not received FDA marketing authorization prior to the NTAP 
application deadline, generally in mid-October, of the year prior to 
the beginning of the fiscal year for which the application is being 
considered. Additionally, a drug that is approved on August 1 or later 
will not have 18 months or more of claims paid under Part B before the 
beginning of the calendar year 2 years following the application 
period, and therefore, manufacturers will have an opportunity to apply 
for increased applicable percentage and for that increased applicable 
percentage to be effective prior the end of the 18-month exclusion from 
the definition of refundable drug (as described in section 
1847A(h)(8)(B)(iii) of the Act).
    We note that for applicants that do not yet have FDA approval, once 
the FDA approves a label for the product, certain aspects regarding, 
for example, vial fill, labeled therapeutic dose, or estimated 
discarded amounts may change after the time the application for 
increased applicable percentage was submitted and when the product is 
FDA-approved. As stated above, we are requiring that applicants notify 
CMS by September 1 when the product is FDA-approved. At that time, CMS 
will evaluate the FDA-approved label and compare it with the 
application for determination of the increased applicable percentage. 
In the case the approved label is no longer in accord with the 
submitted justifications, we will consider the submitted justifications 
as invalid and the application as both incomplete and ineligible for 
consideration for a proposed increased applicable percentage. The 
manufacturer will have an opportunity to apply for an increased 
applicable percentage for the following year's application cycle.
    Comment: Several commenters disagreed with the proposed exclusion 
of weight-based doses, BSA-based doses, varying surface area of a 
wound, loading doses, escalation or titration doses, tapering doses, 
and dose adjustments for toxicity as bases for a unique circumstance. 
Commenters described the challenges involved in achieving consistency 
of vial sizes for individual patients, such as step-in doses that will 
vary for a patient as they adjust to treatment, and the identification 
of optimal vial sizes for these types of drugs. One commenter requested 
an applicable percentage increase of 10 percent for drugs that are 
indicated as loading doses as vial sizes are typically selected for 
subsequent maintenance doses. Commenters added that the introduction of 
additional vial sizes to limit discarded amounts may be impractical due 
to great variance in patient needs, and for some manufacturers, 
economically infeasible. In addition, one commenter stated that example 
of Kyprolis vial sizes in the proposed rule confirms how long it can 
take manufacturers to mitigate discarded drug refund liability, as its 
two additional vial sizes were approved 4 and 6 years after the 
product's initial approval.
    Response: We thank the commenters for their comments on the 
difficulties of reconciling highly varied patient characteristics into 
a limited set of vial or container sizes, as well as those for drugs 
with loading doses. While we acknowledge these challenges posed by 
these circumstances, we do not consider them to be similar to products 
that require filtration during preparation as described in section 
1847A(8)(B)(ii) of the Act because the drug loss in the former cases is 
not unavoidable. In each case, we believe manufacturers can, with vial 
size optimization studies, identify a set of container sizes for which 
less than ten percent of the labeled amount is usable and not necessary 
for the reliable and safe delivery of the labeled therapeutic dose for 
all patients, on average. Regarding the economic feasibility of 
introducing a new vial size or multiple new sizes, we do not have 
sufficient information about individual manufacturers' circumstances to 
address whether introducing new vial sizes or optimizing vial sizes 
would be economically feasible in each circumstance.
    As shown in Table 22 and generally during our analysis of drugs 
from single-dose containers, a vast majority of single-dose drugs are 
manufactured in package sizes that are efficient enough to keep the 
percentage of discarded amounts to less than 10 percent. In the case of 
Kyprolis, we are not aware of the specific circumstances under which 
the manufacturer chose to increase the number of vial sizes. Without 
additional information about the specific circumstances, we cannot 
speculate on particular business decisions of the manufacturer, when 
the development of each vial size began, or how long it took for a new 
vial size to be approved and marketed.

[[Page 79060]]

    Comment: One commenter requested that CMS clarify how long 
increased applicable percentages apply when increased through the 
individual drug application process and subsequent rulemaking. The 
commenter noted that a drug's unique circumstance on which an 
applicable percentage increase is based is unlikely to change year to 
year, and therefore requiring annual applications for the same drug 
should not be required.
    Response: We thank the commenter for their request for 
clarification of the duration of the unique circumstances and increased 
applicable percentages. We clarify that an increased applicable 
percentage, once finalized through rulemaking, continues to apply until 
modified through subsequent rulemaking. We note that drugs meeting the 
criteria for unique circumstances of low volume doses or rarely 
utilized orphan drugs could fluctuate, and we discuss communications of 
which drugs meet such criteria above in this section.
    Comment: Two commenters requested clarification regarding what 
kinds of justifications, including supporting evidence, CMS will 
consider bases of unique circumstances for which increased applicable 
percentages are appropriate. The commenter also requested examples of 
each.
    Response: We thank the commenter for their request for 
clarification of appropriate bases for unique circumstances and 
increased applicable percentages. While we cannot anticipate future 
drug development or what unique circumstances might arise, we can offer 
our analysis of the unique circumstances we consider involving similar 
loss of product as that described in section 1847A(h)(8)(B)(ii) of the 
Act for drugs that are reconstituted in hydrogel and with variable 
dosing based on patient-specific characteristics (87 FR 69727 through 
69731), drugs with low volume doses, and rarely utilized orphan drugs 
(both discussed in section III.A.3.d.(3) of this final rule). Regarding 
examples of evidence, we noted minimum vial fill studies and dose 
preparation studies in the proposed rule, both of which are suitable 
for justifying increased applicable percentages because they can 
establish that certain unusable amounts of a product are necessarily 
included in a container to safely and consistently administered the 
labeled therapeutic dose to a patient.
    After consideration of public comments, we are finalizing our 
proposal regarding the application process for increased applicable 
percentages, including the application deadline of February 1 and, in 
addition, we are finalizing a modification of our proposal by adopting 
a deadline for the FDA-approved labeling of August 1 and the deadline 
for notifying and submitting the FDA-approved label to CMS of September 
1 of the year before the year in which the increased applicable 
percentages would apply, in new Sec.  414.940(e).
e. Clarification for the Definition of Refundable Drug
    As discussed in the CY 2023 PFS final rule (87 FR 69650 through 
69655), we aim to create a consistent coding and payment approach for 
the suite of products currently referred to as skin substitutes. In the 
CY 2024 PFS proposed rule (88 FR 52395), we noted CMS anticipates 
addressing coding and payment for skin substitutes in future 
rulemaking. We explained that while we considered making changes to the 
Medicare Part B payment policies for such products, we proposed that 
billing and payment codes that describe products currently referred to 
as skin substitutes are not counted for purposes of identifying 
refundable drugs for calendar quarters during 2023 and 2024.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Several commenters agreed with the proposal to not 
consider skin substitutes as refundable drugs for 2023 and 2024. One 
commenter added that the exclusion is appropriate because payment for 
skin substitutes is inconsistent across settings and because claims 
edits for appropriate JW and JZ modifier use were not in place for the 
first three quarters of calendar year 2023 to ensure accurate 
accounting of discarded amounts. Two commenters that agreed with the 
proposal disagreed with CMS' assertion that CMS had discretion to count 
these products in the first place, as they fall outside the statutory 
definition of a refundable drug in section 1847A(h)(8)(A) of the Act, 
which applies to products that are either a single-source drug or 
biological (as defined in subsection (c)(6)(D)) or a biosimilar 
biological product (as defined in subsection (c)(6)(H)), neither of 
which describe skin substitutes. The commenters requested that CMS 
acknowledge that skin substitutes are statutorily precluded from the 
policy.
    Response: We thank commenters for their feedback as we continue to 
consider refinements to skin substitute policies. The comment 
solicitation in the CY 2024 PFS proposed rule will inform future policy 
development for the payment of skin substitutes.
    Regarding the lack of enforcement of JW and JZ modifier use through 
the first three quarters of 2023, section 1847A of the Act only speaks 
to the use of JW data for the calculation of reporting discarded 
amounts and assessing refund obligations. In the CY 2023 PFS final rule 
(87 FR 69712 through 69728) we established the JZ modifier and 
finalized plans to edit for JW and JZ modifier use, which are described 
more fully in program instruction,\160\ to improve the quality of 
discarded amount data. Although we proposed in the CY 2023 PFS proposed 
rule to require the JZ modifier beginning January 1, 2023, we delayed 
the requirement in the final rule to October 1, 2023, in response to 
comments to allow a transition period for providers, billing software 
vendors, and MACs to adjust billing and claims review processes (87 FR 
69717). For these reasons, we disagree that this delay prevents us from 
using JW modifier data to calculate discarded drug refunds for the 
first three quarters of 2023.
---------------------------------------------------------------------------

    \160\ https://www.cms.gov/files/document/r12067cp.pdf.
---------------------------------------------------------------------------

    Comment: One commenter requested that we clarify how CMS will 
handle claims for skin substitutes reported with the JW modifier in a 
future payment methodology.
    Response: In the CY 2024 PFS proposed rule (88 FR 52357 through 
52358), we solicited comment on potential approaches to billing but did 
not propose any revisions to the payment approach for skin substitutes 
under Part B for CY 2024. Therefore, we cannot comment on how claims 
for skin substitutes that report JW data, or the reported JW data, will 
be processed under a future payment approach.
    Further discussion of a potential future billing approach for skin 
substitute products is in section II.H of this final rule. For this 
final rule, for CY 2023 and 2024, we are finalizing that JW units of 
skin substitutes will not be used for the discarded drug refund 
calculations and we will not issue reports to manufacturers with 
respect to skin substitutes.
    Comment: One commenter requested that CMS explicitly confirm the 
statutory exclusion for imaging agents in section 1847A(h)(8)(B)(i) of 
the Act includes contrast agents.
    Response: We point the commenter to the discussion in CY 2023 PFS 
final rule (87 FR 69724). In response to two commenters requesting the 
same confirmation, we stated that we recognize contrast agents as a 
category of imaging agents as described in FDA's Guidance for Industry. 
Therefore, we

[[Page 79061]]

clarified that contrast agents are excluded from the definition of 
refundable single-dose container or single-use package drug.
    Comment: Two commenters requested that we treat drugs or 
biologicals that are regarded as multiple source drugs under section 
1847A(c)(6)(C)(ii) of the Act as multiple source drugs for purposes of 
the discarded drug refund.
    Response: The definition of refundable drug under section 
1847A(h)(8)(A) of the Act requires that such drugs are single source 
drugs or biologicals (as defined in subsection (c)(6)(D)) or a 
biosimilar biological product (as defined in subsection (c)(6)(H)). The 
definition of single source drug or biological requires that the drug 
is not a multiple source drug, which is defined at section 
1847A(c)(6)(C) of the Act. Therefore, we agree with the commenter and 
clarify that, under section 1847A(c)(6)(C)(ii) of the Act, single 
source drugs or biologicals that were within the same billing and 
payment code as of October 1, 2003, will be treated as multiple source 
drugs for the purposes of the discarded drug refund.
f. Clarification for the Determination of Discarded Amounts and Refund 
Amounts
    Section 1847A(h) of the Act specifies that discarded amounts of 
refundable drugs are to be determined using a mechanism such as the JW 
modifier used as of the date of enactment of the Infrastructure Act or 
any successor modifier that includes such data as determined 
appropriate by the Secretary. In the CY 2023 PFS final rule (87 FR 
69718 through 69719), we finalized our previously existing policy that 
required billing providers report the JW modifier for all separately 
payable drugs with discarded drug amounts from single use vials or 
single use packages payable under Part B, beginning January 1, 2023.
    In the CY 2024 PFS proposed rule (88 FR 52395), we discussed the 
applicability of the JW modifier in Medicare Advantage claims. We 
stated that since the JW modifier, the mechanism described in section 
1847A(h) of the Act, is not required in Medicare Advantage claims for 
drugs payable under Medicare Part B and there is not a similar 
mechanism to identify discarded units of such drugs that are billed to 
Medicare Advantage plans, we proposed to clarify that the JW modifier 
requirement does not apply to units billed to Medicare Advantage plans 
and that the refund amount calculations under section 1847A(h)(3) of 
the Act will not include units billed to Medicare Advantage plans.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Several commenters expressed support for our proposal to 
exclude units for refundable drugs billed to Medicare Advantage plans 
from the calculation of refund amounts.
    Response: We thank the commenters for their support.
    Comment: While agreeing that the JW modifier is not required for 
units billed to Medicare Advantage plans, one commenter requested that 
we clarify that the definition of a refundable drug as described in 
section 1847A(h)(8) limits the scope of the provision to Part B fee-
for-service claims.
    Response: We thank the commenter for their feedback. As finalized 
in in the 2023 PFS final rule (87 FR 69710 through 69734), our policy 
is to determine the total number of discarded units using the JW 
modifier (or any successor modifier that includes the same data). This 
policy results in the exclusion of units billed to Medicare Advantage 
plans. We do not believe it is necessary to evaluate additional 
arguments for excluding units billed to MA plans in this final rule.
    Comment: One commenter requested clarification regarding whether 
Medicare Advantage plans are permitted to require the reporting of the 
JW modifier. The commenter cited Chapter 4, Section 10.2 of the 
Medicare Managed Care Manual, which states that Medicare Advantage 
plans have discretion to establish their own billing and payment 
procedures, both for contracted and uncontracted providers, and such 
discretion extends to the option to adopt fee-for-service billing 
modifiers.
    Response: We thank the commenter for their request for 
clarification. We are clarifying that since the JW modifier, the 
mechanism described in section 1847A(h)(1) of the Act, is not 
necessarily required by all Medicare Advantage plans, we cannot ensure 
that any JW modifier data gathered by Medicare Advantage plans is 
consistently done so in accordance with our JW and JZ modifier use 
policy, the refund amount calculations under section 1847A(h)(3) of the 
Act will not include units billed to Medicare Advantage plans.
    After reviewing all comments, we are finalizing the clarification 
that we will not include units billed to Medicare Advantage plans in 
calculations under section 1847A(h)(3) of the Act because we cannot 
ensure data for refundable drugs billed to plans is consistently 
collected in accordance with the same reporting requirements. We are 
finalizing the additional clarification that Medicare Advantage plans 
are not required, but are permitted, to adopt the Medicare fee-for-
service JW and JZ modifier requirements for single-dose container drugs 
that are separately payable under Part B; however, those units will not 
be included in the refund amount calculations.
g. Technical Changes
    In the CY 2023 PFS final rule (87 FR 70227) we finalized the 
regulation text for the calculation of the manufacturer refund 
requirement. That text contained an error in two places, Sec.  
[thinsp]414.940(c)(3) and (d), which incorrectly referenced paragraph 
(c)(1)(ii) of that section in reference to the applicable percentage, 
rather than paragraph (c)(2). In the CY 2024 PFS proposed rule (88 FR 
52395), we proposed to correct the textual reference in both paragraphs 
and make additional technical changes to streamline the text.
    We did not receive any comments on these proposed technical 
corrections and are finalizing as proposed.
h. Use of the JW Modifier and JZ Modifier Policy
    In the CY 2023 PFS final rule (87 FR 69723), we discussed the 
applicability of the JW and JZ modifier policy to drugs that are not 
administered by the billing supplier, including drugs furnished through 
a covered item of DME that may be administered by the beneficiary. In 
such cases, suppliers who dispense drugs payable under Medicare Part B 
do not actually administer the drug, as the claim is typically 
submitted prior to the administration of the drug, and the billing 
provider or supplier is not at the site of administration to measure 
discarded amounts. We stated that since we do not believe it would be 
appropriate to collect data about discarded amounts from beneficiaries, 
the reporting requirement does not apply to drugs that are self-
administered by a patient or caregiver in the patient's home. In the 
updated FAQ for the JW/JZ modifier policy \161\ released on January 5, 
2023, we reiterated that suppliers who dispense but do not actually 
administer a separately payable drug are not expected to report the JW 
modifier.
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    \161\ https://www.cms.gov/medicare/medicare-fee-for-service-payment/hospitaloutpatientpps/downloads/jw-modifier-faqs.pdf.
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    In the CY 2024 PFS proposed rule (88 FR 52395) we discussed that 
beginning

[[Page 79062]]

October 1, 2023, we will begin editing for correct use of both the JW 
and JZ modifiers for billing and payment codes for drugs from single-
dose containers (87 FR 69719). However, because currently there is no 
claims modifier to designate that a drug was dispensed, but not 
administered, by the billing supplier, we were concerned that the 
policy finalized last year exempting self-administered drugs from the 
JW/JZ modifier policy may result in claims rejections absent a 
modification. Therefore, we proposed to require that drugs separately 
payable under Part B from single-dose containers that are furnished by 
a supplier who is not administering the drug be billed with the JZ 
modifier, since we continued to believe it is unreasonable to collect 
discarded drug data from beneficiaries.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Two commenters expressed support for the proposal to not 
to apply the discarded drug refund to units of single-dose container 
drugs that are furnished but not administered by the billing supplier. 
The commenters echoed our position that it is not feasible for Medicare 
beneficiaries to track and accurately report discarded amounts.
    Response: We thank the commenters for their support.
    Comment: Two commenters stated they oppose the requirement to 
report the JZ modifier for drugs furnished but not administered by the 
biller. One commenter recommended that instead of requiring the use of 
the JZ modifier, CMS instead improve compliance with the JW modifier 
policy by enhancing provider and supplier education efforts. Two 
commenters suggested another alternative in which CMS develops a new 
modifier to be reported on claims for these drugs to separate them from 
the calculation of discarded drug refund amounts. One commenter added 
that a new modifier would be more appropriate because the supplier 
cannot in fact determine that there were no discarded amounts when the 
patient self-administers the drug for which the supplier is submitting 
a claim, as the reporting of the JZ modifier suggests; rather, the JZ 
modifier's use in this instance in fact means that the discard drug 
refund policy does not apply to these drugs.
    Response: As we noted in the CY 2023 PFS final rule (87 FR 69716 
through 69717), the Committee on Implications of Discarded Weight-Based 
Drugs found compliance with the JW modifier requirement not only varied 
among providers and suppliers, but even providers and suppliers who use 
the modifier do not do so consistently and vary in their reporting from 
one drug to another and across claims for the same patient and 
drug.\162\ We do not believe that provider and supplier education alone 
can obtain the consistent reporting of JW modifier data needed for the 
implementation of this provision.
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    \162\ National Academies of Sciences, Engineering, and Medicine. 
2021. Medications in single-dose vials: Implications of discarded 
drugs. Washington, DC: The National Academies Press. https://doi.org/10.17226/25911. National Academies of Sciences, Engineering, 
and Medicine. 2021. Medications in Single-Dose Vials: Implications 
of Discarded Drugs. Washington, DC: The National Academies Press. 
https://doi.org/10.17226/25911.
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    Regarding the establishment of a new modifier for drugs covered 
under the DMEPOS benefit, we agree this approach would accomplish the 
same objective in avoiding the rejection of claims for which we do not 
expect to receive JW modifier data. We do not, however, see how the 
requirement that suppliers of drugs covered under the DMEPOS benefit 
report a new modifier rather than the JZ modifier would reduce 
administrative burden on the supplier. One potential benefit to the 
program would be, rather, that billing units of such drugs are not 
automatically counted as administered with zero discarded amounts, but 
we do not have any reason, at this time, to believe this would result 
in additional refund obligations. We may revisit this suggestion in 
future rulemaking.
    Comment: One commenter requested that CMS take efforts to minimize 
the discarded drug refund policy's compliance burden on providers and 
suppliers. One commenter stated that because discarded amounts for 
drugs covered under the DMEPOS benefit are consistently far below 10 
percent, the JZ modifier requirement for these drugs does not provide a 
program benefit that justifies the administrative burden it would place 
on suppliers.
    One commenter described the issuance of contradictory guidance by 
DME MACs that has created confusion about whether providers and 
suppliers are required to report the JZ modifier for single-dose 
container drugs that are dispensed but not administered to patients 
beginning July 1, 2023 or October 1, 2023, or not at all. The commenter 
requested that CMS direct DME MACs to update their external fusion pump 
local coverage articles to clarify the JW and JZ modifier policy for 
single-dose drugs that are dispensed, but not administered to patients 
for dates of service between July 1 and October 1, 2023 and for dates 
of service after October 1, 2023, regardless of whether the local 
coverage article is updated in time to reflect the new billing 
requirement.
    Response: As we stated in the CY 2023 PFS final rule discussion on 
provider burden (87 FR 69716), we believe that in most cases the JW and 
JZ modifier requirements impose no new burdens on providers beyond the 
requirement of measuring and reporting discarded amounts by use of the 
JW modifier that predates the enactment of the discarded drug refund 
policy under section 1847A(h) of the Act. Providers and suppliers who 
have been complying with the JW modifier requirement effective January 
1, 2017 have already been assessing and documenting what is needed for 
the JZ modifier, and the new requirement of reporting the JZ modifier 
is minimal and justifiable for the purposes of obtaining more complete 
discarded amount data.
    Regarding the confusion about the billing requirements for 
suppliers who dispense, but do not administer a single-dose drug to 
patients, since we did not finalize the requirement to report the JZ 
modifier in this situation in the CY 2023 PFS final rule, we cannot 
require it to be reported for dates of service in CY 2023. On October 
16, 2023, we updated the JW and JZ Modifier FAQ \163\ to provide 
additional clarity and resolve concerns about processing claims for 
single-dose drugs that are self-administered by a patient or caregiver 
in the patient's home before CY 2024 billing requirement updates take 
effect. The updated FAQ provides reference to a published list of 
specific billing and payment codes to which only single-dose containers 
are assigned, and thus, may require use of the JW or JZ modifiers 
depending on the setting of use. The identified codes should not be 
considered an all-inclusive list of codes that are subject to the JW 
and JZ modifier policy. The list is available on the ASP Billing 
Resources website.\164\
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    \163\ https://www.cms.gov/medicare/medicare-fee-for-service-payment/hospitaloutpatientpps/downloads/jw-modifier-faqs.pdf.
    \164\ https://www.cms.gov/medicare/payment/all-fee-service-providers/medicare-part-b-drug-average-sales-price/asp-billing-resources.
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    Comment: One commenter stated that CMS has long stated that it 
expects providers and suppliers to use drugs in a clinically 
appropriate manner and has consistently advised that all procedures for 
drug reconstitution and administration should conform to applicable FDA 
guidelines, one of which states that any extra amount of the drug 
remaining after the dose is administered must be discarded.

[[Page 79063]]

Another commenter requested clarification of correct JZ modifier use 
when drugs from a single-dose containers are used for multiple 
patients.
    Response: The JW Modifier and JZ Modifier Policy Frequently Asked 
Questions document \165\ reiterates language in Chapter 17 of the 
Medicare Claims Processing Manual,\166\ which states that CMS 
encourages physicians, hospitals and other providers and suppliers to 
care for and administer drugs and biologicals to patients in such a way 
that they can use drugs or biologicals most efficiently, in a 
clinically appropriate manner. In the resources section of the FAQ 
document, there is a link to a memorandum from the Survey and 
Certification Group at CMS regarding entitled Safe Use of Single Dose/
Single Use Medications to Prevent Healthcare-associated 
Infections.\167\ In this memorandum CMS clarified guidance regarding 
the various infection control regulatory requirements to indicate that 
when previously unopened single-dose vials are repackaged consistent 
with aseptic conditions under the requirements of USP <797>, and 
subsequently stored consistent with USP <797> and the manufacturer's 
package insert, it is permissible for healthcare personnel to 
administer repackaged doses derived from single-dose vials to multiple 
patients, provided that each repackaged dose is used for a single 
patient in accordance with applicable storage and handling 
requirements. We reiterate the JZ modifier policy that the modifier is 
used to attest that no amount of drug was discarded from single-dose 
container drugs. To align with the JW modifier policy, the JZ modifier 
is required when there are no discarded amounts of a single-dose 
container drug for which the JW modifier would be required if there 
were discarded amounts. In addition, we clarify that JZ modifier policy 
does not require that the claim line with the JZ modifier account for 
only whole vials of the drug and the JW modifier policy does not 
require that the two claim lines (as described in the modifier FAQ 
document \168\) account for only whole vials of the drug.
---------------------------------------------------------------------------

    \165\ https://www.cms.gov/medicare/medicare-fee-for-service-payment/hospitaloutpatientpps/downloads/jw-modifier-faqs.pdf.
    \166\ https://www.cms.gov/regulations-and-guidance/guidance/
manuals/downloads/clm104c17.pdf.
    \167\ https://www.cms.gov/medicare/provider-enrollment-and-certification/surveycertificationgeninfo/downloads/survey-and-cert-letter-12-35.pdf.
    \168\ https://www.cms.gov/medicare/medicare-fee-for-service-payment/hospitaloutpatientpps/downloads/jw-modifier-faqs.pdf.
---------------------------------------------------------------------------

    Comment: One commenter requested clarification regarding the JW/JZ 
reporting requirements for drugs that are excluded from the definition 
of ``refundable drug'' and are therefore exempt from refunds for 
discarded amounts. The commenter requested that such drugs that do not 
meet the definition of a refundable drug be billed with the JZ 
modifier, similar to those that are furnished but not administered by a 
supplier.
    Response: As stated in the CY 2023 PFS final rule (87 FR 69724), 
even if a drug is excluded from the definition of refundable single-
dose container or single-use package drug (and not subject to refunds), 
for example, multiple source drugs, claims for such drugs furnished 
from a single-dose container are still required to use the JW and JZ 
modifiers in accordance with the policy.
    After reviewing all comments, we are finalizing as proposed the 
requirement that drugs separately payable under Part B from single-dose 
containers that are furnished by a supplier who is not administering 
the drug be billed with the JZ modifier.
i. General Comments
    We received several public comments on these proposals, generally. 
The following is a summary of the comments we received and our 
responses.
    Comment: One commenter expressed support for CMS' ongoing efforts 
to implement section 90004 of the Infrastructure Act by continuing to 
refine the process for manufacturers to provide a refund to CMS for 
certain discarded amounts from refundable drugs. The commenter stated 
that implementation of the discarded drug refund will help reduce waste 
and spending within the Medicare program by discouraging drug 
manufacturers from overfilling single-dose containers.
    Response: We thank the commenter for their support.
    Comment: One commenter states that the discarded drug refund exacts 
financial penalties due to a drug's FDA-approved labeling and efficacy 
and safety profile, and administration of the product by healthcare 
providers, over which a manufacturer exerts no control.
    Response: Section 1847A(h)(3) of the Act requires that the refund 
calculation use the total number of units of the billing and payment 
code of such drug, if any, that were discarded for a given calendar 
quarter for which a refund is due, as determined using a mechanism such 
as the JW modifier. CMS is implementing the law.
    Comment: One commenter noted that for biosimilar biological 
products (hereafter, biosimilars), introducing new vial sizes would not 
be feasible, because manufacturers of biosimilars must offer the same 
vial sizes as the reference product.
    Response: To date, we have not observed any biosimilars that have 
discarded amounts exceeding 10 percent. However, we will continue to 
monitor discarded drug data for biosimilars. We also note that section 
90004 of the Infrastructure Investment and Jobs Act requires the Office 
of Inspector General (OIG), after consultation with CMS and FDA, to 
submit a report to Congress on any reported impact that section 90004 
may have on the licensure, market entry, market retention, or marketing 
of biosimilars. The OIG is expected to issue a report to Congress in 
fiscal year (FY) 2024.\169\
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    \169\ https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000743.asp.
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    Comment: One commenter expressed concern that the discarded drug 
refunds will impact provider reimbursement.
    Response: Since Medicare pays for units of single-dose drugs that 
are administered to the patient as well as units that are discarded 
(and billed using the JW modifier), we do not expect the refund to 
affect reimbursement to providers.
j. Out of Scope Comments
    Comment: We received comments on several topics that were outside 
the scope of the proposed rule. Those topics included the following: 
the contents of the preliminary report (87 FR 69725) and the annual 
refund report described in Sec.  414.940(a)(1) and manufacturers' 
ability to use them to identify potential calculation errors; a request 
that the window for submitting an error report be extended to 60 days; 
several requests for the establishment of an appeals process including 
for calculated refund amounts and for unique circumstance applications; 
support for our reaffirmation of the exclusion of radiopharmaceuticals 
and imaging agents from the definition of refundable drugs; requests 
that all non-refundable drugs or just radiopharmaceuticals and imaging 
agents be excluded from the JW and JZ modifier reporting policy; a 
request that we clarify that all non-refundable drugs single-dose 
container drugs be reported with the JZ modifier; a request for 
clarification on correct JZ modifier use when drugs from a single dose 
vial are used for multiple patients; a request that CMS develop a 
mechanism to automate the reporting of discard amounts in claims 
systems; a request that Medicare compensate provider and suppliers for 
the discarded

[[Page 79064]]

amount reporting burden; support for the JW and JZ modifier edits; 
offers to collaborate with CMS on provider education for the JW and JZ 
modifier requirements; a statement of concern about complications for 
reporting JW and JZ modifier data in systems in which EHR recording for 
single-dose container drugs is automated; a request for a delay in the 
beginning of edits for correct JW and JZ modifier use; a request for 
additional provider education on the discarded drug refund policy; a 
request for a requirement that all skin substitute products report ASP 
data; a request that CMS affirm the 18-month exclusionary period for 
Leqembi begins on October 1, 2023; a request for drugs whose use is 
required by an unrelated manufacturer over which the product's 
manufacturer has no control and the establishment of new HCPCS codes 
for products based on alternative utilization methods to be considered 
to have unique circumstances; a request for newly approved drugs when 
the manufacturer is actively carrying out post-market optimization 
activities to be considered to have unique circumstances; two requests 
that we confirm that certain drugs meet the definition of the rarely 
utilized orphan drugs for which we proposed a unique circumstances; a 
request from several commenters that we extend through rulemaking the 
18-month exclusion period for newly marketed drugs, as described in 
section 1847A(h)(8)(B)(iii) of the Act, to 36 months; a request from 
several commenters for cell and gene therapies and other personalized 
therapies to be considered to have a unique circumstance and have an 
increased applicable percentage, as well as a request that in 
considering future HCPCS applications for these therapies we consider 
the implications of any decision on its potential discarded drug refund 
obligations; and a request for drugs that treat multiple indications 
across unique patient types and characteristics to be considered to 
have unique circumstances.
    Response: While these comments are out of scope for this final rule 
because they do not relate to the specific proposals included in the 
proposed rule, we appreciate the feedback and may consider these 
recommendations for future rulemaking.

B. Rural Health Clinics (RHCs) and Federally Qualified Health Centers 
(FQHCs)

1. Background
a. RHC and FQHC Payment Methodologies
    As provided in 42 CFR part 405, subpart X of our regulations, RHC 
and FQHC visits generally are defined as face-to-face encounters 
between a patient and one or more RHC or FQHC practitioners during 
which one or more RHC or FQHC qualifying services are furnished. RHC 
and FQHC practitioners are physicians, NPs, PAs, CNMs, clinical 
psychologists (CPs), and clinical social workers, and under certain 
conditions, a registered nurse or licensed practical nurse furnishing 
care to a homebound RHC or FQHC patient in an area verified as having 
shortage of home health agencies. We note, as discussed in section 
III.B.2.b. of this final rule, effective January 1, 2024 RHC and FQHC 
practitioners can also be licensed marriage and family therapists or 
mental health counselors. Transitional Care Management (TCM) services 
can also be paid by Medicare as an RHC or FQHC visit. In addition, 
Diabetes Self-Management Training (DSMT) or Medical Nutrition Therapy 
(MNT) sessions furnished by a certified DSMT or MNT program may also be 
considered FQHC visits for Medicare payment purposes. Only medically 
necessary medical, mental health, or qualified preventive health 
services that require the skill level of an RHC or FQHC practitioner 
are RHC or FQHC billable visits. Services furnished by auxiliary 
personnel (for example, nurses, medical assistants, or other clinical 
personnel acting under the supervision of the RHC or FQHC practitioner) 
are considered incident to the visit and are included in the per-visit 
payment.
    RHCs generally are paid an all-inclusive rate (AIR) for all 
medically necessary medical and mental health services and qualified 
preventive health services furnished on the same day (with some 
exceptions). The AIR is subject to a payment limit, meaning that an RHC 
will not receive any payment beyond the specified limit amount. As of 
April 1, 2021, all RHCs are subject to new payment limits on the AIR, 
and this limit will be determined for each RHC in accordance with 
section 1833(f) of the Act.
    FQHCs were paid under the same AIR methodology until October 1, 
2014. Beginning on that date, in accordance with section 1834(o) of the 
Act (as added by section 10501(i)(3) of the Patient Protection and 
Affordable Care Act (Pub. L. 111-148), FQHCs began to transition to the 
FQHC PPS system, in which they are paid based on the lesser of the FQHC 
PPS rate or their actual charges. The FQHC PPS rate is adjusted for 
geographic differences in the cost of services by the FQHC PPS 
geographic adjustment factor (GAF). The rate is increased by 34 percent 
when an FQHC furnishes care to a patient that is new to the FQHC, or to 
a beneficiary receiving an initial preventive physical examination 
(IPPE) or has an annual wellness visit (AWV).
    Both the RHC AIR and FQHC PPS payment rates were designed to 
reflect the cost of all services and supplies that an RHC or FQHC 
furnishes to a patient in a single day. The rates are not adjusted at 
the individual level for the complexity of individual patient health 
care needs, the length of an individual visit, or the number or type of 
practitioners involved in the patient's care. Instead for RHCs, all 
costs for the facility over the course of the year are aggregated and 
an AIR is derived from these aggregate expenditures. The FQHC PPS base 
rate is updated annually by the percentage increase in the FQHC market 
basket reduced by a productivity adjustment.
2. Implementation of the Consolidated Appropriations Act (CAA), 2023
a. Section 4113 of the Consolidated Appropriations Act, 2023
    In the CY 2022 PFS final rule with comment (86 FR 65211), we 
revised the regulatory requirement that an RHC or FQHC mental health 
visit must be a face-to-face (that is, in person) encounter between an 
RHC or FQHC patient and an RHC or FQHC practitioner. We revised the 
regulations under Sec.  405.2463 to state that an RHC or FQHC mental 
health visit can also include encounters furnished through interactive, 
real-time, audio/video telecommunications technology or audio-only 
interactions in cases where beneficiaries are not capable of, or do not 
consent to, the use of devices that permit a two-way, audio/video 
interaction for the purposes of diagnosis, evaluation or treatment of a 
mental health disorder. We noted that these changes aligned with 
similar mental health services furnished under the PFS. We also noted 
that this change allows RHCs and FQHCs to report and be paid for mental 
health visits furnished via real-time, telecommunication technology in 
the same way they currently do when these services are furnished in-
person. In addition, we revised the regulation

[[Page 79065]]

under Sec.  405.2463 to state that there must be an in-person mental 
health service furnished within 6 months prior to the furnishing of the 
telecommunications service and that an in-person mental health service 
(without the use of telecommunications technology) must be provided at 
least every 12 months while the beneficiary is receiving services 
furnished via telecommunications technology for diagnosis, evaluation, 
or treatment of mental health disorders, unless, for a particular 12-
month period, the physician or practitioner and patient agree that the 
risks and burdens outweigh the benefits associated with furnishing the 
in-person item or service, and the practitioner documents the reasons 
for this decision in the patient's medical record (86 FR 65210 and 
65211).
    We also revised the regulation under Sec.  405.2469, FQHC 
supplemental payments, to state that a supplemental payment required 
under this section is made to the FQHC when a covered face-to-face 
(that is, in-person) encounter or an encounter where services are 
furnished using interactive, real-time, telecommunications technology 
or audio-only interactions in cases where beneficiaries do not wish to 
use or do not have access to devices that permit a two-way, audio/video 
interaction for the purposes of diagnosis, evaluation or treatment of a 
mental health disorder occurs between a MA enrollee and a practitioner 
as set forth in Sec.  405.2463. At Sec.  405.2469, we also revised 
paragraph (d) to describe the same in-person visit requirement 
referenced in Sec.  405.2463.
    As discussed in the CY 2023 PFS final rule (87 FR 69738), the 
Consolidated Appropriations Act, 2022 (CAA, 2022) (Pub. L. 117-103, 
March 15, 2022) included the extension of a number of Medicare 
telehealth flexibilities established during the public health emergency 
(PHE) for COVID-19 for a limited 151-day period beginning on the first 
day after the end of the PHE for COVID-19. Specifically, Division P, 
Title III, section 304 of the CAA, 2022, delayed the in-person 
requirements under Medicare for mental health services furnished 
through telehealth under the PFS and for mental health visits furnished 
by RHCs and FQHCs via telecommunications technology until the 152nd day 
after the end of the PHE for COVID-19. Therefore, in the CY 2023 PFS 
final rule (87 FR 69737), we revised the regulations under Sec. Sec.  
405.2463 and 405.2469 again to reflect these provisions.
    As discussed in the CY 2024 PFS proposed rule (88 FR 52396 through 
52397), the CAA, 2023 (Pub. L. 117-328, December 29, 2022) extends the 
Medicare telehealth flexibilities enacted in the CAA, 2022 for a period 
beginning on the first day after the end of the PHE for COVID-19 and 
ending on December 31, 2024, if the PHE ends prior to that date. 
Specifically related to RHCs and FQHCs, section 4113(c) of the CAA, 
2023 amends section 1834(m)(8) of the Act to extend payment for 
telehealth services furnished by FQHCs and RHCs for the period 
beginning on the first day after the end of the COVID-19 PHE and ending 
on December 31, 2024, if the PHE ends prior to that date. We noted that 
payment continued to be made under the methodology established for 
telehealth services furnished by FQHCs and RHCs during the PHE, which 
is based on payment rates that are similar to the national average 
payment rates for comparable telehealth services under the PFS. We also 
noted that we did not believe it necessary to conform the regulation to 
this temporary provision. Rather, we used our authority in section 
4113(h) of the CAA, 2023 to issue program instructions or other 
subregulatory guidance to effectuate this provision to ensure a smooth 
transition after the PHE.\170\
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    \170\ https://www.cms.gov/files/document/rural-health-clinics-and-federally-qualified-health-centers-cms-flexibilities-fight-covid-19.pdf.
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    We explained that section 4113(d) of the CAA, 2023 continues to 
delay the in-person requirements under Medicare for mental health 
services furnished through telehealth under the PFS and for mental 
health visits furnished by RHCs and FQHCs via telecommunications 
technology. That is, for RHCs and FQHCs, in-person visits will not be 
required until January 1, 2025 or, if later, the first day after the 
end of the PHE for COVID-19. Therefore, we stated that we will continue 
to apply the delay of the in-person requirements under Medicare for 
mental health services furnished by RHCs and FQHCs. We noted, the 
Department of Health and Human Services declared an end to the Federal 
PHE for COVID-19 under section 319 of the Public Health Service Act on 
May 11, 2023.\171\
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    \171\ https://www.hhs.gov/coronavirus/covid-19-public-health-emergency/index.html.
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    Accordingly, we proposed to make conforming regulatory text changes 
based on CAA, 2023 to the applicable RHC and FQHC regulations in 42 CFR 
part 405, subpart X, specifically, at Sec.  405.2463, ``What 
constitutes a visit,'' we proposed to amend paragraph (b)(3) and, at 
Sec.  405.2469 ``FQHC supplemental payments,'' we proposed to amend 
paragraph (d) to include the delay of the in-person requirements for 
mental health visits furnished by RHCs and FQHCs through 
telecommunication technology under Medicare beginning January 1, 2025. 
We noted that we are not revising the regulation text to reflect ``or, 
if later, the first day after the end of the PHE for COVID-19'' as the 
legislation states since the end of the PHE was May 11, 2023.
    We noted that in the CY 2023 PFS final rule (87 FR 69738), we 
listed the several other provisions of the CAA, 2022 that apply to 
telehealth services (those that are not mental health visits) furnished 
by RHCs and FQHCs. For details on the other Medicare telehealth 
provisions in the CAA, 2022, see section II.D. of this final rule. We 
also noted that the CAA, 2023 extended the telehealth policies 
mentioned above and enacted in the CAA, 2022 through December 31, 2024.
    We received many comments on the extension of telehealth 
flexibilities under section 4113 of CAA, 2023. The following is a 
summary of the public comments received and our responses:
    Comment: Many commenters generally supported the extension of 
telehealth flexibilities for RHCs and FQHCs and the delay of the in-
person requirements for mental health services, as required under 
section 4113 of CAA, 2023.
    Response: We thank commenters for their support.
    Comment: We received several comments requesting that the COVID-19 
telehealth flexibilities be made permanent. Although one commenter 
acknowledged that CMS does not have the authority to make the changes 
related to payment of FQHCs and RHCs for telehealth services beyond 
December 31, 2024, several commenters requested that CMS work with 
Congress to ensure the telehealth flexibilities remain in place 
indefinitely. One commenter explained that this would include 
telehealth flexibilities related to continuing payment for telehealth 
services, removing the in-person visit requirements for mental health 
visits, expanding the originating site requirements to include any site 
in the U.S. the beneficiary is located (for example, the individual's 
home) and extending coverage and payment of telehealth services that 
are furnished via audio-only communications. Commenters explained that 
they believe if FQHCs and RHCs are no longer able to furnish telehealth 
services to patients after December 31, 2024, this will limit access to 
care and may negatively impact patient health.

[[Page 79066]]

    Response: We thank commenters for their input. The CAA, 2023 does 
not extend these policies beyond December 31, 2024. We do not have the 
authority to make these flexibilities permanent.
    Comment: We received comments from the RHC and FQHC community 
requesting CMS revise the definition of a medical visit so that these 
services can be furnished via telecommunication technologies similar to 
what CMS finalized in the CY 2022 PFS final rule (86 FR 65208 through 
65211) for mental health visits furnished via telecommunication 
technologies. A few commenters urged CMS to revise the ``medical 
visit'' definition before January 1, 2025, stating that they believe 
that this action would avoid significant gaps in care for some of the 
most vulnerable Medicare patients. The commenter suggested that CMS 
consider these consequences if Medicare patients cannot receive virtual 
medical services due to a lapse in coverage and payment. The same 
commenters stated that they believe CMS has the authority to revise 
Sec.  405.2463(b)(1) to define a medical visit as a face-to-face 
encounter or encounter where services are furnished using interactive, 
real-time, audio and video telecommunications technology or audio-only 
interactions in cases where beneficiaries are not capable of or do not 
consent to, the use of devices that permit a two-way audio/video 
interaction for the purposes of diagnosis, evaluation or treatment of 
services under Sec.  405.2463(b)(2). Commenters further stated that if 
CMS were to revise the definition of a ``medical visit'' so that these 
services can be furnished via telecommunication technologies, CMS 
should also amend cost reporting instructions to ensure the costs 
associated with these services are included as ``FQHC services'' on the 
cost report.
    Response: Since we did not make any proposals in this rulemaking 
related to revising the regulatory definition of a ``medical visit'' to 
permit these services be furnished via telecommunication technologies, 
these comments are out of scope. However, we anticipate that the 
extension of payment for distant site telehealth services furnished by 
RHCs and FQHCs through December 31, 2024, as established in the CAA, 
2023, would mitigate concerns regarding gaps in care since it could 
provide time for patients transitioning from virtual to in-person 
services to come into the RHC or FQHC.
    Comment: A commenter stated that given the extension of current RHC 
medical telehealth policy through December 31, 2024, and they requested 
that CMS permit normal coding instead of billing G2025 for all 
allowable Medicare telehealth services. The commenter believes that the 
payment can be achieved through appending the modifier code (95) to 
these services which could better facilitate data collection of RHC 
services performed via telehealth, including proper counting of Annual 
Wellness Visits and other preventive services.
    Response: We thank the commenter for bringing this to our 
attention. We agree that transparency in the services furnished can 
improve data collection and inform payment policies and can explore 
options that may provide RHCs and FQHCs the ability to report the HCPCS 
code that describes the service furnished instead reporting G2025. If 
we were to implement such changes in the claims processing systems, we 
do not believe that it would change the payment policy, that is, 
overall payment would be the same. Therefore, changes in the way RHCs 
and FQHCs would report these services and how CMS pays would be 
effectuated through sub-regulatory guidance.
    Comment: A commenter requested guidance from CMS to clarify for the 
RHC community if distant site telehealth services may be provided 
outside of the RHC's hours of operations. The commenter stated that 
RHCs should not be limited to only offering telehealth during the 
physical RHC's hours of operation. The commenter further explained that 
they believe this policy limits access to care for safety-net patients.
    Response: Currently, RHCs and FQHCs are required to furnish 
services during their hours of operation and if services are furnished 
at times other than the RHC's or FQHC's posted hours of operation, they 
may not be billed to Medicare Part B if the practitioner's compensation 
for these services is included in the RHC/FQHC cost report. This policy 
is discussed in Pub. 100-02 Medicare Benefit Policy Manual, Chapter 13, 
section 40.2 ``Hours of Operation.'' \172\ We appreciate the commenter 
bringing this concern to our attention and we can consider for future 
rulemaking.
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    \172\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c13.pdf.
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    Comment: One commenter encouraged CMS to not impose requirements 
for in-person services beyond what is statutorily required. The 
commenter stated that for patients seeking mental health treatment, the 
issues which prevent them from accessing care existed prior to the 
pandemic and will continue to exist beyond its duration. The commenter 
further stated that it is important to ensure the provisions intended 
to maintain program integrity do not inhibit patient access to care. 
The commenter also stated that providers can utilize their clinical 
judgment to assess if a patient requires an in-person visit.
    Response: We appreciate the feedback from commenters regarding how 
requirements for in-person service when mental health visits are 
furnished by RHCs and FQHCs through telecommunication technology may 
have on access to care. In the CY 2022 PFS final rule (86 FR 65210) we 
finalized a policy that an RHC or FQHC patient must have an in-person 
mental health service furnished within 6 months prior to the furnishing 
of the telecommunications service and that in general, there must be an 
in-person mental health service (without the use of telecommunications 
technology) must be provided at least every 12 months while the 
beneficiary is receiving services furnished via telecommunications 
technology for diagnosis, evaluation, or treatment of mental health 
disorders. We stated that this is consistent with policies finalized 
for mental health services furnished via telehealth under the PFS, and 
that the in-person service requirements apply only to telehealth 
services furnished to a patient receiving the service at home.
    Regarding concerns that the in-person requirements would pose a 
challenge for some beneficiaries, we would like to direct you to Sec.  
405.2463(b)(3) that describes the exceptions to the in-person visit 
requirements. That is, if the patient and practitioner consider the 
risks and burdens of an in-person service and agree that, on balance, 
these outweigh the benefits, and the practitioner documents the basis 
for that decision in the patient's medical record, then the in-person 
visit requirement is not applicable for that 12-month period. 
Situations in which the risks and burdens associated with an in-person 
service may outweigh the benefit could include, but are not limited to, 
instances when an in-person service is likely to cause disruption in 
service delivery or has the potential to worsen the patient's 
condition(s) (86 FR 65211).
    After consideration of public comments, we are finalizing our 
proposal to make conforming regulatory text changes based on CAA, 2023 
to the applicable RHC and FQHC regulations in 42 CFR part 405, subpart 
X, specifically, at Sec.  405.2463, ``What constitutes a visit,'' we 
are finalizing revisions to paragraph (b)(3) and, at Sec.  405.2469 
``FQHC supplemental payments,'' we are finalizing revisions

[[Page 79067]]

to paragraph (d) to include the delay of the in-person requirements for 
mental health visits furnished by RHCs and FQHCs through 
telecommunication technology under Medicare beginning January 1, 2025, 
as proposed.
b. Direct Supervision via Use of Two-way Audio/Video Communications 
Technology
    In the CY 2024 PFS proposed rule (88 FR 52397), we discussed direct 
supervision. Under Medicare Part B, certain types of services are 
required to be furnished under specific minimum levels of supervision 
by a physician or practitioner. See section II.D.2.a. for the 
discussion regarding direct supervision for services under the PFS. For 
RHCs and FQHCs, services and supplies furnished incident to physician's 
services are limited to situations in which there is direct physician 
supervision of the person performing the service, except for certain 
care management services which may be furnished under general 
supervision (Sec.  405.2415(a)(5)). The ``incident to'' policy for RHCs 
and FQHCs is discussed in Pub. 100-02, chapter 13, section 120.1. 
Similar to physician services paid under the PFS, outside the 
circumstances of the PHE, direct supervision of RHC and FQHC services 
does not require the physician to be present in the same room. However, 
the physician must be in the RHC or FQHC and immediately available to 
provide assistance and direction throughout the time the incident to 
service or supply is being furnished to a beneficiary.
    In the CY 2024 PFS proposed rule, we explained that during the 
COVID-19 PHE, the modifications that we made to the regulatory 
definition of direct supervision for services paid under the PFS were 
also applicable to RHCs and FQHCs. We explained in the April 6, 2020 
IFC that given the circumstances of the PHE for the COVID-19 pandemic, 
we recognized that in some cases, the physical proximity of the 
physician or practitioner might present additional exposure risks, 
especially for high risk patients isolated for their own protection or 
cases where the practitioner has been exposed to the virus but could 
otherwise safely supervise from another location using 
telecommunications technology. We believed that the same concerns 
existed for RHCs and FQHCs. In the April 6, 2020 IFC, we allowed the 
supervising professional to be immediately available through virtual 
presence using two-way, real time audio-visual technology, instead of 
requiring their physical presence (85 FR 19245 and 19246).\173\ When 
discussing direct supervision in RHCs and FQHCs, we noted that in 
general, we have modified the requirements for direct supervision to 
include the use of a virtual supervisory presence through the use of 
interactive audio and video telecommunications technology.\174\
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    \173\ https://www.govinfo.gov/content/pkg/FR-2020-04-06/pdf/2020-06990.pdf.
    \174\ https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf.
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    We also explained that we believed that extending this definition 
of direct supervision for RHCs and FQHCs through December 31, 2024, 
would align the timeframe of this policy with many of the previously 
discussed PHE-related telehealth policies that were extended under 
provisions of the CAA, 2023 and we were concerned about an abrupt 
transition to the pre-PHE policy of requiring the physical presence of 
the supervising practitioner beginning after December 31, 2023, given 
that RHCs and FQHCs have established new patterns of practice during 
the PHE for COVID-19. We also believed that RHCs and FQHCs will need 
time to reorganize their practices established during the PHE to 
reimplement the pre-PHE approach to direct supervision without the use 
of audio/video technology. For RHCs and FQHCs, we proposed to continue 
to define ``immediate availability'' as including real-time audio and 
visual interactive telecommunications through December 31, 2024.
    In the absence of evidence that patient safety is compromised by 
virtual direct supervision, we stated that we believe that an immediate 
reversion to the pre-PHE definition of direct supervision may present a 
barrier to access services, such as those furnished incident-to a 
physician's service. Therefore, we solicited comments on whether we 
should consider extending the definition of ``direct supervision'' to 
permit virtual presence beyond December 31, 2024. We explained that 
when compared to professionals paid under the PFS, RHCs and FQHCs have 
a different model of care and payment structure. Therefore, we 
solicited comments from interested parties on potential patient safety 
or quality concerns when direct supervision occurs virtually in RHCs 
and FQHCs; for instance, if certain types of services are more or less 
likely to present patient safety concerns, or if this flexibility would 
be more appropriate when certain types of auxiliary personnel are 
performing the supervised service. We were also interested in potential 
program integrity concerns such as overutilization or fraud and abuse 
that interested parties may have in regard to this policy.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: All commenters supported extending the definition of 
direct supervision to permit virtual presence beyond December 31, 2024. 
Commenters noted that they believe direct supervision has become 
increasingly challenging and the option to provide virtual direct 
supervision has enhanced the quality and provision of healthcare 
services beneficiaries have received in medically underserved, rural 
communities. They also noted using audio-visual technology for 
supervision during the COVID-19 PHE did not create significant clinical 
safety concerns and subsequent formal assessments will confirm the 
safety of virtual direct supervision. As workforce challenges exist and 
are pronounced in some of their rural communities, commenters believe 
this allows RHCs and FQHCs to have a larger community presence, 
including longer hours or more days, and stated that they may not be 
able to maintain these schedules if a physical presence for direct 
supervision is required. Commenters stated that virtual direct 
supervision facilitates timely access to services that on-site 
personnel could effectively deliver.
    Response: We appreciate the commenters' support of extending the 
definition of direct supervision to permit virtual presence in RHCs and 
FQHCs though December 31, 2024. With regard to extending this 
flexibility past December 31, 2024, we may address in future 
rulemaking. We also appreciate the positive feedback received from 
commenters regarding any potential patient safety, quality, or program 
integrity concerns when direct supervision occurs virtually in RHCs and 
FQHCs.
    After consideration of public comments, we are finalizing our 
proposal to extend the definition of direct supervision to permit 
virtual presence in RHCs and FQHCs through December 31, 2024.
c. Section 4121 of the CAA, 2023
    Section 1861(aa) of the Act provides authority under Medicare Part 
B to cover and pay for RHC and FQHC services. Section 1861(aa)(1) of 
the Act defines these services as those furnished by physicians, 
physician assistants, nurse practitioners, nurse-midwives, qualified 
clinical psychologists, clinical social workers, and services and 
supplies furnished incident to

[[Page 79068]]

professional services of these practitioners. The conforming regulation 
text to these provisions are provided in 42 CFR part 405, subpart X 
where we define RHC and FQHC visits as face-to-face encounters between 
a patient and one or more RHC or FQHC practitioners during which one or 
more RHC or FQHC qualifying services are furnished.
    Before passage of CAA, 2023, there was no separate benefit category 
under the statute that recognized the professional services of licensed 
marriage and family therapists (MFTs) or mental health counselors 
(MHCs). As discussed in the CY 2023 PFS final rule (87 FR 69546), 
payment for MFTs was only made under the PFS indirectly when an MFT or 
MHC performed services as auxiliary personnel incident to the services 
of a physician or other practitioner and under general supervision. 
This was also true for RHCs and FQHCs, in that MFTs and MHCs were 
considered auxiliary personnel and the services they provided were 
considered incident to the services of the RHC or FQHC practitioner 
(Sec.  405.2413).
    Section 4121 of Division FF, Title IV, Subtitle C of the CAA, 2023, 
entitled ``Coverage of Marriage and Family Therapist Services and 
Mental Health Counselor Services under Part B of the Medicare 
Program'', amended section 1861(s)(2) of the Act to establish coverage 
of MFT and MHC services (section 1861(s)(2)(II) of the Act). We noted 
that section II.J. of this final rule provides a detailed discussion of 
the provisions in section 4121(a) of CAA, 2023 including the authority 
for coverage of MFT and MHC services, definitions of these 
professionals and their services, and payment under the PFS. Section 
4121(b) of CAA, 2023 amended section 1861(aa)(1)(B) of the Act by 
extending the scope of RHC services to include those furnished by MFTs 
and MHCs as eligible for payment, which is incorporated into FQHC 
services through section 1861(aa)(3)(A) of the Act. We proposed to 
codify payment provisions for MFTs and MHCs under 42 CFR part 405, 
subpart X beginning January 1, 2024. That is, RHC and FQHCs will be 
paid under the RHC AIR and FQHC prospective payment system (PPS), 
respectively, when MFTs and MHCs furnished RHC and FQHC services 
defined in Sec. Sec.  405.2411 and 405.2446. As eligible RHC and FQHC 
practitioners, MFTs and MHCs will follow the same policies and 
supervision requirements as a PA, NP, CNM, CP, and CSW.
    In addition, as discussed in section II.J. of this final rule, we 
proposed to allow addiction counselors that meet all of the applicable 
requirements to enroll in Medicare as MHCs. Therefore, to remain 
consistent with payment policies for professionals billing Medicare 
under the PFS, we proposed that the definitions established for MFTs 
and MHCs under the PFS would also apply for RHCs and FQHCs. In the CY 
2023 PFS final rule (87 FR 69735 through 69737), we discussed the 
coding and payment for HCPCS code G0323 which describes general BHI 
services performed by CPs and CSWs under the PFS. We noted CPs and CSWs 
are statutorily authorized to furnish services in RHCs and FQHCs under 
sections 1861(aa)(1) and (3) of the Act, respectively, and as described 
by Sec.  405.2411(a)(6). We also explained, the payment rate for HCPCS 
code G0323 is based on the payment rate for the current general BHI 
code, 99484. Therefore, in the CY 2023 PFS final rule (87 FR 69737) we 
clarified that when CPs and CSWs provide the services described in 
HCPCS code G0323 in an RHC or FQHC, the RHC or FQHC can bill HCPCS code 
G0511. We further stated RHCs and FQHCs that furnish general BHI 
services are able to bill for this service using HCPCS code G0511, 
either alone or with other payable services on an RHC or FQHC claim for 
dates of service on or after January 1, 2023.
    We noted that in section II.J. of this final rule, we proposed to 
revise the code descriptor for HCPCS code G0323 in order to allow MFTs 
and MHCs, as well as CPs and CSWs, to be able to bill for this monthly 
care integration service. Since MFTs and MHCs are statutorily 
authorized to furnish services in RHCs and FQHCs effective January 1, 
2024, we proposed to clarify that when MFTs and MHCs provide the 
services described in HCPCS code G0323 in an RHC or FQHC, the RHC or 
FQHC can bill for this service using HCPCS code G0511. We believe that 
this policy aligns with our efforts to be consistent with new services 
that are proposed for practitioners billing under the PFS.
    We proposed to make several conforming regulatory changes to 
applicable RHC and FQHC regulations in 42 CFR part 405, subpart X, 
specifically:
     At Sec.  405.2401, Scope and definitions, we proposed to 
amend the section to add definitions for MFT and MHC;
     At Sec.  405.2411, Scope of benefits, we proposed to amend 
the section to include MFT and MHC where other RHC and FQHC 
practitioners are stated;
     At Sec.  405.2415, Incident to services and direct 
supervision, we proposed to amend the section to include MFT and MHC 
where other RHC and FQHC practitioners are stated;
     At Sec.  405.2446, Scope of services, we proposed to amend 
the section to include MFT and MHC services to the scope of services;
     At Sec.  405.2448, Preventive primary services, we 
proposed to amend the section to include MFT and MHC where other RHC 
and FQHC practitioners are stated;
     At Sec.  405.2450, Clinical psychologist and clinical 
social worker services, we proposed to amend the section title to add 
MFT and MHC and include MFT and MHC where other RHC and FQHC 
practitioners are stated;
     At Sec.  405.2452, Services and supplies incident to 
clinical psychologist and clinical social worker services, we proposed 
to amend the section title to add MFT and MHC and include MFT and MHC 
where other RHC and FQHC practitioners are stated;
     At Sec.  405.2463, What constitutes a visit, we proposed 
to amend the section to add MFT and MHC to the list of eligible 
practitioners; and
     At Sec.  405.2468, Allowable costs, we proposed to amend 
the section to add MFTs and MHCs where other RHC and FQHC practitioners 
are listed.
    We received many comments on section 4121 of the CAA, 2023. The 
following is a summary of the comments we received and our responses.
    Comment: Overall, commenters supported the proposals related to 
MFTs and MHCs. Commenters stated that health centers commonly employ 
LMHCs and LMFTs to expand their behavioral health services and that the 
proposed regulatory changes will enable health centers to maximize 
their workforce to meet their patients' needs. Another commenter 
suggested that CMS use the definition of MHC that would include all 
appropriately trained and qualified health professionals currently 
licensed by States or recognized by the National Health Services Corps 
(NHSC).
    Response: We thank the commenters for their support. Regarding 
licensure, we note that while section 1861(lll)(4) of the Act 
establishes the term ``Mental Health Counselor,'' this statutory 
benefit category also includes those who are licensed or certified as a 
clinical professional counselor or, as a professional counselor by the 
State in which the services are furnished to qualify as a mental health 
counselor along with the individuals who are licensed or certified by 
the State as a mental health counselor. Additionally, we proposed and 
are finalizing our provisons to allow addiction counselors who meet all 
applicable requirements to enroll as MHCs. In response to the

[[Page 79069]]

comments received on the variation in nomenclature used across States 
for mental health counselors, we clarify that mental health 
practitioners who meet all of the applicable statutory qualifications 
for the mental health counselor benefit category but are licensed by 
their State under a different title, are eligible to enroll in Medicare 
under the Part B ``Mental Health Counselor'' statutory benefit 
category. We refer to the discussion in section II.J of this final rule 
for more information.
    Comment: One commenter requested that CMS confirm that MFTs and 
MHCs will not be subjected to a productivity standard as is required 
for physicians, NPs, PAs, and CNMs in the RHC setting.
    Response: We thank the commenter for raising this issue. As 
described in the Medicare Benefit Policy Manual, Chapter 13, Section 
80.4, ``RHC Productivity Standards'', ``productivity standards are used 
to help determine the average cost per patient for Medicare 
reimbursement in RHCs. The current productivity standards require 4,200 
visits per full-time equivalent physician and 2,100 visits per full-
time equivalent non-physician practitioner (NP, PA, or CNM)''. 
Additionally, in the Form CMS 222-17, Worksheet B, Part I of the 
Independent RHC Cost Report, and Form CMS-2552-10, Hospital and 
Hospital Care Complex Cost Report, Worksheet M-3, productivity standard 
information is entered for physician, PA, NP, and CNM. Productivity 
standards are not in place for RN, LPN, CP, or CSWs. As discussed in 
this rule, MFTs and MHCs are mental health practitioners and more 
closely aligned with CPs and CSWs and as such we believe that the 
productivity standards also do not apply to MFTs and MHCs.
    Comment: Some commenters requested that CMS consider the inclusion 
of Certified Community Behavioral Health Centers (CCBHCs) in the 
Medicare program, which they stated would offer incredible value to 
beneficiaries. While CCBHCs are not a specific provider type in 
Medicare, CCBHCs are required to establish care coordination with 
entities such as with FQHCs and RHCs. Given this pre-existing 
relationship, the overlap for MFT and MHC services that could be 
furnished in either location, and because behavioral health services 
are optional at FQHCs, advancing a relationship and partnership through 
these entities in the Medicare program could be a point for CMS' 
further exploration as efforts to improve behavioral health care for 
beneficiaries' advance.
    Response: New provider types must be authorized by statute; CMS 
does not have the authority to create new provider types. We did not 
propose adding CCBHCs as a provider type for Medicare, and therefore, 
this comment is out of scope.
    Comment: Some commenters recommended CMS consider broadening the 
FQHC mental health visit by adding health and behavior assessment and 
intervention services (HBAI) codes to the Medicare FQHC mental health 
visit.
    Response: Currently, HBAI services are covered services and can be 
furnished in an FQHC, but they do not qualify as stand-alone billable 
visits in a FQHC. That is, if an HBAI service is furnished during a 
FQHC qualifying visit, the service(s) are included in the visit. Since 
we did not make any proposals related to updates to the FQHC qualifying 
visit list and we note that there are recent coding changes for HBAI 
services, we wish to consider this topic further.
    After consideration of public comments, we are finalizing our 
proposal as proposed to codify payment provisions for MFTs and MHCs 
under 42 CFR part 405, subpart X beginning January 1, 2024. That is, 
RHC and FQHCs will be paid under the RHC AIR and FQHC PPS, 
respectively, when MFTs and MHCs furnish RHC and FQHC services defined 
in Sec. Sec.  405.2411 and 405.2446. As eligible RHC and FQHC 
practitioners, MFTs and MHCs should follow the same policies and 
supervision requirements as a PA, NP, CNM, CP, and CSW.
    In addition, we are finalizing as proposed a provision to allow 
addiction counselors that meet all of the applicable requirements of 
clinical supervised experience in mental health counseling, and that 
are licensed or certified as MHCs, clinical professional counselors, or 
professional counselors by the State in which the services are 
furnished) to enroll in Medicare as MHCs. In remaining consistent with 
payment policies for professionals billing Medicare under the PFS, we 
are also finalizing as proposed a provision applying the definitions 
established for MFTs and MHCs under the PFS to RHCs and FQHCs. Since 
MFTs and MHCs are statutorily authorized to furnish services in RHCs 
and FQHCs effective January 1, 2024, we are finalizing as proposed the 
clarification that when MFTs and MHCs provide the services described in 
HCPCS code G0323 in an RHC or FQHC, the RHC or FQHC can bill HCPCS code 
G0511. Finally, we are finalizing as proposed several conforming 
regulatory changes to applicable RHC and FQHC regulations in 42 CFR 
part 405, subpart X, specifically, Sec. Sec.  405.2401, 405.2411, 
405.2415, 405.2446, 405.2448, 405.2450, 405.2452, 405.2463, and 
405.2468.
d. Section 4124 of the Consolidated Appropriations Act, 2023
    Section 4124 of Division FF of the CAA, 2023 establishes coverage 
and payment under Medicare for the Intensive Outpatient Program (IOP) 
benefit, effective January 1, 2024. IOP may be furnished by hospitals, 
Community Mental Health Centers (CMHCs), FQHCs and RHCs. Payment for 
IOP services furnished by RHCs and FQHCs is to be made at the same 
payment rate as if it were furnished by a hospital.
    In addition to existing mental health services furnished by RHCs 
and FQHCs, this new provision establishes coverage for IOP services 
furnished in RHCs and FQHCs and includes occupational therapy, family 
counseling, beneficiary education, diagnostic services and individual 
and group therapy.
    Please see section VIII.F. of the CY 2024 Hospital Outpatient 
Prospective Payment System and the Ambulatory Surgical Center payment 
system final rule with comment for discussion of the new IOP scope of 
benefits, requirements, physician certification, and payment policies.
3. Updates to Supervision Requirements for Behavioral Health Services 
Furnished at RHCs and FQHCs
    In the CY 2023 PFS final rule (87 FR 69545 through 69548), we 
amended the direct supervision requirement under the ``incident to'' 
regulations for services payable under the PFS to allow behavioral 
health services to be furnished under the general supervision of a 
physician or non-physician practitioner (NPP) when these services or 
supplies are provided by auxiliary personnel incident to the services 
of a physician or NPP. Several commenters expressed support for CMS 
allowing behavioral health services to be furnished under general 
supervision in the RHC and FQHC settings in addition to services paid 
under the PFS. In response to the public comments, we noted that for CY 
2023, the proposed change to the level of supervision for ``incident 
to'' behavioral health services from direct to general was applicable 
only to services payable under the PFS, as services furnished in the 
RHC and FQHC settings were not addressed in the relevant proposal in 
the CY 2023 PFS proposed rule (87 FR 46062 through 46068). We stated we 
may consider changes to the regulations regarding services furnished at 
RHCs and FQHCs in the future.

[[Page 79070]]

    Currently, behavioral health services furnished in the RHC and FQHC 
settings require direct supervision. However, in order to be more 
consistent with applicable policies under the PFS, for CY 2024, we 
proposed to change the required level of supervision for behavioral 
health services furnished ``incident to'' a physician or NPP's services 
at RHCs and FQHCs to allow general supervision, rather than direct 
supervision, consistent with the policies finalized under the PFS for 
CY 2023. Accordingly, we proposed to revise the regulations at 
Sec. Sec.  405.2413 and 405.2415 to reflect that behavioral health 
services can be furnished under general supervision of the physician 
(or other practitioner) when these services or supplies are provided by 
auxiliary personnel incident to the services of a physician (or another 
practitioner). Additionally, as discussed in the CY 2023 PFS final rule 
(87 FR 69547), we noted that at Sec.  410.26(a)(1) we define 
``auxiliary personnel'' as any individual who is acting under the 
supervision of a physician (or other practitioner), regardless of 
whether the individual is an employee, leased employee, or independent 
contractor of the physician (or other practitioner) or of the same 
entity that employs or contracts with the physician (or other 
practitioner), has not been excluded from the Medicare, Medicaid and 
all other Federally-funded health care programs by the Office of 
Inspector General or had his or her Medicare enrollment revoked, and 
meets any applicable requirements to provide incident to services, 
including licensure, imposed by the State in which the services are 
being furnished.
    We received a few comments on our proposal to update the 
supervision requirements for behavioral health services furnished in 
RHCs and FQHCs. The following is a summary of the comments we received 
and our responses.
    Comment: Commenters were overwhelmingly supportive of our proposal 
to change the required level of supervision for behavioral health 
services furnished in RHCs and FQHCs ``incident to'' a physician or 
NPP's services to general supervision rather than direct supervision. 
Commenters stated that these revisions are necessary to ensure FQHCs 
can bill ``incident to'' services furnished by auxiliary personnel on 
the cost report and that the provision will help better meet the health 
needs of vulnerable patient populations.
    Response: We appreciate the commenters' support of our proposal.
    After consideration of public comments, we are finalizing our 
proposal to revise the regulations at Sec. Sec.  405.2413 and 405.2415 
to reflect that behavioral health services can be furnished under 
general supervision of the physician (or other practitioner) when these 
services or supplies are provided by auxiliary personnel incident to 
the services of a physician (or another practitioner), as proposed.
4. General Care Management Services in RHCs and FQHCs
a. Background
    We have been engaged in a multi-year examination of coordinated and 
collaborative care services in professional settings, and as a result 
established codes and separate payment in the PFS to independently 
recognize and pay for these important services. The care coordination 
included in services, such as office visits, do not always adequately 
describe the non-face-to-face care management work involved in primary 
care. Payment for office visits may not reflect all the services and 
resources required to furnish comprehensive, coordinated care 
management for certain categories of beneficiaries, such as those who 
are returning to a community setting following discharge from a 
hospital or skilled nursing facility (SNF) stay.
    As we discussed in the CY 2016 PFS final rule (80 FR 71081 through 
71088), to address the concern that the non-face-to-face care 
management work involved in furnishing comprehensive, coordinated care 
management for certain categories of beneficiaries is not adequately 
paid for as part of an office visit, beginning on January 1, 2015, 
practitioners billing under the PFS are paid separately for CCM 
services when CCM service requirements are met. We explained that RHCs 
and FQHCs cannot bill under the PFS for RHC or FQHC services and 
individual practitioners working at RHCs and FQHCs cannot bill under 
the PFS for RHC or FQHC services while working at the RHC or FQHC. 
Although many RHCs and FQHCs pay for coordination of services within 
their own facilities and may sometimes help to coordinate services 
outside their facilities, the type of structured care management 
services that are now payable under the PFS for patients with multiple 
chronic conditions, particularly for those who are transitioning from a 
hospital or SNF back into their communities, are generally not included 
in the RHC or FQHC payment. Therefore, separate payment was established 
in the CY 2016 PFS final rule (80 FR 71080 through 71088) for RHCs and 
FQHCs that furnish CCM services. We believe the non-face-to-face time 
required to coordinate care is not captured in the RHC AIR or the FQHC 
PPS payment, particularly for the rural and/or low-income populations 
served by RHCs and FQHCs. Allowing separate payment for CCM services in 
RHCs and FQHCs is intended to reflect the additional resources 
necessary for the unique components of CCM services.
    In the CY 2018 PFS final rule (82 FR 53169 and 53180), we finalized 
revisions to the payment methodology for CCM services furnished by RHCs 
and FQHCs and established requirements for general Behavioral Health 
Integration (BHI) and psychiatric Collaborative Care Management (CoCM) 
services furnished in RHCs and FQHCs, beginning on January 1, 2018. We 
also initiated the use of HCPCS code G0511, a General Care Management 
code for use by RHCs or FQHCs when at least 20 minutes of qualified CCM 
or general BHI services are furnished to a patient in a calendar month. 
In the CY 2019 PFS final rule (83 FR 59683), we explained for CY 2018 
the payment amount for HCPCS code G0511 was set at the average of the 3 
national non-facility PFS payment rates for the CCM and general BHI 
codes and updated annually based on the PFS amounts. That is, for CY 
2018 the 3 codes that comprised HCPCS code G0511 were CPT code 99490 
(20 minutes or more of CCM services), CPT code 99487 (60 minutes or 
more of complex CCM services), and CPT code 99484 (20 minutes or more 
of BHI services).
    We also explained that another CCM code was introduced for 
practitioners billing under the PFS, CPT code 99491, which would 
correspond to 30 minutes or more of CCM furnished by a physician or 
other qualified health care professional and is similar to CPT codes 
99490 and 99487 (83 FR 56983). Therefore, for RHCs and FQHCs, we added 
CPT code 99491 as a general care management service and included it in 
the calculation of HCPCS code G0511. Starting on January 1, 2019, RHCs 
and FQHCs were paid for HCPCS code G0511 based on the average of the 
national non-facility PFS payment rates for CPT codes 99490, 99487, 
99484, and 99491 (83 FR 59687).
    In the CY 2021 PFS final rule (85 FR 84697 through 84699), we 
explained that the requirements described by the codes for Principal 
Care Management (PCM) services were similar to the requirements for the 
services described by HCPCS code G0511; therefore, we added HCPCS codes 
G2064 and G2065 to HCPCS code G0511 as general care management services 
for RHCs and FQHCs. Consequently, effective January

[[Page 79071]]

1, 2021, RHCs and FQHCs are paid when a minimum of 30 minutes of 
qualifying PCM services are furnished during a calendar month. The 
payment rate for HCPCS code G0511 for CY 2021 was the average of the 
national non-facility PFS payment rate for the RHC and FQHC care 
management and general behavioral health codes (CPT codes 99490, 99487, 
99484, and 99491), and PCM codes (HCPCS codes G2064 and G2065). We 
noted that in the CY 2022 PFS final rule (86 FR 65118), HCPCS codes 
G2064 and G2065 were replaced by CPT codes 99424 and 99435. Therefore, 
for CY 2022 the payment rate for HCPCS code G0511 was the average of 
the national non-facility PFS payment rate for CPT codes 99490, 99487, 
99484, 99491, 99424, and 99425).
    Most recently, in the CY 2023 PFS final rule (87 FR 69735 through 
69737), we included Chronic Pain Management (CPM) services described by 
HCPCS code G3002 in the general care management HCPCS code G0511 when 
at least 30 minutes of qualifying non-face-to-face CPM services are 
furnished during a calendar month. We explained since HCPCS code G3002 
is valued using a crosswalk to the PCM CPT code 99424, which is 
currently one of the CPT codes that comprise HCPCS code G0511, there 
was no change made to the average used to calculate the HCPCS code 
G0511 payment rate to reflect CPM services.
    Additional information on care management requirements is available 
on the CMS Care Management web page at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Care-Management.html 
and on the CMS RHC and FQHC web pages at https://www.cms.gov/Center/Provider-Type/Rural-Health-Clinics-Center.html and https://www.cms.gov/Center/Provider-Type/Federally-Qualified-Health-Centers-FQHC-Center.html.
b. Remote Physiologic Monitoring (RPM) and Remote Therapeutic 
Monitoring (RTM) Services Furnished in RHCs and FQHCs
    In recent years under the PFS, we have finalized payment for five 
CPT codes in the RPM code family. RPM services include the collection, 
analysis, and interpretation of digitally collected physiologic data, 
followed by the development of a treatment plan, and the managing of a 
patient under the treatment plan (84 FR 62697). Within the suite of 
services that comprise RPM, there is a CPT code that describes the 
initial set-up and patient education on use of the equipment that 
stores the physiologic data.
    After analyzing and interpreting a patient's remotely collected 
physiologic data, we noted that the next step in the process of RPM is 
the development of a treatment plan that is informed by the analysis 
and interpretation of the patient's data. It is at this point that the 
physician or other practitioner develops a treatment plan with the 
patient and/or caregiver (that is, develops a patient-centered plan of 
care) and then manages the plan until the targeted goals of the 
treatment plan are attained, which signals the end of the episode of 
care.
[GRAPHIC] [TIFF OMITTED] TR16NO23.044

    Remote Therapeutic Monitoring (RTM) is a family of five codes 
finalized for Medicare payment in the CY 2022 PFS final rule (86 FR 
65114 through 65117). RTM services involve remote monitoring of 
respiratory system status, musculoskeletal status, therapy adherence, 
or therapy response. There is also a CPT code that describes the 
initial set-up and patient education on use of the equipment that 
stores the physiologic data within the suite of services that comprise 
RTM.

[[Page 79072]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.045

    As discussed in the CY 2024 PFS proposed rule (88 FR 52401), RPM 
and RTM services are not stand-alone billable visits in RHCs and FQHCs. 
When these services are furnished incident to an RHC or FQHC visit, 
payment is included in the RHC's AIR subject to a payment-limit or the 
per visit payment under the FQHC PPS which is the lesser of the PPS 
rate or the FQHC's actual charges.
    In recent years, we have updated RHC and FQHC policies to improve 
payment for care management and coordination. We have provided a 
separate payment to RHCs and FQHCs in addition to the billable visit in 
part for monthly care management and behavioral health integration 
codes, as described in the general care management code, HCPCS code 
G0511, because these are inherently non-face-to-face services that may 
not be accounted for in the per-visit payment for an in-person 
encounter.
    RHCs and FQHCs have inquired about receiving a separate payment for 
RTM and RPM services. They have stated that CMS should expand HCPCS 
code G0511 to include RPM treatment management services to provide 
Medicare beneficiaries in rural and underserved areas access to these 
services or establish G-codes to reimburse RHCs and FQHCs for RPM set-
up and patient education on use of equipment (CPT code 99453) and 
monthly data transmission (CPT code 99554) and do not believe that 
these services are captured in the RHC AIR or FQHC PPS and as such are 
impeding access to these services.
    Therefore, upon further review and in line with our thinking about 
non-face-to-face services previously, we proposed to include the CPT 
codes that are associated with the suite of services that comprise RPM 
and RTM in the general care management HCPCS code G0511 when these 
services are furnished by RHCs and FQHCs since the requirements for RPM 
and RTM services are similar to the non-face-to-face requirements for 
the general care management services furnished in RHCs and FQHCs. We 
explained that allowing a separate payment for RPM and RTM services in 
RHCs and FQHCs is intended to reflect the additional resources 
necessary for the unique components of these services.
    We explained in the CY 2024 proposed rule, that the care 
coordination included in services, such as office visits, does not 
always adequately describe the non-face-to-face care management work 
involved in primary care. Payment for in-person encounters may not 
reflect all the services and resources required to furnish 
comprehensive, coordinated care management. As RPM and RTM services are 
described, particularly, collection and transmission of data and then 
further analysis and interpretation of the data are happening outside 
of the face-to-face visit. RPM and RTM also have principles which are 
consistent with other care management principles, such as, an 
established patient-physician relationship is required, patient consent 
is required at the time that RPM services are furnished, and services 
allow the monitoring of acute conditions and chronic conditions. We 
noted that under the proposal, RPM and RTM services must be medically 
reasonable and necessary, meet all requirements, and not be duplicative 
of services paid to RHCs and FQHCs under the general care management 
code for an episode of care in a given calendar month. As such, we 
proposed that RHCs and FQHCs that furnish RPM and RTM services would be 
able to bill these services using HCPCS code G0511, either alone or 
with other payable services on an RHC or FQHC claim for dates of 
service on or after January 1, 2024.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: All commenters expressed support for our proposal to allow 
RHCs and FQHCs to bill separately for RPM and RTM services. Commenters 
noted they believe allowing RHCs and FQHCs to bill RPM and RTM codes 
outside of the all-inclusive rate or prospective payment systems would 
prevent disparities in care. Commenters also noted the ability to bill 
separately for RPM and RTM services will empower RHCs and FQHCs to 
leverage remote monitoring technologies effectively, ensuring better 
patient outcomes and more efficient healthcare delivery, expanding 
access to innovative care models and improving patient engagement and 
self-management.
    Response: We appreciate the commenters' support of allowing RHCs 
and FQHCs to bill separately for RPM and RTM services.

[[Page 79073]]

    Comment: Some commenters stated that adding RPM and RTM services to 
the general care management code is not sustainable or equitable and 
would like CMS to create a separate code(s) for RPM and RTM services 
that can be billed outside of the RHC AIR or FQHC PPS. Commenters noted 
the proposed payment methodology for HCPCS code G0511 does not fully 
reflect the costs of providing RPM and RTM services in the RHC and FQHC 
settings and requested that CMS modify the reimbursement rate to match 
the national average payment rates for comparable RPM and RTM services 
under the PFS, which would better reflect the complexity of delivering 
RPM and RTM services.
    Response: As we discuss in more detail later, in the CY 2024 
proposed rule, we proposed a revised methodology for the calculation of 
HCPCS code G0511 by analyzing the actual utilization of the services 
using a weighted average of the services that comprise HCPCS code 
G0511. Regarding separate coding and a separate calculation of RPM and 
RTM services, we note that the non-facility rates of the codes 
describing RPM and RTM range from $43.04 to $133.18. As shown in Table 
27, the utilization of the CPT codes with the higher reimbursement 
rates tend to be much lower than the CPT codes with the lower 
reimbursement rates. When we take into account the utilization of all 
the services that comprise HCPCS code G0511, the weighted average is 
$72.98. We believe RPM and RTM services fall squarely into the rate for 
G0511.
    We believe allowing a separate payment for these services along 
with our revised methodology for calculating the rate for G0511 will 
provide adequate payment and support access to these services; however, 
we plan to continue to monitor and explore other options for future 
rulemaking to address any sustainability and efficiencies of these 
policies.
    After consideration of public comments, we are finalizing as 
proposed to add the suite of services that comprise RPM and RTM 
services to the general care management code, G0511 beginning January 
1, 2024 as the requirements for RPM and RTM services are similar to the 
non-face-to-face requirements for the general care management services 
furnished in RHCs and FQHCs.
c. Services Addressing Health-Related Social Needs: Community Health 
Integration Services and Principal Illness Navigation Services
(1) Background
    As discussed in the CY 2024 PFS proposed rule (88 FR 52401), in 
recent years, we have sought to recognize significant changes in health 
care practice and have been engaged in an ongoing, incremental effort 
to identify gaps in appropriate coding and payment for care management/
coordination and primary care services under the PFS (see section 
II.E.4.(27) for the discussion regarding these services under the PFS). 
In congruence with services paid under the PFS, we have similarly 
provided separate payment for transitional care management services, 
chronic care management services, and behavioral health care management 
services to improve payment accuracy to better recognize resources 
involved in care management and coordination for certain patient 
populations. In this effort to improve payment accuracy for care 
coordination in RHCs and FQHCs, in the CY 2024 PFS proposed rule we 
stated we are exploring ways to better identify the resources for 
helping patients with serious illnesses navigate the healthcare system 
or removing health-related social barriers that are interfering with 
their ability to execute a medically necessary plan of care. RHCs and 
FQHCs sometimes obtain information about and help address, social 
determinants of health (SDOH) that significantly impact their ability 
to diagnose or treat a patient. The CPT E/M Guidelines defined SDOH as, 
``Economic and social conditions that influence the health of people 
and communities. Examples may include food or housing insecurity. 
Additionally, RHCs and FQHCs sometimes help newly diagnosed cancer 
patients and other patients with similarly serious, high-risk illnesses 
navigate their care, such as helping them understand and implement the 
plan of care, locate and reach the right practitioners and providers to 
access recommended treatments and diagnostic services, considering the 
personal circumstances of each patient. Payment for these activities, 
to the extent they are reasonable and necessary for the diagnosis and 
treatment of the patient's illness or injury, is currently included in 
the RHC AIR or under the FQHC PPS payment amount for visits and some 
care management services. Medical practice has evolved to increasingly 
recognize the importance of these activities, and we believe RHCs and 
FQHCs are performing them more often.
    However, this work is not explicitly identified in current coding, 
and as such, we believe it is underutilized and undervalued. 
Accordingly, we proposed to create new coding to expressly identify and 
value these services for PFS payment and distinguish them from current 
care management services. Therefore, we considered the new coding for 
purposes of payment to RHCs and FQHCs.
(2) Payment for Community Heath Integration (CHI) Services in RHCs and 
FQHCs
    As discussed in the CY 2024 PFS proposed rule (88 FR 52402), there 
were two new HCPCS codes proposed to describe CHI services performed by 
certified or trained auxiliary personnel, which may include a Community 
Health Worker (CHW), incident to the professional services and under 
the general supervision of the billing practitioner for services paid 
under the PFS. We stated that the requirements for the proposed CHI 
services are similar to the requirements for the general care 
management services furnished by RHCs and FQHCs. As such, we explained 
that we believe the level of care coordination resources required in 
addressing the particular SDOH need(s) that are interfering with, or 
presenting a barrier to, diagnosis or treatment of the patient's 
problem(s) addressed in the CHI initiating visit were not captured in 
the RHC AIR or the FQHC PPS payment, particularly for the rural and/or 
low-income populations served by RHCs and FQHCs. Payment for office 
visits may not reflect all the services and resources involved with CHI 
as described in the proposed HCPCS code below, for example, 
coordination of care, facilitation of access to services, communication 
between settings.
    GXXX1--Community health integration services performed by certified 
or trained auxiliary personnel, including a community health worker, 
under the direction of a physician or other practitioner; 60 minutes 
per calendar month, in the following activities to address social 
determinants of health (SDOH) need(s) that are significantly limiting 
ability to diagnose or treat problem(s) addressed in an initiating E/M 
visit:
     Person-centered assessment, performed to better understand 
the individualized context of the intersection between the SDOH need(s) 
and the problem(s) addressed in the initiating E/M visit.
    ++ Conducting a person-centered assessment to understand patient's 
life story, strengths, needs, goals, preferences and desired outcomes,

[[Page 79074]]

including understanding cultural and linguistic factors.
    ++ Facilitating patient-driven goal-setting and establishing an 
action plan.
    ++ Providing tailored support to the patient as needed to 
accomplish the practitioner's treatment plan.
     Practitioner, Home-, and Community-Based Care Coordination
    ++ Coordinating receipt of needed services from healthcare 
practitioners, providers, and facilities; and from home- and community-
based service providers, social service providers, and caregiver (if 
applicable).
    ++ Communication with practitioners, home- and community-based 
service providers, hospitals, and skilled nursing facilities (or other 
health care facilities) regarding the patient's psychosocial strengths 
and needs, functional deficits, goals, preferences, and desired 
outcomes, including cultural and linguistic factors.
    ++ Coordination of care transitions between and among health care 
practitioners and settings, including transitions involving referral to 
other clinicians; follow-up after an emergency department visit; or 
follow-up after discharges from hospitals, skilled nursing facilities 
or other health care facilities.
    ++ Facilitating access to community-based social services (e.g., 
housing, utilities, transportation, food assistance) to address the 
SDOH need(s).
     Health education--Helping the patient contextualize health 
education provided by the patient's treatment team with the patient's 
individual needs, goals, and preferences, in the context of the SDOH 
need(s), and educating the patient on how to best participate in 
medical decision-making.
     Building patient self-advocacy skills, so that the patient 
can interact with members of the health care team and related 
community-based services addressing the SDOH need(s), in ways that are 
more likely to promote personalized and effective diagnosis or 
treatment.
     Health care access/health system navigation
    ++ Helping the patient access healthcare, including identifying 
appropriate practitioners or providers for clinical care and helping 
secure appointments with them.
     Facilitating behavioral change as necessary for meeting 
diagnosis and treatment goals, including promoting patient motivation 
to participate in care and reach person-centered diagnosis or treatment 
goals.
     Facilitating and providing social and emotional support to 
help the patient cope with the problem(s) addressed in the initiating 
visit, the SDOH need(s), and adjust daily routines to better meet 
diagnosis and treatment goals.
     Leveraging lived experience when applicable to provide 
support, mentorship, or inspiration to meet treatment goals.
    GXXX2--Community health integration services, each additional 30 
minutes per calendar month (List separately in addition to GXXX1).
(3) Payment for Principal Illness Navigation (PIN) Services in RHCs and 
FQHCs
    As discussed in the CY 2024 PFS proposed rule (88 FR 52403), there 
were two new HCPCS codes proposed to describe PIN services for services 
paid under the PFS. These services describe when certified or trained 
auxiliary personnel under the direction of a billing practitioner, 
which may include a patient navigator or certified peer specialist, are 
involved in the patient's health care navigation as part of the 
treatment plan for a serious, high-risk disease expected to last at 
least 3 months, that places the patient at significant risk of 
hospitalization or nursing home placement, acute exacerbation/
decompensation, functional decline, or death. We explained that the 
requirements for the proposed PIN services were also similar to the 
requirements for the general care management services furnished by RHCs 
and FQHCs.
    As such, we explained that we believe the resources required to 
provide the level of care coordination needed for individualized help 
to the patient (and caregiver, if applicable) to identify appropriate 
practitioners and providers for care needs and support, and access 
necessary care timely are not captured in the RHC AIR or the FQHC PPS 
payment, particularly for the rural and/or low-income populations 
served by RHCs and FQHCs. Payment for office visits may not reflect all 
the services and resources involved with PIN as described in the 
proposed HCPCS code below.
    GXXX3--Principal Illness Navigation services by certified or 
trained auxiliary personnel under the direction of a physician or other 
practitioner, including a patient navigator or certified peer 
specialist; 60 minutes per calendar month, in the following activities:
     Person-centered assessment, performed to better understand 
the individual context of the serious, high-risk condition.
    ++ Conducting a person-centered assessment to understand the 
patient's life story, strengths, needs, goals, preferences, and desired 
outcomes, including understanding cultural and linguistic factors.
    ++ Facilitating patient-driven goal setting and establishing an 
action plan.
    ++ Providing tailored support as needed to accomplish the 
practitioner's treatment plan.
     Identifying or referring patient (and caregiver or family, 
if applicable) to appropriate supportive services.
     Practitioner, Home, and Community-Based Care Coordination
    ++ Coordinating receipt of needed services from healthcare 
practitioners, providers, and facilities; home- and community-based 
service providers; and caregiver (if applicable).
    ++ Communication with practitioners, home-, and community-based 
service providers, hospitals, and skilled nursing facilities (or other 
health care facilities) regarding the patient's psychosocial strengths 
and needs, functional deficits, goals, preferences, and desired 
outcomes, including cultural and linguistic factors.
    ++ Coordination of care transitions between and among health care 
practitioners and settings, including transitions involving referral to 
other clinicians; follow-up after an emergency department visit; or 
follow-up after discharges from hospitals, skilled nursing facilities 
or other health care facilities.
    ++ Facilitating access to community-based social services (e.g., 
housing, utilities, transportation, food assistance) as needed to 
address SDOH need(s).
     Health education--Helping the patient contextualize health 
education provided by the patient's treatment team with the patient's 
individual needs, goals, preferences, and SDOH need(s), and educating 
the patient (and caregiver if applicable) on how to best participate in 
medical decision-making.
     Building patient self-advocacy skills, so that the patient 
can interact with members of the health care team and related 
community-based services (as needed), in ways that are more likely to 
promote personalized and effective treatment of their condition.
     Health care access/health system navigation.
    ++ Helping the patient access healthcare, including identifying 
appropriate practitioners or providers for clinical care, and helping 
secure appointments with them.
    ++ Providing the patient with information/resources to consider 
participation in clinical trials or clinical research as applicable.
     Facilitating behavioral change as necessary for meeting 
diagnosis and treatment goals, including promoting

[[Page 79075]]

patient motivation to participate in care and reach person-centered 
diagnosis or treatment goals.
     Facilitating and providing social and emotional support to 
help the patient cope with the condition, SDOH need(s), and adjust 
daily routines to better meet diagnosis and treatment goals.
     Leverage knowledge of the serious, high-risk condition 
and/or lived experience when applicable to provide support, mentorship, 
or inspiration to meet treatment goals.
    GXXX4--Principal Illness Navigation services, additional 30 minutes 
per calendar month (List separately in addition to GXXX3).
    We explained that allowing a separate payment for CHI and PIN 
services in RHCs and FQHCs is intended to reflect the additional time 
and resources necessary for the unique components of care coordination 
services. Therefore, in an effort to have consistency with the new 
services that were being proposed for practitioners billing under the 
PFS, we proposed to include PIN services in the general care management 
HCPCS code G0511 when these services are provided by RHCs and FQHCs.
    We noted that under the proposals to expand the billable services 
under HCPCS code G0511 to include CHI and PIN, each of these services 
must be medically reasonable and necessary, meet all requirements, and 
not be duplicative of services paid to RHCs and FQHCs under the general 
care management code for an episode of care in a given calendar month. 
We expected that our proposal to add the new codes for CHI and PIN to 
the general care management code would also support the CMS pillars 
\175\ for equity, inclusion, and access to care for the Medicare 
population, and improve patient outcomes, including for underserved and 
low-income populations where there is a disparity in access to quality 
care.
---------------------------------------------------------------------------

    \175\ CMS Strategic Plan. https://www.cms.gov/cms-strategic-plan.
---------------------------------------------------------------------------

    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Commenters supported our proposal to allow RHCs and FQHCs 
to bill separately for CHI and PIN services. Commenters noted this will 
allow auxiliary personnel like CHWs to furnish key SDOH interventions 
after an evaluation/management visit and allow RHCs and FQHCs to bill 
for specific care services to patients with high-risk conditions.
    Response: We appreciate the commenters' support of allowing RHCs 
and FQHCs to bill separately for CHI and PIN services.
    Comment: Commenters recommended that CMS consider a standalone 
HCPCS code for CHI and PIN services in RHCs and FQHCs because of the 
potential for increased claim denials for duplicate billing when 
numerous care management services are included in HCPCS code G0511 that 
would potentially require RHCs and FQHCs to bill for more than one care 
management service on the same day for the same beneficiary or 
duplicate claims denied when multiple care management services are 
filed on successive days for the same beneficiary.
    Response: We appreciate the commenter's concerns regarding the 
ability of RHCs and FQHCs to bill for more than one care management 
service per month for the same beneficiary. As we stated in the CY 2024 
PFS proposed rule (88 FR 52403), each of the services included in the 
general care management code must be medically reasonable and 
necessary, meet all requirements, and not be duplicative of services 
paid to RHCs and FQHCs under the general care management code for an 
episode of care in a given calendar month. That is, an RHC or FQHC may 
bill HCPCS code G0511 multiple times in a calendar month as long as all 
requirements are met and there is not double counting. For example, 
RHCs and FQHCs can bill HCPCS code G0511 twice for 20 minutes of 
qualifying CCM services and 30 minutes of qualifying PCM services, as 
long as, the clinical staff minutes do not overlap. Regarding separate 
coding, we believe allowing a separate payment for these services along 
with our revised methodology for calculating the rate for HCPCS code 
G0511 will provide adequate payment and support access to these 
services; however, we plan to continue to monitor and explore other 
options for future rulemaking to address any sustainability and 
efficiencies of these policies.
    Comment: Some commenters stated there should be a provision for 
RHCs and FQHCs to receive additional compensation based on actual time 
spent because CHWs are compensated based on time and not encounters.
    Response: RHCs and FQHCs are paid a per visit amount. We believe 
the commenters concern is being addressed in the revised methodology of 
the calculation for the RHC and FQHC general care management HCPCS code 
G0511 which takes into account the additional time spent in care 
coordination by incorporating all of the applicable add-on codes for 
these services.
    After consideration of public comments and in an effort to be 
consistent with the new services finalized in section II.E.4. of this 
final rule for practitioners billing under the PFS, we are finalizing 
as proposed to include CHI and PIN services in the general care 
management HCPCS code G0511 when these services are provided by RHCs 
and FQHCs. We are also clarifying that RHCs and FQHCs may bill HCPCS 
code G0511 multiple times in a calendar month, as long as all of the 
requirements for each service are met. Finally, we note that the 
placeholder HCPCS codes GXXX1 through GXXX4 that describe CHI and PIN 
services are replaced with HCPCS codes G0019, G0022, G0023, and G0024 
respectively.
    In section II.E.4. of this final rule, we discuss the proposals and 
final policies under the PFS for the SDoH Risk Assessment. In section 
III.S. of this final rule, we discuss proposals and final policies for 
a SDOH Risk Assessment as an optional, additional element of the AWV. 
We received comments from interested parties on how the SDoH Risk 
Assessment will be paid in the RHC and FQHC settings.
    Comment: Commenters supported CMS' proposal to reimburse for an 
SDOH Risk Assessment as part of the Annual Wellness Visit (AWV). Many 
commenters requested clarification on the payment mechanics for the 
SDOH Risk Assessment as an additional element of the AWV in relation to 
the FQHC and RHC bundled payment mechanisms. Commenters also requested 
that we revise Sec.  405.2463(c)(1)(iii) and add the AWV along with the 
initial preventive physical exam as an exception to the FQHC and RHC 
single visit payment when a separate medical or mental health visit is 
made by the patient on the same day. Another commenter also supported 
CMS' proposal to reimburse for the SDOH through the creation of a 
standalone G code under the PFS, but urged CMS to clarify language to 
ensure FQHCs can benefit from this proposal.
    Response: FQHCs and RHCs are currently eligible to furnish the AWV 
and as such, they will also be eligible to furnish a SDOH Risk 
Assessment as an additional element of the AWV. As stated in section 
III.S of this final rule, Medicare will pay 100 percent of the fee 
schedule amount for the SDOH Risk Assessment service (beneficiary cost 
sharing would not be applicable) when this risk assessment is furnished 
to a Medicare beneficiary as an optional element within an AWV (as part 
of the same visit with the same date of service

[[Page 79076]]

as the AWV). This is analogous to the current approach to the ACP 
service, which is an optional service for which beneficiary cost 
sharing is not applicable when furnished as part of the same visit and 
on the same date of service as the AWV. Beneficiary cost sharing is not 
applicable to the AWV and, because the SDOH Risk Assessment will be an 
optional element within the AWV, there will not be any beneficiary cost 
sharing for the SDOH Risk Assessment either when furnished as part of 
the same visit and on the same date of service as the AWV. When ACP is 
furnished as an element of the annual wellness visit (AWV) in an RHC or 
FQHC, only one visit is paid. Maintaining consistency, therefore, when 
SDOH is furnished as an optional element of the AWV, only one visit is 
paid, that is, it will be paid under the AIR or the lesser of charges 
or the PPS rate with the AWV adjustment.
    Consequently, when the SDOH Risk Assessment is furnished with a 
billable visit (other than an AWV) on the same day in an RHC, only the 
visit will be paid under the AIR and coinsurance and deductible will be 
applied. For FQHCs, the SDOH Risk Assessment is not considered a 
qualifying visit. When the assessment is furnished in conjunction with 
a qualifying visit (other than an AWV) on the same day in a FQHC, only 
the visit will be paid under the FQHC PPS and coinsurance will be 
applicable. Additional information on RHC and FQHC billing of the SDoH 
Risk Assessment will be available in subregulatory guidance.
    Regarding the public comments that recommend that Sec.  
405.2463(c)(1)(iii) be revised to add the AWV along with the initial 
preventive physical exam as an exception to the FQHC and RHC single 
visit payment when the patient has a separate medical or mental health 
visit on the same day is out of scope for this rule, this 
recommendation has been informative and we will take it into 
consideration for possible future rulemaking.
d. Proposed Revision to the Calculation of the Payment Amount for the 
General Care Management HCPCS Code G0511
    Currently, HCPCS code G0511 is based on the PFS national average 
non-facility payment rate for each of the services identified as 
billable general care management services. We then add each payment 
rate and divide by the total number of codes to arrive at the payment 
amount for HCPCS code G0511. This payment amount is a flat rate that is 
not subsequently adjusted for locality. As we noted in the CY 2023 PFS 
final rule (87 FR 69735), when determining which services are billable 
under HCPCS code G0511, we do not include the add-on HCPCS codes 
payable under the PFS because RHCs and FQHCs do not pay their 
practitioners based on additional minutes spent by practitioners. 
Instead, we generally include the base codes.
    In the CY 2023 PFS final rule (87 FR 69736), we mentioned that we 
may consider other approaches for calculating the payment rate for 
HCPCS code G0511 as the number of services included in the general care 
management code is growing each year and provided examples. We thought 
to consider in the future valuing HCPCS code G0511 using a weighted 
average of the services that comprise HCPCS code G0511 or using the 
national average of the top three services comprising HCPCS code G0511. 
We welcomed comments on potential methodologies, but noted we did not 
receive any comments.
    As we discussed in the CY 2024 PFS proposed rule (88 FR 52403 
through 52406), we have been engaged in a multi-year examination of 
coordinated and collaborative care services in professional settings, 
and as a result established codes and separate payment in the PFS to 
separately recognize and pay for these important services. The care 
coordination included in services, such as office visits, do not always 
adequately describe the non-face-to-face care management work involved 
in primary care. Payment for in-person encounters may not reflect all 
the services and resources required to furnish comprehensive, 
coordinated care management. Through the last few payment rules, we 
have expanded the general care management services billable using the 
HCPCS code G0511 to be consistent with the policies implemented under 
the PFS.
    In the CY 2024 PFS proposed rule, we noted our proposal to expand 
the billable services under HCPCS code G0511 to include RPM, RTM, CHI, 
and PIN. We explained that if we continue to calculate HCPCS code G0511 
using our current approach, we believed that the value may no longer be 
appropriate payment for those services since we are simply dividing by 
the number of codes that comprise HCPCS code G0511 and as that number 
of services with lower payment rates increases, the value diminishes. 
Therefore, we proposed to revise our method for calculating HCPCS code 
G0511 so that payment for general care management is more appropriate. 
We provided a comparison of our current method to the proposed revised 
approach in the proposed rule and below for ease of reference.
    Based on the current methodology for HCPCS code G0511 as shown in 
Table 25, general care management services are paid at the average of 
the national non-facility PFS payment rates for CPT codes 99490, 99487, 
99484, 99491, 99424 and 99426.
[GRAPHIC] [TIFF OMITTED] TR16NO23.046


[[Page 79077]]


    As shown in Table 26, when we include RPM and RTM services in the 
national non-facility average as discussed above, the payment rate for 
HCPCS code G0511 is reduced to $64.13 based on the national non-
facility PFS payment rates for CY 2023.
[GRAPHIC] [TIFF OMITTED] TR16NO23.047

    As demonstrated by comparing Table 25 to Table 26, using the 
current method of calculating the average of the non-facility rates but 
adding in RPM and RTM services base codes would result in a lower 
payment amount for HCPCS code G0511 compared to the current payment 
amount. We noted our belief that while the policy may address providing 
a payment for furnishing non-face-to-face services, the magnitude of 
the value may not appropriately account for the costs. Therefore, we 
considered and proposed a revised methodology for the calculation by 
looking at the actual utilization of the services. That is, we proposed 
to use a weighted average of the services that comprise HCPCS code 
G0511. In order to use a weighted average, there needed to be data on 
the utilization of the services. We stated we did not have data on 
utilization of the services that comprise HCPCS code G0511 for RHCs and 
FQHCs since HCPCS code G0511 accounts for a variety of services. 
Therefore, we would use the most recently available utilization data 
from the services paid under the PFS, that is, in the physician office 
setting. We explained that we believed that the physician office 
setting provides an appropriate proxy for utilization of these services 
in the absence of actual data because this setting most closely aligns 
with the types of services furnished in RHCs and FQHCs since they 
typically furnish primary care.
    In order to analyze utilization for services paid under the PFS and 
to ensure we accounted for payments accurately, we used CY 2021 claims 
data to look at utilization of the base code for the service and any 
applicable add-on codes used in the same month as well as any base 
codes reported alone in a month for all of the services encompassing 
general care management (that is, the array of services that made up 
HCPCS code G0511). We believed we needed to account for the payment 
associated with the base code along with an applicable add-on code in 
our calculation as this demonstrates a complete encounter. Until actual 
utilization becomes available, RHCs and FQHCs that furnish CPM, GBHI, 
CHI and PIN services would report HCPCS code G0511 when those services 
are furnished; however, they would not be included in the weighted 
average at this time. We stated that once more data is available, we 
will revisit the valuation of HCPCS code G0511 to include CPM, GBHI, 
CHI, and PIN as necessary.
    Table 27 shows the payment amount using the proposed calculation. 
We explained in the proposed rule that the national non-facility 
payment rate associated with each code that comprises HCPCS code G0511 
could be found in Addendum B of the proposed rule. We noted that the 
revised methodology reduces the payment rate for HCPCS code G0511 from 
its current rate for CY 2023, although not significantly.

[[Page 79078]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.048

    Therefore, we proposed to take the weighted average of the base 
code and add-on code pairs, in addition to the individual base codes 
for all of the services that comprise HCPCS code G0511 by using the CY 
2021 PFS utilization to calculate the payment rate for the general care 
management services furnished in RHCs and FQHCs on or after January 1, 
2024. The number on the right side of Table 27 is a weighted average 
which grants more relative weight to the codes in proportion to their 
utilization in 2021 claims data. To calculate the weighted average, we 
multiple the non-facility payment rate times the non-facility 
utilization for each code, sum this total, then divide by the summed 
non-facility utilization for the codes included in the average. In an 
effort to be consistent with practitioners billing under the PFS and to 
account for the additional time spent in care coordination, we 
determined that this approach was a more accurate representation of the 
payment. We stated that we would update HCPCS code G0511 annually based 
on current data available in the PFS.
    We proposed revisions at Sec.  405.2464(c) to reflect the revised 
methodology for calculating the payment amount for general care 
management services beginning January 1, 2024 which would be based on a 
weighted average of the services that comprise HCPCS code G0511 using 
the most recently available PFS utilization data. We welcomed comments 
on this proposed methodology.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Most commenters supported the proposed methodology for 
calculating the payment amount for general care management services, as 
long as the utilization data was pulled from traditional fee-for-
service for physician offices.
    Response: We appreciate the commenters' support of the proposed 
revision methodology for calculating the payment amount for general 
care management services and confirm we will be utilizing the data from 
the PFS for updates.
    Comment: A few commenters expressed concerns that, since the code 
can only be billed once per calendar month, the increased payment rate 
may not sufficiently account for the resources required to provide 
chronic care management, CHI and/or PIN, as well as remote monitoring 
when several of these services are provided in the same month. One 
commenter stated that they believed that CMS does not allow RHCs to 
bill more than one care management service per month for the same 
beneficiary. The commenter stated that fee-for-service providers are 
able to bill for all of these services for one beneficiary during the 
same month, yet RHCs can only provide one of these suites of services 
and bill G0511 once per month per beneficiary. Some commenters 
requested that CMS increase the payment rate for HCPCS code G0511 to 
account for these circumstances when a beneficiary receives multiple 
care management services in a month but they are only able to bill the 
code once per month.
    Response: We appreciate the commenters' raising these concerns. As 
we clarified above, RHCs and FQHCs may bill HCPCS code G0511 multiple 
times in a calendar month, as long as all of the requirements are met 
and resource costs are not counted more than once. We will continue to 
review these services for consideration in future rulemaking.
    Comment: One commenter suggested various approaches to billing for 
multiple iterations of HCPCS code G0511 during a calendar month. 
Suggestions included: using modifiers to identify the service; creating 
a more comprehensive set of HCPCS codes separated by service type or by 
time; or allowing RHCs and FQHCs to bill the full suite of care 
management codes the same way traditional fee-for-service providers or 
hospital outpatient

[[Page 79079]]

departments bill for care management services.
    Response: We appreciate the commenter's recommendations on how to 
operationalize and track HCPCS code G0511 when billed multiple times in 
a calendar month. We did not propose these options in the CY 2024 PFS 
proposed rule; however, we will take these options into consideration 
for future rulemaking.
    Comment: Some commenters requested that CMS add the General 
Behavioral Health Integration (GBHI) code and the Chronic Pain 
Management (CPM) codes into the weighted average for the calculation of 
HCPCS code G0511.
    Response: As we stated in the CY 2024 PFS proposed rule, until 
actual utilization becomes available, RHCs and FQHCs that furnish CPM, 
GBHI, CHI and PIN services would report HCPCS code G0511 when those 
services are furnished. Once more data is available, we will revisit 
the valuation of HCPCS code G0511 to include CPM, GBHI, CHI, and PIN as 
necessary.
    After consideration of public comments, we are finalizing the 
proposal to revise our method for calculating HCPCS code G0511, as 
proposed. That is, on an annual basis we will obtain actual utilization 
of the services that comprise HCPCS code G0511 using the most recently 
available data for the services paid under the PFS. Next, we will take 
the utilization of the base code for the service and any applicable 
add-on codes used in the same month, as well as any base codes reported 
alone in a month, for use in calculating the weighted average. To 
calculate the weighted average, we multiple the non-facility payment 
rate times the non-facility utilization for each code, sum this total, 
then divide by the summed non-facility utilization for the codes 
included in the average. This results in the payment amount for HCPCS 
code G0511. We will continue to publicly post the updated payment rate 
for G0511 on the RHC and FQHC center web pages.
    For CY 2024, and as we demonstrated in the proposed rule, we 
obtained actual utilization of the base code and add-on code pairs, in 
addition to the individual base codes for CCM, PCM, RPM, and RTM by 
using the CY 2021 PFS utilization to calculate the weighted average and 
determine the payment rate for HCPCS code G0511. We will post the final 
CY 2024 payment rate for the general care management HCPCS code G0511 
on the RHC and FQHC center web pages.\176\
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    \176\ https://www.cms.gov/Center/Provider-Type/Rural-Health-Clinics-Center and https://www.cms.gov/medicare/payment/prospective-payment-systems/federally-qualified-health-centers-fqhc-center.
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e. Chronic Care Management Services and Virtual Communication Services 
Requirement for Obtaining Beneficiary Consent
(1) Chronic Care Management Services
    RHCs and FQHCs have been authorized to bill for Chronic Care 
Management (CCM) services since January 1, 2016. The RHC and FQHC 
requirements for billing CCM services have generally followed the 
requirements for practitioners billing under the PFS, with some 
adaptations based on the RHC and FQHC payment methodologies. In fact, 
in the CY 2017 PFS final rule (81 FR 80256-80257) to assure that CCM 
requirements for RHCs and FQHCs were not more burdensome than those for 
practitioners billing under the PFS, we finalized revisions to the 
requirements for CCM services furnished by RHCs and FQHCs similar to 
revisions to the requirements for CCM services finalized under the PFS 
(81 FR 80243 through 80251). Information regarding CCM services is 
available on the CMS Care Management Site.\177\
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    \177\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Care-Management.
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    In the CY 2022 PFS proposed rule (86 FR 39175), we solicited public 
comment on the standard practice used by practitioners to obtain 
beneficiary consent for CCM services. We stated that we have received 
questions from interested parties regarding the consent requirements 
for CCM services. We explained that these questions may have arisen 
because of the many flexibilities allowed in response to the PHE for 
COVID-19. In particular, during the PHE for COVID-19, we allowed 
interested parties to obtain beneficiary consent for certain services 
under general supervision (85 FR 19230, April 6, 2020). We noted that 
before the PHE for COVID-19, we required that beneficiary consent be 
obtained either by a primary care practitioner or a staff member or 
contract employee under the direct supervision of such primary care 
practitioner. We noted that this requirement was consistent with the 
conditions of payment for this service under the PFS. We stated that as 
we consider what policies implemented during the PHE for COVID-19 
should remain in effect beyond the PHE, we were interested in 
understanding how billing practitioners furnishing CCM at different 
service sites (for example, physician office settings, RHCs, FQHCs) 
have been obtaining beneficiary consent over the past year and how 
different levels of supervision impact this activity. We welcomed 
public comment on the issue, specifically on what levels of supervision 
of employees or third party contractors are necessary to obtain 
beneficiary consent when furnishing CCM services and said that we will 
consider such comments in future rulemaking.
    We received 52 comments regarding the standard practice used by 
practitioners to obtain beneficiary consent for CCM services from a 
variety of interested parties including but not limited to individuals, 
hospitals, physicians, RHCs, FQHCs, software companies, and care 
management companies.
    Comment: All commenters supported obtaining consent for care 
management under general supervision. Many commenters requested that 
CMS make this supervision level permanent after the expiration of the 
COVID-19 PHE. They stated that their practice would be unable to 
maintain its current CCM program without the assistance of a third-
party partner. CCM vendors have trained enrollment staff which are 
vital to obtaining proper consent from their patients. Their staff are 
able to educate and inform our patients regarding the CCM program as 
they have been specifically trained to explain the benefits of CCM. 
They explained that vendors have the capacity to call patients and 
receive calls when it is convenient for the patient. They expressed 
concern that they could not replicate these services using only their 
employed staff and that allowing a third party to obtain consent from 
their patients for CCM under general supervision is vital to their CCM 
program.
    One commenter explained that CCM programs are a challenging and 
heavy lift for all providers, regardless of size and available 
resources, and the providers that offer CCM services to their patient 
populations do so because they recognize and value CCM's capacity to 
improve patient outcomes. The commenter stated that they have seen the 
administrative burdens of successful and compliant CCM programs fall 
hardest upon RHCs and FQHCs and noted if CMS were to establish general 
supervision as the guideline for beneficiary consent, this would ease 
those burdens. The commenter noted that CCM codes describing clinical 
staff activities are assigned general supervision and if CMS were to 
carve out beneficiary consent

[[Page 79080]]

from the rest of CCM and impose a heightened administrative burden by 
imposing direct supervisions, RHCs and FQHCs that service the most 
vulnerable and underserved patient populations, would encounter 
challenges that could have negative consequence for their existing CCM 
programs.
    Several commenters stated that they believed an efficient Medicare 
system requires CCM services to leverage the potential of non-face-to-
face modalities, such as EHR systems, patient portals, texting/SMS 
services, chatbot technologies, interactive mobile medical apps, and 
direct patient calls. The commenters explained that while they 
understood CMS' concerns, it is long past due that CMS do away with the 
requirement for a provider to directly obtain consent. Virtual 
modalities more than adequately enable a patient to gain an 
understanding of what they are consenting to at the same level or 
better than an in-person consent process, making the direct consent 
requirement outdated and overburdensome. The commenters encouraged CMS 
to permanently allow providers to obtain beneficiary consent under 
general supervision.
    Response: As discussed in the CY 2024 PFS proposed rule (88 FR 
52406), for the purposes of CCM services furnished under the PFS, we 
require that practitioners obtain informed consent before furnishing a 
beneficiary with CCM services. During the COVID-19 PHE, we clarified 
existing policy about how practitioners could obtain beneficiary 
consent. We explained that practitioners could obtain beneficiary 
consent either at the required initiating visit for CCM (many of which 
Medicare allows to be furnished virtually), or at the same time that 
the CCM service is initiated by auxiliary staff (often independent 
third-party entities) who work to furnish the CCM services. When the 
beneficiary's consent is separately obtained, it may be obtained under 
the general supervision of the billing practitioner and may be verbal 
as long as it is documented in the medical record and includes 
notification of the required information. We noted that now that the 
COVID-19 PHE has ended, we expect that practitioners will continue to 
appropriately obtain informed consent before they start furnishing CCM 
services to a beneficiary.
    In the CY 2024 PFS proposed rule, for purposes of CCM services 
furnished by RHCs and FQHCs, we proposed to clarify the policy of how 
RHC and FQHC practitioners could obtain beneficiary consent. That is, 
while we have stated our intent since allowing RHCs and FQHCs to 
furnish CCM services, is to assure that CCM requirements for RHCs and 
FQHCs were not more burdensome than those for practitioners billing 
under the PFS, we believed our guidance could be clearer. After a 
review of commenters' concerns, we proposed to clarify when, how and by 
whom beneficiary consent for CCM services could be obtained. We 
explained, informed consent to receive CCM services must be obtained 
prior to the start of CCM services. Consent does not have to be 
obtained at the required initiating visit for CCM that must be 
performed by the RHC or FQHC practitioner, but it can be obtained at 
that time. Since the RHC or FQHC practitioner discusses CCM with the 
beneficiary during the initiating visit, if consent is separately 
obtained, it may be obtained under general supervision, and can be 
verbal as long as it is documented in the medical record and includes 
notification of the required information. That is, beneficiary consent 
can be obtained at the same time that the CCM service is initiated by 
auxiliary staff who work to furnish the CCM services. Further, there 
need not be an employment relationship between the person obtaining the 
consent and the RHC or FQHC practitioner. That is, the clinical staff 
obtaining the verbal or written consent can be under contract with the 
RHC or FQHC.
    We noted, it was important to reiterate that the importance of 
obtaining advance beneficiary consent to receive CCM services was to 
ensure the beneficiary is informed, educated about CCM services, and is 
aware of applicable cost sharing. In addition, querying the beneficiary 
about whether another practitioner is already providing CCM services 
helps to reduce the potential for duplicate provision or billing of the 
services. We stated CMS requires the beneficiary be informed on the 
availability of CCM services; that only one practitioner can furnish 
and be paid for these services during a calendar month; and of the 
right to stop the CCM services at any time (effective at the end of the 
calendar month). Again, we believed that it is important that the 
beneficiary grant the consent at the onset of CCM services to have the 
opportunity to understand what services are being billed and note it is 
important for CMS to take a balanced approach between administrative 
burden and potential program integrity concerns. That being said, we 
clarified that we understand that the sequencing and mode of consent 
can take various forms since the beneficiary is given notice and 
verbally consents.
(2) Virtual Communication Services
    In the April 6, 2020 IFC (85 FR 19253 through 19254), we 
implemented on an interim final basis the expansion of services that 
can be included in the payment for virtual communications in RHCs and 
FQHCs. We explained that in order to minimize risks associated with 
exposure to COVID-19, and to provide the best care possible during the 
PHE for the COVID-19 pandemic, we believed that RHCs and FQHC 
practitioners, like many other health care providers, should explore 
the use of interactive communications technology in the place of 
services that would have otherwise been furnished in person and 
reported and paid under the established methodologies.
    To ensure these services would be available to beneficiaries who 
otherwise would not have access to clinically appropriate in-person 
treatment, we placed in our interim final rule a provision stating that 
all virtual communication services billed by HCPCS code G0071 would be 
available to new patients not seen by the RHC or FQHC within the 
previous months and modified requirements regarding when patient 
consent was required for these services, in order to promote timely 
provision of care. Specifically, we allowed consent to be obtained when 
the services were furnished instead of prior to the service being 
furnished and before the services were billed. Consent could also be 
acquired by staff under the general supervision of the RHC or FQHC 
practitioner for the virtual communication codes during the PHE for 
COVID-19.
    We received several comments on these policies and subsequently 
finalized the provisions of the April 6, 2020, IFC without 
modification. However, we stated that when the PHE for COVID-19 ended, 
beneficiary consent for these services would revert back to direct 
supervision and clarified this in the CY 2023 PFS final rule with 
comment period (87 FR 70127 through 70128).
    As discussed in the CY 2024 PFS proposed rule (88 FR 52407), we 
believe the same philosophy applies to consent for virtual 
communications as it does for CCM. In an effort to continue promoting 
access to timely, quality care for Medicare beneficiaries and to align 
with the PFS, we proposed to clarify that the consent from the 
beneficiary to receive virtual communication services can be documented 
by auxiliary staff under general supervision, as well as by the billing 
practitioner. While we continue to believe that beneficiary consent is 
necessary so that the beneficiary is

[[Page 79081]]

notified of cost sharing when receiving these services, we do not 
believe that the timing or manner in which beneficiary consent is 
acquired should interfere with the provision of one of these services.
    We received a few comments on our proposal to clarify beneficiary 
consent for CCM and virtual communications services. The following is a 
summary of the comments we received and our responses.
    Comment: Commenters supported our proposal to clarify obtaining 
beneficiary consent related to CCM and virtual communications services. 
Commenters stated that this flexibility will continue to allow health 
centers to enhance their efficiency by tailoring their operational 
processes and workflows to continue focusing on patient care. 
Commenters also appreciated CMS permitting third-party vendors to 
obtain consent from patients, stating that utilizing technological 
third-party vendors helps decrease administrative burden, allowing 
health center personnel more time to focus on patient care while 
ensuring patients understand the services rendered.
    Response: We appreciate commenters' support of our clarification of 
the policy for obtaining beneficiary consent for CCM and virtual 
communications services.
    After consideration of public comments, we are finalizing our 
clarification as proposed.

C. Rural Health Clinics (RHCs) and Federally Qualified Health Centers 
(FQHCs) Conditions for Certification or Coverage (CfCs)

1. Background and Statutory Authority
    This section of the final rule sets out changes to the RHC and FQHC 
CfCs as required by section 4121 of division FF of the Consolidated 
Appropriations Act (Pub. L. 117-328, December 29, 2022) (CAA 2023). 
Specifically, we are implementing provisions that modify the existing 
RHC and FQHC CfCs at Sec.  491.8(a)(3) to include marriage and family 
therapists (MFTs) and mental health counselors (MHCs) as part of the 
collaborative team approach to provide services under Medicare Part B. 
We also proposed to include definitions of other healthcare 
professionals who are already eligible to provide services at RHCs and 
FQHCs. Lastly, we proposed to update the definition of ``nurse 
practitioner'' to align with current standards of professional 
practice.
    Section 1861(aa) of the Act establishes requirements that RHCs and 
FQHCs must meet to participate in the Medicare Program. These 
requirements are codified in regulations at 42 CFR part 491. For an RHC 
and FQHC to receive Medicare payment for services, it must meet the 
requirements at part 491, which are intended to promote the health and 
safety of care provided to RHC and FQHC patients.
2. Summary of the RHC and FQHC CfCs Proposed Provisions, Public 
Comments, and Responses to Comments
    We proposed to revise the ``Definitions'' section and ``Staffing 
and staff responsibilities'' requirements that RHCs and FQHCs must meet 
to participate in the Medicare program. Commenters included 
individuals, health care professionals, national and State 
associations, patient advocacy organizations, and individual facilities 
that will be impacted by the rule.
a. Definitions (Sec.  491.2)
    At Sec.  491.2, we proposed to define certain terms that are used 
in the RHC and FQHC CfCs. We proposed to define the terms ``clinical 
psychologist (CP),'' ``clinical social worker,'' and ``certified nurse 
midwife (CNM)'' in the CfCs and cross-reference the definitions 
established in the payment requirements at Sec. Sec.  410.77(a), 
410.71(d), and 410.73(a) respectively. This rule also finalizes changes 
to the CfCs to define MFT and MHC services as proposed in section II.J 
of this final rule to indicate that RHC and FQHCs can offer these 
services under their Medicare certification by cross-referencing the 
definitions proposed at Sec. Sec.  410.53 and 410.54.
    Additionally, we proposed revising the existing ``nurse 
practitioner'' (NP) definition at Sec.  491.2 to accurately reflect 
current professional standards by removing the reference to specific 
certifying bodies as they are now outdated. This revision will ensure 
the requirement reflects the breadth of currently available 
certifications. We proposed adding education requirements to paragraph 
(1) of the definition because the American Nurses Association has 
stated that for someone to become an NP, one must be a registered nurse 
or have a bachelor of science in nursing (BSN), complete an NP-focused 
master's or doctoral nursing program, and pass the National NP 
Certification Board Exam.\178\ We proposed to retain paragraphs (2) and 
(3) of the definition, which provides alternative certification and 
education requirements an NP can meet to furnish services in an RHC or 
FQHC if the education requirements in paragraph (1) are not met.
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    \178\ American Association of Nurse Practitioners (2020). The 
Path to Becoming a Nurse Practitioner (NP). https://www.aanp.org/
news-feed/explore-the-variety-of-career-paths-for-nurse-
practitioners#:~:text=To%20become%20an%20NP%2C%20one,national%20NP%20
board%20certification%20exam.
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    We explicitly solicited comments in the proposed rule (88 FR 52408) 
on whether CMS should revise the NP definition for RHCs and FQHCs. 
Specifically, we were interested in whether the definition of NP should 
specify that an NP's certification be in the area of primary care, or 
whether this distinction should be removed. Approximately 3,200 RHCs 
employ 1.25 full-time NPs per RHC, and each NP provides care for nearly 
3,000 visits annually. For a total of 12,000,000 RHC visits 
nationally.\179\ Likewise, there are 12,609 NPs in health centers 
funded and designated by the Health Resources and Services 
Administration that provided more than 30 million clinical and virtual 
visits in 2022.180 181 Removing the certification 
requirement for NPs would allow approximately 60,000 additional NPs to 
be eligible to provide care in RHCs and FQHCs.\182\ NPs are 
instrumental in providing high-quality services to rural and 
underserved communities. Their services are essential in ensuring that 
individuals have access to the care they need, and work alongside 
physicians to provide comprehensive care.
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    \179\ https://digitalcommons.usm.maine.edu/cgi/viewcontent.cgi?article=1016&context=clinics.
    \180\ https://data.hrsa.gov/tools/data-reporting/program-data/national/table?tableName=5&year=2022.
    \181\ https://data.hrsa.gov/tools/data-reporting/program-data/national-lookalikes/table?tableName=5&year=2022.
    \182\ https://www.aanp.org/about/all-about-nps/np-fact-sheet.
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    The latest report from the American Association of Nurse 
Practitioners (AANP) indicates 88 percent of licensed NPs are educated 
and prepared in primary care.\183\ NP students choose their patient 
populations at the time of entry into an NP program.\184\ Doing so 
allows NP education to match the knowledge and skills to the needs of 
patients focusing their academics and clinical study on the patient 
population they will be working with. While NP programs have core 
studies everyone attends (pathology, pharmacology, and physical 
assessment), having a population focus-based education ensures ample 
education to build knowledge and skills in the area where the NP will 
be practicing. NP

[[Page 79082]]

population foci include adult-gerontology acute care, adult-gerontology 
primary care, family, neonatal, pediatric, psychiatric mental health, 
and women's health.\182\ Of those population foci, NPs specialized in 
adult-gerontology acute care, neonatal, pediatric acute care, and 
psychiatric mental health would not be able to furnish services in an 
RHC and FQHC if the primary care certification requirement remained for 
NPs.
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    \183\ https://www.aanp.org/advocacy/advocacy-resource/position-
statements/nurse-practitioners-in-primary-
care#:~:text=Millions%20of%20Americans%20choose%20a.
    \184\ https://www.aanp.org/news-feed/explore-the-variety-of-career-paths-for-nurse-practitioners.
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    We sought comments on whether the specific requirement for NPs to 
be certified in primary care should remain in the definition at Sec.  
491.2.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Commenters supported the proposed revision of the NP 
definition at Sec.  491.2 to remove naming specific certifying boards 
for NPs and adding education requirements. Commenters also responded to 
the proposal supporting a broad definition of a nurse practitioner at 
Sec.  491.2(1). The commenters recommend removing the primary care 
certification specification to allow health centers to employ the most 
qualified candidates who could best serve the clinic or center's 
patient population. One commenter supported the removal of the primary 
care certification requirement, with the understanding that NPs would 
continue to provide services only within their scope of practice. 
Another commenter recommended we amend the proposed definition from ``. 
. . and possesses a Master's degree in nursing or a Doctor of Nursing 
Practice (DNP) doctoral degree,'' to a definition that is inclusive of 
all NP graduate degrees. We did not receive any comments opposing our 
proposal.
    Response: We are appreciative of these comments. Approximately 100 
million individuals lack sufficient access to primary healthcare, with 
65 percent of such access problems happening in rural areas.\185\ Our 
belief is that eliminating the need for primary care certification for 
NPs could aid in resolving staffing shortages that healthcare 
facilities are experiencing in underserved and rural communities.
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    \185\ https://data.hrsa.gov/topics/health-workforce/shortage-areas.
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    When hiring NPs for employment, it is important for RHCs and FQHCs 
to consider the specific patient population they serve, as well as the 
individual education, skills, and training of the NP. NPs have the 
ability to offer comprehensive, patient-centered care in various 
settings, and may have specialized expertise in fields such as 
addiction, psychiatric care, or cardiovascular care.\186\ For new NPs 
providing care in FQHCs, there are opportunities to pursue fellowship, 
training, and residency programs to ensure they have the necessary 
skills to provide quality care.\187\ To further ensure patient safety, 
states may have additional licensure requirements in place. Therefore, 
we are updating the standard at paragraph (1) of the NP definition at 
Sec.  491.2 to require that NPs be certified by a recognized national 
certifying body and possess a master's or doctoral degree in nursing.
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    \186\ https://www.abn.alabama.gov/wp-content/uploads/2019/03/NP-Specialty-Certifications_03202019.pdf.
    \187\ https://www.chc1.com/what-we-do/training-the-next- 
generation/residency-training-programs/.
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    After consideration of the public comments we received, we are 
finalizing this provision with modification by removing language 
specifying that NPs must be certified in primary care. We are 
finalizing the requirement that NPs must be certified by a recognized 
certifying body and possess a master's or doctoral degree in nursing. 
We note that section 1861(aa)(5)(A) of the Act continues to require 
that NPs and PAs only provide such services as they are ``legally 
authorized to perform (in the State in which the individual performs 
such services) in accordance with State law (or the State regulatory 
mechanism provided by State law).''
b. Staffing and Staff Responsibilities (Sec.  491.8)
    Section 4121(b)(1) of the CAA, 2023, Coverage of Certain Mental 
Health Services Provided in Certain Settings Rural Health Clinics and 
Federally Qualified Health Centers amends section 1861(aa)(1)(B) of the 
Act by including MFTs and MHCs to the list of other practitioners whose 
services, when provided in RHCs and FQHCs, are entitled to payment 
under the Medicare program. We proposed to revise the RHC and FQHC CfCs 
to include MFTs and MHCs as recognized staff alongside other 
practitioners such as NPs, PAs, CPs, CSWs, and CNMs, where appropriate 
and as required by the statute.
    At Sec.  491.8(a)(3), we proposed to add MFT and MHC to the list of 
practitioners who may be the owner, employee, or furnish services under 
contract to the clinic or center. Section 1861(aa)(2) and (4) of the 
Act requires that RHC and FQHC staff include one or more physicians, 
and RHCs are also required to employ at least one PA or NP. There are 
no requirements for an RHC or FQHC to employ a CNM, CSW, CP, MHC, or 
MFT. To comply with this requirement, we would expect clinics and 
centers ensure that the needs of the patient population they serve are 
met. As rural areas are increasingly diverse, have significant 
strengths and unique challenges, RHCs and FQHCs play a key role in 
identifying the needs of their patients. A team of diverse 
professionals can take a patient-centered approach to addressing a 
patient's physical and mental health through counseling, case 
management, and provide resources and information to address social 
determinants of health.\188\
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    \188\ https://www.jstor.org/stable/pdf/26554276.pdf?refreqid=excelsior%3A3437750e2633ee53aa5c0afe8caae6ea&ab_segments=&origin=&initiator=&acceptTC=1.
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    Additionally, we proposed to add MFTs and MHCs to Sec.  
491.8(a)(6), which determines which practitioners are required to be 
available to furnish patient care services at all times the clinic or 
center operates. This provision allows MFTs and MHCs to furnish 
services within their scope of practice while helping meet the needs of 
the clinic or center's patient population. The intent of this 
requirement is to ease the burden of staffing shortages in RHCs and 
FQHCs, which is a barrier that prevents individuals from accessing 
physical and mental health services.\189\ MFTs and MHCs can expand the 
pool of mental health professionals available to address practitioner 
shortages in rural communities by providing reimbursable services under 
the Medicare program. We note the statutory provision that defines the 
term ``rural health clinic'' in section 1861(aa)(2)(K)(iv) of the Act 
states that an RHC is not a facility which is primarily for the care 
and treatment of mental diseases.
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    \189\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1851736/.
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    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Many commenters supported expanding Medicare coverage to 
include MFT and MHC services in RHCs and FQHCs. Commenters expressed 
their appreciation for the discussion of the specific barriers to 
accessing mental health and substance use disorder services for people 
living in rural areas and areas where there are shortages of healthcare 
professionals.
    Response: We thank the commenters for their support. We are 
committed to advancing health equity and increasing access to physical 
and mental health services. We aim to increase the number of covered 
behavioral health providers, bridging the gap in the accessibility of

[[Page 79083]]

services to ensure that patients receive comprehensive care.
    Comment: One commenter encouraged CMS to finalize the COVID-19 
Public Health Emergency waiver, which modified the requirement at Sec.  
491.8(b)(1) that physicians must provide medical direction for the 
clinics or center's health care activities and consultation for, and 
medical supervision of, the health care staff with respect to medical 
supervision of NPs to the extent permitted by State law.\190\
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    \190\ https://www.cms.gov/files/document/rural-health-clinics-and-federally-qualified-health-centers-cms-flexibilities-fight-covid-19.pdf.
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    Response: This comment pertains to physician supervision of NPs in 
RHCs and FQHCs rather than to any specific proposed changes to the 
policy proposals set forth in the proposed rule. Therefore, this 
comment is outside the scope of this final rule.
    Comment: One commenter suggested that CMS propose a more permanent 
policy to determine RHC rural location eligibility.
    Response: We did not propose any provisions related to the location 
requirements of RHCs or FQHCs, and therefore this comment is outside 
the scope of this final rule.
    After consideration of the public comments we received, we are 
finalizing these provisions as proposed.

D. Clinical Laboratory Fee Schedule: Revised Data Reporting Period and 
Phase-In of Payment Reductions

1. Background on the Clinical Laboratory Fee Schedule
    Prior to January 1, 2018, Medicare paid for clinical diagnostic 
laboratory tests (CDLTs) on the Clinical Laboratory Fee Schedule (CLFS) 
under section 1833(a), (b), and (h) of the Act. Under the previous 
payment system, CDLTs were paid based on the lesser of: (1) the amount 
billed; (2) the local fee schedule amount established by the Medicare 
Administrative Contractor (MAC); or (3) a national limitation amount 
(NLA), which is a percentage of the median of all the local fee 
schedule amounts (or 100 percent of the median for new tests furnished 
on or after January 1, 2001). In practice, most tests were paid at the 
NLA. Under the previous payment system, the CLFS amounts were updated 
for inflation based on the percentage change in the Consumer Price 
Index for All Urban Consumers (CPI-U) and reduced by a productivity 
adjustment and other statutory adjustments but were not otherwise 
updated or changed. Coinsurance and deductibles generally do not apply 
to CDLTs paid under the CLFS.
    Section 1834A of the Act, as established by section 216(a) of the 
Protecting Access to Medicare Act of 2014 (PAMA), required significant 
changes to how Medicare pays for CDLTs under the CLFS. A final rule 
entitled Medicare Clinical Diagnostic Laboratory Tests Payment System 
(CLFS final rule), which appeared in the Federal Register on June 23, 
2016 (81 FR 41036), implemented section 1834A of the Act at 42 CFR part 
414, subpart G.
    Under the CLFS final rule, ``reporting entities'' must report to 
CMS during a ``data reporting period'' ``applicable information'' 
collected during a ``data collection period'' for their component 
``applicable laboratories.'' The first data collection period occurred 
from January 1, 2016, through June 30, 2016. The first data reporting 
period occurred from January 1, 2017, through March 31, 2017. On March 
30, 2017, we announced a 60-day period of enforcement discretion for 
the application of the Secretary's potential assessment of civil 
monetary penalties for failure to report applicable information with 
respect to the initial data reporting period.\191\
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    \191\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/2017-March-Announcement.pdf.
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    In the CY 2018 PFS proposed rule (82 FR 34089 through 34090), we 
solicited public comments from applicable laboratories and reporting 
entities to better understand the applicable laboratories' experiences 
with data reporting, data collection, and other compliance requirements 
for the first data collection and reporting periods. We discussed these 
comments in the CY 2018 PFS final rule (82 FR 53181 through 53182) and 
stated that we would consider the comments for potential future 
rulemaking or guidance.
    As part of the CY 2019 Medicare PFS rulemaking, we finalized two 
changes to the definition of ``applicable laboratory'' at Sec.  414.502 
(see 83 FR 59667 through 59681, 60074; 83 FR 35849 through 35850, 35855 
through 35862). First, we excluded Medicare Advantage plan payments 
under Part C from the denominator of the Medicare revenues threshold 
calculation to broaden the types of laboratories qualifying as an 
applicable laboratory. Second, consistent with our goal of obtaining a 
broader representation of laboratories that could potentially qualify 
as an applicable laboratory and report data, we also amended the 
definition of applicable laboratory to include hospital outreach 
laboratories that bill Medicare Part B using the CMS-1450 14x Type of 
Bill.
2. Payment Requirements for Clinical Diagnostic Laboratory Tests
    In general, under section 1834A of the Act, the payment amount for 
each CDLT on the CLFS furnished beginning January 1, 2018, is based on 
the applicable information collected during the data collection period 
and reported to CMS during the data reporting period and is equal to 
the weighted median of the private payor rates for the test. The 
weighted median is calculated by arraying the distribution of all 
private payor rates, weighted by the volume for each payor and each 
laboratory. The payment amounts established under the CLFS are not 
subject to any other adjustment, such as geographic, budget neutrality, 
or annual update, as required by section 1834A(b)(4)(B) of the Act. 
Additionally, section 1834A(b)(3) of the Act, implemented at Sec.  
414.507(d), provides for a phase-in of payment reductions, limiting the 
amounts the CLFS rates for each CDLT (that is not a new advanced 
diagnostic laboratory test (ADLT) or new CDLT) can be reduced as 
compared to the payment rates for the preceding year. Under the 
original provisions enacted by section 216(a) of PAMA, for the first 3 
years after implementation (CY 2018 through CY 2020), the reduction 
could not be more than 10 percent per year. For the next 3 years after 
implementation (CY 2021 through CY 2023), section 216(a) of PAMA stated 
that the reduction could not be more than 15 percent per year. Under 
sections 1834A(a)(1) and (b) of the Act, as enacted by PAMA, for CDLTs 
that are not ADLTs, the data collection period, data reporting period, 
and payment rate update were to occur every 3 years. As such, the 
second data collection period for CDLTs that are not ADLTs occurred 
from January 1, 2019, through June 30, 2019, and the next data 
reporting period was originally scheduled to take place from January 1, 
2020, through March 31, 2020, with the next update to the Medicare 
payment rates for those tests based on that reported applicable 
information scheduled to take effect on January 1, 2021.
    Section 216(a) of PAMA established a new subcategory of CDLTs known 
as ADLTs, with separate reporting and payment requirements under 
section 1834A of the Act. The definition of an ADLT is set forth in 
section 1834A(d)(5) of the Act and implemented at Sec.  414.502. 
Generally, under section 1834A(d) of the Act, the Medicare payment rate 
for a new ADLT is equal to its actual list charge during an initial

[[Page 79084]]

period of 3 calendar quarters. After the new ADLT initial period, ADLTs 
are paid using the same methodology based on the weighted median of 
private payor rates as other CDLTs. However, under section 1834A(d)(3) 
of the Act, updates to the Medicare payment rates for ADLTs occur 
annually instead of every 3 years.
    Additional information on the private payor rate-based CLFS is 
detailed in the CLFS final rule, which implemented section 1834A of the 
Act as required by PAMA (81 FR 41036 through 41101) and this 
information is also available on the CMS website.\192\
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    \192\ https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule-clfs/pama-educational-resources.
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3. Previous Statutory Revisions to the Data Reporting Period and Phase-
In of Payment Reductions
    Beginning in 2019, Congress passed a series of legislation to 
modify the statutory requirements for the data reporting period and 
phase-in of payment reductions under the CLFS. First, section 105(a)(1) 
of the Further Consolidated Appropriations Act, 2020 (FCAA) (Pub. L. 
116-94, December 20, 2019) amended the data reporting requirements in 
section 1834A(a) of the Act to delay the next data reporting period for 
CDLTs that are not ADLTs by 1 year so that data reporting would be 
required during the period of January 1, 2021, through March 31, 2021, 
instead of January 1, 2020, through March 30, 2020. The 3-year data 
reporting cycle for CDLTs that are not ADLTs would resume after that 
data reporting period. Section 105(a)(1) of the FCAA also specified 
that the data collection period that applied to the data reporting 
period of January 1, 2021, through March 30, 2021, would be the period 
of January 1, 2019, through June 30, 2019, which was the same data 
collection period that would have applied absent the amendments. In 
addition, section 105(a)(2) of the FCAA amended section 1834A(b)(3) of 
the Act regarding the phase-in of payment reductions to provide that 
payments may not be reduced by more than 10 percent as compared to the 
amount established for the preceding year through CY 2020, and for CYs 
2021 through 2023, payment may not be reduced by more than 15 percent 
as compared to the amount established for the preceding year. These 
statutory changes were consistent with our regulations implementing the 
private payor rate-based CLFS at Sec.  414.507(d) (81 FR 41036).
    Subsequently, section 3718 of the Coronavirus Aid, Relief, and 
Economic Security Act, 2020 (CARES Act) (Pub. L. 116-136, March 27, 
2020) further amended the data reporting requirements for CDLTs that 
are not ADLTs and the phase-in of payment reductions under the CLFS. 
Specifically, section 3718(a) of the CARES Act amended section 
1834A(a)(1)(B) of the Act to delay the next data reporting period for 
CDLTs that are not ADLTs by one additional year, to require data 
reporting during the period of January 1, 2022, through March 31, 2022. 
The CARES Act did not modify the data collection period that applied to 
the next data reporting period for these tests. Thus, under section 
1834A(a)(4)(B) of the Act, as amended by section 105(a)(1) of the FCAA, 
the next data reporting period for CDLTs that are not ADLTs would have 
been based on the data collection period of January 1, 2019, through 
June 30, 2019.
    Section 3718(b) of the CARES Act further amended the provisions in 
section 1834A(b)(3) of the Act regarding the phase-in of payment 
reductions under the CLFS. First, it extended the statutory phase-in of 
payment reductions resulting from private payor rate implementation by 
an additional year, that is, through CY 2024 instead of CY 2023. It 
further amended section 1834A(b)(3)(B)(ii) of the Act to specify that 
the applicable percent for CY 2021 is 0 percent, meaning that the 
payment amount determined for a CDLT for CY 2021 shall not result in 
any reduction in payment as compared to the payment amount for that 
test for CY 2020. Section 3718(b) of the CARES Act further amended 
section 1834A(b)(3)(B)(iii) of the Act to state that the applicable 
percent of 15 percent would apply for CYs 2022 through 2024, instead of 
CYs 2021 through 2023. In the CY 2021 PFS rulemaking (85 FR 50210 
through 50211; 85 FR 84693 through 84694), in accordance with section 
105(a) of the FCAA and section 3718 of the CARES Act, we proposed and 
finalized conforming changes to the data reporting and payment 
requirements at 42 CFR part 414, subpart G.
    Section 4 of the Protecting Medicare and American Farmers from 
Sequester Cuts Act (PMAFSCA) (Pub. L. 117-71, December 10, 2021) made 
additional revisions to the CLFS requirements for the next data 
reporting period for CDLTs that are not ADLTs and to the phase-in of 
payment reductions under section 1834A of the Act. Specifically, 
section 4(b) of PMAFSCA amended the data reporting requirements in 
section 1834A(a) of the Act to delay the next data reporting period for 
CDLTs that are not ADLTs by 1 year, so that data reporting would be 
required during the period of January 1, 2023, through March 31, 2023. 
The 3-year data reporting cycle for CDLTs that are not ADLTs would 
resume after that data reporting period. As amended by section 4 of 
PMAFSCA, section 1834A(a)(1)(B) of the Act provided that in the case of 
reporting with respect to CDLTs that are not ADLTs, the Secretary shall 
revise the reporting period under subparagraph (A) such that--(i) no 
reporting is required during the period beginning January 1, 2020, and 
ending December 31, 2022; (ii) reporting is required during the period 
beginning January 1, 2023, and ending March 31, 2023; and (iii) 
reporting is required every 3 years after the period described in 
clause (ii).
    Section 4 of PMAFSCA did not modify the data collection period that 
applies to the next data reporting period for these tests. Thus, under 
section 1834A(a)(4)(B) of the Act, as amended by section 105(a)(1) of 
the FCAA, the next data reporting period for CDLTs that are not ADLTs 
(January 1, 2023, through March 31, 2023) would continue to be based on 
the data collection period of January 1, 2019, through June 30, 2019, 
as defined in Sec.  414.502.
    Section 4 of PMAFSCA further amended the provisions in section 
1834A(b)(3) of the Act regarding the phase-in of payment reductions 
under the CLFS. First, it extended the statutory phase-in of payment 
reductions resulting from private payor rate implementation by an 
additional year, that is, through CY 2025. It further amended section 
1834A(b)(3)(B)(ii) of the Act to specify that the applicable percent 
for each of CY 2021 and 2022 is 0 percent, meaning that the payment 
amount determined for a CDLT for CY 2021 and 2022 shall not result in 
any reduction in payment as compared to the payment amount for that 
test for CY 2020. Section 4(a) of PMAFSCA further amended section 
1834A(b)(3)(B)(iii) of the Act to state that the applicable percent of 
15 percent would apply for CYs 2023 through 2025, instead of CYs 2022 
through 2024.
    In the CY 2023 PFS rulemaking (87 FR 46068 through 46070; 87 FR 
69741 through 69744, 70225), in accordance with section 4 of PMAFSCA, 
we proposed and finalized conforming changes to the data reporting and 
payment requirements at 42 CFR part 414, subpart G. Specifically, we 
finalized revisions to Sec.  414.502 to update the definitions of both 
the data collection period and data reporting

[[Page 79085]]

period, specifying that for the data reporting period of January 1, 
2023, through March 31, 2023, the data collection period is January 1, 
2019, through June 30, 2019. We also revised Sec.  414.504(a)(1) to 
indicate that initially, data reporting begins January 1, 2017, and is 
required every 3 years beginning January 1, 2023. In addition, we 
finalized conforming changes to our requirements for the phase-in of 
payment reductions to reflect the PMAFSCA amendments. Specifically, we 
finalized revisions to Sec.  414.507(d) to indicate that for CY 2022, 
payment may not be reduced by more than 0.0 percent as compared to the 
amount established for CY 2021, and for CYs 2023 through 2025, payment 
may not be reduced by more than 15 percent as compared to the amount 
established for the preceding year.
    As a result of the statutory revisions under the FCAA, CARES Act, 
and PMAFSCA, there have only been two data collection periods for CDLTs 
that are not ADLTs to date. The first data collection period for these 
tests occurred from January 1, 2016, through June 30, 2016, and the 
second occurred from January 1, 2019, through June 30, 2019. Thus far, 
there has been only one data reporting period for these tests, which 
took place from January 1, 2017, through March 31, 2017. We have 
established CLFS payment rates for these tests using the methodology 
established in PAMA only one time, effective January 1, 2018, based on 
the applicable information collected by applicable laboratories during 
the 2016 data collection period and reported to CMS during the 2017 
data reporting period.
    Additionally, we have applied the phase-in of payment reductions 
for the first 3 years of PAMA implementation, CY 2018 through CY 2020, 
whereby reduction of payment rates could not be more than 10 percent 
per year as compared to the amount established the prior year. However, 
the phase-in of payment reductions set forth in PAMA for years 4 
through 6 of PAMA implementation, whereby payment cannot exceed 15 
percent per year as compared to the amount established the prior year, 
has not yet occurred.
4. Additional Statutory Revisions to the Data Reporting Period and 
Phase-In of Payment Reductions
    Section 4114 of the Consolidated Appropriations Act of 2023 (CAA, 
2023) (Pub. L. 117-328, December 29, 2022) made further revisions to 
the CLFS requirements for the next data reporting period for CDLTs that 
are not ADLTs and to the phase-in of payment reductions under section 
1834A of the Act. Specifically, section 4114(b) of the CAA, 2023 
amended the data reporting requirements in section 1834A(a)(1)(B) of 
the Act to delay the next data reporting period for CDLTs that are not 
ADLTs by 1 year, so that data reporting would be required during the 
period of January 1, 2024, through March 31, 2024, instead of the data 
reporting period of January 1, 2023, through March 31, 2023, 
established under the PMAFSCA. The 3-year data reporting cycle for 
CDLTs that are not ADLTs would resume after that data reporting period. 
As amended by section 4114(b) of the CAA, 2023, section 1834A(a)(1)(B) 
of the Act now provides that in the case of reporting with respect to 
CDLTs that are not ADLTs, the Secretary shall revise the reporting 
period under subparagraph (A) such that--(i) no reporting is required 
during the period beginning January 1, 2020, and ending December 31, 
2023; (ii) reporting is required during the period beginning January 1, 
2024, and ending March 31, 2024; and (iii) reporting is required every 
3 years after the period described in clause (ii).
    Section 4114 of the CAA, 2023 does not modify the data collection 
period that applies to the next data reporting period for these tests. 
Thus, under section 1834A(a)(4)(B) of the Act, as amended by section 
105(a)(1) of the FCAA, the next data reporting period for CDLTs that 
are not ADLTs (January 1, 2024, through March 31, 2024) will continue 
to be based on the data collection period of January 1, 2019, through 
June 30, 2019, as defined in Sec.  414.502.
    Section 4114(a) of the CAA, 2023 further amends the provisions in 
section 1834A(b)(3) of the Act regarding the phase-in of payment 
reductions under the CLFS. First, it extends the statutory phase-in of 
payment reductions resulting from private payor rate implementation by 
an additional year, that is, through CY 2026. It further amends section 
1834A(b)(3)(B)(ii) of the Act to specify that the applicable percent 
for CY 2023 is 0 percent, meaning that the payment amount determined 
for a CDLT for CY 2023 shall not result in any reduction in payment as 
compared to the payment amount for that test for CY 2022. Section 
4114(a) of the CAA, 2023 further amends section 1834A(b)(3)(B)(iii) of 
the Act to state that the applicable percent of 15 percent will apply 
for CYs 2024 through 2026.
5. Conforming Regulatory Changes
    In accordance with section 4114 of the CAA, 2023, in the CY 2024 
PFS proposed rule (88 FR 52410 through 52412), we proposed certain 
conforming changes to the data reporting and payment requirements at 42 
CFR part 414, subpart G. Specifically, we proposed to revise Sec.  
414.502 to update the definitions of both the ``data collection 
period'' and the ``data reporting period,'' specifying that for the 
data reporting period of January 1, 2024, through March 31, 2024, the 
data collection period is January 1, 2019, through June 30, 2019. We 
also proposed to revise Sec.  414.504(a)(1) to indicate that initially, 
data reporting begins January 1, 2017, and is required every 3 years 
beginning January 2024. In addition, we proposed conforming changes to 
our requirements for the phase-in of payment reductions to reflect the 
amendments in section 4114(a) of the CAA, 2023. Specifically, we 
proposed to revise Sec.  414.507(d) to indicate that for CY 2023, 
payment may not be reduced by more than 0.0 percent as compared to the 
payment amount established for that test in CY 2022, and for CYs 2024 
through 2026, payment may not be reduced by more than 15 percent as 
compared to the payment amount established for that test the preceding 
year.
    We noted that the CYs 2023 and 2024 CLFS payment rates for CDLTs 
that are not ADLTs are based on applicable information collected in the 
data collection period of January 1, 2016, through June 30, 2016. Under 
current law, the CLFS payment rates for CY 2025 through CY 2027 will be 
based on applicable information collected during the data collection 
period of January 1, 2019, through June 30, 2019, and reported to CMS 
during the data reporting period of January 1, 2024, through March 31, 
2024.
    The following is a summary of the public comments received on the 
proposed conforming regulatory changes and our responses:
    Comment: Several commenters supported our proposal to revise 
Sec. Sec.  414.502, 414.504, and 414.507 to conform with the current 
statutory provisions governing data reporting and payment for CDLTs on 
the CLFS.
    Response: We appreciate the commenters' support for these 
regulatory changes that reflect the recent statutory revisions required 
by section 4114 of the CAA, 2023.
    Comment: Multiple commenters expressed concerns over the period of 
data collection (January 1, 2019, through June 30, 2019) that would be 
utilized for the next data reporting period (January 1, 2024, through 
March 31, 2024). Commenters noted that private payer rate data from CY 
2019 would be several

[[Page 79086]]

years old and not reflect data on newer CDLTs that were released after 
this data collection period. Commenters also noted that this data 
collection period preceded the COVID-19 pandemic and recent trends of 
rising medical inflation, which has led to supply and labor challenges. 
Thus, commenters were concerned that private payor rates during this 
data collection period would be incongruent with the current economic 
environment and negatively impact subsequent payment under the CLFS.
    Response: We note that section 4114 of the CAA, 2023 did not modify 
the data collection period that applies to the next data reporting 
period for CDLTs that are not ADLTs. Therefore, under section 
1834A(a)(4)(B) of the Act, as amended by section 105(a)(1) of the FCAA, 
the next data reporting period for CDLTs that are not ADLTs (January 1, 
2024, through March 31, 2024) will continue to be based on the data 
collection period of January 1, 2019, through June 30, 2019, as defined 
in Sec.  414.502. Because this requirement is statutory, we are unable 
to modify the data collection period.
    Comment: A few commenters submitted recommendations to CMS related 
to outreach and education activities for data reporting purposes if 
these proposed policies become finalized. One commenter urged CMS to 
notify applicable laboratories as soon as possible if there are any 
future changes to the timeline for data reporting, since significant 
time and resources are required for entities to properly collect and 
report data. Another commenter suggested that CMS implement assertive 
outreach approaches to all applicable laboratories that need 
information and assistance to comply with section 216(a) of PAMA. They 
recommended that CMS make multi-media materials readily available to 
assist applicable laboratories who must fulfill data reporting 
obligations and should partner with national member organizations on 
presentations to inform applicable laboratories on the importance of 
reporting applicable information. They also recommended that CMS use 
its authority to impose civil monetary penalties (CMPs) and state 
publicly its intention to audit applicable laboratories and to impose 
penalties where warranted, in order to signal to all applicable 
laboratories that reporting is not voluntary, but mandatory.
    Response: We appreciate commenters' recommendations related to 
outreach and education for data reporting. Obtaining applicable 
information from applicable laboratories as required under PAMA is 
necessary to establish payment rates for CDLTs, and outreach and 
education activities for applicable laboratories play an important role 
in achieving this objective. Accordingly, we regularly update our 
website and have leveraged different media platforms to disseminate 
various educational materials and other resources to prepare these 
applicable laboratories for data reporting and inform them of changes 
to reporting requirements. For example, we recently created a video on 
how to determine if a laboratory is an applicable laboratory.\193\ 
Overall, CMS shares the commenters' interest in ensuring all applicable 
laboratories have the educational resources needed to report accurate 
and complete data to inform payment rates under the CLFS, and we may 
consider the submitted recommendations for upcoming data reporting 
periods.
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    \193\ https://youtu.be/c3eiPYeRA_U.
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    Additionally, regarding the comments on CMPs, we note that section 
1834A(a)(9)(A) of the Act authorizes the Secretary to apply a CMP in 
cases where the Secretary determines that an applicable laboratory has 
failed to report or made a misrepresentation or omission in reporting 
applicable information under section 1834A(a) of the Act for a CDLT. In 
these cases, the Secretary may apply a CMP in an amount of up to 
$10,000 per day for each failure to report or each such 
misrepresentation or omission. We codified this provision in our 
regulations at Sec.  414.504(e). As we previously stated in the CLFS 
final rule, which implemented section 216(a) of PAMA (81 FR 41069), in 
situations where our review reveals that the data submitted is 
incomplete or incorrect, we will work with the Office of Inspector 
General at the U.S Department of Health and Human Services (HHS OIG) to 
assess whether a CMP should be applied, and if so, the appropriate 
amount based on the specific circumstances.
    Comment: Multiple commenters conveyed concerns over the proposal 
for the phase-in of payment reductions to CLFS payment amounts that 
would be required to resume in CY 2024. Commenters raised that 
potential payment cuts to CDLTs of up to 15 percent could affect access 
to laboratory tests that guide medical decisions and might impact 
laboratories who already face resource constraints to conduct these 
tests. One commenter suggested capping the maximum payment reduction at 
5 percent instead of 15 percent or implementing a more gradual approach 
to payment reductions. Another commenter noted that the CY 2016 base 
year that CMS intends to use for CY 2024 CDLT payment amounts under the 
CLFS is outdated and not representative of all applicable laboratories.
    Response: We thank commenters for expressing their concerns 
regarding potential effects due to the phase-in of payment reductions. 
Nevertheless, we note that the phase-in of payment reductions to the 
CLFS is statutory; therefore, we are unable to alter implementation of 
the payment reductions or the maximum percentage by which payment can 
be reduced compared to the amount established for that test the 
preceding year. Section 1834A(b)(3)(B) of the Act explicitly states 
that there will be a 0 percent payment reduction for CY 2023 and, for 
CYs 2024 through 2026, payment may not be reduced by more than 15 
percent of the amount of payment for the test for the preceding year. 
Additionally, the CY 2016 base year on which the CLFS payment amounts 
will be based for CY 2024 is also statutory. Under sections 1834A(a)(1) 
and (b) of the Act, as enacted by PAMA, for CDLTs that are not ADLTs, 
the data collection period, data reporting period, and payment rate 
update are to occur every 3 years. The second data collection period 
for CDLTs that are not ADLTs occurred from January 1, 2019, through 
June 30, 2019, but a second data reporting period has not yet taken 
place due to the series of legislative delays passed since 2019 that 
modified the statutory data reporting period for such tests. Therefore, 
the only data collection period available for which data has been 
reported for CDLTs that are not ADLTs was the data collection period 
that occurred from January 1, 2016, through June 30, 2016, which will 
inform CY 2024 payment rate amounts for CDLTs that are not ADLTs under 
the CLFS. Lastly, promoting access to medically reasonable and 
necessary CDLTs for Medicare beneficiaries continues to be an important 
priority for CMS. Thus, we will continue to monitor cost and 
utilization data for CDLTs under the CLFS.
    Comment: While commenters agreed with our proposal to make 
conforming regulatory changes to the data reporting period and phase-in 
of payment reductions as mandated by section 4114 of the CAA, 2023, 
they also stated that they would support different types of new 
legislation that would modify these statutory requirements for the 
CLFS. For example, one commenter stated that they are supporting 
legislation that would give CMS new authority to collect private market 
data through

[[Page 79087]]

statistically valid sampling from all laboratory segments for the 
widely available test services where previous data collection was 
inadequate. Another commenter mentioned that they would support 
legislation to eliminate the data reporting requirements or to prohibit 
the use of laboratory-reported information for rate-setting. Commenters 
also indicated they would support legislation to stabilize payment 
rates for CDLTs. Many commenters also urged CMS to work with Congress 
to address these issues.
    Response: We appreciate these comments and value efforts to promote 
access to care to high quality laboratory services for Medicare 
beneficiaries. We also note that any legislative changes would require 
Congressional action.
    Comment: We received a few comments that were out of scope for this 
proposal. A few of these comments included ways to improve the CLFS 
annual payment determination process, expansions to the laboratory date 
of service policy, and/or a request to reconsider requiring hospital 
outreach laboratories to determine their applicable laboratory status.
    Response: We appreciate hearing from commenters on these issues. 
However, these comments are out of scope for this final rule as we did 
not make any proposals on these processes or policies. We could 
consider these requests for future rulemaking or CLFS annual payment 
determination processes as applicable and within our authorities under 
the statute.
    In consideration of these public comments and in accordance with 
section 4114 of the CAA, 2023, we are finalizing the proposed 
conforming changes to the data reporting and phase-in of payment 
reductions at 42 CFR part 414, subpart G, as proposed.

E. Pulmonary Rehabilitation, Cardiac Rehabilitation and Intensive 
Cardiac Rehabilitation Expansion of Supervising Practitioners

    Conditions of coverage for pulmonary rehabilitation (PR), cardiac 
rehabilitation (CR) and intensive cardiac rehabilitation (ICR) are 
codified at 42 CFR 410.47 and 410.49. We proposed revisions to the PR 
and CR/ICR regulations to codify the statutory changes made in section 
51008 of the Bipartisan Budget Act of 2018 (Pub. L. 115-123, February 
9, 2018) (BBA of 2018) which permit other specific practitioners to 
supervise the items and services effective January 1, 2024.
1. Statutory Authority
    Section 144(a) of the Medicare Improvements for Patients and 
Providers Act of 2008 (Pub. L. 110-275, July 15, 2008) (MIPPA) amended 
title XVIII to add new section 1861(eee) of the Act to provide coverage 
of CR and ICR under Medicare part B, as well as new section 1861(fff) 
of the Act to provide coverage of PR under Medicare part B. The statute 
specified certain conditions for coverage of these services and an 
effective date of January 1, 2010. Conditions of coverage for PR, CR 
and ICR consistent with the statutory provisions of section 144(a) of 
the MIPPA were codified in Sec. Sec.  410.47 and 410.49 respectively 
through the CY 2010 PFS final rule with comment period (74 FR 61872 
through 61886 and 62002 through 62003 (PR) 62004 through 62005 (CR/
ICR)). Section 51008 of the BBA of 2018, entitled ``Allowing Physician 
Assistants, Nurse Practitioners, and Clinical Nurse Specialists to 
Supervise Cardiac, Intensive Cardiac and Pulmonary Rehabilitation 
Programs,'' amended sections 1861(eee) and (fff) of the Act, effective 
January 1, 2024. The amendment directs us to add to the types of 
practitioners who may supervise PR, CR and ICR programs to also include 
a physician assistant (PA), nurse practitioner (NP), or clinical nurse 
specialist (CNS).
2. Background
    Under Sec.  410.47(b), Medicare part B covers PR for beneficiaries 
with moderate to very severe chronic obstructive pulmonary disease 
(COPD) (defined as GOLD classification II, III and IV), when referred 
by the physician treating the chronic respiratory disease and allows 
additional medical indications to be established through a national 
coverage determination (NCD). We have not added additional medical 
indications for PR using the NCD process; however, we used notice and 
comment rulemaking through the CY 2022 PFS final rule (86 FR 64996) to 
establish coverage of PR for beneficiaries who have had confirmed or 
suspected COVID-19 and experience persistent symptoms that include 
respiratory dysfunction for at least 4 weeks. In the same final rule, 
we also updated language to improve consistency and accuracy across PR 
and CR/ICR conditions of coverage and removed a PR requirement for 
direct physician-patient contact.
    Under Sec.  410.49(b), Medicare part B covers CR and ICR for 
beneficiaries who have experienced one or more of the following: (1) an 
acute myocardial infarction within the preceding 12 months; (2) a 
coronary artery bypass surgery; (3) current stable angina pectoris; (4) 
heart valve repair or replacement; (5) percutaneous transluminal 
coronary angioplasty (PTCA) or coronary stenting; (6) a heart or heart-
lung transplant; (7) stable, chronic heart failure defined as patients 
with left ventricular ejection fraction of 35 percent or less and New 
York Heart Association (NYHA) class II to IV symptoms despite being on 
optimal heart failure therapy for at least 6 weeks, on or after 
February 18, 2014, for cardiac rehabilitation and on or after February 
9, 2018, for intensive cardiac rehabilitation; or (8) other cardiac 
conditions as specified through an NCD. The NCD process may also be 
used to specify non-coverage of a cardiac condition for ICR if coverage 
is not supported by clinical evidence.
    In 2014, we established coverage of CR through the NCD process (NCD 
20.10.1, Cardiac Rehabilitation Programs for Chronic Heart Failure 
(Pub. 100-03)) to beneficiaries with stable, chronic heart failure. 
Section 51004 of the BBA of 2018 amended section 1861(eee)(4)(B) of the 
Act to expand coverage of ICR to include patients with stable, chronic 
heart failure. Section 410.49 was updated to codify this expansion 
through the CY 2020 PFS final rule (84 FR 62897 through 62899 and 
63188). The CY 2022 PFS final rule (86 FR 64996) updated language in 
Sec.  410.49 to improve consistency and accuracy across PR and CR/ICR 
conditions of coverage.
3. Summary of Proposals for Implementation
    Consistent with the amendments made by section 51008 of the BBA of 
2018 to section 1861(eee) and (fff) of the Act, we proposed additions 
and revisions to language in Sec. Sec.  410.47 and 410.49 as described 
below.
a. Definitions
    We proposed to add a new term, nonphysician practitioner (NPP), to 
Sec. Sec.  410.47(a) and 410.49(a), defined as a PA, NP, CNS as those 
terms are defined in section 1861(aa)(5)(A) of the Act.
    We proposed to amend the term supervising physician at Sec. Sec.  
410.47(a) and 410.49(a) to supervising practitioner and amend the 
definition to mean a physician or NPP.
    Finally, we proposed to amend the definition for pulmonary 
rehabilitation at Sec.  410.47(a) and the definitions for cardiac 
rehabilitation and intensive cardiac rehabilitation (ICR) program at 
Sec.  410.49(a) to specify that these are physician- or NPP-supervised 
programs.
b. Setting
    We proposed to amend Sec. Sec.  410.47(b)(3)(ii)(A) and 
410.49(b)(3)(ii)

[[Page 79088]]

to specify that all settings must have a physician or NPP immediately 
available and accessible for medical consultations and emergencies at 
all times when items and services are being furnished under the 
programs.
c. Supervising Practitioner Standards
    We proposed to amend language at Sec. Sec.  410.47(d) and 410.49(e) 
by specifying that these sections include supervising practitioner 
standards, rather than just supervising physician standards. We also 
removed the third standard in each section (Sec. Sec.  410.47(d)(3) and 
410.49(e)(3)) because specifying that a physician or NPP is licensed to 
practice medicine in the state where a PR/CR/ICR program is offered, or 
any corresponding reference to a NPP being licensed or authorized to 
practice, is redundant to the definition for each practitioner type in 
the Act. Since the physicians and NPPs that may supervise PR/CR/ICR are 
defined at Sec. Sec.  410.47(a) and 410.49(a) by cross-reference to the 
Act, we believe repeating part of that definition in these sections is 
unnecessary.
4. Summary
    We proposed additions and revisions that are necessary to implement 
the amendments to section 1861(eee) and (fff) of the Act set forth in 
section 51008 of the BBA of 2018, which expand the types of 
practitioners that may supervise PR, CR and ICR. This includes changes 
to the regulatory language in the definitions, settings, and 
supervising practitioner standards sections under Sec. Sec.  410.47 and 
410.49. After considering the public comments on our proposed rule 
(discussed below), we continue to believe these amendments to 
Sec. Sec.  410.47 and 410.49 serve to implement the provisions in the 
BBA of 2018 regarding the types of practitioners that may supervise PR, 
CR and ICR beginning January 1, 2024. As such, we are finalizing these 
additions and revisions as proposed. All other provisions of these 
regulations remain unchanged.
    We received public comments on our proposals with several 
supporting the proposed amendments to expand the types of practitioners 
that may supervise PR, CR and ICR and two opposing allowing supervision 
by NPPs.
    Comment: Of the commenters that supported expanding the types of 
practitioners who may supervise these programs, one commenter, who 
supported the allowing NPPs to supervise PR and CR, stated support 
specifically for the definition change and conforming revisions to the 
regulations to expand supervision of PR to NPPs. Another commenter 
supported the proposed definitions and standards. One commenter agreed 
with broadening the definition from supervising physician to 
supervising practitioner to account for additional providers. Several 
commenters stated that the expansion will help to expand access to 
these programs with a few noting that this is especially true in rural 
areas. Several commenters noted workforce shortages and the aging 
workforce to further support the proposals to expand practitioners that 
may supervise these programs.
    Response: We appreciate these supportive comments and are 
finalizing the additions and revisions to Sec. Sec.  410.47 and 410.49 
as proposed.
    Comment: One commenter supported the proposals stating that NPP 
supervision will continue to ensure safety and quality. One commenter 
asserted that advanced practice registered nurses, which include NPs 
and CNSs as explained by this commenter, are highly-trained and their 
education and licensure requirements prepare them to supervise CR and 
PR. Another agreed that advanced practitioners are highly experienced 
with complex patient populations and are fully embedded in the clinical 
practice making the proposed expansion an appropriate extension of 
their skill set in accordance with State licensure laws. One commenter 
stated that NPPs are highly trained to respond if emergencies arise and 
others noted that the ability to supervise is within PAs level of 
expertise. One commenter asserted that allowing NPPs to supervise these 
programs will help promote team-based provision of services and another 
stated that allowing advanced practice nurses to supervise 
rehabilitation services enables the overall healthcare team to function 
more efficiently and leads to better care coordination and patient 
outcomes, thus PAs, NPs and CNSs enhance the continuum of care.
    Response: We appreciate these supportive comments and are 
finalizing the additions and revisions to Sec. Sec.  410.47 and 410.49 
as proposed.
    Comment: One commenter requested that CMS revise the ``physician 
prescribed exercise'' language to include PAs. Citing the 2014 final 
decision memorandum for Cardiac Rehabilitation (CR) Programs--Chronic 
Heart Failure,\194\ this commenter stated that CMS previously declined 
to modify language in this manner because the statute specifies that 
the program is under the supervision of a physician. This commenter 
stated that since this section of the statute has been revised to allow 
PAs to supervise these programs, CMS should now modify this language 
accordingly to ``provider prescribed exercise.'' This commenter further 
requested that if the exact wording cannot be modified due to statutory 
constraints, CMS should reinterpret the intent of this section to 
indicate that health professionals authorized to supervise may also 
prescribe exercise. Additionally, this commenter urged CMS to work with 
Congress to modify physician-centric language in the U.S. Code that 
prohibits PAs and other health professionals from ordering PR, CR and 
ICR.
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    \194\ https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&NCAId=270.
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    Response: Physician-prescribed exercise continues to be a specific 
element of PR, CR and ICR based on the language in sections 
1861(eee)(3) and 1861(fff)(2)(A) of the Act. While the BBA of 2018 
expanded the types of practitioners that may supervise PR in section 
1861(fff)(1) of the Act and CR/ICR in section 1861(eee)(1) of the Act, 
Congress did not change the items and services that these programs must 
furnish, so we are not adopting the commenters suggested change. 
Interested parties may wish to consider working with Congress to pursue 
statutory changes to support those requests.
    Comment: Another commenter noted that under the ACO REACH model, 
NPs are allowed to establish, review, and sign a written care plan for 
PR and CR and requested that this waiver be standardized across all 
relevant payment models and CMS should explore regulatory avenues to 
remove the barrier for patients to be seen by NPs to increase PR and CR 
participation.
    Response: We understand the commenters' request to expand the role 
for NPPs in prescribing, ordering PR, CR, and ICR services and 
establishing, reviewing and signing plans of care for these services 
outside of a payment model; however, we do not believe the current 
statutory language would support the requested changes. Interested 
parties may wish to consider working with Congress to pursue statutory 
changes to support those requests.
    Comment: Some commenters disagreed with the proposed additions and 
revisions to our regulations because they opposed removing the 
requirement that physicians must supervise PR, CR and ICR services, and 
disagreed with expanding supervision requirements to include PAs, NPs 
and CNSs. One of these commenters further explained that the skillsets 
for physicians and NPPs are not interchangeable considering their

[[Page 79089]]

differences in education and training, and NPPs do not have the 
education and training needed to be the head of a care team. This 
commenter asserted that when NPPs practice without supervision the 
result is lower quality, higher cost care with strong evidence that 
increasing scope of practice of NPs and PAs has increased healthcare 
costs. This commenter further stated that the proposals are counter to 
patient preferences as patients believe it is important for a physician 
to be involved in the diagnosis and treatment decisions and expect the 
most qualified person to supervise care to patients with severe cardiac 
conditions. This commenter further requested that if CMS proceeds with 
expanding the types of practitioners that may supervise PR, CR and ICR, 
CMS should not use the overarching term ``nonphysician practitioner'' 
and instead directly reference the specific practitioners because the 
term can lead to confusion. Additionally, this commenter asserted that 
the regulatory language should specify that NPPs must be licensed to 
practice medicine in the State where the PR, CR or ICR program is 
located and where the patient is located when receiving care, and that 
NPPs must adhere to State scope of practice laws.
    Response: We understand that some commenters may not support the 
statutory changes that Congress has enacted but CMS may not simply 
ignore the statute. Our proposed and final rules are consistent with 
the statute and were supported by the majority of public commenters. 
Those commenters suggest that the changes will help to expand access to 
PR, CR, and ICR services for Medicare beneficiaries. We also disagree 
with the commenter's suggestion that using the overarching term 
``nonphysician practitioner'' could be confusing as our proposals 
clearly define the term for use under Sec. Sec.  410.47 and 410.49 and 
include a reference to the statutory definition for those practitioners 
as defined in section 1861(aa)(5)(A) of the Act. Furthermore, and as 
noted above in this final rule, we have determined that specifying that 
NPPs are licensed to practice medicine in the State where a PR/CR/ICR 
program is offered, or any corresponding reference to a NPP being 
licensed or authorized to practice, is unnecessary and would be 
redundant given the definition for each practitioner type in the 
statute. Since the physicians and NPPs that may supervise PR/CR/ICR 
services are defined at Sec. Sec.  410.47(a) and 410.49(a) by cross-
reference to a specific statute, we believe repeating part of that 
definition in these regulatory sections is unnecessary. Therefore, we 
are finalizing these additions and revisions as proposed.

F. Modifications Related to Medicare Coverage for Opioid Use Disorder 
(OUD) Treatment Services Furnished by Opioid Treatment Programs (OTPs)

1. Background
    Section 2005 of the Substance Use-Disorder Prevention that Promotes 
Opioid Recovery and Treatment (SUPPORT) for Patients and Communities 
Act (SUPPORT Act) (Pub. L. 115-271, October 24, 2018) established a new 
Medicare Part B benefit for OUD treatment services furnished by OTPs 
during an episode of care beginning on or after January 1, 2020. In the 
CY 2020 PFS final rule (84 FR 62630 through 62677 and 84 FR 62919 
through 62926), we implemented Medicare coverage and provider 
enrollment requirements and established a methodology for determining 
the bundled payments for episodes of care for the treatment of OUD 
furnished by OTPs. We also established in the CY 2020 PFS final rule 
new codes and finalized bundled payments for weekly episodes of care 
that include methadone, oral buprenorphine, implantable buprenorphine, 
injectable buprenorphine or naltrexone, and non-drug episodes of care, 
as well as add-on codes for intake and periodic assessments, take-home 
dosages for methadone and oral buprenorphine, and additional 
counseling. In the CY 2021 PFS final rule (85 FR 84683 through 84692), 
we adopted new add-on codes for take home supplies of nasal naloxone 
and injectable naloxone. In the CY 2022 PFS final rule (86 FR 65340 and 
65341), we established a new add-on code and payment for a higher dose 
of nasal naloxone. We also revised paragraphs (iii) and (iv) in the 
definition of ``Opioid use disorder treatment service'' at Sec.  
410.67(b) to allow OTPs to furnish individual and group therapy and 
substance use counseling using audio-only telephone calls rather than 
two-way interactive audio/video communication technology after the 
conclusion of the public health emergency (PHE) for COVID-19 in cases 
where audio/video communication technology is not available to the 
beneficiary, provided all other applicable requirements are met (86 FR 
65342).
    More recently, CMS made further modifications and expansions to 
covered services for the treatment of OUD by OTPs in the CY 2023 PFS 
final rule (87 FR 69768 through 69777). Specifically, we revised our 
methodology for pricing the drug component of the methadone weekly 
bundle and the add-on code for take-home supplies of methadone by using 
the payment amount for methadone for CY 2021 updated by the Producer 
Price Index (PPI) for Pharmaceuticals for Human Use (Prescription) to 
better reflect the changes in methadone costs for OTPs over time. 
Additionally, we finalized a modification to the payment rate for 
individual therapy in the non-drug component of the bundled payment for 
an episode of care to base the payment rate on the rate for longer 
therapy sessions that better account for the greater severity of needs 
for patients with an OUD and receiving treatment in the OTP setting. 
Moreover, for the purposes of the geographic adjustment, we clarified 
that services furnished via OTP mobile units will be treated as if the 
services were furnished in the physical location of the OTP for 
purposes of determining payments to OTPs under the Medicare OTP bundled 
payment codes and/or add-on codes to the extent that the services are 
medically reasonable and necessary and are furnished in accordance with 
Substance Abuse and Mental Health Services Administration (SAMHSA) and 
Drug Enforcement Administration (DEA) guidance. We believe that this 
policy enables OTPs to better serve Medicare beneficiaries living in 
underserved areas by providing access to many of the same OUD treatment 
services offered at the brick-and-mortar location of the OTP. We 
continue to monitor utilization of OUD treatment services furnished by 
OTPs to ensure that Medicare beneficiaries have appropriate access to 
care. For CY 2024, we proposed several modifications to the policies 
governing Medicare coverage and payment for OUD treatment services 
furnished by OTPs.
2. Additional Flexibilities for Periodic Assessments Furnished Via 
Audio-Only Telecommunications
    In the CY 2024 PFS proposed rule (88 FR 52414 through 52415), we 
discuss several flexibilities for OTPs regarding the use of 
telecommunications that we have finalized, both during the PHE for 
COVID-19 and outside of the PHE. In the CY 2020 PFS final rule, we 
finalized a policy allowing OTPs to furnish substance use counseling 
and individual and group therapy via two-way interactive audio-video 
communication technology. In the Interim Final Rule with Comment Period 
(IFC) entitled ``Medicare and Medicaid Programs: Policy and Regulatory 
Revisions in Response to the

[[Page 79090]]

COVID-19 Public Health Emergency,'' which appeared in the April 6, 2020 
Federal Register (85 FR 19258), we revised paragraphs (iii) and (iv) in 
the definition of opioid use disorder treatment service at Sec.  
410.67(b) on an interim final basis to allow the therapy and counseling 
portions of the weekly bundles, as well as the add-on code for 
additional counseling or therapy, to be furnished using audio-only 
telephone calls rather than via two-way interactive audio-video 
communication technology during the PHE for the COVID-19 if 
beneficiaries do not have access to two-way audio-video communications 
technology, provided all other applicable requirements are met. In the 
CY 2022 PFS final rule (86 FR 65341 through 65343), we finalized that 
after the conclusion of the PHE for COVID-19, OTPs are permitted to 
furnish substance use counseling and individual and group therapy via 
audio-only telephone calls when audio and video communication 
technology is not available to the beneficiary. As we explained in the 
CY 2022 PFS final rule (86 FR 65342), we interpret the requirement that 
audio/video technology is ``not available to the beneficiary'' to 
include circumstances in which the beneficiary is not capable of or has 
not consented to the use of devices that permit a two-way, audio/video 
interaction because in each of these instances audio/video 
communication technology is not able to be used in furnishing services 
to the beneficiary. More recently in the CY 2023 PFS final rule (87 FR 
69775 through 69777), we further extended telecommunication 
flexibilities for the initiation of treatment with buprenorphine 
outside of the COVID-19 PHE. Specifically, we allowed the OTP intake 
add-on code to be furnished via two-way, audio-video communications 
technology when billed for the initiation of treatment with 
buprenorphine, to the extent that the use of audio-video 
telecommunications technology to initiate treatment with buprenorphine 
is authorized by DEA and SAMHSA at the time the service is furnished. 
We also permitted the use of audio-only communication technology to 
initiate treatment with buprenorphine in cases where audio-video 
technology is not available to the beneficiary, provided all other 
applicable requirements are met.
    In the IFC entitled ``Medicare and Medicaid Programs, Basic Health 
Program, and Exchanges; Additional Policy and Regulatory Revisions in 
Response to the COVID-19 Public Health Emergency and Delay of Certain 
Reporting Requirements for the Skilled Nursing Facility Quality 
Reporting Program,'' which appeared in the May 8, 2020 Federal Register 
(85 FR 27558), we revised paragraph (vii) in the definition of ``Opioid 
use disorder treatment service'' at Sec.  410.67(b) on an interim final 
basis to allow periodic assessments to be furnished during the PHE for 
COVID-19 via two-way interactive audio-video telecommunication 
technology and, in cases where beneficiaries do not have access to two-
way audio-video communication technology, to permit the periodic 
assessments to be furnished using audio-only telephone calls rather 
than via two-way interactive audio-video communication technology, 
provided all other applicable requirements are met. In the CY 2021 PFS 
final rule (85 FR 84690), we finalized our proposal to revise paragraph 
(vii) in the definition of ``Opioid use disorder treatment service'' at 
Sec.  410.67(b) to provide that periodic assessments (HCPCS code G2077) 
must be furnished during a face-to-face encounter, which includes 
services furnished via two-way interactive audio-video communication 
technology, as clinically appropriate, provided all other applicable 
requirements are met, on a permanent basis.
    Furthermore, in the CY 2023 PFS proposed rule (87 FR 46093), we 
solicited comments on whether we should allow periodic assessments to 
continue to be furnished using audio-only communication technology 
following the end of the PHE for COVID-19 for patients who are 
receiving treatment via buprenorphine, and if this flexibility should 
also continue to apply to patients receiving methadone or naltrexone. 
In response, several commenters advocated for CMS to continue to allow 
periodic assessments to be furnished using audio-only when video is not 
available after the end of the PHE. Commenters highlighted that making 
audio-only flexibilities permanent would further promote equity for 
individuals who are economically disadvantaged, live in rural areas, 
are racial and ethnic minorities, lack access to reliable broadband or 
internet access, or do not possess devices with video capability. 
Additionally, a few commenters explained that there is some evidence to 
show higher utilization of audio-only visits for older adults. For 
example, one commenter stated that one analysis of claims data showed 
the proportion of telephonic audio-only visits increases with the age 
of the patient, with ``17 percent of visits delivered via audio-only 
interaction for patients 41-60 years of age, 30 percent for patients 
61-80 years of age, and 47 percent of visits for patients over 81.'' 
\195\ One commenter stated that periodic assessments are no less 
complex than intake/initial assessments, and thus are equally 
appropriate for audio-video and audio-only care. Lastly, several 
commenters expressed support for the use of telecommunications in 
circumstances when the provider and patient have together determined 
that the patient would individually benefit from telehealth services 
and a high quality of care is maintained. They encouraged CMS to expand 
flexibilities to furnish substance use disorder (SUD) services via 
telecommunications to allow providers and patients to decide 
collaboratively the best modality for individualized care. After 
considering these comments, CMS determined that it would be appropriate 
to allow periodic assessments to be furnished audio-only when video is 
not available through the end of CY 2023, to the extent that it is 
authorized by SAMHSA and DEA at the time the service is furnished and, 
in a manner consistent with all applicable requirements. We stated our 
belief that this modification would allow continued beneficiary access 
to these services for the duration of CY 2023 in the event the PHE 
terminated before the end of 2023 and that it would also grant 
additional time for CMS to further consider telecommunication 
flexibilities associated with periodic assessments. Accordingly, we 
revised the requirements related to the periodic assessment services in 
paragraph (vii) in the definition of ``Opioid use disorder treatment 
service'' at Sec.  410.67(b) of the regulations to reflect these 
changes (87 FR 69777).
---------------------------------------------------------------------------

    \195\ 2021 Medicare Coverage and Payment for Audio-Only 
Services: https://www.aamc.org/media/55296/download.
---------------------------------------------------------------------------

    In the CY 2024 PFS proposed rule (88 FR 52415 through 52416), we 
explained that section 4113 of Division FF, Title IV, Subtitle A of the 
Consolidated Appropriations Act of 2023 (CAA, 2023) (Pub. L. 117-328, 
December 29, 2022) extended the telehealth flexibilities enacted in the 
Consolidated Appropriations Act of 2022 (CAA, 2022) (Pub. L. 117-103, 
March 15, 2022). Specifically, it amended sections 1834(m), 1834(o), 
and 1834(y) of the Act to delay the requirement for an in-person visit 
prior to furnishing certain mental health services via 
telecommunications technology by physicians and other practitioners, 
Rural Health Clinics (RHCs), and Federally Qualified Health Centers

[[Page 79091]]

(FQHCs) until dates of service on or after January 1, 2025, if the 
COVID-19 PHE ended prior to that date. Additionally, it extended the 
flexibilities available during the PHE that allow for certain Medicare 
telehealth services defined in section 1834(m)(4)(F)(i) of the Act to 
be furnished via an audio-only telecommunications system through 
December 31, 2024, if the PHE for COVID-19 ends prior to that date. We 
stated that the PHE for COVID-19, which was declared under section 319 
of the Public Health Service Act, expired at the end of the day on May 
11, 2023, so the aforementioned flexibilities will be extended through 
the end of CY 2024 or CY 2025, as applicable.
    To better align coverage for periodic assessments furnished by OTPs 
with the telehealth flexibilities described in section 4113 of the CAA, 
2023, in the CY 2024 PFS proposed rule, we proposed to extend the 
audio-only flexibilities for periodic assessments furnished by OTPs 
through the end of CY 2024. Under this proposal, we stated that we 
would allow periodic assessments to be furnished audio-only when video 
is not available to the extent that use of audio-only communications 
technology is permitted under the applicable SAMHSA and DEA 
requirements at the time the service is furnished, and all other 
applicable requirements are met.\196\ We believe extending this 
flexibility would promote continued beneficiary access to these 
services following the end of the PHE and for the duration of CY 2024. 
During the COVID-19 pandemic, SUD treatment facilities increased 
telemedicine offerings by 143 percent, and as of 2021, almost 60 
percent of SUD treatment facilities offer telehealth.\197\ Notably, 
telephone-based (that is, audio-only) therapy and recovery support 
services provided by SUD programs have been found to be one of the most 
common modes of telehealth for treatment of opioid use disorder.\198\ 
Therefore, extending these audio-only flexibilities for an additional 
year may minimize disruptions associated with the conclusion of the 
PHE. Additionally, we explained that evidence has shown that Medicare 
beneficiaries who are older than 65 years-old, racial/ethnic 
minorities, dual-enrollees, or living in rural areas, or who experience 
low broadband access, low-income, and/or not speaking English as their 
primary language, are more likely to be offered and use audio-only 
telemedicine services than audio-video services.\199\ Other evidence 
also has suggested that while Tribal populations, including American 
Indian and Alaska Natives, have the highest rates of OUD prevalence 
among Medicare beneficiaries, one-third of these populations do not 
have adequate access to high-speed broadband and continue to rely on 
audio-only visits.\200\ Therefore, minimizing disruptions to care for 
beneficiaries currently receiving audio-only periodic assessments may 
further promote health equity and minimize disparities in access to 
care. Lastly, we stated that extending these flexibilities another year 
will allow CMS time to further consider this issue, including whether 
periodic assessments should continue to be furnished using audio-only 
communication technology following the end of CY 2024 for patients who 
are receiving treatment via buprenorphine, methadone, and/or naltrexone 
at OTPs.
---------------------------------------------------------------------------

    \196\ https://www.samhsa.gov/medications-substance-use-disorders/statutes-regulations-guidelines. https://www.deadiversion.usdoj.gov/.
    \197\ https://pubmed.ncbi.nlm.nih.gov/34407631/.
    \198\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8250742/.
    \199\ https://pubmed.ncbi.nlm.nih.gov/33471458/; https://www.kff.org/medicare/issue-brief/medicare-and-telehealth-coverage-and-use-during-the-covid-19-pandemic-and-options-for-the-future/; 
https://journals.lww.com/lww-medicalcare/Fulltext/2021/11000/Disparities_in_Audio_only_Telemedicine_Use_Among.10.aspx.
    \200\ https://docs.fcc.gov/public/attachments/FCC-20-50A1.pdf; 
https://www.cms.gov/files/document/aian-telehealthwebinar.pdf; 
https://www.sciencedirect.com/science/article/pii/S0749379721000921?via%3Dihub.
---------------------------------------------------------------------------

    Accordingly, we proposed to revise paragraph (vii) of the 
definition of ``Opioid use disorder treatment service'' at Sec.  
410.67(b) of the regulations to state that through the end of CY 2024, 
in cases where a beneficiary does not have access to two-way audio-
video communications technology, periodic assessments can be furnished 
using audio-only telephone calls if all other applicable requirements 
are met (88 FR 52416).
    We received many public comments on our proposal to extend the 
audio-only flexibilities for periodic assessments furnished by OTPs 
through the end of CY 2024. The following is a summary of the comments 
we received and our responses.
    Comment: Commenters were very supportive of extending the audio-
only flexibilities for periodic assessments furnished by OTPs through 
the end of CY 2024. Many commenters stated that this proposal, if 
finalized, would meaningfully promote efforts towards improving health 
equity. A few commenters noted that the audio-only extension would be 
beneficial for the Medicare population, as evidence has shown 
clinicians are experiencing a higher utilization of audio-only visits 
for older adults, especially as the age of the patient increases.\201\ 
Commenters also reiterated that audio-only telehealth encounters are 
more prominent among individuals who are older, Black, Hispanic, 
American Indian/Alaskan Native, Spanish-speaking, living in areas with 
low broadband access, low-income, and with public insurance.\202\ 
Additionally, several commenters raised that many underserved 
populations experience challenges partaking in video-based telehealth 
services for several reasons, including not possessing the needed 
technological proficiencies to operate video-based services, not having 
a caregiver able to assist them with appointments, feeling discomfort 
with the use of video, and because of the cost of high-speed internet 
and data required for video technologies. Furthermore, multiple 
commenters provided evidence demonstrating the effectiveness of audio-
only telehealth services on patient outcomes. One commenter cited a 
recent study in which telehealth expansion implemented by CMS during 
the COVID-19 PHE was associated with improved treatment retention and a 
lower likelihood of overdose for patients receiving medications for 
opioid use disorder (MOUD).\203\ Several other commenters shared data 
that audio-only visits produce many of the same benefits as video-based 
visits,\204\ and

[[Page 79092]]

that patients often report that audio-only visits left them feeling 
supported and with greater privacy, provided increased access to 
behavioral health professionals, and helped reduce transportation 
barriers.\205\ Moreover, many commenters shared that our proposal to 
extend audio-only flexibilities for periodic assessments would help 
facilitate collaborative decision-making and allow the provider and 
patient to select the modality of care that best suits the patient's 
needs. Lastly, a few commenters stated that an extension of these 
flexibilities would provide both patients and providers additional time 
to adjust to changes in ways appointments are conducted in preparation 
for a reversion to many policies preceding the COVID-19 pandemic, while 
minimizing potential disruptions to treatment.
---------------------------------------------------------------------------

    \201\ HHS ASPE Issue Brief: Medicare beneficiary use of 
telehealth visits: Early Data from the Start of the COVID-19 
Pandemic (July 27, 2020). https://aspe.hhs.gov/reports/medicare-beneficiary-use-telehealth-visits-early-data-start-covid-19-pandemic.
    \202\ J.A. Rodriguez et al., ``Differences in the Use of 
Telephone and Video Telemedicine Visits During the COVID-19 
Pandemic,'' The American Journal of Managed Care 27, no. 1 (2021), 
https://www.ajmc.com/view/differences-in-the-use-of-telephone-and-video-telemedicine-visits-during-the-covid-19-pandemic; R.P. Pierce 
and J.J. Stevermer, ``Disparities in Use of Telehealth at the Onset 
of the COVID-19 Public Health Emergency,'' Journal of Telemedicine 
and Telecare (2020): 1-7, https://doi.org/10.1177/1357633X20963893; 
J.E. Chang et al., ``Patient Characteristics Associated with Phone 
Versus Video Telemedicine Visits for Substance Use Treatment During 
COVID-19,'' J Addict Med 16, no. 6 (2022): 659-65; C. Shoff, T-C 
Yang, B.A. Shaw, ``Trends in Opioid Use Disorder Among Older Adults: 
Analyzing Medicare Data, 2013-2018,'' American Journal of Preventive 
Medicine 60, no.6 (2021): 850-855, https://doi.org/10.1016/j.amepre.2021.01.010.
    \203\ Jones CM, Shoff C, Hodges K, et al. Receipt of Telehealth 
Services, Receipt and Retention of Medications for Opioid Use 
Disorder, and Medically Treated Overdose Among Medicare 
Beneficiaries Before and During the COVID-19 Pandemic. JAMA 
Psychiatry. Published online August 31, 2022. doi:10.1001/
jamapsychiatry.2022.2284.
    \204\ Danila, M.I., Sun,D., Jackson,L.E., Cutter, G., Jackson, 
E.A., Ford, E.W., DeLaney, E., Mudano, A., Foster, P.J., Rosas, G., 
Melnick, J.A, Curtis,J.R., & Saag, K.G. (2022, November). 
Satisfaction with modes of telemedicine delivery during COVID-19: A 
randomized, single-blind, parallel group, noninferiority trial. The 
American Journal of the Medical Sciences, 364 (5).
    \205\ Kang AW, Walton M, Hoadley A, DelaCuesta C, Hurley L, 
Martin R. Patient Experiences with the Transition to Telephone 
Counseling during the COVID-19 Pandemic. Healthcare (Basel). 
2021;9(6):663. Published 2021 Jun 2. doi:10.3390/healthcare9060663.
---------------------------------------------------------------------------

    Response: We appreciate the positive feedback submitted by 
commenters in response to our proposal to extend audio-only 
flexibilities for periodic assessments furnished by OTPs through CY 
2024. CMS agrees that the proposed policy may further the objectives of 
promoting health equity among underserved populations, be consistent 
with evidence indicating the effectiveness of audio-only services on 
patient utilization and outcomes, help facilitate collaborative 
decision-making between the provider and patient, allow OTPs additional 
time to adjust their activities as flexibilities that were tied to the 
COVID-19 PHE termination, and minimize potential disruptions to care 
for Medicare beneficiaries with an OUD.
    Comment: A few commenters supported extending audio-only 
flexibilities in OTP settings but asserted that greater regulatory 
flexibility must come with additional safeguards. These commenters 
stated that shifting additional services to telehealth settings could 
increase the risk of a diminished quality of care, and that telehealth 
modalities are not appropriate for every doctor and patient 
interaction. The commenters stated that even if telehealth 
flexibilities are extended, periodic in-person visits should be 
required and coupled with a compliance and monitoring process to ensure 
program integrity. These commenters supported extending audio-only 
flexibilities by an additional year in OTP settings because it would 
provide CMS more time to examine how various telecommunications 
modalities can be deployed appropriately while maintaining a high 
quality of care and safety before permanently extending these 
flexibilities.
    Response: We agree with the commenters regarding the importance of 
maintaining standards to ensure safety and quality of care for Medicare 
beneficiaries. Accordingly, we continue to defer to SAMHSA and DEA 
clinical guidance and other applicable requirements to achieve this 
objective.\206\ We will continue to analyze clinical evidence and 
guidance to ensure that any flexibilities to utilize audio-only/audio-
video modalities meet all applicable requirements, and monitor claims 
and utilization data for program integrity purposes. We may address any 
concerns related to these aforementioned issues through future 
rulemaking as needed.
---------------------------------------------------------------------------

    \206\ https://www.samhsa.gov/medications-substance-use-disorders/statutes-regulations-guidelines. https://www.deadiversion.usdoj.gov/.
---------------------------------------------------------------------------

    Comment: Many commenters requested that CMS make the extension for 
audio-only periodic assessments permanent beyond CY 2024. Commenters 
stated that extending this policy permanently would retain a 
beneficiary's right to decide with their provider how best to receive 
their care and would curtail existing barriers that Medicare 
beneficiaries with an OUD may face in accessing care. Another commenter 
urged CMS to work with the DEA and SAMHSA to maintain audio-only 
flexibilities for the treatment of OUD, as they expand access to 
treatment for rural populations.
    Response: We thank commenters for providing this feedback. In the 
CY 2024 PFS proposed rule, we stated that extending these flexibilities 
for audio-only periodic assessments by one additional year would allow 
CMS time to further consider whether periodic assessments should 
continue to be furnished using audio-only communication technology 
following the end of CY 2024. An additional year would also allow CMS 
time to examine whether a permanent flexibility to furnish periodic 
assessments via audio-only telecommunications would be appropriate for 
patients who are receiving treatment via buprenorphine, methadone, and/
or naltrexone at OTPs, and whether proper safeguards are in place so 
these services can be delivered in a way that would not diminish safety 
or quality of care for Medicare beneficiaries with an OUD (88 FR 
52415). We will continue to evaluate this issue, including reviewing 
relevant SAMHSA and DEA guidance on this issue, and may consider 
additional changes through future rulemaking.
    Comment: One commenter stated that they supported CMS's proposal to 
continue to allow OTPs to furnish substance use counseling and 
individual and group therapy via audio-only communications through CY 
2024 when audio-video communication technology is not available to the 
beneficiary.
    Response: We clarify that CMS previously finalized a policy in the 
CY 2022 PFS final rule (86 FR 65342) to allow individual and group 
therapy and substance use counseling to be furnished audio-only after 
the conclusion of the COVID-19 PHE in OTP settings in cases where 
audio-video communication technology is not available to the 
beneficiary, and all other applicable requirements are met. In the CY 
2024 PFS proposed rule, the proposal was specifically related to 
extending current flexibilities for periodic assessments that are 
furnished via audio-only telecommunications through the end of CY 2024.
    Comment: A few commenters acknowledged the recent approval by the 
Food and Drug Administration (FDA) to allow certain naloxone products 
to be available over the counter. These same commenters asked that CMS 
continue to pay for take-home supplies of naloxone provided by OTPs 
whether naloxone is available by prescription or over the counter to 
ensure continued access to this lifesaving drug.
    Response: Although we did not make a proposal related to take-home 
supplies of naloxone, we appreciate that commenters raised this 
important issue. CMS shares in the commenters' interest to ensure 
access to naloxone when medically necessary to treat a potential 
overdose. CMS currently covers take-home supplies of naloxone under 
Medicare Part B within the OTP benefit as described by the HCPCS add-on 
codes G2215 (take-home supply of nasal naloxone), G2216 (take-home 
supply of injectable naloxone), and G1028 (take-home supply of nasal 
naloxone; 2-pack of 8mg per 0.1 mL nasal spray).
    Comment: We received other comments on several topics that were 
outside the scope of the proposed rule. Those topics included the 
following: implementing policy changes to leverage pharmacists to 
deliver clinical services for patients with an OUD; clarifying that 
OTPs can bill Medicare for primary care services so that these

[[Page 79093]]

services can be furnished in conjunction with SUD treatment; and, 
creating new codes for remote therapeutic monitoring (RTM) to allow for 
remote observation of patients receiving take-home doses of methadone.
    Response: While these comments are out of scope for this final rule 
as they do not relate to our proposal to allow OTPs to furnish periodic 
assessments audio-only through CY 2024, we appreciate commenters 
raising these issues and may consider these recommendations for future 
rulemaking.
    After consideration of the public comments, we are finalizing our 
proposal to revise paragraph (vii) of the definition of ``Opioid use 
disorder treatment service'' at Sec.  410.67(b) of the regulations to 
state that through the end of CY 2024, in cases where a beneficiary 
does not have access to two-way audio-video communications technology, 
periodic assessments can be furnished using audio-only telephone calls 
if all other applicable requirements are met.
3. Intensive Outpatient Program (IOP) Services Provided by OTPs
    In the CY 2023 PFS proposed rule, we solicited comments on 
intensive outpatient mental health treatment (87 FR 45943 through 
45944). Commenters emphasized the importance of ensuring access to 
intensive outpatient program (IOP) services in OTP settings and that 
these services are valuable to those with SUDs (for example, OUD), 
including individuals who cannot stabilize at a lower level of care or 
require more care than can be provided in office settings and 
individuals who have stabilized biomedical conditions and the need for 
close monitoring but no longer require a higher level of care for SUD 
treatment, such as partial hospitalization or inpatient care.
    Please see the CY 2024 Outpatient Prospective Payment System (OPPS) 
final rule for the full policy discussion and additional details 
regarding the proposal to establish Medicare payment for IOP services 
provided by OTPs, as well as our responses to comments and final 
policies on these proposals.

G. Medicare Shared Savings Program

1. Executive Summary and Background
a. Purpose
    Eligible groups of providers and suppliers, including physicians, 
hospitals, and other healthcare providers, may participate in the 
Medicare Shared Savings Program (Shared Savings Program) by forming or 
joining an accountable care organization (ACO), and in so, doing agree 
to become accountable for the total cost and quality of care provided 
under Original Medicare to an assigned population of Medicare fee-for-
service (FFS) beneficiaries. Under the Shared Savings Program, 
providers and suppliers that participate in an ACO continue to receive 
Medicare FFS payments under Parts A and B, and the ACO may be eligible 
to receive a shared savings payment if it meets specified quality and 
savings requirements, and in some instances may be required to share in 
losses if it increases health care spending.
    As of January 1, 2023, 10.9 million people with Medicare receive 
care from one of the 573,126 health care providers in the 456 ACOs 
participating in the Shared Savings Program, the largest value-based 
care program in the country.\207\ While the Shared Savings Program 
experienced a decrease in the number of ACOs and assigned beneficiaries 
for 2023, the policies finalized in the CY 2023 PFS final rule (87 FR 
69777 through 69968) are expected to grow participation in the program 
for 2024 and beyond, when many of the new policies are set to go into 
effect. These policies are expected to drive growth in participation, 
particularly in rural and underserved areas, promote equity, advance 
alignment across accountable care initiatives, and increase the number 
of beneficiaries assigned to ACOs participating in the program by up to 
four million over the next several years.\208\ Accordingly, we expect 
these recently finalized changes will support CMS in achieving its goal 
of having 100 percent of people with Original Medicare in a care 
relationship with accountability for quality and total cost of care by 
2030.\209\
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    \207\ Refer to CMS, Shared Savings Program Fast Facts--As of 
January 1, 2023, available at https://www.cms.gov/files/document/2023-shared-savings-program-fast-facts.pdf.
    \208\ See CMS Press Release, ``CMS Announces Increase in 2023 in 
Organizations and Beneficiaries Benefiting from Coordinated Care in 
Accountable Care Relationship'', January 17, 2023, available at 
https://www.cms.gov/newsroom/press-releases/cms-announces-increase-2023-organizations-and-beneficiaries-benefiting-coordinated-care-accountable.
    \209\ Ibid. See also, Seshamani M., Fowler E., Brooks-LaSure C., 
Building On The CMS Strategic Vision: Working Together For A 
Stronger Medicare. Health Affairs. January 11, 2022. Available at 
https://www.healthaffairs.org/do/10.1377/forefront.20220110.198444. 
CMS, Innovation Center Strategy Refresh, available at https://innovation.cms.gov/strategic-direction-whitepaper (Innovation Center 
Strategic Objective 1: Drive Accountable Care, pages 13-17).
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    To further advance Medicare's overall value-based care strategy of 
growth, alignment, and equity, and to respond to concerns raised by 
ACOs and other interested parties, we proposed changes to the Shared 
Savings Program as described in section III.G. of the CY 2024 PFS 
proposed rule (88 FR 52416 through 52498), and we sought public 
comments which we summarize and respond to in sections III.G.2. through 
III.G.8. of this final rule. We proposed changes to the quality 
performance standard and reporting requirements under the Alternative 
Payment Model (APM) Performance Pathway (APP) within the Quality 
Payment Program (QPP) that would continue to move ACOs toward digital 
measurement of quality and align with the QPP. Further, we proposed to 
add a third step to the step-wise beneficiary assignment methodology 
under which we would use an expanded period of time to identify whether 
a beneficiary has met the requirement for having received a primary 
care service from a physician who is an ACO professional in the ACO to 
allow additional beneficiaries to be eligible for assignment, as well 
as proposing related changes to how we identify assignable 
beneficiaries used in certain Shared Savings Program calculations. 
Additionally, we proposed updates to the definition of primary care 
services used for purposes of beneficiary assignment to remain 
consistent with billing and coding guidelines. We also proposed 
refinements to the financial benchmarking methodology for ACOs in 
agreement periods beginning on January 1, 2024, and in subsequent 
years, to cap the risk score growth in an ACO's regional service area 
when calculating regional trends used to update the historical 
benchmark at the time of financial reconciliation for symmetry with the 
cap on ACO risk score growth; further mitigate the impact of the 
negative regional adjustment on the benchmark to encourage 
participation by ACOs caring for medically complex, high-cost 
beneficiaries; specify the circumstances in which CMS would recalculate 
the prior savings adjustment for changes in values used in benchmark 
calculations due to compliance action taken to address avoidance of at-
risk beneficiaries, or as a result of the issuance of a revised initial 
determination of financial performance for a previous performance year 
following a reopening of ACO shared savings and shared losses 
calculations; and apply the same CMS-HCC risk adjustment methodology 
applicable to the calendar year corresponding to the performance year 
in calculating risk scores for Medicare FFS beneficiaries for each 
benchmark year. We also proposed to refine our policies for the newly 
established advance investment payments (AIP) and

[[Page 79094]]

to make updates to other programmatic areas, including the program's 
eligibility requirements, and make timely technical changes to the 
regulations for clarity and consistency. Lastly, we solicited comments 
on potential future developments to Shared Savings Program policies, 
including with respect to incorporating a new track that would offer a 
higher level of risk and potential reward than currently available 
under the ENHANCED track, refining the three-way blended benchmark 
update factor and the prior savings adjustment, and promoting ACO and 
community-based organization (CBO) collaboration.
b. Statutory and Regulatory Background on the Shared Savings Program
    On March 23, 2010, the Patient Protection and Affordable Care Act 
(Pub. L. 111-148) was enacted, followed by enactment of the Health Care 
and Education Reconciliation Act of 2010 (Pub. L. 111-152) on March 30, 
2010, which amended certain provisions of the Patient Protection and 
Affordable Care Act (hereinafter collectively referred to as ``the 
Affordable Care Act''). Section 3022 of the Affordable Care Act amended 
Title XVIII of the Act (42 U.S.C. 1395 et seq.) by adding section 1899 
of the Act to establish the Medicare Shared Savings Program (Shared 
Savings Program) to facilitate coordination and cooperation among 
healthcare providers to improve the quality of care for Medicare FFS 
beneficiaries and reduce the rate of growth in expenditures under 
Medicare Parts A and B. (See 42 U.S.C. 1395jjj.)
    Section 1899 of the Act has been amended through subsequent 
legislation. The requirements for assignment of Medicare FFS 
beneficiaries to ACOs participating under the program were amended by 
the 21st Century Cures Act (the CURES Act) (Pub. L. 114-255, December 
13, 2016). The Bipartisan Budget Act of 2018 (Pub. L. 115-123, February 
9, 2018), further amended section 1899 of the Act to provide for the 
following: expanded use of telehealth services by physicians or 
practitioners participating in an applicable ACO to furnish services to 
prospectively assigned beneficiaries; greater flexibility in the 
assignment of Medicare FFS beneficiaries to ACOs by allowing ACOs in 
tracks under retrospective beneficiary assignment a choice of 
prospective assignment for the agreement period; permitting Medicare 
FFS beneficiaries to voluntarily identify an ACO professional as their 
primary care provider and requiring that such beneficiaries be notified 
of the ability to make and change such identification, and mandating 
that any such voluntary identification will supersede claims-based 
assignment; and allowing ACOs under certain two-sided risk models to 
establish CMS-approved beneficiary incentive programs.
    The Shared Savings Program regulations are codified at 42 CFR part 
425. The final rule establishing the Shared Savings Program appeared in 
the November 2, 2011 Federal Register (Medicare Program; Medicare 
Shared Savings Program: Accountable Care Organizations; final rule (76 
FR 67802) (hereinafter referred to as the ``November 2011 final 
rule'')). A subsequent major update to the program rules appeared in 
the June 9, 2015 Federal Register (Medicare Program; Medicare Shared 
Savings Program: Accountable Care Organizations; final rule (80 FR 
32692) (hereinafter referred to as the ``June 2015 final rule'')). The 
final rule entitled, ``Medicare Program; Medicare Shared Savings 
Program; Accountable Care Organizations--Revised Benchmark Rebasing 
Methodology, Facilitating Transition to Performance-Based Risk, and 
Administrative Finality of Financial Calculations,'' which addressed 
changes related to the program's financial benchmark methodology, 
appeared in the June 10, 2016 Federal Register (81 FR 37950) 
(hereinafter referred to as the ``June 2016 final rule''). A final 
rule, ``Medicare Program; Revisions to Payment Policies Under the 
Physician Fee Schedule and Other Revisions to Part B for CY 2019; 
Medicare Shared Savings Program Requirements; Quality Payment Program; 
Medicaid Promoting Interoperability Program; Quality Payment Program--
Extreme and Uncontrollable Circumstance Policy for the 2019 MIPS 
Payment Year; Provisions From the Medicare Shared Savings Program--
Accountable Care Organizations--Pathways to Success; and Expanding the 
Use of Telehealth Services for the Treatment of Opioid Use Disorder 
Under the Substance Use-Disorder Prevention That Promotes Opioid 
Recovery and Treatment (SUPPORT) for Patients and Communities Act'', 
appeared in the November 23, 2018 Federal Register (83 FR 59452) 
(hereinafter referred to as the ``November 2018 final rule'' or the 
``CY 2019 PFS final rule''). In the November 2018 final rule, we 
finalized a voluntary 6-month extension for existing ACOs whose 
participation agreements would otherwise expire on December 31, 2018; 
allowed beneficiaries greater flexibility in designating their primary 
care provider and in the use of that designation for purposes of 
assigning the beneficiary to an ACO if the clinician they align with is 
participating in an ACO; revised the definition of primary care 
services used in beneficiary assignment; provided relief for ACOs and 
their clinicians impacted by extreme and uncontrollable circumstances 
in performance year 2018 and subsequent years; established a new 
Certified Electronic Health Record Technology (CEHRT) use threshold 
requirement; and reduced the Shared Savings Program quality measure set 
from 31 to 23 measures (83 FR 59940 through 59990 and 59707 through 
59715).
    A final rule redesigning the Shared Savings Program appeared in the 
December 31, 2018 Federal Register (Medicare Program: Medicare Shared 
Savings Program; Accountable Care Organizations--Pathways to Success 
and Extreme and Uncontrollable Circumstances Policies for Performance 
Year 2017; final rule (83 FR 67816) (hereinafter referred to as the 
``December 2018 final rule'')). In the December 2018 final rule, we 
finalized a number of policies for the Shared Savings Program, 
including a redesign of the participation options available under the 
program to encourage ACOs to transition to two-sided risk models; new 
tools to support coordination of care across settings and strengthen 
beneficiary engagement; and revisions to ensure rigorous benchmarking.
    In the interim final rule with comment period (IFC) entitled 
``Medicare and Medicaid Programs; Policy and Regulatory Revisions in 
Response to the COVID-19 Public Health Emergency'', which was effective 
on the March 31, 2020 date of display and appeared in the April 6, 2020 
Federal Register (85 FR 19230) (hereinafter referred to as the ``March 
31, 2020 COVID-19 IFC''), we removed the restriction that prevented the 
application of the Shared Savings Program extreme and uncontrollable 
circumstances policy for disasters that occur during the quality 
reporting period if the reporting period is extended to offer relief 
under the Shared Savings Program to all ACOs that may be unable to 
completely and accurately report quality data for 2019 due to the PHE 
for COVID-19 (85 FR 19267 and 19268).
    In the IFC entitled ``Medicare and Medicaid Programs; Basic Health 
Program, and Exchanges; Additional Policy and Regulatory Revisions in 
Response to the COVID-19 Public Health Emergency and Delay of Certain 
Reporting Requirements for the Skilled Nursing Facility Quality 
Reporting Program'' which was effective on May 8, 2020, and appeared in 
the May 8, 2020

[[Page 79095]]

Federal Register (85 FR 27550) (hereinafter referred to as the ``May 8, 
2020 COVID-19 IFC''), we modified Shared Savings Program policies to: 
(1) allow ACOs whose agreement periods expired on December 31, 2020, 
the option to extend their existing agreement period by 1-year, and 
allow ACOs in the BASIC track's glide path the option to elect to 
maintain their current level of participation for performance year 
2021; (2) adjust program calculations to remove payment amounts for 
episodes of care for treatment of COVID-19; and (3) expand the 
definition of primary care services for purposes of determining 
beneficiary assignment to include telehealth codes for virtual check-
ins, e-visits, and telephonic communication. We also clarified the 
applicability of the program's extreme and uncontrollable circumstances 
policy to mitigate shared losses for the period of the PHE for COVID-19 
starting in January 2020 (85 FR 27573 through 27587).
    We have also made use of the annual CY PFS rules to address quality 
reporting for the Shared Savings Program and certain other issues. For 
summaries of certain policies finalized in prior PFS rules, refer to 
the CY 2020 PFS proposed rule (84 FR 40705), the CY 2021 PFS final rule 
(85 FR 84717), the CY 2022 PFS final rule (86 FR 65253 and 65254), and 
the CY 2023 PFS final rule (87 FR 69779 and 69780). In the CY 2023 PFS 
final rule (87 FR 69777 through 69968), we finalized changes to Shared 
Savings Program policies, including to: provide advance shared savings 
payments in the form of advance investment payments to certain new, low 
revenue ACOs that can be used to support their participation in the 
Shared Savings Program; provide greater flexibility in the progression 
to performance-based risk; establish a health equity adjustment to an 
ACO's Merit-based Incentive Payment System (MIPS) quality performance 
category score used to determine shared savings and losses to recognize 
high quality performance by ACOs serving a higher proportion of 
underserved populations; incorporate a sliding scale reflecting an 
ACO's quality performance for use in determining shared savings for 
ACOs, and revise the approach for determining shared losses for 
ENHANCED track ACOs; modify the benchmarking methodology to strengthen 
financial incentives for long term participation by reducing the impact 
of ACOs' performance and market penetration on their benchmarks, and to 
support the business case for ACOs serving high-risk and high dually 
eligible populations to participate, as well as mitigate bias in 
regional expenditure calculations for ACOs electing prospective 
assignment; expand opportunities for certain low revenue ACOs 
participating in the BASIC track to share in savings; make changes to 
policies within other programmatic areas, including the program's 
beneficiary assignment methodology, requirements related to marketing 
material review and beneficiary notifications, the SNF 3-day rule 
waiver application, and data sharing requirements.
    Policies applicable to Shared Savings Program ACOs for purposes of 
reporting for other programs have also continued to evolve based on 
changes in the statute. The Medicare Access and CHIP Reauthorization 
Act of 2015 (MACRA) (Pub. L. 114-10, April 16, 2015) established the 
Quality Payment Program. In the CY 2017 Quality Payment Program final 
rule with comment period (81 FR 77008), we established regulations for 
the MIPS and Advanced APMs and related policies applicable to eligible 
clinicians who participate in APMs, including the Shared Savings 
Program. We have also made updates to policies under the Quality 
Payment Program through the annual CY PFS rules.
c. Summary of Shared Savings Program Provisions
    In sections III.G.2. through III.G.7. of this final rule, we 
summarize and respond to public comments received on the proposed 
modifications to the Shared Savings Program's policies discussed in 
section III.G. of the CY 2024 PFS proposed rule (88 FR 52416 through 
52498). Some commenters' suggestions for modifications to Shared 
Savings Program policies went beyond the scope of the proposals 
discussed in section III.G. of the CY 2024 PFS proposed rule and will 
not be addressed in this section of this final rule. As a general 
summary, we are finalizing the following changes to Shared Savings 
Program policies to:
     Revise the quality reporting and the quality performance 
requirements (section III.G.2. of this final rule), including the 
following:
    ++ Allow Shared Savings Program ACOs the option to report quality 
measures under the APP on only their Medicare beneficiaries through 
Medicare CQMs (section III.G.2.b. of this final rule).
    ++ Update the APP measure set for Shared Savings Program ACOs 
(section III.G.2.c. of this final rule).
    ++ Revise the calculation of the health equity adjustment 
underserved multiplier (section III.G.2.d. of this final rule).
    ++ Use historical data to establish the 40th percentile MIPS 
Quality performance category score used for the quality performance 
standard (section III.G.2.e. of this final rule).
    ++ Apply a Shared Savings Program scoring policy for excluded APP 
measures and APP measures that lack a benchmark (section III.G.2.f. of 
this final rule).
    ++ Require Spanish language administration of the CAHPS for MIPS 
survey (section III.G.2.g. of this final rule).
    ++ Align CEHRT requirements for Shared Savings Program ACOs with 
MIPS (section III.G.2.h. of this final rule).
    ++ Revise the requirement to meet the case minimum requirement for 
quality performance standard determinations (section III.G.2.j. of this 
final rule).
     Revise the policies for determining beneficiary assignment 
(section III.G.3 of this final rule).
    ++ Modify the step-wise beneficiary assignment methodology and 
approach to identifying the assignable beneficiary population (section 
III.G.3.a of this final rule).
    ++ Update the definition of primary care services used in 
beneficiary assignment at Sec.  425.400(c) (section III.G.3.b of this 
final rule).
     Revise the policies on the Shared Savings Program's 
benchmarking methodology (section III.G.4 of this final rule).
    ++ Modify the calculation of the regional update factor used to 
update the historical benchmark between benchmark year (BY) 3 and the 
performance year by capping an ACO's regional service area risk score 
growth through use of an adjustment factor to provide more equitable 
treatment for ACOs and for symmetry with the cap on ACO risk score 
growth (section III.G.4.b of this final rule).
    ++ Further mitigate the impact of the negative regional adjustment 
on the benchmark to encourage participation by ACOs caring for 
medically complex, high-cost beneficiaries (section III.G.4.c of this 
final rule).
    ++ Specify the circumstances in which CMS will recalculate the 
prior savings adjustment for changes in values used in benchmark 
calculations due to compliance action taken to address avoidance of at-
risk beneficiaries, or as a result of the issuance of a revised initial 
determination of financial performance for a previous performance year 
(section III.G.4.d of this final rule).

[[Page 79096]]

    ++ Specify use of the CMS-HCC risk adjustment methodology 
applicable to the calendar year corresponding to the performance year 
in calculating prospective HCC risk scores for Medicare FFS 
beneficiaries for the performance year, and for each benchmark year of 
the ACO's agreement period (section III.G.4.e. of this final rule).
     Refine AIP policies, including the following (section 
III.G.5 of this final rule):
    ++ Modify AIP eligibility requirements to allow an ACO to elect to 
advance to a two-sided model level of the BASIC track's glide path 
beginning with the third performance year of the 5-year agreement 
period in which the ACO receives advance investment payments.
    ++ Modify AIP recoupment and recovery polices to forgo immediate 
collection of advance investment payments from an ACO that terminates 
its participation agreement early in order to early renew under a new 
participation agreement to continue its participation in the Shared 
Savings Program.
    ++ Modify termination policies to specify that CMS will immediately 
terminate advance investment payments to an ACO for future quarters if 
the ACO voluntarily terminates its participation agreement.
    ++ Modify ACO reporting requirements to require ACOs to submit 
spend plan updates and actual spend information to CMS in addition to 
publicly reporting such information.
    ++ Modify AIP requirements to permit ACOs to seek reconsideration 
review of all quarterly payment calculations.
     Update Shared Savings Program eligibility requirements, 
including the following (section III.G.6 of this final rule):
    ++ Remove the option for ACOs to request an exception to the shared 
governance requirement that 75 percent control of an ACO's governing 
body must be held by ACO participants.
    ++ Codify the existing Shared Savings Program operational approach 
to specify that CMS determines that an ACO participant TIN participated 
in a performance-based risk Medicare ACO initiative if it was or will 
be included on a participant list used in financial reconciliation for 
a performance year under performance-based risk during the five most 
recent performance years.
     Make technical changes to references in Shared Savings 
Program regulations (section III.G.7 of this final rule), including to 
update assignment selection references to either Sec.  425.226(a)(1) or 
Sec.  425.400(a)(4)(ii) in subpart G of the regulations, correct 
typographical errors in the definitions in Sec.  425.20, and update 
certain terminology used in Sec.  425.702.
    We solicited comments in the CY 2024 proposed rule regarding our 
intent to propose future policies aligning the APP measure set for 
Sharing Savings Program ACOs with the quality measures under the 
``Universal Foundation'' beginning in performance year 2025 (as 
described in section III.G.2.b.(2). of this final rule). We also 
solicited comments on MIPS Value Pathway reporting for specialists in 
Shared Savings Program ACOs (as described in section III.G.2.i. of this 
final rule).
    In addition, in the CY 2024 PFS proposed rule, we solicited 
comments on potential future developments to Shared Savings Program 
policies (as discussed in section III.G.8. of this final rule), 
including: incorporating a track with higher risk and potential reward 
than the ENHANCED track; modifying the amount of the prior savings 
adjustment through potential changes to the 50 percent scaling factor 
used in determining the adjustment, as well as considerations for 
potential modifications to the positive regional adjustment to reduce 
the possibility of inflating the benchmark; potential refinements to 
the Accountable Care Prospective Trend (ACPT) and the three-way blended 
benchmark update factor over time to further mitigate potential ratchet 
effects within the update factor; and policies to promote ACO and CBO 
collaboration.
    In combination, the policies we are adopting for the Shared Savings 
Program in this final rule are anticipated to improve the incentive for 
ACOs to sustainably participate and earn shared savings in the program. 
On net, total program spending is estimated to decrease by $330 million 
over the 10-year period 2024 through 2033. These changes are also 
anticipated to support the goals outlined in the CY 2023 PFS final rule 
for growing the program with a particular focus on including 
underserved beneficiaries.
    Certain policies, including both existing policies and the new 
policies adopted in this final rule, rely upon the authority granted in 
section 1899(i)(3) of the Act to use other payment models that the 
Secretary determines will improve the quality and efficiency of items 
and services furnished under the Medicare program, and that do not 
result in program expenditures greater than those that would result 
under the statutory payment model. The following policies require the 
use of our authority under section 1899(i) of the Act: the 
modifications to the calculation of regional component of the three-way 
blended update factor to cap regional service area risk score growth 
for symmetry with the ACO risk score growth cap, as described in 
section III.G.4.b of this final rule and the refinements to AIP 
policies as described in section III.G.5. of this final rule. Further, 
certain existing policies adopted under the authority of section 
1899(i)(3) of the Act that depend on use of the assigned population and 
assignable beneficiary populations will be affected by the addition of 
a new third step of the beneficiary assignment methodology and the 
revisions to the definition of ``assignable beneficiary'' described in 
section III.G.3. of this final rule, including the following: the 
amount of advance investment payments; factors used in determining 
shared losses for ACOs under two-sided risk models (including 
calculation of the variable MSR/MLR based on the ACO's number of 
assigned beneficiaries, and the applicability of the extreme and 
uncontrollable circumstances policy for mitigating shared losses for 
ACOs under two-sided risk models); and calculation of the ACPT, 
regional and national components of the three-way blended benchmark 
update factor. As described in the Regulatory Impact Analysis in 
section VI. and elsewhere in this final rule, the changes we are 
finalizing to our payment methodology are expected to improve the 
quality and efficiency of care and are not expected to result in a 
situation in which the payment methodology under the Shared Savings 
Program, including all policies adopted under the authority of section 
1899(i) of the Act, results in more spending under the program than 
would have resulted under the statutory payment methodology in section 
1899(d) of the Act. We will continue to reexamine this projection in 
the future to ensure that the requirement under section 1899(i)(3)(B) 
of the Act that an alternative payment model not result in additional 
program expenditures continues to be satisfied. In the event that we 
later determine that the payment model that includes policies 
established under section 1899(i)(3) of the Act no longer meets this 
requirement, we would undertake additional notice and comment 
rulemaking to make adjustments to the payment model to assure continued 
compliance with the statutory requirements.

[[Page 79097]]

2. Quality Performance Standard and Other Reporting Requirements
a. Background
    Section 1899(b)(3)(C) of the Act states that the Secretary shall 
establish quality performance standards to assess the quality of care 
furnished by ACOs and seek to improve the quality of care furnished by 
ACOs over time by specifying higher standards, new measures, or both 
for purposes of assessing such quality of care. As we stated in the 
November 2011 final rule establishing the Shared Savings Program (76 FR 
67872), our principal goal in selecting quality measures for ACOs has 
been to identify measures of success in the delivery of high-quality 
health care at the individual and population levels. In the November 
2011 final rule, we established a quality measure set spanning four 
domains: patient experience of care, care coordination/patient safety, 
preventative health, and at-risk population (76 FR 67872 through 
67891). We have subsequently updated the measures that comprise the 
quality performance measure set for the Shared Savings Program through 
rulemaking in the CY 2015, 2016, 2017, 2019, and 2023 PFS final rules 
(79 FR 67907 through 67921, 80 FR 71263 through 71269, 81 FR 80484 
through 80488, 83 FR 59707 through 59715, 87 FR 69860 through 69763, 
respectively).
b. Option for Shared Savings Program ACOs To Report Medicare CQMs
(1) Background
    In the CY 2021 PFS final rule, we finalized modifications to the 
Shared Savings Program quality reporting requirements and quality 
performance standard for performance year 2021 and subsequent 
performance years (85 FR 84720). For performance year 2021 and 
subsequent years, ACOs are required to report quality data via the 
Alternative Payment Model (APM) Performance Pathway (APP). Pursuant to 
policies finalized under the CY 2022 and CY 2023 PFS (86 FR 65685; 87 
FR 69858), to meet the quality performance standard under the Shared 
Savings Program through performance year 2024, ACOs must report the ten 
CMS Web Interface measures or the three eCQMs/MIPS CQMs, and the CAHPS 
for MIPS survey. In performance year 2025 and subsequent performance 
years, ACOs must report the three eCQMs/MIPS CQMs and the CAHPS for 
MIPS survey.
    Since the CY 2021 PFS final rule was issued, interested parties 
have continued to express concerns about requiring ACOs to report all 
payer/all patient eCQMs/MIPS CQMs via the APP due to the cost of 
purchasing and implementing a system wide infrastructure to aggregate 
data from multiple ACO participant TINs and varying EHR systems (86 FR 
65257). In the CY 2022 PFS, commenters supported our acknowledgement of 
the complexity of the transition to all payer/all patient eCQM/MIPS 
CQMs (86 FR 65259). Additionally, one commenter questioned how data 
completeness standards could be met, given the issues of deduplication 
and patients adding or moving insurance coverage (87 FR 65260). In 
public comments to the CY 2023 PFS proposed rule, some commenters 
expressed multiple concerns regarding the requirement to report all 
payer/all patient eCQMs/MIPS CQMS beginning in performance year 2025, 
such as issues related to meeting all payer data requirements, data 
completeness requirements, data aggregation and deduplication issues, 
and interoperability issues among different EHRs (87 FR 69837). In the 
CY 2023 PFS final rule, we explained these comments went beyond the 
scope of our proposals. These comment letters included details of the 
commenters' concerns. Specifically, some commenters, which included 
ACOs, noted the financial burden of aggregating, deduplicating, and 
exporting eCQM data across multiple TINs and EHRs. Commenters, 
including ACOs, expressed concerns that the requirement to report all 
payer measures ties performance to patients that the ACO does not 
actively manage, increases the difficulty of meeting data completeness, 
and may negatively impact an ACO's performance by including patients 
seen by specialists. We also acknowledged that as the transition to 
reporting all-payer eCQMs/MIPS CQMs continues, the health equity 
adjustment which we finalized in the CY 2023 PFS final rule (87 FR 
69842) will support ACOs that may experience challenges with the new 
quality reporting requirement and will provide an incentive for ACOs to 
serve underserved populations during the transition to reporting eCQMs/
MIPS CQMs. In the CY 2023 PFS final rule, we stated that we are 
continuing to monitor the impact of these policies as we gain more 
experience with ACOs reporting all payer/all patient eCQMs/MIPS CQMs 
and, further, that we are exploring how to address some of the concerns 
related to data aggregation and the all payer requirement and may 
revisit these and related issues in future rulemaking based on lessons 
learned (87 FR 69833).
    Consistent with our goal to support ACOs in the transition to all 
payer/all patient eCQMs/MIPS CQMs, in the CY 2023 PFS final rule we 
extended the eCQM/MIPS CQM reporting incentive through PY 2024 to 
provide an incentive to ACOs to report the eCQMs/MIPS CQMs, while 
allowing them time to gauge their performance on the eCQMs/MIPS CQMs 
before full reporting of these measures is required beginning in 
performance year 2025 (87 FR 69835). Building on our goal to provide 
technical support to ACOs and to help ACOs build the skills necessary 
to aggregate and match patient data to report all payer/all patient 
eCQMs/MIPS CQMS, in December 2022, we hosted a webinar to support ACOs 
in the transition to reporting all payer/all patient eCQMs/MIPS CQMs 
and released a guidance document on the topic. Resources from the 
``Reporting MIPS CQMs and eCQMs in the APM Performance Pathway'' 
webinar are available at https://youtu.be/LDrpoGnnRQs. The guidance 
document, entitled ``Medicare Shared Savings Program: Reporting MIPS 
CQMs and eCQMs in the Alternative Payment Model Performance Pathway 
(APP)'' is available in the Quality Payment Program Resource Library at 
https://qpp-cm-prod-content.s3.amazonaws.com/uploads/2179/APP%20Guidance%20Document%20for%20ACOs.pdf. We are committed to 
continuing to support ACOs in the transition to all payer/all patient 
eCQMs/MIPS CQMs and in the transition to digital quality measurement 
reporting.
(2) Reporting the Medicare CQMs
    In light of the concerns raised by ACOs and other interested 
parties and our commitment to supporting ACOs in the transition to 
digital quality measure reporting, for performance year 2024 and 
subsequent performance years as determined by CMS, we proposed in the 
CY 2024 PFS proposed rule to establish the Medicare CQMs for 
Accountable Care Organizations Participating in the Medicare Shared 
Savings Program (Medicare CQMs) as a new collection type for Shared 
Savings Program ACOs reporting on the Medicare CQMs (reporting quality 
data on beneficiaries eligible for Medicare CQMs as defined at Sec.  
425.20) within the APP measure set and administering the CAHPS for MIPS 
Survey as required under the APP (88 FR 52420 through 52424). As stated 
in the CY 2024 PFS proposed rule (88 FR 52420), Medicare CQMs would 
serve as a transition collection type to help some ACOs build the 
infrastructure, skills, knowledge, and expertise necessary to

[[Page 79098]]

report all payer/all patient MIPS CQMs and eCQMs by defining a 
population of beneficiaries that exist within the all payer/all patient 
MIPS CQM Specifications and tethering that population to claims 
encounters with ACO professionals with specialties used in assignment. 
Specifically, we believe that Medicare CQMs would address the concern 
raised by ACOs that--for ACOs with a higher proportion of specialty 
practices and/or multiple EHR systems--the broader all payer/all 
patient eligible population would capture beneficiaries with no primary 
care relationship to the ACO. Further, we believe that ACOs, 
particularly ACOs with a higher proportion of specialty practices and/
or multiple EHRs, would be able to utilize Medicare Part A and B claims 
data to help identify the ACO's eligible population and validate the 
ACO's patient matching and deduplication efforts. For these reasons, we 
believe that it is appropriate to establish Medicare CQMs as a new 
collection type for Shared Savings Program ACOs only.
    In the CY 2024 PFS proposed rule (88 FR 52420), we stated that we 
recognized that Medicare CQMs might not be the most suitable collection 
type for some ACOs, particularly ACOs with a single-EHR platform, a 
high proportion of primary care practices, and/or ACOs composed of 
participants with experience reporting all payer/all patient measures 
in traditional MIPS. We also encouraged ACOs to evaluate all quality 
reporting options to determine which collection type is most 
appropriate based on the ACO's unique composition and technical 
infrastructure. In addition to our proposal to report quality data 
utilizing the Medicare CQMs collection type, in performance year 2024, 
ACOs would have the option to report quality data utilizing the CMS Web 
Interface measures, eCQMs, and/or MIPS CQMs collection types (88 FR 
52420). As described in our proposal, in performance year 2025 and 
subsequent performance years as determined by CMS, ACOs would have the 
option to report quality data utilizing the eCQMs, MIPS CQMs, and/or 
Medicare CQMs collection types (88 FR 52420).
    We stated in the CY 2024 PFS proposed rule (88 FR 52421) that our 
long-term goal continues to be to support ACOs in the adoption of all 
payer/all patient measures. We would monitor the reporting of quality 
data utilizing the Medicare CQMs collection type. For example, one 
indicator to evaluate Medicare CQMs would be to assess if there are any 
Medicare CQMs topped out as described at Sec.  414.1380(b)(1)(iv). 
Therefore, in the 4th year the measure could be removed and would no 
longer be available for reporting during the performance period (83 FR 
59761). Once the measure has reached an extremely topped out status 
(for example, a measure with an average mean performance within the 
98th to 100th percentile range), we may propose the measure for removal 
in the next rulemaking cycle, regardless of whether or not it is in the 
midst of the topped out measure lifecycle, due to the extremely high 
and unvarying performance where meaningful distinctions and improvement 
in performance can no longer be made, after taking into account any 
other relevant factors (83 FR 59763). Separately, we may specify higher 
standards, new measures, or both--up to and including proposing to 
sunset the Medicare CQM collection type in future rulemaking--to ensure 
that Medicare CQMs conform to the intent of section 1899(b)(3)(C) of 
the Act and the priorities established in the CMS National Quality 
Strategy (88 FR 52421).
    We also remain steadfast in our commitment to support providers in 
the transition from traditional MIPS to APMs and Advanced APMs. In our 
proposal, we acknowledged that Medicare CQMs may not be the preferred 
collection type for all ACOs. ACOs that are composed of participants 
with experience reporting all payer/all patient measures in traditional 
MIPS would continue to have the option to report all payer/all patient 
measures (88 FR 52421). In supporting providers in the transition from 
traditional MIPS to APMs and Advanced APMs, we also recognized the 
corresponding need to support ACOs in the transition to all payer/all 
patient reporting (88 FR 52421). In addition to the technical support 
that we would continue to provide ACOs, we believe that the Medicare 
CQM collection type would aid some ACOs in the transition to all payer/
all patient measures by allowing ACOs to focus patient matching and 
data aggregation efforts on ACO professionals with specialties used in 
assignment while the ACO builds the infrastructure necessary to report 
on a broader eligible population (88 FR 52421).
    To facilitate the reporting of Medicare CQMs, we proposed to amend 
the definition of ``Collection Type'' to include the Medicare CQM as an 
available collection type in MIPS for ACOs that participate in the 
Shared Savings Program (88 FR 52563). We noted that the Medicare CQMs 
collection type would serve as a transition collection type and be 
available as determined by CMS (88 FR 52421). Additionally, we proposed 
to establish data submission and completeness criteria pertaining to 
the Medicare CQMs for the MIPS quality performance category (88 FR 
52567).
    A Medicare CQM is essentially a MIPS CQM reported by an ACO under 
the APP on only the ACO's Medicare FFS beneficiaries, instead of its 
all payer/all patient population. We proposed to define a beneficiary 
eligible for Medicare CQMs at Sec.  425.20 as a beneficiary identified 
for purposes of reporting Medicare CQMs who is either of the following:
     A Medicare FFS beneficiary (as defined at Sec.  425.20) 
who--
    ++ Meets the criteria for a beneficiary to be assigned to an ACO 
described at Sec.  425.401(a); and
    ++ Had at least one claim with a date of service during the 
measurement period from an ACO professional who is a primary care 
physician or who has one of the specialty designations included in 
Sec.  425.402(c), or who is a physician assistant (PA), nurse 
practitioner (NP), or clinical nurse specialist (CNS).
     A Medicare FFS beneficiary who is assigned to an ACO in 
accordance with Sec.  425.402(e) because the beneficiary designated an 
ACO professional participating in an ACO as responsible for 
coordinating their overall care.
    While this definition refers to beneficiaries that have been 
assigned to an ACO, it nonetheless differs from our basic assignment 
methodology described under subpart E and from the concept of 
assignable beneficiary defined at Sec.  425.20. Specifically, the use 
of the terms of ``claim'' (instead of primary care services) and 
``measurement period'' (instead of assignment window) in the definition 
are synchronous with the application of all payer/all patient MIPS CQM 
Specifications in reporting Medicare CQMs. For example, we define 
primary care services as the set of services identified by the 
Healthcare Common Procedure Coding System (HCPCS) and revenue center 
codes designated under Sec.  425.400(c). Each all payer/all patient 
MIPS CQM Specification identifies eligible encounters that, in part, 
identify patients that should be included in the measure's eligible 
population.
    In the CY 2024 PFS proposed rule, we stated that our proposed 
definition for beneficiary eligible for Medicare CQMs is intended to 
create alignment with the all payer/all patient MIPS CQM Specifications 
(88 FR 52421). The HCPCS and revenue center codes designated under 
Sec.  425.400(c) as primary care services for purposes of assignment 
under the Shared Savings

[[Page 79099]]

Program only partially overlap with the codes designated as eligible 
encounters used to identify the eligible population in all payer/all 
patient MIPS CQM Specifications (88 FR 52421). Applying primary care 
service codes or deferring to the basic assignment methodology under 
subpart E to identify the beneficiaries eligible for Medicare CQMs 
would have the unintended result of limiting the codes used to identify 
eligible encounters in the Medicare CQM Specification to only the codes 
that overlap with primary care services (88 FR 52421). Similarly, we 
defined the assignment window as the 12-month period used to assign 
beneficiaries to the ACO. In a manner that is identical to the all 
payer/all patient MIPS CQM Specifications, the Medicare CQM 
Specifications would identify the measurement period applicable to each 
measure (88 FR 52421). Applying the 12-month period used in assignment 
or deferring to the basic assignment methodology under Subpart E to 
identify the beneficiaries eligible for Medicare CQMs would have the 
unintended result of reducing the beneficiaries eligible for Medicare 
CQMs to only patients that had an eligible encounter during the overlap 
of the assignment window as defined at Sec.  425.20 and the measurement 
period as defined in the Medicare CQM Specifications (88 FR 52421).
    In the CY 2024 PFS proposed rule, we proposed to establish the data 
completeness criteria threshold for the Medicare CQM collection type, 
in which a Shared Savings Program ACO that meets the reporting 
requirements under the APP would submit quality measure data for 
Medicare CQMs on the APM Entity's applicable beneficiaries eligible for 
the Medicare CQMs, as proposed at Sec.  425.20, who meet the measure's 
denominator criteria (88 FR 52567). We also proposed the following data 
completeness criteria thresholds for Medicare CQMs:
     At least 75 percent for the CY 2024, CY 2025, and CY 2026 
performance periods/2026, 2027, and 2028 MIPS payment years, 
respectively.
     At least 80 percent for the CY 2027 performance period/
2029 MIPS payment year.
    With the Medicare CQMs collection type serving as a transition 
collection type under the APP that would be available as determined by 
CMS, we proposed in the CY 2024 PFS proposed rule to establish the 
aforementioned data completeness criteria thresholds in advance of the 
applicable performance periods (88 FR 52567). In our proposal, we 
recognized that it is advantageous to delineate the expectations for 
ACOs as they prepare to meet the quality reporting requirements for the 
Medicare CQMs collection type under the APP (88 FR 52421). We would 
assess the availability of the Medicare CQM as a collection type under 
the APP during the initial years of implementation and determine the 
timeframe to sunset the Medicare CQM as a collection type in future 
rulemaking.
    As described in our proposal, an ACO that reports Medicare CQMs in 
an applicable performance year would aggregate patient data for 
beneficiaries who are eligible for Medicare CQMs, as proposed at Sec.  
425.20, across all ACO participants (88 FR 52422). The ACO would then 
match the aggregated patient data with each Medicare CQM Specification 
to identify the eligible population for each measure. The ACO's 
aggregated ACO submission must account for 100 percent of the eligible 
and matched patient population across all ACO participants. Data 
completeness is calculated based on submitted data. We believe that the 
proposal to establish the Medicare CQM collection type would address 
the concerns from ACOs regarding the capability of meeting the data 
completeness requirement for all payer data. Specifically, our proposal 
to define beneficiaries eligible for Medicare CQMs aims to focus ACOs' 
reporting efforts on beneficiaries with an encounter with an ACO 
professional with a specialty used in assignment and thereby reduce the 
potential for missing or un-matched patient data. It is important to 
note that ACOs that include or are composed solely of FQHCs or RHCs 
must report quality data on behalf of the FQHCs or RHCs that 
participate in the ACO. To clarify, while FQHCs and RHCs that provide 
services that are billed exclusively under FQHC or RHC payment 
methodologies are exempt from reporting traditional MIPS, FQHCs and 
RHCs that participate in APMs, such as the Shared Savings Program, are 
considered APM Entity groups described at Sec.  414.1370.
    To facilitate population-based activities related to improving 
health through quality measurement of Medicare CQMs and to aid ACOs in 
the process of patient matching and data aggregation necessary to 
report Medicare CQMs, we stated in the CY 2024 PFS proposed rule that 
we would provide ACOs a list of beneficiaries who are eligible for 
Medicare CQMs within the ACO. As set forth in our regulations at Sec.  
425.702, we share certain aggregate reports with ACOs under specific 
conditions, and this information includes demographic data that 
represents the minimum data necessary for ACOs to conduct health care 
operations work, which includes demographic and diagnostic information 
necessary to report quality data. We proposed that the list of 
beneficiaries eligible for Medicare CQMs to be shared once annually, at 
the beginning of the quality data submission period (88 FR 52422). 
Since we would not have full run-out on performance year claims data 
prior to the start of the quality data submission period, the list of 
beneficiaries eligible for Medicare CQMs would not be a complete list 
of beneficiaries that should be included on an ACO's Medicare CQMs 
reporting. ACOs would have to ensure that all beneficiaries that meet 
the applicable Medicare CQM Specification and also meet the definition 
of a beneficiary eligible for Medicare CQMs proposed under Sec.  425.20 
are included in the ACO's eligible population/denominator for reporting 
each Medicare CQM. We proposed to add new paragraph (c)(1)(iii) to 
Sec.  425.702 as follows:
    For performance year 2024 and subsequent performance years, at the 
beginning of the quality submission period, CMS, upon the ACO's request 
for the data for purposes of population-based activities relating to 
improving health or reducing growth in health care costs, protocol 
development, case management, and care coordination, provides the ACO 
with information about its FFS population.
     The following information is made available to ACOs 
regarding beneficiaries eligible for Medicare CQMs as defined at Sec.  
425.20:
    ++ Beneficiary name.
    ++ Date of birth.
    ++ Beneficiary identifier.
    ++ Sex.
     Information in the following categories, which represents 
the minimum data necessary for ACOs to conduct health care operations 
work, is made available to ACOs regarding beneficiaries eligible for 
Medicare CQMs as defined at Sec.  425.20:
    ++ Demographic data such as enrollment status.
    ++ Health status information such as risk profile and chronic 
condition subgroup.
    ++ Utilization rates of Medicare services such as the use of 
evaluation and management, hospital, emergency, and post-acute 
services, including the dates and place of service.
    The list of beneficiaries eligible for Medicare CQMs shared by CMS 
would aim to help ACOs aggregate, and match and deduplicate patient 
data. We proposed including the minimum data necessary to facilitate 
the reporting of Medicare CQMs including beneficiary identifier, 
gender, date of birth and

[[Page 79100]]

death (if applicable), chronic condition subgroup, and the NPIs of the 
top three frequented providers in the ACO (88 FR 52422). We also 
proposed to include health status information such as risk profile and 
chronic condition subgroup to the extent that such data would aid ACOs 
in identifying patients that meet the denominator criteria for the 
Medicare CQM Specifications (88 FR 52422). We would also provide 
technical assistance to ACOs when reporting the Medicare CQMs, 
including providing technical resource documents. Our proposal to 
create Medicare CQMs is intended to support ACOs through the transition 
to reporting the all payer/all patient eCQMs/MIPS CQMs and to 
facilitate quality assessment improvement activities (as described in 
the definition of health care operations at 45 CFR 164.501) since we 
would provide ACOs with a list of beneficiaries eligible for Medicare 
CQM reporting to aid in patient matching and data deduplication.
    In the CY 2021 PFS final rule (85 FR 84733), we finalized the 
following three all payer/all patient eCQMs/MIPS CQMs under the APP for 
performance year 2021 and subsequent performance years:
     Quality ID#: 001 Diabetes: Hemoglobin A1c (HbA1c) Poor 
Control;
     Quality ID#: 134 Preventive Care and Screening: Screening 
for Depression and Follow-Up Plan; and
     Quality ID#: 236 Controlling High Blood Pressure.
    In section IV.A.4.e of the CY 2024 PFS proposed rule (88 FR 52422), 
we proposed to add these measures as Medicare CQMs to the APP measure 
set for Shared Savings Program ACOs beginning with performance year 
2024 and subsequent performance years. ACOs may report the three 
Medicare CQMs, or a combination of eCQMs/MIPS CQMs/Medicare CQMs, to 
meet the Shared Savings Program quality reporting requirement at Sec.  
425.510(b) and the quality performance standard at Sec.  425.512(a)(5).
    As a result, to meet the Shared Savings Program reporting 
requirements:
     For performance year 2024, an ACO would be required to 
report the 10 measures under the CMS web interface measures, or the 
three eCQMs/MIPS CQMs/Medicare CQMs. In addition, an ACO would be 
required to administer the CAHPS for MIPS Survey, and CMS will 
calculate the two claims-based measures.
     For performance year 2025 and subsequent performance 
years, an ACO would be required to report the three eCQMs/MIPS CQMs/
Medicare CQMs. In addition, an ACO would be required to administer the 
CAHPS for MIPS Survey, and CMS will calculate the two claims-based 
measures.
    ACOs may still report via the APP using the all payer/all patient 
eCQM/MIPS CQM collection types and may report different collection 
types for each measure.
    In conjunction with the proposed changes to Sec.  425.512(a)(2), we 
proposed to incorporate Medicare CQMs into the existing quality 
performance standard policies for new ACOs at Sec.  425.512(a)(2)(i), 
(ii), and (iii) (88 FR 52423). Accordingly, we proposed that for the 
first performance year of an ACO's first agreement period under the 
Shared Savings Program, if the ACO reports data via the APP and meets 
MIPS data completeness requirement at Sec.  414.1340 and receives a 
MIPS Quality performance category score under Sec.  414.1380(b)(1), the 
ACO will meet the quality performance standard under the Shared Savings 
Program, if:
     For performance year 2024. The ACO reports the 10 CMS Web 
Interface measures or the three eCQMs/MIPS CQMs/Medicare CQMs, and 
administers a CAHPS for MIPS survey under the APP.
     For performance year 2025 and subsequent performance 
years. The ACO reports the three eCQMs/MIPS CQMs/Medicare CQMs and 
administers a CAHPS for MIPS survey under the APP.
    Additionally, we proposed to incorporate Medicare CQMs into the 
existing policies at Sec.  425.512(a)(5)(iii) for when an ACO would not 
meet the quality performance standard or the alternative quality 
performance standard. Accordingly, we proposed that an ACO would not 
meet the quality performance standard or the alternative quality 
performance standard if:
     For performance year 2024, if an ACO (1) does not report 
any of the 10 CMS Web Interface measures or any of the three eCQMs/MIPS 
CQMs/Medicare CQMs and (2) does not administer a CAHPS for MIPS survey 
under the APP.
     For performance year 2025 and subsequent performance 
years, if an ACO (1) does not report any of the three eCQMs/MIPS CQMs/
Medicare CQMs and (2) does not administer a CAHPS for MIPS survey under 
the APP.
    We did not propose to add Medicare CQMs to the eCQM/MIPS CQM 
reporting incentive described at Sec.  425.512(a)(5)(i)(A)(2) for 
performance year 2024. The eCQM/MIPS CQM reporting incentive intends to 
provide an incentive to ACOs to report the all payer/all patient eCQMs/
MIPS CQMs while allowing them time to gauge their performance on the 
all payer/all patient eCQMs/MIPS CQMs before full reporting of these 
measures is required beginning in performance year 2025.
    Under the goals of the CMS National Quality Strategy, we are moving 
towards a building-block approach to streamline quality measure across 
CMS quality programs for the adult and pediatric populations. This 
``Universal Foundation'' of quality measure would focus provider 
attention, reduce burden, identify disparities in care, prioritize 
development of interoperable, digital quality measures, allow for 
cross-comparisons across programs, and help identify measurement gaps. 
Following in the proposals under MIPS, we intend to propose future 
policies aligning the APP measure set for Sharing Savings Program ACOs 
with the quality measures under the ``Universal Foundation'' beginning 
in performance year 2025. These Universal Foundation measures are 
proposed to be adopted into the existing the Value in Primary Care MVP 
as discussed in Table B.11 of Appendix 3: MVP Inventory of the CY 2024 
PFS proposed rule (88 FR 52423). By creating alignment with the 
Universal Foundation in the Value in Primary Care MVP and the APP 
measure set by 2025, primary care clinicians would develop familiarity 
with the same quality measures that are reported in the APP while in 
MIPS. We expect this alignment would reduce the barriers to 
participation in the Shared Savings Program. The following is a summary 
of the comments we received and our responses.
    Comment: Many commenters supported the proposal to establish the 
Medicare CQMs as a new collection type for Shared Savings Program ACOs. 
Several commenters were supportive of our proposal that Medicare CQMs 
would be reported by Shared Savings Program ACOs on only the ACO's 
Medicare FFS beneficiaries. Commenters stated that reporting on 
Medicare patients will help ACOs bridge to all payer reporting and that 
the policy will encourage more ACOs to participate in the Shared 
Savings Program and transition into accountable care. Commenters also 
stated that the policy will help expand the number of beneficiaries in 
accountable care and support CMS' strategic direction. Another 
commenter shared that Medicare CQMs will ensure a more direct 
comparison between populations than the all-payer eCQM and will 
mitigate complications related to payer mix. Another commenter noted 
that reporting specific to Medicare beneficiaries is the most 
appropriate measure of ACO quality performance. One commenter stated 
that limiting

[[Page 79101]]

reporting to Medicare patients, versus all payer data, will be an 
important step towards reducing burden for providers in ACOs and 
encouraging specialist participation. Another commenter shared that 
CQMs for the Medicare FFS patients with a treatment relationship to ACO 
professionals with a primary care or related specialty ensures that CMS 
receives meaningful quality information on the ACO's influence on the 
Medicare FFS population.
    A few commenters agreed that Medicare CQMs would address most of 
ACOs' concerns regarding all payer/all patient reporting, such as 
difficulties reporting for those ACOs with a higher proportion of 
specialty practices or groups with multiple EHRs, beneficiaries with no 
primary care relationship, and shouldering a greater burden when 
matching and deduplicating patient records. Other commenters noted 
Medicare CQMs reduce concerns about specialists reporting on primary 
care focused measures. Commenters shared that Medicare CQMs were 
responsive to several key concerns raised by ACOs regarding feasibility 
of implementing eCQMs/MIPS CQMs, including equity concerns.
    One commenter agreed that Medicare CQMs would serve as an 
intermediary step to help ACOs build the infrastructure, skills, 
knowledge, and expertise required to report eCQMs/MIPS CQMs. A few 
commenters stated that Medicare CQMs will provide a learning period and 
additional time to address barriers in reporting eCQMs.
    A few commenters noted that Medicare CQMs will ease the concern 
with the state of readiness of reporting on eCQMs and reduce 
administrative burden and cost relative to an all-payer reporting 
requirement. One commenter stated that the transition away from the Web 
Interface reporting has created a large resource burden on ACOs to 
develop new processes, hire vendors, and manage frequently changing 
requirements, and additional support and flexibility will allow ACOs to 
meet these requirements and promote digital quality measurement 
reporting rather than creating additional costs and unnecessary burden.
    One commenter stated that Medicare CQMs are far better matched to 
ACOs' reporting capabilities than all-payer eCQMs, which would 
otherwise be required if this proposal is not finalized. Another 
commenter noted that ACOs with participants on multiple EHR systems may 
still be challenged when gathering and aggregating data to report, but 
the option to report using Medicare CQMs should provide ACOs with 
adequate opportunities to overcome this challenge and prepare them to 
report all payer/all patient eCQMs/MIPS CQMs.
    Response: We appreciate commenters' recognition of the role that 
Medicare CQMs could have in advancing digital quality measurement, 
supporting ACOs in developing processes to gather and aggregate data 
for care coordination and quality improvement, and bridging the gap to 
all payer quality measurement.
    Comment: Several commenters expressed concern about the 
implementation of Medicare CQMs beginning in performance year 2024. A 
few commenters stated that ACOs will most likely need more time to 
implement these changes than allotted in this proposal. One commenter 
stated that we should limit reporting to the list of beneficiaries 
eligible for Medicare CQMs provided by CMS in the initial performance 
year of Medicare CQMs to ensure greater uptake by ACOs given the 
complexity and time it will take to identify patients. One commenter 
suggested delaying the implementation of Medicare CQMs until 
performance year 2027 if reporting is not limited.
    Response: We acknowledge concerns about the implementation of 
Medicare CQMs. Implementing Medicare CQMs in performance year 2024 is 
appropriate as Medicare CQMs are an optional collection type. Medicare 
CQMs are intended to support ACOs in transitioning to all payer/all 
patient measures and to address concerns about the feasibility of 
reporting eCQMs/MIPS CQMs that requires aggregating and deduplicating 
an even larger volume of patient data, which would otherwise have been 
required starting in 2025. We recognize that Medicare CQMs might not be 
the suitable collection type for some ACOs. In performance year 2024, 
ACOs would have the option to report quality data utilizing the CMS Web 
Interface measures, eCQMs, and/or MIPS CQMs collection types. Under our 
proposal, in performance year 2025 and subsequent performance years, 
ACOs would have the option to report quality data utilizing the eCQMs, 
MIPS CQMs, and/or Medicare CQMs collection types. We encourage ACOs to 
evaluate all quality reporting options to determine which collection 
type is most appropriate based on the ACO's unique composition and 
technical infrastructure.
    In response to comments which suggest limiting reporting, as 
discussed later in this section of the final rule, we are modifying our 
proposal to provide a quarterly list of beneficiaries eligible for 
Medicare CQMs which will provide ACOs with more frequent cumulative 
list of beneficiaries eligible for the measure to facilitate 
population-based activities related to improving health through quality 
measurement and to aid ACOs in the process of patient matching and data 
aggregation necessary for reporting quality measures.
    Comment: One commenter applauded us for our willingness to assist 
ACOs that might be struggling to operationalize payer-agnostic 
reporting solutions but disagreed with Medicare CQMs being unilaterally 
offered to only Shared Savings Program ACOs and not to organizations 
that may struggle with the exact same reporting barriers on the MIPS 
reporting side. The commenter questioned why the Medicare CQM reporting 
option was not also made available in the form of a (modified) eCQM and 
noted that there are organizations participating in either the Shared 
Savings Program or MIPS who report via eCQMs that may face the same 
barriers of multiple EHR systems and/or high proportions of specialty 
practices that we have cited as an impetus for the proposal of Medicare 
CQMs.
    Response: We refer the reader to past MIPS rules, where CMS has 
consistently stated that it would use all-payer measures in MIPS where 
possible to create a more comprehensive picture of the practice 
performance (81 FR 77098). Alongside that goal, we also stated that we 
aim to simplify reporting and reduce administrative burden (81 FR 
77098). ACOs face unique challenges in matching patients and 
aggregating their data for quality measures. These challenges are not 
commonly shared by MIPS eligible clinicians. Further, we did not 
propose to establish a Medicare eCQM because of the complexity and 
potential technical burden ACOs and their vendors would face in 
implementing eCQMs for a Medicare-only population. As discussed in the 
CY 2024 PFS proposed rule (88 FR 52420), we proposed Medicare CQMs in 
light of concerns raised by ACOs and other interested parties and our 
commitment to supporting ACOs in the transition to digital quality 
measure reporting. Medicare CQMs would serve as a transition collection 
type to help some ACOs build the infrastructure, skills, knowledge, and 
expertise necessary to report all payer/all patient MIPS CQMs and eCQMs 
by defining a population of beneficiaries that exist within the all 
payer/all patient MIPS CQM Specifications and tethering that population 
to claims encounters with ACO professionals with specialties used in 
assignment. Specifically, Medicare CQMs would address the concern 
raised by ACOs that for ACOs with a higher proportion of specialty 
practices the

[[Page 79102]]

broader all payer/all patient eligible population would capture 
beneficiaries with no primary care relationship to the ACO. Further, 
given ACOs are commonly made up of multiple practices using multiple 
EHRs, ACOs would be able to utilize Medicare Parts A and B claims data 
to help identify the ACO's eligible population and to validate the 
ACO's patient matching and deduplication efforts. For these reasons, it 
is appropriate to establish Medicare CQMs as a new collection type for 
Shared Savings Program ACOs only.
    Comment: Many commenters raised questions and concerns regarding 
how CMS will determine the appropriate Medicare CQM population for 
these measures. Some commenters noted that the proposed denominator 
eligibility criteria are similar to but differ in timeline from the 
current assignment methodology and that this creates unnecessary 
complexity, potentially leading to confusion in identifying the 
appropriate Medicare ACO population. A few commenters suggested we 
combine the new Medicare CQM assignment methodology with the existing 
assignment methodology, which would mitigate potential challenges and 
ensure a smoother implementation process. A few commenters recommended 
that CMS limit the list of beneficiaries eligible for Medicare CQMs to 
beneficiaries that are attributed to the ACO. One commenter stated that 
depending on an ACO's selected assignment methodology, they may not be 
fully aware of their full assignable population and that we should 
limit reporting under Medicare CQMs to the ACO's assigned population 
rather than the assignable. Several commenters asked that we clarify if 
the list of beneficiaries eligible for Medicare CQMs is limited to 
assigned beneficiaries or if it includes all assignable beneficiaries 
eligible for the measure. A few commenters suggested using the existing 
ACO population base to create less confusion.
    Response: In response to commenters' suggestions that we align the 
definition of beneficiary eligible for Medicare CQM with our assignment 
methodology, we note that our proposal aims to align Medicare CQMs with 
the all payer/all patient measure specifications because Medicare CQMs 
are intended to support ACOs in the transition to all payer/all patient 
measures. For reasons previously mentioned, our proposal would limit 
Medicare CQM reporting to beneficiaries that had an encounter with an 
ACO professional with a specialty used in assignment or who were 
voluntarily assigned to the ACO. Our proposed approach balances our 
commitment to the transition to all payer/all patient measures and the 
need to provide additional support to some ACOs as they build the 
skills and infrastructure necessary to report digital quality measures.
    In addition, the term ``attributed'' means that the patient had the 
plurality of their care with the ACO. The definition of a beneficiary 
eligible for Medicare CQM does not require that a patient had the 
plurality of their care with the ACO and, as such, the list of 
beneficiaries eligible for Medicare CQMs is broader than the ACO's 
attributed population.
    Comment: One commenter recommended that we limit the list to 
Medicare patients who have an encounter with a physician with a 
specialty utilized in step 1 of attribution under the current 
assignment methodology. A commenter stated that the proposal limits 
quality reporting to Medicare patients with a primary care visit 
instead of all patients with any type of visit.
    Response: As discussed in the June 2015 final rule, primary care 
services can generally be defined based on the type of service 
provided, the type of provider specialty that provides the service, or 
both (80 FR 32748). The list of provider specialties used in assignment 
was based on public comments and recommendations by CMS medical 
officers knowledgeable about the services typically performed by 
physicians and non-physician practitioners (80 FR 32750). In finalizing 
the list of specialties used in assignment, we attempted to limit the 
list of physician specialty types that would be excluded from the 
assignment process to those physician specialties that would very 
rarely, if ever, provide primary care to beneficiaries (80 FR 32750). 
Tethering the Medicare CQM population to claims encounters with ACO 
professionals with specialties used in assignment limits the ACO's 
quality reporting to patients with a care relationship with the ACO and 
is responsive to feedback from ACOs and other interested parties.
    Further, our proposed definition for a beneficiary eligible for 
Medicare CQMs does not require a primary care visit in order to create 
alignment with the all payer/all patient MIPS CQM Specifications. The 
HCPCS and revenue center codes designated under Sec.  425.400(c) as 
primary care services for purposes of assignment under the Shared 
Savings Program only partially over-lap with the codes designated as 
eligible encounters used to identify the eligible population in all 
payer/all patient MIPS CQM Specifications. Applying primary care 
service codes or deferring to the basic assignment methodology under 
subpart E to identify the beneficiaries eligible for Medicare CQMs 
would have the unintended result of limiting the codes used to identify 
eligible encounters in the Medicare CQM Specification to only the codes 
that overlap with primary care services.
    Medicare CQMs are an all beneficiary Medicare measure (not just ACO 
assigned beneficiaries) and is designed to help ACOs address challenges 
with aggregating patient data required to report Medicare CQMs and the 
all payer/all patient MIPS CQMs and eCQMs in the future.
    Comment: One commenter asked how the assignable Medicare population 
reporting requirements will apply to ACOs that have elected prospective 
versus retrospective assignment.
    Response: Our proposed definition for beneficiary eligible for 
Medicare CQM is the same for ACOs under preliminary prospective 
assignment with retrospective reconciliation and ACOs under prospective 
assignment. In a manner that is identical to the all payer/all patient 
MIPS CQM Specifications, the Medicare CQM Specifications would identify 
the measurement period applicable to each measure along with the 
beneficiary encounters for inclusion in the measure regardless of the 
ACO's assignment election.
    Comment: One commenter requested that CMS provide further technical 
specifications on the eligibility of beneficiaries who meet the CQM 
requirement, the process for identifying these beneficiaries within 
EMRs/Vendor systems, and the impacts of FQHC/RHC in quality score as 
these entities would not traditionally be included in MIPS. This 
commenter added that this will allow ACOs to better determine next 
steps for moving away from the Web Interface reporting, while allowing 
better stewardship of resources to do this work.
    Response: As stated in our proposal, ACOs that include or are 
composed solely of FQHCs or RHCs must report quality data on behalf of 
the FQHCs or RHCs that participate in the ACO (88 FR 52422). To 
clarify, while FQHCs and RHCs that provide services that are billed 
exclusively under FQHC or RHC payment methodologies are exempt from 
reporting traditional MIPS, FQHCs and RHCs that participate in APMs, 
such as the Shared Savings Program, are considered APM Entity groups 
described at Sec.  414.1370 (88 FR 52422). It may be helpful to note 
that the three quality measures (for example, eCQMs, MIPS CQMs, 
Medicare CQMs) included

[[Page 79103]]

in the APP measure set for PY 2024 overlap with measures that health 
centers report via the Uniform Data System (UDS). This experience 
reporting quality measures may be helpful for health centers that 
participate in the Shared Savings Program as they transition to the APP 
measure set.
    Further, we will provide technical guidance and specifications to 
ACOs to support ACOs in the identification of beneficiaries eligible 
for Medicare CQMs. Specifically, parameters for the list of 
beneficiaries eligible for Medicare CQMs will be included along with 
the list of beneficiaries eligible for Medicare CQMs in the ACO's 
Quarterly Informational Report Packages.
    Comment: A few commenters were concerned that ACOs reporting 
Medicare CQMs would need to collect data from specialist practices that 
do not care for any Shared Savings Program attributed patients.
    Response: Medicare CQMs include beneficiaries who had at least one 
claim with a date of service during the measurement period from an ACO 
professional who is a primary care physician, who has one of the 
specialty designations included in Sec.  425.402(c), or who is a PA, 
NP, or CNS or is assigned to the ACO through voluntary alignment (88 FR 
52421). We note that in the proposed definition of beneficiary eligible 
for Medicare CQMs under Sec.  425.20, we incorrectly used the phrase 
``certified nurse specialist'' (88 FR 52754). In this final rule, we 
are finalizing our proposed definition of beneficiary eligible for 
Medicare CQMs under Sec.  425.20, with a modification for clarity, and 
to ensure consistency of terminology across provisions, to reference 
``clinical nurse specialist'' instead of ``certified nurse 
specialist.''
    We recognize the care delivered to beneficiaries by a range of 
clinicians. ACOs that include specialists included in the Medicare CQM 
definition would need to collect data from those specialists in order 
to submit true, accurate, and complete data when reporting Medicare 
CQMs. ACOs and other interested parties can access the list of 
specialty designations used in assignment in Table 9 of the ``Shared 
Savings and Losses, Assignment and Quality Performance Standard 
Methodology Specifications.'' This document is updated annually and can 
be access on the Shared Savings Program website at https://www.cms.gov/medicare/payment/fee-for-service-providers/shared-savings-program-ssp-acos/guidance-regulations. As discussed elsewhere in this section of 
the final rule, we will provide ACOs with a list of beneficiaries 
eligible for Medicare CQMs that can be used by ACOs in identifying 
encounters with specialists that should be included in quality measure 
reporting and improvement.
    Comment: Several commenters had concerns related to data 
aggregation and deduplication when submitting Medicare CQMs. One 
commenter stated that, because the eligible population for Medicare 
CQMs would be broader than the ACO assigned population, many ACOs must 
still hire data aggregation vendors. A few commenters noted that most 
ACOs will require significant process workflow and software development 
if targeting only Medicare beneficiary data. A few commenters stated 
that ACOs face an initial reporting burden of collecting data from 
member practices on disparate EMRs and that this burden exists 
regardless of the scale of data collected. Commenters stated that 
Medicare CQMs do not resolve underlying challenges with electronic 
quality measurement and require significant manual data aggregation and 
patient matching across many tax identification numbers (TINs) and 
electronic health records (EHRs) types. One commenter stated that 
eliminating the all payer/all patient approach is helpful for large 
ACOs with multiple participants and EHR systems, but that the Medicare 
CQM option is still complex and requires data aggregation, patient 
matching and deduplication.
    Response: We acknowledge commenters concerns related to data 
aggregation and deduplication when submitting Medicare CQMs and 
recognize ACOs will have to develop these capabilities to aggregate and 
exchange data either in-house or through vendors but that the movement 
toward digital quality data will help further enhance ACOs' care 
coordination and quality improvement capabilities. As discussed 
elsewhere in this section of the final rule, we will provide ACOs with 
a list of beneficiaries eligible for Medicare CQMs to support ACOs in 
the aggregation and deduplication of patient data.
    In our proposal, we recognized that that Medicare CQMs may not be 
the suitable collection type for some ACOs (88 FR 52420). We encourage 
ACOs to evaluate all quality reporting options to determine which 
collection type is most appropriate based on the ACO's unique 
composition and technical infrastructure. In addition to our proposal 
to report quality data utilizing the Medicare CQMs collection type, in 
performance year 2024, ACOs would have the option to report quality 
data utilizing the CMS Web Interface measures, eCQMs, and/or MIPS CQMs.
    To support ACOs in the transition to digital quality measures, in 
December 2022, we hosted a webinar to support ACOs in the transition to 
reporting all payer/all patient eCQMs/MIPS CQMs and released a guidance 
document on the topic. Specifically, the webinar focused on the APP, 
guidance and resources for reporting via the APP, and questions and 
answers from ACOs and their vendors. Resources from the ``Reporting 
MIPS CQMs and eCQMs in the APM Performance Pathway'' webinar are 
available at https://youtu.be/LDrpoGnnRQs and https://qpp.cms.gov/resources/webinars. The guidance document, entitled ``Medicare Shared 
Savings Program: Reporting MIPS CQMs and eCQMs in the Alternative 
Payment Model Performance Pathway (APP)'' is available in the Quality 
Payment Program Resource Library at https://qpp-cm-prod-content.s3.amazonaws.com/uploads/2179/APP%20Guidance%20Document%20for%20ACOs.pdf. The guidance describes how 
ACOs should identify an appropriate combination of data variables to 
achieve consistent and replicable patient matching that provides the 
most complete and accurate data to meet the measure specification and 
valid and reliable measure performance. The guidance highlights these 
common variables that ACOs have used to achieve patient matching rates 
of 90 percent or higher, which is sufficient for quality reporting, and 
goes on to indicate that ACOs should use 100 percent of this matched, 
deduplicated population to determine the eligible population for each 
measure.
    Comment: Some commenters noted that the Medicare CQM proposal does 
not advance digital quality measurement as it leaves the eCQM reporting 
option unchanged, while one commenter noted that that Medicare CQMs do 
not advance digital quality measurement because CQMs do not use CEHRT. 
A commenter urged CMS to focus on addressing the existing gaps in 
digital infrastructure and equity--a prerequisite to advancing digital 
measurement--and to continue working with the Office of the National 
Coordinator for Health IT (ONC) to advance consensus-based standards 
for digital quality measurement and interoperability.
    Another commenter stated that Medicare CQMs will not inherently 
advance their capabilities to report on eCQMs such as the adoption of 
CEHRT across ACO participants, processes to

[[Page 79104]]

enable aggregation of quality measurement data across all ACO 
participants, the ability to assess data completeness and efficiently 
calculate quality measures outcomes or the generation of QRDA-III 
files. Another commenter advocated for CMS to identify an alternative 
pathway to transmit data in a standardized way to enable successful 
patient matching, such as use of a national patient identifier or 
revisions to QRDA I formats. One commenter stated that incorporating 
additional demographics in the data (QRDA I or FHIR) may improve 
patient matching and support deduplication and suggested that CMS 
consider introducing extra demographic criteria in their CMS 
Implementation Guide or QRDA I specifications to enhance patient 
matching accuracy.
    Response: Medicare CQMs would help ACOs build the infrastructure, 
skills, knowledge, and expertise necessary to aggregate patient data 
consistent with our goals described in our Digital Quality Measurement 
(dQM) Strategic Roadmap, which can be accessed at https://ecqi.healthit.gov/sites/default/files/CMSdQMStrategicRoadmap_032822.pdf. Improving data aggregation skills 
will support ACOs in their adoption of all payer/all patient eCQMs/MIPS 
CQMs and the transition to dQMs.
    As discussed in Domain Three: Optimize Data Aggregation of the dQM 
Strategic Roadmap, data aggregators currently play a vital role in the 
acquisition, processing, transmission, analysis, and application of 
digital health information. Aggregation of digital data is critical for 
measures that depend on information from multiple providers or sources. 
However, a solution that requires CMS to serve as the only data 
aggregator is neither cost effective nor desirable for our goals for 
accountable care. We recognize that providers and care settings are at 
different stages of readiness to adopt dQMs and that the timeframe for 
transition to dQMs across different quality reporting programs varies. 
As stated in our dQM Strategic Roadmap, we anticipate the transition 
may be paced with the uptake of FHIR API technology.
    In response to suggestions regarding QRDA I or other file formats, 
QRDA I is based on the Health Level Seven International[supreg] 
(HL7[supreg]) Clinical Document Architecture (CDA) and does include 
demographic specifications. However, we note we did not propose QRDA I 
for Medicare CQMs and, further, that implementation guide updates are 
beyond the scope of our proposal. As described elsewhere in this 
section of the final rule, to support ACOs in the aggregation and 
deduplication of patient data, we will provide ACOs with a quarterly 
list of beneficiaries eligible for Medicare CQM.
    Comment: One commenter stated that Medicare CQMs will still require 
creating a QRDA file, which increases the administrative burden and 
cost for ACOs.
    Response: Medicare CQMs conform to the measure specifications 
included on MIPS CQMs, not eCQMs. Thus, there is no data type 
designation determination requiring QRDA. We anticipate providing 
technical guidance to ACOs and their vendors to support successful 
adoption of Medicare CQM reporting in accordance with the use of 
multiple data submission types as permitted under the MIPS data 
submission standards.
    Comment: A couple commenters requested clarification as to whether 
a third party intermediary is required to submit Medicare CQMs if an 
ACO has multiple electronic health record systems, or if an ACO can 
collect, match, and de-duplicate their own data if they have the 
expertise.
    Response: Medicare CQMs may be submitted by the ACO or a third 
party intermediary. Medicare CQMs would be subject to the data 
submission requirements detailed at Sec.  414.1325 which provide, 
``[e]xcept for the Medicare Part B claims submission type, the data may 
also be submitted on behalf of the individual MIPS eligible clinician 
or group by a third party intermediary described at Sec.  414.1400.''
    Comment: We received several comments in support of our proposal to 
provide ACOs a list of beneficiaries who are eligible for Medicare CQMs 
within the ACO. However, many commenters stated that it will add 
significant burden for ACOs to ensure that the list is complete, and 
that we should limit reporting of Medicare CQMs to the list of 
beneficiaries provided by CMS. One commenter stated ACOs will struggle 
to comprehensively identify the patient population for which they must 
report Medicare CQMs. Another commenter noted that ACOs operating under 
prospective assignment with retrospective reconciliation may not have 
the data necessary to determine their assignable populations. Several 
commenters suggested that limiting the reporting of Medicare CQMs to 
the patients provided on the CMS-issued list at the beginning of the 
reporting period would reduce the burden associated with reporting 
significantly and make the option a more feasible one for 2024. One 
commenter asked how ACOs could use the list of beneficiaries eligible 
for Medicare CQMs with incomplete claims data at the start of the 
reporting year. The commenter stated that CMS should ensure that the 
population is clear and knowable to ACOs during the reporting period.
    One commenter noted that sharing data once annually may lead to 
missing data points and may compromise data completeness, while another 
commenter expressed that the proposal creates confusion, and CMS would 
not be able to provide timely beneficiary information to ACOs for 
reporting purposes. One commenter suggested that we limit reporting 
requirements to beneficiaries that are aligned at both the beginning 
and the end of the performance period, while another commenter 
recommended that calculations be performed on the back end of the 
reporting trail by CMS and that the list is automatically furnished 
biannually. Other commenters suggested that CMS should establish the 
set of beneficiaries for which ACOs report Medicare CQMs based on third 
quarter roster file it provides to ACOs and the beneficiaries that have 
a claim in the last quarter and reduce burden by adding additional 
demographic data elements. The commenter requested that we work with 
interested parties to come up with a process to ensure ACOs know/can 
report on their eligible patients.
    Response: We acknowledge the concerns and challenges raised by 
commenters regarding ACOs needing to ensure that the list of 
beneficiaries eligible for Medicare CQMs is complete. To support ACOs 
in reporting Medicare CQMs, we are modifying our proposal to provide 
ACOs with a list of beneficiaries eligible for Medicare CQMs once 
annually, at the beginning of the quality data submission period. 
Instead, we will provide each ACO with a list of beneficiaries eligible 
for Medicare CQMs each quarter throughout the performance year as part 
of the ACO's Quarterly Informational Reports Packages in order to give 
ACOs access to the full 12 months of encounters necessary to report 
Medicare CQMs. The list will be cumulative and updated quarterly to 
reflect the most recent quarter's data. For example, encounters with 
dates of service January 1st through March 31st of the performance year 
will be included in the first quarter list. First quarter report 
packages are typically delivered to ACOs in May of the performance 
year. The second quarter list will include encounters with dates of 
service January 1st through June 30th of the performance year. Second 
quarter report packages are typically delivered to ACOs in August of 
the

[[Page 79105]]

performance year. The third quarter list will include encounters with 
dates of service January 1st through September 30th of the performance 
year. Third quarter report packages are typically delivered to ACOs in 
November of the performance year. Lastly, the fourth quarter list of 
beneficiaries eligible for Medicare CQMs will include encounters with 
dates of service January 1st through December 31st of the performance 
year. Fourth quarter report packages are typically delivered to ACOs in 
February of the year following the performance year. The Quarterly 
Informational Reports Packages are delivered to ACOs via the data hub 
in the ACO Management System (ACO-MS). This list will reduce burden 
relative to the proposed annual list by giving ACOs a complete list of 
beneficiaries eligible for Medicare CQMs. The fourth quarter list will 
allow ACOs to verify that they have accounted for all beneficiaries 
eligible for Medicare CQMs.
    The cadence of updating the list throughout the performance year 
will enable ACOs to aggregate data throughout the performance year. 
ACOs may use the fourth quarter list to ensure that all beneficiaries 
eligible for Medicare CQMs are captured in the ACOs' reporting. Sharing 
data throughout the performance year will allow ACOs to prepare the 
majority of their submission data in advance of the submission period 
and then use the fourth quarter list to ensure that all beneficiaries 
that are eligible for Medicare CQMs are captured in the ACOs' 
reporting.
    Additionally, the quarterly list will reduce reporting burden 
relative to the proposed annual list by including beneficiary-level 
age, diagnosis, encounter, and exclusion flags on the list of 
beneficiaries eligible for Medicare CQMs to aid ACOs in identifying the 
denominator eligible population for each measure to the extent that 
such data can be identified through claims and Medicare administrative 
systems. It is important to note that these flags are meant to assist 
ACOs in the aggregation of data and do not replace the need for ACOs to 
evaluate their patient population against each Medicare CQM 
Specification prior to submission, including confirming the 
beneficiaries meet the denominator criteria for the measure. In a 
manner identical to MIPS CQM Specifications, the Medicare CQM 
Specifications will allow for the use of multiple sources of data (for 
example, multiple EHRs, paper records, registries, patient management 
systems) to compile a measure's numerator and denominator. ACOs should 
use all available data, including the list of beneficiaries eligible 
for Medicare CQMs provided by CMS, to ensure that the ACO's quality 
data is true, accurate, and complete.
    Comment: Several commenters had concerns about the timing of the 
claims run-out that would be used to determine the complete list of 
beneficiaries eligible for Medicare CQMs. A commenter shared that it 
would be helpful for CMS to define what is considered the recommended 
time to allow for claims run out for the patient list to be considered 
completed and to identify on the list patients that have been 
``excluded'' from the reporting denominator. One commenter suggested 
that we extend the reporting window such that ACOs will have full 90-
day claims run out for Medicare CQM data; for example, move the 
reporting deadline from March 31 to at least April 30, providing this 
can be done without delaying ACO financial reconciliations. The 
commenter added that ACOs should have confidence they can access the 
full and accurate list of patients whose data is used in quality 
measurement. One commenter asked if we considered a claims run-out 
period prior to the submission window for Medicare CQMs to ensure that 
the ACO can determine the appropriate and accurate measure population 
prior to calculation and submission.
    A few commenters noted that the proposal's focus on claims during 
the measurement period could lead to discrepancies due to claims 
reporting delays of up to a year.
    Response: We clarify our use of the phrase ``run-out'' at 88 FR 
52422 of our proposal. We intended to use the phrase ``run-out'' to 
indicate that the list of beneficiaries eligible for Medicare CQMs that 
we proposed to share prior to the start of the quality data submission 
period would not include a full 12-months of encounter data. Medicare 
CQM Specifications would be identical to MIPS CQM Specifications. As 
such, ACOs would be able to utilize multiple sources of information 
(for example, multiple EHRs, paper records, registries, patient 
management systems) to aggregate Medicare CQM performance data. ACOs 
would not be limited to the use of claims data to report Medicare CQMs. 
While ACOs would be required to report on a full 12-months of 
performance data for Medicare CQMs, unlike Part B claims measures, no 
claims run-out would be required to report Medicare CQMs.
    Comment: One commenter recommended that we apply the incentive to 
report eCQMs/MIPS CQMs to Medicare CQMs. The commenter noted that we 
should reward maximum savings to ACOs that achieve the quality 
performance standard.
    Response: As stated in the CY 2024 PFS proposed rule (88 FR 52423), 
we did not propose to add Medicare CQMs to the eCQM/MIPS CQM reporting 
incentive described at Sec.  425.512(a)(5)(i)(A)(2) for performance 
year 2024. The incentive is for all payer/all patient eCQM/MIPS CQM 
reporting. Since Medicare CQMs would include only Medicare FFS 
beneficiaries, Medicare CQMs are not a form of all payer/all patient 
reporting. As such, they are not included in the eCQM/MIPS CQM 
reporting incentive. We note that the alternative quality performance 
standard, which we finalized in the CY 2023 PFS final rule (88 FR 
69831), would be applicable to ACOs that report Medicare CQMs when 
those ACOs are otherwise eligible for scaled savings/losses.
    Comment: Several commenters opposed the Medicare CQM proposal. One 
commenter stated that creating an ACO-specific measure specification 
creates additional burden on both practices and health care vendors 
(that is, EHR vendors, registry vendors, and health care IT vendors) to 
maintain the same measure based off multiple specifications. The 
commenter added that the measure benchmark will not be the same across 
the different collection types, leading to confusion and non-comparable 
results. Another commenter concluded that reporting Medicare CQMs would 
require a third-party vendor resulting in an increased reporting 
expense because their current vendor does not support CQM.
    Another commenter shared that they do not believe that introduction 
of new types of quality measures advances the goals of the Quality 
Payment Program and will likely lead to confusion among clinicians and 
administrative staff working on the program since Medicare CQMs are 
only available to Shared Savings Program ACOs and should not be 
categorized the same as MIPS CQMs/eCQMs available to all MIPS-eligible 
clinicians.
    Another commenter opposed the proposal and stated that we are 
moving backwards by allowing ACOs to report on assigned and 
``assignable'' Medicare beneficiaries. The commenter stated that ACOs 
should be required to report all payer data. This commenter stated they 
believe that the proposal will devalue the utility of publicly reported 
information and fall short of providing useful information to consumers 
about ACOs. They added that the proposal would create another point of 
disparity between MIPS, MVPs, and the Shared

[[Page 79106]]

Savings Program: making fair comparisons across each impossible. The 
commenter questioned whether the proposal would meet the standard 
established section 1899(b)(3)(C) of the Act which states that, the 
Secretary shall establish quality performance standards to assess the 
quality of care furnished by ACOs and seek to improve the quality of 
care furnished by ACOs over time by specifying higher standards, new 
measures, or both for purposes of assessing such quality of care as it 
would seem that limiting the ACO's reporting to only Medicare Patients 
is lowering the standards not ``specifying higher standards.''
    Response: We acknowledge commenters concerns regarding the creation 
of the Medicare CQM Specifications and direct readers to this section 
of this final rule for discussion on this topic. A measure 
specification for the Medicare CQMs collection type must be established 
in order for such collection type to have its own benchmark separate 
from the other collections, for example, MIPS CQMs collection type or 
eCQMs collection type. We direct readers to our discussion of 
benchmarks in this section of the final rule to address concerns 
related to Medicare CQM benchmarking. Lastly, we direct readers to the 
discussion in this section of the final rule where we clarify that 
third-party intermediaries are permitted, but not required for 
reporting Medicare CQMs.
    As discussed in our proposal, our long-term goal continues to be to 
support ACOs in the adoption of all payer/all patient measures (88 FR 
52421). The Shared Savings Program has historically permitted an ACO to 
report on a sample of attributed Medicare beneficiaries through the CMS 
Web Interface. While we have encouraged and incentivized ACOs to 
transition to the reporting of all payer data for MIPS CQMs and/or 
eCQMs, many have commented on the complexity of doing so due to their 
difficulty matching and aggregating patient data across the various EHR 
systems used by their constituent clinician practices (88 FR 52420). We 
previously extended the availability of the CMS Web Interface in the 
Shared Savings Program to provide relief for these practices (86 FR 
65262). Medicare CQMs provide a transition path for ACOs that have 
difficulty reporting patient data by limiting the beneficiaries for 
which an ACO must match and aggregate data to only Medicare 
beneficiaries that are eligible to be included. This is the logical 
next step in the reporting of digital quality measures as it is 
inclusive of the ACO's broader Medicare FFS population, which is larger 
than the sample currently used in the CMS Web Interface, but not as 
large as the all payer/all patient population that must be reported for 
an eCQM or MIPS CQM.
    Comment: Many commenters suggested that we establish Medicare CQMs 
as a permanent option that is in place until digital quality 
measurement and reporting is feasible for all ACOs. Commenters outlined 
several benefits for making Medicare CQMs permanent, including reducing 
the ACOs need to choose, invest in, and implement multiple reporting 
types prior to digital quality measurement and reporting options 
becoming available, and that while the requirements for reporting are 
challenging, Medicare CQMs will still be an improvement over the other 
reporting options currently available. Another commenter noted that 
their EHR vendor does not plan to support Medicare CQMS because it is a 
temporary reporting option not in alignment with or contributing to the 
adoption of eCQMs. One commenter stated that understanding the timeline 
for sunsetting Medicare CQMs will help ACOs take the necessary steps to 
prepare for eCQM reporting and make decisions about continued 
participation in the program.
    Another commenter urged CMS to maintain the Medicare CQM reporting 
option for ACOs until digital quality measurement and reporting is 
feasible for all ACO participants, especially small and independent 
providers who will need more technical assistance, resources, and 
support during this transition. Many commenters stated that Medicare 
CQMs should be a permanent collection types due to issues transitioning 
to all payer/all patient measures.
    Response: We have heard that ACOs need a better understanding of 
how long Medicare CQMs will be an available collection type as they 
prepare to report quality measures for future performance years. 
Medicare CQMs are intended to serve as a transition to all payer/all 
patient reporting and not as a permanent collection type. We 
acknowledge that ACOs are at different stages of readiness to adopt all 
payer/all patient measures and we intend for Medicare CQMs to be 
available to ACOs during their transition to all patient/all payer 
reporting. We expect that the sunsetting of the Medicare CQM collection 
type may be paced with the uptake of FHIR API technology, but this will 
be assessed on industry readiness and CMS requirements.
    Comment: Many commenters suggested that we to consider a data 
completeness requirement lower than 75 percent for ACOs reporting 
eCQMs, MIPS CQMs, or Medicare CQMs due to the complexities of multiple 
practices and EHRs involved in a single ACO, and the significant burden 
and investment required by ACOs and participant providers to be able to 
complete any one of these reporting options.
    One commenter suggested that we apply the same data completeness 
thresholds utilized for MIPS CQMs and Medicare CQMs to eCQMs and 
recommended that data completeness thresholds be applied at the ACO-
level. A few commenters recommended that we maintain a 75 percent data 
completeness requirement for ACO quality measure reporting. The 
commenter stated that CMS should require ACOs to report on 100 percent 
of their assigned beneficiaries only and that this would be consistent 
with other payers' quality reporting methodology and allows all quality 
measures to utilize a uniform denominator set, while another few 
commenters expressed concern about the impact of potentially requiring 
100 percent data completeness for any of the measure types in the 
future.
    One commenter noted that it is unclear which data completeness 
standard the agency proposes to adopt, and that the proposal mentions 
both establishing data completeness at 75 percent for the CY 2024, CY 
2025, and CY 2026 performance periods, as well as 100 percent data 
completeness in terms of aggregating, matching, and de-duplicating 
data. One commenter stated that our methodology and baseline for 
determining data completeness is unclear, so ACOs and others lack 
insight into whether they are submitting appropriately complete data.
    Response: The data completeness criteria threshold of at least 75 
percent for the Medicare CQMs aligns with the data completeness 
criteria threshold established for eCQM and MIPS CQM collection types 
for the CY 2024, CY 2025, and CY 2026 performance periods/2026, 2027, 
and 2028 MIPS payment years as discussed in section IV.A.4.f.(1)(d) of 
this final rule. It is appropriate for Medicare CQMs, eCQMs, and MIPS 
CQMs to have the same data completeness criteria in order to prevent 
confusion and complexity and to maintain a level of consistency in the 
program. Additionally, CMS will provide all ACOs with a list of 
beneficiaries eligible for Medicare CQMs each quarter, which will aid 
ACOs in satisfying data completeness by enabling ACOs to aggregate data 
throughout the performance year and use the fourth quarter list to 
ensure that

[[Page 79107]]

all beneficiaries eligible for Medicare CQMs are captured in the ACOs' 
reporting.
    To meet the data completeness criteria, ACOs must report quality 
performance data (``Performance Met,'' ``Performance Not Met,'' or 
denomination exclusions/exceptions) for at least 75 percent of the 
eligible and matched denominator population for the performance year. 
In our proposal, we stated that, ``The ACO's aggregated ACO submission 
must account for 100 percent of the eligible and matched patient 
population across all ACO participants'' (88 FR 52422). By this we mean 
that ACOs must aggregate quality performance data from all of their ACO 
participants. Once patient data are matched and de-duplicated across 
all of the ACO's participants, the ACO would then match the aggregated 
patient data with each Medicare CQM Specification to identify the 
eligible population for each measure. To aid ACOs in meeting data 
completeness, CMS will provide each ACO with a list of beneficiaries 
eligible for Medicare CQMs each quarter in order to give ACOs access to 
the full 12 months of encounters necessary to report Medicare CQMs.
    In response to commenters suggestion that CMS should require ACOs 
to report on 100 percent of their assigned beneficiaries, we direct 
readers to the discussion in this section of the final rule regarding 
the alignment of beneficiaries eligible for Medicare CQMs and the all 
payer/all patient measure specification.
    Comment: Many commenters expressed concern regarding our larger 
goal to require all ACOs to report all payer eCQMs/MIPS CQMs. Many 
commenters noted concerns that the current state of data standards and 
interoperability will not yet fully enable ACOs to meet the eCQM 
reporting requirements successfully.
    Some commenters supported the transition to eCQM/MIPS CQM 
reporting. One commenter shared their belief that reporting eCQMs is a 
better reflection of overall quality, while another commenter 
encouraged CMS to continue working with providers to facilitate the 
transition to all payer/all patient measures even as/if the provider or 
ACO chooses to report Medicare CQMs.
    Response: We did not propose any changes to the previously 
finalized policies regarding all payer eCQMs/MIPS CQMs. We note that 
the Medicare CQM collection type that we are finalizing in this rule 
addresses many of concerns about all payer/all patient shared by ACOs 
and other interested parties. Specifically, because beneficiaries 
eligible for Medicare CQMs must have had a claim encounter with an ACO 
professional with a specialty used in assignment, Medicare CQMs would 
address the concern raised by ACOs that for ACOs with a higher 
proportion of specialty practices and/or multiple EHR systems, the 
broader all payer/all patient eligible population would capture 
beneficiaries with no primary care relationship to the ACO. Further, 
ACOs, particularly ACOs with a higher proportion of specialty practices 
and/or multiple EHRs, would be able utilize Medicare Part A and B 
claims data to help identify the ACO's eligible population and to 
validate the ACO's patient matching and deduplication efforts. For 
these reasons it is appropriate to establish Medicare CQMs as a new 
collection type for Shared Savings Program ACOs.
    After consideration of the public comments received, we are 
finalizing our proposal to define a beneficiary eligible for Medicare 
CQMs at Sec.  425.20. As discussed elsewhere in this section of the 
final rule, we are finalizing our proposed definition of beneficiary 
eligible for Medicare CQMs under Sec.  425.20, with a modification for 
clarity, and to ensure consistency of terminology across provisions, to 
reference ``clinical nurse specialist'' instead of ``certified nurse 
specialist.'' Specifically, we are finalizing the definition of a 
beneficiary eligible for Medicare CQMs at Sec.  425.20 as a beneficiary 
identified for purposes of reporting Medicare CQMs for ACOs 
participating in the Medicare Shared Savings Program (Medicare CQMs) 
who is either of the following:
     A Medicare FFS beneficiary (as defined at Sec.  425.20) 
who--
    ++ Meets the criteria for a beneficiary to be assigned to an ACO 
described at Sec.  425.401(a); and
    ++ Had at least one claim with a date of service during the 
measurement period from an ACO professional who is a primary care 
physician or who has one of the specialty designations included in 
Sec.  425.402(c), or who is a physician assistant, nurse practitioner, 
or clinical nurse specialist.
     A Medicare FFS beneficiary who is assigned to an ACO in 
accordance with Sec.  425.402(e) because the beneficiary designated an 
ACO professional participating in an ACO as responsible for 
coordinating their overall care.
    Additionally, we are finalizing our proposal with modifications to 
reflect that the list of beneficiaries eligible for Medicare CQMs will 
be shared more than once annually to add new paragraph (c)(1)(iii) to 
Sec.  425.702 as follows:
    For performance year 2024 and subsequent performance years, CMS, 
upon the ACO's request for the data for purposes of population-based 
activities relating to improving health or reducing growth in health 
care costs, protocol development, case management, and care 
coordination, provides the ACO with information about its FFS 
population.
     The following information is made available to ACOs 
regarding beneficiaries eligible for Medicare CQMs as defined at Sec.  
425.20:
    ++ Beneficiary name.
    ++ Date of birth.
    ++ Beneficiary identifier.
    ++ Sex.
     Information in the following categories, which represents 
the minimum data necessary for ACOs to conduct health care operations 
work, is made available to ACOs regarding beneficiaries eligible for 
Medicare CQMs as defined at Sec.  425.20:
    ++ Demographic data such as enrollment status.
    ++ Health status information such as risk profile and chronic 
condition subgroup.
    ++ Utilization rates of Medicare services such as the use of 
evaluation and management, hospital, emergency, and post-acute 
services, including the dates and place of service.
    As discussed in section IV.A.4.e of this final rule, we are 
finalizing our proposal to establish Medicare CQMs for Accountable Care 
Organizations Participating in the Medicare Shared Savings Program 
(Medicare CQMs) as a new collection type for Shared Savings Program 
ACOs reporting on the Medicare CQMs (reporting quality data on 
beneficiaries eligible for Medicare CQMs as defined at Sec.  425.20) 
within the APP measure set and administering the CAHPS for MIPS Survey 
as required under the APP.
    As discussed in section IV.A.4.f.(1)(d) of this final rule, we are 
not finalizing the proposal to establish the data completeness criteria 
threshold of at least 80 percent for the CY 2027 performance period/
2029 MIPS payment year.
(3) Benchmarking Policy for Medicare CQMs
    As the Shared Savings Program adopted the APP (see, for example, 
Sec.  425.512(a)(3)(i)), benchmarks for quality measures used by the 
program are those established under the MIPS policies at Sec.  
414.1380(b)(1)(ii). We proposed that new benchmarks for scoring ACOs on 
the Medicare CQMs under MIPS would be developed in alignment with MIPS 
benchmarking

[[Page 79108]]

policies (88 FR 52423). As historical Medicare CQM data would not be 
available at the time of the proposal, we proposed for performance year 
2024 and 2025 to score Medicare CQMs using performance period 
benchmarks. Similarly, as quality performance data are submitted via 
Medicare CQM and baseline period data become available to establish 
historical benchmarks, we proposed for performance year 2026 and for 
subsequent performance years to transition to using historical 
benchmarks for Medicare CQMs when baseline period data are available to 
establish historical benchmarks in a manner that is consistent with the 
MIPS benchmarking policies at Sec.  414.1380(b)(1)(ii).
    The following is a summary of the comments we received on these 
proposals and our responses.
    Comment: A few commenters supported CMS' proposal to use 
performance period benchmarks for performance years 2024 and 2025 
before transitioning to historical benchmarks starting with performance 
year 2026.
    Response: We thank the commenters for their support.
    Comment: Several commenters were concerned about the proposal to 
score Medicare CQMs in performance years 2024 and 2025 using 
performance period benchmarks. One commenter stated that the use of 
same year percentile rankings is in direct conflict with CMS' stated 
desire to have all Traditional Medicare beneficiaries in accountable 
relationships by 2030 as in-year percentile calculations would result 
in a percent of participants to fail. The commenter also noted that the 
use of a historical period would create the opportunity for 
improvement. Another commenter stated that ACOs need Medicare CQM 
benchmarks to understand the impact of reporting Medicare CQMs compared 
to CMS Web Interface. A few commenters stated that benchmarks should be 
established prior to the start of the performance year and that having 
unknown benchmarks will discourage ACOs from reporting Medicare CQMs. 
One commenter added that benchmarks should be based on historical 
performance on which everyone can improve.
    Response: As discussed in the CY 2024 PFS proposed rule (88 FR 
52423), we proposed that new benchmarks for scoring ACOs on the 
Medicare CQMs under MIPS would be developed in alignment with MIPS 
benchmarking policies. Since Medicare CQMs would be subject to MIPS 
scoring policies, the application of MIPS benchmarking policies to 
Medicare CQMs is both logical and necessary for implementation of the 
new collection type. MIPS benchmarks are specific to each collection 
type (for example, eCQM, MIPS CQM, Medicare CQM, CMS Web Interface, 
Consumer Assessment of Healthcare Providers and Systems (CAHPS) for 
MIPS Survey measures, and Part B claims measures). Because benchmarks 
are specific to collection type, a measure reported as an eCQM will be 
compared to a different benchmark than the same measure reported as a 
MIPS CQM or Medicare CQM.
    In response to commenters concerns regarding the use of performance 
period benchmarks, as described in the MIPS Quality Benchmark Overview 
which is updated for each performance year and posted in the Quality 
Payment Program Resource Library, if a quality measure or collection 
type does not have a historical benchmark, we will attempt to calculate 
benchmarks based on data submitted for the performance period. The PY 
2023 MIPS Quality Benchmark Overview can be accessed at https://qpp-cm-prod-content.s3.amazonaws.com/uploads/2272/2023%20Quality%20Benchmarks.zip. We can establish performance period 
benchmarks when at least 20 instances of the measure are reported 
through the same collection type and meet data completeness and case 
minimum requirements and have a performance rate greater than 0% (or 
less than 100% for inverse measures). Consistent with MIPS benchmarking 
policies, since historical data would not be available for the Medicare 
CQM collection type in the first and second year of implementation, we 
proposed for performance years 2024 and 2025 to score Medicare CQMs 
using performance period benchmarks. In further alignment with MIPS 
benchmarking policies, we proposed for performance year 2026 and 
subsequent performance years to transition using historical benchmarks 
for Medicare CQMs when baseline period data are available to establish 
historical benchmarks in a manner that is consistent with the MIPS 
benchmarking policies at Sec.  414.1380(b)(1)(ii). Benchmarks for the 
Medicare CQMs will be updated annually and posted on the Quality 
Payment Program Resource Library at https://qpp.cms.gov/resources/resource-library.
    Comment: Several commenters expressed concerns about the use of 
MIPS benchmarking policies to establish benchmarks for Medicare CQMs. 
Commenters stated that the use of 20 entities reporting at least 20 
patients was not a reliable basis for benchmarks, and benchmarks would 
vary year-to-year based on changes in the number of entities reporting. 
A few commenters stated that, on review of the existing benchmarking 
process for MIPS CQMs, eCQMs, and now Medicare CQMs, they do not 
believe that the process for distributing performance across deciles is 
transparent nor does this approach as constructed produce information 
that is meaningful. The commenters stated that the approach also 
assumes that all measures should be scored with the potential to 
achieve 100% (or 0% if it is an inverse measure) and may not reflect 
clinical knowledge or practical considerations of quality. A few 
commenters stated that CMS needs to revise the benchmark methodology to 
increase transparency, consider the impact of random fluctuation, and 
adjust for practical considerations of comparison and relative 
performance. One commenter noted that ACOs have virtually no 
opportunity to improve scores based on data due to the current 
benchmarks and data lags. One commenter was concerned that that some 
ACOs could receive zero points or at most seven points.
    Response: The MIPS benchmarking requirement of 20 submissions of at 
least 20 cases was established in the CY 2017 Quality Payment Program 
final rule as the minimum standard for establishing a benchmark to 
reliably score measures (81 FR 77277). In order for a benchmark to be 
established for the Medicare CQMs collection type, there would need to 
be a minimum of 20 Shared Savings Program ACOs with at least 20 cases 
reporting the measure and such submissions would need to meet the data 
completeness criteria requirement and have a performance rate greater 
than zero in order for a reliable benchmark to be established (42 CFR 
414.1380(b)(1)(ii)(A)). For the CY 2024 performance period, benchmarks 
have not yet been established for the Medicare CQMs collection type 
since CY 2024 will be the first year in which such collection type will 
be available and as a result, performance period benchmarks will be 
established for the Medicare CQMs collection type if the benchmarking 
requirement of 20 submissions of at least 20 cases is met (Sec.  
414.1380(b)(1)(ii)). With the number of Shared Savings Program ACOs 
reporting under the APP in order to meet the Shared Savings Program's 
quality performance standard, there is little variation in the volume 
of Shared Savings Program ACOs reporting data. As a result, we do not 
expect the establishment of reliable benchmarks for Medicare CQMs to be 
an issue.
    To ensure that we establish robust benchmarks, each benchmark must 
have

[[Page 79109]]

a minimum of 20 submissions that meet the data completeness requirement 
and meet the required case minimum criteria (20 cases) for scoring 
(Sec.  414.1380(b)(1)(ii)(A)). The benchmarking methodology relies on 
assigning points based on decile distributions with decimals. A decile 
distribution requires at least 10 observations. We doubled the 
requirement to 20 to be able to assign decimal point values and 
minimize cliffs between deciles (81 FR 77277). We establish benchmarks 
using a percentile distribution, separated into deciles, because it 
translates measure-specific score distributions into a uniform 
distribution of those reporting the measure based on actual performance 
values. For each set of benchmarks, we calculate the decile breaks for 
measure performance and assign points for a measure based on which 
benchmark decile range the clinician's measure performance rate is 
between (81 FR 77286). For the quality performance category measures, 
we use the case minimum requirements for the quality measures used in 
the 2018 Value Modifier (VM) program (see Sec.  414.1265): 20 cases for 
all quality measures (81 FR 77287). We referred readers to Table 46 of 
the CY 2016 PFS final rule (80 FR 71282), which summarized the analysis 
of the reliability of certain claims-based measures used for the 2016 
VM payment adjustment. The benchmarking policy and decile scoring 
system allow the program to score clinicians on quality performance in 
the program relative to care as it is provided in actual clinical 
settings by scoring according to data submitted through participants. 
This allows us to drive improvements in clinical care that is more 
considerate of real-world practice and responsive to changes over time.
    Comment: A few commenters suggested that we apply the MIPS scoring 
rules for new measures which establish a 7-point scoring floor, 
provided data completeness requirements are met, and a 5-point floor in 
year two. Commenters noted that, during this 2-year phase, ACOs would 
be better able/willing to allocate limited resources to technical 
development and workflows associated with the transition. Stratifying 
Medicare only data without a ``point floor'' guarantee, according to 
commenters, may result in ACOs choosing to simply submit all payer data 
versus Medicare only data as it will be a lighter lift. In addition, 
committing to performance against unknown benchmarks for this new 
collection type, ACOs would have no way to gauge near real-time 
performance which has been a staple of the program.
    Response: We note that the scoring policy providing measure 
achievement points of a 7-point scoring floor and a 5-point scoring 
floor pertains to the submission of new MIPS quality measures during 
their first 2 years in MIPS. Specifically, under the scoring policy for 
new MIPS quality measures in Sec.  414.1380(b)(1)(i)(C), the measure 
achievement points available for the submission of a new MIPS quality 
measure (having a benchmark, and meeting case minimum and data 
completeness requirements) in its first year of MIPS are between 7 and 
10 measure achievement points and the submission of a new MIPS quality 
measure (having a benchmark, and meeting case minimum and data 
completeness requirements) in its second year of MIPS are between 5 and 
10 measure achievement points. The scoring policy for new MIPS quality 
measures is not applicable to the establishment of a new collection 
type or the application of a newly available collection type to an 
existing MIPS quality measure. In the CY 2022 PFS final rule, we noted 
that such policy will not apply to measures that have existed as a MIPS 
quality measure but are being introduced for a new collection type (86 
FR 65500). For example, if a MIPS quality measure is currently 
available as a MIPS CQM and it becomes newly available as an eCQM or 
Medicare CQM, the application of the newly available collection type to 
an existing MIPS quality measure would not be considered a new measure 
under such scoring policy.
    To operationalize the implementation of the Medicare CQMs 
collection type, specifically the capability to distinguish between the 
submission of data for a Medicare CQM and a MIPS CQM to CMS, we created 
an identifier that reflects the Quality number associated with a 
quality measure (that is, Q001, Q134, and Q236) followed by the letters 
``SSP.'' For the reporting of Medicare CQMs, the identifiers are as 
follows: 001SSP, 134SSP, and 236SSP. We note that the Medicare CQM 
identifiers must be included in the submission files. We will take 
these comments into consideration for future rulemaking.
    In response to the comment that ACOs would have no way to gauge 
near real-time performance which has been a staple of the program, we 
note that Medicare CQMs would transition to historical benchmarks when 
sufficient base period data are available to establish historical 
benchmarks in a manner that is consistent with MIPS benchmarking 
policies. We also direct readers to the discussion in section 
III.G.2.e. of this final rule regarding our finalized policy to adopt a 
historical 40th percentile quality performance standard for performance 
year 2024 and subsequent performance years. In section III.G.2.e of 
this final rule, we are finalizing, as proposed, the proposal to 
provide ACOs with the 40th percentile MIPS Quality performance category 
score that would be used as the quality performance standard for a 
given performance year prior by the start of the performance year, 
which supports the ability for ACOs to understand and meet quality 
goals, allocate resources effectively, and ultimately support patients 
and improve quality outcomes. Lastly, as described at Sec.  
425.512(a)(4)(ii) and (5)(ii), in performance years beginning on or 
after January 1, 2023, ACOs that achieve a quality performance score 
equivalent to or higher than the 10th percentile of the performance 
benchmark on at least one of the four outcome measures in the APP 
measure set and are otherwise eligible to share in savings would share 
in savings on a sliding scale (87 FR 69832). This alternative quality 
performance standard will help to mitigate impacts on shared savings 
and losses as ACOs transition to a new collection type.
    Comment: Several commenters asked how benchmarks would be developed 
if fewer than 20 ACOs report Medicare CQMs.
    Response: In the unlikely event that fewer than 20 instances of a 
Medicare CQM are reported that meet the data completeness and case 
minimum requirements, the MIPS scoring policy for measures that lack a 
benchmark would apply to that Medicare CQM. See Sec.  
414.1380(b)(1)(i)(A).
    Comment: Since the Medicare CQMs would be available only to Shared 
Savings Program ACOs, a few commenters were concerned about ACOs being 
compared only to other ACOs that report Medicare CQMs. One commenter 
stated their preference to have their quality performance compared to 
all other participants on these measures. Another commenter stated that 
CMS should stop measuring ACOs against each other and instead measure 
ACOs on a national standard so that all ACOs can pass and do not lose 
out on savings due to arbitrary quality decile cut points.
    Response: Given that benchmarks are specific to each collection 
type and that we proposed to establish Medicare CQMs as a new 
collection type for only Shared Savings Program ACOs, only ACO data 
will be available to benchmark Medicare CQMs.

[[Page 79110]]

Additionally, the health equity adjustment would be applicable to 
Medicare CQMs for purposes of determining shared saving payments/
losses. The application of the health equity adjustment would help 
improve performance when ACOs deliver high quality care to underserved 
patient populations. For these reasons, it is appropriate to establish 
benchmarks for Medicare CQMs that are consistent with MIPS benchmarking 
policies. ACOs that prefer to be compared to clinicians at large may do 
so by reporting eCQMs or MIPS CQMs, for which CMS calculates a 
benchmark using data reported by MIPS eligible clinicians reporting 
under the chosen collection type.
    Comment: Commenters suggested the following alternative 
recommendations regarding establishing benchmarks for Medicare CQMs: 
A1c control and blood pressure control measures be considered topped 
out measures and depression screening be considered pay-for-reporting 
until benchmarks can be set for Medicare CQMs; for performance years 
2024 and 2025, use CMS Web Interface benchmarks or make Medicare CQM 
measures pay-for-reporting; consider a process similar to the recent 
benchmarking of the CMS Web Interface measures where benchmarks would 
be defined based on pre-determined distributions of performance and 
thresholds are not dependent on random fluctuations in performance or 
on the fact that a measure is new to the program.
    Response: We thank commenters for their feedback. The Shared 
Savings Program sunset our pay for reporting policy in PY 2020, and 
MIPS scoring policies do not include pay for reporting. As such, we 
would not apply pay for reporting to Medicare CQMs.
    To address commenters suggestion that we consider a process similar 
to benchmarking of CMS Web Interface measures, we wish to underscore 
that MIPS benchmarking policies establish benchmarks for CMS Web 
Interface using historical data. Performance on CMS Web Interface 
measures are based on a sample of the ACO's beneficiaries and ACOs that 
have performed high on CMS Web Interface measures. We anticipate that 
ACO performance may fluctuate as ACOs transition to new collection 
types, like Medicare CQMs. Once historical data are available for 
Medicare CQMs consistent with MIPS benchmarking policies, we proposed 
to transition to using historical benchmarks.
    After consideration of public comments, we are finalizing our 
proposal to establish new benchmarks for scoring ACOs on the Medicare 
CQMs under MIPS in alignment with MIPS benchmarking policies. As 
historical Medicare CQM data would not be available, we are finalizing 
that for performance years 2024 and 2025, we will score Medicare CQMs 
using performance period benchmarks. We are also finalizing that, for 
performance year 2026 and subsequent performance years, when baseline 
period data are available to establish historical benchmarks in a 
manner that is consistent with the MIPS benchmarking policies at Sec.  
414.1380(b)(1)(ii), we will score Medicare CQMs using historical 
benchmarks.
(4) Expanding the Health Equity Adjustment to Medicare CQMs
    In the CY 2023 PFS final rule (87 FR 69838 through 69858), for 
performance year 2023 and subsequent performance years, we finalized a 
health equity adjustment to upwardly adjust the MIPS Quality 
performance score for ACOs that report eCQMs/MIPS CQMs, are high 
performing on quality, and serve a higher proportion of underserved 
beneficiaries. As we stated in the CY 2023 PFS final rule, the goals of 
the health equity adjustment include rewarding ACOs serving a high 
proportion of underserved beneficiaries and supporting ACOs with the 
transition to eCQMs/MIPS CQMs (87 FR 69841).
    Consistent with the goal of supporting ACOs in their transition to 
all payer/all patient eCQMs/MIPS CQMs, we proposed that ACOs that 
report Medicare CQMs would be eligible for the health equity adjustment 
to their quality performance category score when calculating shared 
savings payments (88 FR 52423). We proposed to revise Sec.  425.512(b) 
to specify that, for performance years 2024 and subsequent performance 
years, we would calculate a health equity adjusted quality performance 
score for an ACO that reports the three Medicare CQMs or a combination 
of eCQMs/MIPS CQMs/Medicare CQMs in the APP measure set, meeting the 
data completeness requirement at Sec.  414.1340 for each measure, and 
administers the CAHPS for MIPS survey (except as specified in Sec.  
414.1380(b)(1)(vii)(B)). This proposal would advance equity within the 
Shared Savings Program by supporting ACOs that deliver high quality 
care and serve a high proportion of underserved individuals. Applying 
the health equity adjustment to an ACO's quality performance category 
score when reporting Medicare CQMs would encourage ACOs to treat 
underserved populations.
    The following is a summary of the comments we received on these 
proposals and our responses.
    Comment: We received several comments in support of our proposal to 
expand the health equity adjustment to Medicare CQMs. One commenter 
stated that the adjustment is necessary to correct the unintended 
consequence of disincentivizing the care of underserved populations in 
value-based payment systems. Another commenter noted the importance of 
a health equity adjustment in recognition of ACOs serving a high 
proportion of underserved beneficiaries who have traditionally lacked 
access to care or non-clinical resources that significantly impact 
their health.
    One commenter supported our focus on health equity but stated these 
changes and financial implications are occurring too rapidly and urged 
a delay of at least one year. The commenter was concerned that the 
proposed calculation may not account for all components of health 
equity and noted the need for more funding and time for analysis and 
development. Another commenter supported our proposal, but they did not 
believe that a health equity adjustment is sufficient to address the 
underlying discrepancies in all-payer/all-patient measurement across 
vastly different patient populations. Another ACO concluded that it is 
unfair to compare a multispecialty group against other groups that 
either do not have specialists or have carved their specialists out of 
their ACOs, and that a more viable solution would be to require primary 
care services to have been provided to patients before they are 
eligible for eCQM reporting for measures that are intended to track 
performance of primary care.
    One commenter was opposed to our proposal to expand the health 
equity adjustment to Medicare CQMs and questioned the legality of 
providing financial incentives to ACOs (providers) to provide more 
services to people of certain races, sexualities, and religions.
    Response: In response to the commenter that alluded to providing 
financial incentives to ACOs (providers) to provide more services to 
people of certain races, sexualities, and religions, our proposal to 
expand the health equity adjustment to Medicare CQMs does not 
incentivize ACOs, ACO providers/suppliers, or ACO professionals to 
provide more services to individuals based on race, sexuality, 
religion, or any other protected class. By applying the health equity 
adjustment to ACO's MIPS Quality performance category score when 
determining shared savings and shared losses for ACOs,

[[Page 79111]]

ACOs are rewarded for delivering high quality care and serving a high 
proportion of underserved individuals. Here, the proportion of 
underserved beneficiaries is determined using the Area Deprivation 
Index, enrollment in the Medicare Part D low-income subsidy, and dual 
eligibility for Medicare and Medicaid (42 CFR 425.512(b)(2)(iv)(A)). 
For a fuller discussion of how we found these factors to represent a 
method for determining the proportion of underserved beneficiaries, 
please see the CY 2023 PFS final rule (87 FR 69838 through 69842). This 
approach is agnostic of race, gender, sexuality, and religion. As 
stated in Executive Order 13985, ``Executive Order on Advancing Racial 
Equity and Support for Underserved Communities Through the Federal 
Government,'' by advancing equity across the Federal Government, we can 
create opportunities for the improvement of communities that have been 
historically underserved, which benefits everyone. Extending the health 
equity adjustment to Medicare CQMs is consistent with our goal of 
promoting health equity across the health care system.
    To address commenter's concern that the proposed calculation may 
not account for all components of health equity and may need more 
funding and time for analysis and development, we note that the health 
equity adjustment is designed to upwardly adjust the ACO's quality 
performance score and will not financially penalize ACOs. The health 
equity adjustment promotes health equity in a value-based care program, 
while simultaneously avoiding the pitfalls of other pay-for-equity type 
approaches. This health equity adjustment will not risk adjusting away 
disparities (thereby masking them) and does not set lower quality 
standards for underserved populations--rather, this provision will 
reward those providers who provide excellent care for underserved 
populations. Furthermore, these bonus points represent the sole 
motivation for ACOs seeking to improve quality and health equity.
    In response to commenters' suggestion that we require primary care 
services to have been provided to patients before they are eligible for 
eCQM reporting for measures that are intended to track performance of 
primary care, we direct readers to this section of the final rule where 
we discuss the alignment of beneficiaries eligible for Medicare CQMs 
and the all payer/all patient Measure Specifications.
    After consideration of public comments, we are finalizing our 
proposal that ACOs reporting Medicare CQMs will be eligible for the 
health equity adjustment to their quality performance category score 
when calculating shared savings payments. We are also finalizing our 
proposal to revise Sec.  425.512(b) to specify that, for performance 
years 2024 and subsequent performance years, we will calculate a health 
equity adjusted quality performance score for an ACO that reports the 
three Medicare CQMs or a combination of eCQMs/MIPS CQMs/Medicare CQMs 
in the APP measure set, meeting the data completeness requirement at 
Sec.  414.1340 for each measure, and administers the CAHPS for MIPS 
survey (except as specified in Sec.  414.1380(b)(1)(vii)(B)).
(5) Summary of Final Policies
    In Table 28 of this final rule, we summarize the changes to the 
regulation at Sec.  [thinsp]425.512(a)(4) and (5) to reflect the 
changes we are finalizing to the quality reporting requirements and 
quality performance standard for performance year 2024 and subsequent 
performance years. Performance benchmarks for performance year 2024 
used to determine the 10th, 30th, and 40th percentiles for purposes of 
evaluating the eCQM/MIPS CQM reporting incentive described at Sec.  
425.512(a)(5)(i)(A)(2) will be posted on the Quality Payment Program 
Resource Library website at https://qpp.cms.gov/resources/resource-library.
    We direct readers to the MIPS measure benchmarking policies 
described at Sec.  414.1380(b)(1)(ii) and to both the quality benchmark 
and performance period benchmark documentation posted on the Quality 
Payment Program Resource Library website at https://qpp.cms.gov/resources/resource-library for more details. Performance benchmarks 
differ by collection type (that is, eCQM, MIPS CQM, Medicare CQM (as 
finalized), CMS Web Interface) and are updated for each performance 
year.
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c. APP Measure Set
(1) Background
    We refer readers to Table 29, which lists the measures included in 
the final APP measure set that will be reported by Shared Savings 
Program ACOs for performance year 2023 and subsequent performance 
years. These are the same measures finalized in the CY 2023 PFS final 
rule (87 FR 69862); however, we noted that the Collection Type for each 
measure has been updated. As finalized in the CY 2023 PFS final rule 
(87 FR 69863), we included the measure type in Table 29 for each 
measure in the measure set to provide ACOs a list of

[[Page 79113]]

the outcome measures for purposes of meeting the quality performance 
incentive for reporting eCQMs/MIPS CQMs. This information is also 
relevant to the alternative quality performance standard under which 
ACOs that fail to meet the quality performance standard to qualify for 
the maximum sharing rate, but that achieve a quality performance score 
at the 10th percentile on 1 of the 4 outcome measures in the APP 
measure set, may be eligible to share in savings on a sliding scale (87 
FR 69861). We noted inclusion of this information does not change any 
of the measures in the measure set.
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[[Page 79114]]


BILLING CODE 4120-01-C
(2) Revisions
    The CMS Web Interface collection type under the APP includes 10 
measures. We refer readers to Table Group E of Appendix 1 of this final 
rule for the proposed substantive changes to measure specifications for 
9 out of 10 CMS Web Interface measures starting with performance year 
2024. As proposed, the changes would update measures and align the CMS 
Web Interface measures with the practice workflows of the MIPS CQM 
collection type.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: We received a comment expressing appreciation for not 
making any significant changes to the APP measure set.
    Response: We thank the commenter for their support.
    We received many comments about issues that were not related to the 
proposals included in this section of the proposed rule. The issues 
were related to the clinical merits of adding the three Medicare CQMs 
to the APP measure set, the financial, administrative, resource, and 
technical burden of this policy on ACOs and healthcare vendors, and the 
scheduled sunsetting of the CMS Web Interface in PY 2024. We refer 
readers to section IV.A.4.e., Reporting the Medicare CQMs, of this 
final rule for the disposition of our proposal to add three Medicare 
CQMs to the APP measure set.
    Additionally, we requested information on the APP measure set and 
the Universal Foundation within the Medicare CQM proposal (88 FR 
52423). We thank the commenters for their feedback and will take the 
comments under consideration in future rule making, as we evaluate the 
impact of aligning the APP measure set with the Universal Foundation 
measures and existing Value in Primary Care MVP.
    In the CY 2021 PFS final rule (85 FR 84733), we finalized the 
following three all payer/all patient eCQMs/MIPS CQMs under the APP for 
performance year 2021 and subsequent performance years:
     Quality ID#: 001 Diabetes: Hemoglobin A1c (HbA1c) Poor 
Control;
     Quality ID#: 134 Preventive Care and Screening: Screening 
for Depression and Follow-Up Plan; and
     Quality ID#: 236 Controlling High Blood Pressure.
    In section IV.A.4.e of this final rule, we are finalizing our 
proposal to add these measures as Medicare CQMs to the APP measure set 
for Shared Savings Program ACOs beginning with performance year 2024 
and subsequent performance years.
d. Modifications to the Health Equity Adjustment Underserved Multiplier
(1) Background
    Consistent with our goal of rewarding ACOs that include a higher 
proportion of underserved beneficiaries while delivering high quality 
care, we finalized in the CY 2023 PFS final rule (87 FR 69836 through 
69857) the application of a health equity adjustment that adds up to 10 
bonus points to an ACO's MIPS Quality performance category score based 
on certain criteria. The health equity adjustment is applied to an 
ACO's MIPS quality performance category score when the ACO reports the 
three all-payer eCQMs/MIPS CQMs in performance year 2023 and, as 
proposed in section III.G.2.b.(4) of this final rule, the three eCQMs/
MIPS CQMs/Medicare CQMs starting in performance year 2024. To qualify 
for the health equity adjustment, the ACO must also meet the data 
completeness requirement at Sec.  414.1340 and administer the CAHPS for 
MIPS survey (except as specified in Sec.  414.1380(b)(1)(vii)(B)). The 
health equity adjustment is conditional on (1) high quality measure 
performance and (2) providing care for a proportion of underserved 
populations greater than or equal to a predetermined floor.
    The goal of the health equity adjustment is to reward ACOs with 
high performance scores on quality measures and that serve a high 
proportion of underserved beneficiaries. Correspondingly, the health 
equity adjustment bonus points are calculated by multiplying the ACO's 
performance scaler by the ACO's underserved multiplier. An ACO's 
performance scaler is designed to identify top performance among ACOs 
reporting all-payer eCQMs/MIPS CQMs in performance year 2023 and, as 
proposed in section III.G.2.b.(4) of this final rule, eCQMs/MIPS CQMs/
Medicare CQMs in performance year 2024. The performance scaler is an 
aggregated value across all eCQM/MIPS CQM measures and is determined 
based on if the ACO's measure performance was in the top, middle, or 
bottom third of ACO performance for that performance year. We refer 
readers to section III.G.4.b.(7).(c) of the CY 2023 PFS final rule (87 
FR 69843 through 69845) for more details on the performance scaler 
calculation.
    The underserved multiplier is designed to identify ACOs serving 
high proportions of underserved beneficiaries. As described in the CY 
2023 PFS final rule (87 FR 69845 through 69849), the underserved 
multiplier is a proportion, ranging from zero to one, of the ACO's 
assigned beneficiary population for the performance year that is 
considered underserved based on the highest of: (1) the proportion of 
the ACO's assigned beneficiaries residing in a census block group with 
an Area Deprivation Index (ADI) national percentile rank of at least 
85; or (2) the proportion of the ACO's assigned beneficiaries who are 
enrolled in Medicare Part D low-income subsidy (LIS) or are dually 
eligible for Medicare and Medicaid. The use of both the ADI and 
Medicare and Medicaid dual eligibility or LIS status to assess 
underserved populations in the health equity adjustment allows CMS to 
consider both broader neighborhood level characteristics and individual 
characteristics among CMS beneficiaries.
    The CY 2023 PFS final rule did not state how CMS intended to 
compute the proportion of beneficiaries with an ADI national percentile 
rank of at least 85 with respect to beneficiaries for whom a numeric 
national percentile rank value is not available. We do not believe it 
is appropriate to assign a zero to the beneficiaries without an ADI 
national percentile rank in the calculation. Doing so would unfairly 
disadvantage ACOs with such beneficiaries vis-[agrave]-vis those ACOs 
with beneficiaries that all have an ADI national percentile rank by 
lowering their scores. The CY 2023 PFS final rule (87 FR 69846) stated 
that the proportion of the ACO's assigned beneficiaries residing in a 
census block group with an ADI national percentile rank of at least 85 
is computed using the number of assigned beneficiaries. A footnote 
stated that in computing the proportion of beneficiaries dually 
eligible for Medicare and Medicaid, we would use for each beneficiary 
the fraction of the year (referred to as person years) in which they 
were eligible for the aged/dual eligible enrollment type or for which 
they were eligible for the ESRD or disabled enrollment type and dually 
eligible for Medicare and Medicaid. In response to public comment, we 
finalized the proposal to include LIS as a modification to the 
calculation of the underserved multiplier (87 FR 69849). In calculating 
the LIS proportion, CMS uses the same methodology it adopted for 
calculating dually eligible beneficiaries: person years.
(2) Revisions
    In the CY 2024 PFS proposed rule (88 FR 52429 through 52430), we 
proposed to revise the underserved multiplier

[[Page 79115]]

calculation to specify the calculations in more detail and bring 
greater consistency between the calculation of the proportion of ACOs' 
assigned beneficiaries residing in a census block group with an ADI 
national percentile rank of at least 85 and the proportion of ACOs' 
assigned beneficiaries who are enrolled in Medicare Part D LIS or are 
dually eligible for Medicare and Medicaid. Specifically, we proposed to 
remove beneficiaries who do not have a numeric national percentile rank 
available for ADI from the health equity adjustment calculation for 
performance year 2023 and subsequent performance years. Beneficiaries 
without a national percentile ADI rank would appear neither in the 
numerator nor in the denominator of the proportion.
    While we established a policy for the treatment of aligned 
beneficiaries for whom an ADI national percentile rank could not 
reasonably be calculated for use in the AIPs risk factors-based score 
(87 FR 69796 through 69797), we neither proposed nor finalized a policy 
for such beneficiaries with respect to the calculation of the health 
equity adjustment underserved multiplier--nor do we believe the policy 
we finalized for AIP is appropriate for calculating the health equity 
adjustment. In the CY 2023 PFS final rule (87 FR 69800), we finalized 
the use of imputing a value of 50 for the ADI national percentile rank 
if there is insufficient data to match a beneficiary to an ADI national 
percentile rank for calculating AIP risk factors-based scores. There 
are important differences in the implications of using an imputed value 
of 50 for calculating the AIP risk factors-based scores and for 
calculating the underserved multiplier. The imputed ADI ranking of 50 
corresponds to the average national ADI ranking and would be the most 
neutral imputed value and would avoid biasing an ACO's payments in 
either direction for risk factor-based scores in the AIP calculation. 
The use of an ADI ranking of 50 in the underserved multiplier, however, 
would result in that beneficiary not counting in the numerator of the 
underserved multiplier proportion because only beneficiaries with an 
ADI of at least 85 are counted in the numerator. Therefore, we proposed 
to exclude beneficiaries without a national percentile ADI rank from 
the health equity adjustment underserved multiplier (88 FR 52429). This 
approach is more equitable because it will remove a beneficiary without 
an ADI rank from the denominator and the numerator of the calculation 
of an ACO's underserved multiplier instead of penalizing ACOs that have 
such beneficiaries.
    It is in the public interest to apply this change starting with 
performance period 2023. Section 1871(e)(1)(A)(ii) of the Act 
authorizes the Secretary to retroactively apply a substantive change in 
Medicare regulations if the Secretary determines that failure to apply 
the change retroactively would be contrary to the public interest. 
Here, applying this change starting with performance period 2023 is in 
the public interest because, absent further specification of how to 
treat beneficiaries without a national percentile ADI rank current 
policy may unfairly penalize ACOs for reasons beyond their control. 
Current policy counts beneficiaries with missing ADI ranks in the 
underserved multiplier denominator and contributes zero to the 
numerator, thereby reducing the health equity adjustment for ACOs with 
such beneficiaries and harming their ability to meet the quality 
performance standard and receive shared savings.
    Separately, in the CY 2024 PFS proposed rule (88 FR 52430), we 
proposed to modify the calculation of the proportion of assigned 
beneficiaries dually eligible for Medicare and Medicaid and the 
calculation of the proportion of assigned beneficiaries enrolled in LIS 
to use the number of beneficiaries rather than person years for 
calculating the proportion of the ACO's assigned beneficiaries who are 
enrolled in LIS or who are dually eligible for Medicare and Medicaid 
starting in performance year 2024. For example, when calculating the 
underserved multiplier component of the health equity adjustment to an 
ACO's quality performance score for ACOs that report the three eCQMs/
MIPS CQMs/Medicare CQMs, the proportion would be equal to the number of 
assigned beneficiaries with any months enrolled in LIS or dually 
eligible for Medicare and Medicaid divided by total number of assigned 
beneficiaries. We did not propose to alter the calculation of the 
proportion of beneficiaries residing in a census block group with an 
ADI national percentile rank of at least 85, which is already based on 
the number of assigned beneficiaries. Person years would continue to be 
used in financial calculations where beneficiary experience is 
stratified by Medicare enrollment type (ESRD, disabled, aged/dual 
eligible, and aged non/dual eligible) and where it is important to 
account for partial year enrollment to ensure accuracy. This policy 
change will bring greater consistency between the two proportions used 
in determining the underserved multiplier. It also acknowledges that 
beneficiaries with partial year as compared to full year LIS enrollment 
or dual eligibility are also socioeconomically vulnerable and 
strengthens incentives for ACOs to serve this population. Further, 
inclusion of beneficiaries with partial year LIS enrollment in the 
underserved multiplier provides increased incentive for ACOs to help 
facilitate LIS enrollment for beneficiaries who meet eligibility 
criteria.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Most commenters supported our proposed modifications to 
the health equity adjustment underserved multiplier. Several commenters 
expressed their appreciation for CMS's continued focus on health equity 
and providing access and accountable care to underserved patients. 
Other commenters stated that the health equity adjustment encourages 
providers to continue providing high quality care to underserved 
beneficiaries. One commenter stated that the modifications to the 
underserved multiplier would improve efficacy and consistency in 
identifying ACOs' underserved populations.
    Response: We appreciate the comments in support of the proposed 
modifications to the health equity adjustment underserved multiplier. 
As we discussed in the proposed rule, the goal of the health equity 
adjustment is to reward ACOs with high performance scores on quality 
measures and that serve a high proportion of underserved beneficiaries. 
We agree with the commenters that these modifications will specify the 
calculations in more detail and bring greater consistency between the 
calculation of the proportion of ACOs' assigned beneficiaries residing 
in a census block group with an ADI national percentile rank of at 
least 85 and the proportion of ACOs' assigned beneficiaries who are 
enrolled in Medicare Part D LIS or are dually eligible for Medicare and 
Medicaid.
    Comment: Several commenters expressed concern that the national ADI 
rank score is inadequate in identifying underserved beneficiaries 
living in high cost-of-living areas. Commenters' concerns with the 
national ADI rank score included that it overly relies on income and 
home values, can mask urban poverty, and may not be a good proxy for 
patient-level social risk factors. One commenter gave the example that 
all the District of Columbia has a National ADI less than the 85th 
percentile. Another commenter stated

[[Page 79116]]

that an ACO in San Francisco or Seattle will be disadvantaged by any 
index that uses rent and mortgage expenses to calculate a score but 
does not account for the large population of unhoused individuals. Two 
commenters recommended to remove the ADI from the health equity 
adjustment underserved multiplier calculation because it is weighted 
toward income and home values. One commenter recommended exploring 
other data sources as they become available for revisions to the 
underserved multiplier. Other commenters recommended incorporating a 
regional approach to identifying underserve beneficiaries such as 
including or replacing the National ADI rank score with State ADI rank 
scores in the underserved multiplier calculation. Two commenters noted 
that CMS Innovation models, including the ACO Realizing Equity, Access, 
and Community Health (REACH) and the Making Care Primary models, have 
announced inclusion of the State ADI rank score in their health equity 
adjustments for upcoming performance years.
    Response: We did not propose any changes to the previously 
finalized policy of using the national ADI rank score in the health 
equity adjustment underserved multiplier; rather, we proposed to 
exclude beneficiaries without a national percentile ADI rank from the 
health equity adjustment underserved multiplier. Therefore, these 
comments are considered to be out of scope. However, we are continuing 
to assess the impact of using the national ADI in the health equity 
adjustment in the Shared Savings Program and the use of state ADI in 
the health equity adjustments used in CMS innovation models. 
Additionally, we note that for the purposes of the underserved 
multiplier, we use the ``greater of'' the percentage of individuals who 
are dually eligible or receiving low-income subsidies, or live in an 
area with an ADI of 85 or above. This means that for areas with lower 
average ADIs, if the ACO still serves a low-income population with a 
higher percentage of individuals who are dually eligible or receiving 
low-income subsidies, the ACO could still qualify for an upwards 
adjustment. CMS will continue to examine the learnings from the CMS 
Innovation Models and external researchers to contemplate improvements 
to the measures of geographic deprivation over time. We may consider 
these and other suggestions in future rulemaking.
    Comment: Several commenters requested CMS to consider allowing all 
ACOs to be eligible for the health equity adjustment regardless of 
quality measure collection type. Specifically, commenters requested 
that ACOs reporting via the CMS Web Interface be eligible for the 
health equity adjustment.
    Response: We direct commenters to our response to similar comments 
regarding the eCQMs/MIPS CQMs reporting requirement for health equity 
adjustment eligibility in the CY 2023 PFS final rule (87 FR 69841 
through 69842). Specifically, we explained that while we understand the 
concerns raised by commenters regarding the eCQMs/MIPS CQMs reporting 
criteria for being eligible to receive a health equity adjustment, the 
health equity adjustment is designed to upwardly adjust the ACO's 
quality performance score and will not financially penalize ACOs that 
are not eligible for the adjustment such as those that do not report 
using eCQMs/MIPS CQMs. We further explained that as the transition to 
reporting all-payer eCQMs/MIPS CQMs continues, with this reporting 
mechanism becoming mandatory starting in PY 2025, the health equity 
adjustment would reinforce the timeline while supporting ACOs that may 
be experiencing challenges with the new quality reporting requirement 
and providing an incentive for ACOs not to seek to avoid underserved 
populations during the transition to reporting eCQMs/MIPS CQMs.
    Comment: One commenter requested that CMS monitor the impact of the 
proposed change of dropping beneficiaries without a National ADI rank 
score to ensure it does not negatively affect rural ACOs already 
struggling to succeed in the Shared Savings Program.
    Response: We acknowledge the commenter's concern. As we stated in 
the CY 2023 PFS final rule (87 FR 69841), the inclusion of National 
ADI, Medicare and Medicaid eligibility, and LIS status in the 
underserved multiplier calculation provides opportunity for identifying 
underserved populations for all providers, whether in rural or urban 
areas. Further, as we noted in the CY 2023 PFS final rule (87 FR 69796) 
in a preliminary review of Medicare beneficiary information, less than 
2 percent of Medicare beneficiaries could not be matched to a census 
block group due to missing or insufficient mailing address data, and 
approximately 1 percent of Medicare beneficiaries had sufficient 
address data but were in a U.S. census block group without a national 
percentile rank due to data suppression criteria. Based on the 
statistical analysis provided, we do not anticipate a significant 
impact of the proposed change on ACOs in rural areas. We will assess 
the impacts of the policy in rural areas and may make refinements as 
needed in future rulemaking.
    Comment: One commenter requested CMS clarify what is being 
identified as health equity in the context of performance, as well as 
what is being measured.
    Response: We refer readers to CY 2022 PFS final rule (86 FR 65382 
through 65384) for a detailed explanation of health care outcome 
inequities and health equity. In the CY 2022 PFS final rule, we used 
the definition of health equity established in Executive Order 13985, 
issued on January 25, 2021, as ``the consistent and systematic fair, 
just, and impartial treatment of all individuals, including individuals 
who belong to underserved communities who have been denied such 
treatment, such as Black, Latino, and Indigenous and Native American 
persons, Asian Americans and Pacific Islanders and other persons of 
color; members of religious minorities; lesbian, gay, bisexual, 
transgender, and queer (LGBTQ+) persons; persons with disabilities; 
persons who live in rural areas; and persons otherwise adversely 
affected by persistent poverty or inequality.'' In response to the 
question of what is being measured, we direct readers to section 
III.G.4.b.(7)(d) of the CY 2023 PFS final rule (86 FR 69845 through 
69849) where we finalized the inputs for the calculation of the 
underserved multiplier. Specifically, we state that we use the higher 
value of either the proportion of an ACO's assigned beneficiary 
population that is considered underserved based on beneficiaries who 
are from underserved neighborhoods, identified using ADI data, or the 
proportion of an ACO's assigned beneficiary population that are dually 
eligible for Medicare and Medicaid or enrolled in Medicare Part D Low-
Income Subsidy (LIS).
    Comment: Some commenters requested CMS consider changes that were 
not related to the proposals included in this section of the proposed 
rule. The requests included: increase the health equity adjustment 
bonus points to have a greater and faster impact on the lives of the 
most at-risk beneficiaries; instead of using Medicare Part D LIS 
enrolled status in the underserved multiplier calculation, CMS should 
use Medicare Part D LIS eligible to account for those beneficiaries who 
have not enrolled, but whose income is lower than 150 percent of the 
federal poverty level; expand the number of diagnoses allowed on 
Medicare claims to accommodate the use of Z-codes or otherwise allow 
documentation of Z-codes in addition to

[[Page 79117]]

the current limit of diagnosis codes on Medicare claims.
    Response: We note that we did not propose any changes to these 
previously finalized policies in the proposed rule, and therefore, 
these comments are considered to be out of scope.
    In conclusion, after review of the public comments received, we are 
finalizing at 42 CFR 425.512(b)(2)(iv)(A) our proposal to remove 
beneficiaries who do not have a numeric national percentile rank 
available for ADI from the health equity adjustment calculation for PY 
2023 and subsequent performance years and to use the number of 
beneficiaries, rather than person years, for calculating the proportion 
of the ACO's assigned beneficiaries who are enrolled in LIS or who are 
dually eligible for Medicare and Medicaid, starting in PY 2024.
e. Use of Historical Data To Establish the 40th Percentile MIPS Quality 
Performance Category Score
(1) Background
    In the CY 2023 PFS final rule (87 FR 69858), we finalized that 
beginning performance year 2024, one of the ways for an ACO to meet the 
Shared Savings Program quality performance standard and share in 
savings at the maximum rate under its track (or payment model within a 
track) is for the ACO to achieve a health equity adjusted quality 
performance score that is equivalent to or higher than the 40th 
percentile across all MIPS Quality performance category scores, 
excluding entities/providers eligible for facility based-scoring.
    In the CY 2022 PFS proposed and final rules (86 FR 39274 and 86 FR 
65271), we stated that, for a given performance year, the 30th or 40th 
percentile across all MIPS Quality performance category scores would be 
calculated after MIPS final scoring is complete based on the 
distribution across all MIPS Quality performance category scores, 
excluding entities/providers eligible for facility-based scoring. 
Therefore, we are not able to provide performance rate information 
prior to or during the performance year. Nevertheless, we stated that 
we believe that publicly displaying prior year performance scores that 
equate to the 30th and 40th percentile across all MIPS Quality 
performance category scores for the applicable performance year would 
still provide helpful information for ACOs to determine what level of 
quality performance they would need to meet in order to satisfy the 
quality performance standard under the Shared Savings Program. We 
stated that we would release this historical information on the Shared 
Savings Program website when it becomes available.
    In the CY 2022 PFS proposed rule (86 FR 39274), we also explained 
that interested parties have expressed concerns regarding the lack of 
information on the level of quality performance that would equate to 
the 30th or 40th percentile MIPS Quality performance category score and 
that would enable an ACO to be eligible to share in savings or to avoid 
maximum shared losses, if applicable. We noted that interested parties 
have expressed concern that these data are not publicly available prior 
to the start of a performance year and that they do not believe that 
ACOs have a way of determining what quality score they would need to 
achieve to meet the quality performance standard.
    In the CY 2022 PFS proposed rule (86 FR 39274), we also solicited 
comments on whether publicly displaying prior year performance scores 
that equate to the 30th or 40th MIPS Quality performance category 
scores would help to address ACOs' concerns regarding the lack of 
advance information regarding the quality performance score they must 
meet in order to satisfy the quality performance standard under the 
Shared Savings Program. Several commenters supported publicly 
displaying prior year performance scores that equate to the 30th or 
40th percentile across all MIPS Quality category performance scores, 
and one commenter expressed concern that publicly displaying prior year 
performance scores is not the optimal way to address concerns of 
interested parties and indicated that performance is volatile and the 
30th (or 40th) percentile may change significantly from year to year 
depending upon changes in quality performance in MIPS (86 FR 65271).
    We clarified in the CY 2023 PFS proposed rule (87 FR 46148) and 
final rule (87 FR 69867) that we use the submission-level MIPS Quality 
performance category scores (unweighted distribution of scores) to 
determine the 30th percentile and 40th percentile MIPS Quality 
performance category scores for purposes of establishing the applicable 
quality performance standard under the Shared Savings Program. In the 
CY 2024 PFS proposed rule (88 FR 52430 and 52431), we stated that in 
light of public comments and concerns about the predictability of the 
40th percentile MIPS Quality performance category score due to changes 
in MIPS scoring policies over time--including MIPS scoring changes 
impacting measures that lack a benchmark or case minimum as described 
at Sec.  414.1380(b)(1)(i)(A), measure achievement points as described 
at paragraph (b)(1)(i), new measures (years 1 and 2 of a measure's use) 
as described at paragraph (b)(1)(i)(C), new sub-group reporting option 
as described at Sec.  414.1318(a), and MIPS High Priority and End to 
End Bonus Points as described at Sec.  414.1380(b)(1)(v)--and as a 
result of the concerns expressed by ACOs and other interested parties 
and as we gain experience with aligning Shared Savings Program 
reporting and scoring policies with MIPS, we believe that a revised 
methodology is needed to calculate the 40th percentile MIPS Quality 
performance category score for the quality performance standard for 
performance year 2024 and subsequent performance years.
    Additionally, we stated in the CY 2024 PFS proposed rule (88 FR 
52431) that as MIPS scoring policies evolve over time, changes in MIPS 
scoring policy have the potential to adjust the year-to-year 
comparability of MIPS Quality performance category scores. Between 
performance years 2022 and 2023, there were MIPS policy changes to 
measures that lack a benchmark or case minimum as described at Sec.  
414.1380(b)(1)(i)(A), measure achievement points as described at 
paragraph (b)(1)(i), new measures (years 1 and 2 of a measure's use) as 
described at paragraph (b)(1)(i)(C), and a new sub-group reporting 
option as described at Sec.  414.1318(a). Additionally, MIPS High 
Priority and End to End Bonus Points were sunset in performance year 
2022 as described at Sec.  414.1380(b)(1)(v). The projected 40th 
percentile MIPS Quality performance category score for performance year 
2023 does not reflect these proposed methodological changes. To 
minimize reliance on a single year of performance data, the use of 
multiple years of historical data could be used to ``smooth'' out the 
impact of MIPS scoring policy changes on the quality performance 
standard in any 1 year. At the same time, using too many years of data 
to average scores may include a greater number of years that do not 
reflect current policies.
(2) Revisions
    In the CY 2024 PFS proposed rule (88 FR 52431), we proposed to use 
historical submission-level MIPS Quality performance category scores to 
calculate the 40th percentile MIPS Quality performance category score 
for performance year 2024 and subsequent performance years. 
Specifically, we proposed to use a rolling 3-performance year average 
with a lag of 1-performance year (for example, the 40th percentile MIPS 
Quality performance category

[[Page 79118]]

score used for the quality performance standard for performance year 
2024 would be based on averaging the 40th percentile MIPS Quality 
performance category scores from performance years 2020 through 2022). 
We believe that our proposal to use a 3-year historical average is 
consistent with the proposal under section IV.A.4.h.(2) of the CY 2024 
proposed rule that would permit, for purposes of establishing a 
performance threshold as identified in Sec.  414.1405(b), a time span 
of up to 3 consecutive performance periods for performance year 2024 
and subsequent performance years.
    We would provide ACOs with the performance score that equates to 
the 40th percentile MIPS Quality performance category score that would 
be used as the quality performance standard for a given performance 
year prior to the start of the performance year (for example, the 40th 
percentile MIPS Quality performance category score based on historical 
data and applicable for performance year 2024 would be released on the 
Shared Savings Program website in December 2023).
    The use of 3 historical base years would mitigate issues that may 
arise from using a single year historical reference such as scoring, 
policy, and/or performance anomalies, such as a pandemic, specific to 
the historical base year. Additionally, the use of historical data 
would allow additional time for data availability and limit the 
potential impact of MIPS Targeted Review as described at Sec.  414.1385 
and other MIPS scoring corrections. This approach is also responsive to 
the concerns ACOs, and other interested parties have with the 
predictability of the current method of calculating the 40th percentile 
MIPS Quality performance category score. However, we acknowledged that 
by using historical benchmarks, the benchmark would not reflect the 
most recent policies, measure specifications, and scores (88 FR 52431). 
For example, the historical base years are 2-4 years removed from the 
performance year and could reflect data that may have anomalies 
specific to the base year that would render those data inconsistent 
with the performance year's quality performance. Additionally, changes 
to measure specifications for measures included in the APP measure set 
may result in the historical base period including measures that are 
different than the corresponding measures that were applicable during 
the performance year. This could further reduce the comparability of 
historic base year data with the performance year's quality performance 
data.
    Table 29 in the CY 2024 PFS proposed rule (88 FR 52432) shows the 
40th percentile MIPS Quality performance category scores for 
performance years 2018 through 2021 based on the current methodology as 
published in the CY 2023 PFS final rule (87 FR 69868). The proposed 
methodology would be effective for performance year 2024 and subsequent 
performance years. We have added to Table 30 the projected 40th 
percentile MIPS Quality performance category scores for performance 
years 2022 and 2023 based on the proposed methodology for illustrative 
purposes. The projected 40th percentile MIPS Quality performance 
category score used for the quality performance standard for 
performance year 2022 is based on the average of the 40th percentile 
MIPS Quality performance category scores from performance years 2018 
through 2020, and the projected 40th percentile MIPS Quality 
performance category score used for the quality performance standard 
for performance year 2023 is based on the average of the 40th 
percentile MIPS Quality performance category scores from performance 
years 2019 through 2021. The years are averaged at equal weights. For 
example, we would calculate the projected 40th percentile MIPS Quality 
performance category score used for the quality performance standard 
for performance year 2022 by first summing the 2018 (70.80), 2019 
(70.82), and 2020 (75.59) 40th percentile Quality performance category 
score values to arrive at a value of 217.21 [70.80 + 70.82 + 75.59 = 
217.21]. We would then divide the value of 217.21 by three (the number 
of years included in the historical reference period) to arrive at a 
projected 40th percentile MIPS Quality performance category score of 
72.40 for 2022 [217.21 / 3 = 72.40]. Note that this example illustrates 
averaging the 2018, 2019, and 2020 40th percentile MIPS Quality 
performance category score values.
    In the CY 2024 PFS proposed rule (88 FR 52432), we solicited 
comments on our proposal to use a 3-performance year rolling average 
with a lag of 1-performance year to calculate the 40th percentile MIPS 
Quality performance category score used for the quality performance 
standard for performance year 2024 and subsequent performance years. 
Using a 1-year lag would help ensure the availability of base period 
data by limiting the possibility that data availability is negatively 
impacted by scoring, policy, and/or performance anomalies from the 
prior performance year. In the development of our proposal to use a 3-
performance year rolling average with a lag of 1-performance year to 
calculate the 40th percentile MIPS Quality performance category score 
used for the quality performance standard for performance year 2024 and 
subsequent performance years, we considered another alternative 
methodology, which was to establish a historical quality performance 
standard based on the year immediately prior to the performance year's 
quality performance score across all MIPS Quality performance category 
scores, excluding entities/providers eligible for facility-based 
scoring (88 FR 52432). We also solicited comments on other alternative 
methodologies we should consider to calculate the 40th percentile MIPS 
Quality performance category score for the quality performance 
standard.
    The following is a summary of the comments we received on our 
proposal to use historical data to establish the 40th percentile MIPS 
Quality performance category score and our responses.
    Comment: Several commenters supported our proposal to use 
historical submission-level MIPS Quality performance category scores to 
calculate the 40th percentile MIPS Quality performance category score 
for performance year 2024 and subsequent performance years and to 
provide ACOs with the 40th percentile MIPS Quality performance category 
score that would be used as the quality performance standard for a 
given performance year prior to the start of the performance year. 
Several commenters noted that the proposal would provide ACOs with more 
certainty and predictability regarding what the quality targets are in 
advance of the performance period starting and mitigate the potential 
impact of annual program changes affecting the MIPS Quality performance 
category scores. A few commenters stated that basing the threshold on 
historical data will provide transparency around the threshold 
calculation. One commenter stated that the proposal would alleviate 
issues with scoring and performance anomalies as was seen during the 
COVID-19 pandemic and limit the impact of the MIPS Targeted Review and 
MIPS scoring corrections; however, the commenter noted using historical 
benchmarks will not reflect the most recent scores and measure 
specifications.
    Response: We appreciate commenters' support and agree that 
providing ACOs with the 40th percentile MIPS Quality performance 
category score that would be used as the quality performance

[[Page 79119]]

standard for a given performance year prior by the start of the 
performance year supports ACOs' ability to understand and meet quality 
goals, allocate resources effectively, and ultimately support patients 
and improve quality outcomes.
    Comment: A few commenters that supported the proposal also 
expressed concerns that data from performance years 2020 to 2022 are 
not likely to yield a meaningful comparison given the impact of the 
COVID-19 pandemic and the extreme and uncontrollable circumstances 
policies applied in those years and suggested that CMS could consider a 
weighted average approach that gives more credit to the most recent 
year (that is, performance year 2022). Another commenter supportive of 
the proposal recommended that CMS assess whether a longer or 
potentially different lookback period would be more appropriate for 
performance year 2024, given that the lookback period for performance 
year 2024 will reflect years heavily impacted by the COVID-19 pandemic. 
Another commenter supportive of the proposal stated that implementation 
of the proposed methodology should be delayed until after the CMS Web 
Interface sunsets and transition to eCQMs/MIPS CQMs/Medicare CQMs 
reporting occurs. The commenter further stated that the rolling 3-year 
performance average with a lag of 1-performance year will eventually 
help solve for changes in scoring policies; however, in the first year 
that scores are based on eCQMs/MIPS CQMs/Medicare CQMs, the historical 
submission-level MIPS Quality performance category score will be 
predominantly based on CMS Web Interface measures. Should CMS finalize 
the proposal, the commenter recommended CMS set guardrails during the 
transition period to ensure that ACOs transitioning to the eCQMs/MIPS 
CQMs/Medicare CQMs are not unfairly penalized against historical MIPS 
Quality performance standards that do not adequately consider 
historical eCQM/MIPS CQM/Medicare CQM submission data.
    Response: The methodology we are finalizing provides a guardrail by 
minimizing the reliance on a single year of performance data that may 
have anomalies specific to the performance year, such as a pandemic, 
and by using multiple years of historical data to prevent a cliff and 
``smooth'' out the impact of MIPS scoring policy changes on the quality 
performance standard in any one year. As explained in the CY 2024 PFS 
proposed rule, as MIPS scoring policies evolve over time, changes in 
MIPS scoring policy have the potential to adjust the year-to year 
comparability of MIPS Quality performance category scores (88 FR 
52431).
    Comment: One commenter opposed the proposal stating that it creates 
the potential for an unlevel playing field because the benchmark would 
not reflect the most recent policies, measure specifications, and 
scores as the base years used would be 2-4 years prior, and there may 
be significant anomalies making it more difficult to achieve that score 
years later. The commenter noted that in performance year 2025, when 
all organizations will be reporting using eCQMs, the historic 
percentiles, based largely on CMS Web Interface measures reported in 
performance years 2021 to 2023, would be more difficult to achieve with 
eCQM reporting. Additionally, the commenter stated that the playing 
field would not completely level out until performance year 2029 when 
all historic years used in the calculation require reporting via eCQMs, 
and only if there were no other significant changes to the measures and 
reporting requirements.
    Response: In the CY 2021 PFS final rule (85 FR 84720 through 
84722), we aligned the Shared Savings Program quality reporting 
requirements with the APP and have worked over time to align with MIPS 
scoring policies (see 86 FR 65253 and 65254; 87 FR 69779 and 69780 for 
a summary of certain finalized policies); however, we acknowledged that 
MIPS scoring changes could occur that may impact the predictability of 
the 40th percentile MIPS Quality performance category score. We 
acknowledged in the CY 2024 PFS proposed rule (88 FR 52431) that by 
using historical benchmarks, the benchmark would not reflect the most 
recent policies, measure specifications, and scores.
    As we stated in the CY 2024 PFS proposed rule (88 FR 52431), and 
some commenters agreed, the use of 3 historical base years would 
mitigate issues that may arise from using a single year historical 
reference such as scoring, policy, and/or performance anomalies, such 
as a pandemic, that are specific to the historical base year. 
Additionally, the use of historical data would allow additional time 
for data availability. While we understand concerns about the 
transition from the CMS Web Interface in performance year 2024 and the 
historical data changing over time with more ACOs increasingly 
submitting eCQMs/MIPS CQMs/Medicare CQMs data, delaying the proposal to 
use a rolling 3-performance year average with a lag of 1-performance 
year to calculate the 40th percentile MIPS Quality performance category 
score would result in a delay to mitigate potential MIPS scoring policy 
changes and a delay in providing ACOs with their benchmark target prior 
to the start of the performance year. For these reasons, the 
implementation of the proposed methodology should not be delayed until 
after the CMS Web Interface sunsets.
    Additionally, the 40th percentile MIPS Quality performance category 
score is not based solely on Shared Savings Program ACOs. Out of the 
30,000-40,000 MIPS eligible clinicians and APM entities in the MIPS 
Quality performance category score unweighted distribution, less than 
500 are ACOs. As stated in the CY 2023 PFS final rule (87 FR 69867), 
the unweighted distribution of Quality performance category scores is 
based on the Quality performance category scores of the submitting MIPS 
eligible clinicians and APM entities (for example, ACOs, other APM 
entities, group practices, and individual clinicians). For illustrative 
purposes, we are providing an example using the average (instead of the 
30th or 40th percentile) for the quality performance standard. In this 
example, there are three submitting entities: an ACO, a MIPS eligible 
clinician that is a group practice, and an individual MIPS eligible 
clinician. The MIPS Quality performance category scores for these 
submitting entities are 90 for the ACO, 70 for the group practice, and 
50 for the individual clinician. The average of the unweighted 
distribution of scores is (90 + 70 + 50)/3 = 70 where each submitting 
entity contributes one score. The weighted distribution of scores takes 
into account the number of individual providers from each submitting 
entity. The ACO has 10 providers, the MIPS Group has four providers, 
and the individual MIPS provider has one provider. The average of the 
weighted distribution is ((90 x 10) + (70 x 4) + (50 x 1))/15 = 82. 
Thus, by using a weighted distribution of scores when calculating the 
40th percentile MIPS Quality performance category score for the quality 
performance standard, each of the ACO's individual providers would be 
contributing to the calculation rather than the ACO itself, and the 
ACO's score would be counted once. As noted in the CY 2023 PFS final 
rule (87 FR 69867 and 69868), we use the submission-level MIPS Quality 
performance category scores (unweighted distribution of scores) to 
determine the 30th percentile and 40th percentile MIPS Quality 
performance category scores for purposes of establishing the applicable 
quality performance standard. The use of the

[[Page 79120]]

unweighted distribution of scores aligns with the MIPS and Shared 
Savings Program benchmarking policies.
    Furthermore, not all MIPS eligible clinicians and APM entities 
report the CMS Web Interface measures, and for performance years 2023 
and 2024, the CMS Web Interface collection type is only available for 
APM Entities reporting the APM Performance Pathway, such as Shared 
Savings Program ACOs. Historical benchmark years are thus likely to 
reflect eCQM and MIPS CQM reporting more quickly than if they were 
based on Shared Savings Program ACOs alone, even as the CAHPS for MIPS 
Survey measure and the two administrative claims measures also 
contribute to an ACO's MIPS Quality performance category score.
    Comment: One commenter noted that they supported an alternative 
methodology we considered during the development of our proposal, which 
was to establish a historical quality performance standard based on the 
year immediately prior to the performance year's quality performance 
score across all MIPS Quality performance category scores. They noted 
that the playing field would then be leveled in performance year 2026 
under this methodology.
    Response: We appreciate the commenter's response to our request for 
comment on alternative methodologies for consideration in calculating 
the historical submission-level MIPS Quality performance category 
score. Prior to the publication of the CY 2024 PFS proposed rule, in 
addition to our proposed methodology, we evaluated two alternative 
methodologies for calculating a historical MIPS Quality performance 
category score: establishing the historical quality performance 
standard based on the year immediately prior to the performance year; 
and also based on a 2-performance year rolling average with a lag of 1-
performance year. Of the methodologies we considered, the 3-year 
historical benchmark with a 1-year lag best accounts for the 
anticipated learning curve that ACOs may encounter as they transition 
to eCQM/MIPS CQM/Medicare CQM reporting. This methodology allows ACOs 
to know in advance what MIPS 40th percentile Quality performance 
category score they will need to achieve in order to meet the quality 
performance standard for performance year 2024 and subsequent 
performance years. With this predictability, ACOs can work to meet this 
target as they evaluate and develop strategies to continue to improve 
their quality performance for performance year 2024 and subsequent 
performance years.
    Comment: One commenter requested that CMS provide better scoring 
toolkits, methodologies, and sample scoring calculations to ACOs and 
QCDRs, similar to the MIPS scoring toolkits released annually, in 
advance of and during the performance period so that clear scoring 
predictions and calculations can support ACOs in improving their 
quality of care. A few commenters suggested that CMS provide 
prospective information on both the quality score that would qualify an 
ACO for savings and the methodology used to calculate the benchmarks.
    Response: We thank the commenters for their feedback. We plan to 
provide updates to the APP Toolkit available at https://qpp.cms.gov/resource-library and other educational documents for ACOs to include 
Medicare CQM guidance and specifications and associated policies as 
close to the start of the performance as possible.
    For information on how shared savings and shared losses are 
calculated, please refer to the Medicare Shared Savings Program Shared 
Savings and Losses and Assignment Methodology and Quality Performance 
Standard Specifications, available on the Shared Savings Program 
website under Program Guidance & Specifications (for example, in 
Version 11 (PDF, 1.9MB), refer to Section 4.3 Performance Year 
Financial Reconciliation Calculations). Version 11 is available at 
https://www.cms.gov/files/document/medicare-shared-savings-program-shared-savings-and-losses-and-assignment-methodology-specifications.pdf-2.
    Comment: Several commenters requested that CMS publish MIPS Quality 
performance category scores in the Public Use Files (PUF) to bring 
greater transparency to the calculation of the 40th percentile MIPS 
Quality performance category score calculation.
    Response: We appreciate the commenters' feedback. In the Medicare 
Shared Savings Program Performance Year Financial and Quality Results 
PUF, we provided several ACO-specific variables related to quality 
performance results including the ACO's quality score, an indicator 
whether the ACO met the quality performance standard, indicators for 
each of the three measure reporting options (that is, Web Interface, 
eCQM, MIPS CQM), and an indicator whether the ACO did not completely 
report quality for any of the reporting options. We may consider adding 
additional ACO-specific variables in future years. ACOs can review 
their measure-specific performance used to calculate their MIPS Quality 
performance category score along with their final MIPS Quality 
performance category score in their MIPS performance feedback report. 
ACOs are also required to publicly report their quality measure scores 
on their websites per Sec.  425.308(b)(5). We also provide quality 
measure benchmarks for the current performance year on the Shared 
Savings Program website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/program-guidance-and-specifications.
    Comment: One commenter requested that CMS publish the percentile 
performance thresholds for the individual quality measures prior to the 
performance year.
    Response: For measures that have historical benchmarks, we 
generally publish them around the start of each performance year at 
https://www.cms.gov/medicare/payment/fee-for-service-providers/shared-savings-program-ssp-acos/guidance-regulations. Measures with 
performance period benchmarks--which include the administrative claims 
measures: Measure# 479 Hospital-Wide, 30-Day, All-Cause Unplanned 
Readmission (HWR) Rate for MIPS Groups and Measure# 484 Clinician and 
Clinician Group Risk-standardized Hospital Admission Rates for Patients 
with Multiple Chronic Conditions--are published after the submission 
period for the applicable performance year. Benchmark resources are 
published in the Quality Payment Program resource library and are 
updated for each performance year at https://qpp.cms.gov/resources/resource-library.
    Comment: One commenter stated that if Medicare CQMs are established 
as proposed, there will not be any historical data for these measures. 
Therefore, the commenter requested that CMS clarify how the proposal to 
use a rolling 3-performance year average with a lag of 1 performance 
year will incorporate Medicare CQMs to calculate the 40th percentile 
MIPS Quality performance category score.
    Response: We acknowledge that Medicare CQM data will not be part of 
the performance year 2024 and 2025 historic reference periods, but the 
2026 historic reference period will be inclusive of MIPS Quality 
performance category scores that are based on Medicare CQMs reported in 
performance year 2024. As finalized in section III.G.2.b of this final 
rule, performance year 2024 will be the first year that Medicare CQMs 
will be available for Shared Savings Program ACOs under the APP. As a 
result, historical Medicare CQM data will not

[[Page 79121]]

be available at the time the 40th percentile MIPS Quality performance 
category score is calculated for performance years 2024 and 2025; 
however, the historical data will be available at the time the 40th 
percentile MIPS Quality performance category score is calculated for 
performance year 2026 (based on the average of the 40th percentile MIPS 
Quality performance category score from performance years 2022 through 
2024). With the sunsetting of the CMS Web Interface at the end of 
performance year 2024 and as more ACOs transition to reporting eCQMs/
MIPS CQMs/Medicare CQMs, the historic 3-year performance average of the 
MIPS Quality Performance Category Score will gradually incorporate 
additional Medicare CQM data in each subsequent performance year.
    After consideration of the public comments, we are finalizing our 
proposal to use historical submission-level MIPS Quality performance 
category scores to calculate the 40th percentile MIPS Quality 
performance category score for performance year 2024 and subsequent 
performance years. Specifically, we will use a rolling 3-performance 
year average with a lag of 1-performance year (for example, the 40th 
percentile MIPS Quality performance category score used for the quality 
performance standard for performance year 2024 will be based on 
averaging the 40th percentile MIPS Quality performance category scores 
from performance years 2020 through 2022). We will provide ACOs with 
the performance score that equates to the 40th percentile MIPS Quality 
performance category score that would be used as the quality 
performance standard for a given performance year prior to the start of 
the performance year (for example, the 40th percentile MIPS Quality 
performance category score based on historical data and applicable for 
performance year 2024 would be released on the Shared Savings Program 
website in December 2023).
    Table 30 shows the 40th percentile MIPS Quality performance 
category scores for performance years 2018 through 2021 based on the 
current methodology as published in the CY 2023 PFS final rule (87 FR 
69868). The methodology we are finalizing in this final rule will be 
effective for performance year 2024 and subsequent performance years. 
We added the projected 40th percentile MIPS Quality performance 
category scores for performance year 2022 based on the methodology we 
are finalizing for illustrative purposes to Table 30. We note that 
Table 30 is same as Table 29 that was included in the CY 2024 PFS 
proposed rule (88 FR 52432). Based on the actual 40th percentile MIPS 
Quality performance category score values in Table 30, we can provide, 
for illustrative purposes, the 40th percentile MIPS Quality performance 
category score value for the quality performance standard for 
performance year 2024. We calculate the projected 40th percentile MIPS 
Quality performance category score used for the quality performance 
standard for performance year 2024 by first summing the 2020 (75.59), 
2021 (77.83), and 2022 (77.73) 40th percentile Quality performance 
category score values to arrive at a value of 231.15 [75.59 + 77.83 + 
77.73 = 231.15]. Note that performance year 2023 is skipped for the 
one-year lag. We then divide the value of 231.15 by three (the number 
of years included in the historical reference period) to arrive at a 
40th percentile MIPS Quality performance category score value of 77.05 
for performance year 2024 [231.15 / 3 = 77.05].
[GRAPHIC] [TIFF OMITTED] TR16NO23.051


[[Page 79122]]


f. Apply a Shared Savings Program Scoring Policy for Excluded APP 
Measures and APP Measures That Lack a Benchmark
(1) Background
    In the CY 2021 PFS final rule (85 FR 84720 through 84734), we 
finalized an approach that aligns the Shared Savings Program quality 
performance scoring methodology with the MIPS scoring methodology. We 
also stated that for each quality measure that an ACO submits that has 
significant changes, the total available measure achievement points are 
reduced by 10 points under the APP under current MIPS scoring policy 
(Sec.  414.1380(b)(1)(vii)(A)) (85 FR 84725)). In the CY 2021 PFS final 
rule (85 FR 84901), we finalized policies at Sec.  
414.1380(b)(1)(vii)(A) to provide that for each measure under MIPS that 
is submitted, if applicable, and impacted by significant changes, 
performance is based on data for 9 consecutive months of the applicable 
CY performance period. If such data are not available or may result in 
patient harm or misleading results, the measure is excluded from a MIPS 
eligible clinician's total measure achievement points and total 
available measure achievement points. We stated that ``significant 
changes'' means changes to a measure that are outside the control of 
the clinician and its agents and may result in patient harm or 
misleading results. Significant changes include, but are not limited 
to, changes to codes (such as ICD-10, CPT, or HCPCS codes), clinical 
guidelines, or measure specifications. As described at Sec.  
414.1380(b)(1)(vii)(A), measures that are excluded due to significant 
changes are excluded from a MIPS eligible clinician's total measure 
achievement points and total available measure achievement points.
    In performance year 2022, two of the eCQMs/MIPS CQMs that are part 
of the APP measure set were excluded from MIPS measure achievement 
points and total available measure achievement points for the MIPS 
Quality performance category under Sec.  414.1380(b)(1)(vii)(A). 
Specifically, the eCQM version of the Preventive Care and Screening: 
Screening for Depression and Follow-up Plan measure (Quality ID #134) 
and the Controlling High Blood Pressure measure (Quality ID #236) were 
excluded. Thus, under MIPS scoring policies, ACOs reporting one or both 
of these measures had their total measure achievement points and total 
available measure achievement points reduced by 10 (for reporting one 
measure) or 20 (for reporting both measures) points, respectively. 
Under the APP, these ACOs were still required to report all 6 measures; 
however, their performance year 2022 MIPS Quality performance category 
score was based on the 4 or 5 non-excluded measures (depending on 
whether the ACO reported one or both excluded measures) in the APP 
measure set. Consequently, the resulting MIPS Quality performance 
category score for an ACO that would have performed well on the 
excluded quality measures would be lower than it otherwise would have 
been if those measures were not excluded. Alternatively, if an ACO 
would have performed poorly on the excluded quality measures, then the 
resulting MIPS Quality performance category score would be higher than 
it otherwise would have been if those measures were not excluded. In 
either scenario, an ACO is required to report quality performance for 
all measures under the APP and has no control over whether and which 
measures are excluded.
(2) Revisions
    Given that the Shared Savings Program does not determine which 
quality measures are excluded and that ACOs do not have a choice of 
measures they can report under the APP, we do not want to adversely 
impact shared savings determinations for events outside the ACOs' 
control, such as in the event a measure is excluded. Therefore, in the 
CY 2024 PFS proposed rule (88 FR 52432 and 52433), we proposed that, 
for performance year 2024 and subsequent performance years, if (1) an 
ACO reports all required measures under the APP and meets the data 
completeness requirement at Sec.  414.1340 for all required measures 
and receives a MIPS Quality performance category score under Sec.  
414.1380(b)(1), and (2) the ACO's total available measure achievement 
points used to calculate the ACO's MIPS Quality performance category 
score for the performance year is reduced due to measure exclusion 
under Sec.  414.1380(b)(1)(vii)(A), then we would use the higher of the 
ACO's health equity adjusted quality performance score or the 
equivalent of the 40th percentile MIPS Quality performance category 
score across all MIPS Quality performance category scores, excluding 
entities/providers eligible for facility-based scoring, to determine 
whether the ACO meets the quality performance standard required to 
share in savings at the maximum rate under its track (or payment model 
within a track), for the relevant performance year. This policy aims to 
alleviate the potential adverse impacts to shared savings 
determinations that may arise in the event that one or more of the 
quality measures required under the APP is excluded. We also proposed 
to make conforming changes to the regulation text Sec.  425.512 by 
revising paragraph (a)(5)(i) and adding paragraph (a)(7).
    We finalized in the CY 2023 PFS final rule (87 FR 69845) that 
unscored measures are removed from the calculation of an ACO's health 
equity adjustment, effectively receiving a performance scaler of 0 for 
those measures. However, we inadvertently did not codify this policy in 
the Code of Federal Regulations. Therefore, in the CY 2024 PFS proposed 
rule (88 FR 52433), we proposed to codify this policy by revising Sec.  
425.512(b)(3)(ii)(B) to state that CMS assigns a value of 0 for each 
measure that CMS does not evaluate because the measure is unscored. We 
proposed that the regulation text changes would be effective for 
performance year 2023 and subsequent performance years as the policy 
was finalized in the CY 2023 PFS final rule to calculate the health 
equity adjustment for performance year 2023 and subsequent performance 
years.
    We also proposed that quality measures impacted by the MIPS policy 
at Sec.  414.1380(b)(1)(vii)(A) are unscored measures for the purposes 
of calculating the health equity adjustment; therefore, excluded 
measures would not render an ACO ineligible for the health equity 
adjustment as long as the ACO reports all required measures under the 
APP and meets the data completeness requirement at Sec.  414.1340 for 
all required measures and receives a MIPS Quality performance category 
score under Sec.  414.1380(b)(1).
    We proposed a change to the MIPS policy to remove the 10 percent 
threshold for changes to codes, clinical guidelines, or measure 
specifications for all measure types and are finalizing this policy as 
proposed (88 FR 52592 and 52593). We believe that our proposal to apply 
a floor to an ACO's Quality performance category score in determining 
the ACO's quality performance standard in the event that the ACO's 
total available measure achievement points used to calculate the ACO's 
MIPS Quality performance category score for the performance year is 
reduced under Sec.  414.1380(b)(1)(vii)(A) functions in concert with 
our proposal being finalized in section IV.A.1.b.(2)(d) of this final 
rule. We refer readers to section IV.A.1.b.(2)(d) of this final rule 
for further discussion of the finalized changes to the MIPS scoring 
policy.
    The following is a summary of the comments we received on the 
proposal

[[Page 79123]]

to establish a Shared Savings Program scoring policy for excluded APP 
measures and our response.
    Comment: All comments we received were in support of the proposal 
to apply a Shared Savings Program scoring policy for excluded APP 
measures. Several commenters stated that these changes will ensure that 
ACOs are not negatively impacted by measure changes or benchmark issues 
that occur mid-year and are outside the ACO's control.
    Response: Although several commenters stated that the proposed 
changes will ensure that ACOs are not negatively impacted by benchmark 
issues, we did not consider applying the proposed scoring policy to 
measures with benchmark issues as we were developing the proposals for 
the CY 2024 PFS proposed rule.
    Under Sec.  414.1380(b)(1)(i)(A), beginning with the CY 2023 
performance period/2025 MIPS payment year, for eCQMs and MIPS CQMs, 
that meet the MIPS data completeness requirement but do not have a 
benchmark (for example, a historical or performance period benchmark) 
will receive zero achievement points (or 3 points for small practices). 
The scoring policies applicable to eCQMs and MIPS CQMs would also be 
applicable to Medicare CQMs beginning in performance year 2024. Given 
that the Shared Savings Program does not determine which quality 
measures do not have a benchmark and that ACOs do not have a choice of 
measures they can report under the APP, we do not want to adversely 
impact shared savings determinations for events outside the ACOs' 
control, such as in the event a measure does not have a benchmark. 
Therefore, we are finalizing at Sec.  425.512(a)(7) the proposed policy 
with modification to include eCQMs, MIPS CQMs, and Medicare CQMs within 
the APP measure set that do not have a benchmark as described at Sec.  
414.1380(b)(1)(i)(A). We are also clarifying that this policy will not 
apply if an ACO's MIPS Quality performance category score is not 
impacted by measure exclusion or the lack of a benchmark.
    We also sought public comment on our proposal to revise Sec.  
425.512(b)(3)(ii)(B) to state that, for the purposes of calculating the 
health equity adjustment to an ACO's quality score, CMS assigns a value 
of 0 for each measure that CMS does not evaluate because the measure is 
unscored. We proposed that the regulation text changes would be 
effective for performance year 2023 and subsequent performance years as 
the policy to calculate the health equity adjustment for performance 
year 2023 and subsequent performance years was finalized in the CY 2023 
PFS final rule. Additionally, we proposed that quality measures 
impacted by the MIPS policy at Sec.  414.1380(b)(1)(vii)(A) are 
unscored measures for the purposes of calculating the health equity 
adjustment; therefore, excluded measures would not render an ACO 
ineligible for the health equity adjustment as long as the ACO reports 
all required measures under the APP and meets the data completeness 
requirement at Sec.  414.1340 for all required measures and receives a 
MIPS Quality performance category score under Sec.  414.1380(b)(1). We 
note that our summary of comment and response for this proposal is not 
sequential to the policy's placement in our proposed rule. The 
placement here is not consequential to the finalization of the policy.
    We did not receive public comments on these proposals; and 
therefore, we are finalizing these policies as proposed.
    After consideration of the public comments, to determine whether 
the ACO meets the quality performance standard required to share in 
savings at the maximum rate under its track (or payment model within a 
track), we are finalizing at Sec.  425.512(a)(7) that for performance 
year 2024 and subsequent performance years, if an ACO reports all of 
the required measures, meeting the data completeness requirement at 
Sec.  414.1340 of this subchapter for each measure in the APP measure 
set and receiving a MIPS Quality performance category score as 
described at Sec.  414.1380(b)(1) of this subchapter, CMS will use the 
higher of the ACO's health equity adjusted quality performance score or 
the equivalent of the 40th percentile MIPS Quality performance category 
score across all MIPS Quality performance category scores, excluding 
entities/providers eligible for facility-based scoring, for the 
relevant performance year when the ACO meets either of the following:
    (i) The ACO's total available measure achievement points used to 
calculate the ACO's MIPS Quality performance category score is reduced 
under Sec.  414.1380(b)(1)(vii)(A) of this subchapter.
    (ii) At least one of the eCQMs/MIPS CQMs/Medicare CQMs does not 
have a benchmark as described at Sec.  414.1380(b)(1)(i)(A) of this 
subchapter.
    We are also finalizing conforming changes to Sec.  425.512 by 
revising paragraph (a)(5)(i) and adding paragraph (a)(7).
    In proposing to bifurcate our scoring policies for the performance 
year 2024 and subsequent performance years we inadvertently failed to 
update Sec.  425.512(b)(3)(i) to properly refer to the new Sec.  
425.512(a)(7). Among other things, Sec.  425.512(b)(3)(i) applies the 
health equity adjustment calculated pursuant to Sec.  425.512(b) to 
performance year 2024 and subsequent performance years.\210\ We are 
finalizing a modification to add the determination of quality 
performance score for an ACO affected by this Shared Savings Program 
Scoring Policy to the list of uses of the ACO's health equity adjusted 
quality performance score. Specifically, we are revising redesignated 
paragraph (b)(4)(i) to read as follows: In determining whether the ACO 
meets the quality performance standard as specified under paragraphs 
(a)(4)(i)(A), (a)(5)(i)(A)(1), (a)(5)(i)(B), and (a)(7) of this 
section.
---------------------------------------------------------------------------

    \210\ Except in the case of an ACO that meets the quality 
performance standard pursuant to Sec.  425.512(a)(5)(i)(B).
---------------------------------------------------------------------------

g. Require Spanish Language Administration of the CAHPS for MIPS Survey
(1) Background
    We have created official translations of the CAHPS for MIPS survey 
in seven languages, including Spanish, Cantonese, Korean, Mandarin, 
Portuguese, Russian, and Vietnamese (81 FR 77386), in addition to the 
required administration of English survey. However, use of these 
translations is mostly voluntary, with the exception of a requirement 
to administer the Spanish translation of the CAHPS for MIPS Survey for 
patients residing in Puerto Rico. Organizations (groups, virtual 
groups, subgroups, and APM entities) that elect CAHPS for MIPS must 
contract with a CMS-approved survey vendor to administer the survey and 
must request survey translations for the vendor to administer the 
survey in an optional language. Generally, the use of survey 
translations adds additional survey administration cost to the 
organization.
(2) Revisions
    As discussed in section IV.A.4.f.(1)(c)(ii) of this final rule, we 
proposed to require Spanish language administration of the CAHPS for 
MIPS survey for organizations that elect CAHPS for MIPS. Specifically, 
we proposed to require organizations to contract with a CMS-approved 
survey vendor that, in addition to administering the survey in English, 
will administer the Spanish survey translation to Spanish-preferring 
patients using the procedures detailed

[[Page 79124]]

in the CAHPS for MIPS Quality Assurance Guidelines beginning with 2024 
survey administration. This proposal is part of our efforts to advance 
health equity. We refer readers to section IV.A.4.f.(1)(c)(ii) of this 
final rule for further discussion of our proposal related to the CAHPS 
for MIPS survey.
    The Quality Payment Program proposed Spanish language survey 
administration requirement for the CAHPS for MIPS Survey can be found 
in section IV.A.4.f.(1)(c)(ii) of this final rule. Comments received 
for the Spanish language requirement for the Shared Savings Program are 
included in section IV.A.4.f.(1)(c)(ii) with comments received by the 
Quality Payment Program. We refer readers to section 
IV.A.4.f.(1)(c)(ii) of this final rule, where we finalize this policy 
as proposed.
h. Align CEHRT Requirements for Shared Savings Program ACOs With MIPS
(1) Background
    Many of our programs require the use of certified electronic health 
record (EHR) technology (CEHRT), including the Quality Payment Program, 
Shared Savings Program, and other value-based payment initiatives. For 
the Shared Savings Program, section 1899(b)(2)(G) of the Act requires 
participating ACOs to define processes to report on quality measures 
and coordinate care, such as through the use of telehealth, remote 
patient monitoring, and other such enabling technologies. In addition, 
section 1899(b)(3)(D) of the Act authorizes the Secretary to 
incorporate reporting requirements and incentive payments from section 
1848 of the Act into the Shared Savings Program, such as requirements 
and payments related to electronic prescribing and electronic health 
records, including using alternative criteria for determining whether 
to make such incentive payments. Under these authorities, we have 
incorporated reporting requirements related to the adoption and use of 
CEHRT in our regulations, including specifically cross-referencing the 
Quality Payment Program's definition of CEHRT (Sec.  414.1305) in our 
regulatory definition of CEHRT at Sec.  425.20. For the Shared Savings 
Program and Quality Payment Program, CEHRT currently is defined at 
Sec.  414.1305 as EHR technology (which could include multiple 
technologies) certified by the Office of the National Coordinator for 
Health Information Technology (ONC) under the ONC Health IT 
Certification Program as meeting the 2015 Edition Base EHR definition, 
set forth at 45 CFR 170.102, and a designated set of the 2015 Edition 
health information technology (IT) certification criteria as further 
provided therein.
    The Health Information Technology for Economic and Clinical Health 
Act (HITECH Act), sections 13001 through 13424 of the American Recovery 
and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5, February 17, 2009), 
established ONC under the Department of Health and Human Services, 
authorizing ONC to adopt standards for certifying health IT. ONC has 
codified its standards, implementation specifications, certification 
criteria, and certification program for health IT under 45 CFR part 
170. Specifically, ONC has codified its certification criteria for 
health IT, including EHRs, at 45 CFR 170.315, which are currently 
referred to as the ``2015 Edition health IT certification criteria.'' 
For more information regarding ONC's current policies, standards, and 
certification requirements for health IT, please refer to 45 CFR part 
170, particularly Sec.  170.315, and the ONC Certification of Health IT 
website at https://www.healthit.gov/topic/certification-ehrs/certification-health-it.
    In the CY 2019 PFS final rule (83 FR 59982 through 59988), we 
adopted three key requirements related to ACOs' use of CEHRT, beginning 
with the performance years starting on January 1, 2019.
    First, ACOs must certify annually, at the end of each performance 
year, that the percentage of eligible clinicians participating in the 
ACO who use CEHRT to document and communicate clinical care to their 
patients or other health care providers meets or exceeds the applicable 
percentage during the current performance year. The ACO's eligible 
clinicians must use CEHRT that meets the definition in our regulation 
at Sec.  425.20, which provides that CEHRT has the same meaning as 
under the Quality Payment Program at Sec.  414.1305. Specifically, we 
updated our regulations at Sec.  425.506(f) to reflect that, beginning 
with the performance years starting on January 1, 2019:
     ACOs in a track that does not meet the financial risk 
standard to be an Advanced APM, which includes ACOs participating under 
BASIC track Levels A through D, must certify annually that at least 50 
percent of the eligible clinicians participating in the ACO use CEHRT 
to document and communicate clinical care to their patients or other 
health care providers.
     ACOs in a track that meets the financial risk standard to 
be an Advanced APM, which includes ACOs participating under BASIC track 
Level E or the ENCHANCED track, must certify annually that the 
percentage of eligible clinicians participating in the ACO that use 
CEHRT to document and communicate clinical care to their patients or 
other health care providers meets or exceeds the threshold established 
under the Quality Payment Program at Sec.  414.1415(a)(1)(i). Under 
this requirement, for performance years beginning in 2019, 75 percent 
of eligible clinicians must use CEHRT to document and communicate 
clinical care to their patients or health care providers.
    Second, we also revised the Shared Savings Program requirements for 
data submission and certifications at Sec.  425.302(a)(3)(iii) to 
require the ACO to certify at the end of each performance year, that 
the percentage of eligible clinicians participating in the ACO that use 
CEHRT to document and communicate clinical care to their patients or 
other health care providers meets or exceeds the applicable percentage 
specified by CMS at Sec.  425.506(f).
    Finally, we updated our regulations at Sec.  425.20 to incorporate 
the definition of CEHRT at Sec.  414.1305 that applies under the 
Quality Payment Program. The Quality Payment Program's regulation at 
Sec.  414.1305 defines CEHRT as EHR technology (which could include 
multiple technologies) certified under the ONC Health IT Certification 
Program that meets the 2015 Edition Base EHR definition at Sec.  
170.102 and has been certified as meeting certain other criteria set 
forth in ONC's 2015 Edition health IT certification criteria at Sec.  
170.315 as further described in Sec.  414.1305. Applying the Shared 
Savings Program's definition at Sec.  425.20, ACOs under the Shared 
Savings Program must use EHR technology meeting the Quality Payment 
Program's definition of CEHRT at Sec.  414.1305 to meet the 
requirements set forth in our regulation at Sec.  425.506(f). In the 
Health Data, Technology, and Interoperability: Certification Program 
Updates, Algorithm Transparency, and Information Sharing proposed rule 
(88 FR 23746 through 23917), which appeared in the April 18, 2023, 
Federal Register, ONC has proposed to discontinue the year-themed 
``editions,'' which ONC first adopted in 2012, to distinguish between 
sets of health IT certification criteria finalized in different rules. 
ONC has proposed to instead maintain a single set of ``ONC 
Certification Criteria for Health IT,'' which would be updated in an 
incremental fashion in closer alignment to standards development cycles 
and regular health information technology

[[Page 79125]]

(IT) development timelines (88 FR 23757 through 23762).) As further 
discussed in section IV.A.4.f.(4)(c) of this final rule, we are 
finalizing our proposal to modify the Quality Payment Program's 
definition of CEHRT at Sec.  414.1305 to flexibly incorporate any 
changes by ONC to its definition of Base EHR and its certification 
criteria for Health IT.
(2) Removing CEHRT Use Threshold Requirements and Requiring Reporting 
of the MIPS Promoting Interoperability Performance Category
    To streamline CEHRT threshold requirements for ACOs and align with 
the Quality Reporting Program's Merit-Based Incentive Payment System 
(MIPS), we proposed to sunset the Shared Savings Program CEHRT 
threshold requirements and modify our regulations at Sec.  425.506(f) 
to indicate that they will be applicable only through performance year 
2023 (88 FR 52433). We further proposed, for performance years 
beginning on or after January 1, 2024, unless otherwise excluded, to 
require that all MIPS eligible clinicians, Qualifying APM Participants 
(QPs), and Partial Qualifying APM Participants (Partial QPs) (each as 
defined at Sec.  414.1305 of this subchapter) participating in the ACO, 
regardless of track, satisfy all of the following:
     Report the MIPS Promoting Interoperability (PI) 
performance category measures and requirements to MIPS according to 42 
CFR part 414 subpart O as either of the following--
    ++ All MIPS eligible clinicians, QPs, and partial QPs participating 
in the ACO as an individual, group, or virtual group; or
    ++ The ACO as an APM entity.
     Earn a MIPS performance category score for the MIPS 
Promoting Interoperability performance category at the individual, 
group, virtual group, or APM entity level.
    A MIPS eligible clinician, QP, Partial QP, or ACO as an APM entity 
may be excluded from the requirements proposed at Sec.  425.507(a) if 
the MIPS eligible clinician, QP, Partial QP, or ACO as an APM entity--
     Does not exceed the low volume threshold set forth at 
Sec.  414.1310(b)(1)(iii);
     Is an eligible clinician as defined at Sec.  414.1305 who 
is not a MIPS eligible clinician and has opted to voluntarily report 
measures and activities for MIPS as set forth in Sec.  414.1310(b)(2); 
or
     Has not earned a performance category score for the MIPS 
Promoting Interoperability performance category because the MIPS 
Promoting Interoperability performance category has been reweighted in 
accordance with applicable policies set forth at Sec.  414.1380(c)(2).
    We proposed to codify this new requirement at Sec.  425.507.
    Specifically, we proposed that any requirements applicable to MIPS 
eligible clinicians reporting on objectives and measures specified by 
CMS for the MIPS Promoting Interoperability performance category would 
apply to MIPS eligible clinicians, QPs, and Partial QPs participating 
in an ACO at Sec.  425.507(a). We further proposed that if any of these 
requirements for a MIPS eligible clinician reporting for the MIPS 
Promoting Interoperability performance category, including objectives 
and measures, are amended through rulemaking (such as adoption, 
modification, or removal of an objective or measure), then the new or 
modified requirements will also be applicable to MIPS eligible 
clinicians, QPs, and Partial QPs participating in an ACO under Sec.  
425.507. For instance, in section IV.A.4.f.(4) of this final rule, we 
proposed several modifications to the MIPS Promoting Interoperability 
performance category's requirements, including modifying the 
performance period at Sec.  414.1320, as well as specific measures such 
as the High Priority Safety Assurance Factors for EHR Resilience 
(SAFER) Guides measure. To the extent these or other policies are 
finalized through rulemaking, then these requirements would also be 
applicable to ACO participants as provided by our proposal here.
    To further align with applicable requirements for the MIPS 
Promoting Interoperability performance category, we proposed that MIPS 
eligible clinicians, QPs, Partial QPs, and ACOs as APM entities may be 
exempt from our proposed regulation at Sec.  425.507(a) if the MIPS 
eligible clinician, QP, Partial QP, or ACO as an APM entity: (1) does 
not exceed the low volume threshold set forth at Sec.  
414.1310(b)(1)(iii); (2) is an eligible clinician as defined at Sec.  
414.1305 who is not a MIPS eligible clinician and has opted to 
voluntarily report measures and activities for MIPS as set forth in 
Sec.  414.1310(b)(2); or (3) has not earned a performance category 
score for the MIPS Promoting Interoperability performance category 
because the MIPS Promoting Interoperability performance category has 
been reweighted in accordance with applicable policies set forth at 
Sec.  414.1380(c)(2). However, if such MIPS eligible clinicians, QPs, 
and Partial QPs do report the MIPS Promoting Interoperability 
performance category as an individual, group, or virtual group or the 
ACO reports MIPS Promoting Interoperability performance category as an 
APM entity, the MIPS eligible clinicians, QPs, and Partial QP the 
exemption would not apply for purposes of satisfying our proposed 
regulation at Sec.  425.507 (88 FR 52433).
    Exclusions to MIPS eligible clinicians described at Sec.  
414.1310(b)(1)(iii) include eligible clinicians who do not exceed the 
MIPS low volume threshold. Eligible clinicians who are not MIPS 
eligible clinicians have the option to voluntarily report measures and 
activities for MIPS as described at Sec.  414.1310(b)(2). Federally 
Qualified Health Centers (FQHC) or Rural Health Clinics (RHC) who 
provide services that are billed exclusively under the FQHC or RHC 
payment methodologies may voluntarily report the MIPS Promoting 
Interoperability performance category as a group, virtual group, or APM 
entity. MIPS eligible clinicians, QPs, and Partial QPs practicing in 
FQHCs or RHCs who provide services that are billed exclusively under 
FQHC or RHC payment methodologies may voluntarily report the MIPS 
Promoting Interoperability performance category as an individual, 
group, virtual group, or APM entity. It is important to note that 
exclusions to MIPS eligible clinicians as described at Sec.  
414.1310(b)(1)(i) and (ii) are not applicable to our proposal at Sec.  
425.507 because QPs and Partial QPs are required to report MIPS 
Promoting Interoperability performance category for purposes of 
satisfying the Shared Savings Program proposal at Sec.  425.507. 
Examples of applicable exclusions under Sec.  414.1380(c)(2) for 
reweighting of the MIPS Promoting Interoperability performance category 
include, but are not limited to, the following:
     MIPS eligible clinicians, QPs, and Partial QPs 
participating in the ACO who are granted a hardship exception under 
Sec.  414.1380(c)(2)(i)(C) at the individual, group, virtual group, or 
APM entity level.
     MIPS eligible clinicians, QPs, and Partial QPs that are 
eligible for reweighting of the Promoting Interoperability performance 
category at the individual, group, virtual group, or APM entity level 
as described at Sec.  414.1380(c)(2)(i)(A)(4).
     MIPS eligible clinicians, QPs, and Partial QPs that are 
eligible for reweighting of the Promoting Interoperability performance 
category as described at Sec.  414.1380(c)(2)(i)(A)(4).\211\
---------------------------------------------------------------------------

    \211\ In the CY 2024 PFS proposed rule (88 FR 52435), we 
referenced the exclusion for MIPS eligible clinicians, QPs, and 
Partial QPs that are eligible for reweighting of the Promoting 
Interoperability performance category as described at Sec.  
414.1380(c)(2)(i)(A)(4) twice in error. This error has been 
addressed in this final rule.

---------------------------------------------------------------------------

[[Page 79126]]

    Incorporating MIPS Promoting Interoperability performance 
category's requirements into the Shared Savings Program will alleviate 
the burden that the current policy creates for ACOs. Because the Shared 
Savings Program CEHRT attestation requirement and the MIPS Promoting 
Interoperability category requirements are not the same, ACOs have the 
burden of managing compliance with two different CEHRT program 
requirements. In finalizing the Shared Savings Program CEHRT 
attestation in the CY 2019 PFS final rule, we stated our desire to 
continue to promote and encourage CEHRT use by ACOs and their ACO 
participants and ACO providers/suppliers, and our desire to better 
align with the goals of the Quality Payment Program and the criteria 
for participation in certain alternative payment models tested by the 
Innovation Center (83 FR 59983). Given our unified goal and vision for 
the use of CEHRT, our proposal at Sec.  425.507 will allow ACOs to 
focus on a unified set of program requirements for the use of CEHRT and 
reduce the administrative burden of managing compliance with a 
different set of program requirements with the same aim.
    While ACOs would be able to report the MIPS Promoting 
Interoperability category at the individual, group, virtual group, or 
APM entity level for purposes of satisfying our proposed policy at 
Sec.  425.507, we encourage ACOs to evaluate reporting the MIPS 
Promoting Interoperability performance category at the APM entity level 
for purposes of satisfying the Shared Savings Program regulation 
proposed at Sec.  425.507. In the CY 2023 PFS final rule, we finalized 
a policy to introduce a voluntary reporting option for APM entities to 
report the MIPS Promoting Interoperability performance category at the 
APM entity level beginning with the CY 2023 performance period (87 FR 
70033). For purposes of MIPS scoring and payment adjustments, if the 
ACO reports the MIPS Promoting Interoperability performance category at 
the APM entity level, the APM entity's score for the MIPS Promoting 
Interoperability performance category would be the first score 
identified to generate the APM entity level score. If the ACO does not 
report the MIPS Promoting Interoperability performance category at the 
APM entity level, the ACO's individual and group scores would be 
calculated as a weighted average up to the APM entity level to generate 
the APM entity level score for purposes of scoring the MIPS Promoting 
Interoperability performance category. If an eligible clinician reports 
the MIPS Promoting Interoperability performance category at the 
individual or group level under traditional MIPS or the APM Performance 
Pathway (APP) in addition to reporting the MIPS Promoting 
Interoperability performance at the APM entity level via the APP, for 
purposes of MIPS scoring and payment adjustments, that eligible 
clinician would receive the higher of their individual, group, or APM 
entity Promoting Interoperability performance category score. For more 
information about reporting the MIPS Promoting Interoperability 
performance category at the APM entity level, we direct readers to the 
MIPS Promoting Interoperability User Guide, which is updated each 
performance year, in the QPP Resource library at https://qpp.cms.gov/resources/resource-library. We anticipate releasing subregulatory 
guidance for ACOs that participate in the Shared Savings Program about 
voluntarily reporting the MIPS Promoting Interoperability performance 
category at the APM entity level in future performance years.
    We solicited comments on our proposal that, for performance years 
beginning on or after January 1, 2024, unless otherwise excluded, to 
require that all MIPS eligible clinicians, Qualifying APM Participants 
(QPs), and Partial Qualifying APM Participants (Partial QPs) (each as 
defined at Sec.  414.1305) participating in the ACO, regardless of 
track, satisfy all of the following:
     Report the MIPS Promoting Interoperability (PI) 
performance category measures and requirements to MIPS according to 42 
CFR part 414 subpart O as either of the following--
    ++ All MIPS eligible clinicians, QPs, and partial QPs participating 
in the ACO as an individual, group, or virtual group; or
    ++ The ACO as an APM entity.
     Earn a MIPS performance category score for the MIPS 
Promoting Interoperability performance category at the individual, 
group, virtual group, or APM entity level.
    A MIPS eligible clinician, QP, Partial QP, or ACO as an APM entity 
may be excluded from the requirements proposed at Sec.  425.507(a) if 
the MIPS eligible clinician, QP, Partial QP, or ACO as an APM entity--
     Does not exceed the low volume threshold set forth at 
Sec.  414.1310(b)(1)(iii);
     Is an eligible clinician as defined at Sec.  414.1305 who 
is not a MIPS eligible clinician and has opted to voluntarily report 
measures and activities for MIPS as set forth in Sec.  414.1310(b)(2); 
or
     Has not earned a performance category score for the MIPS 
Promoting Interoperability performance category because the MIPS 
Promoting Interoperability performance category has been reweighted in 
accordance with applicable policies set forth at Sec.  414.1380(c)(2).
    We proposed to codify this new requirement at Sec.  425.507.
    We also solicited comments on an alternative proposal to narrow the 
proposal to require ACOs to report the measures and requirements under 
the MIPS Promoting Interoperability performance category, in accordance 
with our regulations at 42 CFR part 414 subpart O, at the APM entity 
level. This alternative proposal would remove the option for MIPS 
eligible clinicians, Qualifying APM Participants (QPs), and Partial 
Qualifying APM Participants (Partial QPs) (each as defined at Sec.  
414.1305) participating in the ACO to report the MIPS Promoting 
Interoperability performance category at the individual, group, or 
virtual group level for purposes of satisfying our proposal at Sec.  
425.507.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: We received a few comments in support of the proposal to 
align CEHRT requirements with MIPS, citing the importance of meaningful 
CEHRT use and of expanding provider participation in Promoting 
Interoperability. One commenter also stated that the proposal will 
support CMS' goal of advancing eCQM capabilities among ACO 
participants, since use of CEHRT includes the ability to standardize 
the capture and reporting of data relevant for quality reporting. 
Another commenter supported aligning CEHRT requirements because it 
would lead to comprehensive reporting requirements across ACOs and 
facilitate better care coordination.
    Response: We thank commenters for their support.
    Comment: Several commenters were opposed to the proposal citing 
concerns that the proposal would increase administrative burden, 
especially for small practices, and discourage participation in the 
Shared Savings Program.
    Response: We are finalizing with modifications our proposal to 
align the Shared Savings Program CEHRT requirement with MIPS Promoting 
Interoperability to clarify the requirement that an ACO participant, 
ACO provider/supplier, and ACO

[[Page 79127]]

professional that is a MIPS eligible clinician, Qualifying APM 
Participant (QP), or Partial Qualifying APM Participant (Partial QP) 
(each as defined at Sec.  414.1305 of this chapter) satisfy all of the 
requirements detailed at Sec.  425.507(a). In response to the 
commenters' concerns that our proposal would increase administrative 
burden and discourage participation in the Shared Savings Program, our 
intent is to allow the ACO to exclude an ACO participant, ACO provider/
supplier, or ACO professional from reporting MIPS Promoting 
Interoperability performance category in accordance with applicable 
policies that exclude or otherwise exempt eligible clinicians from 
reporting the MIPS Promoting Interoperability performance category as 
set forth in 42 CFR part 414 subpart O, provided however, that an ACO 
participant, ACO provider/supplier, or ACO professional cannot be 
excluded from the requirements specified in Sec.  425.507(a) solely on 
the basis of being a QP or Partial QP. We are finalizing our proposal 
with modifications to make clear the examples of exclusions that would 
be applicable to the requirements specified at Sec.  425.507(a). 
Applicable exclusions to paragraph (a) may include the following:
     Low volume threshold as set forth at Sec.  
414.1310(b)(1)(iii),
     Eligible clinician as defined at Sec.  414.1305 of this 
chapter who is not a MIPS eligible clinician as set forth in Sec.  
414.1310(b)(2),
     Reweighting of the MIPS Promoting Interoperability 
performance category to zero percent of the final score in accordance 
with applicable policies set forth at Sec.  414.1380(c)(2).
    These modifications are consistent with our original proposal that 
the Shared Savings Program's CEHRT requirements fully align with MIPS 
Promoting Interoperability performance category's requirements (88 FR 
52434).
    For example, if an ACO has 40 ACO participants that are MIPS 
eligible clinicians and 10 of the ACO participants do not earn a MIPS 
Promoting Interoperability performance category score because the ACO 
participants did not exceed the low volume threshold as set forth at 
Sec.  414.1310(b)(1)(iii), then the ACO does not count in its public 
reporting the 10 ACO participants that did not earn a MIPS Promoting 
Interoperability performance category score because the ACO 
participants did not exceed the low volume threshold.
    In another example, if in the ACO in the example above, 5 of the 10 
ACO participants that did not exceed the low volume threshold as set 
forth at Sec.  414.1310(b)(1)(iii), voluntarily report under the MIPS 
Promoting Interoperability performance category, those 5 ACO 
participants must be included in the in the number of ACO participants, 
ACO providers/suppliers, or ACO professionals that the ACO publicly 
reports. In this example, the ACO must publicly report the 35 ACO 
participants [(30 ACO participants without an exclusion) + (5 ACO 
participants that voluntarily reported) = 35 ACO participants] that 
earned a MIPS Promoting Interoperability performance category score. 
The ACO in this example does not count in its public reporting the 5 
ACO participants that did not earn a MIPS Promoting Interoperability 
performance category score because the ACO participants did not exceed 
the low volume threshold.
    In response to the comment regarding burden to small practices, we 
are assessing the appropriateness of exemptions to the requirements at 
Sec.  425.507(a) based on Special status as defined at Sec.  414.1305 
and may address this in future rulemaking. We also note that the new 
reporting option to report MIPS Promoting Interoperability performance 
category at the ACO level, in addition to group reporting options, will 
help alleviate individual clinician reporting burden.
    ACOs will have access to the MIPS eligibility status of the 
eligible clinicians that participate in the ACO at our website at 
https://qpp.cms.gov. ACOs are encouraged to check their participant's 
MIPS eligibility before and during the performance year to ensure that 
they have the most up to date eligibility information.
    Comment: Several commenters stated that they believe that this 
reporting requirement would create a disincentive for ACOs to 
participate in an Advanced APM and obtain QP status. Many commenters 
believed that the proposal is at odds with MIPS policies that exclude 
QPs and Partial QPs from reporting MIPS. One commenter stated that QP 
determinations at the National Provider Identifier (NPI) level, instead 
of the ACO entity level, will initiate significant reporting challenges 
for ACOs that have to report for both QP and non-QP providers. One 
commenter was concerned that the Advanced APM must require all 
participating eligible clinicians to use CEHRT, citing that this could 
have the unintended consequence of limiting non-physician qualified 
health care professional participation in APMs due to financial 
constraints.
    A few commenters had concerns that this requirement negates the 
benefit of APM participation for providers that alleviated some of the 
administrative reporting burden under MIPS. These commenters noted that 
they believe that aligning ACO reporting to the MIPS Promoting 
Interoperability requirements undercuts a primary benefit of APM 
participation for individual providers, thus weakening the incentive to 
participate in the program.
    Response: In response to commenters' concerns about additional 
burden for QPs and Partial QPs, the new reporting option to report the 
MIPS Promoting Interoperability performance category at the ACO level, 
in addition to group reporting options, will help alleviate individual 
clinician's reporting burden.
    Regarding commenters' statements that they believe that this 
reporting requirement would create a disincentive for ACOs to 
participate in an Advanced APM and obtain QP status, we wish to clarify 
that QP and Partial QP status are dependent, in part, on the APM being 
compliant with the Advanced APM criteria set forth at Sec.  414.1415. 
Our proposal to align the Shared Savings Program's CEHRT requirement 
with MIPS Promoting Interoperability is compliant with the policy we 
are finalizing in section IV.A.4.n. of this final rule regarding 
Advanced APMs' requirement to use CEHRT for PY 2025 and subsequent 
performance years. This policy will sunset the current 75 percent CEHRT 
use requirement for Advanced APMs and replace it with a requirement 
that to be an Advanced APM, the APM must require all eligible 
clinicians in each participating APM Entity, or for APMs in which 
hospitals are the participants, each hospital, to use CEHRT. This 
policy is consistent with section 1833(z)(3)(D)(i)(I) of the Act, which 
generally requires that Advanced APMs require their participants to use 
CEHRT as defined in section 1848(o)(4) of the Act (88 FR 52627). As 
such, for Level E of the BASIC Track and the ENHANCED track of the 
Shared Savings Program to be eligible to be considered Advanced APMs in 
PY 2025 and subsequent performance years, the Shared Savings Program 
needs to update our CEHRT requirement to align with our proposal for 
CEHRT use for Advanced APMs, as well as maintain compliance with the 
other Advanced APM criteria detailed at Sec.  414.1415.
    Comment: Several commenters were concerned about the timeline for 
the implementation of this requirement given that ACOs must remove 
practices from their ACO participation list before the final rule is 
published. Commenters also had concerns that the proposed timeline does 
not allow ACOs time to bring small practices into compliance with CEHRT 
requirements. Many

[[Page 79128]]

commenters urged CMS to delay the implementation of these proposals.
    Response: We recognize the concerns raised by commenters that 
finalizing this requirement for the PY 2024 would limit ACO's ability 
to work with their new ACO participants, ACO providers/suppliers, and 
ACO professionals to meet the CEHRT and MIPS Promoting Interoperability 
performance category reporting requirement. Therefore, after 
consideration of the public comments we received on this proposal, we 
have decided to delay implementation of this requirement to performance 
years beginning on or after January 1, 2025. The proposal would promote 
consistent CEHRT use across all Shared Savings Program ACOs, advance 
digital quality measurement, promote interoperability among clinicians 
through greater availability of digital data, and further align the 
Shared Savings Program with MIPS.
    Comment: A few commenters opposed the proposal to align the Shared 
Savings Program's CEHRT requirements with MIPS, citing the different 
goals and functions of MIPS, the Shared Savings Program, and APMs. One 
commenter stated that that MIPS measures quality within point-in-time 
encounters by clinicians, whereas ACOs coordinate care across the 
continuum.
    Response: The MIPS Promoting Interoperability performance 
category's reporting requirements are more comprehensive than the 
Advanced APM requirements and address key functions that can facilitate 
better care coordination and quality measurement and improvement. For 
example, the MIPS Promoting Interoperability performance category 
requires clinicians to demonstrate use of CEHRT and attest that they 
engage in activities to support CEHRT use and health information 
exchange, as well as activities to prevent information blocking or 
actions that limit interoperability. In contrast, the Shared Savings 
Program attestation requirement provides limited insight into CEHRT 
capabilities and use by ACOs.
    MIPS and more advanced value-based arrangements, like the Shared 
Savings Program, operate on a continuum, with clinicians making 
decisions annually about whether to continue in MIPS or join more 
advanced payment models.\212\ As we advance towards our goal to have 
all people with Traditional Medicare in an accountable care 
relationship with a health care provider by 2030, as outlined in our 
Innovation Strategy Refresh which can be accessed at https://www.cms.gov/priorities/innovation/strategic-direction-whitepaper, 
alignment between MIPS and advanced value-based arrangements, like the 
Shared Savings Program, will ease the transition to accountable care. 
When value-based models are aligned, it becomes easier for health care 
providers to understand how they can succeed and provide high quality 
care, which lowers barriers to participation and accelerates adoption 
of value-based arrangements.
---------------------------------------------------------------------------

    \212\ ``The Medicare Value-Based Care Strategy: Alignment, 
Growth, And Equity'', Health Affairs Forefront, July 21, 2022. DOI: 
10.1377/forefront.20220719.558038.
---------------------------------------------------------------------------

    Comment: One commenter sought clarification on the impact on the 
ACO if individual clinicians within the ACO do not meet the MIPS 
Promoting Interoperability performance category's reporting 
requirements.
    Response: We thank commenters for their comments. We are making an 
additional modification to paragraph (b) to specify exclusions that may 
be applicable for purposes of satisfying the Shared Savings Program 
requirements at Sec.  425.507(a). Specifically, we are clarifying in 
Sec.  425.507(b) our intention that any applicable policies that 
exclude or otherwise exempt eligible clinicians from reporting the MIPS 
Promoting Interoperability performance category as set forth in 42 CFR 
part 414, subpart O also apply to exclude ACO participants, ACO 
providers/suppliers, and ACO professionals from meeting the reporting 
requirement set forth in Sec.  425.507(a). However, we are also 
clarifying in Sec.  425.507(b), an ACO participant, ACO provider/
supplier, or ACO professional cannot be excluded from the requirements 
specified in Sec.  425.507(a) solely on the basis of being a QP or 
Partial QP; we expect QPs and Partial QPs in an ACO to report MIPS 
Promoting Interoperability performance category unless they are 
excluded or exempt from doing so under another applicable MIPS policy. 
This is consistent with our original proposal that the Shared Savings 
Program's CEHRT requirements fully align with MIPS Promoting 
Interoperability performance category's requirements (88 FR 52435). 
Together, these modifications more clearly delineate the obligations of 
ACO participants, ACO providers/suppliers, and ACO professionals under 
this policy.
    We refer readers to Table 31 of this final rule for a non-
exhaustive list of exclusions for that may be applicable to reporting 
the MIPS Promoting Interoperability performance category for purposes 
of satisfying the Shared Savings Program CEHRT policy for performance 
years beginning on or after January 1, 2025.
BILLING CODE 4120-01-P

[[Page 79129]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.052


[[Page 79130]]


[GRAPHIC] [TIFF OMITTED] TR16NO23.053


 
 
 
* Certain exclusions to MIPS eligible clinician are described at Sec.
 425.507(b)(1) and (b)(2).
** Reweighting of the MIPS Promoting Interoperability performance
 category are described at Sec.   425.507(b)(3).
 


[[Page 79131]]

BILLING CODE 4120-01-C
    It may be helpful to note that an FQHC or RHC that bills 
exclusively under the FQHC or RHC payment methodologies and that meets 
one or more of the exclusions described at Sec.  425.507(b) and in 
Table 31 of this final rule for the applicable performance year are not 
required to report and/or earn a score in the MIPS Promoting 
Interoperability performance category for purposes of satisfying the 
Shared Savings Program CEHRT Alignment policy for that performance 
year. Similarly, the ACO does not count in the number of ACO 
participants, ACO providers/suppliers, and ACO professionals that the 
ACO publicly reports an FQHC or RHC that bills exclusively under the 
FQHC or RHC payment methodologies and meets one or more of the 
exclusions described at Sec.  425.507(b) and in Table 31 of this final 
rule for the applicable performance year, unless that FQHC or RHC 
voluntarily reports under the MIPS Promoting Interoperability 
performance category.
    Beginning in PY 2025 and subsequent performance years, if an ACO 
fails to meet the requirements at Sec.  425.507 and Sec.  
425.308(b)(9), CMS may take remedial action before termination for 
noncompliance as described at Sec.  425.216, which includes providing a 
warning notice, requesting a corrective action plan (CAP) from the ACO, 
or placing the ACO on a special monitoring plan.
    ACOs are required to manage their ACO participant and ACO provider/
supplier lists. Additionally, to address noncompliance with the 
requirements of the Shared Savings Program and other program integrity 
issues, including those identified by CMS, participant agreements must 
permit the ACO to take remedial action against the ACO participant, and 
must require the ACO participant to take remedial action against its 
ACO providers/suppliers, including imposition of a corrective action 
plan, denial of incentive payments, and termination of the ACO 
participant agreement as detailed at Sec.  425.116(a)(7).
    Comment: One commenter suggested that the goal of this proposal 
could better be achieved by requesting that EHR developers pull data 
automatically from CEHRT systems and report this data to provide CMS 
with data regarding adoption, use, and interoperability of CEHRT with 
less burden to ACOs.
    Response: We note that the commenter's suggested approach could 
lead to under-reporting of the use of CEHRT, which would not support 
our goal of ensuring that ACO participants have robust CEHRT 
capabilities, nor would it provide a complete and accurate picture of 
ACO capabilities and could lead to compliance actions as previously 
noted. Our proposal to align the Shared Savings Program CEHRT 
requirement with MIPS Promoting Interoperability is the best way to 
allow ACOs to focus on a unified set of program requirements for the 
use of CEHRT. Additionally, the new reporting option to report MIPS 
Promoting Interoperability performance category at the ACO level, in 
addition to group reporting options, will help alleviate individual 
clinician reporting burden.
    After consideration of public comments, we are finalizing, with 
modification and minor technical corrections, our proposal to align the 
Shared Savings Program's CEHRT requirements with MIPS, to delay the 
implementation of these amended policies until PY 2025. The 
modification to delay implementation of this proposal by 1-year is 
responsive to public feedback raising concerns that finalizing this 
requirement for the PY 2024 would limit ACO's ability to work with new 
ACO participants on their CEHRT readiness. This delay will allow ACOs 
ample time to consider the readiness of ACO participants, ACO 
providers/suppliers, and ACO professionals that are MIPS eligible 
clinicians, Qualifying APM Participants (QPs), or Partial Qualifying 
APM Participants (Partial QPs) to meet the requirements of the MIPS 
Promoting Interoperability performance category.
    We are finalizing our proposal with modification to our new CEHRT 
reporting policy at Sec.  425.507(a) for performance years beginning on 
or after January 1, 2025, unless otherwise excluded, an ACO 
participant, ACO provider/supplier, and ACO professional that is a MIPS 
eligible clinician, Qualifying APM Participant (QP), or Partial 
Qualifying APM Participant (Partial QP) (each as defined at Sec.  
414.1305), regardless of track, must satisfy all of the following:
     Report the MIPS Promoting Interoperability (PI) 
performance category measures and requirements to MIPS according to 42 
CFR part 414, subpart Oat the individual, group, virtual group, or APM 
entity level.
     Earn a MIPS performance category score for the MIPS 
Promoting Interoperability performance category at the individual, 
group, virtual group, or APM entity level.
    We are finalizing at Sec.  425.507(b) that an ACO participant, ACO 
provider/supplier, or ACO professional is excluded from the 
requirements specified in Sec.  425.507(a) in accordance with 
applicable policies that exclude or otherwise exempt eligible 
clinicians from reporting the MIPS Promoting Interoperability 
performance category as set forth in 42 CFR part 414, subpart O, 
provided however, that an ACO participant, ACO provider/supplier, or 
ACO professional cannot be excluded from the requirements specified at 
Sec.  425.507(a) solely on the basis of being a QP or Partial QP. 
Applicable exclusions may include:
     Low volume threshold as set forth at Sec.  
414.1310(b)(1)(iii) of this chapter.
     Eligible clinician as defined at Sec.  414.1305 of this 
chapter who is not a MIPS eligible clinician as set forth in Sec.  
414.1310(b)(2) of this chapter.
     Reweighting of the MIPS Promoting Interoperability 
performance category to zero percent of the final score in accordance 
with applicable policies set forth at Sec.  414.1380(c)(2) of this 
chapter.
    We are finalizing our proposal with modifications to codify this 
new requirement at Sec.  425.507.
(3) Updating Public Reporting Requirements
    As described in the CY 2019 final rule (80 FR 32813 through 32815), 
we believe that one important aspect of patient-centered care is 
patient engagement and transparency, which can be achieved by the 
public reporting of ACO quality and cost performance. Public reporting 
helps to hold ACOs accountable and may improve a beneficiary's ability 
to make informed health care choices, as well as facilitate an ACO's 
ability to improve the quality and efficiency of its care. To ensure 
our public reporting requirements reflect our proposal to require 
reporting of objectives, measures, and activities under the MIPS 
Promoting Interoperability performance category as discussed above, in 
CY 2024 final rule (85 FR 52436) we also proposed to require ACOs to 
publicly report the number of MIPS eligible clinicians, Qualifying APM 
Participants (QPs), and Partial Qualifying APM Participants (Partial 
QPs) (each as defined at Sec.  414.1305) participating in the ACO that 
earn a MIPS performance category score for the MIPS Promoting 
Interoperability performance category at the individual, group, virtual 
group, or APM entity level as proposed at Sec.  425.507. We proposed to 
codify this requirement at Sec.  425.308(b)(9).
    We proposed that MIPS eligible clinicians, QPs, and Partial QPs who 
would be excluded from reporting under the proposed regulation at Sec.  
425.507(b) as discussed previously may be excluded from the number of 
MIPS eligible clinicians, QPs, or Partial

[[Page 79132]]

QPs that the ACO publicly reports under our proposed regulation at 
Sec.  425.308(b)(9). However, if such MIPS eligible clinicians, QPs, 
and Partial QPs do report the MIPS Promoting Interoperability 
performance category as an individual, group, or virtual group, or the 
ACO reports the MIPS Promoting Interoperability performance category as 
an APM entity, the MIPS eligible clinicians, QPs, and Partial QPs 
should be included in the number of MIPS eligible clinicians, QPs, and 
Partial QPs that the ACO publicly reports under our proposed regulation 
at Sec.  425.308(b)(9).
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: One commenter supported the proposal to publicly report 
the number of MIPS eligible clinicians, QPs, and Partial QPs 
participating in the ACO that earn a MIPS performance category score 
for the MIPS Promoting Interoperability performance category at the 
individual, group, virtual group, or APM entity level. This commenter 
supported the public reporting requirement as a way to hold ACOs more 
accountable.
    Response: We thank commenters for their support.
    Comment: One commenter did not support the public reporting 
requirement, citing that this information could fluctuate often and 
would be confusing to Medicare beneficiaries instead of being 
informative.
    Response: Public reporting may improve a beneficiary's ability to 
make informed health care choices, as well as facilitate an ACO's 
ability to improve the quality and efficiency of its care. As such, 
this requirement will ensure that our public reporting requirements 
reflect our proposal to require reporting of objectives, measures, and 
activities under the MIPS Promoting Interoperability performance 
category and promote robust CEHRT use and capabilities by ACOs.
    After consideration of public comments, we are finalizing with 
modifications our proposal to update the Shared Savings Program public 
reporting requirements to delay the implementation of these revisions 
until PY 2025. The modification to delay implementation of this 
proposal by 1-year aligns with our modification to delay the 
implementation of our proposal to align the Shared Savings Program 
CEHRT requirement with MIPS. We are also finalizing modifications to 
our proposal at Sec.  425.308(b)(9) to conform with our language 
finalized at Sec.  425.507.
    Lastly, as we discussed in our proposal if MIPS eligible 
clinicians, QPs, and Partial QPs that are excluded under Sec.  
425.507(b) report the MIPS PI performance category, the MIPS eligible 
clinicians, QPs, or Partial QPs should be included in the number of 
MIPS eligible clinicians, QPs, or Partial QPs that the ACO publicly 
reports under our proposed regulation at Sec.  425.308(b)(9) (88 FR 
52436). We are finalizing modifications to our proposal at Sec.  
425.308(b)(9) to make clear in our regulation text that ACOs must 
include in the public reporting the number of ACO participants, ACO 
providers/suppliers, and ACO professionals that are excluded under 
Sec.  425.507(b) that voluntarily reported and received a MIPS 
Promoting Interoperability performance category score for the 
applicable performance year.
    We are finalizing that for performance year 2025 and subsequent 
performance years, the total number of ACO participants, ACO providers/
suppliers, and ACO professionals that are MIPS eligible clinicians, 
Qualifying APM Participants (QPs), or Partial Qualifying APM 
Participants (Partial QPs) (each as defined at Sec.  414.1305 of this 
chapter) that earn a MIPS performance category score for the MIPS 
Promoting Interoperability performance category as set forth in Sec.  
425.507, that is comprised of the following--
     The number of ACO participants, ACO providers/suppliers, 
and ACO professionals that meet the requirements of Sec.  425.507(a) 
and are not excluded under Sec.  425.507(b) for the applicable 
performance year; and
     The number of ACO participants, ACO providers/suppliers, 
and ACO professionals that are excluded under Sec.  425.507(b) that 
voluntarily reported and received a MIPS Promoting Interoperability 
performance category score for the applicable performance year.
(4) Updating Annual Certification Requirements
    We find that the MIPS Promoting Interoperability performance 
category's reporting requirements are more comprehensive and better 
address the key functions that facilitate better care coordination and 
quality measurement for ACOs. Our proposal to align the Shared Savings 
Program CEHRT requirements with MIPS would allow for greater insight 
into CEHRT use among ACO clinicians.
    Currently, under Sec.  425.302(a)(3)(iii), at the end of each 
performance year, ACOs must certify that the percentage of eligible 
clinicians participating in the ACO that use CEHRT to document and 
communicate clinical care to their patients or other health care 
providers meets or exceeds the applicable CEHRT threshold percentage 
specified at Sec.  425.506(f). As discussed in section III.G.2.h.(2) of 
this final rule, we proposed to sunset the Shared Savings Program CEHRT 
threshold requirements and modify Sec.  [thinsp]425.506(f) to indicate 
that they will end with performance year 2023.
    To ensure our certification requirements align with our proposal in 
section III.G.2.h.(2) of this final rule, we also proposed to revise 
our regulation at Sec.  425.302(a)(3)(iii) to make the current Shared 
Savings Program Annual Certification requirement applicable for only 
performance years 2019 through 2023. That is, we proposed to sunset the 
CEHRT certification requirement in the Shared Savings Program by 
amending regulations to no longer require ACO clinicians to report the 
percentage of eligible clinicians participating in the ACO that use 
CEHRT to document and communicate clinical care to their patients or 
other health care providers meets or exceeds the applicable percentage 
specified at Sec.  425.506(f).
    We solicited comments on our proposal to sunset the CEHRT 
certification requirement in the Shared Savings Program at Sec. Sec.  
425.302(a)(3)(iii) and 425.506(f) and to add new requirements at Sec.  
425.507, as previously discussed. We also solicited comments on our 
proposal to add a new requirement for public reporting in Sec.  
425.308(b)(9), as previously discussed.
    We did not receive public comments on our proposal to modify our 
annual certification requirement at Sec.  425.302(a)(3)(iii). We are 
finalizing our proposal with modification to delay the alignment of the 
Shared Savings Program CEHRT requirement with MIPS Promoting 
Interoperability until PY 2025. Specifically, we are finalizing 
revisions to our regulation at Sec.  425.302(a)(3)(iii) to make the 
current Shared Savings Program Annual Certification requirement 
applicable for only performance years 2019 through 2024.
i. MIPS Value Pathway (MVP) Reporting for Specialists in Shared Savings 
Program ACOs--Request for Information (RFI)
    In the CY 2021 PFS proposed rule (85 FR 50232 and 50233), we 
proposed that for performance year 2021 and subsequent performance 
years, ACOs would be assessed on a measure set under the APP for Shared 
Savings Program ACOs. As part of finalizing the APP measure set (85 FR 
34727), we stated that the transition to the APP

[[Page 79133]]

measure set was intended to reduce reporting burden and eliminate 
differences in the way ACOs are scored compared to their MIPS eligible 
clinicians, while also moving toward a more outcome-based, primary care 
focused measure set. Additionally, we stated that we selected the 
measures to be included because they are broadly applicable for the 
primary care population and population health goals that are associated 
with the Shared Savings Program.
    We received public comments raising concerns about the challenges 
and applicability of these measures to specialists that are part of 
their ACOs (85 FR 34727). Commenters provided feedback that: reducing 
the number of ACO quality measures would make specialists less likely 
to participate in the Shared Savings Program; the proposed measures are 
not relevant to ophthalmology specialty practices and suggested that 
the same measure sets used in MIPS be permitted for reporting through 
the APP or a protocol be put in place to determine if the measures are 
relevant to the clinicians reporting under the APP; CMS should work 
with interested parties to refine the current set of measures to make 
it more appropriate for ACOs, which are responsible for total cost of 
care for the populations they serve; CMS should clarify if the outcome 
measures selected are representative of all of the different types of 
populations that ACOs treat and recommended that CMS take patient 
compliance and case mix into consideration when selecting measures 
because some patients may take longer to achieve health goals and ACOs 
may not have the same relative volume of patients with diagnoses such 
as diabetes and hypertension.
    In the CY 2022 PFS proposed rule (86 FR 39270), we solicited 
comments on reporting options for specialist providers within an ACO. 
Specifically, we stated that we have heard from interested parties that 
the population health/primary care focused measures in the APP are not 
applicable for specialist providers within an ACO. We noted in the 
final rule that we may consider feedback we received to inform future 
rulemaking (86 FR 65264).
    In the CY 2022 PFS final rule (86 FR 65376), MVPs were finalized to 
be available for reporting beginning with the CY 2023 performance 
period of MIPS, with the notion that MVPs will be implemented through 
notice and comment rulemaking over the next few years to offer 
clinically relevant quality reporting for specialists and more granular 
specialty data (through subgroup reporting) for patients to make 
informed decisions about the care they receive. Building upon our 
commitment to align quality measures across CMS,\213\ we refer readers 
to Appendix 3: MVP Inventory, where we finalize the maintenance changes 
to the Value in Primary Care MVP. We noted that the primary care MVP 
would create continuity between the primary care measures assessed 
under MIPS and the measures providers would be accountable for in the 
Medicare Shared Savings Program.
---------------------------------------------------------------------------

    \213\ Jacobs D, Schreiber M, Seshamani M, Tsai D, Fowler E, 
Fleisher L. Aligning Quality Measures across CMS--The Universal 
Foundation. New England Journal of Medicine, March 2, 2023, 
available at https://www.nejm.org/doi/full/10.1056/NEJMp2215539.
---------------------------------------------------------------------------

    In the CY 2024 PFS proposed rule (88 FR 52437), we noted that in 
light of the public comments described above and the finalization and 
continued development of the MVPs, we believe we need incentives for 
specialists in Shared Savings Program ACOs to report clinically 
relevant quality measures and to allow patients, referring clinicians, 
and ACOs to have more information regarding specialists involved in 
patient care. We believe that encouraging specialists to report on MVPs 
will lead to increased specialty engagement in the Shared Savings 
Program, thereby holding specialists accountable for quality 
improvement.
    Beginning in CY 2023, specialists that report under MIPS, including 
specialists that participate in Shared Savings Program ACOs, have the 
option to register to report MVPs for the applicable CY performance 
period as described at Sec.  414.1365(b) as a group, subgroup, or 
individual and to report on relevant MVP quality measures as described 
at Sec.  414.1365(c). In the proposed rule, we solicited comments on 
scoring incentives that would be applied to an ACO's health equity 
adjusted quality performance score beginning in performance year 2025 
when specialists who participate in the ACO report quality MVPs as 
described at Sec.  414.1365(c)(1) (88 FR 52437).
    We described in the proposed rule that, similar to the health 
equity adjustment finalized in the CY 2023 PFS final rule (87 FR 
69838), we are considering bonus points for ACOs with specialists 
reporting quality MVPs as described at Sec.  414.1365(c)(1) that would 
be applied after MIPS scoring is complete (88 FR 52437). ACOs may 
receive up to a maximum of 10 additional points added to their ACO's 
health equity adjusted quality performance score if they meet the data 
completeness requirement at Sec.  414.1340 and receives a MIPS Quality 
performance category score under Sec.  414.1380(b)(1), in addition to 
administering the CAHPS for MIPS survey. In addition to specialists 
that participate in the ACO reporting quality MVPs described at Sec.  
414.1365(c)(1), an ACO would be required to report all measures in the 
APP measure set, meet the data completeness requirement at Sec.  
414.1340 and receive a MIPS Quality performance category score under 
Sec.  414.1380(b)(1) to be eligible for bonus points.
    As stated in our proposed rule, our overarching intent is to have 
specialists participate in ACOs in a meaningful way and to collect 
quality data that is comparable to data reported by other specialty 
providers in quality MVPs (88 FR 52437). We solicited comments on our 
overall approach to align quality measures in the Adult Universal 
Foundation with measures used for evaluation in the Medicare Shared 
Savings Program. We also solicited comments on the following aspects of 
MVP reporting for specialists in Shared Savings Program ACOs:
     In order to highlight specialty clinical practice within 
ACOs, how should we encourage specialist reporting of MVPs?
     How should we encourage the reporting of MVPs to collect 
quality data that is comparable to data reported by other specialty 
providers in quality MVPs and to address clinician concerns over 
measure appropriateness?
     How should we consider encouraging specialists to report 
the MVP that is most relevant to their clinical practice?
     How should we distinguish bonus points for ACOs that 
report on a larger volume of patients through MVPs?
     How should we provide ACOs with bonus points to their 
health equity adjusted quality performance score when an ACO's 
specialty clinicians report MVPs?
     What concerns and considerations should we be aware of 
when assessing ACOs for quality performance based on reporting quality 
measures within MVPs?
     Would incentivizing specialty MVPs create a disincentive 
for ACOs to report primary care focused APP and/or MVP measures?
     In the event that MIPS quality measures in MVPs are 
excluded under Sec.  414.1380(b)(1)(vii)(A), should we apply the 
proposed Shared Savings Program scoring policy for excluded APP 
measures as described in section III.G.2.f. of this final rule?
    As previously noted, providing ACOs with bonus points to their 
health equity adjusted quality performance score

[[Page 79134]]

when ACOs' specialty clinicians report MVPs serves to encourage 
reporting of MVPs. Therefore, we do not intend to establish bonus 
points as a permanent policy. We solicited comments on how long we 
should have bonus points in place in order to incentivize MVP 
reporting. Once specialists are reporting MVPs, overall aggregate 
specialty performance within an ACO could be assessed. We solicited 
comments on if and how CMS should consider assessing overall specialty 
performance as part of the APP in the future.
    We noted that in section IV.A.1.b. of this final rule, we included 
an RFI on how we can leverage MIPS policies to enable more Medicare 
beneficiaries to benefit from accountable care relationships within 
APMs and provide rigorous performance standards for those clinicians 
who report MVPs and remain in MIPS. We appreciate the feedback we 
received in response to this comment solicitation. We may consider this 
information to inform future rulemaking.
j. Revisions to the Requirement To Meet the Case Minimum Requirement 
for Quality Performance Standard Determinations
(1) Background
    For the eCQM/MIPS CQM reporting incentive for performance year 2024 
and for the extreme and uncontrollable circumstances policy (Sec.  
425.512(a)(2), (a)(5)(i)(A)(2), (c)(3)), we require ACOs to meet the 
case minimum requirement at Sec.  414.1380 to determine the quality 
performance standard for ACOs in the first performance year of their 
first agreement period.
    Section 414.1380 includes policies related to all of MIPS scoring 
and is not specific to the Quality performance category. Further, the 
phrase ``case minimum'' is mentioned in multiple paragraphs at Sec.  
414.1380. The broad reference to Sec.  414.1380 under Sec.  
425.512(a)(2), (a)(5)(i)(A)(2), and (c)(3) does not specify which 
paragraph at Sec.  414.1380 is applicable when applying case minimum 
for purposes of determining an ACO's quality performance standard. We 
believe that the references to meeting the case minimum requirement at 
Sec.  414.1380 in the context of determining an ACO's quality 
performance standard under Sec.  425.512(a)(2), (a)(5)(i)(A)(2), and 
(c)(3) is not sufficient in describing our policy's intent, which is to 
apply the MIPS Quality performance category scoring policies as 
described at Sec.  414.1380(b)(1) in determining the ACO quality 
performance standard.
(2) Revisions
    To alleviate confusion regarding the reference to case minimum in 
determining the ACO quality performance standard for performance year 
2024 and subsequent performance years, we proposed to replace the 
references to meeting the case minimum requirement at Sec.  414.1380 
from Sec.  425.512(a)(2), (a)(5)(i)(A)(2), and (c)(3) with the 
requirement that the ACO must receive a MIPS Quality performance 
category score under Sec.  414.1380(b)(1) in order to meet the quality 
performance standard (88 FR 52438). As described in our proposed rule, 
this revision would correct the purpose of our reference to case 
minimums by incorporating all of the applications of case minimums in 
the MIPS Quality performance category scoring policies in our policies 
to determine an ACO's quality performance standard under the Shared 
Savings Program (88 FR 52438). For example, under current policy at 
Sec.  414.1380(b)(1)(i)(A)(2)(ii) in performance year 2024, if an ACO 
does not meet the case minimum requirement on an administrative claims-
based measure, that measure would be excluded from the ACO's MIPS 
Quality performance category measure achievement points (numerator) and 
total available measure achievement points (denominator). If the ACO in 
this example meets the data completeness requirement at Sec.  414.1340 
for the ten CMS Web Interface measures or the three eCQMs/MIPS CQMs/
Medicare CQMs and administers a CAHPS for MIPS survey, the ACO would 
receive a MIPS Quality performance category score. The resulting MIPS 
Quality performance category score in this example would be used to 
determine the ACO's quality performance standard under the Shared 
Savings Program.
    All ACOs that participated in the Shared Savings Program were 
affected by an extreme and uncontrollable circumstance as described at 
Sec.  425.512(c)(1) for performance years 2021, 2022, and 2023 due to 
the COVID-19 public health emergency. As stated in our proposal, we 
believe that any unintended impact of meeting the case minimum 
requirement at Sec.  414.1380 in evaluating an ACO's quality 
performance standard for performance years 2021, 2022, and 2023 was 
mitigated by the application of the extreme and uncontrollable 
circumstance policy (88 FR 52438). Specifically, we stated that it is 
not our intent to exclude an ACO who received a MIPS Quality 
performance category score, but reported less than 20 cases on any 
measure(s) in the APP measure set from achieving the quality 
performance standard under Sec.  425.512(a)(2), (a)(5)(i)(A)(2), and 
(c)(3), if that ACO is otherwise eligible to meet the quality 
performance standard (88 FR 52438).
    Separately, we proposed to address a gap in the current rule 
regarding the ``minimum beneficiary sampling requirement'' at Sec.  
414.1380(b)(1)(vii)(B) (88 FR 52439). This policy provides for a 10-
point reduction in the total available measure achievement points for 
MIPS eligible clinicians that submit five measures or fewer and 
register for the CAHPS for MIPS survey but do not meet the minimum 
beneficiary sampling requirement. As we stated in our proposal, the 
case minimum is not applicable to the CAHPS for MIPS survey, we did not 
intend to preclude ACOs that do not meet the minimum beneficiary 
sampling requirement to field a CAHPS for MIPS survey from meeting the 
Shared Savings Program quality performance standard or the alternative 
quality performance standard (88 FR 52439). We proposed revisions to 
the following regulation text sections:
     At Sec.  425.512(a)(2)(ii) and (iii), we proposed to 
replace the phrase ``case minimum requirement at Sec.  414.1380 of this 
subchapter'' with the phrase ``receives a MIPS Quality performance 
category score under Sec.  414.1380(b)(1) of this subchapter.''
    Additionally, we proposed to replace the phrase ``CAHPS for MIPS 
survey'' with the phrase ``CAHPS for MIPS survey (except as specified 
in Sec.  414.1380(b)(1)(vii)(B) of this subchapter)'' (88 FR 52439). To 
read as follows: For the first performance year of an ACO's first 
agreement period under the Shared Savings Program, the ACO would meet 
the quality performance standard under the Shared Savings Program, if:
    ++ For performance year 2024. If the ACO reports data via the APP 
and meets the data completeness requirement at Sec.  414.1340 of this 
subchapter on the ten CMS Web Interface measures or the three eCQMs/
MIPS CQMs/Medicare CQMs, and the CAHPS for MIPS survey (except as 
specified in Sec.  414.1380(b)(1)(vii)(B) of this subchapter), and 
receives a MIPS Quality performance category score under Sec.  
414.1380(b)(1) of this subchapter, for the applicable performance year.
    ++ For performance year 2025 and subsequent performance years. If 
the ACO reports data via the APP and meets the data completeness 
requirement at Sec.  414.1340 of this subchapter on the three eCQMs/
MIPS CQMs/Medicare CQMs and the CAHPS for MIPS survey

[[Page 79135]]

(except as specified in Sec.  414.1380(b)(1)(vii)(B) of this 
subchapter), and receives a MIPS Quality performance category score 
under Sec.  414.1380(b)(1) of this subchapter, for the applicable 
performance year.
     At Sec.  425.512(a)(5)(i)(A)(2), we proposed to remove the 
phrase ``and the case minimum requirement at Sec.  414.1380 of this 
subchapter.'' As follows: If the ACO reports the three eCQMs/MIPS CQMs 
in the APP measure set, meeting the data completeness requirement at 
Sec.  414.1340 of this subchapter for all three eCQMs/MIPS CQMs, and 
achieving a quality performance score equivalent to or higher than the 
10th percentile of the performance benchmark on at least one of the 
four outcome measures in the APP measure set and a quality performance 
score equivalent to or higher than the 40th percentile of the 
performance benchmark on at least one of the remaining five measures in 
the APP measure set.
    ++ We are not including a requirement under Sec.  
425.512(a)(5)(i)(A)(2) for the ACO to receive a MIPS Quality 
performance category score under Sec.  414.1380(b)(1). As described at 
Sec.  414.1380(b)(1)(vii), the MIPS Quality performance category score 
is the sum of all the measure achievement points divided by the sum of 
total available measure achievement points for the quality performance 
category. As stated in our proposal, it would not be appropriate to 
require an ACO to receive a MIPS Quality performance category score in 
determining whether the ACO met the Shared Savings Program quality 
performance standard based on measure-level performance (such as in the 
case of the eCQM/MIPS CQM reporting incentive) (88 FR 52439).
     At Sec.  425.512(c)(3)(iii), we proposed to remove the 
phrase ``case minimum'' for performance 2024 and subsequent performance 
years and replace with the phrase ``receives a MIPS Quality performance 
category score under Sec.  414.1380(b)(1) of this subchapter.'' To read 
as follows: For performance year 2024 and subsequent performance years, 
if the ACO reports quality data via the APP and meets the data 
completeness requirement at Sec.  414.1340 of this subchapter and 
receives a MIPS Quality performance category score under Sec.  
414.1380(b)(1) of this subchapter, CMS will use the higher of the ACO's 
health equity adjusted quality performance score or the equivalent of 
the 40th percentile MIPS Quality performance category score across all 
MIPS Quality performance category scores, excluding entities/providers 
eligible for facility-based scoring, for the relevant performance year.
    We proposed to revise Sec.  425.512(a)(5)(iii)(A) and (B) to read 
as follows:
     For performance year 2024, the ACO does not report any of 
the ten CMS Web Interface measures, any of the three eCQMs/MIPS CQMs/
Medicare CQMs and does not administer a CAHPS for MIPS survey (except 
as specified in Sec.  414.1380(b)(1)(vii)(B) of this subchapter) under 
the APP.
     For performance year 2025 and subsequent years, the ACO 
does not report any of the three eCQMs/MIPS CQMs/Medicare CQMs and does 
not administer a CAHPS for MIPS survey (except as specified in Sec.  
414.1380(b)(1)(vii)(B) of this subchapter) under the APP.
    Additionally, we proposed to add clarifying language to the 
proposed redesignated paragraph (b)(2) of Sec.  425.512 on calculating 
an ACO's health equity adjusted quality performance score as follows:
     For performance year 2024 and subsequent performance 
years, CMS would calculate the ACO's health equity adjusted quality 
performance score as the sum of: the ACO's MIPS Quality performance 
category score for all measures in the APP measure set, and the ACO's 
health equity adjustment bonus points calculated in accordance with 
paragraph (b)(3) of this section, to which the sum of these values may 
not exceed 100 percent, if the following requirements are met: (1) The 
ACO reports the three eCQMs/MIPS CQMs/Medicare CQMs in the APP measure 
set; (2) meets the data completeness requirement at Sec.  414.1340 for 
the three eCQMs/MIPS CQMs/Medicare CQMs; and (3) administers the CAHPS 
for MIPS survey (except as specified in Sec.  414.1380(b)(1)(vii)(B)).
    The following is a summary of the comments we received on these 
proposals and our responses.
    Comment: Two commenters supported our proposal to revise the 
requirement to meet the case minimum requirement for quality 
performance standard determinations. One commenter stated that they 
believe that this proposal will better incorporate all case minimums in 
the MIPS Quality performance category scoring policy to determine an 
ACO's quality performance standard under the Shared Savings Program.
    Response: We appreciate the commenters' support.
    After consideration of public comments, we are finalizing the 
policies as proposed. For performance year 2024 and subsequent 
performance years, we are finalizing our proposal to replace the 
references to meeting the case minimum requirement at Sec.  414.1380 
from Sec.  425.512(a)(2), (a)(5)(i)(A)(2), and (c)(3) with the 
requirement that the ACO must receive a MIPS Quality performance 
category score under Sec.  414.1380(b)(1) in order to meet the quality 
performance standard. We are also finalizing our proposal to address a 
gap in the current rule regarding the ``minimum beneficiary sampling 
requirement'' at Sec.  414.1380(b)(1)(vii)(B) (88 FR 52439). We are 
also finalizing revisions to the following regulation text sections as 
proposed:
     At Sec.  425.512(a)(2)(ii) and (iii), replace the phrase 
``case minimum requirement at Sec.  414.1380 of this subchapter'' with 
the phrase ``receives a MIPS Quality performance category score under 
Sec.  414.1380(b)(1) of this subchapter.''
     To replace the phrase ``CAHPS for MIPS survey'' with the 
phrase ``CAHPS for MIPS survey (except as specified in Sec.  
414.1380(b)(1)(vii)(B) of this subchapter).'' To read as follows: For 
the first performance year of an ACO's first agreement period under the 
Shared Savings Program, the ACO will meet the quality performance 
standard if it meets the requirements under this paragraph (a)(2).
    ++ For performance year 2024. If the ACO reports data via the APP 
and meets the data completeness requirement at Sec.  414.1340 of this 
subchapter on the ten CMS Web Interface measures or the three eCQMs/
MIPS CQMs/Medicare CQMs, and the CAHPS for MIPS survey (except as 
specified in Sec.  414.1380(b)(1)(vii)(B) of this subchapter), and 
receives a MIPS Quality performance category score under Sec.  
414.1380(b)(1) of this subchapter, for the applicable performance year.
    ++ For performance year 2025 and subsequent performance years. If 
the ACO reports data via the APP and meets the data completeness 
requirement at Sec.  414.1340 of this subchapter on the three eCQMs/
MIPS CQMs/Medicare CQMs and the CAHPS for MIPS survey (except as 
specified in Sec.  414.1380(b)(1)(vii)(B) of this subchapter), and 
receives a MIPS Quality performance category score under Sec.  
414.1380(b)(1) of this subchapter, for the applicable performance year.
     At Sec.  425.512(a)(5)(i)(A)(2), to remove the phrase 
``and the case minimum requirement at Sec.  414.1380 of this 
subchapter.'' To read as follows: If the ACO reports the three eCQMs/
MIPS CQMs in the APP measure set, meeting

[[Page 79136]]

the data completeness requirement at Sec.  414.1340 of this subchapter 
for all three eCQMs/MIPS CQMs, and achieving a quality performance 
score equivalent to or higher than the 10th percentile of the 
performance benchmark on at least one of the four outcome measures in 
the APP measure set and a quality performance score equivalent to or 
higher than the 40th percentile of the performance benchmark on at 
least one of the remaining five measures in the APP measure set.
     At Sec.  425.512(c)(3)(iii), to remove the phrase ``case 
minimum'' for performance 2024 and subsequent performance years and 
replace with the phrase ``receives a MIPS Quality performance category 
score under Sec.  414.1380(b)(1) of this subchapter.'' To read as 
follows: For performance year 2024 and subsequent performance years, if 
the ACO reports quality data via the APP and meets the data 
completeness requirement at Sec.  414.1340 of this subchapter and 
receives a MIPS Quality performance category score under Sec.  
414.1380(b)(1) of this subchapter, CMS will use the higher of the ACO's 
health equity adjusted quality performance score or the equivalent of 
the 40th percentile MIPS Quality performance category score across all 
MIPS Quality performance category scores, excluding entities/providers 
eligible for facility-based scoring, for the relevant performance year.
    We are finalizing our proposal to revise Sec.  
425.512(a)(5)(iii)(A) and (B) to read as follows:
     For performance year 2024, the ACO does not report any of 
the ten CMS Web Interface measures, any of the three eCQMs/MIPS CQMs/
Medicare CQMs and does not administer a CAHPS for MIPS survey (except 
as specified in Sec.  414.1380(b)(1)(vii)(B) of this subchapter) under 
the APP.
     For performance year 2025 and subsequent years, the ACO 
does not report any of the three eCQMs/MIPS CQMs/Medicare CQMs and does 
not administer a CAHPS for MIPS survey (except as specified in Sec.  
414.1380(b)(1)(vii)(B) of this subchapter) under the APP.
    Additionally, we are finalizing the addition of clarifying language 
to the redesignated paragraph (b)(2) of Sec.  425.512 on calculating an 
ACO's health equity adjusted quality performance score as follows:
     For performance year 2024 and subsequent performance 
years. For an ACO that reports the three eCQMs/MIPS CQMs/Medicare CQMs 
in the APP measure set, meeting the data completeness requirement at 
Sec.  414.1340 of this subchapter for all three eCQMs/MIPS CQMs/
Medicare CQMs, and administers the CAHPS for MIPS survey (except as 
specified in Sec.  414.1380(b)(1)(vii)(B) of this subchapter), CMS 
calculates the ACO's health equity adjusted quality performance score 
as the sum of the ACO's MIPS Quality performance category score for all 
measures in the APP measure set and the ACO's health equity adjustment 
bonus points calculated in accordance with paragraph (b)(3) of this 
section. The sum of these values may not exceed 100 percent.
3. Determining Beneficiary Assignment Under the Shared Savings Program
a. Modifications to the Step-Wise Assignment Methodology and Approach 
To Identifying the Assignable Beneficiary Population
(1) Background
(a) Background on Assignment Methodology
    Section 1899(c)(1) of the Act, as amended by the CURES Act and the 
Bipartisan Budget Act of 2018, provides that the Secretary shall 
determine an appropriate method to assign Medicare FFS beneficiaries to 
an ACO based on their utilization of primary care services provided by 
physicians in the ACO and, in the case of performance years beginning 
on or after January 1, 2019, services provided by a FQHC or RHC. As we 
have explained in earlier rulemaking, the term ``assignment'' for 
purposes of the Shared Savings Program in no way implies any limits, 
restrictions, or diminishment of the rights of Medicare FFS 
beneficiaries to exercise freedom of choice in the physicians and other 
health care practitioners from whom they receive covered services. In 
the context of the Shared Savings Program, ``assignment'' refers to an 
operational process by which Medicare will determine whether a 
beneficiary has chosen to receive a sufficient level of certain primary 
care services from physicians and other health care practitioners 
associated with a specific ACO so that the ACO may be appropriately 
designated as exercising basic responsibility for that beneficiary's 
care.\214\
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    \214\ See for example, 76 FR 67851, and 83 FR 67863.
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    The regulations governing the assignment methodology under the 
Shared Savings Program are in 42 CFR part 425, subpart E. Under claims-
based assignment, we determine a Medicare FFS beneficiary is assigned 
to an ACO if the beneficiary meets the criteria in Sec.  425.401(a) to 
be eligible for assignment to an ACO, and the beneficiary's utilization 
of primary care services meets the criteria established under the 
assignment methodology specified in Sec. Sec.  425.402 and 425.404. 
Section 425.402 specifies a step-wise assignment methodology for 
determining an ACO's assigned beneficiary population based on 
beneficiaries' use of primary care services. In accordance with Sec.  
425.402(b)(1), as a ``pre-step'' in the two-step claims-based 
assignment process, CMS identifies all beneficiaries who had at least 
one primary care service furnished by a physician who is an ACO 
professional in the ACO and who is a primary care physician as defined 
under Sec.  425.20 or has one of the primary specialty designations 
specified in Sec.  425.402(c). This pre-step is designed to satisfy the 
statutory requirement under section 1899(c)(1) of the Act that 
beneficiaries be assigned to an ACO based on their use of primary care 
services furnished by physicians participating in the ACO. 
Beneficiaries who meet the pre-step requirement are then assigned to an 
ACO through either one of two steps specified in Sec.  425.402(b)(3) 
and (b)(4).
    Under the first step of the assignment process, a beneficiary who 
is eligible for assignment and meets the pre-step requirement is 
assigned to an ACO if the allowed charges for primary care services 
furnished to the beneficiary during the assignment window by primary 
care physicians, nurse practitioners (NPs), physician assistants (PAs), 
and clinical nurse specialists (CNSs) who are ACO professionals in the 
ACO are greater than the allowed charges for primary care services 
furnished during the assignment window by primary care physicians, NPs, 
PAs, or CNSs who are ACO professionals in any other ACO, or not 
affiliated with any ACO and identified by a Medicare-enrolled billing 
TIN. The second step of the assignment methodology applies to the 
remainder of the beneficiaries who are eligible for assignment and meet 
the pre-step requirement, who have not had a primary care service 
rendered during the assignment window by any primary care physician, 
NP, PA, or CNS, either inside or outside the ACO. The beneficiary will 
be assigned to an ACO if the allowed charges for primary care services 
furnished to the beneficiary during the assignment window by physicians 
who are ACO professionals with specialty designations specified in 
Sec.  425.402(c) are greater than the allowed charges for primary care 
services furnished during the assignment window by physicians with such

[[Page 79137]]

specialty designations who are ACO professionals in any other ACO, or 
who are unaffiliated with an ACO and are identified by a Medicare-
enrolled billing TIN.
    The Shared Savings Program step-wise assignment process is offered 
in two similar, but distinct, claims-based assignment methodologies, 
prospective assignment and preliminary prospective assignment with 
retrospective reconciliation. Consistent with the requirements of 
section 1899(c)(2)(A) of the Act, we offer all Shared Savings Program 
ACOs the opportunity to select their assignment methodology annually, 
starting with agreement periods beginning on July 1, 2019. We use the 
same step-wise assignment methodology under Sec.  425.402 to assign 
beneficiaries to ACOs under prospective assignment and ACOs under 
preliminary prospective assignment with retrospective reconciliation.
    In the June 2015 final rule (80 FR 32699), we finalized the 
definition of ``assignment window'' under Sec.  425.20 to mean the 12-
month period used to assign beneficiaries to an ACO. As described in 
the December 2018 final rule (83 FR 67861), the assignment window for 
ACOs under prospective assignment is a 12-month period offset from the 
calendar year (for example, October through September preceding the 
calendar year), while for ACOs under preliminary prospective assignment 
with retrospective reconciliation, the assignment window is the 12-
month period based on the calendar year. Operationally, in determining 
beneficiary assignment for each performance year and benchmark year, we 
identify allowed charges for services billed under the HCPCS and CPT 
codes included in the applicable definition of primary care services 
under Sec.  425.400(c), and according to the step-wise assignment 
methodology specified in subpart E of the Shared Savings Program's 
regulations, during all months of the 12-month period of the assignment 
window.
    The step-wise assignment methodology was initially established with 
the November 2011 final rule and was modified through subsequent 
rulemaking. For instance, with the June 2015 final rule, we modified 
the approach to include claims for primary care services furnished by 
non-physician practitioners (NPs, PAs, and CNSs) in step 1 of the 
assignment methodology rather than in step 2, and to exclude services 
provided by certain physician specialties from step 2 of the assignment 
process. We refer readers to the November 2011 final rule (76 FR 67853 
through 67858) and the June 2015 final rule (80 FR 32748 through 32755) 
for a discussion of the relevant background and related considerations. 
Generally, as we have previously explained in rulemaking (see, for 
example, 76 FR 67853 through 67855; see also 80 FR 32748 and 32754), 
the step-wise assignment methodology maintains the statutory 
requirement to conduct claims-based beneficiary assignment based on 
beneficiaries' utilization of physician primary care services, 
recognizing the necessary and appropriate role of certain specialists 
in providing primary care services, such as in areas with primary care 
physician shortages. Further, including services furnished by NPs, PAs, 
and CNSs in determining where a beneficiary has received the plurality 
of primary care services in step 1 of the assignment methodology helps 
ensure that a beneficiary is assigned to the ACO whose ACO participants 
are actually providing the plurality of primary care for that 
beneficiary, and thus, should be responsible for managing the patient's 
overall care, or is not assigned to any ACO if the plurality of the 
beneficiary's primary care is furnished by practitioners in a non-ACO 
entity (see, for example, 80 FR 32748).
    Various Shared Savings Program operations are based on the ACO's 
assigned population, or consider the size of the ACO's assigned 
population, which are summarized as follows:
     Within the Shared Savings Program's financial methodology:
    ++ CMS determines benchmark and performance year expenditures based 
on the ACO's assigned population as specified under subpart G of the 
regulations.
    ++ CMS determines the counties to include in the ACO's regional 
service area based on the ACO's assigned population (refer to 
definition of ACO's regional service area in Sec.  425.20), and uses 
the ACO's assigned population in determining the share of assignable 
beneficiaries in the ACO's regional service area that are assigned to 
the ACO (see Sec. Sec.  425.601(a)(5)(v) and 425.652(a)(5)(v)) which is 
applied in calculating the two-way blend of national and regional 
growth rates used to trend forward BY1 and BY2 expenditures to BY3 
according to Sec. Sec.  425.601(a)(5)(iv) and 425.652(a)(5)(iv) and as 
part of the blended growth rates used to update the benchmark according 
to Sec. Sec.  425.601(b) and 425.652(b)(2). CMS also uses the ACO's 
regional service area to determine the regional adjustment to the ACO's 
historical benchmark according to Sec.  425.656.
    ++ CMS considers the proportion of the ACO's assigned beneficiary 
population that is dually eligible for Medicare and Medicaid and the 
difference between the ACO's weighted average prospective HCC risk 
score for BY3 taken across the four Medicare enrollment types and when 
calculating the offset factor applied to negative regional adjustments 
(see Sec.  425.656(c)(4)).
    ++ CMS considers the size of the ACO's assigned population in 
calculating the proration factor when determining the ACO's eligibility 
for the prior savings adjustment (see Sec.  425.658(b)(3)), as well as 
in determining the minimum savings rate (MSR)/minimum loss rate (MLR) 
for ACOs that select the option to have their MSR/MLR calculated based 
on the number of beneficiaries assigned to the ACO (refer to Sec.  
425.605(b)(2)(i)(C) (BASIC track) and Sec.  425.610(b)(1)(iii) 
(ENHANCED track)).
    ++ CMS determines average prospective HCC risk scores for assigned 
beneficiaries for purposes of adjusting assigned beneficiary 
expenditures for severity and case mix (refer to Sec. Sec.  
425.601(a)(3) and (10), 425.605(a)(1), and 425.610(a)(2), (3) and 
(10)), adjusting for differences in severity and case mix between the 
ACO's assigned beneficiary population and the assignable beneficiary 
population for the ACO's regional service area according to Sec. Sec.  
425.601(a)(8)(i)(C) and 425.656(b)(3), and adjusting the flat dollar 
amount ACPT for differences in severity and case mix between the ACO's 
BY3 assigned beneficiary population and the national assignable FFS 
population according to Sec.  425.660(b)(4).
     In determinations related to an ACO's eligibility for 
participation for the Shared Savings Program:
    ++ CMS determines expenditures based on the ACO's assigned 
population when identifying if the ACO is a high revenue or low revenue 
ACO (as defined under Sec.  425.20).
    ++ CMS considers whether an ACO meets the requirement to have at 
least 5,000 Medicare FFS assigned beneficiaries (see Sec.  425.110).
    ++ CMS uses the ACO's number of assigned beneficiaries in 
calculating and recalculating the amount of the repayment mechanism 
required for ACOs participating under a two-sided model (see Sec.  
425.204(f)).
     For ACOs eligible to receive AIPs (see Sec.  425.630(b)), 
CMS considers the size of the ACO's assigned population and the risk 
factors-based score of those beneficiaries in determining the quarterly 
payment amount (see Sec.  425.630(f)).

[[Page 79138]]

     For ACOs that meet the reporting requirements for 
receiving a health equity adjusted quality performance score (see Sec.  
425.512(b)), CMS considers the proportion of the ACO's assigned 
beneficiary population that is underserved in determining the ACO's 
health equity adjustment bonus points (see Sec.  425.512(b)(2)(iv)).
     For ACOs affected by an extreme and uncontrollable 
circumstance, CMS considers the proportion of the ACO's assigned 
beneficiaries residing in an area identified under the Quality Payment 
Program as being affected by an extreme and uncontrollable circumstance 
in determining the ACO's quality score (see Sec.  425.512(c)(1)(i)). 
CMS considers the percentage of the ACO's performance year assigned 
beneficiary population affected by an extreme and uncontrollable 
circumstance in determining the amount of shared losses owed by ACOs 
under a two-sided model (refer to Sec. Sec.  425.605(f)(1) and 
425.610(i)(1)).
     For ACOs that have established a beneficiary incentive 
program, beneficiaries assigned to an ACO who receive a qualifying 
service are eligible to receive an incentive payment (see Sec.  
425.304(c)(3)(ii) through (iv)).
     In accordance with the Shared Savings Program regulations 
under subpart H, CMS provides ACOs with certain aggregate reports and 
beneficiary-identifiable claims data on the ACO's assigned beneficiary 
population.
    Further, a non-claims-based process for voluntary alignment applies 
to all Shared Savings Program ACOs and is used to supplement claims-
based assignment. Section 1899(c) of the Act, as amended by section 
50331 of the Bipartisan Budget Act of 2018, requires the Secretary to 
permit a Medicare FFS beneficiary to voluntarily identify an ACO 
professional as their primary care provider for purposes of assignment 
to an ACO. In the November 2018 final rule (83 FR 59959 through 59964), 
we finalized changes to the beneficiary voluntary alignment policies 
CMS previously established to implement the requirements under section 
1899(c)(2)(B) of the Act (refer to Sec.  425.402(e), as revised). In 
the November 2018 final rule (83 FR 59964), we revised the requirements 
related to primary care services and practitioner specialties 
previously established for the voluntary alignment process. As a result 
of this change, a voluntarily aligned beneficiary is no longer required 
to receive a primary care service from an ACO professional to be 
assigned to the ACO in which the beneficiary's designated primary care 
clinician is participating. Additionally, the revision established that 
a beneficiary can be voluntarily aligned to an ACO based on their 
selection of any ACO professional as their primary clinician, 
regardless of the ACO professional's specialty and including NPs, PAs, 
and CNSs. As specified in Sec.  425.402(e)(1), and subject to Sec.  
425.402(e)(2), assignment under voluntary alignment supersedes any 
assignment that otherwise may have occurred under claims-based 
assignment.
(b) Background on Identification and Uses of the Assignable Beneficiary 
Population Under the Shared Savings Program
    To identify the assignable beneficiary population, which is used in 
program financial calculations, we apply a similar logic as is used to 
identify the Medicare beneficiaries who can be assigned to an ACO in 
the pre-step to the claims-based assignment methodology (see, for 
example, 81 FR 5843, and 81 FR 37985). In the June 2016 final rule (81 
FR 37950), we finalized policies to use the assignable beneficiary 
population (a subset of the larger population of Medicare FFS 
beneficiaries) as the basis of certain calculations that had previously 
been based on the overall Medicare FFS population, including 
expenditures used to trend and update ACOs' historical benchmarks and 
to establish the truncation thresholds used in expenditure 
calculations. In the June 2016 final rule (see 81 FR 37985 through 
37988), we finalized the definition of ``assignable beneficiary'' under 
Sec.  425.20 to mean a Medicare FFS beneficiary who receives at least 
one primary care service with a date of service during a specified 12-
month assignment window from a Medicare-enrolled physician who is a 
primary care physician or who has one of the specialty designations 
included in Sec.  425.402(c). We specified that the assignable 
population used to calculate national and regional benchmarking factors 
was to be identified using the 12-month calendar year assignment window 
corresponding to the benchmark or performance year for all ACOs, 
regardless of assignment methodology which applied to the ACO, which at 
that time was determined by an ACO's track. We explained our belief 
that using assignable beneficiaries across all program calculations 
based on national and regional FFS expenditures would result in factors 
that are generally more comparable to ACO expenditures than factors 
based on the overall Medicare FFS population, which can include non-
utilizers of health care services and other beneficiaries not eligible 
for assignment (see, for example, 81 FR 5843 and 5844).
    In the CY 2023 PFS final rule (87 FR 69929 through 69932), we 
finalized a modification to this policy, applicable for agreement 
periods beginning on January 1, 2024, and in subsequent years, to 
calculate risk-adjusted regional expenditures and the share of 
assignable beneficiaries assigned to an ACO using county-level values 
based on the assignable population identified using an assignment 
window that is consistent with the ACO's assignment methodology 
selection for the applicable performance year. (Refer to Sec. Sec.  
425.652(a)(5)(v)(A) and (b)(2)(iv)(A), and 425.654(a)(1)(i).) Under 
this approach, for ACOs selecting prospective assignment, we will use 
an assignable population of beneficiaries that is identified based on 
the offset assignment window (for example, October through September 
preceding the calendar year) and for ACOs selecting preliminary 
prospective assignment with retrospective reconciliation, we will use 
an assignable population of beneficiaries identified based on the 
calendar year assignment window (87 FR 69930). We also specified in the 
CY 2023 PFS final rule (87 FR 69931) that we would continue to compute 
all factors used in calculations that are based on the national 
assignable FFS population using an assignable population identified 
based on the calendar year assignment window. For ACOs participating 
under agreement periods beginning on or after July 1, 2019, and before 
January 1, 2024, we will continue to identify the assignable population 
that is the basis for calculating national and regional factors using 
the 12-month period based on a calendar year, which aligns with the 
assignment window for preliminary prospective assignment with 
retrospective reconciliation, regardless of the ACO's assignment 
methodology. (See Sec.  425.601. See also 87 FR 69929, for a 
description of relevant background.)
    The assignable beneficiary population is used in various 
calculations under the Shared Savings Program, including the following:
     CMS determines the 99th percentile of national Medicare 
FFS expenditures for assignable beneficiaries for purposes of 
truncating beneficiary expenditures in order to minimize variation from 
catastrophically large claims (see Sec. Sec.  425.601(a)(4) and (c)(3), 
425.605(a)(3), 425.610(a)(4)(ii), 425.652(a)(4), and 425.654(a)(3)).
     CMS determines average county FFS expenditures based on 
expenditures for the assignable

[[Page 79139]]

population of beneficiaries in each county of an ACO's regional service 
area (see Sec. Sec.  425.601(c) and 425.654(a)) for purposes of 
calculating the ACO's regional FFS expenditures (see Sec. Sec.  
425.601(d) and 425.654(b)). CMS also determines the share of assignable 
beneficiaries in the ACO's regional service area that are assigned to 
the ACO (see Sec. Sec.  425.601(a)(5)(v) and 425.652(a)(5)(v)). The 
ACO's regional FFS expenditures and the share of assignable 
beneficiaries in the ACO's regional service area that are assigned to 
the ACO are used in the following calculations:
    ++ Trend forward BY1 and BY2 expenditures to BY3 according to 
Sec. Sec.  425.601(a)(5) and 425.652(a)(5).
    ++ Determine the blended growth rates used to update the benchmark 
according to Sec. Sec.  425.601(b) and 425.652(b)(2).
    ++ Determine the adjustment to the ACO's benchmark according to 
Sec. Sec.  425.601(a)(8) and 425.652(a)(8).
     CMS determines national per capita FFS expenditures for 
assignable beneficiaries for purposes of capping the regional 
adjustment to the ACO's historical benchmark according to Sec. Sec.  
425.601(a)(8)(ii)(C) and 425.656(c)(3), capping the prior savings 
adjustment according to Sec.  425.652(a)(8)(iv), and determining a flat 
dollar amount ACPT according to Sec.  425.660(b)(3).
     CMS determines national growth rates for assignable 
beneficiaries that are used to trend forward BY1 and BY2 expenditures 
to BY3 according to Sec. Sec.  425.601(a)(5)(ii) and 425.652(a)(5)(ii) 
and to determine the blended growth rates used update the benchmark 
according to Sec. Sec.  425.601(b)(2) and 425.652(b)(2)(i).
     CMS determines average prospective HCC risk scores for 
assignable beneficiaries for purposes of adjusting county FFS 
expenditures for severity and case mix of assignable beneficiaries in 
the county according to Sec. Sec.  425.601(c)(4) and 425.654(a)(4), 
calculating the regional adjustment to the historical benchmark by 
adjusting for differences in severity and case mix between the ACO's 
assigned beneficiary population and the assignable beneficiary 
population for the ACO's regional service area according to Sec. Sec.  
425.601(a)(8)(i)(C) and 425.656(b)(3), and adjusting the flat dollar 
amount ACPT for differences in severity and case mix between the ACO's 
BY3 assigned beneficiary population and the national assignable FFS 
population according to Sec.  425.660(b)(4).
(c) Concerns About Beneficiaries Excluded From the Current Assignment 
Methodology Based on the Pre-Step Requirement and Definition of an 
Assignable Beneficiary
    We have established a goal that 100 percent of beneficiaries 
enrolled in Original Medicare be involved in a care relationship with 
accountability for quality and total cost of care by 2030.\215\ We have 
also established health equity as a top priority through our CMS 
Framework for Health Equity (2022-2032).\216\ However, we believe that 
the assignment pre-step and definition of assignable beneficiary may 
create barriers for some beneficiaries otherwise eligible for 
assignment to be assigned to ACOs. Revising the pre-step and definition 
of assignable beneficiary thus represents an opportunity to expand the 
assigned and assignable populations.
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    \215\ Seshamani M., Fowler E., Brooks-LaSure C., Building On The 
CMS Strategic Vision: Working Together For A Stronger Medicare. 
Health Affairs. January 11, 2022. Available at https://www.healthaffairs.org/do/10.1377/forefront.20220110.198444.
    \216\ Centers for Medicare & Medicaid Services, The CMS 
Framework for Health Equity 2022-2032 (April 2022), available at 
https://www.cms.gov/files/document/cms-framework-health-equity.pdf.
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    ACOs and other interested parties have also raised concerns that 
the current pre-step and definition of assignable beneficiary create 
barriers for some beneficiaries to be assigned to ACOs. For example, in 
previous proposed rules, we have received input from commenters that 
the pre-step requirement, as implemented in the current assignment 
methodology, systematically excludes from assignment beneficiaries who 
only received primary care from NPs, PAs, and CNSs. In response to the 
CY 2023 PFS proposed rule, a commenter noted that the current claims-
based assignment methodology creates a barrier for NPs and their 
patients to participate in ACOs.\217\
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    \217\ See comment letter from American Association of Nurse 
Practitioners, to Chiquita Brooks-LaSure, Administrator, CMS 
(September 6, 2022), available at https://www.regulations.gov/comment/CMS-2022-0113-21927.
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    Additional analysis by CMS has found that expanding the assignment 
methodology to allow more opportunities for beneficiaries to be 
assignable based on their receipt of primary care services provided by 
NPs, PAs, or CNSs would reduce the barriers for underserved 
beneficiaries to be assigned to ACOs. As described elsewhere in this 
section of this final rule, we have modeled the impact of revising the 
step-wise assignment methodology and expanding the definition of an 
assignable beneficiary. We observed that such an approach could add to 
the ACO-assigned population\218\ and the national assignable 
population\219\ identified under current Shared Savings Program 
policies a population of beneficiaries that are more likely to be 
disabled, be enrolled in the Medicare Part D low-income subsidy (LIS) 
and reside in areas with higher ADI scores. The newly added 
beneficiaries to the ACO-assigned and national assignable populations 
also had a lower average prospective HCC risk score, lower total per 
capita-year spending, higher hospice utilization rate, and higher 
mortality rate than the ACO-assigned and national assignable 
populations under current Shared Savings Program policies. Therefore, 
we believe that adjusting the assignment methodology within the 
flexibility available under the statute so that additional 
beneficiaries can be included in the population of beneficiaries 
assigned to ACOs participating in the Shared Savings Program, and 
modifying the definition of assignable beneficiary to include a broader 
population, would make meaningful steps toward greater health equity 
and align with priorities recently emphasized in our CMS Framework for 
Health Equity (2022-2032).\220\
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    \218\ By ``ACO-assigned population,'' we refer to the population 
of beneficiaries assigned to ACOs pursuant to the Shared Savings 
Program assignment methodology specified under 42 CFR part 425, 
subpart E.
    \219\ By ``national assignable population'' we refer to the 
population of beneficiaries that meet the definition of assignable 
beneficiary under Sec.  425.20, across the national population of 
Medicare FFS enrollees. We use this term for clarity, in certain 
contexts, to underscore a reference to the assignable population 
determined at the national level, across the Medicare FFS 
population.
    \220\ Centers for Medicare & Medicaid Services, The CMS 
Framework for Health Equity 2022-2032 (April 2022), available at 
https://www.cms.gov/files/document/cms-framework-health-equity.pdf.
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(2) Revisions
(a) Overview of Revisions To Incorporate Use of an Expanded Window for 
Assignment
    Section 1899(c)(1)(A) of the Act requires that claims-based 
assignment to ACOs be based on beneficiaries' utilization of primary 
care services furnished by ACO professionals who are physicians. In the 
CY 2024 PFS proposed rule (88 FR 52440 through 52449), we proposed to 
use an expanded window for assignment in a new step 3 to the claims-
based assignment process to identify additional beneficiaries for ACO 
assignment (described in section III.G.3.a.(2)(b). of the proposed 
rule, 88 FR 52444 through 52446), and we

[[Page 79140]]

proposed to modify the definition of ``assignable beneficiary'' to be 
consistent with this use of an expanded window for assignment to 
identify additional beneficiaries to include in the assignable 
population after application of the existing methodology (described in 
section III.G.3.a.(2)(c). of the proposed rule, 88 FR 52446 and 52447). 
We proposed to add a new definition of ``Expanded window for 
assignment'' in Sec.  425.20 to mean the 24-month period used to assign 
beneficiaries to an ACO, or to identify assignable beneficiaries, or 
both that includes the applicable 12-month assignment window (as 
defined under Sec.  425.20) and the preceding 12 months (described in 
section III.G.3.a.(2)(a). of the proposed rule, 88 FR 52443 through 
52444).
    The following is a brief summary of the proposed uses of the 
expanded window for assignment, described in greater detail elsewhere 
within section III.G.3.a of the proposed rule. First, we proposed that 
beneficiaries would be assigned to ACOs pursuant to the proposed step 3 
to the beneficiary assignment methodology only after the current steps 
1 and 2 have been carried out, and step 3 would apply only to 
beneficiaries who do not meet the pre-step requirement but who received 
at least one primary care service during the proposed expanded window 
for assignment with an ACO professional who is a primary care physician 
or a physician who has one of the specialty designations included in 
Sec.  425.402(c). Beneficiaries qualifying for step 3 would be assigned 
based on the plurality of allowed charges for primary care services 
during this expanded window for assignment. Second, the proposed 
revision to the definition of an assignable beneficiary would similarly 
include beneficiaries who received at least one primary care service 
during the proposed expanded window for assignment from a Medicare-
enrolled physician who is a primary care physician or who has one of 
the specialty designations included in Sec.  425.402(c). In combination 
with using the expanded window for assignment for identifying 
beneficiaries who received at least one primary care service from a 
primary care physician or a physician whose specialty designation is 
used in assignment, under both the proposed step 3 for assignment and 
proposed revised definition of an assignable beneficiary, we would 
continue to consider whether beneficiaries received at least one 
primary care service during the 12-month assignment window. We proposed 
that these changes would be effective for the performance year 
beginning on January 1, 2025, and subsequent performance years.
    As we explained in the CY 2024 PFS proposed rule (see 88 FR 52443 
through 52444), a number of factors informed our consideration of the 
duration of the expanded window for assignment. We stated our belief 
that a 24-month expanded window for assignment, as opposed to a longer 
period, would prioritize primary care services that were provided more 
recently. Through the proposed modifications to the assignment 
methodology and the definition of assignable beneficiary, we sought to 
better account for beneficiaries who may be receiving their primary 
care predominantly from non-physician practitioners during the 12-month 
assignment window, but who received care from a physician in the 
preceding 12 months, in recognition of the statutory requirement in 
section 1899(c) of the Act that claims-based assignment be based on 
receipt of primary care services from physicians who are ACO 
professionals. We stated our belief that primary care services 
furnished by NPs, PAs, and CNSs during the 12-month assignment window 
could reflect their work in clinical teams in collaboration with and 
under the supervision of physicians, and thereby represent a 
continuation of the beneficiary's primary care relationship with a 
physician from the previous year. Furthermore, use of a 24-month 
expanded window for assignment would build on experience we have gained 
and lessons learned from testing Medicare ACO initiatives by the Center 
for Medicare and Medicaid Innovation (Innovation Center), specifically 
from the use of a 2-year beneficiary alignment period in the ACO 
Realizing Equity, Access, and Community Health (REACH) Model and the 
Next Generation ACO (NGACO) Model.\221\
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    \221\ See, for example, CMS, Center for Medicare & Medicaid 
Innovation, ACO Realizing Equity, Access, and Community Health 
(REACH) Model, PY2023 Financial Operating Guide: Overview, available 
at https://innovation.cms.gov/media/document/aco-reach-py2023-financial-op-guide (refer to Appendix B, Beneficiary Alignment 
Procedures). See also, CMS, Center for Medicare & Medicaid 
Innovation, Next Generation ACO Model Benchmarking Methods (December 
15, 2015), available at https://innovation.cms.gov/files/x/nextgenaco-methodology.pdf (refer to Appendix A, Next Generation ACO 
Model Alignment Procedures). In summary, under the ACO REACH Model 
and NGACO Model the alignment period consists of two alignment 
years. The first alignment year is the 12- month period ending 18 
months prior to the start of the relevant performance year or base 
year. The second alignment year is the 12-month period ending 6 
months prior to the start of the relevant performance year or base 
year.
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    We also explained our belief that it would be timely to propose 
modifications to the definition of ``assignment window'' under Sec.  
425.20 for improved clarity and consistency with the programmatic 
applications of the assignment window. Under the existing definition, 
assignment window means the 12-month period used to assign 
beneficiaries to an ACO. However, under existing Shared Savings Program 
policies and under the proposed changes described in section III.G.3.a 
of the proposed rule, we use the term assignment window in referencing 
our identification of assignable beneficiaries. Therefore, we proposed 
to modify the definition of assignment window to mean the 12-month 
period used to assign beneficiaries to an ACO, or to identify 
assignable beneficiaries, or both (88 FR 52443).
    We solicited comments on proposed modifications to Sec.  425.20, to 
revise the definition of ``assignable beneficiary,'' ``assignment 
window,'' and add a new definition of ``expanded window for 
assignment''.
    We summarize and respond to public comments we received on these 
proposals elsewhere in this section of this final rule.
(b) Revisions To Add a Step 3 to the Beneficiary Assignment Methodology
    For the performance year beginning on January 1, 2025, and 
subsequent performance years, we proposed to revise the step-wise 
beneficiary assignment methodology, as described in Sec.  425.402, to 
include a step 3, which we proposed would utilize the proposed expanded 
window for assignment to identify additional beneficiaries for 
assignment among Medicare FFS beneficiaries who were not identified 
under the existing pre-step. (Refer to 88 FR 52444 through 52446.) 
Specifically, step 3 would identify all such beneficiaries not 
identified by the pre-step criterion specified in Sec.  425.402(b)(1), 
who also meet the following criteria:
    (1) Received at least one primary care service with a non-physician 
ACO professional (NP, PA, or CNS) in the ACO during the applicable 12-
month assignment window.
    (2) Received at least one primary care service with a physician who 
is an ACO professional in the ACO and who is a primary care physician 
as defined under Sec.  425.20 or who has one of the primary specialty 
designations included in Sec.  425.402(c) during the applicable 24-
month expanded window for assignment.
    A beneficiary meeting the aforementioned criteria would then be 
assigned to the ACO if the allowed charges for primary care services

[[Page 79141]]

furnished to the beneficiary by ACO professionals in the ACO who are 
primary care physicians, non-physician ACO professionals, or physicians 
with specialty designations included in Sec.  425.402(c) during the 
applicable expanded window for assignment are greater than the allowed 
charges for primary care services furnished by primary care physicians, 
physicians with specialty designations included in Sec.  425.402(c), 
NPs (as defined at Sec.  410.75(b)), PAs (as defined at Sec.  
410.74(a)(2)), and CNSs (as defined at Sec.  410.76(b)) who are ACO 
professionals in any other ACO or not affiliated with any ACO and 
identified by a Medicare-enrolled billing TIN.
    Further, in order to be assigned to an ACO through the step-wise 
assignment methodology, we proposed that a Medicare FFS beneficiary 
would continue to need to meet the eligibility criteria in Sec.  
425.401(a) for the 12-month assignment window, regardless of whether 
the beneficiary is assigned to an ACO in step 1 or 2, or proposed step 
3. Under the proposed approach, beneficiaries who do not receive any 
primary care services during the assignment window would continue to be 
excluded from claims-based assignment as they are under the current 
assignment methodology. Beneficiaries who meet the pre-step based on a 
12-month assignment window (as specified in Sec.  425.402(b)(1)) but 
are not assigned to an ACO in steps 1 or 2 would also continue to not 
be assigned to an ACO as these beneficiaries would not be considered 
for assignment in step 3. The proposed changes also would not change 
beneficiary voluntary alignment, which would continue to supersede 
claims-based assignment, as specified in Sec.  425.402(e).
    As specified in Sec.  425.400(a)(3)(ii), beneficiaries who are 
prospectively assigned to an ACO will remain assigned to the ACO at the 
end of the benchmark or performance year, unless they meet any of the 
exclusion criteria under Sec.  425.401(b). As a result, under claims-
based assignment, a beneficiary prospectively assigned to an ACO is not 
eligible for assignment to a different ACO for the same benchmark or 
performance year.\222\ We proposed to continue to apply this approach 
for beneficiaries prospectively assigned at step 1, step 2, or proposed 
step 3. In other words, a beneficiary who is assigned to an ACO based 
on prospective assignment through step 1 or 2 or proposed step 3 would 
remain assigned to that ACO for the benchmark or performance year 
(unless they meet any of the exclusion criteria under Sec.  
425.401(b)). Under this approach, a beneficiary prospectively assigned 
to an ACO for a benchmark or performance year would not be assigned to 
another ACO under prospective assignment or to an ACO under preliminary 
prospective assignment with retrospective reconciliation, even if the 
other ACO provides the plurality of the beneficiary's primary care 
services during the relevant benchmark or performance year.
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    \222\ See, for example, Medicare Shared Savings Program, Shared 
Savings and Losses, Assignment and Quality Performance Standard 
Methodology Specifications (version #11, January 2023), available at 
https://www.cms.gov/files/document/medicare-shared-savings-program-shared-savings-and-losses-and-assignment-methodology-specifications.pdf-2 (see section 2.3.2.2, ``Prospective 
Assignment'').
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    We explained that the use of a 24-month expanded window for 
assignment would also require changes to the timeframe for which we 
recognize additional primary care service codes related to the COVID-19 
Public Health Emergency (PHE), as outlined in Sec.  425.400(c)(2). 
Under Sec.  425.400(c)(2), we use certain additional primary care 
service codes in determining beneficiary assignment under Sec.  
425.400(c)(1) when the assignment window for a benchmark or performance 
year includes any month(s) during the COVID-19 PHE (as defined in Sec.  
400.200). In accordance with Sec.  425.400(c)(2)(ii), the additional 
primary care service codes are applicable to all months of the 
assignment window, when the assignment window includes any month(s) 
during the COVID-19 PHE, with the exception of certain additional CPT 
codes (99441, 99442, and 99443) which we use in determining assignment 
until they are longer payable under Medicare FFS payment policies (as 
specified under Sec.  425.400(c)(2)(i)(A)(2)). We refer readers to 
discussions in earlier rulemaking for the development of this policy, 
including 85 FR 84748 through 84755, 85 FR 84791 through 84793, and 86 
FR 65276. We proposed to modify the regulations at Sec.  
425.400(c)(2)(i) and (ii) to incorporate references to the expanded 
window for assignment, such that we would apply the additional primary 
care service codes to all months of the assignment window or applicable 
expanded window for assignment when the assignment window or applicable 
expanded window for assignment includes any month(s) during the COVID-
19 PHE (88 FR 52445). We explained that these proposed changes would be 
necessary to capture the additional codes related to the COVID-19 PHE 
when using the expanded window for assignment in determining assignment 
for a benchmark or performance year.\223\
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    \223\ See, for example, HHS Secretary Xavier Becerra Statement 
on End of the COVID-19 Public Health Emergency (May 11, 2023), 
available at https://www.hhs.gov/about/news/2023/05/11/hhs-secretary-xavier-becerra-statement-on-end-of-the-covid-19-public-health-emergency.html. See also Letter to U.S. Governors from HHS 
Secretary Xavier Becerra on renewing COVID-19 Public Health 
Emergency (PHE) (February 9, 2023), available at https://www.hhs.gov/about/news/2023/02/09/letter-us-governors-hhs-secretary-xavier-becerra-renewing-covid-19-public-health-emergency.html 
(specifying the U.S. Department of Health and Human Services was 
planning for the COVID-19 PHE to end on May 11, 2023).
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    The proposed use of an expanded window for assignment in an 
enhanced step-wise assignment methodology would result in a greater 
overall number of beneficiaries assigned to ACOs. All beneficiaries who 
are assigned to an ACO under the current methodology would continue to 
be assigned to an ACO under the proposed methodology. Under the 
proposed methodology, a beneficiary who does not meet the current pre-
step requirement would also be eligible to be assigned to an ACO if 
they (a) received at least one primary care service from a NP, PA, or 
CNS who is an ACO professional in the ACO during the applicable 
assignment window and (b) received at least one primary care service 
from a primary care physician or physician with a specialty used in 
assignment who is an ACO professional in the ACO during the applicable 
expanded window for assignment.
    Under proposed changes, the 12-month assignment window would 
continue to represent the period used to identify allowed charges for 
primary care services received from ACO professionals and analogous 
practitioners not participating in an ACO, for purposes of claims-based 
beneficiary assignment during steps 1 and 2. Thus, most beneficiaries 
currently assigned to an ACO under the existing assignment methodology 
would continue to be assigned to the same ACO under the proposed 
changes. We anticipated that only a very small share of beneficiaries 
would be assigned to a different ACO under the proposed assignment 
methodology, and any change in ACO assignment would be due to the 
operational order in which assignment is run and the precedence of 
prospective assignment over preliminary prospective assignment with 
retrospective reconciliation. Specifically, there may be a small share 
of beneficiaries who would be prospectively assigned to an ACO under 
the proposed step 3 for prospective assignment that differs from the 
retrospective ACO the beneficiary is

[[Page 79142]]

currently assigned to under steps 1 or 2 for preliminary prospective 
assignment with retrospective reconciliation. This precedence of 
prospective assignment follows the current assignment methodology, 
which currently assigns beneficiaries via steps 1 and 2 of prospective 
assignment to an ACO that may be different than the ACO to which the 
beneficiary would have been assigned via steps 1 or 2 if assigned to an 
ACO under preliminary prospective assignment with retrospective 
reconciliation. For the average retrospective ACO, the share of 
assigned beneficiaries affected by this precedence of prospective 
assignment has historically been very small, approximately 1.3 percent 
from 2018 through 2021.
    The proposed addition of step 3 would add a population of otherwise 
omitted beneficiaries by using the expanded window for assignment to 
identify the required physician visit with an ACO professional and to 
determine the plurality of allowed charges for primary care services. 
Functionally, the beneficiaries who would be newly assigned are 
beneficiaries who received a primary care service from an ACO 
professional who is a primary care physician (as defined under Sec.  
425.20) or who has one of the specialty designations included in Sec.  
425.402(c) in the 12-month period prior to the assignment window and 
received a primary care service from a NP (as defined at Sec.  
410.75(b)), a PA (as defined at Sec.  410.74(a)(2)), or a CNS (as 
defined at Sec.  410.76(b)) during the assignment window. Notably, the 
proposed step 3 would continue to be consistent with section 
1899(c)(1)(A) of the Act, because a beneficiary would have to have 
received a primary care service from a primary care physician or 
physician with a specialty used in assignment who is an ACO 
professional in the ACO during the expanded window for assignment to be 
eligible for assignment to the ACO.
    Similar to any other change that affects beneficiary assignment, 
the proposed use of an expanded window for assignment in a step 3 could 
impact downstream aspects of the Shared Savings Program that rely on 
the assigned population, including the following potential effects:
     Larger populations of assigned beneficiaries could 
contribute to more ACOs meeting minimum size requirements to 
participate in the program.
     A larger assigned population would result in lower minimum 
savings rates for ACOs subject to a variable minimum savings rate (that 
is, ACOs in a one-sided risk model on the BASIC track's glide path or 
ACOs in a two-sided risk model that elected a variable minimum savings 
rate). Lower minimum savings rates reflect a lower threshold for ACOs 
to meet in order to share in savings. Similarly, a larger assigned 
population would result in a lower minimum loss rate for ACOs 
participating in a two-sided risk model with a variable minimum loss 
rate, which reflects a lower threshold for ACOs participating in a two-
sided risk model to meet before they must share in losses.
     A larger assigned population would enable higher 
performance payment limits, which are based on a percentage of an ACO's 
total benchmark expenditures. As an ACO's assigned beneficiary 
population increases, so too do the ACO's total benchmark expenditures. 
Because the maximum shared savings an ACO can earn is determined as a 
percentage of total benchmark expenditures, a larger assigned 
population would result in a higher performance payment limit. 
Similarly, a larger assigned population would result in larger loss 
sharing limits for ACOs in two-sided risk models because loss sharing 
limits are also determined as a percentage of aggregate benchmarks.
     A larger assigned population could affect an ACO's revenue 
status as the ACO's ACO participants' total Medicare Parts A and B FFS 
revenue would not change but the ACO's assigned beneficiary 
population's total Medicare Parts A and B FFS expenditures would 
increase. In other words, revenue-to-expenditure ratios would decrease 
for ACOs that receive a larger assigned beneficiary population. 
Compared to the current assignment methodology, the proposed assignment 
methodology change could result in some ACOs being identified as low 
revenue instead of high revenue. As a result, other program elements 
tied to revenue status could then be affected by the proposed changes, 
specifically an ACO's eligibility for AIPs.
     Changes in the assigned population could directly affect 
ACOs' average risk scores, mix of beneficiaries across enrollment 
types, regional service area, and total expenditures during benchmark 
and performance years.
    Expected impacts on several other program elements would depend on 
differences in the changes observed for beneficiaries added to the 
assignable population versus beneficiaries added to the ACO's assigned 
beneficiaries. For example, the impact of the proposed change to the 
assignment methodology on ACO performance would depend in part on the 
difference in spending levels and trends between those beneficiaries 
added to the assignable population, nationally and within an ACO's 
regional service area, versus those beneficiaries added to the ACO's 
assigned beneficiary population. The data shared with ACOs on their 
assignable and assigned beneficiaries would change under the proposed 
policy as the population of assignable and assigned beneficiaries 
changes.
    We proposed modifications to subpart E of the Shared Savings 
Program regulations to specify the revised beneficiary assignment 
methodology. We proposed to specify the new step 3 in a new provision 
at Sec.  425.402(b)(5). We also proposed technical and conforming 
changes to incorporate the revised methodology. We proposed to amend 
Sec.  425.402(b)(1), describing the existing pre-step of the assignment 
methodology that would remain applicable for step 1 and step 2, to 
refer to the identification of all beneficiaries who had ``at least one 
primary care service during the applicable assignment window with a 
physician who is an ACO professional in the ACO and who is a primary 
care physician as defined under Sec.  425.20 or who has one of the 
primary specialty designations included in [Sec.  425.402(c)]'' 
(emphasis added to reflect revised text). In Sec.  425.402(c), which 
indicates the primary specialty designations used in assignment, we 
proposed to specify that the listed specialties would be considered for 
ACO professionals in step 2 (as described in Sec.  425.402(b)(4)) and 
the proposed step 3 (which would become a new provision at Sec.  
425.402(b)(5)) of the assignment methodology. In Sec.  
425.400(a)(2)(ii), which generally describes quarterly updates to 
preliminary prospective assignment with retrospective reconciliation, 
we proposed to specify that assignment would be updated quarterly based 
on the most recent 12 or 24 months of data, as applicable, under the 
methodology described in Sec. Sec.  425.402 and 425.404. Lastly, in 
Sec.  425.400(a)(3)(i), which generally describes prospective 
assignment of beneficiaries to ACOs at the beginning of each benchmark 
or performance year, we proposed to amend the reference that specifies 
that we base prospective assignment on the beneficiary's use of primary 
care services in the most recent 12 months for which data are 
available, to specify instead the beneficiary's use of primary care 
services in the most recent 12 months or 24 months, as applicable, for 
which data are available, using the assignment methodology described in 
Sec. Sec.  425.402 and 425.404.

[[Page 79143]]

    We summarize and respond to public comments we received on these 
proposals elsewhere in this section of this final rule.
(c) Revisions to the Definition of an Assignable Beneficiary
    As described in the CY 2024 PFS proposed rule (88 FR 52446 through 
52447), consistent with the previously described proposal to use an 
expanded window for assignment in an enhanced step-wise assignment 
methodology, we proposed to revise the definition of Assignable 
beneficiary in Sec.  425.20 to include additional beneficiaries who 
would be identified using the expanded window for assignment. Under the 
proposal, we would continue to utilize the criterion in the existing 
definition, under which assignable beneficiary means a Medicare FFS 
beneficiary who receives at least one primary care service with a date 
of service during a specified 12-month assignment window from a 
Medicare-enrolled physician who is a primary care physician or who has 
one of the specialty designations included in Sec.  425.402(c). 
Further, for the performance year beginning January 1, 2025 and 
subsequent performance years, we proposed that a Medicare FFS 
beneficiary who does not meet this requirement but who meets both of 
the following criteria would also be considered an assignable 
beneficiary:
     Receives at least one primary care service with a date of 
service during a specified 24-month expanded window for assignment from 
a Medicare-enrolled physician who is a primary care physician or who 
has one of the specialty designations included in Sec.  425.402(c).
     Receives at least one primary care service with a date of 
service during a specified 12-month assignment window from a Medicare-
enrolled practitioner who is a NP (as defined at Sec.  410.75(b)), PA 
(as defined at Sec.  410.74(a)(2)), or a CNS (as defined at Sec.  
410.76(b)).
    We explained that the proposed use of an expanded window for 
assignment would result in a greater number of beneficiaries included 
in the assignable population (88 FR 52446). All beneficiaries who are 
currently assignable would continue to be assignable under the proposed 
revisions to the definition of an assignable beneficiary. Under the 
proposed definition, beneficiaries who do not receive any primary care 
services during the assignment window would continue to be excluded 
from the population of assignable beneficiaries, just as they are 
excluded in the current definition of an assignable beneficiary. In 
other words, the 12-month assignment window would continue to represent 
the timeframe within which beneficiaries must receive at least one 
primary care service to be identified as an assignable beneficiary. 
Moreover, to identify a broader assignable population under this 
proposed approach, we specified it would be important to consider the 
criterion for the beneficiary to have received a primary care service 
during the 12-month assignment window to be met through a service 
furnished from a non-physician practitioner (NP, PA, and CNS), or from 
a primary care physician or a physician who has one of the specialty 
designations included in Sec.  425.402(c) (as is required under the 
current definition).
    The proposed approach to expanding the assignable beneficiary 
population could impact downstream aspects of the Shared Savings 
Program that rely on the assignable population, including the following 
effects:
     Changes in the distribution of expenditures among the 
national assignable population could affect the thresholds used to 
truncate expenditures.
     Changes in average per capita expenditures and risk scores 
among assignable beneficiaries in a given benchmark year could affect 
the average risk-adjusted spending within ACOs' regional service areas, 
which could affect regional adjustments.
     Differential changes in average per capita expenditures 
and risk scores over time could affect trend and update factors that 
are based on changes in expenditures for the national assignable 
population and in the risk-adjusted expenditures for the population of 
assignable beneficiaries in an ACO's regional service area.
     Changes in average prospective HCC risk scores for the 
national assignable population could affect the factors used to 
renormalize risk scores each benchmark and performance year and to 
risk-adjust the flat-dollar ACPT amounts.
     Changes in the number of assignable beneficiaries across 
ACO regional service areas could affect ACOs' market shares, which 
determine the weights used for blending the national and regional 
benchmark trend and update factors.
     Changes in the level of national FFS expenditures for the 
assignable population could affect the caps applied to the regional 
adjustment and prior savings adjustment to the historical benchmark and 
the calculation of the flat-dollar ACPT amount.
    Under the current regulations, the time period we use to identify 
the assignable population that will be used to calculate different 
factors used in program financial calculations depends on whether it is 
a national or regional factor, the start date of an ACO's agreement 
period and, in some cases, an ACO's selected assignment methodology. 
Under the proposed revised definition of assignable beneficiary, for 
all ACOs (regardless of agreement period start date), for the 
performance year beginning on January 1, 2025, and subsequent 
performance years, for benchmark year and performance year factors 
based on the national assignable population, we would identify the 
assignable population using the 24-month expanded window for assignment 
comprised of the 12-month calendar year assignment window, which aligns 
with the assignment window for preliminary prospective assignment with 
retrospective reconciliation, and the preceding 12 months. We noted 
that under the proposal we would also use the 24-month expanded window 
for assignment comprised of the 12-month calendar year assignment 
window and the preceding 12 months when identifying the assignable 
population for regional factors for performance year 2025 and 
subsequent performance years for use in calculations for ACOs that are 
continuing in agreement periods that began before January 1, 2024 (88 
FR 52447).
    For ACOs participating in agreement periods beginning on January 1, 
2024, and in subsequent years, for performance year 2025 and in 
subsequent years for regional factors, we would identify the assignable 
population using the 24-month expanded window for assignment that is 
consistent with the beneficiary assignment methodology selected by the 
ACO for the performance year according to Sec.  425.400(a)(4)(ii). That 
is, for ACOs selecting preliminary prospective assignment with 
retrospective reconciliation, we would use the 24-month expanded window 
for assignment comprised of the 12-month calendar year assignment 
window and the preceding 12 months. For ACOs selecting prospective 
assignment, the 24-month expanded window for assignment would be 
comprised of the 12-month, offset assignment window plus the preceding 
12 months. For example, we would use October 1, 2022, to September 30, 
2024, as the 24-month expanded window for assignment to identify the 
assignable population for performance year 2025 for ACOs under 
prospective assignment.
    We proposed technical and conforming changes to provisions in 
subpart G of the Shared Savings

[[Page 79144]]

Program regulations that refer to the assignment window used to 
identify the assignable beneficiary population to incorporate 
references to the proposed approach to using an expanded window for 
assignment in identifying the assignable population for performance 
year 2025 and in subsequent performance years (88 FR 52447). We 
explained that the regulations establishing the benchmarking 
methodology for ACOs with agreement periods beginning before January 1, 
2024, do not directly reference the assignment window, and thus would 
not require conforming changes. However, there are benchmarking 
methodology provisions for ACOs with agreement periods beginning on 
January 1, 2024, and in subsequent years that directly refer to the 
assignment window. Thus, we proposed to amend these provisions to 
specify that the assignable population would be identified for the 
relevant benchmark year or the performance year (as applicable) using 
the assignment window or expanded window for assignment that is 
consistent with the beneficiary assignment methodology selected by the 
ACO for the performance year according to Sec.  425.400(a)(4)(ii):
     In Sec. Sec.  425.652(a)(5)(v)(A) and (b)(2)(iv)(A), 
provisions on calculating the county-level share of assignable 
beneficiaries who are assigned to the ACO for each county in the ACO's 
regional service area for purposes of calculating the blended national-
regional growth rates used in trending and updating the benchmark 
(respectively).
     In the provision on redetermination of the regional 
adjustment for the second or each subsequent performance year during 
the term of the agreement period in Sec.  425.652(a)(9)(ii).
     In the provision on the calculation of average county FFS 
expenditures for assignable beneficiaries in each county in the ACO's 
regional service area in Sec.  425.654(a)(1)(i).
     In the provision on adjusting for differences in severity 
and case mix between the ACO's assigned beneficiary population for BY3 
and the assignable beneficiary population for the ACO's regional 
service area for BY3, in calculating average per capita expenditures 
for the ACO's regional service area, in Sec.  425.656(b)(3).
    Similarly, we also proposed to specify in the new provision at 
Sec.  425.655(b)(1) that the assignable population that would be used 
to calculate average county prospective HCC and demographic risk scores 
for purposes of calculating the proposed regional risk score growth cap 
adjustment factor (refer to section III.G.4.b. of this final rule) 
would be identified for the relevant benchmark year or the performance 
year (as applicable) using the assignment window or expanded window for 
assignment that is consistent with the beneficiary assignment 
methodology selected by the ACO for the performance year according to 
Sec.  425.400(a)(4)(ii) (88 FR 52447).
    We solicited comments on our proposed modifications to the 
definition of assignable beneficiary in Sec.  425.20. We also solicited 
comments on our proposed technical and conforming changes to references 
to the identification of assignable beneficiaries in subpart G of the 
Shared Savings Program regulations, as well as in the proposed new 
regulation at Sec.  425.655 (on calculating the regional risk score 
growth cap adjustment factor), to incorporate the use of the assignment 
window or expanded window for assignment in identification of the 
assignable beneficiary population.
    We summarize and respond to public comments we received on these 
proposals elsewhere in this section of this final rule.
(d) Simulations To Understand the Potential Effect of Proposed Changes
    To understand the potential impact of using an expanded window for 
assignment to identify assignable beneficiaries, we simulated the 
impact of using the proposed definition of an assignable beneficiary 
using data for performance year (PY) 2021.\224\ To simplify the 
analysis, this simulation used CY 2021 as the assignment window. Thus, 
the expanded window for assignment spanned from January 1, 2020, 
through December 31, 2021. We used a calendar year basis because we do 
not expect the impact of the proposed changes to meaningfully differ 
between retrospective and prospective assignment windows, the latter of 
which uses an offset window. In this analysis, the national assignable 
population included a total of 26.2 million beneficiaries based on the 
current methodology. The simulation applying the proposed policies then 
added 762,156 newly assignable beneficiaries, growing the national 
assignable population by about 2.9 percent. Additional analysis on 
estimated impacts of the proposed changes was included in the 
Regulatory Impact Analysis in section VI.E. of the proposed rule (see 
88 FR 52706 through 52710, and 88 FR 52731). We solicited comments on 
the proposed approach and the potential effects of the proposed 
approach, including its effects modeled in the aforementioned 
simulation and its effects in other scenarios that commenters might 
have considered. We anticipated continuing additional simulations on 
the effect of the proposed changes to the assignment methodology to 
further inform our understanding of the potential impacts of the 
proposal and indicated that we planned to publish results from such 
additional simulations in the final rule.
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    \224\ In the CY 2024 PFS proposed rule (88 FR 52448), we 
incorrectly stated that the simulation used the proposed definition 
for an assignable beneficiary and proposed step 3, using the set of 
ACOs and data for performance year 2021. This language inadvertently 
indicated that we simulated the potential impact of using an 
expanded window for assignment on both the assignable and ACO-
assigned populations. The original simulation only simulated the 
impact of using an expanded window for assignment on the assignable 
population.
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    As described in the CY 2024 PFS proposed rule, the original 
simulation results suggest that an expanded window for assignment may 
increase access to accountable care for underserved beneficiaries. 
Relative to the national assignable population as determined under the 
current assignment methodology, the group of added beneficiaries from 
the expanded window for assignment simulation were more likely to be 
disabled Medicare enrollees, resided in areas with slightly higher 
average Area Deprivation Index (ADI) national percentile rank (a 
measure of neighborhood socioeconomic disadvantage), and had a larger 
share with at least one month of Medicare Part D LIS enrollment (refer 
to Table 32).

[[Page 79145]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.054

    These simulation results also suggest that using a 24-month 
expanded window for assignment in proposed step 3 of the claims-based 
assignment methodology would increase access to accountable care among 
beneficiaries with Medicare coverage for part of a year (such as 
beneficiaries who die during the performance year). The group of added 
assignable beneficiaries in the simulation previously described had a 
lower average prospective HCC risk score, lower total per capita 
spending in CY 2021, higher hospice utilization, and a higher mortality 
rate when compared to assignable beneficiaries identified using the 
current definition of assignable beneficiary. These results suggest 
that beneficiaries who would be added to the assignable population 
under the proposed changes may benefit from greater care coordination 
through ACOs.
    We summarize and respond to public comments we received on these 
considerations elsewhere in this section of this final rule.
(e) Implementation of Revisions
    In the CY 2024 PFS proposed rule (88 FR 52449), we proposed that 
the expanded window for assignment and revised step-wise assignment 
methodology would be applicable to all ACOs for the performance year 
beginning on January 1, 2025, and in subsequent performance years. For 
example, for a calendar year assignment window that runs from January 
1, 2025, through December 31, 2025, the expanded window for assignment 
would run from January 1, 2024, through December 31, 2025. For an 
offset assignment window that runs from October 1, 2023, through 
September 30, 2024, the expanded window for assignment would run from 
October 1, 2022, through September 30, 2024. Consistent with how we 
have implemented previous changes to the Shared Savings Program 
assignment methodology, we would use the new methodology each time 
assignment is determined for a given benchmark or performance year and, 
as applicable, to determine the eligibility of ACOs applying to enter 
into or renew participation in the Shared Savings Program. For example, 
applicant eligibility for PY 2024 will be determined during CY 2023. We 
explained that we would not be able to review public comments and 
decide whether to finalize the proposed changes in sufficient time to 
apply the expanded window for assignment and revised methodology for PY 
2024 applications. Additionally, we anticipated that the proposed 
revised approach, if finalized, would require significant operational 
changes to the Shared Savings Program assignment methodology, which 
would take time to prepare in advance of initial use of the approach 
during the application process. For these reasons, we would not be able 
to apply the expanded window for assignment and revised step-wise 
beneficiary assignment methodology for the performance year starting on 
January 1, 2024, and we proposed to apply this change beginning with 
the performance year starting on January 1, 2025.

[[Page 79146]]

    We proposed that we would apply the proposed revised approach to 
determining beneficiary assignment and the revised definition of 
assignable beneficiary in establishing, adjusting, updating, and 
resetting historical benchmarks for ACOs entering new agreement periods 
beginning on January 1, 2025, and subsequent years. Also consistent 
with how we have implemented previous changes to the assignment 
methodology, we proposed that we would adjust benchmarks for all ACOs 
in agreement periods for which performance year 2025 is a second or 
subsequent performance year at the start of performance year 2025, so 
that the ACO benchmarks reflect the use of the same assignment rules 
and definition of assignable beneficiary as would apply in the 
performance year (refer to Sec. Sec.  425.601(a)(9) and 425.652(a)(9)). 
We noted our belief that the expanded window for assignment and 
proposed step 3 represent a valuable change that would fill an 
important gap in the current assignment methodology. We stated that we 
have outlined a renewed vision and strategy for driving health system 
transformation to achieve equitable outcomes through high-quality, 
affordable, person-centered care for all beneficiaries.\225\ In a 
January 2022 article, we stated our goal that 100 percent of people 
with Original Medicare will be in a care relationship with 
accountability for quality and total cost of care by 2030.\226\ Many 
Medicare FFS beneficiaries are currently excluded from the assignable 
and Shared Savings Program assigned populations despite receiving 
primary care from ACO professional NPs, PAs, and CNSs during the 
existing 12-month assignment window, and these excluded beneficiaries 
tend to come from populations characterized by greater social risk 
factors. We explained more specifically that beneficiaries likely to be 
added to the assignable population are more likely to be disabled, be 
enrolled in the Medicare Part D LIS, and reside in areas with higher 
ADI scores. We explained our belief that the proposed change to the 
assignment methodology represents an opportunity to not only grow the 
share of Medicare beneficiaries involved in accountable care 
relationships but to also support efforts to improve health equity in 
the Medicare program.
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    \225\ See, for example, CMS Innovation Center ``Strategic 
Direction'' web page, at https://innovation.cms.gov/strategic-direction. See also, CMS, Innovation Center Strategy Refresh, 
available at https://innovation.cms.gov/strategic-direction-
whitepaper.
    \226\ Seshamani M., Fowler E., Brooks-LaSure C., Building On The 
CMS Strategic Vision: Working Together For A Stronger Medicare. 
Health Affairs. January 11, 2022. Available at https://www.healthaffairs.org/do/10.1377/forefront.20220110.198444.
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    We solicited comments on the proposed changes to establish a new 
defined term in Sec.  425.20, expanded window for assignment, for use 
in a proposed additional step 3 in the beneficiary assignment 
methodology and in identifying the assignable beneficiary population, 
revisions to the definition of assignable beneficiary, as well as 
proposed technical and conforming changes to provisions of the Shared 
Savings Program regulations, including the definition of assignment 
window under Sec.  425.20, and provisions within subpart E and subpart 
G. We explained that the proposed changes, if finalized, would be 
applicable for the performance year beginning on January 1, 2025, and 
subsequent performance years. We welcomed comments on all aspects of 
the proposed changes, including the length of the expanded window for 
assignment. We also solicited comments on additional policies that CMS 
should consider for potential future rulemaking on our assignment 
methodology, with the goal of increasing the number of Original 
Medicare FFS beneficiaries assigned to an ACO, particularly in 
underserved communities.
    We received public comments on the proposals and considerations 
described in section III.G.3.a of the CY 2024 PFS proposed rule. The 
following is a summary of the comments we received and our responses.
    Comment: A large majority of commenters addressing our proposed 
modifications to the assignment methodology and to the definition of an 
assignable beneficiary were broadly supportive of an approach that 
would better account for beneficiaries' primary care relationships with 
non-physician practitioners. Some commenters expressed support for the 
overall goal of expanding access to accountable care, particularly for 
beneficiaries in rural and other areas experiencing primary care 
physician shortages.
    Among these commenters, approximately half supported finalizing 
modifications as proposed. These commenters agreed that proposed 
changes would better account for beneficiaries' primary care 
relationships with non-physician practitioners and help bring a greater 
number of underserved beneficiaries into the Shared Savings Program.
    Although generally supporting the proposals, many commenters shared 
various concerns about the proposed approach to include additional 
beneficiaries in the assigned and assignable populations based on 
primary care services provided by non-physician practitioners, and 
suggested changes to the proposed approach to address these concerns, 
including changes that may require modifications to other Medicare 
policies.
    Response: We summarize and respond to commenters' specific concerns 
and suggestions throughout the rest of this section of this final rule. 
Following consideration of all public comments received, we are 
finalizing these proposals without modification. We believe these 
proposals represent important strides toward including additional 
beneficiaries in the ACO-assigned and the national assignable 
populations, improving beneficiary access to accountable care 
(particularly among underserved beneficiaries), and moving toward 
greater health equity, in alignment with priorities emphasized in our 
CMS Framework for Health Equity (2022-2032).\227\ These changes are 
also aligned with HHS' Initiative to Strengthen Primary Care \228\ 
because, by better recognizing and considering the variety of clinician 
types who participate in delivering high-quality primary care, these 
changes advance coordinated, integrated primary care and promote health 
equity.
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    \227\ Centers for Medicare & Medicaid Services, The CMS 
Framework for Health Equity 2022-2032 (April 2022), 16-22, available 
at https://www.cms.gov/files/document/cms-framework-health-equity.pdf.
    \228\ U.S. Department of Health and Human Services, Request for 
Information (RFI): HHS Initiative to Strengthen Primary Health Care, 
87 FR 38168 through 38170 (June 27, 2022).
---------------------------------------------------------------------------

    Comment: Many commenters requested additional analysis and 
information on the potential impact on ACOs of the proposed 
modifications to the assignment methodology and definition of an 
assignable beneficiary, asking for more information on either one or a 
combination of the proposals. One commenter requested that CMS make 
such additional information available with sufficient time for ACOs to 
review it prior to entering agreement periods beginning on January 1, 
2025. Other commenters, including both those that expressed general 
support for and others that opposed the proposed changes, asked for 
further analysis by CMS before finalizing the proposed changes.
    Many commenters specifically requested analysis on more years of 
data than the one year of data used for the simulation analysis 
described in the CY 2024 PFS proposed rule. Some commenters pointed to 
the simulation of changes to the national assignable population 
provided in Table 30 of the

[[Page 79147]]

CY 2024 PFS proposed rule (see 88 FR 52448), which relied on PY 2021 
data, which they noted was impacted by anomalies related to the COVID-
19 pandemic. These commenters suggested that CMS expand this simulation 
to include data from additional years, such as 2019, 2020, 2021, and 
2022.
    Several commenters expressed concern that revising the definition 
of an assignable beneficiary will have varying effects on ACOs' 
financial performance due to the definition's effect on the national 
and regional assignable populations, which are used to calculate an 
ACO's benchmark. In particular, these commenters explained that while 
CMS estimated that the overall growth in the national assignable 
population will be small, CMS did not examine changes to regional 
assignable populations, which are used in certain calculations to 
adjust and update ACOs' financial benchmarks. As a result, some 
commenters were concerned that rural ACOs might be disproportionately 
affected, in part due to their smaller size.
    Given these concerns, commenters urged CMS to provide additional 
analysis of the impact of the revisions to the definition of assignable 
beneficiary and proposed step 3 to assess financial and performance-
related factors, including the following:
     Impacts to ACO benchmarks.
     Potential changes to regional factors based on regional 
FFS expenditures calculated with the new definition of an assignable 
beneficiary to ensure that any implementation of these proposals does 
not result in unintended consequences for rural ACOs and ACOs in 
underserved communities.
     Changes to ACO per beneficiary per year expenditures and 
average risk scores under the new definition of assignable beneficiary.
     Differential impact ``based on geography, ACO size and 
composition,'' ACOs participating under preliminary prospective 
assignment with retrospective reconciliation versus ACOs under 
prospective assignment, and ACOs with large beneficiary populations 
receiving care from safety net providers.
     The impact of the proposed changes on various Shared 
Savings Program calculations, including minimum savings rates, 
performance payment limits, risk adjustment, and the determination of 
an ACO's status as high revenue or low revenue.
    Several commenters urged CMS to provide additional analysis to 
assess the impact of the proposed changes at the individual ACO level, 
and with specificity for sub-populations of beneficiaries by 
demographic factors. In particular, these commenters urged CMS to 
provide this analysis to ensure the proposals would not have disparate 
impacts on ACO financial performance, and as several commenters put it, 
result in ``artificial winners and losers.'' However, the commenters 
did not provide specific suggestions on how to conduct this analysis.
    Response: In the CY 2024 PFS proposed rule (88 FR 52448 through 
52449), we described results from our analysis simulating the impact of 
our proposed modifications to the definition of an assignable 
beneficiary on the assignable population, and these results are 
restated in section III.G.3.a.(2)(d) of this final rule. Following 
publication of that proposed rule, we further simulated our proposed 
changes on both the assignable and ACO-assigned populations using 
multiple years of data. While the original analysis focused on 
simulating the impact of our proposed changes on the assignable 
population for PY 2021, in these later analyses, we simulated changes 
for both the assignable and ACO-assigned populations for PYs 2019 and 
2021 using the set of 364 ACOs that participated in the Shared Savings 
Program in both of those PYs. The additional simulation also allowed us 
to further examine how these proposals would impact ACOs, including the 
expected impact of these proposals on ACO financial performance 
measured in terms of gross savings. Furthermore, the additional 
analysis using two years of data allowed us to confirm that findings 
from PY 2021--a year affected by the PHE for COVID-19--were not 
anomalous. As with the initial analysis, we simplified this additional 
analysis by using CYs 2019 and 2021 as the respective assignment 
windows for each of these PYs, which would align with the assignment 
window for preliminary prospective assignment with retrospective 
reconciliation. Thus, the expanded window for assignment spanned from 
January 1, 2020, through December 31, 2021 for CY 2021, and from 
January 1, 2018, through December 31, 2019 for CY 2019.
    We agree with commenters that providing findings of additional 
analysis of the impact of the revisions to the definition of assignable 
beneficiary and proposed step 3 to assess financial and performance-
related factors is important to illustrate the policy changes, and we 
remain committed to ensuring program transparency. The additional 
analysis we summarize in this section addresses commenters' requests 
for more information on the impact of the proposed changes on 
assignment of beneficiaries, ACO benchmarks, ACO gross savings, and ACO 
per capita savings and average risk scores in both a year affected by 
the PHE for COVID-19 and a year not affected by the PHE for COVID-19. 
The simulation of the impact of the proposed changes on ACO benchmarks 
and gross savings accounts for changes to regional adjustments and 
regional risk ratios as a result of the proposed step 3 and the 
proposed changes to the definition of an assignable beneficiary, 
thereby addressing the requests from commenters for additional analysis 
on the impact of the proposed changes on ``regional factors.''
    We note that commenters did not include detailed recommended 
specifications for analyzing differential impacts on a number of 
metrics or factors relevant to the Shared Savings Program. We believe 
our analysis based on the following factors (described in greater 
detail in this response) corresponds to the general categories of 
analysis requested by commenters: distinguishing ACOs based on their 
number of assigned beneficiaries as an indicator of ACO size; 
distinguishing ACOs based on their market share in their regional 
service areas; \229\ distinguishing ACOs located in urban versus ACOs 
in rural areas based a classification system for identifying the 
urbanicity of the counties in which the ACO's assigned beneficiaries 
reside; \230\ and distinguishing ACOs according to what commenters 
referred to as ``ACO composition'' (to mean the demographic factors of 
the ACOs' assigned beneficiaries) or share of underserved populations, 
according to the ACO's proportion of assigned beneficiary person years 
by Medicare enrollment type, share of beneficiaries with an ADI 
national percentile rank of 85 or greater, and share of beneficiaries 
with at least

[[Page 79148]]

one month of Medicare Part D LIS enrollment. Our additional analysis 
examined the differential financial impact on, and possible unintended 
consequences for, different groups of ACOs based on their proportion of 
assigned beneficiaries dually eligible for Medicare and Medicaid.
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    \229\ An ACO's aggregate market share is calculated as the 
weighted average of the share of assignable beneficiaries in the 
ACO's regional service area that are assigned to the ACO for the 
performance year for each Medicare enrollment type. In calculating 
this weighted average, the weight applied to the share for each 
Medicare enrollment type is equal to the ACO's performance year 
assigned beneficiary person years for that enrollment type.
    \230\ For this analysis, we classified ACOs into urbanicity 
categories (for example, ``Large Central Metropolitan,'' or 
``Noncore'') as defined by the U.S. Census Bureau Delineation files, 
available at https://www.census.gov/geographies/reference-files/time-series/demo/metro-micro/delineation-files.html, and using the 
National Center for Health Statistics (NCHS) Urban-Rural 
Classification Scheme for Counties, available at https://www.cdc.gov/nchs/data_access/urban_rural.htm, based on the 
urbanicity of the counties in which their assigned beneficiaries 
reside. We classified ACOs into the urbanicity category representing 
the plurality of their assigned beneficiaries.
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    A comparison of the simulated impact on the assignable population 
for PY 2019 and PY 2021 revealed similar patterns between the two 
years, suggesting that the PHE for COVID-19 likely did not meaningfully 
affect the PY 2021 simulation results shared in the CY 2024 PFS 
proposed rule. As with PY 2021, in PY 2019 the group of added 
beneficiaries from the expanded window for assignment simulation were 
more likely to be disabled Medicare enrollees and have an ADI national 
percentile rank of 85 or greater, and a larger share of these 
beneficiaries had at least one month of Medicare Part D LIS enrollment 
(refer to Table 33). Additionally, for both PY 2019 and PY 2021, the 
group of added assignable beneficiaries in the simulation had a lower 
average prospective HCC risk score, lower total per capita spending in 
CY 2021, and higher hospice utilization when compared to the population 
identified using the current definition of assignable beneficiary.
BILLING CODE 4120-01-P

[[Page 79149]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.055

BILLING CODE 4120-01-C
    We present similar results in Table 34 for the simulations of the 
proposed addition of step 3 to the beneficiary assignment methodology. 
The simulations increased the total number of beneficiaries assigned to 
ACOs by 2.1 percent in PY 2019 and by 2.3 percent in PY 2021. Across 
both PY 2019 and PY 2021, the vast majority of ACOs (95.4 percent in PY 
2019 and 93.9 percent in PY 2021) observed an increase between 0 and 5 
percent in their number of assigned beneficiaries. Under these 
simulations, no ACOs observed a decrease in size of their assigned 
beneficiary population. Characteristics of beneficiaries newly added to 
the ACO-assigned populations for PY 2019 and PY 2021 resembled those of 
beneficiaries newly added to the national assignable population in the 
analysis described in the CY 2024 PFS proposed rule (88 FR 52448 
through 52449). Compared to the ACO-assigned population under the 
current assignment methodology, beneficiaries newly added pursuant to 
proposed step 3 were more likely to be disabled Medicare enrollees and 
have an ADI national percentile rank of 85 or greater and a larger 
share of these beneficiaries had at least one month of Medicare Part D 
LIS enrollment. This group of

[[Page 79150]]

beneficiaries newly added to the ACO-assigned population also had a 
lower average prospective HCC risk score, lower total per capita 
spending, and higher hospice utilization rate in PY 2019 and PY 2021 
when compared to the ACO-assigned population under the current 
assignment methodology.
BILLING CODE 4120-01-P

[[Page 79151]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.056

BILLING CODE 4120-01-C

    Note: Percentages in the table may not sum to 100% due to 
rounding. Similarly, total person years assigned to an ACO under 
current assignment methods and the total

[[Page 79152]]

person years added to the ACO-assigned population in the simulation 
may not sum to the total person years assigned to an ACO under the 
simulation due to rounding.

    We also simulated the impact of the proposed modifications to the 
assignment methodology and the definition of an assignable beneficiary 
on ACOs' financial performance, measured in terms of gross savings 
(that is, benchmarks minus expenditures). To conduct this financial 
impact simulation, we made additional simplifying assumptions. We 
assumed that CY 2019 represented Benchmark Year 3 (BY3) and that CY 
2021 represented PY2. We then calculated key benchmarking components to 
simulate ACOs' updated benchmarks and compared these updated benchmarks 
to ACOs' simulated PY 2021 expenditures to estimate gross savings. We 
then made gross savings estimates using the current assignment 
methodology and definition of assignable beneficiary and compared those 
estimates to gross savings estimates made using the proposed 
modifications to the beneficiary assignment methodology and definition 
of an assignable beneficiary.
    As summarized in Table 35, on average, the simulated financial 
impact of the proposed modifications to the beneficiary assignment 
methodology and to the definition of an assignable beneficiary was 
relatively small. We observed slight average decreases in ACOs' per 
capita benchmarks that we attribute primarily to a slight decrease (1.7 
percent) in the average regional adjustment. When analyzing combined 
impacts on ACO's benchmarks and performance year spending, we observed 
that average ACO per capita gross savings decreased by $4.30, or 1.3 
percent, but total gross savings increased by an average $66,618, or 
0.9 percent. In other words, in these illustrative analyses based on 
2019 and 2021 data although the average ACO generated lower gross 
savings on a per capita basis, the average ACO generated greater total 
dollar savings due to an increase in the total number of assigned 
beneficiaries. Actual financial impacts from the proposed modifications 
to the beneficiary assignment methodology and to the definition of an 
assignable beneficiary, may vary based on how ACOs increase care 
coordination and multiple other factors. Impacts on actual gross 
savings calculations starting in PY2024 might be even more limited than 
the relatively modest impacts estimated from the simulation because the 
simulation compared a 2019 base year to a 2021 performance year (and 
corresponding lookback period) that included unusual effects of COVID-
19 on utilization of primary care services.
[GRAPHIC] [TIFF OMITTED] TR16NO23.057

    The impacts on individual ACOs were also relatively small for a 
majority of ACOs. Approximately half of ACOs (49.5 percent) observed 
greater total gross savings under the simulation using an assignment 
methodology that included the proposed step 3 and revised definition of 
an assignable beneficiary, and the magnitude of these changes was 
relatively small. Approximately two-thirds of ACOs (66.8 percent) saw 
changes in their total gross savings that were within plus or minus 10 
percent of what they observed under the current methodology; nearly 
half (47.3 percent) were within plus or minus 5 percent. We also found 
that for very few ACOs, the direction of their performance changed, 
from generating gross savings to observing gross losses, and vice 
versa. Only 3 ACOs switched from generating total gross savings to 
observing total gross losses, while 6 ACOs switched from generating 
total gross losses to observing total gross savings. The changes in 
performance that we observed for these ACOs was somewhat expected given 
that ACOs with total gross savings or losses closer to zero are 
especially likely to switch from generating savings to observing 
losses, or vice versa, because the threshold for them to do so is very 
low.
    We also examined whether the simulated financial impact of the 
proposed addition of step 3 and the revised definition of assignable 
beneficiary differed by ACOs with different characteristics, but we did 
not observe any meaningful differences. For example, ACOs located in 
the most urban areas (classified as ``Large Central Metropolitan'') 
observed a median impact on their total gross savings that was similar 
to the impact on ACOs located in the most rural areas (classified as 
``Noncore''). We similarly found no meaningful differences in financial 
impact between ACOs with different market shares in their regional 
service area, between ACOs with different levels of penetration across 
all Shared Savings Program ACOs in their regional service area,\231\ 
between ACOs of different sizes (that is, ACOs with relatively large 
assigned beneficiary populations versus ACOs with relatively small 
populations), between ACOs with higher versus lower shares of 
beneficiaries dually eligible for Medicare and Medicaid, or between 
ACOs under prospective assignment versus preliminary prospective 
assignment with retrospective reconciliation.
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    \231\ The penetration level across all Shared Savings Program 
ACOs is calculated as the weighted average of the share of 
assignable beneficiaries in the ACO's regional service area that are 
assigned to any Shared Savings Program ACO for the performance year 
for each Medicare enrollment type.
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    Comparing the simulation results for low revenue ACOs and high 
revenue ACOs (as defined according to Sec.  425.20), we found that high 
revenue ACOs observed a more positive average impact from the simulated 
addition of step 3 to the assignment methodology on their per capita 
and total gross savings (-$8.61 versus -$0.14 for per capita savings 
impact, and -$15,255 versus $145,835 for total savings impact for low 
revenue and high revenue ACOs, respectively). However, the mean 
difference in these impacts was small relative to the large variation 
in impact within both subgroups.
    In summary, we found that proposed modifications to add step 3 to 
the beneficiary assignment methodology

[[Page 79153]]

added a meaningful number of beneficiaries to the ACO-assigned 
population, and when combined with proposed revisions to the definition 
of an assignable beneficiary, had a relatively small impact on gross 
savings performance for a majority of ACOs. Furthermore, the simulated 
impact of these proposals did not appear to differ meaningfully between 
ACOs with different characteristics, as explained previously in this 
section, including for ACOs located in rural areas and for ACOs with 
higher versus lower shares of beneficiaries dually eligible for 
Medicare and Medicaid.
    With respect to the request from one commenter that CMS further 
assess the impact of the proposed changes on various Shared Savings 
Program calculations, including minimum savings rates, performance 
payment limits, risk adjustment, and the determination of an ACO's 
status as high revenue or low revenue, our analysis did not directly 
examine all of these calculations. However, we note that our findings 
on the impact of the proposed changes on ACOs' assigned beneficiary 
populations imply mostly small decreases in minimum savings rates (due 
to small increases in the size of ACOs' assigned populations) and 
slightly higher performance payment limits (due to increases in ACOs' 
total benchmarks related to their larger assigned beneficiary 
populations). While ACO participant revenue would not be affected by 
the proposed changes, we anticipate small increases in total assigned 
beneficiary expenditures (due to larger assigned beneficiary 
populations), which could lead to fewer ACOs being identified as high 
revenue ACOs. We also note that our analysis did incorporate risk 
adjustment when estimating the updated benchmarks used to calculate 
simulated gross savings under both the current and proposed assignment 
methodologies and definitions of assignable beneficiary. The relatively 
small estimated impacts on gross savings imply that the proposed 
changes to the assignment methodology and definition of assignable 
beneficiaries will have a limited impact on risk adjustment 
calculations.
    We considered the findings from this additional analysis in our 
decision of whether to finalize these proposals. Because the additional 
analysis did not show meaningful differential impacts on ACOs among the 
different groups of ACOs we described previously, we did not see reason 
to modify or delay the proposed changes. The findings suggest it is 
unlikely that the proposed changes will have significant negative 
consequences on ACOs, and we continue to anticipate that the benefits 
of the proposed changes such as recognizing the clinicians that are 
providing high-quality primary care, expanding access to accountable 
care, particularly for beneficiaries in rural and other areas 
experiencing primary care physician shortages, and reducing the 
barriers for underserved beneficiaries to be assigned to ACOs, will 
outweigh any risk of potential negative effects.
    Comment: Many commenters, including those supportive of and those 
opposed to the proposals to revise the definition of assignable 
beneficiary and add step 3 to the step-wise assignment methodology, 
raised concerns about CMS's ability to distinguish between non-
physician practitioners who practice primary care and those who 
practice specialty care, resulting in the assignment of beneficiaries 
that is driven by specialty care provided by ACO professionals (such as 
after an acute event requiring specialty care), rather than being 
reflective of the beneficiaries' primary care relationships with the 
ACO. A few commenters indicated that the concerns about the lack of 
specialty code designations for non-physician practitioners has been an 
ongoing issue, and commenters worried that the proposed new step 3 
would exacerbate this problem in the context of beneficiary assignment. 
Commenters tended to explain that these circumstances result from an 
increase in non-physician practitioners working in specialty practices, 
and the lack of specialty designations in the Medicare health care 
provider taxonomy code classification for these practitioners by which 
to identify and remove such providers from use in assignment.
    Commenters further described their concerns about this dynamic. 
Some commenters stated that beneficiaries receiving care from non-
physician practitioners working in specialty practices tend to be those 
beneficiaries receiving a high-cost procedure or care for an acute 
condition in that performance year and are not assigned to the same ACO 
again in future performance years, affecting the ACO's ability to 
coordinate the beneficiaries' care and in turn the ACO's ability to 
reduce expenditures below its benchmark and improve the quality of care 
furnished to those beneficiaries. According to one commenter, such 
circumstances, where an ACO is held accountable for the care furnished 
to a beneficiary whose care is not being coordinated by the ACO, makes 
it harder for participating ACOs to succeed and thus creates 
disincentives for new ACOs to participate in the Shared Savings 
Program. A few commenters suggested that the impact of this concern 
would be dependent on an ACO's composition and that ACOs containing 
large multispecialty practices or academic medical centers would 
experience higher rates of specialist-driven assignment related to care 
delivered by non-physician practitioners in these settings. One 
commenter, shared concerns that the proposed approach would lead to 
beneficiaries being assigned to their ACO due to a visit with a non-
physician practitioner who is ``not participating in nor understand[s] 
the population health objectives'' crucial to the ACO's success. One 
commenter expressed concern about assignment of beneficiaries residing 
in long-term nursing facility settings. This commenter noted that non-
physician practitioners provide a significant amount of wound care and 
behavioral health care, which affects the determination of where a 
beneficiary receives the plurality of their primary care services and 
results in beneficiaries failing to be assigned to an ACO with which 
they have a ``primary care relationship.''
    Response: After further considering existing evidence and our 
analysis of the population that would be newly assigned under the 
proposed step 3 of the assignment methodology, we do not share the 
commenters' concerns regarding the potential impact on assignment 
resulting from a lack of secondary specialty code designations for non-
physician practitioners. We agree and recognize that non-physician 
practitioners may practice as specialty providers. However, in the June 
2015 final rule (80 FR 32749 through 32750) when we finalized changes 
to step 1 of the assignment methodology to include claims for primary 
care services furnished by NPs, PAs, and CNSs under step 1 of the step-
wise assignment methodology, commenters noted, and we agreed, that most 
non-physician practitioners have been trained in primary care or in 
providing services in primary care settings, or both. Recent research 
and analysis also support this point. A 2022 survey by the American 
Association of Nurse Practitioners found that 88.0 percent of NPs are 
certified in an area of primary care and that 70.3 percent deliver 
primary care.\232\ In addition, we performed an analysis of 2022 
Medicare claims data and found that only 7 percent of primary care

[[Page 79154]]

services identified under Sec.  425.400(c) billed by NPs, PAs, and CNSs 
participating in ACOs were billed through medical groups comprised 
mostly (greater than 50 percent) of physicians with specialties that 
are not used in assigning beneficiaries to ACOs. In contrast, 93 
percent were billed through either medical groups comprised mostly of 
primary care physicians or multi-specialty practices comprised mostly 
of clinicians with primary care or other specialty designations used in 
beneficiary assignment under Sec.  425.402(c). Furthermore, claims-
based beneficiary assignment currently is and will continue to be based 
on allowed charges for primary care services identified under Sec.  
425.400(c); therefore, to the extent NPs, PAs, and CNSs furnish 
specialty care services not included in the definition of primary care 
services used in assignment, such services would not be considered in 
assigning beneficiaries.
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    \232\ Refer to American Association of Nurse Practitioners, NP 
Fact Sheet (Updated November 2022), available at https://www.aanp.org/about/all-about-nps/np-fact-sheet.
---------------------------------------------------------------------------

    Additionally, under the current assignment methodology, only a very 
small share of claims-based assigned beneficiaries (approximately 2.2 
percent of beneficiaries assigned under preliminary prospective 
assignment with retrospective reconciliation and approximately 3.3 
percent of beneficiaries assigned under prospective assignment in PY 
2022) are assigned in step 2 based on the plurality of primary care 
services provided by specialty physicians. Because only 7 percent of 
primary care services billed by NPs, PAs, and CNSs were billed through 
medical groups comprised mostly of physicians with specialties that are 
not used in assigning beneficiaries to ACOs, and because specialty 
services that might be billed by such specialist non-physician 
practitioners are not included in the primary care services identified 
for purposes of assigning beneficiaries (under Sec.  425.400(c), we 
believe it is unlikely that a significantly high proportion of 
beneficiaries assigned to ACOs based on the revised step-wise 
methodology would be assigned to ACOs based on their receipt of primary 
care services provided by specialist non-physician practitioners.
    Many beneficiaries have an established relationship with a 
physician and maintain their primary care relationship with the 
physician's practice through subsequent visits with NPs, PAs, and CNSs. 
The new step 3 is designed and expected to capture beneficiaries who 
receive their primary care from ACOs that rely on advanced practice 
provider care models--that is, ACOs in which NPs, PAs, and CNSs 
collaborate with primary care physicians and other physicians with 
specialties used in assignment to manage their patients' primary care. 
We believe that assignment of these beneficiaries to ACOs under step 3 
reflects assignment of these beneficiaries to the ACOs that primarily 
managed their primary care during the expanded window for assignment.
    Elsewhere in our response to comments in this section of this final 
rule we describe our additional analysis of the proposed changes to 
both the assignment methodology and to the definition of an assignable 
beneficiary. Our analysis shows that approximately 83 percent of 
beneficiaries newly added to the ACO-assigned population under step 3 
for PY 2019 received at least one primary care service (as defined at 
Sec.  425.400(c)) from a primary care physician (as defined at Sec.  
425.20), as opposed to a physician who has one of the specialty 
designations included in Sec.  425.402(c), at the same ACO in 2018 that 
they were assigned to for PY 2019.\233\ On average, we found that those 
primary care physician visits accounted for a majority of allowed 
charges for all primary care services received by those beneficiaries 
in 2018. This finding further supported the notion that the NPs, PAs, 
and CNSs seen by new step 3-assigned beneficiaries in the assignment 
window at the ACO were an extension of a primary care relationship 
between the beneficiaries and primary care physicians in the ACO in the 
prior year, suggesting further that these NPs, PAs, and CNSs are 
serving a primary care rather than specialty function. In other words, 
the ACO that was assigned a beneficiary in step 3 for PY 2019 was the 
ACO which included the primary care physicians who most often provided 
the beneficiary's primary care in the 12-months preceding the 
assignment window, and, during the assignment window, the beneficiary 
continued to receive primary care services from non-physician 
practitioners participating in the ACO.
---------------------------------------------------------------------------

    \233\ We conducted this additional sub-analysis on one of the 
PYs in the simulation by examining the specific types of 
practitioners seen by beneficiaries newly added to the ACO assigned 
population with the step 3 simulation. For this sub-analysis, we 
selected PY 2019 to avoid any possible confounding effects of the 
PHE for COVID-19. The remaining 17 percent received at least one 
primary care service, as defined at Sec.  425.400(c), from a 
physician who has one of the specialty designations included in 
Sec.  425.402(c) and no primary care services from a primary care 
physician.
---------------------------------------------------------------------------

    We also note that beneficiaries assigned in step 3 must have 
received a primary care service from a Medicare-enrolled physician who 
is a primary care physician or who has one of the specialty 
designations included in Sec.  425.402(c) during the expanded window 
for assignment. As we noted in the June 2015 final rule (80 FR 32750), 
we expect that specialist physicians often take the role of primary 
care physicians in the overall treatment of beneficiaries with certain 
chronic conditions, and such patterns are captured in step 2 in the 
current assignment methodology. As explained previously in this 
section, our analysis suggests that non-physician practitioners 
functioning as specialists represent a minority of non-physician 
practitioners. However, consistent with that analysis and similar to 
primary care services furnished by specialist physicians that are 
captured by step 2, to the extent that primary care services are 
furnished by specialist non-physician practitioners, we believe that 
those non-physician specialists would likely be acting as primary care 
providers and considering the primary care they provide as part of our 
assignment methodology would be appropriate for identifying the ACO 
professionals most responsible for a beneficiary's primary care. As a 
result, we believe that the proposed step 3 reflects an improved 
approach for capturing existing primary care relationships that include 
non-physician practitioners.
    We acknowledge commenters' concern that some ACOs with large 
multispecialty practices may have higher likelihood of having a 
beneficiary assigned based on services furnished by specialty-focused 
non-physician practitioners. However, we do not believe this concern 
outweighs the benefits of our proposal. As our analysis of 2022 
Medicare claims data suggests and we explain elsewhere in this section 
of this final rule, we do not believe that a significant percentage of 
beneficiaries will be assigned to ACOs pursuant to step 3 based on 
their receipt of primary care services provided by specialist non-
physician practitioners. Step 3 will apply to a very limited, specific 
population of beneficiaries, namely beneficiaries who, during the 
assignment window, did not have a visit with a primary care physician 
or a physician with one of the specialty designations included in Sec.  
425.402(c) who is an ACO professional in the ACO. Furthermore, as 
explained previously in this section, our analysis of the expected 
impact of the new step 3 indicates that, during the expanded window for 
assignment, the vast majority of beneficiaries newly added to the ACO-
assigned population under step 3 will likely have received one or more 
primary care services from a primary

[[Page 79155]]

care physician (as defined at Sec.  425.20), as opposed to a physician 
who has one of the specialty designations included in Sec.  425.402(c), 
who is participating in the ACO to which the beneficiary is assigned. 
In addition, our analysis suggests a high likelihood that those primary 
care physician visits will account for most of the beneficiaries' 
primary care services furnished in the 12 months preceding the 
assignment window and that those beneficiaries will receive primary 
care services from non-physician practitioners participating in the ACO 
during the assignment window.
    We are limited in the extent to which we can address the 
commenter's concern about assignment of beneficiaries residing in long-
term nursing facilities as a result of services for wound care or 
behavioral health care because the commenter did not provide sufficient 
information that we can use to identify the services about which they 
are concerned (such as the related HCPCS and CPT codes included in the 
definition of primary care services). Generally, we believe Medicare 
FFS beneficiaries residing in long-term care facilities, among other 
beneficiaries added to ACOs' assigned populations in step 3, would 
benefit from better care coordination through ACOs. In addition, as 
explained previously in this section, we do not believe that a 
significant percentage of beneficiaries will be assigned to ACOs 
pursuant to step 3 based on their receipt of primary care services 
provided by specialist non-physician practitioners, and we continue to 
anticipate that the benefits of the proposed changes will outweigh any 
risk of potential negative effects.
    Comment: Among comments raising concerns about distinguishing 
between non-physician practitioners working as specialists from those 
working in primary care, most asked for a more refined approach and 
offered various suggestions for distinguishing between these different 
types of providers. As explained by some commenters, these suggestions 
were oriented towards ensuring that non-physician practitioners who 
deliver primary care, as opposed to specialty care, play a prominent 
role in ACO assignment. One commenter specifically noted that changes 
accounting for the specialty of non-physician practitioners used in 
assignment should apply to both step 1 and the proposed new step 3 of 
the assignment process.
    One suggestion common across multiple comments was for CMS to 
consider developing a new taxonomy to identify primary care or 
specialty care focused non-physician practitioners and to update the 
Provider Enrollment, Chain, and Ownership System (PECOS) to incorporate 
this new taxonomy. A few commenters suggested that to start this 
process, CMS could collect this information as an optional field in the 
Medicare provider enrollment application. One commenter stated an 
alternative option could be to expand the current specialty codes 
utilized in determining assignment, such as through rulemaking or 
guidance, because the current codes are too generic to differentiate 
between NPs, PAs, and CNSs that primarily practice primary care versus 
specialty care. Another commenter urged CMS to consider using patient 
relationship codes established under MACRA.\234\
---------------------------------------------------------------------------

    \234\ For more information on MACRA patient relationship codes, 
refer to https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Patient-Relationship-Categories-and-Codes-webinar-FAQ.PDF.
---------------------------------------------------------------------------

    Several commenters suggested revising Shared Savings Program 
policies to permit participation by ACOs comprised of ACO participants 
identified by a combination of NPIs and Medicare-enrolled billing TINs 
through which one or more ACO providers/suppliers bill Medicare. One 
commenter stated that such a change would enable the integration of 
specialists into the Shared Savings Program because it would allow ACOs 
to ``segment primary care providers and specialist providers,'' but did 
not provide additional details on what they meant by segmenting 
providers and how it would enable that integration. Similarly, some 
commenters requested that, without means to distinguish non-physician 
practitioners who practice primary care from those who practice 
specialty care, ACOs be permitted to identify specialty-focused 
practitioners so that CMS could ensure that services furnished by those 
practitioners to beneficiaries would not be considered as part of 
beneficiary assignment.
    One commenter asked CMS to provide clarification on guardrails CMS 
intends to implement to ensure that a beneficiary with a complex 
condition being managed by a specialist outside the ACO and for whom 
that specialty care comprises the bulk of the beneficiary's care is not 
assigned to an ACO based on the services by NPs or PAs who are ACO 
professionals in that ACO.
    More generally, some commenters noted that ACOs struggle to 
maintain assignment year-to-year for beneficiaries assigned ``through 
specialists,'' and some suggested that CMS should explore strategies to 
support ACOs in ``leveraging specialty-driven assignment'' to develop 
longitudinal primary care relationships with these beneficiaries, but 
these commenters did not clarify whether the specialists they are 
concerned about include non-physician practitioners and did not provide 
specific suggestions on what these strategies could be.
    Other commenters stated that CMS needs to conduct in-depth analysis 
to ensure more patients are not assigned to ACOs as a result of care 
provided by ``specialists'' under the proposed changes. Some commenters 
recommended this analysis include differences in risk scores and costs 
for beneficiaries assigned to ACOs as a result of care provided by 
specialists to inform future policy development, but commenters did not 
specify whether specialists in this analysis would include non-
physician practitioners.
    Response: At this time, we will not establish additional procedures 
to distinguish between non-physician practitioners working as 
specialists from those working in primary care for purposes of step 3, 
or as some commenters requested, for step 1 of the assignment process. 
In the June 2015 final rule (80 FR 32749 through 32750) when we 
finalized changes to step 1 of the assignment methodology to include 
claims for primary care services furnished by NPs, PAs, and CNSs under 
step 1 of the assignment process, some commenters suggested that CMS 
take additional steps to assure that the NPs, PAs and CNSs considered 
under step 1 are truly primary care providers in order to better assure 
accurate assignment of beneficiaries to ACOs based on beneficiaries' 
receipt of primary care services. In our response to these commenters 
in the June 2015 final rule, we stated that at that time we would not 
establish special procedures to determine whether NPs, PAs, and CNSs 
are performing primary care and not specialty care. We continue to 
believe that most non-physician practitioners have been trained in 
primary care or provide services in primary care settings or both. In 
addition, as explained previously in this section, our analysis 
suggests that non-physician practitioners functioning as specialists 
represent a minority of non-physician practitioners and we do not 
believe that a significant percentage of beneficiaries will be assigned 
to ACOs pursuant to step 3 based on their receipt of primary care 
services provided by specialist non-physician practitioners. 
Furthermore, similar special procedures to distinguish between 
practitioners working as specialists from those working in primary care 
have posed

[[Page 79156]]

significant challenges in the past when applied in the context of RHC 
and FQHC services. As we explained in the CY 2018 PFS final rule that 
removed the attestation requirement for RHC and FQHC participants (82 
FR 53210), the procedure that relied on ACOs to report and identify all 
individual physicians that directly provide primary care services 
within ACO participant RHCs and FQHCs for purposes of beneficiary 
assignment is prone to error and can create significant operational 
burdens.
    We decline to adopt the suggestions by commenters to further 
differentiate use of claims billed as a primary care service by non-
physician practitioners in assignment through changes to the Medicare 
provider specialty code taxonomy. Currently, Medicare claims do not 
contain the necessary information to distinguish services by non-
physician practitioners provided in a primary care versus specialty 
capacity. Creating new codes or modifying the Medicare provider 
specialty code taxonomy would require review and approval through 
rulemaking, and include consideration of several factors such as: 
whether the specialty has the authority to bill Medicare and if the 
specialty treats a significant volume of the Medicare population; 
evidence that the practice pattern of the specialty is markedly 
different from that of other specialties; evidence of any specialized 
training and/or certification required by the providers; credentialing 
or other recognition by another organization, such as the American 
Board of Medical Specialties; and the availability of a corresponding 
Healthcare Provider Taxonomy Code.
    We also decline to change the Shared Savings Program policies to 
permit participation by ACOs comprised of ACO participants identified 
by a combination of NPIs and Medicare-enrolled billing TINs through 
which one or more ACO providers/suppliers bill Medicare, instead of 
requiring that all ACO participants that comprise an ACO be identified 
by a Medicare-enrolled TIN through which one or more ACO providers/
suppliers bill Medicare. Commenters requesting we make such a change go 
beyond the scope of our proposals described in the CY 2024 PFS proposed 
rule. However, we noted that as we stated in previous rulemaking (80 FR 
67874), we believe that defining ACO participants to include all NPIs 
that have reassigned their billing rights to the ACO participant TIN is 
a means to allow the ACO's redesigned care processes to more broadly 
reach all Medicare FFS beneficiaries that may receive care from ACO 
participants and provides incentives for lower-performing providers 
within an ACO participant TIN to improve. We also continue to have 
concerns about ACOs selecting only the highest-performing providers 
within a practice to be part of the ACO while less efficient and less 
effective providers are not part of the ACO, because this structure 
could have negative implications for patients seen by the ACO 
participant and for the Medicare Trust Funds. Therefore, we continue to 
believe that maintaining the definition of ACO participant at the TIN 
level continues to be an effective approach in achieving the program's 
goals of improved care and reduced expenditures, for Medicare FFS 
beneficiaries more broadly.
    We also decline to incorporate patient relationship categories and 
codes established under MACRA into our assignment methodology at this 
time. These HCPCS Level II modifier codes are currently being tested 
for their potential use in the attribution methodology for the cost 
measures being used under MACRA. Reporting is currently voluntary to 
help collect data for testing and educate clinicians and stakeholders 
about the proper use of these code modifiers. In addition, given that 
the codes are based on categories of patient relationships, it is not 
clear how they could be incorporated into the claims-based assignment 
process. Use of patient relationship codes might require structural 
changes to the assignment process that were not contemplated in the CY 
2024 PFS proposed rule. Absent data on how they may impact beneficiary 
assignment in the Shared Savings Program, it is not clear how we might 
use the patient relationship codes in beneficiary assignment or what 
the effect of that use may be. Possible use of these patient 
relationship codes in beneficiary ACO assignment would require 
additional investigation and request for comments.
    Finally, we decline to adopt a policy to ensure that beneficiaries 
are not assigned to an ACO due to services provided by NPs, PAs, and 
CNSs if the majority of the beneficiary's care is provided by a 
specialist physician outside the ACO. We note that under step 3, a 
beneficiary who received primary care from an NP, PA, or CNS 
participating in an ACO but received the plurality of their primary 
care during the expanded window for assignment from a specialist 
physician outside of a given ACO would not be assigned to that ACO.
    Comment: Several commenters expressed support for the proposed 
definition of the expanded window for assignment, that is, the 24-month 
period used to assign beneficiaries to an ACO, or to identify 
assignable beneficiaries, or both that includes the applicable 12-month 
assignment window and the preceding 12 months. Some commenters 
explained their belief that the proposed approach would appropriately 
align the expanded window for assignment with the different 12-month 
assignment windows for ACOs under prospective assignment versus 
preliminary prospective assignment with retrospective reconciliation. 
Another commenter explained that the proposed definition of the 
expanded window for assignment would better account for beneficiaries 
who receive primary care from NPs, PAs, and CNSs.
    One commenter encouraged CMS to consider revising the expanded 
window for assignment to 36 months, to align the window with the CMS 
definition of an established patient relationship.\235\ The commenter 
explained that this is an already-defined timeframe and that using such 
an approach could assist with increasing beneficiary participation in 
an ACO.
---------------------------------------------------------------------------

    \235\ CMS defines an established patient as a person who 
receives professional services from the physician, non-physician 
practitioner, or another physician of the same specialty who belongs 
to the same group practice within the previous 3 years. Refer to 
CMS, Evaluation and Management Services Guide, MLN Booklet 
(MLN006764 August 2023), pg. 17, available at https://www.cms.gov/outreach-and-education/medicare-learning-network-mln/mlnproducts/downloads/eval-mgmt-serv-guide-icn006764.pdf.
---------------------------------------------------------------------------

    Response: We appreciate the commenters' support for the proposed 
definition of the expanded window for assignment, which we are 
finalizing as proposed. We agree with the commenter's sentiment that a 
24-month expanded window for assignment will better account for 
beneficiaries who receive primary care from NPs, PAs and CNSs.
    We are unsure how to interpret the statements from some commenters 
that the proposed approach would appropriately align the expanded 
window for assignment with the different 12-month assignment windows 
for ACOs under prospective assignment versus preliminary prospective 
assignment with retrospective reconciliation. As we explained in the 
proposed rule (88 FR 52443), the expanded window for assignment for 
prospective assignment will differ from the expanded window for 
assignment for preliminary prospective assignment with retrospective 
reconciliation. The expanded window for assignment to be defined at 
Sec.  425.20 will mean the 24-month period used to assign beneficiaries 
to an ACO, or to identify assignable beneficiaries, or both, that 
includes the applicable 12-month

[[Page 79157]]

assignment window (as defined under Sec.  425.20) and the preceding 12 
months. For example, for a calendar year assignment window that runs 
from January 1, 2025, through December 31, 2025, the expanded window 
for assignment would run from January 1, 2024, through December 31, 
2025. For an offset assignment window that runs from October 1, 2023, 
through September 30, 2024, the expanded window for assignment would 
run from October 1, 2022, through September 30, 2024.
    At this time, we decline to adopt the commenter's suggestion to use 
a 36-month expanded window for assignment, but will continue to monitor 
beneficiary assignment to ACOs in the future and consider proposing 
additional changes, as appropriate. As we described in section 
III.G.3.a.(2)(a) of this final rule, we believe that a 24-month 
expanded window for assignment, as opposed to a longer period, would 
prioritize primary care services that were provided more recently. We 
believe that primary care services furnished by nurse practitioners, 
physician assistants, and clinical nurse specialists during the 12-
month assignment window could reflect their work in clinical teams in 
collaboration with and under the supervision of physicians, and thereby 
represent a continuation of the beneficiary's primary care relationship 
with a physician from the previous year. Furthermore, use of a 24-month 
expanded window for assignment builds on experience we have gained and 
lessons learned from testing Medicare ACO initiatives by the Innovation 
Center, specifically from the use of a two-year beneficiary alignment 
period in the ACO REACH Model and the NGACO Model.
    Comment: Some commenters expressed concerns that the expanded 
window for assignment might inappropriately assign beneficiaries based 
on their receipt of services from practitioners who no longer serve as 
their primary care provider. One commenter urged CMS not to finalize 
the expanded window over concerns about beneficiaries who might reside 
in multiple states for different parts of the year.
    Response: As with the existing step-wise methodology, the revised 
approach would determine assignment based on the plurality of allowed 
charges for primary care services furnished to the beneficiary during 
the assignment window or expanded window for assignment, regardless of 
whether the beneficiary may live in different geographic areas at 
different points in time in the assignment window or expanded window 
for assignment. In the June 2015 final rule (80 FR 32745), we reported 
results of an analysis we conducted that indicated that beneficiary 
relocation out of an ACO's service area impacted only a very small 
number of beneficiaries within an ACO's assigned population, and these 
beneficiaries did not represent a significant portion of the ACO's 
assigned population. We do not expect that expanding the window for 
assignment to 24 months would meaningfully change this outcome. In 
addition, we believe that beneficiaries who generally live in multiple 
geographic areas over the course of a year may be likely to follow a 
similar pattern each calendar year of changing locations and obtaining 
primary care services. We do not expect a 12-month change in the length 
of the assignment window to significantly change how those 
beneficiaries are assigned because we believe they generally would 
maintain that same pattern across a 24-month window. We reiterate our 
belief, explained in the June 2015 final rule, that continuing to 
include those beneficiaries who have not permanently moved, but who 
otherwise live in two or more geographic locations during the year, 
provides an excellent opportunity for ACOs to make sure the care for 
such beneficiaries is coordinated.
    Comment: A few commenters, addressing our statement in the proposed 
rule that, as with the current step-wise methodology, under the 
proposed step 3 a beneficiary prospectively assigned to an ACO for a 
benchmark or performance year would not be assigned to another ACO 
under prospective assignment or preliminary prospective assignment with 
retrospective reconciliation, even if the other ACO provides the 
plurality of the beneficiary's primary care services during the 
relevant benchmark or performance year, asked that CMS monitor for any 
effects that the precedence of prospective assignment may have on 
smaller ACOs subject to preliminary prospective assignment with 
retrospective reconciliation, to which beneficiaries prospectively 
assigned to another ACO through step-wise assignment, including the 
proposed step 3, could not be assigned.
    One commenter described concerns that the expanded window for 
assignment would increase the number of beneficiaries assigned to ACOs 
based on a timeframe that ``is not most reflective of the primary care 
physician relationship,'' with a disproportionately negative impact on 
ACOs operating under prospective assignment. The commenter explained 
that under prospective assignment, beneficiaries who have not seen a 
physician who is an ACO professional in the applicable 12-month 
assignment window but are assigned to an ACO based on the expanded 
window for assignment will be ``locked in'' to that ACO for the 
performance year; however, under preliminary prospective assignment 
with retrospective reconciliation many of these beneficiaries would 
``drop'' from the assignment list over the course of the performance 
year as new claims and services are considered in assignment. The 
commenter further cited concerns that preliminary prospective 
assignment with retrospective reconciliation serves as a means for ACOs 
to ``game'' assignment by encouraging higher-cost beneficiaries to 
receive care from providers that do not bill under an ACO participant 
TIN in the ACO, and focusing on ensuring lower-cost beneficiaries 
remain assigned to the ACO. The commenter suggested that CMS make 
assignment using the expanded window for assignment an annual option 
for ACOs to elect along with the choice of preliminary prospective 
assignment with retrospective reconciliation or prospective assignment. 
In the alternative, if the expanded window for assignment is used in 
our methodology for assigning beneficiaries to all ACOs, the commenter 
suggested that CMS remove the option for ACOs to select preliminary 
prospective assignment with retrospective reconciliation and require 
all ACOs to participate under prospective assignment.
    Response: In the CY 2024 PFS proposed rule (88 FR 52445), we 
acknowledged that there may be a small share of beneficiaries who would 
be prospectively assigned to an ACO under the proposed step 3 for 
prospective assignment that differs from the ACO the beneficiary is 
currently assigned to under steps 1 or 2 under preliminary prospective 
assignment with retrospective reconciliation. We noted that this 
precedence of prospective assignment follows the current assignment 
methodology, which currently assigns beneficiaries via steps 1 and 2 of 
prospective assignment to an ACO that may be different than the ACO to 
which the beneficiary would have been assigned via steps 1 or 2 if 
assigned to an ACO under preliminary prospective assignment with 
retrospective reconciliation. For the average ACO under preliminary 
prospective assignment with retrospective reconciliation, the share of 
assigned beneficiaries affected by this

[[Page 79158]]

precedence of prospective assignment has historically been very small, 
approximately 1.3 percent from 2018 through 2021. We anticipate 
monitoring the impact of the use of step 3 on the size of ACOs' 
assigned populations, including for differences in impact based on an 
ACO's selection of assignment methodology, and on smaller ACOs, 
including with respect to ACOs' ability to meet the requirement to have 
at least 5,000 assigned beneficiaries under Sec.  425.110(a).
    We also believe that the benefits of the proposed changes to the 
step-wise methodology outweigh the risk of prospectively assigning a 
beneficiary in step 3 to an ACO based on a physician visit and the 
beneficiary's use of primary care services during the expanded window 
for assignment instead of to another ACO to which the beneficiary would 
have been assigned under preliminary prospective assignment with 
retrospective reconciliation based on the plurality of allowed charges 
for primary care services furnished to the beneficiary during the 
benchmark or performance year. Overall, we expect that a very small 
proportion of beneficiaries assigned in step 3 will fall into this 
category, while the vast majority of beneficiaries assigned in step 3 
will be beneficiaries who would not have otherwise been brought into an 
accountable care relationship.
    Additionally, we do not share the concerns of the commenter who 
stated that the expanded window for assignment would increase the 
number of beneficiaries assigned to ACOs based on a timeframe that ``is 
not most reflective of the primary care physician relationship,'' with 
a disproportionately negative impact on ACOs operating under 
prospective assignment. We refer the commenter to the additional 
analysis that we describe elsewhere in this section of this final rule, 
indicating that, during the expanded window for assignment, a large 
majority of beneficiaries assigned to ACOs pursuant to step 3 will have 
received one or more primary care services from a primary care 
physicians (as defined at Sec.  425.20), as opposed to a physician who 
has one of the specialty designations included in Sec.  425.402(c), who 
is participating in the ACO to which the beneficiary is assigned. 
Further, we note that ACOs have the option to elect prospective 
assignment or preliminary prospective assignment with retrospective 
reconciliation on an annual basis. ACOs that share the concern of the 
commenter could elect the methodology they find most appropriate for 
their ACO. With respect to the concern over gaming beneficiary 
assignment by encouraging higher-cost beneficiaries to receive care 
from providers and suppliers that do not bill under an ACO participant 
TIN in the ACO, we do not expect step 3 to incentivize or enable an ACO 
to engage in this type of behavior to a greater degree than the current 
step-wise methodology does, and we remind the commenter that we monitor 
ACO avoidance of at-risk beneficiaries pursuant to the regulations at 
Sec.  425.316(b).
    We decline to adopt the commenter's suggestion to allow ACOs the 
option to elect whether to use the expanded window for assignment for 
purposes of assignment each year. The proposed expanded window for 
assignment would apply to both the step 3 in the assignment methodology 
and to the definition of an assignable beneficiary. We believe it is 
necessary to maintain symmetry between the step-wise assignment 
methodology and the definition of an assignable beneficiary. Applying 
the expanded window for assignment in the step-wise beneficiary 
assignment methodology but not to the definition of an assignable 
beneficiary, or vice-versa, could create programmatic inconsistencies 
and may result in differential changes in average per capita 
expenditures and risk scores, resulting in inaccurate benchmarks due to 
distortions to benchmark trend and update factors that are based on 
changes in expenditures for the national assignable population and in 
the risk-adjusted expenditures for the population of assignable 
beneficiaries in an ACO's regional service area. Elsewhere in this 
section of this final rule, we explain that numerous aspects of the 
Shared Savings Program rely on the ACO-assigned population and the 
assignable population (see sections III.G.3.a.(2)(b) and (c) of this 
final rule). That is, various aspects of the program's benchmarking and 
financial methodology applicable to all ACOs, such as in the 
calculation of the regional adjustment and in the calculation of 
regional service area expenditures, will be determined in part by the 
national and regional populations of assignable beneficiaries 
identified through use of an expanded window for assignment. We also 
decline to adopt an alternative that would allow ACOs the option to 
elect whether to use the expanded window for assignment for both 
assignment and establishing the assignable population. It would be 
operationally complex and unduly burdensome for CMS to create multiple 
assignable beneficiary populations for different ACOs using different 
definitions of an assignable beneficiary. It would also be 
operationally complex and unduly burdensome to perform beneficiary 
assignment using step 3 for some ACOs but not for others. Among other 
operational concerns, with each distinct beneficiary assignment 
methodology, we would need to apply precedence rules for handling cases 
when a given beneficiary is assigned to different ACOs under different 
methodologies. Doing so would create excessive complexity in 
administering the program and excessive complexity for ACOs 
participating in the program to review and track.
    We decline to adopt the suggestion by the commenter to require ACOs 
to participate under prospective assignment. Section 1899(c)(2)(A) of 
the Act, as amended by the Bipartisan Budget Act of 2018, provides that 
the Secretary shall permit ACOs to choose to have Medicare FFS 
beneficiaries assigned prospectively, rather than retrospectively. 
Consistent with section 1899(c)(2)(A) of the Act, we offer all Shared 
Savings Program ACOs in agreement periods beginning on July 1, 2019, 
and in subsequent years the opportunity to select their beneficiary 
assignment methodology annually.
    Comment: One commenter, who supported the proposed approach, 
requested CMS clarify in the final rule that an eligible beneficiary 
who received at least one primary care service with an NP, PA, or CNS 
participating in the ACO during the applicable 12-month assignment 
window would be considered an assignable beneficiary in certain cases. 
Specifically, the commenter described the following cases:
     The primary care physician, who used to be an ACO 
professional in the ACO and provided the primary care service to the 
beneficiary in the 12 months preceding the assignment window, is no 
longer billing under the TIN of an ACO participant during the 
applicable 12-month assignment window;
     The ACO participant, which was the entity whose TIN the 
primary care physician was billing under when they provided the primary 
care service to the beneficiary in the 12-month period preceding the 
assignment window, is no longer participating in the Shared Savings 
Program ACO during the applicable 12-month assignment window; and
     The physician, an ACO professional in the ACO who had one 
of the primary specialty designations identified in Sec.  425.402(c) 
and provided the primary care service to the beneficiary in the 12 
months preceding the assignment

[[Page 79159]]

window, changed specialty designation in the PECOS and no longer had 
one of the primary specialty designations identified in Sec.  
425.402(c) during the applicable 12-month assignment window.
    Response: We interpret this commenter's question as requesting 
clarification of whether a beneficiary would be considered assignable 
to the ACO. We note that to actually be assigned, the beneficiary would 
have to have received the plurality of their primary care services from 
ACO professionals participating in the ACO during the applicable 12-
month assignment window for steps 1 and 2 or during the expanded window 
for assignment for step 3. In the first case, the beneficiary would be 
considered assignable because the Shared Savings Program recognizes 
primary care services at the ACO-TIN level, and not at the ACO-TIN-NPI 
(that is, practitioner) level. In the second case, if the TIN was 
removed from the ACO's ACO participant list for the performance year 
that beneficiary assignment is being conducted for, then the 
beneficiary would not be assignable to the ACO on the basis of primary 
care services billed under that TIN. In the third case, the beneficiary 
would be assignable if the physician's specialty on the claim indicates 
a primary care physician or one of the specialty designations included 
in Sec.  425.402(c). Note that CMS does not use PECOS to determine 
physician specialty, but rather uses the physician's specialty listed 
on the claim record.
    Comment: One commenter, which supported the inclusion of step 3, 
explained that it had conducted an analysis and found that expanding 
the window for assignment and adding step 3 had the desired effect of 
expanding the number of beneficiaries assigned to ACOs. Additionally, 
the commenter stated that they found that the proposed step 3 ``led to 
assignment in approximately 90 percent of the cases where the 
beneficiary went from ineligible to eligible under the policy.'' The 
commenter considered the effect of the policy to be a substantial 
improvement.
    Response: We do not have sufficient information about the 
commenter's analysis to fully address the commenter's statement. 
However, we do agree with the commenter that the inclusion of a step 3 
would increase the number of beneficiaries assigned to ACOs on average. 
In the analysis we presented in the CY 2024 PFS proposed rule (88 FR 
52448 through 52449), we found that the proposed policies added 762,156 
newly assignable beneficiaries for PY 2021, growing the national 
assignable population by about 2.9 percent. Elsewhere in this section 
of this final rule, we describe the additional simulations we conducted 
on the proposed step 3 in the beneficiary assignment methodology, which 
showed that step 3 would have increased the total number of 
beneficiaries assigned to ACOs by 2.1 percent in PY 2019 and by 2.3 
percent in PY 2021.
    Comment: One commenter suggested that CMS also revise the existing 
definition of ``assignable beneficiary'' under Sec.  425.20 using a 
similar approach as the proposed step 3.
    Response: We believe the commenter may have misunderstood the 
proposal. We proposed to modify the definition of ``assignable 
beneficiary'' (described in section III.G.3.a.(2)(c). of this final 
rule) to include use of an expanded window for assignment to identify 
additional beneficiaries to include in the assignable population and to 
be consistent with the use of an expanded window for assignment under a 
new step 3 in the claims-based assignment process (described in section 
III.G.3.a.(2)(b). of this final rule). We proposed to add a new 
definition of ``Expanded window for assignment'' in Sec.  425.20 to 
mean the 24-month period used to assign beneficiaries to an ACO, or to 
identify assignable beneficiaries, or both that includes the applicable 
12-month assignment window (as defined under Sec.  425.20) and the 
preceding 12 months. See also, section III.G.3.a.(2)(a) of this final 
rule in which we provide an overview of the proposed revisions to 
incorporate use of an expanded window for assignment. We proposed that 
these changes would be effective for the performance year beginning on 
January 1, 2025, and subsequent performance years.
    Comment: Some commenters expressed concerns that the Shared Savings 
Program's risk adjustment and benchmarking methodologies would not 
adequately account for complex and high-needs beneficiaries newly 
assigned to ACOs under the proposed modifications to the step-wise 
assignment methodology and the definition of an assignable beneficiary. 
Some of these commenters suggested the potential need for modifications 
to the risk adjustment and benchmarking methodologies to mitigate any 
adverse effects on ACOs that may result from the inclusion of these 
beneficiaries in their assigned beneficiary populations.
    One commenter pointed to concerns about the adequacy of the cap on 
ACO risk score growth in the context of CMS' proposed step 3 that will 
assign more underserved individuals who may have complex conditions 
that are not properly diagnosed to Shared Savings Program ACOs. The 
commenter explained that these individuals typically have not had an 
established, stable primary care relationship, and as a result, their 
risk scores are likely to be unreliable. Once assigned to a Shared 
Savings Program ACO, these beneficiaries' conditions will be diagnosed 
and they will begin receiving treatment, which will raise the ACO's per 
capita costs. However, due to CMS' policy of capping HCC score growth 
at 3 percent plus changes in demographics, risk scores will not 
increase to reflect these changes. As a result, according to the 
commenter, ACOs that are assigned more complex, historically 
underserved beneficiaries through step 3 in the assignment methodology 
will experience losses and may be forced to stop participating in the 
Shared Savings Program.
    Some commenters urged CMS to conduct further analysis on the impact 
of the proposed step 3 and proposed changes to the definition of an 
assignable beneficiary to determine if modifications to the risk 
adjustment and benchmarking methodologies are needed to address the 
effects of adding potentially higher cost and more complex patients to 
the ACO-assigned and national assignable populations. A few commenters 
suggested that CMS analyze the distribution of assignable beneficiaries 
to help determine the need for updates to the risk adjustment and 
benchmarking methodologies. Another commenter asked for additional data 
on the impact of the proposed step 3 on ACOs in rural and other 
different geographic regions in connection with regional trend factors 
used to establish and update the benchmark. This commenter also stated 
that CMS should ensure that the addition of step 3 to the assignment 
methodology would not harm any ACO, indicating that ACOs that are 
adversely affected would likely exit the program. Another commenter 
recommended adjusting beneficiaries' risk scores to account for the 
addition to the assigned beneficiary population of a significant number 
of patients for whom acuity has not been adequately captured, for 
example, by assigning a floor on the average risk score, such as 1.0, 
to avoid unintended consequences. Another commenter similarly requested 
that CMS make additional risk adjustment or benchmarking changes to 
mitigate potential negative impacts to ACOs from the inclusion of more 
complex and high-needs beneficiaries in the expanded ACO-assigned 
population.

[[Page 79160]]

This commenter also suggested a more gradual transition of the proposed 
changes during the initial performance years in order to smooth 
potential effects and asked that CMS monitor for unintended 
consequences and have a plan for addressing any unintended consequences 
in a timely and responsive manner. Several commenters specified that 
CMS should investigate the impacts of specialty-driven assignment, 
including differences in risk scores and costs for beneficiaries 
assigned as a result of care provided by specialists, but the 
commenters did not specify whether specialists in this analysis should 
include non-physician practitioners. If the data show that these 
beneficiaries have higher risk scores and higher costs, the commenters 
suggested that CMS consider addressing these factors through changes to 
the risk adjustment and benchmarking policies.
    Response: In responding to comments elsewhere in this section of 
this final rule, we describe the results of additional simulations we 
have conducted on the impact of the proposed changes to the assignment 
methodology and to the definition of an assignable beneficiary. As part 
of those simulations, we examined the expected impact of the proposed 
changes on ACO financial performance.
    We believe that the additional simulations described in this final 
rule demonstrate that any downward effects on the average ACO's 
historical and updated benchmarks as a result of changes in the risk 
profile of its beneficiary population or the assignable population in 
the ACO's regional service area are offset by an average increase in 
the number of beneficiaries assigned to the ACO, allowing the ACO the 
opportunity to earn a larger shared savings payment. Our findings 
suggest that the risk ratios used to adjust an ACO's historical 
benchmark will not be adversely affected by the proposed changes 
because we would apply the proposed changes when determining assignment 
for the benchmark years, as well as the performance year. Furthermore, 
the findings from our simulations suggest that the proposed changes to 
the assignment methodology and the definition of assignable beneficiary 
are unlikely to result in adverse impacts on risk adjustment between 
the ACO's assigned beneficiary population and the ACO's regional 
service area. Under these simulations, we found that the 
characteristics of beneficiaries newly added to the ACO-assigned 
population for PY 2021 resembled those of beneficiaries newly added to 
the national assignable population in the analysis described in the CY 
2024 PFS proposed rule (88 FR 52443).
    Under the methodology for capping ACO risk score growth that was 
finalized for agreement periods starting on January 1, 2024, and in 
subsequent years in the CY 2023 PFS final rule (87 FR 69932 through 
69946), we will use prospective HCC risk scores to adjust the 
historical benchmark for changes in severity and case mix for all 
assigned beneficiaries between BY3 and the performance year, with 
positive adjustments subject to a cap equal to the ACO's aggregate 
growth in demographic risk scores between BY3 and the performance year 
plus 3 percentage points (herein referred to as the ``aggregate 
demographics plus 3 percent cap''). When we finalized the aggregate 
demographics plus 3 percent cap in the CY 2023 final rule (87 FR 
69940), we acknowledged that the policy balanced competing concerns 
between the need to allow for some upward growth in prospective HCC 
risk scores between the benchmark period and the performance year and 
the concern that those risk scores, in general, are susceptible to 
coding initiatives. Specifically, we stated our belief that the policy 
we were finalizing would be protective of the Trust Funds by limiting 
incentives for coding intensity as it would retain the 3 percent cap on 
growth in prospective HCC risk scores after accounting for all changes 
in demographic risk scores for the ACO's overall assigned beneficiary 
population, while also allowing for more significant changes in 
prospective HCC risk scores for certain enrollment types with smaller 
numbers of assigned beneficiaries and for potentially higher benchmarks 
than the current risk adjustment methodology for ACOs that care for 
larger proportions of high risk beneficiaries in the aged/dual 
eligible, disabled, and ESRD enrollment types. Additionally, as 
described in section III.G.4.b of this final rule, we are finalizing 
the proposal to cap regional service area risk score growth for 
symmetry with the cap on ACO risk score growth, which our modeling 
suggests will be advantageous to ACOs that see greater risk score 
growth in their regional service area.
    We have not examined differences in the beneficiaries assigned as 
result of care provided by specialists versus primary care 
practitioners in connection with the costs and risk scores. However, as 
we noted elsewhere in this section of this final rule, our analysis 
suggests that assignment of these beneficiaries to ACOs in step 3 
reflects assignment of these beneficiaries based on the ACOs that 
primarily managed their primary care during the expanded window for 
assignment. Additionally, our analysis shows that the proposed revision 
to the definition of assignable beneficiary and the addition of a new 
step 3 in the assignment methodology would lead the average ACO's total 
gross savings to increase.
    Comment: Some commenters addressed the effective date of the 
proposed changes to the assignment methodology and the identification 
of the assignable beneficiary population. A few commenters requested 
that the proposed changes be finalized to apply beginning with PY 2024. 
Another commenter urged CMS to allow currently participating ACOs to 
elect to have beneficiaries assigned to them only under the current 
assignment methodology until the start of a new agreement period, given 
their concern that the proposed approach would exacerbate ``ongoing 
challenges of specialty attribution.'' One commenter requested that CMS 
share ACO-specific modeling and analysis of the impact of the expanded 
window for assignment and the proposed revisions to the assignment 
methodology with sufficient time for review prior to signing a 
participation agreement for entering an agreement period in the Shared 
Savings Program beginning on January 1, 2025.
    Response: We decline to adopt the commenters' recommendations to 
implement the proposed changes to the assignment methodology and the 
definition of assignable beneficiary starting in PY 2024. In the CY 
2024 PFS proposed rule (refer to section III.G.3.a.(2)(e) of this final 
rule), we set forth reasons why we would not be able to apply the 
expanded window for assignment and revised step-wise beneficiary 
assignment methodology for the performance year starting on January 1, 
2024. We explained that consistent with how we have implemented 
previous changes to the Shared Savings Program assignment methodology, 
we would use the new methodology each time assignment is determined for 
a given benchmark or performance year and, as applicable, to determine 
the eligibility of ACOs applying to enter into or renew participation 
in the Shared Savings Program. For example, applicant eligibility for 
PY 2024 will be determined during CY 2023. Additionally, we anticipated 
that the proposed revised approach, if finalized, would require 
significant operational changes to the Shared Savings Program 
assignment methodology, which would take time to prepare in advance of 
initial use of the approach during the application process. In light of 
these factors, we continue to believe there is insufficient time to 
apply the expanded

[[Page 79161]]

window for assignment and revised step-wise beneficiary assignment 
methodology for the performance year starting on January 1, 2024.
    We agree with the feedback of commenters in response to our 
proposals, as described elsewhere in this section of this final rule, 
that ACOs and other interested parties need time to evaluate the impact 
of the proposed revised assignment methodology, including the new step 
3, and the revised definition of assignable beneficiary, in advance of 
the start of PY 2025. In response to the commenter who requested that 
CMS share ACO-specific modeling and analysis of the impact of the 
expanded window for assignment and the proposed revisions to the 
assignment methodology with sufficient time for review prior to signing 
a participation agreement for entering an agreement period in the 
Shared Savings Program beginning on January 1, 2025, we note that 
elsewhere in our response to comments in this section of this final 
rule, and in the Regulatory Impact Analysis (see section VI.E.10. of 
this final rule), we describe additional analysis we have undertaken to 
estimate the impact of these proposals on ACOs, including on their 
financial performance and assigned beneficiary populations. We also 
provide ACOs with an estimate of their total number of assigned 
beneficiaries during the application cycle which the ACO can review 
prior to signing a participation agreement for entering a new agreement 
period.
    We also decline to adopt an alternative approach whereby currently 
participating ACOs could elect to have beneficiaries assigned to them 
only under the current assignment methodology until those ACOs enter a 
new agreement period on or after January 1, 2025. The Shared Savings 
Program's longstanding approach is to implement changes to the 
assignment methodology on a performance year basis, and as we describe 
elsewhere in section III.G.3.a.(2)(e) of this final rule, we believe it 
is necessary to maintain symmetry between the assignment methodology 
and the definition of an assignable beneficiary to avoid programmatic 
inconsistencies that may result in inaccurate benchmarks. Furthermore, 
we have particular concern about allowing ACOs to ``opt in'' to certain 
policies that may affect updates and adjustments to their benchmark 
within an agreement period, as this would create an opportunity for 
selective behavior without the counterbalance of benchmark rebasing and 
would introduce significant operational complexity.
    Comment: One commenter generally expressed its belief that the 
``gold standard'' for assignment is always voluntary, prospective 
patient attribution, which both empowers patients by placing them at 
the center of their healthcare decision making and helps providers 
proactively manage care for the patients they know they are responsible 
for.
    Response: We re-emphasize, as described in the background for our 
proposals in the CY 2024 PFS proposed rule (see section III.G.3.a.(1) 
of this final rule), that assignment for purposes of the Shared Savings 
Program in no way implies any limits, restrictions, or diminishment of 
the rights of Medicare FFS beneficiaries to exercise freedom of choice 
in the physicians and other health care practitioners from whom they 
receive covered services. To the extent that the commenter may have 
been referencing the non-claims-based process for voluntary alignment 
that applies to all Shared Savings Program ACOs and is used to 
supplement claims-based assignment (as specified in Sec.  425.402(e)), 
we reiterate that the proposed changes would not change the fact that 
beneficiary voluntary alignment supersedes claims-based assignment.
    Comment: A few commenters suggested changes to increase the extent 
to which assignment may be based upon services by non-physician 
practitioners. Specifically, a few commenters suggested that CMS 
exercise the waiver authority under section 1899(f) of the Act to waive 
the statutory requirement under section 1899(c)(1)(A) of the Act that 
beneficiaries be assigned to an ACO based on their use of primary care 
services furnished by physicians participating in the ACO, which is the 
basis for the assignment methodology's pre-step requirement. These 
commenters suggested that CMS allow beneficiaries to be assigned based 
on their receipt of primary care services provided by an NP, PA, or CNS 
who is an ACO professional. One commenter urged CMS to work with 
Congress to remove the physician-centric assignment language in section 
1899 of the Act, a change which the commenter noted they believe would 
allow for simplification of the beneficiary assignment process.
    Response: Section 1899(f) of the Act provides that the Secretary 
may waive such requirements of sections 1128A and 1128B and title XVIII 
of the Act as may be necessary to carry out the provisions of section 
1899 of the Act. Section 1899(c)(1) of the Act, as amended by the CURES 
Act and the Bipartisan Budget Act of 2018, provides that the Secretary 
shall determine an appropriate method to assign Medicare FFS 
beneficiaries to an ACO based on their utilization of primary care 
services provided by physicians in the ACO and, in the case of 
performance years beginning on or after January 1, 2019, services 
provided by a FQHC or RHC. We continue to believe that assigning 
beneficiaries to an ACO based on their receipt of primary care services 
furnished by physicians participating in the ACO is consistent with 
section 1899 of the Act, and that, to be consistent with that section, 
a claims-based assignment methodology must include a requirement that a 
beneficiary assigned to an ACO have received a primary care service 
from a physician participating in the ACO. We thank the commenters for 
their suggestion regarding possible future statutory changes to the 
beneficiary assignment requirements.
    Comment: Several commenters responded to our request for comments 
on additional policies we should consider for potential future 
rulemaking on our assignment methodology, with the goal of increasing 
the number of Original Medicare FFS beneficiaries assigned to an ACO, 
particularly in underserved communities.
    One commenter suggested lowering the minimum number of assigned 
beneficiaries required to support participation among smaller ACOs. A 
few commenters suggested changes to the voluntary alignment 
methodology, including the use of a paper process for beneficiaries to 
identify their primary care provider. One commenter also requested that 
voluntary alignment be a quarterly process and that CMS ``confirm the 
selection through data.''
    A few commenters made several recommendations to address concerns 
about assignment of beneficiaries receiving facility-based care (such 
as long-term care from a nursing facility, or short-term rehabilitative 
and skilled care in nursing facilities), and specifically about 
beneficiaries who have recently transitioned from receiving care from 
community-based primary care practitioners to facility-based primary 
care practitioners. One commenter, an ACO that exclusively serves 
Medicare beneficiaries who are long-term residents of nursing 
facilities, explained that the ACO experiences large year-over-year 
increases in the number of beneficiaries excluded from retrospective 
assignment as the result of the beneficiary already being prospectively 
assigned to another Shared Savings Program ACO or already being 
assigned to another Medicare shared savings initiative. The commenter 
explained that as a result of

[[Page 79162]]

these policies, newly institutionalized beneficiaries are assigned to 
an ACO based on care from their former community-based primary care 
practitioners rather than care from facility-based primary care 
practitioners, creating what the commenter refers to as ``misalignment 
from an accountability of care and value-based care participation 
perspective.'' Similarly, another commenter stated that under current 
Shared Savings Program assignment policies, beneficiaries newly 
admitted to a nursing facility for long-term care are often 
``misaligned'' to their previous community-based primary care 
practitioner because services received from the new nursing facility-
based practitioner are not captured in the assignment window. These 
commenters recommended CMS exclude the Long-Term Institutionalized 
(LTI) population from initial assignment algorithms to prevent ``their 
misalignment to outdated community-based primary care relationships 
that no longer provide care to these LTI beneficiaries,'' and run a 
``separate LTI population assignment process'' that identifies primary 
care physician visits and calculates the plurality of primary care 
services provided in facilities identified by place of service codes 
31, 32, or 33, excluding primary care services provided during a Part A 
Skilled Nursing Facility (SNF) stay. Additionally, the commenters 
requested that CMS provide monthly, detailed beneficiary information to 
ACOs participating under preliminary prospective assignment with 
retrospective reconciliation regarding beneficiaries who received at 
least one primary care service from an ACO provider during the 
performance year and who have been prospectively assigned to ACOs 
participating in other shared savings initiatives or to other Shared 
Savings Program ACOs.
    Response: We appreciate these thoughtful comments in response to 
our comment solicitation. We may consider this information and these 
suggestions to inform future rulemaking.
    After consideration of the public comments, we are finalizing our 
proposal to use an expanded window for assignment in a new step 3 to 
the claims-based assignment process to identify additional 
beneficiaries for ACO assignment (described in section III.G.3.a.(2)(b) 
of this final rule), for performance year 2025 and subsequent 
performance years. Specifically, we are modifying subpart E of the 
Shared Savings Program regulations to specify the revised beneficiary 
assignment methodology. We are specifying the new step 3 in a new 
provision at Sec.  425.402(b)(5). We are also finalizing as proposed 
technical and conforming changes to incorporate the revised 
methodology. We are amending Sec.  425.402(b)(1), describing the 
existing pre-step of the assignment methodology that would remain 
applicable for step 1 and step 2, to refer to the identification of all 
beneficiaries who had ``at least one primary care service during the 
applicable assignment window with a physician who is an ACO 
professional in the ACO and who is a primary care physician as defined 
under Sec.  425.20 or who has one of the primary specialty designations 
included in [Sec.  425.402(c)]'' (emphasis added to reflect revised 
text). In Sec.  425.402(c), which indicates the primary specialty 
designations used in assignment, we are finalizing our proposal to 
specify that the listed specialties will be considered for ACO 
professionals in step 2 (as described in Sec.  425.402(b)(4)) and step 
3 (in the new provision at Sec.  425.402(b)(5)) of the assignment 
methodology. In Sec.  425.400(a)(2)(ii), which generally describes 
quarterly updates to preliminary prospective assignment with 
retrospective reconciliation, we are finalizing our proposal to specify 
that assignment will be updated quarterly based on the most recent 12 
or 24 months of data, as applicable, under the methodology described in 
Sec. Sec.  425.402 and 425.404. Lastly, in Sec.  425.400(a)(3)(i), 
which generally describes prospective assignment of beneficiaries to 
ACOs at the beginning of each benchmark or performance year, we are 
finalizing our proposal to amend the reference that specifies that we 
base prospective assignment on the beneficiary's use of primary care 
services in the most recent 12 months for which data are available, to 
specify instead the beneficiary's use of primary care services in the 
most recent 12 months or 24 months, as applicable, for which data are 
available, using the assignment methodology described in Sec. Sec.  
425.402 and 425.404.
    We are also finalizing our proposed amendments to Sec.  425.20. We 
are finalizing our proposed modifications of the definition of 
``assignable beneficiary'' to be consistent with the use of an expanded 
window for assignment in the new step 3 of the assignment methodology, 
to identify additional beneficiaries to include in the assignable 
population after application of the existing methodology. Specifically, 
we will continue to utilize the criterion in the existing definition, 
under which assignable beneficiary means a Medicare FFS beneficiary who 
receives at least one primary care service with a date of service 
during a specified 12-month assignment window from a Medicare-enrolled 
physician who is a primary care physician or who has one of the 
specialty designations included in Sec.  425.402(c). Further, for 
performance year 2025 and subsequent performance years, a Medicare FFS 
beneficiary who does not meet this requirement but who meets both of 
the following criteria will also be considered an assignable 
beneficiary:
    (1) Receives at least one primary care service with a date of 
service during a specified 24-month expanded window for assignment from 
a Medicare-enrolled physician who is a primary care physician or who 
has one of the specialty designations included in Sec.  425.402(c).
    (2) Receives at least one primary care service with a date of 
service during a specified 12-month assignment window from a Medicare-
enrolled practitioner who is an NP (as defined at Sec.  410.75(b)), PA 
(as defined at Sec.  410.74(a)(2)), or CNS (as defined at Sec.  
410.76(b)).
    We are finalizing our proposed revisions to the definition of 
``assignment window,'' for clarity and consistency, to mean the 12-
month period used to assign beneficiaries to an ACO, or to identify 
assignable beneficiaries, or both. We are also finalizing our proposal 
to add a new definition of ``expanded window for assignment'' to mean 
the 24-month period used to assign beneficiaries to an ACO, or to 
identify assignable beneficiaries, or both that includes the applicable 
12-month assignment window (as defined under Sec.  425.20) and the 
preceding 12 months.
    We are finalizing our proposal to amend provisions in subpart G of 
the Shared Savings Program regulations, within Sec. Sec.  425.652, 
425.654, and 425.656, that refer to the assignment window used to 
identify the assignable beneficiary population in order to incorporate 
references to the approach to using an expanded window for assignment 
in identifying the assignable population for performance year 2025 and 
subsequent performance years. We refer readers to the description of 
these changes, as proposed, in section III.G.3.a.(2)(c) of this final 
rule. Similarly, we are also finalizing our proposal to specify in the 
new provision we are finalizing at Sec.  425.655(b)(1) that the 
assignable population that will be used to calculate average county 
prospective HCC and demographic risk scores for purposes of calculating 
the regional risk score growth cap adjustment factor (refer to section 
III.G.4.b. of this final rule) will be identified for the relevant 
benchmark year or the performance year (as

[[Page 79163]]

applicable) using the assignment window or expanded window for 
assignment that is consistent with the beneficiary assignment 
methodology selected by the ACO for the performance year according to 
Sec.  425.400(a)(4)(ii).

b. Revisions to the Definition of Primary Care Services Used in Shared 
Savings Program Beneficiary Assignment

(1) Background
    Section 1899(c)(1) of the Act, as amended by the CURES Act and the 
Bipartisan Budget Act of 2018, provides that for performance years 
beginning on or after January 1, 2019, the Secretary shall assign 
beneficiaries to an ACO based on their utilization of primary care 
services provided by a physician who is an ACO professional and all 
services furnished by RHCs and FQHCs. However, the statute does not 
specify a list of services considered to be primary care services for 
purposes of beneficiary assignment.
    In the November 2011 final rule (76 FR 67853), we established the 
initial list of services, identified by Current Procedural Terminology 
(CPT) and Healthcare Common Procedure Coding System (HCPCS) codes, that 
we considered to be primary care services. In that final rule, we 
indicated that we intended to monitor CPT and HCPCS codes and would 
consider making changes to the definition of primary care services to 
add or delete codes used to identify primary care services if there 
were sufficient evidence that revisions were warranted. We have updated 
the list of primary care service codes in subsequent rulemaking (refer 
to 80 FR 32746 through 32748; 80 FR 71270 through 71273; 82 FR 53212 
through 53213; 83 FR 59964 through 59968; 85 FR 27582 through 27586; 85 
FR 84747 through 84756; 85 FR 84785 through 84793; 86 FR 65273 through 
65279; 87 FR 69821 through 69825) to reflect additions or modifications 
to the codes that have been recognized for payment under the PFS and to 
incorporate other changes to the definition of primary care services 
for purposes of the Shared Savings Program.
    For the performance year beginning on January 1, 2023, and 
subsequent performance years, we defined primary care services in Sec.  
425.400(c)(1)(vii) for purposes of assigning beneficiaries to ACOs 
under Sec.  425.402 as the set of services identified by the following 
HCPCS/CPT codes:
     CPT codes:
    ++ 96160 and 96161 (codes for administration of health risk 
assessment).
    ++ 99201 through 99215 (codes for office or other outpatient visit 
for the evaluation and management of a patient).
    ++ 99304 through 99318 (codes for professional services furnished 
in a nursing facility; professional services or services reported on an 
FQHC or RHC claim identified by these codes are excluded when furnished 
in a SNF).
    ++ 99319 through 99340 (codes for patient domiciliary, rest home, 
or custodial care visit).
    ++ 99341 through 99350 (codes for evaluation and management 
services furnished in a patient's home).
    ++ 99354 and 99355 (add-on codes, for prolonged evaluation and 
management or psychotherapy services beyond the typical service time of 
the primary procedure; when the base code is also a primary care 
service code under this paragraph (c)(1)(vi)).
    ++ 99421, 99422, and 99423 (codes for online digital evaluation and 
management).
    ++ 99424, 99425, 99426, and 99427 (codes for principal care 
management services).
    ++ 99437, 99487, 99489, 99490 and 99491 (codes for chronic care 
management).
    ++ 99439 (code for non-complex chronic care management).
    ++ 99483 (code for assessment of and care planning for patients 
with cognitive impairment).
    ++ 99484, 99492, 99493 and 99494 (codes for behavioral health 
integration services).
    ++ 99495 and 99496 (codes for transitional care management 
services).
    ++ 99497 and 99498 (codes for advance care planning; services 
identified by these codes furnished in an inpatient setting are 
excluded).
     HCPCS codes:
    ++ G0402 (code for the Welcome to Medicare visit).
    ++ G0438 and G0439 (codes for the annual wellness visits).
    ++ G0442 (code for alcohol misuse screening service).
    ++ G0443 (code for alcohol misuse counseling service).
    ++ G0444 (code for annual depression screening service).
    ++ G0463 (code for services furnished in ETA hospitals).
    ++ G0506 (code for chronic care management).
    ++ G2010 (code for the remote evaluation of patient video/images).
    ++ G2012 and G2252 (codes for virtual check-in).
    ++ G2058 (code for non-complex chronic care management).
    ++ G2064 and G2065 (codes for principal care management services).
    ++ G0317, G0318, and G2212 (code for prolonged office or other 
outpatient visit for the evaluation and management of a patient).
    ++ G2214 (code for psychiatric collaborative care model).
    ++ G3002 and G3003 (codes for chronic pain management).
     Primary care service codes include any CPT code identified 
by CMS that directly replaces a CPT code specified in paragraph 
(c)(1)(vii)(A) of Sec.  425.400 or a HCPCS code specified in paragraph 
(c)(1)(vii)(B) of Sec.  425.400, when the assignment window (as defined 
in Sec.  425.20) for a benchmark or performance year includes any day 
on or after the effective date of the replacement code for payment 
purposes under FFS Medicare.
(2) Revisions
    Based on feedback from ACOs and our further review of the HCPCS and 
CPT codes that are currently recognized for payment under the PFS or 
that we proposed to recognize for payment starting in CY 2024, we 
believe it would be appropriate to amend the definition of primary care 
services used in the Shared Savings Program assignment methodology to 
include certain additional codes and to make other technical changes to 
the definition of primary care services for use in determining 
beneficiary assignment for the performance year starting on January 1, 
2024, and subsequent performance years, in order to remain consistent 
with billing and coding under the PFS.
    We proposed to revise the definition of primary care services used 
for assignment in the Shared Savings Program regulations to include the 
following additions: (1) Smoking and Tobacco-use Cessation Counseling 
Services CPT codes 99406 and 99407; (2) Remote Physiologic Monitoring 
CPT codes 99457 and 99458; (3) Cervical or Vaginal Cancer Screening 
HCPCS code G0101; (4) Office-Based Opioid Use Disorder Services HCPCS 
codes G2086, G2087, and G2088; (5) Complex Evaluation and Management 
services Add-on HCPCS code G2211, if finalized under the Medicare FFS 
payment policy; (6) Community Health Integration (CHI) services HCPCS 
codes GXXX1 and GXXX2, if finalized under the Medicare FFS payment 
policy; (7) Principal Illness Navigation (PIN) services HCPCS codes 
GXXX3 and GXXX4, if finalized under the Medicare FFS payment policy; 
(8) SDOH Risk Assessment HCPCS code GXXX5, if finalized under the 
Medicare FFS payment policy; (9) Caregiver Behavior Management Training 
CPT codes 96202 and 96203, if finalized under the

[[Page 79164]]

Medicare FFS payment policy; and (10) Caregiver Training services CPT 
codes 9X015, 9X016, and 9X017, if finalized under the Medicare FFS 
payment policy. The following provides additional information about the 
HCPCS codes that we proposed to add to the definition of primary care 
services used for purposes of beneficiary assignment:
     Smoking and tobacco-use cessation counseling services CPT 
codes 99406 and 99407: Effective January 1, 2008, CPT codes 99406 
(Smoking and tobacco-use cessation counseling visit; intermediate, 
greater than 3 minutes up to 10 minutes) and 99407 (Smoking and 
tobacco-use cessation counseling visit; intensive, greater than 10 
minutes) were implemented for billing for smoking and tobacco-use 
cessation counseling services. As described in Medicare National 
Coverage Determinations (NCD) Manual, Publication 100-3, chapter 1, 
section 210.4.1, tobacco use remains the leading cause of preventable 
morbidity and mortality in the U.S. and is a major contributor to the 
nation's increasing medical costs. Despite the growing list of adverse 
health effects associated with smoking, more than 45 million U.S. 
adults continue to smoke and approximately 1,200 die prematurely each 
day from tobacco-related diseases. Since these are recognized as 
preventive services,\236\ similar to other preventive services such as 
alcohol misuse screening and counseling (HCPCS codes G0442 and G0443) 
which are currently included in the definition of primary care services 
for purposes of beneficiary assignment, we believe it appropriate to 
include CPT codes that identify counseling to prevent tobacco use in 
the definition of primary care services for purposes of beneficiary 
assignment.
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    \236\ Medicare Learning Network (MLN006559, May 2023) Medicare 
Preventive Services Quick Reference Chart, available at https://www.cms.gov/Medicare/Prevention/PrevntionGenInfo/medicare-preventive-services/MPS-QuickReferenceChart-1.html#TOBACCO.
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     Remote Physiologic Monitoring CPT codes 99457 and 99458: 
Chronic care remote physiologic monitoring (RPM) services involve the 
collection, analysis, and interpretation of digitally collected 
physiologic data, followed by the development of a treatment plan, and 
the managing of a patient under the treatment plan. In the CY 2020 PFS 
final rule (84 FR 62697) we finalized a revised CPT code 99457 (Remote 
physiologic monitoring treatment management services, clinical staff/
physician/other qualified health care professional time in a calendar 
month requiring interactive communication with the patient/caregiver 
during the month; initial 20 minutes) and added CPT code 99458 (Remote 
physiologic monitoring treatment management services, clinical staff/
physician/other qualified health care professional time in a calendar 
month requiring interactive communication with the patient/caregiver 
during the month; additional 20 minutes) to adopt the CPT Editorial 
Panel revised structure for CPT code 99457. The new code structure 
retained CPT code 99457 as a base code that describes the first 20 
minutes of the treatment management services and uses a new add-on code 
to describe subsequent 20-minute intervals of the service. We further 
designated CPT codes 99457 and 99458 as care management services 
because care management services include establishing, implementing, 
revising, or monitoring treatment plans, as well as providing support 
services, and because RPM services include establishing, implementing, 
revising, and monitoring a specific treatment plan for a patient 
related to one or more chronic conditions that are monitored remotely. 
Because these remote therapeutic monitoring services are designated as 
care management services \237\ and because we broadly include care 
management services (for example, CPT codes 99437, 99487, 99489, 99490 
and 99491) in the Shared Savings Program definition of primary care 
services for purposes of beneficiary assignment, we stated in the CY 
2024 PFS proposed rule (88 FR 52451) that we believed CPT codes 99457 
and 99458 should also be included in the definition of primary care 
services for purposes of beneficiary assignment.
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    \237\ Medicare Physician Fee Schedule Care Management Services 
Information, available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Care-Management.
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     Cervical or Vaginal Cancer Screening Code HCPCS code 
G0101: Section 4102 of the Balanced Budget Act of 1997 provides for 
coverage of screening pelvic examinations (including a clinical breast 
examination) for all female beneficiaries, subject to certain frequency 
and other limitations.\238\ Cervical and vaginal cancer screening and 
clinical breast examination are important preventive health care 
services intended to detect early cancer, precancers and sexually 
transmitted infections. HCPCS code G0101 (Cervical or vaginal cancer 
screening; pelvic and clinical breast examination) can be reimbursed by 
Medicare Part B every 2 years. For patients who are considered high 
risk, reimbursement is allowed on an annual basis. Obstetrics/
gynecology and gynecology/oncology are identified as physician 
specialty designations for purposes of identifying primary care 
services furnished to beneficiaries used in assignment operations 
according to Sec.  425.402(c), so we believe it appropriate to use 
wellness and preventive care visits provided by these specialists in 
our definition of primary care services used in assignment. We consider 
these to be a preventive health service that can be provided in a 
primary care setting \239\ similar to the annual wellness visit (AWV) 
HCPCS codes G0438 and G0439, which are already included in the Shared 
Savings Program definition of primary care services used in assignment, 
so we believe that they should be included in the definition of primary 
care services for purposes of beneficiary assignment.
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    \238\ Medicare National Coverage Determination for Screening Pap 
Smears and Pelvic Examinations for Early Detection of Cervical or 
Vaginal Cancers (Pub. No. 100-3, Manual Section 210.2), available at 
https://www.cms.gov/medicare-coverage-database/view/
ncd.aspx?NCDId=185#:~:text=Section%204102%20of%20the%20Balanced%20Bud
get%20Act%20of,beneficiaries%2C%20subject%20to%20certain%20frequency%
20and%20other%20limitations.
    \239\ Medicare Learning Network (MLN006559, May 2023) Medicare 
Preventive Services Quick Reference Chart, available at https://www.cms.gov/Medicare/Prevention/PrevntionGenInfo/medicare-preventive-services/MPS-QuickReferenceChart-1.html#PELVIC.
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     Office-Based Opioid Use Disorder Services HCPCS Codes 
G2086, G2087, and G2088: In the CY 2020 PFS final rule (84 FR 62568), 
we finalized our proposal to establish bundled payments for the overall 
treatment of Opioid Use Disorder (OUD), including management, care 
coordination, psychotherapy, and counseling activities HCPCS codes 
G2086 (Office-based treatment for opioid use disorder, including 
development of the treatment plan, care coordination, individual 
therapy and group therapy and counseling; at least 70 minutes in the 
first calendar month), G2087 (Office-based treatment for opioid use 
disorder, including care coordination, individual therapy and group 
therapy and counseling; at least 60 minutes in a subsequent calendar 
month), and G2088 (Office-based treatment for opioid use disorder, 
including care coordination, individual therapy and group therapy and 
counseling; each additional 30 minutes beyond the first 120 minutes 
(List separately in addition to code for primary procedure)). Refer to 
the CY 2020 PFS final rule (84 FR 62673) for detailed, technical 
discussion regarding the description, payment, and utilization of these 
HCPCS codes.

[[Page 79165]]

    The bundled payment under the PFS for office-based treatment for 
OUD was intended to create an avenue for physicians and other health 
professionals to bill for a bundle of services that is similar to the 
bundled OUD treatment services benefit, but not furnished by an Opioid 
Treatment Program (OTP). By creating a separate bundled payment for 
these services under the PFS, we hoped to incentivize increased 
provision of counseling and care coordination for patients with OUD in 
the office setting, thereby expanding access to OUD care. In the 
proposed rule we noted that use of these codes is limited to only 
beneficiaries diagnosed with OUD and these codes should not be billed 
for beneficiaries who are receiving treatment at an OTP, as we believe 
that would be duplicative since the bundled payments made to OTPs cover 
similar services for the treatment of OUD.
    Because the separately reportable initiating visit requirement for 
the OUD bundle HCPCS codes G2086, G2087 and G2088 is similar to the 
separately reportable initiating visit requirements for chronic care 
management (CCM) services, and behavioral health integration services 
(BHI), as they include overall management and care coordination 
activities, we stated we believed these services should be considered 
primary care services for purposes of beneficiary assignment.\240\ 
Additionally, as we stated in the proposed rule, we anticipated that 
the billing clinician, likely an addiction medicine specialist, would 
manage the patient's overall OUD care, as well as supervise any other 
individuals participating in the treatment, such as those billing 
incident to services of the billing physician or other practitioner, 
which is similar to the requirements related to the furnishing of 
psychiatric collaborative care model (CoCM) services. CCM, BHI, CoCM, 
and alcohol misuse screening and counseling services are included in 
our definition of primary care services, so we believe that HCPCS codes 
G2086, G2087 and G2088 are appropriate to be included in the definition 
of primary care services for purposes of beneficiary assignment. For 
additional clarity, incident to services are services rendered to a 
patient by a provider other than the physician treating the patient 
more broadly, that are an integral, although incidental, part of the 
patient's normal course of diagnosis or treatment of an injury or 
illness. These services are billed as Medicare Part B services, as if 
the original physician personally provided the care using that 
physician's NPI number. As we stated in the proposed rule, we 
anticipated that these services would often be billed by addiction 
specialty practitioners but note that these codes are not limited to 
use by any particular physician or non-physician practitioner 
specialty. Further, since addiction medicine is identified as one of 
the physician specialty designations for purposes of identifying 
primary care services used in assignment operations according to Sec.  
425.402(c)(13), we believed it would be appropriate to include care 
coordination services provided by these specialists in our definition 
of primary care services used for purposes of beneficiary assignment.
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    \240\ Medicare Physician Fee Schedule Office-Based Opioid Use 
Disorder (OUD) Treatment Billing Information, available at https://www.cms.gov/medicare/physician-fee-schedule/office-based-opioid-use-disorder-oud-treatment-billing.
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    We further recognized that OUD bundle HCPCS codes G2086, G2087 and 
G2088 are identified as codes for alcohol and substance abuse-related 
diagnoses that are excluded from Shared Savings Program Claim and Claim 
Line Feeds. Given this, we want to make transparent that ACOs will not 
be able to see the claims that may have been used in assignment for 
beneficiaries receiving OUD services, and possibly not be able to 
identify why certain beneficiaries were assigned to their ACO related 
to these codes.
     Complex Evaluation and Management Services Add-on HCPCS 
Code G2211, if finalized under Medicare FFS payment policy: As 
discussed in section II.F. of the CY 2024 PFS proposed rule (88 FR 
52350 through 88 FR 52356), HCPCS add-on code G2211 (Visit complexity 
inherent to evaluation and management associated with medical care 
services that serve as the continuing focal point for all needed health 
care services and/or with medical care services that are part of 
ongoing care related to a patient's single, serious condition or a 
complex condition. (Add-on code, list separately in addition to office/
outpatient evaluation and management visit, new or established)) can be 
reported in conjunction with office/outpatient (O/O) evaluation and 
management (E/M) visits to better account for additional resources 
associated with primary care, or similarly ongoing medical care related 
to a patient's single, serious condition, or complex condition (84 FR 
62854 through 62856, 85 FR 84571). Section 113 of Division CC of the 
Consolidated Appropriations Act, 2021 (Pub. L. 116-260, December 27, 
2020) imposed a moratorium on Medicare payment for this service by 
prohibiting CMS from making payment under the PFS for inherently 
complex E/M visits described by HCPCS code G2211 (or any successor or 
substantially similar code) before January 1, 2024. The moratorium on 
Medicare payment under the PFS for HCPCS code G2211 will end on 
December 31, 2023, therefore we proposed to make HCPCS code G2211 
separately payable effective January 1, 2024. Refer to section II.E of 
this final rule for finalized detailed, technical discussion regarding 
the description, payment, and utilization of this HCPCS code.
    Since HCPCS code G2211 is an add-on code used in conjunction with 
O/O E/M services and such services are included in our definition of 
primary care services, we stated in the CY 2024 PFS proposed rule that 
we believed that the proposed inclusion of HCPCS code G2211 is 
consistent with our intent to encompass primary care and wellness 
services in the definition of primary care services used for purposes 
of beneficiary assignment.
     Community Health Integration Services HCPCS Codes GXXX1 
and GXXX2, if finalized under Medicare FFS payment policies: In section 
II.E of the proposed rule (88 FR 52307 through 88 FR 52350), we 
proposed separate coding, payment, service elements and documentation 
requirements for the following CHI services:
    GXXX1 Community health integration (CHI) services performed by 
certified or trained auxiliary personnel including a community health 
worker, under the direction of a physician or other practitioner; 60 
minutes per calendar month, in the following activities to address 
social determinants of health (SDOH) need(s) that are significantly 
limiting ability to diagnose or treat problem(s) addressed in an 
initiating E/M visit:
     Person-centered assessment, performed to better 
understand the individualized context of the intersection between the 
SDOH need(s) and problem(s) addressed in the initiating E/M visit.
    ++ Conducting a person-centered assessment to understand patient's 
life story, strengths, needs, goals, preferences and desired outcomes, 
including understanding cultural and linguistic factors.
    ++ Facilitating patient-driven goal-setting and establishing an 
action plan.
    ++ Providing tailored support to the patient as needed to 
accomplish the practitioner's treatment plan.
     Practitioner, Home, and Community-Based Care Coordination

[[Page 79166]]

    ++ Coordination with practitioner; home, and community-based 
service providers; and caregiver (if applicable).
    ++ Communication with practitioners, home- and community-based 
service providers, hospitals, and skilled nursing facilities (or other 
health care facilities) regarding the patient's psychosocial strengths 
and needs, functional deficits, goals, preferences, and desired 
outcomes, including cultural and linguistic factors.
    ++ Coordination of care transitions between and among health care 
practitioners and settings, including transitions involving referrals 
to other clinicians; follow-up after an emergency department visit; or 
follow-up after discharges from hospitals, skilled nursing facilities 
or other health care facilities.
    ++ Facilitating access to community-based social services (e.g., 
housing, utilities, transportation, food assistance) to address SDOH 
need(s).
     Health education- Helping the patient contextualize health 
education provided by the patient's treatment team with the patient's 
individual needs, goals, and preferences, in the context of the SDOH 
need(s), and educating the patient on how to best participate in 
medical decision-making.
     Building patient self-advocacy skills, so that the patient 
can interact with members of the health care team and related 
community-based services addressing the SDOH need(s), in ways that are 
more likely to promote personalized and effective diagnosis and 
treatment.
     Health care access/health system navigation:
    ++ Helping the patient access care, including identifying 
appropriate practitioners or providers for clinical care and helping 
secure appointments with them.
     Facilitating behavioral change as necessary for meeting 
diagnosis and treatment goals, including promoting patient motivation 
to participate in care and reach person-centered diagnosis or treatment 
goals.
     Facilitating and providing social and emotional support to 
help the patient cope with the problem(s) addressed in the initiating 
visit, the SDOH need(s), and adjust daily routines to better meet 
diagnosis and treatment goals.
    GXXX2--Community health integration services, each additional 30 
minutes per calendar month (List separately in addition to GXXX1).
    As described in section II.E of the proposed rule, all auxiliary 
personnel who provide CHI services must be certified or trained to 
perform all included service elements and authorized to perform them 
under applicable State laws and regulations. Under Sec.  410.26(a)(1) 
of our regulations, auxiliary personnel must meet any applicable 
requirements to provide incident to services, including licensure, 
imposed by the State in which the services are being furnished.\241\ A 
billing practitioner may arrange to have CHI services provided by 
auxiliary personnel external to, and under contract with, the 
practitioner or their practice, such as through a community-based 
organization (CBO) that employs CHWs, if all of the ``incident to'' and 
other requirements and conditions for payment of CHI services are met. 
The payment policy described in section II.E of this final rule 
explains that we would expect the auxiliary personnel performing the 
CHI services to communicate regularly with the billing practitioner to 
ensure that CHI services are appropriately documented in the medical 
record, and to continue to involve the billing practitioner in 
evaluating the continuing need for CHI services to address the SDOH 
need(s) that limit the practitioner's ability to diagnose and treat the 
problem(s) addressed in the initiating visit. Refer to section II.E of 
this final rule for the finalized detailed, technical discussion 
regarding the proposed description, payment and utilization of these 
HCPCS codes.
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    \241\ CHW Roles As Outlined In The C3 Project available at 
https://chwtraining.org/c3-project-chw-skills/.
---------------------------------------------------------------------------

    Since the proposal described in section II.E. of the proposed rule 
proposed to designate CHI services as care management services that may 
be furnished under general supervision under Sec.  410.26(b)(5) and 
because we broadly include care management services in the definition 
of primary care services used for purposes of beneficiary assignment, 
we stated that we believed it would be similarly appropriate to include 
CHI services in the list of primary care services used for purposes of 
beneficiary assignment. Additionally, since CHI services require an 
initiating E/M visit and these services can be billed as incident to by 
the billing practitioner who bills for the CHI initiating E/M visit, 
and E/M services are currently included in the list of primary care 
services used for purposes of beneficiary assignment, we also stated 
that we believed it would be similarly appropriate to include CHI 
services in the list of primary care services used for purposes of 
beneficiary assignment.
     Principal Illness Navigation (PIN) Services HCPCS codes 
GXXX3 and GXXX4, if finalized under Medicare FFS payment policies: In 
section II.E of the proposed rule, we proposed new coding for Principal 
Illness Navigation (PIN) services. In considering the appropriate 
patient population to receive these services, we considered the patient 
population eligible for principal care management service codes (CPT 
codes 99424 through 99427), as well as clinical definitions of 
``serious illness.'' For example, one peer-review study defined 
``serious illness'' as a health condition that carries a high-risk of 
mortality and either negatively impacts a person's daily function or 
quality of life, or excessively strains their caregivers.\242\ Another 
study describes a serious illness as a health condition that carries a 
high-risk of mortality and commonly affects a patient for several 
years, while some measure serious illness by the amount of urgent 
health care use (911 calls, emergency department visits, repeated 
hospitalizations) and polypharmacy.\243\ The navigation services such 
patients need are similar to CHI services, SDOH need(s) may be fewer or 
not present. Accordingly, a parallel set of services focused on 
patients with a serious, high-risk illness who may not necessarily have 
SDOH-related needs was proposed. PIN services could be furnished 
following an initiating E/M visit addressing a single high-risk 
disease.
---------------------------------------------------------------------------

    \242\ Kelley AS, Bollens-Lund E., Identifying the Population 
with Serious Illness: The ``Denominator'' Challenge. J Palliat Med. 
2018 Mar;21(S2): S7-S16. doi: 10.1089/jpm.2017.0548. Epub 2017 Nov 
10. PMID: 29125784; PMCID: PMC5756466. available at https://pubmed.ncbi.nlm.nih.gov/29125784/.
    \243\ Silver, Alison. Serious Illness: A High Priority for 
Accountable Care. The American Journal of Accountable Care. 
2020;8(2):32-33. available at https://www.ajmc.com/view/serious-illness-a-high-priority-for-accountable-care.
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    The following codes would be reported for PIN services:
    GXXX3 Principal Illness Navigation services by certified or trained 
auxiliary personnel under the direction of a physician or other 
practitioner, including a patient navigator or certified peer 
specialist; 60 minutes per calendar month, in the following activities:
     Person-centered assessment, performed to better understand 
the individualized context of the serious, high-risk condition.
    ++ Conducting a person-centered assessment to understand the 
patient's life story, needs, goals, preferences, and desired outcomes, 
including understanding cultural and linguistic factors.

[[Page 79167]]

    ++ Facilitating patient-driven goal setting and creating an action 
plan.
    ++ Providing tailored support as needed to accomplish the 
practitioner's treatment plan.
     Identifying or referring patient (and caregiver or family, 
if applicable) to appropriate supportive services.
     Practitioner, Home, and Community-Based Care Coordination
    ++ Coordinating receipt of needed services from healthcare 
practitioners, providers and facilities; home-, and community-based 
service providers; and caregiver (if applicable).
    ++ Communication with practitioners, home-, and community-based 
service providers, hospitals, and skilled nursing facilities (or other 
health care facilities) regarding the patient's psychosocial strengths 
and needs, functional deficits, goals, and preferences, including 
cultural and linguistic factors.
    ++ Coordination of care transitions between and among health care 
practitioners and settings, including transitions involving referrals 
to other clinicians; follow-up after an emergency department visit; or 
follow-up after discharges from hospitals, skilled nursing facilities 
or other health care facilities.
    ++ Facilitating access to community-based social services (e.g., 
housing, utilities, transportation, food assistance) as needed to 
address SDOH need(s).
     Health education- Helping the patients contextualize 
health education provided by the patient's treatment team with the 
patient's individual needs, goals, preferences, and SDOH need(s), and 
educating the patient (and caregiver, if applicable) on how to best 
participate in medical decision-making.
     Building patient self-advocacy skills, so that the patient 
can interact with members of the health care team and related 
community-based services (as needed), in ways that are more likely to 
promote personalized and effective treatment of their condition.
     Health care access / health system navigation.
    ++ Helping the patient access healthcare, identifying appropriate 
practitioners or providers for clinical care and helping secure 
appointments with them.
     Facilitating behavioral change necessary for meeting 
diagnosis and treatment goals, including promoting patient motivation 
to participate in care and reach person-centered diagnosis or treatment 
goals.
     Facilitating and providing social and emotional support 
for the patient to help the patient cope with the condition, SDOH 
need(s), and adjust daily routines to better meet diagnosis or 
treatment goals.
     Leverage knowledge of the serious, high-risk condition 
and/or lived experience when applicable to provide support, mentorship, 
or inspiration to meet treatment goals.
    GXXX4--Principal Illness Navigation services, additional 30 minutes 
per calendar month (List separately in addition to GXXX3).
    As discussed in section II.E of the proposed rule, a billing 
practitioner may arrange to have PIN services provided by auxiliary 
personnel who are external to, and under contract with, the 
practitioner or their practice, such as through a community-based 
organization (CBO) that employs CHWs, if all of the ``incident to'' and 
other requirements and conditions for payment of PIN services are met. 
We will expect the auxiliary personnel performing the PIN services to 
communicate regularly with the billing practitioner to ensure that PIN 
services are appropriately documented in the medical record, and to 
continue to involve the billing practitioner in evaluating the 
continuing need for PIN services to address the serious, high-risk 
condition. Refer to section II.E of this final rule for finalized 
detailed, technical discussion regarding the description, payment and 
utilization of these HCPCS codes.
    Since the proposal described in section II.E. of the proposed rule 
proposed to designate PIN services as care management services that may 
be furnished under general supervision under Sec.  410.26(b)(5) and 
because we broadly include care management services in the list of 
primary care services used for purposes of beneficiary assignment, we 
believed it would be similarly appropriate to include PIN services in 
the list of primary care services used for purposes of beneficiary 
assignment. Additionally, since these services are meant to provide 
assistance to the beneficiary through communication and coordination 
with practitioners, providers, including referrals to other clinicians 
and follow-up after emergency or inpatient care, we stated in the CY 
2024 PFS proposed rule that we believed that these services can further 
the ACO's goal of care coordination and the provision of value-based 
care, and therefore, should be included in the definition of primary 
care services for purposes of beneficiary assignment. Further, since 
PIN services require an initiating E/M visit and these services can be 
billed as incident to by the billing practitioner who bills for the PIN 
initiating E/M visit, and E/M services are currently included in the 
list of primary care services used for purposes of beneficiary 
assignment, we stated that we believed it would be similarly 
appropriate to include PIN services in the list of primary care 
services used for purposes of beneficiary assignment.
     SDOH Risk Assessment HCPCS code GXXX5, if finalized under 
Medicare FFS payment policies: In section II.E of the proposed rule, we 
proposed a new stand-alone G code, GXXX5 (administration of a 
standardized, evidence-based Social Determinants of Health Risk 
Assessment tool, 5-15 minutes, at most every 6 months.) to identify and 
value the work involved in the utilization of SDOH risk assessment as 
part of a comprehensive social history when medically reasonable and 
necessary in relation to an E/M visit. SDOH risk assessment through a 
standardized, evidence-based tool can more effectively and consistently 
identify unmet SDOH needs and enables comparisons across populations. 
The SDOH risk assessment must be furnished by the practitioner on the 
same date they furnish an E/M visit, as the SDOH assessment would be 
reasonable and necessary when used to inform the patient's treatment 
plan that is established during the visit. Finalized required elements 
are described in detail in the payment policy described in section II.E 
of this final rule.
    Under the proposal described in section II.E. of the proposed rule 
(88 FR 52307 through 88 FR 52350), the practitioner billing or 
furnishing the SDOH risk assessment would be required to have the 
ability to furnish CHI or other care management services. Given the 
multifaceted nature of SDOH needs, ensuring adequate referral to 
appropriate services and supports is critical for addressing both the 
SDOH need and the impact of that need on the patient's health. Refer to 
section II.E and III.R of this final rule for finalized detailed, 
technical discussion regarding the description, payment, and 
utilization of this HCPCS code.
    Additionally, the proposal detailed in section III.S. of the 
proposed rule (88 FR 52548 through 88 FR 52553) proposed to add 
elements to the AWV by adding a new SDOH Risk Assessment as an 
optional, additional element with an additional payment. Under that 
proposal, the SDOH Risk Assessment would be separately payable with no 
beneficiary cost sharing when furnished as part of the same visit with 
the same date of service as the AWV and would inform the care the 
patient is receiving during the visit, including taking a medical and 
social history, applying health assessments, and conducting

[[Page 79168]]

prevention services education and planning.
    Since the proposals described in sections II.E. and III.S. of the 
proposed rule proposed that these services would be provided in 
conjunction with professional services, such as E/M visits, which can 
be provided in a primary care setting, we stated in the proposed rule 
that we believed it would be appropriate to include these services in 
the definition of primary care services for purposes of beneficiary 
assignment. Additionally, since these are separately payable services 
when provided with an AWV and the AWV is included in the Shared Savings 
Program definition of primary care services for purposes of beneficiary 
assignment, we stated we believed it would be appropriate to include 
SDOH risk assessment in the definition of primary care services for 
purposes of beneficiary assignment. Further, since these services 
precede the utilization of CHI, PIN, and Care Management services, 
which are either currently included or proposed to be included in the 
definition of primary care services for purposes of assignment, we 
stated that we believed the inclusion of the new SDOH risk assessment 
HCPCS code would be appropriate as well.
     Caregiver Behavior Management Training CPT Codes 96202 and 
96203, if finalized under Medicare FFS payment policy: CPT code 96202 
(Multiple-family group behavior management/modification training for 
guardians/caregivers of patients with a mental or physical health 
diagnosis, administered by physician or other qualified health care 
professional (without the patient present), face-to-face with multiple 
sets of guardians/caregivers; initial 60 minutes) and its add-on code, 
CPT code 96203 (Multiple-family group behavior management/modification 
training for guardians/caregivers of patients with a mental or physical 
health diagnosis, administered by physician or other qualified health 
care professional (without the patient present), face-to-face with 
multiple sets of guardians/caregivers; each additional 15 minutes (List 
separately in addition to code for primary service)) are two new codes 
created by the CPT Editorial Panel during its February 2021 meeting 
used to report the total duration of face-to-face time spent by the 
physician or other qualified health professional providing group 
training to guardians or caregivers of patients. Although the patient 
does not attend the group trainings, the goals and outcomes of the 
sessions focus on interventions aimed at improving the patient's daily 
life.
    In section II.E. of the proposed rule, an active payment status for 
CPT codes 96202 and 96203 (caregiver behavior management/modification 
training services) was proposed for CY 2024. These codes allow treating 
practitioners to report training furnished to a caregiver, in tandem 
with the diagnostic and treatment services furnished directly to the 
patient, in strategies and specific activities to assist the patient to 
carry out the treatment plan. Caregiver behavior management/
modification training services may be reasonable and necessary when 
they are integral to a patient's overall treatment and furnished after 
the treatment plan (or therapy plan of care) is established. The 
caregiver behavior management/modification training services themselves 
need to be congruent with the treatment plan to effectuate the desired 
patient outcomes.
    For purposes of caregiver behavior management/modification training 
services, our proposal required that a caregiver receiving behavior 
management/modification training services be a family member, friend, 
or neighbor who provides unpaid assistance to the patient, assisting or 
acting as a proxy for a patient with an illness or condition of short 
or long-term duration (not necessarily chronic or disabling). In this 
context, caregivers would be trained by the treating practitioner in 
strategies and specific activities that improve symptoms, functioning, 
adherence to treatment, and/or general welfare related to the patient's 
primary clinical diagnoses. Under the proposal, caregiver behavior 
management/modification training services could be furnished directly 
by the treating practitioner or provided by auxiliary personnel 
incident to the treating practitioner's professional services as 
specified in Sec.  410.26, as applicable for the types of practitioners 
whose covered services include ``incident to'' services. Refer to 
section II.E of this final rule for finalized detailed, technical 
discussion regarding the description, payment, and utilization of these 
CPT codes.
    Since the proposal described in section II.E. of the proposed rule 
proposed that these services could be billed as incident to by the 
billing practitioner who could be a primary care physician who also 
bills for an E/M visit, and these services cannot duplicate services 
provided in conjunction with transitional care management, CCM, BHI 
services, and virtual check-in services which are currently included in 
the list of primary care services used for purposes of beneficiary 
assignment, we stated in the proposed rule that we believed that these 
services should be included in the definition of primary care services 
for purposes of beneficiary assignment in support of the Shared Savings 
Program's goal to provide coordinated, high quality care to an ACO's 
Medicare beneficiaries.
     Caregiver Training Services CPT codes 9X015, 9X016, and 
9X017, if finalized under Medicare FFS payment policy: CPT codes 9X015 
(Caregiver training in strategies and techniques to facilitate the 
patient's functional performance in the home or community (e.g., 
activities of daily living [ADLs], instrumental ADLs [IADLs], 
transfers, mobility, communication, swallowing, feeding, problem 
solving, safety practices) (without the patient present), face-to-face; 
initial 30 minutes), add-on code, CPT code 9X016 (each additional 15 
minutes (List separately in addition to code for primary service) (Use 
9X016 in conjunction with 9X015)), and 9X017 (Group caregiver training 
in strategies and techniques to facilitate the patient's functional 
performance in the home or community (e.g., activities of daily living 
[ADLs], instrumental ADLs [IADLs], transfers, mobility, communication, 
swallowing, feeding, problem solving, safety practices) (without the 
patient present), face-to-face with multiple sets of caregivers) are 
new codes created by the CPT Editorial Panel during its October 2022 
meeting. The three codes are to be used to report the total duration of 
face-to-face time spent by the physician or other qualified health 
professional providing individual or group training to caregivers of 
patients. Although the patient does not attend the trainings, the goals 
and outcomes of the sessions focus on interventions aimed at improving 
the patient's ability to successfully perform activities of daily 
living (ADLs). Activities of daily living generally include ambulating, 
feeding, dressing, personal hygiene, continence, and toileting.
    These codes allow treating practitioners to report the training 
furnished to a caregiver, in tandem with the diagnostic and treatment 
services furnished directly to the patient, in strategies and specific 
activities to assist the patient to carry out the treatment plan. As 
discussed above, we believe training furnished to a caregiver may be 
reasonable and necessary when it is integral to a patient's overall 
treatment and furnished after the treatment plan (or therapy plan of 
care) is established. The Caregiver Training Services (CTS) themselves 
need to be congruent with the treatment plan to effectuate the desired 
patient outcomes, especially in medical treatment scenarios where the

[[Page 79169]]

caregiver receiving CTS is necessary to ensure a successful treatment 
outcome for the patient.
    In section II.E. of the proposed rule, we proposed an active 
payment status for CPT codes 9X015, 9X016, and 9X017 for CY 2024. CTS 
may be furnished directly by the treating practitioner or provided by 
auxiliary personnel incident to the treating practitioner's 
professional services as specified in 42 CFR 410.26, as applicable for 
the types of practitioners whose covered services include ``incident 
to'' services. Under the proposal, 9X015, 9X016, and 9X017 would be 
designated as ``sometimes therapy.'' This means that the services 
represented by these codes are always furnished under a therapy plan of 
care when provided by PTs, OTs, and SLPs; but, in cases where they are 
appropriately furnished by physicians and NPPs outside a therapy plan 
of care (that is, where the services are not integral to a therapy plan 
of care), they can be furnished under a treatment plan by physicians 
and NPPs. Refer to section II.E of this final rule for finalized, 
detailed, technical discussion regarding the description, payment, and 
utilization of these HCPCS codes.
    The proposal described in section II.E. of the proposed rule 
proposed that these services could be billed as incident to by the 
billing practitioner who could be a primary care physician who also 
bills for an E/M visit. Additionally, these services cannot duplicate 
services provided in conjunction with transitional care management, 
CCM, BHI services, and virtual check-in services which are currently 
included in the list of primary care services used for purposes of 
beneficiary assignment and these services are reported to Medicare only 
when furnished in conjunction with treatment for particular conditions 
and reflected in a plan of care. In the proposed rule, we stated that 
we believed they should be included in the definition of primary care 
services for purposes of beneficiary assignment in support of the 
Shared Savings Program's goal to give coordinated, high quality care to 
an ACO's Medicare beneficiaries.
    We proposed to specify a revised definition of primary care 
services in a new provision of the Shared Savings Program regulations 
at Sec.  425.400(c)(1)(viii) to include the list of HCPCS and CPT codes 
specified in Sec.  425.400(c)(1)(vii) along with the proposed 
additional CPT codes 99406 and 99407, and 99457 and 99458, 96202 and 
96203, if finalized under the Medicare FFS payment policy; and 9X015, 
9X016, and 9X017, if finalized under the Medicare FFS payment policy 
and HCPCS codes G0101; G2086, G2087, and G2088; G2211, if finalized 
under the Medicare FFS payment policy; GXXX1 and GXXX2, if finalized 
under Medicare FFS payment policy; GXXX3 and GXXX4, if finalized under 
the Medicare FFS payment policy; and GXXX5, if finalized under the 
Medicare FFS payment policy; as discussed in the preceding paragraphs. 
We proposed that the new provision at Sec.  425.400(c)(1)(viii) would 
be applicable for use in determining beneficiary assignment for the 
performance year starting on January 1, 2024, and subsequent 
performance years.
    We solicited comments on these proposed changes to the definition 
of primary care services used for assigning beneficiaries to Shared 
Savings Program ACOs for the performance year starting on January 1, 
2024, and subsequent performance years. We also solicited comments on 
any other existing HCPCS or CPT codes and new HCPCS or CPT codes 
proposed elsewhere in this final rule that we should consider adding to 
the definition of primary care services for purposes of assignment in 
future rulemaking.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Most commenters were supportive of our proposal to add the 
following codes to the definition of primary care services used in 
assignment: (1) Smoking and Tobacco-use Cessation Counseling Services 
CPT codes 99406 and 99407; (2) Cervical or Vaginal Cancer Screening 
HCPCS code G0101; (3) Visit complexity inherent to evaluation and 
management services add-on (referred to as Complex Evaluation and 
Management Services Add-on in the proposed rule) HCPCS code G2211; (4) 
CHI services HCPCS codes GXXX1 and GXXX2; (5) PIN services HCPCS codes 
GXXX3 and GXXX4; (6) Caregiver Behavior Management Training CPT codes 
96202 and 96203; (7) Caregiver Training Services CPT codes 9X015, 
9X016, and 9X017; and (8) SDOH Risk Assessment HCPCS code GXXX5. These 
commenters stated that these codes accurately reflect comprehensive, 
coordinated, whole-person primary care.
    Many commenters expressed support for our proposal to include 
caregiver training and SDOH risk assessment services in the definition 
of primary care services used for purpose of beneficiary assignment, 
noting that they work well together with other CMS initiatives and 
further support ACOs in providing comprehensive, coordinated, whole-
person primary care, recognizing the importance of capturing 
information on and screening for SDOH. One commenter recognized that 
considering SDOH risk assessment services in beneficiary assignment 
could potentially improve the health of a wide swath of Medicare 
beneficiaries by increasing access to social determinants of health 
risk assessments and ``making them more affordable''.
    One commenter stated their support for inclusion of several 
behavioral health services, sexual and reproductive health-related 
services, and several team-based care services as these additions would 
help primary care practices in ACOs continue to move closer to 
providing whole-patient, comprehensive primary care.
    Response: We agree with commenters who recognize that our proposal 
to revise the definition of primary care services used for assignment 
will align well with other CMS initiatives, specifically those that 
promote health equity, and will help primary care practices to continue 
to move closer to providing whole-patient, comprehensive primary care. 
Without additional context, it is not clear how the inclusion of a 
service in the definition of primary care services used for Shared 
Savings Program beneficiary assignment would be likely to make a 
particular included service more affordable for beneficiaries. We 
interpret the comment from the commenter who supports inclusion of 
several behavioral health services, sexual and reproductive health-
related services, and several team-based care services to be referring 
to our proposals related to smoking and tobacco-use cessation 
counseling services, cervical or vaginal cancer screening, OUD 
services, PIN services, CHI services, SDOH risk assessment services, 
and caregiver behavior management training services, and caregiver 
training services, and we appreciate this commenter's support.
    Comment: Many commenters, while stating their support for the 
inclusion of the codes proposed, also urged CMS to continue to monitor 
the impact of expanding the definition of primary care services to 
include the ``additional PFS codes'', and to respond to any identified 
unintended consequences and consider changes to mitigate any unintended 
consequences in a timely manner. Several commenters urged CMS not to 
move forward with the proposal to expand the list of primary care 
services/codes in beneficiary assignment, stating many of the proposed 
codes would be new codes to the CY 2024 PFS and it is unclear what 
redistributive impact the proposed codes would have on assignment and 
encouraged CMS to perform additional analysis on potential

[[Page 79170]]

impact of this policy and allow for an appropriate phase-in period. 
Another commenter recommended ``thorough, multi-year testing to ensure 
that patients are not aligned to ACOs strictly because of billing 
practices by clinicians unsuited for patient care coordination''. One 
commenter recommended a ``phase-in period to better understand how the 
expanded beneficiary population will impact care delivery and financial 
assumptions''. The commenter stated that for some ACOs, this newly 
attributed population may represent a higher risk/acuity with ``no 
growth option for the ACO's risk score to accurately reflect the change 
resulting from a CMS rule''. Another commenter did not support the 
inclusion of the code for SDOH risk assessment as it does not have 
utilization history and so they noted it is premature to use it in 
assignment under in the Shared Savings Program.
    Response: As described in our proposed rule, we consider these 
codes to be primary care and wellness services that fit within the 
definition of primary care services. It is important for the definition 
of primary care services used for purposes of beneficiary assignment to 
remain in sync with billing and coding updates and changes and include 
appropriate new CPT and HCPCS codes as they are implemented. Waiting 
for a phase-in of new assignment codes or conducting multi-year testing 
of codes could result in beneficiaries not being assigned to an ACO 
based on primary care services that are provided by their primary care 
provider as utilization of these services is implemented. Implementing 
billing and coding updates and changes as they are finalized under the 
PFS is important for purposes of assignment to ensure that 
beneficiaries are assigned appropriately as services billed shifts from 
already existing CPT/HCPCS codes to new CPT/HCPCS codes. If the Shared 
Savings Program is out of sync with changes and updates, assignment of 
beneficiaries could be inaccurate. Commenters were not specific in 
discussing unintended consequences that could occur should these 
services be added to the definition of primary care services used in 
beneficiary assignment. Therefore, we do not know what consequences 
they are concerned about and so we are not persuaded by these comments.
    With regard to the commenter concerned that adding these codes will 
result in the assignment of higher risk beneficiaries to the ACO and 
that the higher risk profile of these beneficiaries will not be full 
recognized as a result of the cap on an ACO's risk score growth during 
an agreement period, we note that the Shared Savings Program uses the 
CMS-HCC prospective risk adjustment model which adjusts for changes in 
severity and case mix and accounts for differences in health status of 
an ACO's assigned beneficiary population between the benchmark and 
performance years. Additionally, adding these codes in conjunction with 
other risk adjustment policies finalized in this rule (section III.G.4) 
would help mitigate impacts on the cap on prospective HCC risk score 
growth, and we are providing these updates to increase accountable care 
for beneficiaries. For more information on risk adjustment in the 
Shared Savings Program, please review the Shared Savings and Losses, 
Assignment and Quality Performance Standard Methodology Specifications, 
Version 11.\244\ Commenters did not go into detail regarding what 
redistributive impacts could be or what specifically could be impacted 
and so we are not persuaded by these comments.
    The SDOH Risk Assessment service is an optional, additional element 
of the AWV with an additional payment and no applicable beneficiary 
cost sharing, and the AWV is included in the definition of primary care 
services used for purposes of assignment. Additionally, we note that 
these services precede the inclusion of current services included in 
the definition of PCS for purposes of assignment, which are already 
included in the definition of primary care services for purposes of 
assignment. Accordingly, we are not persuaded by the comment suggesting 
we should not include this service in the definition of primary care in 
light of its limited utilization history.
    In section II.E of this final rule, we also recognize the AWV as an 
initiating visit for PIN services when the AWV is furnished by a 
practitioner who has identified in the AWV a high-risk condition(s) 
that would qualify for PIN services under this rule. The AWV is 
included in the definition of primary care services used for purposes 
of assignment and so provides further rationale for the inclusion of 
PIN services in said definition.
    Additionally, we are not persuaded by the commenters concerns 
suggesting that the proposed additional codes could assign patients to 
ACOs through clinicians unsuited for patient care coordination. For 
example, as described in section II.E of this final rule, we clarified 
that all auxiliary personnel who provide CHI services must be certified 
or trained to perform all included service elements and, as relevant, 
authorized to perform them under applicable State laws and regulations. 
For States that do not have applicable requirements for certification 
and training, it is the billing practitioner's responsibility to ensure 
the auxiliary personnel have been certified and trained in accordance 
with our final requirements.
    Comment: One commenter cautioned that inclusion of the proposed 
codes will lead to assignment based on services furnished by 
specialists who are not positioned to provide comprehensive primary 
care. Another commenter who supported the inclusion of many of the 
codes recommended CMS remember the unique considerations related to 
differentiating assignment between primary care and specialty care 
services as part of beneficiary assignment and asked that CMS monitor 
to ensure the services included in the assignment methodology continue 
to support the delivery of comprehensive, coordinated, whole-person 
primary care and do not have the unintended consequence of disrupting 
ongoing patient-physician relationships.
    Some commenters expressed support for inclusion of all the proposed 
revisions with the exception of the code for cervical or vaginal cancer 
screening since this service is provided by obstetricians or 
gynecologists and including this code in the assignment methodology 
risks shifting assignment away from primary care relationships in favor 
of specialty care. Another commenter urged CMS to consider removing 
tobacco-use cessation counseling services from the list because they 
are concerned that it will assign beneficiaries to the ACO that may not 
accurately reflect patients who are may not be receiving primary care 
services from ACO physicians, as physicians across different 
specialties will provide tobacco-use cessation counseling services. 
Other commenters recommend that we monitor the billing of these codes 
to ensure that their addition is not shifting beneficiary attribution 
away from primary care relationships in favor of specialty care.
    Response: We acknowledge the commenters who opposed or expressed 
concerns about inclusion of some of the codes on the basis that they 
may shifting assignment away from primary care relationships in favor 
of specialty care. Consistent with our current methodology, if services 
billed under these codes are provided by specialists not considered for 
purposes of beneficiary assignment, then the services will not be 
considered in beneficiary assignment.

[[Page 79171]]

    The cervical or vaginal cancer screening preventive health service 
can be provided in a primary care setting similar to the AWV HCPCS 
codes G0438 and G0439, which are already included in the Shared Savings 
Program definition of primary care services used in assignment. 
Additionally, as noted in this section of this final rule, obstetrics/
gynecology and gynecology/oncology are identified as physician 
specialty designations considered for purposes of identifying primary 
care services furnished to beneficiaries used in assignment operations 
according to Sec.  425.402(c), so we are not persuaded by these 
comments.
    Smoking and tobacco-use cessation counseling services are 
recognized as preventive services, like other preventive services such 
as alcohol misuse screening and counseling, the AWV, and depression 
screening, which are currently included in the definition of primary 
care services for purposes of beneficiary assignment. Further, smoking 
and tobacco-use cessation counseling services encourage comprehensive, 
coordinated whole person-centered care and can be provided in a primary 
care setting. Additionally, these services are generally billed in 
conjunction with an E/M visit which is currently included in the 
definition of primary care services. Finally, smoking-related diseases 
are a leading cause of death among individuals with substance use 
disorders, and individuals who treat their addiction to tobacco and 
other substances at the same time are 25 percent more likely to sustain 
their recovery, compared to the individuals who do not address tobacco 
while in recovery from alcohol and other drugs.\245\ In support of the 
CMS' goal to expand mental health services and SUD treatment, we 
believe it to be important for us to recognize these services for 
purposes of beneficiary assignment. For these reasons, and the reasons 
stated in this section of this final rule, we continue to believe they 
should be included in our assignment methodology.
---------------------------------------------------------------------------

    \245\ Lung Cancer Screening Billing Guide Addendum for 
Behavioral Health available at https://www.lung.org/getmedia/5adda30d-6738-4e3e-8666-621cc5120d4d/ala-billing-guide-addendum.pdf.
---------------------------------------------------------------------------

    Comment: Some commenters expressed opposition to the inclusion of 
the office-based OUD services until CMS includes these codes in the 
Claim and Claim Line Feeds (CCLFs) provided to ACOs and further 
advocated for CMS to provide them with timely, actionable patient data, 
including data for Substance Use Disorder (SUD), to ACOs. One commenter 
described ACOs as still lacking access to vital SUD-related data on 
their patients due to the fact that under current regulations, care 
coordination is not considered by CMS to fall under treatment, payment, 
and health care operations. This commenter stated the CARES Act allows 
sharing of this important data after initial patient consent, which 
will allow CMS to deliver this critical information to providers 
operating in ACOs.
    Response: As described at Sec.  425.708(c), in accordance with 42 
U.S.C. 290dd-2 and the implementing regulations at 42 CFR part 2, CMS 
does not share beneficiary identifiable claims data relating to the 
diagnosis and treatment of alcohol and substance abuse without the 
explicit written consent of the beneficiary. As we explained in the 
June 2015 final rule (80 FR 32741), beneficiary identifiable 
information that is made available under Sec.  425.704 would include 
Parts A, B and D data, but would exclude any information related to the 
diagnosis and treatment of alcohol or substance abuse. As we discussed 
in the April 2011 proposed rule (76 FR 19557), 42 U.S.C. 290dd-2 and 
the implementing regulations at 42 CFR part 2 restrict the disclosure 
of patient records by federally conducted or assisted substance abuse 
programs. Such data may be disclosed only with the prior written 
consent of the patient, or as otherwise provided in the statute and 
regulations. To assist ACOs in identifying the best sources for 
beneficiary medical record data, we provide the ACO with the TIN and 
NPI of the ACO participant and ACO professionals that provided the most 
recent primary care service to the beneficiary on each quarterly 
report. We also provide ACOs deidentified aggregate information related 
to substance use that may be helpful for understanding their patient 
population as described in Sec.  425.702. We encourage ACOs and ACO 
participants to establish their own processes to access patients' 
health information directly, in accordance with applicable laws for 
purposes of care coordination.
    As stated in the proposed rule, the OUD bundle HCPCS codes G2086, 
G2087, and G2088 have similar uses and requirements as other services 
that are included in our definition of primary care services, such as 
CCM, BHI, CoCM and alcohol misuse screening and counseling services and 
as such are appropriate to be included in the definition of primary 
care services for purposes of beneficiary assignment. Specifically, 
these services include the overall management and care coordination of 
beneficiaries being treated for SUD in an office setting.
    Comment: Some commenters supported the proposal to include remote 
physiologic monitoring (RPM) CPT codes 99457 and 99458 and stated their 
belief that inclusion of these codes builds on support already provided 
for digital health (for example, adding G2012 and G2252 codes for 
virtual check-ins). One commenter stated that RPM enables providers to 
gain a comprehensive understanding of the patients' conditions while at 
home, facilitating more coordinated and engaged care efforts, which is 
particularly useful for patients who may have transportation or other 
barriers to frequent primary care access. One commenter added in their 
support for inclusion of RPM codes that include remote physiologic and 
therapeutic monitoring, artificial intelligence, and other tools. 
Another commenter stated that the proposed inclusion of RPM codes as 
primary care services for purposes of assignment, similar to how other 
CCM codes are so included, further aligns remote care and communication 
and aids in advancing RPM into value-based care models. This commenter 
welcomes this technical policy fix and appreciates that we have not 
``precluded furnishing and billing for the full range of RPM codes 
while gaining provider/patient entry into shared savings.'' This 
commenter does ask that we clarify whether the intent is solely to 
track these services for assignment and eligibility for shared savings, 
which they state could fall short in expanding the use of RPM in the 
Shared Savings Program. One commenter stated support for the inclusion 
of RPM since the devices involved in these codes and the clinicians who 
read the results are important elements in patient care and care 
management services but urged CMS to reexamine and clarify the 
assignment methodology to ensure that third-party device companies and 
specialists who use the devices involved in these codes do not 
inadvertently impact Shared Savings Program attribution, cautioning 
that when these devices are billed by clinicians who do not provide a 
beneficiary's primary care services, it is important that those billing 
codes are not used to assign a beneficiary or remove a them from their 
primary care provider's assignment list. Many commenters supported the 
inclusion of the RPM services but expressed concern that these codes 
can also be billed by specialists and that CMS should monitor the 
billing of RPM to ensure their addition is not shifting

[[Page 79172]]

beneficiary attribution away from primary care relationships in favor 
of specialty care.
    Many commenters recommended that CMS not include RPM services in 
the definition of primary care services used for purposes of 
assignment. One commenter stated that while these codes may be billed 
by primary care providers to support the overall management of a 
patient's care, the codes can also be billed by specialists and can 
only be billed by one treating provider for a given patient. Therefore, 
if a specialist is billing these codes to support management of a 
specific condition, that patient's primary care provider would not be 
able to also provide RPM treatment management services to the patient. 
One commenter also stated that since these services are billed monthly, 
the allowed charges for RPM services furnished by a specialist could 
surpass the allowed charges for primary care services furnished by the 
primary care provider. A few commenters suggested the proposal to add 
RPM be terminated, or not finalized, since not all groups/clinicians 
who utilize these codes contribute to an ACO's population health 
practice, or initiatives to care for its patients. One commenter, while 
universally supportive of an expanded set of primary care services, 
cited their analysis that showed that RPM has an uptake by certain 
physician specialties (that is, cardiology) and recommended that CMS 
monitor utilization to ensure that the specialty of clinicians 
continues to be considered in determining whether a service is 
considered to be a primary care service for purposes of beneficiary 
assignment. This commenter further stated that many cardiologists are 
enrolled in Medicare under an internal medicine specialty but function 
as a cardiologist. Since internal medicine is one of the specialties 
identified as a primary care physician in step 1 of the Shared Savings 
Program assignment methodology while cardiologists are not included 
until step 2, this could result in inappropriate assignment under the 
Shared Savings Program. With the continued proliferation of care 
management services, this commenter also urged CMS to monitor 
utilization to ensure clinician specialty is considered in determining 
whether a service is considered to be a qualifying primary care service 
for purposes of beneficiary assignment. Another commenter cautioned 
against using RPM for ACO assignment given the significant rise in its 
use among certain medical specialties. They stated that, while well 
intended, addition of this service code could result in increased 
beneficiary churn and assignment of beneficiaries who do not have a 
true primary care relationship with ACO professionals in the ACO. Some 
commenters recommended that CMS collect experience from ACOs before 
adding RPM to the list of services used in assignment. They noted that 
they believe that it has the potential to ``pull attribution away from 
ACO providers'' and could attribute more patients based on services 
received from specialists due to the quantity of billing done for 
specific chronic conditions and the amounts of those bills.
    A few commenters expressed concern about the intended purpose of 
including RPM codes in the definition of primary care services used for 
assignment. One commenter noted that they believe that if reimbursement 
for these codes counts ``towards the ACO's benchmark for purposes of 
determining whether the ACO is eligible for shared savings,'' it could 
be a disincentive for some practitioners to order these services. This 
commenter suggested that services billed under RPM and Remote 
Therapeutic Monitoring codes be reimbursable to providers that 
participate in an ACO without the cost of services billed under the 
codes being factored into the determination of an ACO's eligibility for 
shared savings.
    Response: We are persuaded by comments concerned about or opposed 
to adding RPM services to the definition of primary care services for 
purposes of assignment, and thus are not finalizing the proposed 
inclusion of CPT codes 99457 and 99458 for RPM services in the 
definition of primary care services. As commenters stated, while these 
services can be billed for both primary and specialty care, the 
services can only be billed by one provider in a 30-day period and are 
more often billed by specialty providers. As a result, including these 
codes in the definition of primary care services for purposes of 
assignment could inappropriately impact the determination of where a 
beneficiary received a plurality of their primary care services.
    After further consideration, we believe that it would be 
inappropriate to include these services in the definition of primary 
care services used for purposes of beneficiary assignment in the Shared 
Savings Program. Although we are not finalizing our proposal to add RPM 
services to the definition of primary care services used for purposes 
of beneficiary assignment, we do want to clarify that these services 
will be reflected in the calculation of expenditures for ACO-assigned 
beneficiaries for each benchmark year and each performance year.\246\
---------------------------------------------------------------------------

    \246\ See Medicare Shared Savings Program, Shared Savings and 
Losses, Assignment and Quality Performance Standard Methodology 
Specifications (version #11, January 2023), available at https://www.cms.gov/files/document/medicare-shared-savings-program-shared-savings-and-losses-and-assignment-methodology-specifications.pdf-2 
(see section 3.1, ``Calculating ACO-Assigned Beneficiary 
Expenditures'').
---------------------------------------------------------------------------

    Comment: One commenter responded to our solicitation of comments on 
any other existing HCPCS or CPT codes and new HCPCS or CPT codes 
proposed elsewhere in the proposed rule that we should consider adding 
to the definition of primary care services for purposes of assignment 
in future rulemaking. This commenter urged us to include Care 
Management Services for Behavioral Health Conditions HCPCS code G0323 
in the definition of primary care services used for purposes of 
beneficiary assignment, as it is not only similar to services already 
included in the definition, such as BHI services (codes 99484, 99492, 
99493 and 99494) and HCPCS code G2214 for psychiatric collaborative 
care model, it would also help recognize the participation of clinical 
psychologists in the Shared Savings Program.
    Response: We agree that HCPCS code G0323 is a BHI service; however, 
this code describes general BHI that a clinical psychologist or 
clinical social worker performs to account for monthly care 
integration.\247\ Under section 1899(c)(1)(A) of the Act, beneficiaries 
must be assigned to an ACO based on their receipt of primary care 
services furnished by an ACO professional who is a physician (as 
defined in section 1861(r)(1)) of the Act), or a practitioner that is a 
PA, NP, CNS (as defined in section 1842(b)(18)(C)(i) of the Act). We 
continue to believe that assigning beneficiaries to ACOs based on their 
receipt of primary care services furnished by an ACO professional who 
is a physician, and in addition, based on their receipt of primary care 
services furnished by a PA, NP, or CNS, consistent with the definition 
in Sec.  425.20 of an ACO professional, is consistent with requirements 
of the Act. Section 1899 of the Act does not specifically allow for 
assignment of beneficiaries to an ACO based on their receipt of primary 
care services from clinical social workers or clinical psychologists 
(as defined in sections

[[Page 79173]]

1842(b)(18)(C)(iv) and 1842(b)(18)(C)(v) of the Act).
---------------------------------------------------------------------------

    \247\ Medicare Learning Network (MLN909432, May 2023) Behavioral 
Health Integration Services, available at https://www.cms.gov/files/document/mln909432-behavioral-health-integration-services.pdf.
---------------------------------------------------------------------------

    After consideration of public comments, we are finalizing a revised 
definition of primary care services in a new provision of the Shared 
Savings Program regulations at Sec.  425.400(c)(1)(viii) to include the 
list of HCPCS and CPT codes specified in Sec.  425.400(c)(1)(vii) along 
with the following additions: CPT codes 99406 and 99407; 96202 and 
96203; and 9X015, 9X016, and 9X017 (which are being finalized as 97550, 
97551, and 97552, respectively) and HCPCS codes G0101; G2086, G2087, 
and G2088; G2211; GXXX1 and GXXX2 (which are being finalized as G0019 
and G0022, respectively) and; GXXX3 and GXXX4 (which are being 
finalized as G0023 and G0024, respectively); and GXXX5 (which is being 
finalized as G0136), as discussed in the preceding paragraphs. We are 
not finalizing our proposal to include CPT codes 99457 and 99458. We 
are finalizing as proposed that the new provision at Sec.  
425.400(c)(1)(viii) would be applicable for use in determining 
beneficiary assignment for the performance year starting on January 1, 
2024, and subsequent performance years.
    In section II.E of this final rule, certain code descriptions are 
being finalized with revisions:
    (1) G0019 Community health integration (CHI) services performed by 
certified or trained auxiliary personnel including a community health 
worker, under the direction of a physician or other practitioner; 60 
minutes per calendar month, in the following activities to address 
social determinants of health (SDOH) need(s) that are significantly 
limiting ability to diagnose or treat problem(s) addressed in an 
initiating E/M visit:
     Person-centered assessment, performed to better understand 
the individualized context of the intersection between the SDOH need(s) 
and problem(s) addressed in the initiating E/M visit.
    ++ Conducting a person-centered assessment to understand patient's 
life story, strengths, needs, goals, preferences and desired outcomes, 
including understanding cultural and linguistic factors.
    ++ Facilitating patient-driven goal-setting and establishing an 
action plan.
    ++ Providing tailored support to the patient as needed to 
accomplish the practitioner's treatment plan.
     Practitioner, Home, and Community-Based Care Coordination
    ++ Coordinating receipt of needed services from healthcare 
practitioners, providers, and facilities; and from home- and community-
based service providers, social service providers, and caregiver (if 
applicable).
    ++ Communication with practitioners, home- and community-based 
service providers, hospitals, and skilled nursing facilities (or other 
health care facilities) regarding the patient's psychosocial strengths 
and needs, functional deficits, goals, preferences, and desired 
outcomes, including cultural and linguistic factors.
    ++ Coordination of care transitions between and among health care 
practitioners and settings, including transitions involving referrals 
to other clinicians; follow-up after an emergency department visit; or 
follow-up after discharges from hospitals, skilled nursing facilities 
or other health care facilities.
    ++ Facilitating access to community-based social services (e.g., 
housing, utilities, transportation, food assistance) to address SDOH 
need(s).
     Health education- Helping the patient contextualize health 
education provided by the patient's treatment team with the patient's 
individual needs, goals, and preferences, in the context of the SDOH 
need(s), and educating the patient on how to best participate in 
medical decision-making.
     Building patient self-advocacy skills, so that the patient 
can interact with members of the health care team and related 
community-based services addressing the SDOH need(s), in ways that are 
more likely to promote personalized and effective diagnosis and 
treatment.
     Health care access/health system navigation:
    ++ Helping the patient access care, including identifying 
appropriate practitioners or providers for clinical care and helping 
secure appointments with them.
     Facilitating behavioral change as necessary for meeting 
diagnosis and treatment goals, including promoting patient motivation 
to participate in care and reach person-centered diagnosis or treatment 
goals.
     Facilitating and providing social and emotional support to 
help the patient cope with the problem(s) addressed in the initiating 
visit, the SDOH need(s), and adjust daily routines to better meet 
diagnosis and treatment goals.
     Leveraging lived experience when applicable to provide 
support, mentorship, or inspiration to meet treatment goals.
    (2) G0023 Principal Illness Navigation services by certified or 
trained auxiliary personnel under the direction of a physician or other 
practitioner, including a patient navigator or certified peer 
specialist; 60 minutes per calendar month, in the following activities:
     Person-centered assessment, performed to better understand 
the individualized context of the serious, high-risk condition.
    ++ Conducting a person-centered assessment to understand the 
patient's life story, needs, goals, preferences, and desired outcomes, 
including understanding cultural and linguistic factors and including 
unmet SDOH needs (that are not separately billed).
    ++ Facilitating patient-driven goal setting and creating an action 
plan.
    ++ Providing tailored support as needed to accomplish the 
practitioner's treatment plan.
     Identifying or referring patient (and caregiver or family, 
if applicable) to appropriate supportive services.
     Practitioner, Home, and Community-Based Care Coordination
    ++ Coordinating receipt of needed services from healthcare 
practitioners, providers and facilities; home-, and community-based 
service providers; and caregiver (if applicable).
    ++ Communication with practitioners, home-, and community-based 
service providers, hospitals, and skilled nursing facilities (or other 
health care facilities) regarding the patient's psychosocial strengths 
and needs, functional deficits, goals, and preferences, including 
cultural and linguistic factors.
    ++ Coordination of care transitions between and among health care 
practitioners and settings, including transitions involving referrals 
to other clinicians; follow-up after an emergency department visit; or 
follow-up after discharges from hospitals, skilled nursing facilities 
or other health care facilities.
    ++ Facilitating access to community-based social services (e.g., 
housing, utilities, transportation, food assistance) as needed to 
address SDOH need(s).
     Health education--Helping the patients contextualize 
health education provided by the patient's treatment team with the 
patient's individual needs, goals, preferences, and SDOH need(s), and 
educating the patient (and caregiver, if applicable) on how to best 
participate in medical decision-making.
     Building patient self-advocacy skills, so that the patient 
can interact with members of the health care team and related 
community-based services (as needed), in ways that are more likely to 
promote personalized and effective treatment of their condition.
     Health care access/health system navigation.

[[Page 79174]]

    ++ Helping the patient access healthcare, identifying appropriate 
practitioners or providers for clinical care and helping secure 
appointments with them.
    ++ Providing the patient with information/resources to consider 
participation in clinical trials or clinical research as applicable.
     Facilitating behavioral change necessary for meeting 
diagnosis and treatment goals, including promoting patient motivation 
to participate in care and reach person-centered diagnosis or treatment 
goals.
     Facilitating and providing social and emotional support 
for the patient to help the patient cope with the condition, SDOH 
need(s), and adjust daily routines to better meet diagnosis or 
treatment goals.
     Leverage knowledge of the serious, high-risk condition 
and/or lived experience when applicable to provide support, mentorship, 
or inspiration to meet treatment goals.
4. Benchmarking Methodology
a. Overview
    In section III.G.4 of the CY 2024 PFS proposed rule (88 FR 52456 
through 52483), we proposed modifications to the benchmarking 
methodology under the Shared Savings Program. We proposed a combination 
of modifications to the Shared Savings Program's benchmarking 
methodology to encourage sustained participation by ACOs in the 
program. Specifically, we proposed to revise the benchmarking 
methodology by modifying the existing calculation of the regional 
update factor used to update the historical benchmark between benchmark 
year (BY) 3 and the performance year (section III.G.4.b of the proposed 
rule). We also proposed to further mitigate the impact of the negative 
regional adjustment to the historical benchmark (section III.G.4.c of 
the proposed rule). Additionally, we proposed refinements to the prior 
savings adjustment calculation methodology (section III.G.4.d of the 
proposed rule), that would apply in the establishment of benchmarks for 
renewing ACOs and re-entering ACOs entering an agreement period 
beginning on January 1, 2024, and in subsequent years, to account for 
the following: a change in savings earned by the ACO in a benchmark 
year due to compliance action taken to address avoidance of at-risk 
beneficiaries or a change in the amount of savings or losses for a 
benchmark year as a result of issuance of a revised initial 
determination under Sec.  425.315. Finally, we proposed to specify in 
the regulations an approach to calculating prospective HCC risk scores 
used in Shared Savings Program benchmark calculations, applicable for 
agreement periods beginning on January 1, 2024, and in subsequent 
years, in which we would use the CMS-HCC risk adjustment model(s) 
applicable to the calendar year corresponding to the performance year 
to calculate a Medicare FFS beneficiary's prospective HCC risk score 
for the performance year, and for each benchmark year of the ACO's 
agreement period (section III.G.4.e of the proposed rule). Our specific 
proposals are discussed in detail in the following sections.
b. Cap Regional Service Area Risk Score Growth for Symmetry With ACO 
Risk Score Cap
(1) Background
    In the June 2016 final rule (81 FR 37977 through 37981), we 
established a policy of utilizing a regional growth rate to update the 
benchmark annually. In that rule, we finalized a policy that, for ACOs 
in their second or subsequent agreement period whose rebased historical 
benchmark incorporates an adjustment to reflect regional expenditures, 
the annual update to the benchmark would be calculated as a growth rate 
that reflects growth in risk adjusted regional per beneficiary FFS 
spending for the ACO's regional service area, for each of the following 
populations of beneficiaries: ESRD, disabled, aged/dual eligible, aged/
non-dual eligible (refer to Sec.  425.603(d)).
    In proposing and finalizing the regional growth rate policy, we 
explained that incorporating regional expenditures in the benchmark 
would make the ACO's cost target more independent of its historical 
expenditures and more reflective of FFS spending in its region. We also 
explained that the use of regional trend factors to trend forward BY1 
and BY2 to BY3 in resetting ACO benchmarks and regional growth rates 
used to update the historical benchmark to the performance year 
annually would likely result in relatively higher benchmarks for ACOs 
that are low growth relative to their region compared to benchmarks for 
ACOs that are high growth relative to their region (refer to 81 FR 
37955).
    In the December 2018 final rule (83 FR 68013 through 68031), we 
finalized a proposal to use a blend of national and regional trend 
factors to trend forward BY1 and BY2 to BY3 when determining the 
historical benchmark and a blend of national and regional update 
factors to update the historical benchmark to the performance year for 
all agreement periods beginning on or after July 1, 2019 (refer to 
Sec.  425.601(a) and (b)). Under this policy, the national component of 
the blended trend and update factors receives a weight equal to the 
share of assignable beneficiaries in the regional service area that are 
assigned to the ACO, computed by taking a weighted average of county-
level shares. The regional component of the blended trend and update 
factors receives a weight equal to 1 minus the national weight. 
Calculations are made separately for each Medicare enrollment type. In 
the December 2018 final rule (83 FR 68024), we acknowledged that, for 
an ACO that serves a high proportion of beneficiaries in select 
counties making up its regional service area (referred to herein as 
having ``high market share''), a purely regional trend would be more 
influenced by the ACO's own expenditure patterns, making it more 
difficult for the ACO to outperform its benchmark and conflicting with 
our goal to move ACOs away from benchmarks based solely on their own 
historical costs. Incorporating national trends that are more 
independent of an ACO's own performance was therefore intended to 
reduce the influence of the ACO's assigned beneficiaries on the 
ultimate blended trend and update factors applied.
    In the CY 2023 PFS final rule (87 FR 69881 through 69899), we 
finalized a policy for agreement periods starting on or after January 
1, 2024, under which we will update the historical benchmark between 
BY3 and the performance year for each year of the agreement period 
using a three-way blend calculated as a weighted average of a two-way 
blend of national and regional growth rates determined after the end of 
each performance year and a fixed projected growth rate determined at 
the beginning of the ACO's agreement period called the Accountable Care 
Prospective Trend (ACPT) (refer to Sec.  425.652(b)). Under this 
policy, we will make separate calculations for expenditure categories 
for each Medicare enrollment type. We explained that incorporating this 
prospective trend in the update to the benchmark would insulate a 
portion of the annual update from any savings occurring as a result of 
the actions of ACOs participating in the Shared Savings Program and 
address the impact of increasing market penetration by ACOs in a 
regional service area on the existing blended national-regional growth 
factor.
    For ACOs in agreement periods beginning on July 1, 2019, and in 
subsequent years, we account for changes in severity and case mix of 
the ACO's assigned beneficiary population

[[Page 79175]]

when establishing the benchmark for an agreement period and also in 
adjusting the benchmark for each performance year during the agreement 
period. In accordance with Sec.  425.601(a)(3) and Sec.  425.652(a)(3), 
in establishing the benchmark, we adjust expenditures for changes in 
severity and case mix using CMS Hierarchical Condition Category (CMS-
HCC) prospective risk scores (herein referred to as prospective HCC 
risk scores). Pursuant to Sec.  425.601(a)(10) and Sec.  
425.652(a)(10), we further adjust the ACO's historical benchmark at the 
time of reconciliation for a performance year to account for changes in 
severity and case mix for the ACO's assigned beneficiary population 
between BY3 and the performance year (refer to Sec.  425.605(a)(1), 
(a)(2); Sec.  425.610(a)(2), (a)(3)). In performing this risk 
adjustment, we make separate adjustments for the population of assigned 
beneficiaries in each Medicare enrollment type used in the Shared 
Savings Program (ESRD, disabled, aged/dual eligible, aged/non-dual 
eligible).
    As finalized in the CY 2023 PFS final rule (87 FR 69932 through 
69946), for agreement periods beginning on or after January 1, 2024, we 
will use prospective HCC risk scores to adjust the historical benchmark 
for changes in severity and case mix for all assigned beneficiaries 
between BY3 and the performance year, with positive adjustments subject 
to a cap equal to the ACO's aggregate growth in demographic risk scores 
between BY3 and the performance year plus 3 percentage points (herein 
referred to as the ``aggregate demographics plus 3 percent cap'') 
(refer to Sec.  425.605(a)(1)(ii); Sec.  425.610(a)(2)(ii)). This cap 
applies only if the ACO's aggregate growth in prospective HCC risk 
scores between BY3 and the performance year across all of the Medicare 
enrollment types (ESRD, disabled, aged/dual eligible, aged/non-dual 
eligible) exceeds this cap. If the cap is determined to apply, the 
value of the cap is the maximum increase in prospective HCC risk scores 
(expressed as a ratio of the ACO's performance year risk score to the 
ACO's BY3 risk score) for the applicable performance year, such that 
any positive adjustment between BY3 and the performance year cannot be 
larger than the value of the aggregate demographics plus 3 percent cap 
for any of the Medicare enrollment types. This cap is applied 
separately for the population of beneficiaries in each Medicare 
enrollment type.
    In the CY 2023 PFS final rule, we further explained that we were 
finalizing the aggregate demographics plus 3 percent cap to address 
concerns with the prior approach to risk adjustment, which used 
prospective HCC risk scores to adjust the historical benchmark for 
changes in severity and case mix for all assigned beneficiaries between 
BY3 and the performance year, subject to a cap of positive 3 percent 
for the agreement period that was applied separately by Medicare 
enrollment type (referred to herein as the ``3 percent cap'') (refer to 
Sec.  425.605(a)(1)(i); Sec.  425.610(a)(2)(i)). The 3 percent cap was 
finalized through the December 2018 final rule (83 FR 68013) and is 
applicable to ACOs in agreement periods beginning on or after July 1, 
2019, and prior to January 1, 2024.
    We believe that the aggregate demographics plus 3 percent cap 
addresses several concerns raised by interested parties \248\ about the 
3 percent cap by: accounting for higher volatility in prospective HCC 
risk scores for certain Medicare enrollment types due to smaller sample 
sizes; allowing for higher benchmarks than the prior risk adjustment 
methodology for ACOs that care for larger proportions of beneficiaries 
in aged/dual eligible, disabled and ESRD enrollment types (which are 
frequently subject to the 3 percent cap); and continuing to safeguard 
the Trust Funds by limiting returns from coding initiatives. However, 
the demographics plus 3 percent cap does not address concerns from 
certain interested parties that the current policy places a cap on an 
ACO's risk score growth between BY3 and the performance year but does 
not place a cap on the regional prospective HCC risk score growth 
between BY3 and the performance year, which is reflected in the 
regional growth rate used to calculate the update factor (pursuant to 
Sec.  425.652(b)(2)(ii)).\249\
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    \248\ For summaries of these concerns of interested parties, 
refer to the CY 2022 PFS final rule (86 FR 65302 through 65306), CY 
2023 PFS final rule (87 FR 69932 through 69934).
    \249\ For summaries of these concerns of interested parties, 
refer to the CY 2021 PFS final rule (85 FR 84783 through 84785), the 
CY 2022 PFS final rule (86 FR 65302 through 65306), and the CY 2023 
PFS final rule (87 FR 66942 and 69943).
---------------------------------------------------------------------------

    Under the methodology finalized in CY 2023 PFS final rule, as 
described in Sec.  425.652(b), we express the regional update factor, 
used to update the historical benchmark to the performance year, as the 
ratio of an ACO's performance year regional service area risk adjusted 
expenditures to its BY3 regional service area risk adjusted 
expenditures for each Medicare enrollment type. Table 36 provides a 
numeric example of the current methodology for calculating the regional 
update factor for the ESRD Medicare enrollment type for a hypothetical 
ACO with a regional service area that includes counties A, B, C, and D.
    Under Sec.  425.654, an ACO's regional expenditures are calculated 
using risk adjusted county FFS expenditures. The counties included in 
the ACO's regional service area are based on the ACO's assigned 
beneficiary population for the applicable benchmark or performance 
year. We determine average county FFS expenditures based on 
expenditures for the assignable population \250\ of beneficiaries in 
each county in the ACO's regional service area. We make separate 
calculations for each Medicare enrollment type. We adjust these county-
level FFS expenditures (refer to Table 36, rows [A] and [F]) for 
severity and case mix of assignable beneficiaries in the county using 
county-level prospective HCC risk scores (refer to Table 36, rows [B] 
and [G]). The adjustment is made by dividing the county-level FFS 
expenditures for the Medicare enrollment type by county-level 
prospective HCC risk scores for the Medicare enrollment type, resulting 
in risk adjusted county-level FFS expenditures shown in Table 36 rows 
[C] and [H].
---------------------------------------------------------------------------

    \250\ Assignable beneficiary expenditures are calculated using 
the payment amounts included in Parts A and B FFS claims with dates 
of service in the 12-month calendar year that corresponds to the 
relevant benchmark or performance year, using a 3-month claims run 
out with a completion factor. These expenditure calculations exclude 
IME and DSH payments, and the supplemental payment for IHS/Tribal 
hospitals and Puerto Rico hospitals; and consider individually 
beneficiary identifiable final payments made under a demonstration, 
pilot or time limited program. Refer to Sec.  425.654(a)(2). The 
assignable population of beneficiaries is identified for the 
assignment window corresponding to the relevant benchmark or 
performance year that is consistent with the assignment window that 
applies under the beneficiary assignment methodology selected by the 
ACO for the performance year according to Sec.  425.400(a)(4)(ii). 
Refer to Sec.  425.654(a)(1)(i). We refer readers to the discussion 
of the proposed changes to the methodology for identifying the 
assignable beneficiary population in section III.G.3.a of the 
proposed rule.
---------------------------------------------------------------------------

    We then calculate an ACO's regional expenditures for each Medicare 
enrollment type by weighting these risk adjusted county-level FFS 
expenditures according to the ACO's proportion of assigned 
beneficiaries \251\ in the county for that Medicare enrollment type 
(refer to Table 36, rows [D] and [I]), determined by the number of the 
ACO's assigned beneficiaries in the applicable population (according to 
Medicare enrollment type) residing in the county in relation to the 
ACO's total number of assigned beneficiaries in the applicable 
population (according to Medicare enrollment type) for the relevant 
benchmark or performance year. We

[[Page 79176]]

then aggregate those values for each population of beneficiaries 
(according to Medicare enrollment type) across all counties within the 
ACO's regional service area \252\ (refer to Table 36, rows [E] and 
[J]).
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    \251\ Proportions are calculated using beneficiary person years.
    \252\ Refer to the Medicare Shared Savings Program, Shared 
Savings and Losses, Assignment and Quality Performance Standard 
Methodology Specifications (version #11, January 2023), sections 
4.1.1 ``Determining Regional FFS Expenditures'' and 4.1.4 ``Risk 
Adjusting and Updating the Historical Benchmark'', available at 
https://www.cms.gov/files/document/medicare-shared-savings-program-shared-savings-and-losses-and-assignment-methodology-specifications.pdf-2.
---------------------------------------------------------------------------

    We then calculate the regional update factor as the ratio of an 
ACO's performance year expenditures to BY3 regional expenditures. This 
calculation is performed separately for each Medicare enrollment type. 
Refer to Table 36, row [K] for an example of how the regional update 
factor would be calculated for the ESRD Medicare enrollment type. This 
calculation would then be repeated for each of the other Medicare 
enrollment types.
[GRAPHIC] [TIFF OMITTED] TR16NO23.058

    While the regional expenditures for BY3 and the performance year 
are risk adjusted, as described previously in this section, there is 
currently no cap on prospective HCC risk score growth in an ACO's 
regional service area between BY3 and the performance year. As 
discussed previously in this section, ACOs and other interested parties 
have expressed concerns that the program's current cap on ACO risk 
score growth between BY3 and the performance year does not account for 
risk score growth in the ACO's regional service area and that there is 
not an equivalent cap on regional risk score growth. High prospective 
HCC risk score growth in an ACO's regional service area between BY3 and 
the performance year has the effect of decreasing the regional update 
factor, resulting in a lower updated benchmark for the ACO than if the 
regional risk score growth was capped (assuming that the risk score 
growth was high enough to be capped). In past rulemaking, some 
commenters have encouraged CMS to adopt a policy of applying a cap on 
ACO risk score growth after accounting for regional increase in risk 
scores.\253\ Others have suggested more generally that CMS align the 
use of a risk adjustment cap for the ACO and its region by applying a 
consistent capping policy to both.\254\
---------------------------------------------------------------------------

    \253\ Refer to CY 2021 PFS final rule (85 FR 84784).
    \254\ Refer to CY 2021 PFS final rule (85 FR 84784) and CY 2023 
PFS final rule (87 FR 69943).
---------------------------------------------------------------------------

    In the CY 2022 PFS proposed rule (86 FR 39294 through 39295), we 
sought comment on an alternate approach to capping ACO prospective HCC 
risk score growth between BY3 and the performance year in relation to 
the prospective HCC risk score growth in the ACO's regional service 
area. The option we presented was to allow an ACO's risk score growth 
cap to increase above 3 percent by a percentage of the difference 
between the 3 percent cap and risk score growth in the ACO's regional 
service area for a given Medicare enrollment type. In this alternate 
approach (herein referred to as the ``3 percent cap plus regional 
difference''), the percentage applied would be equal to 1 minus the 
ACO's regional market share for the Medicare enrollment type. For 
example, if regional risk score growth for a particular Medicare 
enrollment type was 5 percent and the ACO's regional market share was 
20 percent, we would increase the cap on the ACO's risk score growth 
for that Medicare enrollment type by an amount equal to the difference 
between the regional risk score growth and the 3 percent cap (2 
percent) multiplied by one minus the ACO's regional market share (80 
percent). Thus, the ACO would face a cap for this Medicare enrollment 
type equal to 4.6 percent instead of 3 percent (3 percent + (2 percent 
x 80 percent)). This approach would raise the 3 percent cap while 
limiting the ability for ACOs

[[Page 79177]]

with high market share to increase their cap by engaging in coding 
intensity initiatives that raise the regional prospective HCC risk 
score. As discussed in the CY 2022 PFS final rule, a few commenters 
noted their support for this 3 percent cap plus regional difference 
methodology.\255\ However, MedPAC expressed concern that increasing the 
cap beyond 3 percent could effectively reward ACOs for greater coding 
intensity in their region, particularly for those with higher market 
share.256 257
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    \255\ Refer to 86 FR 65304.
    \256\ Refer to 86 FR 65303 through 65305.
    \257\ Refer to Letter from MedPAC to Chiquita Brooks-LaSure, 
Administrator, CMS (September 9, 2021), regarding File code CMS-
1751-P (pages 16-18 ``Risk adjustment methodology''), available at 
https://www.medpac.gov/wp-content/uploads/2021/10/09092021_PartB_CMS1751_MedPAC_Comment_V2_SEC.pdf.
---------------------------------------------------------------------------

    In the CY 2023 PFS final rule (87 FR 69932 through 69946), we 
indicated that we had considered the 3 percent cap plus regional 
difference methodology described in the CY 2022 PFS proposed rule when 
developing policies for the CY 2023 PFS proposed rule. However, we 
opted not to propose this policy and instead proposed, and ultimately 
finalized, the aggregate demographics plus 3 percent cap. One reason we 
did not propose the 3 percent cap plus regional difference was that a 
relatively small share of ACOs affected by the 3 percent cap operated 
in regional service areas where regional risk score growth was greater 
than 3 percent, indicating that this was not a widespread issue 
impacting ACO performance. Additionally, we explained that we still had 
concerns that allowing the cap on an ACO's risk score growth to 
increase with regional risk score growth could incentivize ACOs, 
particularly those with high market share, to engage in coding behavior 
that would increase their cap, even if this incentive would be 
mitigated to some degree by limiting the allowable increase in the cap 
based on the ACO's market share. Under the 3 percent cap, ACOs with 
high market share have a disincentive to engage in coding initiatives, 
as it could increase risk score growth in their regional service area 
and potentially decrease the value of the regional component of their 
update factor. We noted that raising the 3 percent cap based on risk 
score growth in an ACO's regional service area could change these 
incentives and encourage ACOs to engage in coding initiatives. In 
addition to finalizing the aggregate demographics plus 3 percent cap, 
in the CY 2023 PFS final rule, we noted that we declined to consider an 
approach that would impose a direct cap on risk score growth in an 
ACO's regional service area (87 FR 69932 through 69947). As with the 3 
percent cap plus regional difference, we were concerned that such an 
approach would create adverse incentives for coding behavior, 
especially for ACOs with high market share.
    In response to the discussion of the cap on prospective HCC risk 
score growth in the CY 2023 PFS proposed rule, commenters took the 
opportunity to reiterate their concerns that the program's current cap 
on ACO risk score growth between BY3 and the performance year does not 
account for risk score growth in the ACO's regional service area and 
suggested ways to incorporate a cap on regional risk score growth. A 
couple of commenters requested that the risk score cap be allowed to 
further increase for ACOs in regions where risk score growth exceeds 
the cap, with one stating that a flat percentage cap will always 
disadvantage ACOs in regions where risk score growth exceeds the cap 
and another stating that this additional flexibility would ensure ACOs 
are not disadvantaged by operating in underserved communities. 
Additionally, many commenters supported capping regional risk score 
growth in addition to capping ACO risk score growth. Several of those 
commenters stated that it was critical that, whatever policy CMS 
adopted for capping ACOs' risk score growth, the same policy must also 
apply to regional risk score growth. Several commenters noted that CMS 
should not apply adjustments to only one side of the equation, that is, 
capping ACO risk ratios without capping regional risk ratios, with many 
commenters saying this would lead to unintended consequences and 
another commenter stated it would have inequitable results. Several 
commenters stated that not capping increases in regional risk scores 
would stifle growth in exactly the areas CMS wants growth the most. A 
few commenters explained that lack of regional risk score growth caps 
incentivizes ACOs not to grow in places with certain types of 
populations, such as those with increasing health burdens, higher 
needs, or higher numbers of aged/dual and disabled enrollees.\258\ In 
response to these comments, we indicated that we would continue to 
monitor the impacts of regional risk score growth and might propose 
further refinements to our risk adjustment policies in future 
rulemaking.\259\
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    \258\ Refer to 87 FR 69942 through 69943.
    \259\ Refer to 87 FR 69943.
---------------------------------------------------------------------------

(2) Revisions
    Since the publication of the CY 2023 PFS final rule, we have 
performed further analysis on prospective HCC risk score growth in 
ACOs' regional service area between BY3 and the performance year and 
considered ways in which we could reduce impacts to ACOs in regions 
with high risk score growth, particularly when such growth is not due 
to the ACO's own complete and accurate coding, while also limiting the 
impact from coding initiatives, particularly among ACOs with high 
market share. Based on this additional analysis, which is detailed 
later in this section, in the CY 2024 PFS proposed rule (88 FR 52459 
through 52465), we proposed to modify the calculation of the regional 
update factor used to update the historical benchmark between BY3 and 
the performance year. The proposed approach would cap prospective HCC 
risk score growth in an ACO's regional service area between BY3 and the 
performance year by applying an adjustment factor to the regional 
update factor. This cap on regional risk score growth would be applied 
independently of the cap on an ACO's own prospective HCC risk score 
growth between BY3 and the performance year, meaning that this proposed 
cap on prospective HCC risk score growth in an ACO's regional service 
area would be applied whether or not the ACO's prospective risk score 
growth was capped when updating the benchmark between BY3 and the 
performance year. We explained that applying these caps independently 
would be more equitable to ACOs serving high-risk patients in regions 
with high risk score growth and avoid creating incentives for ACOs to 
avoid high-risk and more medically complex patients. Adjusting the 
regional service area risk score growth cap based on the percentage of 
original Medicare FFS beneficiaries the ACO serves in the region would 
help to mitigate the impact an ACO's own coding initiatives have on 
risk score growth in the ACO's regional service area, particularly when 
the ACO has a greater influence on its regional service area risk score 
growth rate.
    To determine the cap on prospective HCC risk score growth in an 
ACO's regional service area, we proposed to follow a similar 
methodology as the one adopted in the CY 2023 PFS final rule \260\ for 
capping ACO risk score growth, codified at Sec. Sec.  425.605(a)(1)(ii) 
and 425.610(a)(2)(ii), while additionally accounting for an ACO's 
aggregate

[[Page 79178]]

market share. The effect of the regional risk score growth cap would be 
to increase the regional component of the update factor for ACOs in 
regions with aggregate regional prospective HCC risk score growth above 
the cap, with ACOs with higher aggregate market shares seeing smaller 
increases, all else being equal. ACOs in regions with aggregate 
regional prospective HCC risk score growth below the cap would not be 
affected by the proposed policy.
---------------------------------------------------------------------------

    \260\ 87 FR 69932 through 69946.
---------------------------------------------------------------------------

    As we explained in the CY 2024 PFS proposed rule, by symmetrically 
limiting risk score growth within both an ACO's assigned beneficiary 
population and its region, this proposed approach is expected to 
improve the accuracy of the regional update factors for ACOs operating 
in regional service areas with high risk score growth, particularly in 
later years of the 5-year agreement period where the difference between 
an ACO's BY3 and performance year regional risk scores is expected to 
be the greatest. We explained our belief that capping regional risk 
score growth would strengthen incentives for ACOs to form or continue 
to operate in regions with high-risk score growth and thereby 
incentivize ACOs to care for higher risk beneficiaries. This approach 
would also offer an incentive for potential applicant ACOs that may be 
examining recent risk score growth in their region and making the 
decision whether to participate in the Shared Savings Program. 
Additionally, by adjusting the regional risk score growth cap based on 
ACO market share, we noted that the proposal would also maintain a 
disincentive against coding intensity for ACOs with high market share.
    To implement the new cap on regional risk score growth, we proposed 
to multiply the original regional update factor used to update the 
historical benchmark between BY3 and the performance year (determined 
in accordance with Sec.  425.652(b)(2)(ii)) by a regional risk score 
growth cap adjustment factor. The regional risk score growth cap 
adjustment factor would be calculated as follows:
     Step 1: Calculate county-level risk scores. We would 
calculate county-level prospective HCC and demographic risk scores by 
Medicare enrollment type for both BY3 and the performance year. To do 
this for a given benchmark or performance year, we would first 
determine the renormalized, prospective HCC and demographic risk score 
for each assignable beneficiary \261\ in each county in the ACO's 
regional service area. For both HCC and demographic risk scores, we 
would then compute the weighted average risk score for each county for 
each Medicare enrollment type by multiplying each assignable 
beneficiary's risk score for that Medicare enrollment type by the 
beneficiary's person years enrolled in that Medicare enrollment type, 
summing these weighted risk scores across all assignable beneficiaries 
for that Medicare enrollment type in the county, and then dividing by 
total person years for that Medicare enrollment type among assignable 
beneficiaries in the county. We noted that this approach would be 
similar to the approach that is currently used to determine county-
level prospective HCC risk scores as an intermediate step in 
calculating risk adjusted regional expenditures under the current 
methodology.\262\
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    \261\ Consistent with our proposal to revise the definition of 
an assignable beneficiary (refer to section III.G.3.a of the 
proposed rule), we proposed that the assignable population of 
beneficiaries for a benchmark or performance year would be 
identified using the assignment window or expanded window for 
assignment that is consistent with the beneficiary assignment 
methodology selected by the ACO for the applicable performance year 
according to Sec.  425.400(a)(4)(ii).
    \262\ Refer to the Medicare Shared Savings Program, Shared 
Savings and Losses, Assignment and Quality Performance Standard 
Methodology Specifications (version #11, January 2023), section 
4.1.1 ``Determining Regional FFS Expenditures'', available at 
https://www.cms.gov/files/document/medicare-shared-savings-program-shared-savings-and-losses-and-assignment-methodology-specifications.pdf-2.
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     Step 2: Calculate regional risk scores. We would calculate 
regional-level BY3 and performance year prospective HCC and demographic 
risk scores as a weighted average of county-level HCC and demographic 
risk scores for the Medicare enrollment type (calculated in step 1), 
with weights reflecting the proportion of the ACO's assigned 
beneficiaries \263\ in the county. This proportion is determined by the 
number of the ACO's assigned beneficiaries (by Medicare enrollment 
type) residing in each county in relation to the ACO's total number of 
assigned beneficiaries for that Medicare enrollment type for the 
relevant benchmark or performance year. These would be the same weights 
as used to calculate regional expenditures under Sec.  425.654(b).
---------------------------------------------------------------------------

    \263\ Proportions are calculated using beneficiary person years.
---------------------------------------------------------------------------

     Step 3: Determine aggregate growth in regional risk 
scores. To calculate aggregate growth in regional risk scores, we would 
first calculate growth in prospective HCC and demographic risk scores 
between BY3 and the performance year for each Medicare enrollment type, 
expressed as the ratio of the performance year regional risk score for 
a Medicare enrollment type (calculated in step 2) to the BY3 regional 
risk score for that enrollment type (calculated in step 2). We would 
next take a weighted average of the regional prospective HCC or 
demographic risk ratios, as applicable, across the four Medicare 
enrollment types, where the weight applied to the growth in risk scores 
for each Medicare enrollment type would be the ACO's performance year 
assigned beneficiary person years for the Medicare enrollment type 
multiplied by the ACO's regionally adjusted historical benchmark 
expenditures for the Medicare enrollment type.\264\
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    \264\ These are the same weights that are to be used when 
calculating weighted average ACO prospective HCC and demographic 
risk ratios under the risk adjustment methodology adopted in the CY 
2023 PFS final rule (87 FR 69932 through 69946) and codified in 
Sec. Sec.  425.605(a)(1)(ii)(C) and 425.610(a)(2)(ii)(C).
---------------------------------------------------------------------------

     Step 4: Determine the cap on regional risk score growth. 
We would first calculate the non-market share adjusted cap on the ACO's 
regional risk score growth as the sum of the aggregate growth in 
regional demographic risk scores (calculated in step 3) and 3 
percentage points.\265\
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    \265\ This is similar to the calculation of the cap on ACO 
prospective HCC risk score growth finalized in the CY 2023 PFS (87 
FR 69932 through 69946) and codified in Sec. Sec.  
425.605(a)(1)(ii)(A) and 425.610(a)(2)(ii)(A).
---------------------------------------------------------------------------

    We would next adjust the cap to reflect the ACO's aggregate market 
share. We would calculate an ACO's aggregate market share as a weighted 
average of the ACO's market share across the four Medicare enrollment 
types. An ACO's market share for each Medicare enrollment type would be 
equal to the weight that is applied to the national component of the 
blended update factor in the two-way blend that is calculated as the 
share of assignable beneficiaries in the ACO's regional service area 
that are assigned to the ACO for the applicable performance year (refer 
to Sec.  425.652(b)(2)(iv)). The weights for each Medicare enrollment 
type used to compute the weighted average would be the ACO's 
performance year assigned person years for the Medicare enrollment 
type.
    We would adjust the cap on regional risk score growth to reflect 
the ACO's aggregate market share by adding to the non-market share 
adjusted cap the product of:
    ++ The ACO's aggregate market share, and
    ++ The difference (subject to a floor of zero) between:
    --The aggregate regional prospective HCC risk score growth 
(calculated in step 3), and

[[Page 79179]]

    --The non-market share adjusted cap (calculated first in this 
step).
    This adjustment of the cap on regional risk score growth using the 
ACO's aggregate market share creates a sliding scale. Assuming that an 
ACO has aggregate regional prospective HCC risk score growth above the 
non-market share adjusted cap, an ACO with close to 0 percent aggregate 
market share would receive a market share adjusted cap on regional risk 
score growth close to the aggregate growth in regional demographic risk 
scores plus 3 percentage points and an ACO with 100 percent aggregate 
market share would receive a market share adjusted cap on regional risk 
score growth equal to the aggregate regional prospective HCC risk score 
growth calculated in step 3 (which is effectively no cap at all). Under 
this approach, as an ACO's aggregate market share increases, so does 
the cap on the ACO's regional risk score growth, ultimately limiting 
the potential increase to the regional update factor for ACOs with high 
market share.
     Step 5: Determine the regional risk score growth cap 
adjustment factor. First, we would determine if the ACO's regional risk 
score growth is subject to a cap by comparing the ACO's aggregate 
regional prospective HCC risk score growth (calculated in step 3) to 
the market share adjusted cap on regional risk score growth (calculated 
in step 4).
    ++ If the aggregate regional prospective HCC risk score growth does 
not exceed the cap on regional risk score growth, the ACO's regional 
risk score growth would not be subject to the cap. For these ACOs we 
would set the risk score growth cap adjustment factor equal to 1 for 
each Medicare enrollment type (which is effectively no adjustment).
    ++ If the aggregate regional prospective HCC risk score growth 
exceeds the market share adjusted cap, the ACO's regional risk score 
growth is subject to the cap. For these ACOs we would next determine 
whether the cap on regional risk score growth applies for each Medicare 
enrollment type. To do this, we would compare regional prospective HCC 
risk score growth for each Medicare enrollment type (calculated in step 
3) with the market share adjusted cap (calculated in step 4). If the 
regional risk score growth for a Medicare enrollment type does not 
exceed the cap, the enrollment type is not subject to the cap and the 
regional risk score growth cap adjustment factor for that Medicare 
enrollment type is set equal to 1 (effectively no adjustment). 
Otherwise, the Medicare enrollment type is subject to the cap and we 
would set the adjustment factor for the Medicare enrollment type equal 
to the regional prospective HCC risk score growth for the Medicare 
enrollment type (calculated in step 3) divided by the market share 
adjusted cap calculated in step 4. In this case, the adjustment factor 
for the Medicare enrollment type would represent a measure of how far 
above the cap the regional prospective HCC risk score growth is.
    Table 37 provides a numeric example of the calculation of the 
regional risk score growth cap adjustment factor for a hypothetical ACO 
that is determined to be subject to the market share adjusted cap. 
Table 37 begins at the end of step 2 of the calculation, and therefore 
only reflects regional-level calculations and does not include the 
county-level calculations:
BILLING CODE 4120-01-P

[[Page 79180]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.059

BILLING CODE 4120-01-C
    In this example, the hypothetical ACO was in a regional service 
area with aggregate prospective HCC risk score growth (a weighted 
average risk ratio of 1.039, refer to row [H]) above the market share 
adjusted cap of 1.021 (refer to row [N]). The ACO's regional 
prospective HCC risk score growth (shown in row [E]) was above this cap 
for three of the four Medicare enrollment types (all but the aged/dual 
eligible Medicare enrollment type). Therefore, the regional risk score 
growth cap adjustment factor (refer to row [Q]) calculated for those 
three capped Medicare enrollment types was above one, and the regional 
risk score growth cap adjustment factor calculated for the one uncapped 
Medicare enrollment type was equal to one. Once the regional risk score 
growth cap adjustment factors are multiplied by the original regional 
update factors used to update the historical benchmark between BY3 and 
the performance year, the regional update factor would increase for the 
three capped Medicare

[[Page 79181]]

enrollment types. For example, if the original regional update factor 
for the ESRD Medicare enrollment type was 0.976, then the final 
regional ESRD update factor after the application of the regional risk 
score growth cap adjustment factor would be 1.000 (the product of 0.976 
and the regional risk score growth cap adjustment factor of 1.025). 
There would be no change to the original regional update factor for the 
uncapped aged/dual eligible Medicare enrollment type as it would be 
multiplied by one. Because of the increase in original regional update 
factor for the three capped Medicare enrollment types, this 
hypothetical ACO would have a higher updated benchmark under this 
proposed policy than under current policy.
    However, if an ACO was in a regional service area with aggregate 
prospective HCC risk score growth that was not above the regional risk 
score growth cap, the regional risk score growth cap adjustment factor 
for all Medicare enrollment types would be equal to one, thus resulting 
in no change to the original regional update factor for any Medicare 
enrollment type, and therefore, no change to the ACO's updated 
benchmark compared to current policy.
    As we described in the CY 2024 PFS proposed rule, this proposed 
policy would help increase the accuracy of the regional update factor 
for ACOs operating in regional service areas with high risk score 
growth, including those serving more medically complex beneficiaries, 
therefore increasing incentives for ACOs to form or continue 
participation in such areas. We further explained that incorporating 
the market share adjustment helps to mitigate concerns related to 
coding intensity for ACOs with high market share and thus a relatively 
high level of influence over risk scores in their regional service area 
as discussed in section III.G.4.b.(1) of the proposed rule, and 
therefore, would protect the Trust Funds by continuing to limit 
incentives for this behavior.
    We simulated the impact of the proposed policy using PY 2021 
financial reconciliation data for ACOs in agreement periods beginning 
on or after July 1, 2019. This simulation found that 38 of the 332 ACOs 
(11 percent) would have been subject to the cap on regional risk score 
growth determined in step 4 of the proposed methodology, and therefore, 
would have had a higher regional update factor than under current 
policy for at least one Medicare enrollment type. Thirty-six of those 
38 ACOs were subject to the 3 percent cap on their own risk score 
growth for at least one enrollment type in actual PY 2021 results. 
Table 38 shows the percentage of ACOs determined to be subject to the 
cap on regional risk score growth for each Medicare enrollment type and 
the average increase in the regional update factor for that enrollment 
type among those ACOs.
[GRAPHIC] [TIFF OMITTED] TR16NO23.060

    In the proposed rule, we explained that while this modeling shows 
that only a small proportion of ACOs would have benefitted from this 
policy in PY 2021, our analyses have also shown that this proportion is 
predicted to increase as more ACOs advance farther into their 5-year 
agreement period. This prediction was supported by the finding that 
ACOs in the simulation were significantly more likely to be impacted if 
their agreement period started in 2019 with a BY3 of 2018 (16 percent) 
than if their agreement period started in 2020 with a BY3 of 2019 (6 
percent).\266\ Because the analysis of PY 2021 data demonstrates that 
circumstances like the PHE for COVID-19 and progression along a 5-year 
agreement period can interact to increase the share of ACOs in regional 
service areas with aggregate regional risk score growth above the cap, 
we determined that our initial concerns about creating adverse 
incentives for coding behavior by capping regional risk score growth, 
as discussed in section III.G.4.b.(1) of the proposed rule, were 
outweighed by the potential harm to ACOs in regions with high risk 
score growth, particularly when such growth is not due to the ACO's own 
coding activities. Additionally, we stated that the market share 
adjustment to the cap on regional risk score growth would limit overly 
advantaging ACOs with high market share if they participate in coding 
initiatives.
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    \266\ While analysis of average FFS risk score changes at the 
hospital referral region (HRR) level further supports the assumption 
that more ACOs would be impacted toward the end of their 5-year 
agreement period, such analysis also indicates that variation from 
the PHE for COVID-19 likely accentuated this phenomenon in the 
simulation on PY2021 data. For this reason, the finding in the 
PY2021 simulation that 16 percent of 2019 starters were impacted is 
likely indicative of an upper bound for the share of ACOs 
potentially impacted by PY5 in agreement periods that start in 2024 
or later (that is, where the impact of the PHE for COVID-19 on risk 
score growth between BY3 and the PY is minimal relative to risk 
score growth from 2018 to 2021 and from 2019 to 2021 in this 
simulation). This footnote has been revised, from footnote 187 in 
the CY 2024 PFS proposed rule (88 FR 52463), to clarify how findings 
from the PY 2021 simulation may be relevant in projecting risk score 
growth for agreement periods starting in 2024 or later.
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    Table 39 displays information on the impact of the market share 
adjustment on the cap on regional risk score growth within our 
simulation of the application of the proposed policy in PY 2021 for the 
ACOs with the minimum, median, and maximum aggregate market share that 
were found to be subject to the cap on regional risk score growth.

[[Page 79182]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.061

    Based on this data in Table 39, the majority of ACOs found to be 
impacted in this simulation had a relatively small aggregate market 
share, with a median of about 13 percent. Because of this, the median 
increase to the cap on regional risk score growth from the market share 
adjustment was small (0.001). (This is both the median increase among 
all 38 impacted ACOs and the increase for the impacted ACOs with the 
median market share). Further analysis showed that results were similar 
among both rural and urban ACOs. Of the 38 impacted ACOs, 34 were 
classified as urban and had a median aggregate market share of about 12 
percent. The remaining four impacted ACOs were rural ACOs with a median 
aggregate market share of about 24 percent. While the market share was 
higher on average among rural ACOs, average market share for both types 
of ACOs was under 25 percent and both groups had only a small median 
increase to the cap on regional risk score growth from the market share 
adjustment of 0.001.\267\
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    \267\ For this analysis, ACOs were classified as rural if the 
plurality of their assigned beneficiaries resided in either 
micropolitan or noncore counties and urban if the plurality of their 
assigned beneficiaries resided in either large central metro, large 
fringe metro, medium metro, or small metro counties as defined by 
The United States Census Bureau and the Office of Management and 
Budget (OMB).
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    ACOs with a larger aggregate market share received a larger 
increase in the cap on regional risk score growth due to the market 
share adjustment. For example, in Table 39, the ACO with the highest 
market share of 53.6 percent (an ACO that has a regional service area 
in an urban area), had a 20 percent increase in its cap from the market 
share adjustment, going from a non-market share adjusted cap of 1.008 
to an adjusted cap of 1.028. As we explained in the CY 2024 PFS 
proposed rule, while the impact of the market share adjustment on the 
cap on regional risk score growth would be small for the majority of 
ACOs, this market share adjustment was important to address both our 
own concerns related to incentives for coding intensity and the similar 
concerns raised by MedPAC in the CY 2023 PFS final rule, as discussed 
in section III.G.4.b.(1) of the proposed rule. The market share 
adjustment to the cap limits the adverse coding incentives that can 
arise when allowing larger benchmark increases when an ACO increases 
its coding, especially for ACOs with high market share. Specifically, 
ACOs with high market share would still have a disincentive to engage 
in coding initiatives, as these initiatives could increase risk score 
growth in their regional service area and potentially decrease the 
value of the regional component of their update factor.
    We explained that apart from the market share adjustment, the 
calculation of the proposed cap on regional risk score growth between 
BY3 and the performance year would be calculated in the same way as the 
aggregate demographics plus 3 percent cap on ACO risk score growth 
under Sec. Sec.  425.605(a)(1)(ii)(A) and 425.610(a)(2)(ii)(A). 
Specifically, the cap would be calculated as the aggregate growth in 
regional demographic risk scores between BY3 and the performance year 
plus 3 percentage points, prior to application of the market share 
adjustment. Additionally, we noted that as a result of incorporating 
the risk adjustment into the regional update factor at the county 
level, the current methodology does not directly calculate a regional 
risk ratio that can be directly modified. The proposed approach of 
modifying the regional update factor by multiplying by an adjustment 
factor would achieve the goal of reducing the impact of regional risk 
score growth while leaving the existing methodology for calculating 
risk-adjusted regional expenditures intact.
    In the CY 2024 PFS proposed rule, we explained that in earlier 
rulemaking (see 87 FR 69887 and 69888) we have used our authority under 
section 1899(i)(3) of the Act to adopt a three-way blended benchmark 
update factor (weighted one-third ACPT, and two-thirds national-
regional blend) for agreement periods beginning on January 1, 2024, and 
in subsequent years, in place of an update factor based on the 
projected absolute amount of growth in national per capita expenditures 
for Parts A and B services under the original FFS program as called for 
in section 1899(d)(1)(B)(ii) of the Act. We also acknowledged that the 
changes we were proposing to the regional component of the three-way 
blended update factor would similarly require continued use of our 
statutory authority under section 1899(i)(3) of the Act. Section 
1899(i)(3) of the Act grants the Secretary the authority to use other 
payment models, including payment models that use alternative 
benchmarking methodologies, if the Secretary determines that doing so 
would improve the quality and efficiency of items and services 
furnished under the Medicare program and program expenditures under the 
alternative methodology would be equal to or lower than those that 
would result under the statutory payment model. We explained our belief 
that the changes to the methodology for updating the benchmark that we 
were proposing pursuant to section 1899(i)(3) of the Act would improve 
the quality and efficiency of items and services furnished under the 
Medicare Program. More specifically, we explained our belief that the 
proposed changes to the

[[Page 79183]]

regional component of the update factor would--in the context of the 
downward effects on the benchmark resulting from elevated variation in 
regional average prospective HCC risk score growth as shown in the PY 
2021 analysis--reinforce the incentive for ACOs to enter and remain in 
the Shared Savings Program, particularly in regions with changing 
populations. Moreover, we stated our belief that the proposed approach, 
by encouraging ACOs to enter and continue participation in the Shared 
Savings Program, would lead to improvement in the quality of care 
furnished to Medicare FFS beneficiaries because participating ACOs have 
an incentive to perform well on quality measures in order to maximize 
the shared savings they may receive. In addition, as discussed in the 
Regulatory Impact Analysis (section VII. of the proposed rule), it was 
our belief that the proposed changes to the regional component of the 
three-way blended update factor, in combination with the other 
proposals for which we were required to use our authority under section 
1899(i)(3) of the Act, would result in a marginal impact that we 
estimated would result in $330 million in lower net spending over the 
10-year projection window, which supported our finding that the 
relatively minor changes to program spending resulting from these 
proposed changes would not violate the requirements of section 
1899(i)(3)(B) of the Act. We stated that we would continue to reexamine 
this projection in the future to ensure that the requirement under 
section 1899(i)(3)(B) of the Act that an alternative payment model not 
result in additional program expenditures continues to be satisfied. In 
the event that we later determine that the payment model established 
under section 1899(i)(3) of the Act no longer meets this requirement, 
we would undertake additional notice and comment rulemaking to make 
adjustments to the payment model to assure continued compliance with 
the statutory requirements.
    We proposed to revise the Shared Savings Program regulations 
governing the calculation of the regional growth rate when updating the 
historical benchmark between BY3 and the performance year at Sec.  
425.652(b)(2)(ii)(C) to incorporate a regional risk score growth cap 
adjustment factor. (In the preamble of the CY 2024 proposed rule (88 FR 
52465), we inadvertently referred to Sec.  425.652(c) instead of Sec.  
425.652(b)(2)(ii)(C); however, the proposed changes to the regulations 
text correctly reflected the intended revisions to Sec.  
425.652(b)(2)(ii)(C).) We also proposed to add a new section to the 
regulations at Sec.  425.655 to describe the calculation of the 
adjustment factor.
    We solicited comments on the proposed changes to calculation of the 
regional component of the update factor for agreement periods beginning 
on or after January 1, 2024.
    We received public comments on this proposal. The following is a 
summary of the comments we received and our responses.
    Comment: Many commenters supported the overall proposal to cap 
regional service area risk score growth for symmetry with the ACO risk 
score cap. A couple of commenters appreciated CMS' receptiveness to the 
concerns of interested parties while another thanked CMS for ensuring 
physicians in certain geographies are not disincentivized from 
participating in the Shared Savings Program.
    Commenters cited a variety of reasons for their support of the 
proposal. Several commenters discussed the effect that the policy would 
have on ACOs that care for underserved beneficiaries or medically 
complex, high-risk beneficiaries, with many saying that it would 
strengthen incentives to continue providing care to such beneficiaries 
and another saying that it would bolster the financial stability of 
ACOs caring for that population. Multiple commenters stated the 
proposal supports CMS' strategic objective to increase the number of 
beneficiaries in care relationships with more accountability for 
quality care.
    Several commenters discussed the effect that the policy would have 
on health care providers or ACOs that operate in regions with high risk 
score growth. Several commenters stated that the proposal would 
strengthen incentives for new ACOs to form or for current ACOs to 
continue participating in the Shared Savings Program, and one commenter 
stated that the proposal would be equitable for such ACOs. Another 
commenter stated that the policy would create a more equitable 
marketplace for all and incentivize ACO growth in rural and underserved 
markets. One commenter stated the policy would prevent ACOs with higher 
risk score growth from ``getting hit twice'' with regional risk score 
growth. One commenter noted they believed the policy would guard 
against a small number of health systems dramatically altering the 
financial landscape of a region. One commenter tentatively supported 
the proposal but requested that CMS monitor closely to ensure the 
policy does not unduly penalize certain ACOs in regions with changing 
demographics beyond the ACOs' control, such as an elderly population 
approaching the peak years for Medicare spending.
    Several commenters described the policy as addressing what they 
considered flaws with existing policy for updating the benchmark. A 
couple of commenters suggested that the policy would address unfairness 
or inequity that exists under current policy. Another commenter stated 
that the policy would improve accuracy in accounting for regional 
service area risk score growth. Another commenter appreciated that CMS 
intends to make methodology changes that substantively address the 
commenter's underlying concerns with the balance of national and 
regional trends in Shared Savings Program ACO benchmarks.
    MedPAC supported the proposal to cap regional risk score growth 
with an adjustment for an ACO's market share, stating that the proposal 
reasonably protects ACOs from coding that may be out of their control, 
depending on an ACO's share of the market. MedPAC suggested the 
proposal was a reasonable approach in the absence of an alternative 
policy for updating the historical benchmark by using administrative 
update factors or a policy to address the underlying differences 
between ACOs' risk scores and the average risk score for the assignable 
beneficiary population. However, MedPAC stated that the proposed 
approach should be viewed as an interim step because it does not 
address the underlying issues with coding incentives and regional 
benchmarking. We further summarize MedPAC's comments on the proposed 
modifications to the benchmarking methodology elsewhere in section 
III.G.4 of this final rule.
    Response: We agree with commenters that the proposed policy would 
encourage participation by ACOs in regions with changing beneficiary 
demographics and health status beyond the ACOs' control and improve the 
accuracy of the regional update factors for ACOs operating in regional 
service areas with high risk score growth. We also agree with 
commenters that the proposed policy would incentivize ACOs to care for 
higher risk beneficiaries.
    Comment: Some commenters specifically stated support for adjusting 
the cap based on market share, with one commenter stating that the 
adjustment would maintain a disincentive against coding intensity for 
ACOs with high market share and another recognizing the need to limit 
the impact of coding

[[Page 79184]]

initiatives, particularly among ACOs with high market share, to avoid 
potentially adverse incentives.
    Response: We agree with commenters that adjusting the regional 
service area risk score growth cap based on the percentage of 
assignable beneficiaries the ACO serves in the region would help to 
mitigate the impact of the ACO's own coding initiatives on risk score 
growth in the ACO's regional service area, particularly when the ACO 
has a greater influence on its regional service area risk score growth 
rate. As an ACO's aggregate market share increases, so does the cap on 
the ACO's regional risk score growth, ultimately limiting the potential 
increase to the regional update factor for ACOs with high market share. 
This adjustment to the cap would have the effect of ACOs with higher 
aggregate market shares seeing smaller increases in the regional 
component of the update factor, all else being equal.
    Comment: Many commenters supporting the proposal requested that the 
policy be made effective for all ACOs, not just ACOs in agreement 
periods starting on or after January 1, 2024, and a few commenters 
recommended that ACOs in existing agreement periods should be given the 
option of whether to receive the new policy. Some of these commenters 
described limiting the policy to ACOs entering new agreement periods as 
``unfair.'' A few commenters noted that because the CY 2024 PFS 
proposed rule was issued after the application deadline for agreement 
periods starting on January 1, 2024, ACOs in the middle of a current 
agreement period missed the opportunity to submit applications for 
early renewal that would allow them to take advantage of this and other 
proposed changes to the program's benchmarking policies in PY 2024, if 
finalized. A few other commenters opined that requiring ACOs to go 
through the early renewal process to benefit from the policy was 
burdensome for ACOs. One commenter noted that the early renewal process 
also created burden for CMS and additionally suggested that it could 
risk disruption to the program and lead to large swings in cohort 
sizes.
    Response: We decline commenters' suggestions to modify the timing 
of applicability for this policy and the other changes to the financial 
benchmarking methodology discussed in sections III.G.4.c-e of this 
final rule. The revisions we are making in this final rule to the 
benchmarking methodology, including the cap on regional service area 
risk score growth, will apply to all ACOs entering a new agreement 
period beginning on or after January 1, 2024. In section III.G.4.e of 
this final rule, we explain our concerns with applying benchmarking 
changes to ACOs within an agreement period in responding to similar 
suggestions in connection with the proposed revisions to the risk 
adjustment methodology.
    Comment: Multiple supportive commenters urged CMS to adopt a higher 
cap for an ACO's risk score growth. Several commenters urged CMS to 
increase the current aggregate demographics plus 3 percent cap on ACO 
risk score growth between BY3 and the performance year to 5 percent and 
to apply a symmetrical cap on decreases in risk scores. These 
commenters stated that ``the current methodology of normalizing risk 
adjustment in a region can penalize ACOs that have been coding 
accurately and that maintain the same level of risk over their 
agreement period.'' Another commenter requested that CMS increase the 
``regional cap'' to 5 percent and cap negative risk score growth at 5 
percent, saying that the ``current practice of normalizing regional 
risk adjustment penalizes ACOs that code accurately and maintain the 
same level of risk.''
    One commenter expressed support for the proposal to cap regional 
risk score growth but also urged CMS to ``remove'' the cap on ACO risk 
score growth, but their comment also included a request that the cap be 
increased to 5 percent after accounting for demographics.
    One commenter requested that CMS review whether the ``3 percent cap 
in risk score growth'' is a fair policy throughout a 5-year agreement 
period. The commenter reasoned that HCC scores are based on a previous 
year's data and ``may not reflect active changes in acuity among the 
population.'' The commenter stated their belief that this disadvantages 
ACOs that treat the most serious or complex Medicare beneficiaries and 
recommended that CMS consider additional guardrails for years of high 
volatility--as seen post COVID-19--to protect ACOs that experience 
growth in the risk of the population they serve. The commenter also 
suggested CMS adjust prior year financial settlements, particularly PY 
2021 and PY 2022, for ACOs that experienced high risk score growth.
    Response: In some cases, it was not clear if the commenters were 
referring to the cap on an ACO's own risk score growth or the proposed 
cap on an ACO's regional service area risk score growth. However, 
because a higher cap on increases in risk scores in an ACO's regional 
service area would not provide the same level of protection to ACOs 
against risk score increases in their regional service area, we 
interpret these comments to be requesting a higher cap on HCC risk 
score increases and a cap on prospective HCC risk score decreases 
within an ACO's own assigned beneficiary population. We appreciate 
these commenters' suggestions but note that their suggestions go beyond 
the scope of the proposed modifications to the Shared Savings Program's 
benchmarking methodology. The policy of capping risk score growth for 
an ACO's assigned beneficiaries during an agreement period using the 
demographics plus 3 percent cap was finalized in the CY 2023 PFS final 
rule (87 FR 69932 through 69946). We refer these commenters to the 
discussion in the CY 2023 PFS final rule (87 FR 69942) for an 
explanation of why we have concluded that it would be inappropriate to 
increase the demographics plus 3 percent cap or to limit the impact of 
prospective HCC risk score decreases.
    Comment: One commenter expressed concern over CMS's existing and 
proposed risk adjustment policies, stating that the policies are 
founded on a perspective that ACO participants are routinely and 
consistently over coding. The commenter suggested that there are ACOs 
that serve populations whose health risks do increase substantially 
over time or whose historical health risks were not fully documented by 
reported diagnoses, and that they note no evidence to indicate that 
most physicians in the Shared Savings Program are deliberately 
manufacturing codes to improve reimbursement.
    Response: As we described in section III.G.4.b.(1) of this final 
rule, it is important to consider the incentives a risk adjustment 
methodology may introduce for coding intensity. In the CY 2023 PFS 
final rule (87 FR 69932 through 69946), we highlighted recent research 
that provided evidence that a majority of CMS-HCC risk score growth for 
beneficiaries assigned to ACOs may come from coding initiatives and not 
from changes in beneficiary demographics or deteriorating health 
status. As a result, we acknowledge the need to limit the upward growth 
in prospective HCC risk scores in the ACO's regional service area 
between the benchmark period and the performance year, given that those 
risk scores are also susceptible to coding initiatives. The proposed 
policy for capping risk score growth in an ACO's regional service area 
would limit potential harm to ACOs in regions with high risk score 
growth when such growth is not due to the ACO's own coding activities 
while also protecting the Trust Funds by ensuring that benchmarks do 
not become overly inflated such that an

[[Page 79185]]

ACO would have to do very little to continue to earn a shared savings 
payment.
    Comment: One commenter requested that CMS exclude beneficiaries 
that are aligned to ACO REACH ACOs from the regional risk score 
calculation. The commenter stated their belief that the ACO REACH 
model's concurrent risk scoring methodology incentivizes ACOs 
participating in that model to do more coding, driving up risk scores 
in the region and thus negatively effecting Shared Savings Program ACOs 
operating in the same region.
    Response: We decline to consider an approach that would exclude 
certain assignable beneficiaries from the calculation of regional risk 
score growth. We have concerns that removing certain FFS beneficiaries, 
such as beneficiaries assigned to Medicare Shared Savings Program ACOs 
or aligned to ACOs participating in the ACO REACH Model, from the 
population of assignable beneficiaries included in an ACO's regional 
service area could lead regional growth rates for areas with high ACO 
penetration to be based on very small sample sizes such that the 
resulting regional update factor determined for these ACOs could lack 
validity. We also have concerns that removing certain FFS beneficiaries 
from an ACO's regional service area could incentivize ACOs--including 
Shared Savings Program ACOs and ACOs in the ACO REACH Model--to work in 
combination to favorably influence their regional spending. We noted 
similar concerns in the CY 2023 PFS final rule (87 FR 69926 and 69927) 
when discussing an alternative benchmarking policy that would remove an 
ACO's own assigned beneficiaries, or all Shared Savings Program 
assigned beneficiaries, from financial calculations based on the ACO's 
regional service area. However, in the CY 2023 PFS final rule (87 FR 
69899) we finalized a three-way blended update factor that incorporates 
the Accountable Care Prospective Trend (ACPT). The ACPT is a 
prospectively projected administrative growth factor that is not 
influenced by actual performance by a single ACO, multiple ACOs in a 
region, or all ACOs nationally, and therefore, will help address the 
wider issue of multiple neighboring ACOs influencing the regional 
trend.
    Comment: One commenter recommended that CMS control for the new 
prospective HCC risk score model phase-in, if finalized, in determining 
the regional risk score growth cap.
    Response: We believe this comment could be interpreted in multiple 
ways and would require additional clarity before we could further 
consider the commenter's suggestion. However, we note that for 
agreement periods beginning January 1, 2024, and in subsequent years, 
the proposed policy to cap regional risk score growth would provide 
symmetry with how we will cap ACO risk score growth and is expected to 
improve the accuracy of the regional update factor for ACOs operating 
in regional service areas with greater risk score growth. In addition, 
the use of a consistent risk score model for the performance year and 
all benchmark years, as described in section III.G.4.e of this final 
rule, is intended to more accurately assess changes in the level of 
risk for an ACO's assigned beneficiary population over time.
    After consideration of the public comments, we are finalizing our 
proposal to cap regional service area risk score growth for symmetry 
with the ACO risk score growth cap and to adjust the cap on regional 
risk score growth to reflect the ACO's aggregate market share without 
modification. This change will apply to agreement periods beginning 
January 1, 2024, and subsequent years. We are revising the Shared 
Savings Program regulations governing the calculation of the regional 
growth rate when updating the historical benchmark between BY3 and the 
performance year at Sec.  425.652(b)(2)(ii)(C) to incorporate a 
regional risk score growth cap adjustment factor. We are also 
finalizing our proposal to add a new section to the regulations at 
Sec.  425.655 to describe the calculation of this adjustment factor. We 
have made one minor editorial change to the text of Sec.  
425.655(f)(2)(i) as it appeared in the proposed rule to remove a 
misplaced word.
c. Mitigating the Impact of the Negative Regional Adjustment on the 
Benchmark To Encourage Participation by ACOs Caring for Medically 
Complex, High-Cost Beneficiaries
(1) Background
    In earlier rulemaking we have discussed our use of the Secretary's 
discretion under section 1899(d)(1)(B)(ii) of the Act to adjust the 
historical benchmark by ``such other factors as the Secretary 
determines appropriate'' in order to adjust ACO historical benchmarks 
to reflect FFS expenditures in the ACO's regional service area (81 FR 
37962). We initially established a regional adjustment in a benchmark 
rebasing methodology that applied to ACOs entering a second agreement 
period beginning on January 1, 2017, January 1, 2018, or January 1, 
2019 (Sec.  425.603(c) through (g)), before modifying our policy to 
apply this adjustment program wide beginning with agreement periods 
starting on July 1, 2019, and in subsequent years (Sec.  
425.601(a)(8)). In the CY 2023 PFS final rule (87 FR 69915 through 
69923) we modified the way we would calculate the regional adjustment 
for ACOs in agreement periods starting on January 1, 2024, and in 
subsequent years (Sec.  425.656). We also finalized a policy that would 
modify the way we would apply the regional adjustment to the benchmark 
that would also take into account a new adjustment for prior savings 
that would be available to eligible ACOs (Sec.  425.652(a)(8)).
    In accordance with Sec.  425.601(a)(8), for ACOs in agreement 
periods beginning on or after July 1, 2019 and before January 1, 2024, 
we adjust historical benchmark expenditures by Medicare enrollment type 
(ESRD, disabled, aged/dual eligible Medicare and Medicaid 
beneficiaries, aged/non-dual eligible Medicare and Medicaid 
beneficiaries) by a percentage of the difference between the average 
per capita expenditure amount for the ACO's regional service area and 
the average per capita amount of the ACO's historical benchmark 
(referred to herein as the ``regional adjustment''). The percentage 
applied in calculating the regional adjustment depends on whether the 
ACO has lower or higher spending compared to the ACO's regional service 
area and the agreement period for which the ACO is subject to the 
regional adjustment, according to the phase-in schedule of applicable 
weights. We cap the per capita dollar amount of the regional adjustment 
for each Medicare enrollment type at a dollar amount equal to positive 
or negative 5 percent of national per capita FFS expenditures for Parts 
A and B services under the original Medicare FFS program in benchmark 
year (BY) 3 for assignable beneficiaries (as defined in Sec.  
[thinsp]425.20) in that Medicare enrollment type identified for the 12-
month calendar year corresponding to BY3 (Sec.  
[thinsp]425.601(a)(8)(ii)(C)) (referred to herein as positive or 
negative 5 percent of national per capita FFS expenditures for 
assignable beneficiaries, and as the ``symmetrical cap,'' terms which 
we consider to be synonymous). We then apply the capped regional 
adjustment for each Medicare enrollment type by adding it to the 
historical benchmark expenditure for that enrollment type. A positive 
regional adjustment for a given Medicare enrollment type increases the 
benchmark for that enrollment type, whereas a negative regional 
adjustment

[[Page 79186]]

decreases the benchmark for that enrollment type.
    With the policies finalized in the CY 2023 PFS final rule (87 FR 
69915 through 69923), we sought to reduce the impact of negative 
regional adjustments in several ways for agreement periods beginning on 
January 1, 2024, and subsequent years. First, we finalized a policy 
that replaced the negative 5 percent cap on the negative regional 
adjustment with a negative 1.5 percent cap. Under this policy, we would 
continue to cap positive adjustments for each Medicare enrollment type 
at a dollar amount equal to 5 percent of national per capita FFS 
expenditures for assignable beneficiaries for that enrollment type but 
would cap negative adjustments for each enrollment type at a dollar 
amount equal to negative 1.5 percent of national per capita FFS 
expenditures for assignable beneficiaries for that enrollment type. 
Additionally, after applying the negative 1.5 percent cap, we would 
apply an offset factor that would gradually decrease the negative 
regional adjustment amount for a given Medicare enrollment type as an 
ACO's proportion of dually eligible Medicare and Medicaid beneficiaries 
increases or its weighted average prospective HCC risk score increases. 
Finally, for an ACO eligible for the prior savings adjustment for which 
the regional adjustment expressed as a single value (based on taking a 
person year weighted average across the four Medicare enrollment types) 
is negative, we would further offset the regional adjustment by the 
prior savings adjustment. In the CY 2023 PFS final rule (87 FR 69919) 
we expressed our belief that by reducing the impact of negative 
regional adjustments, these policies would incentivize ACOs that serve 
high-cost beneficiaries to join or continue to participate in the 
Shared Savings Program.
    These policies to reduce the impact of negative regional 
adjustments are reflected in several new sections of the regulations. 
Section 425.652 is the main provision that describes the methodology 
for establishing, adjusting, and updating the benchmark for agreement 
periods beginning on January 1, 2024, and in subsequent years, 
including the interaction of the regional adjustment and the prior 
savings adjustment. Sections 425.656 and 425.658 provide additional 
detail on the calculations of the regional adjustment and the prior 
savings adjustment, respectively.
    Table 40 illustrates how the caps on the regional adjustment would 
be calculated and applied to positive and negative regional adjustments 
at the Medicare enrollment type level under the policy finalized in the 
CY 2023 PFS final rule. Note that the uncapped regional adjustment 
values would be calculated using the applicable percentage phase-in 
weight based on whether the ACO has lower or higher spending as 
compared to its regional service area and the ACO's agreement period 
subject to a regional adjustment as described in Sec.  425.656(d). For 
example, if an ACO is considered to have lower spending compared to the 
ACO's regional service area, and it is the ACO's first agreement period 
subject to the regional adjustment, we would use a weight of 35 percent 
when applying the regional adjustment. If an ACO is considered to have 
higher spending compared to the ACO's regional service area, and it is 
the ACO's first agreement period subject to the regional adjustment, we 
would use a weight of 15 percent when applying the regional adjustment.
[GRAPHIC] [TIFF OMITTED] TR16NO23.062

    The hypothetical ACO in this example has a mix of positive and 
negative regional adjustments across the four enrollment types. The 
ACO's uncapped aged/non-dual eligible adjustment is outside the 
negative 1.5 percent cap and thus changes from -$307 to -$166 when the 
cap is applied. The ACO's adjustments for the other three enrollment 
types are all within the applicable positive or negative caps, and 
thus, are unaffected. The ACO's overall weighted average regional 
adjustment (calculated by multiplying the adjustment for each 
enrollment type by the corresponding enrollment type proportion and 
then summing across the four enrollment types) changes from -$209 to -
$111 when the negative regional adjustment cap is applied, reducing the 
per capita impact of the negative regional adjustment by $98.
    Under the methodology adopted in the CY 2023 PFS final rule (87 FR 
69917 and 69920), after we apply the caps, we next apply an offset 
factor to any negative regional adjustments at the enrollment type 
level. The offset factor is based on the following: [A] the ACO's 
overall proportion of BY3 assigned beneficiaries that are dually 
eligible for Medicare and Medicaid (including dually eligible ESRD, 
disabled, and aged beneficiaries) \268\ and [B] the ACO's

[[Page 79187]]

weighted average prospective HCC risk score for BY3 taken across the 
four Medicare enrollment types.\269\ Before taking this weighted 
average, the risk score for each enrollment type is first renormalized 
by dividing by the national mean risk score for the assignable FFS 
population for that enrollment type identified for the calendar year 
corresponding to BY3. Specifically, the offset factor is calculated as:
---------------------------------------------------------------------------

    \268\ In computing this proportion, we use for each beneficiary 
the fraction of the year (referred to as person years) in which they 
were eligible for the aged/dual eligible enrollment type or for 
which they were eligible for the ESRD or disabled enrollment type 
and dually eligible for Medicare and Medicaid.
    \269\ In computing this weighted average, we apply a weight to 
the risk score for BY3 for an enrollment type that is equal to the 
product of the ACO's BY3 per capita expenditures for that enrollment 
type and the ACO's BY3 person years for that enrollment type.
---------------------------------------------------------------------------

    Offset factor = [A] + ([B] - 1)
    We apply the offset factor, which is subject to a minimum of zero 
and a maximum of one, by subtracting its value from 1 and multiplying 
this difference by the negative regional adjustment for each Medicare 
enrollment type, calculated as:
    Final regional adjustment = Negative regional adjustment x (1 - 
Offset factor)
    The higher an ACO's proportion of dually eligible beneficiaries or 
the higher its risk score, the larger the offset factor would be and 
the larger the reduction to the overall negative regional adjustment. 
If the offset factor is equal to the maximum value of one, the ACO 
would not receive a negative regional adjustment for any enrollment 
type, because each negative adjustment would be multiplied by a value 
of 1 minus the offset factor, or 0. For these ACOs, the overall 
weighted average regional adjustment would either be 0 (if the ACO had 
negative adjustments for all four enrollment types prior to the 
application of the offset factor) or positive (if the ACO had a mix of 
positive and negative adjustments at the enrollment type level prior to 
the application of the offset factor). If the offset factor is equal to 
the minimum value of zero, the ACO would receive no benefit from the 
offset factor.
    To illustrate how the offset factor would be calculated and 
applied, assume that the hypothetical ACO from Table 40 had a 
proportion of dually eligible beneficiaries of 0.130 and a weighted 
average prospective HCC risk score for BY3 of 1.240. The offset factor 
for this ACO would be calculated as:
    Offset factor = 0.130 + (1.240 - 1) = 0.370
    This factor would be applied as illustrated in Table 41 by 
multiplying the negative regional adjustment for each applicable 
Medicare enrollment type by 1 minus the offset factor or 0.630.
[GRAPHIC] [TIFF OMITTED] TR16NO23.063

    Here, the offset factor is applied to the regional adjustments for 
the disabled and aged/non-dual eligible populations, as both are 
negative, but not to the regional adjustments for the ESRD and aged/
dual eligible populations, which are both positive. Taking the weighted 
average across the enrollment types following application of the offset 
factor shows that the ACO's overall weighted regional adjustment 
changes from -$111 before the offset to -$55 after the offset, further 
reducing the per capita impact of the negative regional adjustment by 
$56. The overall per capita impact of both the cap and offset factor 
for this ACO would be $154.
    In the CY 2023 PFS final rule (87 FR 69918 and 69921), we presented 
simulations of the combined impact of the cap and offset factor 
relative to the symmetrical positive and negative 5 percent cap then in 
place for ACOs in agreement periods beginning on July 1, 2019, and in 
subsequent years. The results of these simulations, which used data 
from PY 2020 historical benchmarks for ACOs in agreement periods 
starting on or after July 1, 2019, and from PY 2022 historical 
benchmarks for ACOs starting an agreement period on January 1, 2022, 
found the negative regional adjustment for almost every ACO that had an 
overall negative regional adjustment in the PY 2020 and PY 2022 data 
under the symmetrical cap would have been reduced (or eliminated), with 
an average per capita impact of approximately $114 for PY 2020 and $48 
for PY 2022. ACOs with higher weighted average BY3 prospective HCC risk 
scores and higher proportions of dually eligible Medicare and Medicaid 
beneficiaries had overall greater reductions in their negative regional 
adjustments. Four ACOs in the PY 2020 simulation and one in the PY 2022 
simulation had an offset factor of 1, meaning they would have received 
a full offset to their negative regional adjustments.
    Under a separate policy also finalized in the CY 2023 PFS final 
rule, an ACO beginning an agreement period on January 1, 2024, and in 
subsequent years that is a renewing or re-entering ACO may be eligible 
to receive an adjustment to its benchmark to account for savings 
generated in performance years that correspond to the benchmark years 
of its new agreement period. A full discussion of this policy can be 
found in that earlier rulemaking (87 FR 69899 through 69915). The 
policy was designed such that an eligible ACO would receive the higher 
of its overall positive regional adjustment or its prior savings 
adjustment, or a combination of the two if its overall regional 
adjustment is negative and it had prior savings. ACOs ineligible for 
the prior savings adjustment would receive the regional adjustment 
(computed as described earlier in this section applying a 5 percent cap 
on positive regional adjustments and a -1.5 percent cap and offset 
factor on negative regional adjustments). Specifically, if the regional 
adjustment, expressed as a single value, is positive, the ACO would 
receive a final adjustment equal to the

[[Page 79188]]

higher of the regional adjustment or an adjustment based on the ACO's 
prior savings (see Sec.  425.652(a)(8)(iii)(B)). If the regional 
adjustment, expressed as a single value, is negative, we would 
calculate the final adjustment as described in Sec.  
425.652(a)(8)(iii)(A), with the ACO receiving either a smaller negative 
regional adjustment or a positive adjustment for prior savings 
depending on the relative size of the negative regional adjustment and 
the ACO's pro-rated prior savings.
    Based on further consideration, in the CY 2024 PFS proposed rule 
(88 FR 52467) we expressed our belief that it was important and timely 
to revisit the policy that allows for negative adjustments to be 
applied in establishing the benchmark for ACOs. While we did not 
consider eliminating negative regional adjustments program-wide in CY 
2023 PFS rulemaking, one commenter noted that there is an argument for 
doing so. We explained our belief that further mitigating the impact of 
the negative regional adjustment for ACOs with high-cost populations, 
thereby resulting in higher benchmarks for ACOs compared to the 
recently finalized methodology, could further bolster the business case 
for Shared Savings Program participation by such ACOs.
    As we discussed in the CY 2023 PFS proposed rule (87 FR 46161), 
there is evidence that certain aspects of the program's benchmarking 
methodology, notably the regional adjustment to the benchmark, may 
deter participation among ACOs with spending above their regional 
service area including those serving medically complex, high-cost 
populations. High-cost ACOs are underrepresented in the Shared Savings 
Program, with around 86 percent of all participating ACOs receiving an 
overall positive regional adjustment in PY 2022 indicating that a 
majority of ACOs are lower spending than their regional service area. 
We also observed that ACOs that received an overall negative regional 
adjustment for PY 2022 were less likely to continue participation in 
the program in PY 2023 than were ACOs that received an overall positive 
regional adjustment, with 22 percent of ACOs with a negative overall 
adjustment leaving the program compared to 12 percent of ACOs with a 
positive overall adjustment. Since PY 2017 the overall annual average 
share of ACOs that leave the program has been 12 percent. A recent 
academic study also found evidence suggesting selective participation 
among ACOs in response to the original adoption of a regional 
adjustment in 2017, with the composition of ACOs between 2017 to 2019 
increasingly shifting to providers with lower preexisting levels of 
spending.\270\ The authors attributed these changes to a combination of 
the entry of new ACOs with lower baseline spending, the exit of higher-
spending ACOs, and the reconfiguration of ACO participant lists to 
favor lower-spending practices among ACOs continuing participation in 
the program.
---------------------------------------------------------------------------

    \270\ Lyu P, Chernew M, McWilliams J. Benchmarking Changes And 
Selective Participation In The Medicare Shared Savings Program. 
Health Affairs. May 1, 2023. Available at https://www.healthaffairs.org/doi/10.1377/hlthaff.2022.01061.
---------------------------------------------------------------------------

    Relatedly, we have observed that negative regional adjustments may 
make it more difficult for ACOs to succeed in the program financially. 
Between PY 2017, when regional adjustments were first introduced in the 
Shared Savings Program, and PY 2021, ACOs that received negative 
regional adjustments have been consistently less likely to share in 
savings than ACOs that received positive regional adjustments. For 
example, in PY 2021 we observed that 37 percent of ACOs that received a 
negative regional adjustment shared in savings compared to 63 percent 
among those with a positive adjustment.
    In the CY 2024 PFS proposed rule (88 FR 52468), we stated that 
eliminating the possibility that an ACO will receive an overall 
negative regional adjustment to its benchmark in combination with the 
other elements of the benchmarking methodology finalized in the CY 2023 
PFS final rule, would work together to further our efforts to ensure 
sustainability of the benchmarking methodology. More specifically, we 
believed this policy change would further encourage continued 
participation among high-cost ACOs that serve medically complex 
beneficiaries by eliminating the potential of a lower benchmark due to 
an overall negative regional adjustment. It may also encourage ACOs 
serving such populations that may have otherwise been discouraged from 
participating in the Shared Savings Program by the idea of a lower 
benchmark to join. We noted that the implementation of this policy 
would allow ACOs to serve the most vulnerable populations while 
lessening the concern of how their patient population may affect their 
performance in the program. We also stated our belief that program 
participation by ACOs serving these populations has the potential, over 
time, to produce cost savings for the Medicare Trust Funds by improving 
care coordination and quality of care for such beneficiaries.
    Additionally, we stated that eliminating overall negative regional 
adjustments could further incentivize greater participation among ACOs 
whose ACO participants have historically been less efficient than other 
providers and suppliers in their regions. Such ACOs may have the 
greatest potential to generate cost savings for the Medicare Trust 
Funds by adopting more efficient practices, and therefore, their 
participation in the program should not be discouraged.
(2) Revisions
    In light of these considerations, in the CY 2024 PFS proposed rule 
(88 FR 52468 through 52472) we proposed to modify the policies we 
adopted in the CY 2023 PFS final rule so as to prevent any ACO from 
receiving an adjustment that would cause its benchmark to be lower than 
it would have been in the absence of a regional adjustment. 
Specifically, we proposed the following approach to calculate and apply 
the regional adjustment, or the regional adjustment in combination with 
the prior savings adjustment, if applicable, for ACOs in agreement 
periods starting on January 1, 2024, and in subsequent years:
     We would continue to calculate the original uncapped 
regional adjustment by Medicare enrollment type using the applicable 
percentage phase-in weight based on whether the ACO has lower or higher 
spending compared to its regional service area and the ACO's agreement 
period subject to a regional adjustment as described in Sec.  
425.656(d).
     We would continue to apply the 5 percent cap on positive 
regional adjustments and the -1.5 percent cap and offset factor on 
negative regional adjustments at the enrollment type level, as 
finalized in the CY 2023 PFS final rule and described in Sec.  
425.656(c). For the performance year beginning on January 1, 2025, and 
subsequent performance years, the national assignable FFS population 
used to calculate the caps would reflect the revised definition of 
assignable beneficiary that incorporates the expanded window for 
assignment. (See section III.G.3.a of this final rule for a description 
of the proposed revisions to the definition of assignable beneficiary.)
     After applying the cap and offset factor (if applicable), 
we would express the regional adjustment as a single per capita value 
by calculating a person year weighted average of the Medicare 
enrollment type-specific regional adjustment values.
     If the ACO's regional adjustment amount (expressed as a 
single per capita value) is positive, the ACO would

[[Page 79189]]

receive a regional adjustment, according to the approach we finalized 
in the CY 2023 PFS final rule. That is, we would apply the enrollment 
type-specific regional adjustment amounts separately to the historical 
benchmark expenditures for each Medicare enrollment type. If the ACO is 
also eligible for a prior savings adjustment, the ACO would receive the 
higher of the two adjustments. If the regional adjustment amount 
(expressed as a single per capita value) is higher, we would apply the 
enrollment type-specific regional adjustment amounts separately to the 
historical benchmark expenditures for each Medicare enrollment type. If 
the prior savings adjustment is higher, we would apply the adjustment 
in the manner finalized in the CY 2023 PFS final rule as a flat dollar 
amount applied separately to the historical benchmark expenditures for 
each Medicare enrollment type.
     If the ACO's regional adjustment amount (expressed as a 
single per capita value) is negative, the ACO would receive no regional 
adjustment to its benchmark for any enrollment type. If the ACO is 
eligible for a prior savings adjustment, it would receive the prior 
savings adjustment as its final adjustment, without any offsetting 
reduction for the negative regional adjustment.
    Under the proposed approach, ACOs that would face a negative 
overall adjustment to their benchmark based on the methodology adopted 
in the CY 2023 PFS final rule would benefit, as they would now receive 
no downward adjustment. Additionally, ACOs that have a negative 
regional adjustment amount (expressed as a single value) and are 
eligible for a prior savings adjustment under the policy adopted in the 
CY 2023 PFS final rule (Sec.  425.658) would also be expected to 
benefit from the proposed policy. Specifically, these ACOs could 
receive a larger positive adjustment to their benchmark or a positive 
adjustment instead of a negative adjustment, as we would no longer 
offset the prior savings amount by the negative regional adjustment 
amount when determining the final adjustment that would apply to the 
ACO's benchmark as described in the current regulations in Sec.  
425.652(a)(8)(iii)(A).\271\ In the proposed rule, we stated our belief 
that by increasing the potential benefit of the prior savings 
adjustment in this manner, our proposed policy would be responsive to 
the comments discussed in the CY 2023 PFS final rule recommending that 
CMS make the prior savings adjustment more favorable, particularly for 
ACOs serving high-risk populations (see 87 FR 69910 through 69914).
---------------------------------------------------------------------------

    \271\ For examples of the calculation of the final adjustment 
when an ACO is eligible for a prior savings adjustment and the 
overall regional adjustment is negative under the policy adopted in 
the CY 2023 PFS final rule, please refer to Tables 65 and 66 of the 
CY 2023 PFS final rule (87 FR 69904 and 69905). In Table 65 the 
hypothetical ACO receives a positive final adjustment and in Table 
66 a negative final adjustment.
---------------------------------------------------------------------------

    Importantly, no ACO would be made worse off under the proposed 
policy. ACOs that have an overall positive regional adjustment amount 
would continue to receive the same adjustment to their benchmark as 
they would under the methodology finalized in the CY 2023 PFS final 
rule calculated and applied as described in the current regulations at 
Sec. Sec.  425.656 and 425.652(a)(8), respectively. For these ACOs, the 
regional adjustment would continue to reflect the percentage phase-in 
weight based on whether the ACO has lower or higher spending compared 
to its regional service area and the ACO's agreement period subject to 
a regional adjustment as described in Sec.  425.656(d) and we would 
continue to allow negative adjustments to be applied at the enrollment 
type level for those ACOs that receive a positive overall regional 
adjustment. We explained our belief that this would be appropriate 
because these ACOs would continue to receive a positive overall 
adjustment to their benchmark and thus should already have greater 
incentive to join or continue participation in the program than ACOs 
that might otherwise face an adjustment that reduces their benchmark.
    Tables 41 and 42 present hypothetical examples to demonstrate how 
we would determine the final adjustment to an ACO's benchmark under the 
proposed policy. Both tables include two hypothetical ACOs. The first 
ACO, ACO A, is the same hypothetical ACO as illustrated in Tables 39 
and 40 within this section and has an overall negative regional 
adjustment. The second ACO, ACO B, has an overall positive regional 
adjustment. Table 42 assumes that both ACOs are ineligible for a prior 
savings adjustment, whereas Table 43 shows how the calculation would 
change if both ACOs were eligible for such an adjustment.
BILLING CODE 4120-01-P

[[Page 79190]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.064

BILLING CODE 4120-01-C
    In Table 42, because ACO A had an overall negative regional 
adjustment and was not eligible for a prior savings adjustment, the ACO 
ultimately receives no adjustment, upward or downward, to its 
benchmark. For ACO B, whose overall regional adjustment is positive, 
the final adjustment is the regional adjustment, which is applied by 
adding the regional adjustment specific to each enrollment type 
(reflecting the percentage weight determined for the ACO and after the 
application of the cap and offset factor, if applicable) to the ACO's 
pre-adjustment historical benchmark expenditures for that enrollment 
type.
BILLING CODE 4120-01-P

[[Page 79191]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.065

BILLING CODE 4120-01-C
    In Table 43, both ACO A and ACO B are eligible for a prior savings 
adjustment. Because ACO A has a negative overall regional adjustment, 
its final adjustment is automatically set equal to the prior savings 
adjustment of $58. The adjustment is applied as a flat dollar amount by 
adding the $58 to the ACO's historical benchmark expenditures (row [A]) 
for each enrollment type. For ACO B, by contrast, the final adjustment 
is determined by comparing the regional adjustment amount (expressed as 
a single value) to the prior savings adjustment amount and using the 
higher of the two. In this case the ACO would receive a final 
adjustment equal to the prior savings adjustment of $239. Like with ACO 
A, this would be applied to the ACO's historical benchmark expenditures 
for each enrollment type as a flat dollar amount.
    In revisiting simulations done with the PY 2020 data described 
earlier in this section, there were 36 ACOs (of the 43 ACOs with a 
negative regional adjustment under the policy with the symmetrical cap) 
simulated to have a negative overall regional adjustment after the 
application of the cap and offset factor. Among these, 31 would not 
have been eligible for a prior savings adjustment and would have had 
this negative regional adjustment applied to their benchmark under the 
policy adopted in the CY 2023 PFS final rule. Under the new proposed 
policy, these ACOs would receive no adjustment to their benchmark. The 
average per capita benefit of eliminating the downward adjustment would 
be $30.
    The remaining five ACOs would have been eligible for the prior 
savings adjustment. These ACOs would have received a positive final 
adjustment to their benchmark under the methodology adopted in the CY 
2023 PFS final rule but would receive a larger positive adjustment 
under the new proposed policy, with an average per capita increase of 
$26. This is because we would no longer be offsetting the prior savings 
amount by the negative regional adjustment as part of determining the 
final adjustment to the ACO's benchmark as would happen under the 
methodology finalized in the CY 2023 PFS final rule and codified at 
Sec.  425.652(a)(8)(iii)(A).
    In the PY 2022 simulation described earlier in this section, there 
were 26 ACOs (of the 27 ACOs with a negative regional adjustment under 
the policy

[[Page 79192]]

with the symmetrical cap) that would have had a negative regional 
adjustment, expressed as a single per capita value, after the 
application of the policy adopted in the CY 2023 PFS final rule. Among 
these, 14 ACOs would not have been eligible for a prior savings 
adjustment and would have their full negative regional adjustment 
eliminated under the new proposed policy, with an average impact of 
$66. The remaining 12 ACOs that would have been eligible for a prior 
savings adjustment would see a larger positive adjustment under the 
proposed policy, with an average increase of $14.
    In the CY 2024 PFS proposed rule (88 FR 52472), we explained our 
belief that the proposed changes to the calculation and application of 
the regional adjustment, including its interaction with the prior 
savings adjustment, would strengthen incentives for participation among 
ACOs that may otherwise be subject to a downward adjustment to their 
benchmark due to the negative regional adjustment. We noted that the 
proposed policy, if finalized, would not adversely impact any ACO's 
benchmark relative to the policy that was finalized in CY 2023 PFS 
final rule, all else being equal, but would tend to increase benchmarks 
for ACOs that have historically had higher spending than their regional 
service area. Based on our simulations using data from PY 2020 and PY 
2022, the estimated average increase to the overall benchmark would be 
between 0.2 and 0.4 percent but could be larger in future years when 
more ACOs would be subject to higher phase-in weights for calculating 
the negative regional adjustment that would apply (alone or in 
combination with the prior savings adjustment) under the policy adopted 
in the CY 2023 PFS final rule. We also noted that ACOs that would 
benefit from the proposed policy are likely to include those that serve 
high-cost, medically complex patients or those whose ACO participants 
have historically been less efficient than their regional counterparts 
but may have the potential to generate the greatest savings to Medicare 
through their participation in the Shared Savings Program.
    We proposed to implement the changes described in this section 
through revisions to Sec. Sec.  425.652, 425.656, and 425.658. 
Specifically, within Sec.  425.652, which is the section that sets 
forth the methodology for establishing, adjusting, and updating the 
benchmark for agreement periods beginning on January 1, 2024, and in 
subsequent years, we proposed revisions to Sec.  425.652(a)(8). As 
revised, this provision would describe how we would determine and apply 
the adjustment to an ACO's benchmark depending on whether the ACO is 
eligible for a prior savings adjustment and whether the ACO's regional 
adjustment, expressed as a single value, is positive or negative. This 
provision would also establish that if an ACO is not eligible to 
receive a prior savings adjustment and has a regional adjustment, 
expressed as a single value that is negative or zero, the ACO will not 
receive an adjustment to its benchmark.
    We proposed to revise Sec.  425.656 (which describes the 
calculation of the regional adjustment) and Sec.  425.658 (which 
describes the calculation of the prior savings adjustment) to include 
certain elements of each calculation that were previously described in 
Sec.  425.652(a)(8). Specifically, we proposed to revise Sec.  425.656 
to redesignate paragraphs (d) and (e) as paragraphs (e) and (f) 
(respectively) and to specify in a new paragraph (d) that we would 
express the regional adjustment as a single value, and use this value 
in determining whether a regional adjustment or a prior savings 
adjustment would be applied to the ACO's benchmark in accordance with 
Sec.  425.652(a)(8) (as revised under the proposed rule). We also 
proposed modifications to update certain cross-references within Sec.  
425.656 for accuracy and consistency with the proposed revisions to the 
section.
    We proposed to revise Sec.  425.658 to redesignate paragraph (c) as 
paragraph (d). We proposed to add a new paragraph (c) under Sec.  
425.658 specifying that we would calculate the per capita savings 
adjustment as the lesser of 50 percent of the pro-rated average per 
capita savings amount (computed as described in Sec.  
425.658(b)(3)(ii)) and the cap equal to 5 percent of national per 
capita FFS expenditures for assignable beneficiaries for BY3 expressed 
as a single value by taking a person-year weighted average of the 
Medicare enrollment-type specific values. We proposed to revise newly 
redesignated paragraph (d) of Sec.  425.658 to specify CMS would 
compare the per capita prior savings adjustment with the regional 
adjustment, expressed as a single value as described in Sec.  
425.656(d), to determine the adjustment, if any, that would be applied 
to the ACO's benchmark in accordance with Sec.  425.652(a)(8).
    Additionally, we proposed to make the following conforming changes:
     In Sec.  425.600(f)(4)(ii), we proposed to remove the 
reference ``425.656(d)'' and add in its place the reference 
``425.656(e)''.
     In Sec.  425.611(c)(2)(iii), we proposed to remove the 
reference ``Sec.  425.652(a)(8)(iv)'' and add in its place the 
reference ``Sec.  425.658(c)(1)(ii)''.
     In Sec.  425.652(a)(9)(v), we proposed to remove the 
wording that references CMS redetermining the adjustment to the 
benchmark based on ``a combination of'' the redetermined regional 
adjustment and the prior savings adjustment.
     In Sec.  425.658(b)(3)(i), which specifies that the ACO is 
not eligible to receive an adjustment for prior savings if the average 
per capita amount computed in Sec.  425.658(b)(2) is less than or equal 
to zero, we proposed to remove the sentence: ``The ACO will receive the 
regional adjustment to its benchmark as described in Sec.  425.656.''
    We solicited comments on these proposed changes.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Many commenters supported the proposal to further mitigate 
the impact of negative regional adjustment to the benchmark. A number 
of these commenters suggested that the policy would increase program 
participation among ACOs with higher costs than their region by 
removing disincentives or barriers to entry, and would encourage more 
ACOs to care for underserved, medically complex and high-cost patients. 
Another commenter suggested that eliminating the regional adjustment, 
along with the proposed cap on HCC risk score growth in an ACO's 
regional service area, would ensure that physicians in certain 
geographies are not disincentivized from participating.
    MedPAC indicated that they concurred with the proposal to remove 
negative regional adjustments, though they expressed more general 
concerns about the regional adjustment overall, as discussed later in 
this section. In explaining their support for the policy, they noted 
their agreement with CMS that better incentives are needed to induce 
participation among health care providers serving beneficiaries with 
relatively higher spending. Another commenter stated their belief that 
the policy presented a near term solution for addressing selective 
participation by encouraging high cost ACOs to participate and, by 
doing so, would enable larger aggregate savings for Medicare.
    Several commenters opined on the types of ACOs that would likely 
benefit from the proposed policy, if finalized. Among those mentioned 
were ACOs caring for medically complex, high cost,

[[Page 79193]]

or high-risk patients, ACOs serving high proportions of dually eligible 
patients, and ACOs with rural ACO participants. Some of these 
commenters indicated the policy, together with the other benchmarking 
proposals, would ``level the playing field'' for health care providers 
serving at-risk populations.
    Other commenters noted that under the proposal, ACOs eligible for a 
prior savings adjustment would not have those savings offset by a 
negative regional adjustment, with one commenter explaining that this 
would make the prior savings adjustment more favorable, particularly 
for ACOs serving high-risk populations and a few commenters citing the 
favorable impact on the prior savings adjustment as the reason for 
their support of the proposal.
    Expressing tentative support for this and the other proposed 
benchmarking policies, one commenter recommended that CMS move to 
finalize these proposals but warned that none had yet been tested via 
real world application. Another commenter suggested that the proposed 
modifications to the negative regional adjustment, similar to the 
proposal to cap regional risk score growth, would improve coding 
accuracy, although they did not explain why they held this belief.
    Response: We agree with commenters that the proposed approach to 
further reducing the impact of the negative regional adjustment will 
facilitate participation of ACOs in the Shared Savings Program, 
particularly ACOs with spending above spending in their regional 
service area and those serving medically complex, high-cost 
populations, which are the beneficiaries that can benefit the greatest 
from better care coordination offered by ACOs. We expect this policy 
will help to promote agency goals of promoting health equity and having 
100 percent of people with Original Medicare in an accountable care 
relationship by 2030, while also benefitting the Trust Funds by 
encouraging participation from ACOs serving populations and 
beneficiaries with highest potential for reducing spending and 
improving quality and patient experience through better care 
coordination.
    Comment: Many commenters supported the proposal and requested that 
the policy be made effective for all ACOs, not just ACOs in agreement 
periods starting on or after January 1, 2024. A few commenters 
recommended that ACOs in existing agreement periods should be given the 
option of whether to receive the new policy. Some commenters described 
limiting the policy to ACOs entering new agreement periods as 
``unfair.'' One commenter argued that the proposed methodology to 
further mitigate the impact of negative regional adjustments would be 
beneficial for new ACOs serving high cost, high-risk populations, but 
would not provide any new protection for existing ACOs in the midst of 
current agreement periods or for renewing ACOs that already expected a 
full offset of the negative regional adjustment per the policy 
finalized in the CY 2023 PFS final rule. A few commenters noted that 
because the CY 2024 PFS proposed rule was issued after the application 
deadline for agreement periods starting on January 1, 2024, ACOs in the 
middle of a current agreement period missed the opportunity to submit 
applications for early renewal that would allow them to take advantage 
of this and other proposed changes to the program's benchmarking 
policies in PY 2024, if finalized.
    A few other commenters opined that requiring ACOs to go through the 
early renewal process to benefit from the policy was burdensome for 
ACOs. One commenter noted that the early renewal process also created 
burden for CMS and additionally suggested that it could risk disruption 
to the program and lead to large swings in cohort sizes. Several 
commenters indicated that failure to apply the policy to all ACOs in 
the program would penalize current ACOs serving costlier patients, work 
against the program's health equity goals, or add unnecessary confusion 
and complexity. A few commenters cited the benefits of applying the 
policy to all ACOs, with one commenter noting that this would promote 
consistency across the program and avoid disparate impacts across ACOs 
and another suggesting this would encourage ACO growth and recognize 
challenges current ACOs are facing.
    Response: We decline commenters' suggestions to modify the timing 
of applicability for this policy and the other changes to the financial 
benchmarking methodology policies discussed in sections III.G.4.b-e of 
this final rule. The revisions we are making in this final rule to the 
benchmarking methodology, including the changes to mitigate the impact 
of the negative regional adjustment, will apply to ACOs entering a new 
agreement period beginning on or after January 1, 2024. In section 
III.G.4.e of this final rule, we explain our concerns with applying 
benchmarking changes to ACOs within an agreement period in responding 
to similar suggestions in connection with the proposed revisions to the 
risk adjustment methodology.
    Comment: Several commenters expressed concern that none of the 
benchmark proposals in the proposed rule, including the proposal to 
further mitigate the impact of negative regional adjustments, would 
solve the ratchet effect where ACOs' benchmarks will continue to be 
lower over time as they reduce spending in their populations and future 
benchmarks are rebased using lower historic spending. A few commenters 
cautioned that if the policy to further mitigate negative regional 
adjustments is successful in bringing more inefficient ACOs into the 
program, this could increase the rate at which a given region becomes 
more efficient. They claimed that this, in turn, could exacerbate the 
ratchet effect for ACOs that are already efficient and now would be 
competing against a region getting more efficient at a faster pace. One 
such commenter strongly recommended that the policy to eliminate the 
negative regional adjustments be coupled with changes to address 
benchmark ratcheting that they claim occurs for regionally efficient 
ACOs at rebasing, particularly as ACOs enter later agreement periods. 
Another commenter encouraged CMS to monitor for possible unintended 
consequences of any of the proposed benchmarking policies if finalized 
in this final rule, including any disproportionate impacts on certain 
types of ACOs or patient populations, and to be receptive to feedback 
from industry partners and to look for additional ways to continuously 
improve benchmarking and risk adjustment methodologies. In particular, 
these commenters urged CMS to look for ways to address the ratcheting 
effect and to retain high performing ACOs in the program.
    One commenter stated that they do not believe that the additional 
modifications to the benchmarking methodology proposed in the CY 2024 
PFS proposed rule go far enough to protect existing ACOs serving high 
cost, underserved populations, like themselves, from experiencing 
dramatic ratchets to their benchmarks upon their next agreement 
renewal. In light of this belief, the commenter offered multiple 
recommendations related to the prior savings adjustment and 
administratively set benchmarks, determinations of Qualifying 
Alternative Payment Model Participants (QPs), quality reporting and 
measures, risk adjustment, and beneficiary assignment (all summarized 
elsewhere in this final rule) that would allow their ACO to sustainably 
continue its participation in the program. Another commenter also urged 
CMS to develop a long-term vision for benchmarks that relies on an 
administrative benchmarking approach.

[[Page 79194]]

    Response: Among the benchmarking policies finalized in the CY 2023 
PFS final rule were two policies that were aimed at limiting the extent 
to which an ACO's own past success or the past success of other ACOs, 
at reducing expenditures would affect the ACO's benchmark in future 
agreement periods. First, the prior savings adjustment (see 87 FR 69898 
through 69915) provides for a positive adjustment to be applied to the 
historical benchmark for ACOs that generated savings in the 3 years 
immediately preceding their current agreement period. This adjustment 
is directly connected to an ACO's own success at reducing expenditures, 
as ACOs achieving greater savings can potentially receive larger 
positive adjustments. We expect that eliminating the impact of negative 
regional adjustments on the prior savings adjustment, as proposed, will 
increase the effectiveness of the prior savings adjustment in 
addressing concerns about ratcheting. Second, the inclusion of a 
prospectively-determined component, the Accountable Care Prospective 
Trend (ACPT), in the factor used to update the benchmark to the 
performance year for agreement periods starting on or after January 1, 
2024 (see 87 FR 69881 to 69898) will help to address the ratchet effect 
by insulating a portion of the update factor from the impact that ACO 
savings can have on retrospective national and regional spending 
trends. In May 2023, we published specifications detailing the 
methodology for computing the ACPT and explaining how it will be 
incorporated into the update factor.\272\ We expect that the ACPT will 
help to address ratcheting concerns raised regarding the negative 
regional adjustment policy, that were interpreted to suggest if less 
efficient ACOs join the program and are successful in reducing 
expenditures for their assigned beneficiaries, regional trends facing 
already-efficient ACOs will be lower than they otherwise would.
---------------------------------------------------------------------------

    \272\ See Medicare Shared Savings Program, Shared Savings and 
Losses, Assignment and Quality Performance Standard Methodology 
Specifications of the Accountable Care Prospective Trend (ACPT) and 
Three-Way Blended Benchmark Update Factor (version #1, May 2023), 
available at https://www.cms.gov/files/document/medicare-ssp-acpt-specifications.pdf.
---------------------------------------------------------------------------

    As the prior savings adjustment and the three-way blended update 
factor that includes the ACPT apply only for agreement periods starting 
on or after January 1, 2024, we have not yet had a chance to gauge 
their success in meeting their intended aims in practice or to assess 
whether they have unintended consequences. We have continued to 
actively solicit feedback on what additional measures should be taken 
in the Shared Savings Program to further assuage concerns held by ACOs 
and other interested parties regarding the ratchet effect and the need 
for appropriate incentives to encourage ACOs to join the program and 
remain in the program over multiple agreement periods. For example, in 
the CY 2024 PFS proposed rule (see 88 FR 52494 through 52496), we 
sought comment on potential future modifications to both the prior 
savings adjustment and the benchmark update factor. As discussed in 
section III.G.8 of this final rule, we will take these suggestions and 
recommendations into consideration as we assess changes to propose in 
future notice and comment rulemaking.
    Comment: One commenter requested that CMS make the data used to 
make the calculations of adjustments transparent to ACOs, which they 
believed would aid ACOs and their ACO participants in planning how to 
care for these patients. The same commenter also opined that ACOs 
should have a reliable way to appeal CMS's determination with enough 
time to have any appeals resolved prior to payment and participation in 
subsequent performance years but did not specify whether they were 
referring to determinations of shared savings payments or some other 
aspect of the payment methodology.
    Response: ACOs receive historical benchmark reports which 
transparently detail the historical benchmark calculation, including 
the computation of positive and negative regional adjustments and, when 
it was applicable in the past, the prior savings adjustment. 
Modifications to the methodology for calculating the historical 
benchmark finalized in this rule will be reflected in such reports to 
provide additional transparency of benchmark calculations for ACOs 
beginning agreement periods on January 1, 2024, and in subsequent 
years. Additionally, we make various data available to ACOs to further 
promote transparency of our benchmarking calculations. For example, 
ACOs receive information on county of residence for all assigned 
beneficiaries in the Assignment List Report that is provided for each 
benchmark and performance year. ACOs can use this information in 
conjunction with public use files containing per capita expenditures 
and average risk scores for assignable beneficiaries (available on 
data.cms.gov) to estimate regional expenditures used in benchmark 
calculations.
    The reconsideration review process for the Shared Savings Program 
is codified in 42 CFR part 425, subpart I of the program regulations. 
Consistent with section 1899(g) of the Act, Sec.  425.802(a) states 
that an ACO may appeal an initial determination that is not prohibited 
from administrative or judicial review under Sec.  425.800 by 
requesting a reconsideration review by a CMS reconsideration official. 
The initial determination or revised initial determination of the 
benchmark for an ACO in accordance with section 1899(d) of the Act is 
listed among the Shared Savings Program determinations that are 
prohibited from reconsideration, appeal, or other administrative or 
judicial review as specified in Sec.  425.800. Additional information 
regarding the reconsideration review process is provided in the 
Medicare Shared Savings Program, Requesting Technical Assistance And 
Reconsideration Review Guidance (version #9, August 2022), available at 
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/sharedsavingsprogram/Downloads/Reconsideration-Review-Process-Guidance.pdf.
    Comment: Several commenters, as part of their comments on our 
proposal to mitigate the impact of the negative regional adjustment, 
also recommended that CMS take additional action to support ACOs 
serving medically complex beneficiaries, including dual eligible 
beneficiaries or those in underserved areas, and to further strengthen 
incentives for high-cost providers and suppliers to participate in the 
Shared Savings Program. One commenter encouraged CMS to continue to 
update its benchmarking methodologies to account for unfair financial 
outcomes realized by ACOs treating medically complex patients, many of 
whom they noted, are dual-eligible, but did not offer specific 
suggestions for achieving this goal. Several other commenters offered 
suggestions that went beyond the scope of the proposed modifications, 
or beyond the scope of the program's benchmarking methodology, 
including the following:
     ``Lowering the cap'' based on the share of the ACO's 
population that is attributed through Step 2 assignment to support ACOs 
that include a significant portion of high needs beneficiaries or 
beneficiaries aligned through specialists, although it was unclear 
which cap the commenter was referencing in this suggestion.
     Supporting facilities serving medically complex 
beneficiaries such as by facilitating partnerships with community 
organizations.

[[Page 79195]]

     Providing positive incentives to ACOs serving dually 
eligible and other medically complex beneficiaries.
     Incorporating a positive adjustment to the benchmark to 
accommodate increased spending that will occur when an ACO increases 
access to care for underserved areas.
    Response: The commenters' suggestions go beyond the scope of the 
modifications proposed to mitigate impacts of the negative regional 
adjustment, including the proposed modifications of the interaction 
between the regional adjustment and the prior savings adjustment. 
However, we note that in the CY 2023 PFS final rule we finalized other 
changes to the program's financial methodologies (in addition to the 
modifications to the negative regional adjustment) that we expect will 
benefit ACOs serving complex or underserved beneficiaries. For example, 
we finalized changes to the risk adjustment methodology to better 
account for medically complex, high-cost beneficiaries (see 87 FR 69932 
through 69946) and a new policy to provide increased opportunities for 
low revenue ACOs, which may include smaller rural ACOs, to share in 
savings (see 87 FR 69946 through 69952). We also note that in the CY 
2024 PFS proposed rule we sought comment on how to promote 
collaboration between ACOs and community-based organizations and refer 
readers to section III.G.8. of this final rule where we summarize the 
feedback we received.
    Comment: Several commenters called on CMS to consider providing 
support for ACOs receiving a positive regional adjustment that have 
already lowered costs in the communities they serve. Some suggested 
that the caps on the positive regional adjustment and the new prior 
savings adjustment effectively serve as a further cap on savings, which 
they believe should be addressed to ensure that successful ACOs remain 
in the Shared Savings Program. Another commenter recommended several 
modifications to positive regional adjustments, including applying a 
factor that would take into account the proportion of an ACO's assigned 
beneficiary population that is underserved, setting the cap on positive 
regional adjustments equal to 5 percent of BY3 risk-adjusted regional 
expenditures by Medicare enrollment type, and using a 50 percent weight 
to calculate positive regional adjustments starting with the first 
agreement period.
    Response: We decline to make any modifications to the methodology 
for calculating positive regional adjustments, including the 
calculation of the cap on positive regional adjustments or the phase-in 
of weights used to calculate the adjustment, or to the calculation of 
the cap on the prior savings adjustment at this time. Such suggestions 
go beyond the scope of the proposed policy which was focused on 
encouraging participation by ACOs caring for medically complex, high-
cost beneficiaries. Furthermore, the caps on positive regional 
adjustments and prior savings adjustments are an important mechanism to 
protect the Trust Funds by ensuring that benchmarks are not overly 
inflated such that an ACO would have to do very little to continue to 
earn a shared savings payment.
    Comment: While supporting our specific proposal to mitigate the 
impact of negative regional adjustments, MedPAC, consistent with their 
comments on the CY 2023 PFS proposed rule (see 87 FR 69913), urged CMS 
to use the prior savings adjustment as a means to phase out the 
regional adjustment to the benchmark entirely. They suggested that the 
factor used in computing the prior savings adjustment (currently 50 
percent) could be scaled up based on an ACO's regional efficiency. In 
addition to incorporating regional efficiency into the scaling factor 
used for the prior savings adjustment, MedPAC suggested that CMS could 
provide other incentives for current ACOs to remain in the program, 
such as scaling the shared savings rate based on efficiency and 
assuring protection from shared losses up to an amount equivalent to 
the current regional adjustment calculation.
    Response: These comments go beyond the scope of policies proposed 
in the CY 2024 PFS proposed rule. However, we will take these 
suggestions for alternative approaches to incorporating regional 
efficiency into the program's financial methodology into consideration 
along with other feedback we have received in response to our comment 
solicitation (refer to section III.G.8 of this final rule) as we 
contemplate potential future changes to the program's financial 
methodology. Should we decide that additional modifications to the 
program's financial methodology are needed, we would propose such 
changes through future notice and comment rulemaking.
    After consideration of the public comments, we are finalizing our 
proposal to further mitigate impacts of negative regional adjustments. 
We are also finalizing our proposed revisions to provisions of the 
Shared Savings Program regulations specifying the calculation of the 
regional adjustment (Sec.  425.656), the calculation of the prior 
savings adjustment (Sec.  425.658), and the interaction between these 
adjustments (Sec.  425.652(a)(8)), with minor non-substantive 
modifications to the provisions at Sec.  425.652(a)(8)(ii), (iii), and 
(iv)(B), and Sec.  425.658(c) introductory text, for improved clarity 
and to ensure consistency of terminology across provisions.
    Specifically, we are revising Sec.  425.652 to specify how we will 
determine and apply the adjustment to an ACO's benchmark depending on 
whether the ACO is eligible for a prior savings adjustment and whether 
the ACO's regional adjustment, expressed as a single value, is positive 
or negative. If the ACO is not eligible to receive a prior savings 
adjustment and the regional adjustment is positive, the ACO will 
receive an adjustment equal to the positive regional adjustment. If the 
ACO is eligible to receive a prior savings adjustment and the regional 
adjustment is positive, the ACO will receive an adjustment equal to the 
higher of the two adjustments. If the ACO is not eligible to receive a 
prior savings adjustment and the regional adjustment is zero or 
negative, the ACO will not receive an adjustment to its benchmark. If 
an ACO is eligible to receive a prior savings adjustment and the 
regional adjustment is zero or negative, the ACO will receive an 
adjustment equal to the prior savings adjustment.
    We are revising Sec.  425.656 to specify how we will express the 
regional adjustment as a single value and use this value in determining 
whether a regional adjustment or prior savings adjustment will be 
applied to the ACO's benchmark. We are revising Sec.  425.658 to 
specify that we will calculate the per capita prior savings adjustment 
as the lesser of 50 percent of the pro-rated average per capita savings 
amount (computed as described in Sec.  425.658(b)(3)(ii)) and the cap 
equal to 5 percent of national per capita FFS expenditures for 
assignable beneficiaries for BY3 expressed as a single value. We are 
also finalizing as proposed the conforming revisions to provisions of 
subpart G, described in greater detail previously in this section of 
this final rule.
    These changes will apply to agreement periods beginning on January 
1, 2024, and in subsequent years.
d. Modifications to the Prior Savings Adjustment
(1) Background
    Under section 1899(d)(1)(B)(ii) of the Act, an ACO's benchmark must 
be reset at the start of each agreement period using the most recent 
available 3 years of expenditures for Parts A and B

[[Page 79196]]

services for beneficiaries assigned to the ACO. Section 
1899(d)(1)(B)(ii) of the Act provides the Secretary with discretion to 
adjust the historical benchmark by such other factors as the Secretary 
determines appropriate. Under this authority, as described in the CY 
2023 PFS final rule (87 FR 69898 through 69915), we established a prior 
savings adjustment that will apply when establishing the benchmark for 
ACOs entering a second agreement period beginning on January 1, 2024, 
or in subsequent years, to account for the average per capita amount of 
savings generated during the ACO's prior agreement period.
    The prior savings adjustment adopted in the CY 2023 PFS final rule 
is designed to adjust an ACO's benchmark to account for the average per 
capita amount of savings generated by the ACO across the 3 performance 
years prior to the start of its current agreement period for new and 
renewing ACOs. In the CY 2023 PFS final rule (87 FR 69899), we 
explained that reinstituting a prior savings adjustment would be 
broadly in line with our interest in addressing dynamics to ensure 
sustainability of the benchmarking methodology. Specifically, such an 
adjustment would help to mitigate the rebasing ratchet effect on an 
ACO's benchmark by returning to an ACO's benchmark an amount that 
reflects its success in lowering growth in expenditures while meeting 
the program's quality performance standard in the performance year's 
corresponding to the benchmark years for the ACO's new agreement 
period. We also explained our belief that a prior savings adjustment 
could help address an ACO's effects on expenditures in its regional 
service area that result in reducing the regional adjustment added to 
the historical benchmark.
    In the CY 2023 PFS final rule (87 FR 69899), we explained that, in 
order to mitigate the potential for rebased benchmarks for ACOs that 
are lower-spending compared with their regional service area and that 
achieved savings in the benchmark period to become overinflated, we 
believed that adjusting an ACO's benchmark based on the higher of 
either the prior savings adjustment or the ACO's positive regional 
adjustment would be appropriate. Additionally, we believed it would be 
appropriate to use a prior savings adjustment to offset negative 
regional adjustments for ACOs that are higher spending compared to 
their regional service area. We noted that this would permit ACOs that 
are subject to a negative regional adjustment, but that have generated 
savings in prior years, to receive a relatively higher benchmark.
    In the CY 2024 PFS proposed rule (88 FR 52473 and 52474), we 
explained that under the methodology finalized in the CY 2023 PFS final 
rule and codified at Sec.  425.658 of the regulations, the prior 
savings adjustment that will apply in the establishment of benchmarks 
for renewing ACOs and re-entering ACOs entering an agreement period 
beginning on January 1, 2024, and in subsequent years, would be 
calculated as follows: \273\
---------------------------------------------------------------------------

    \273\ Because the discussion that follows describes the 
methodology for determining the prior savings adjustment as adopted 
in the CY 2023 PFS final rule, it does not reflect the changes to 
further mitigate the negative regional adjustment that we proposed 
in the CY 2024 PFS proposed rule. Please see section III.G.4.c of 
this final rule for a discussion of those proposals and our final 
policies to mitigate the negative regional adjustment for agreement 
periods beginning on January 1, 2024, and in subsequent years.
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     Step 1: Calculate total per capita savings or losses in 
each performance year that constitutes a benchmark year for the current 
agreement period. For each performance year we will determine an 
average per capita amount reflecting the quotient of the ACO's total 
updated benchmark expenditures minus total performance year 
expenditures divided by performance year assigned beneficiary person 
years. CMS will apply the following requirements in determining the 
amount of per capita savings or losses for each performance year:
    ++ The per capita savings or losses will be set to zero for a 
performance year if the ACO was not reconciled for the performance 
year.
    ++ If an ACO generated savings for a performance year but was not 
eligible to receive a shared savings payment for that year due to 
noncompliance with Shared Savings Program requirements, the per capita 
savings for that year will be set to zero.
    ++ For a new ACO that is identified as a re-entering ACO, per 
capita savings or losses will be determined based on the per capita 
savings or losses of the ACO in which the majority of the ACO 
participants in the re-entering ACO were participating.
     Step 2: Calculate average per capita savings. Calculate an 
average per capita amount of savings by taking a simple average of the 
values for each of the 3 performance years as determined in Step 1, 
including values of zero, if applicable. We will use the average per 
capita amount of savings to determine the ACO's eligibility for the 
prior savings adjustment as follows:
    ++ If the average per capita value is less than or equal to zero, 
the ACO will not be eligible for a prior savings adjustment. The ACO 
will receive the regional adjustment to its benchmark.
    ++ If the average per capita value is positive, the ACO will be 
eligible for a prior savings adjustment.
     Step 3: Apply a proration factor to the per capita savings 
calculated in Step 2 equal to the ratio of the average person years for 
the 3 performance years that immediately precede the start of the ACO's 
current agreement period (regardless of whether these 3 performance 
years fall in one or more prior agreement periods), and the average 
person years in benchmark years for the ACO's current agreement period, 
capped at 1. If the ACO was not reconciled for one or more of the 3 
years preceding the start of the ACO's current agreement period, the 
person years from that year (or years) will be excluded from the 
averages in the numerator and the denominator of this ratio. For a new 
ACO that is identified as a re-entering ACO, the person years of the 
ACO in which the majority of the ACO participants of the re-entering 
ACO were participating will be used in the numerator of the 
calculation. This ratio will be redetermined for each performance year 
during the agreement period in the event of any changes to the number 
of average person years in the benchmark years as a result of changes 
to the ACO's certified ACO participant list, a change to the ACO's 
beneficiary assignment methodology selection, or changes to the 
beneficiary assignment methodology.
     Step 4: Determine final adjustment to benchmark. Compare 
the pro-rated positive average per capita savings from Step 3 with the 
ACO's regional adjustment, determined as specified in the regulation at 
Sec.  425.656, expressed as a single per capita value by taking a 
person-year weighted average of the Medicare enrollment type-specific 
regional adjustment values.
    ++ If the regional adjustment, expressed as a single value, is 
negative or zero, calculate the sum of the regional adjustment value 
and the pro-rated positive average per capita savings value and 
determine the final adjustment as follows:
    --If the sum is positive, the ACO will receive a prior savings 
adjustment in place of the negative regional adjustment equal to the 
lesser of 50 percent of the sum of the pro-rated average per capita 
savings and the regional adjustment and 5 percent of national per 
capita FFS expenditures for Parts A and B services under the original 
Medicare FFS program in BY3 for assignable beneficiaries identified for 
the 12-month calendar year

[[Page 79197]]

corresponding to BY3. The adjustment will be applied as a flat dollar 
amount to the historical benchmark expenditures for each of the 
following populations of beneficiaries: ESRD, disabled, aged/dual 
eligible Medicare and Medicaid beneficiaries, and aged/non-dual 
eligible Medicare and Medicaid beneficiaries.
    --If this sum is negative, this will constitute the amount of the 
negative regional adjustment applied to the ACO's historical benchmark. 
The adjustment will be applied as a flat dollar amount to the 
historical benchmark expenditures for the following populations of 
beneficiaries: ESRD, disabled, aged/dual eligible Medicare and Medicaid 
beneficiaries, and aged/non-dual eligible Medicare and Medicaid 
beneficiaries.
    ++ If the regional adjustment, expressed as a single value, is 
positive, the ACO will receive an adjustment to the benchmark equal to 
the higher of the following:
    --The positive regional adjustment amount. The adjustment will be 
applied separately to the historical benchmark expenditures for each of 
the following populations of beneficiaries in accordance with Sec.  
425.656(c): ESRD, disabled, aged/dual eligible Medicare and Medicaid 
beneficiaries, and aged/non-dual eligible Medicare and Medicaid 
beneficiaries.
    --A prior savings adjustment equal to the lesser of 50 percent of 
the pro-rated positive average per capita savings value and 5 percent 
of national per capita FFS expenditures for Parts A and B services in 
BY3 for assignable beneficiaries identified for the 12-month calendar 
year corresponding to BY3. The adjustment will be applied as a flat 
dollar amount to the historical benchmark expenditures for each of the 
following populations of beneficiaries: ESRD, disabled, aged/dual 
eligible Medicare and Medicaid beneficiaries, and aged/non-dual 
eligible Medicare and Medicaid beneficiaries.
    As we explained in the CY 2023 PFS final rule (87 FR 69900) in 
calculating an ACO's average per capita prior savings over the 3 
performance years immediately preceding the start of its agreement 
period, we believe that a safeguard is needed to ensure that ACOs that 
achieved savings for a performance year that serves as a benchmark year 
for the current agreement period, but were ineligible to receive a 
shared savings payment due to noncompliance with Shared Savings Program 
requirements, are not subsequently eligible to have a portion of those 
savings included in their historical benchmark. Without such a 
safeguard, we would be rewarding an ACO, despite its noncompliance, 
through a higher benchmark in its subsequent agreement period. This 
would conflict with the sanction imposed on the ACO for its 
noncompliance during the performance year(s) of its prior agreement 
period. Accordingly, under the prior savings adjustment policy we 
finalized in the CY 2023 PFS final rule, if an ACO was ineligible to 
share in savings for any performance year in the 3 performance years 
immediately preceding the start of its agreement period due to 
noncompliance with Shared Savings Program requirements, we will set at 
zero the per capita amount of savings for the affected performance 
year(s) when calculating the prior savings adjustment.
    There are a variety of reasons that could result in an ACO's 
ineligibility to receive a shared savings payment due to noncompliance. 
In accordance with Sec. Sec.  425.605(c)(2), and 425.610(c)(2), an ACO 
does not qualify to receive shared savings for a performance year if it 
failed to meet the quality performance standard as specified under 
Sec.  425.512 or otherwise did not maintain its eligibility to 
participate in the Shared Savings Program. Furthermore, an ACO will not 
receive any shared savings payments during the time it is under a 
corrective action plan (CAP) for avoidance of at-risk beneficiaries and 
is not eligible to receive shared savings for the performance year 
attributable to the time that necessitated the CAP (the time period 
during which the ACO avoided at-risk beneficiaries) (refer to Sec.  
425.316(b)(2)(ii)(B) and (C)).
    In the CY 2023 PFS rulemaking to establish the current prior 
savings adjustment, we did not describe how we would account for 
certain circumstances where there could be changes to the values used 
in calculating the prior savings adjustment. Such changes could occur 
for changes in savings earned by ACOs in accordance with Sec.  
425.316(b)(2)(ii)(B) or (C) as a result of a compliance action to 
address avoidance of at-risk beneficiaries or issuance of a revised 
initial determination of financial performance under Sec.  425.315. If 
CMS determines that an ACO, its ACO participants, any ACO providers/
suppliers, or other individuals or entities performing functions or 
services related to the ACO's activities avoids at-risk beneficiaries 
and requires the ACO to submit a CAP, the ACO will not receive any 
shared savings payments during the time it is under the CAP (Sec.  
425.316(b)(2)(ii)(B)), and it will not at any time be eligible to 
receive shared savings for the performance year attributable to the 
time that necessitated the CAP (Sec.  425.316(b)(2)(ii)(C)). Upon 
completion of an ACO's CAP for avoidance of at-risk beneficiaries, CMS 
may release shared savings payments withheld from an ACO during the 
time it was under a CAP under Sec.  425.316(b)(2)(ii)(B), so long as 
the shared savings are not attributable to the time that necessitated 
the CAP (that is, the time period during which the ACO avoided at-risk 
beneficiaries). Thus, depending on the timing of compliance actions 
undertaken by CMS, the amount of savings eligible for inclusion in the 
prior savings adjustment under Sec.  425.658(b)(1), may change as a 
result of the compliance action. For instance, the total savings 
eligible for inclusion in the prior savings adjustment may increase 
after the completion of a CAP and release of a shared savings payment 
withheld under Sec.  425.316(b)(2)(ii)(B). Further, if an initial 
determination of financial performance was already made and shared 
savings payments distributed and then the ACO was found to have avoided 
at-risk beneficiaries, and therefore, ineligible to receive a shared 
savings payment for the performance year, CMS would recoup the shared 
savings for the time period during which the ACO avoided at-risk 
beneficiaries. This latter scenario would result in a decrease in the 
total amount of savings eligible for inclusion in the prior savings 
adjustment calculation.
    Further, if we determine that the amount of shared savings due to 
the ACO or the amount of shared losses owed by the ACO has been 
calculated in error, under Sec.  425.315 CMS may reopen its prior 
determination and issue a revised initial determination: (1) at any 
time in the case of fraud or similar fault as defined in Sec.  405.902; 
or (2) not later than 4 years after the date of the notification to the 
ACO of the initial determination of savings or losses for the relevant 
performance year, for good cause. If these situations--changes in the 
amount of shared savings for a prior performance year under Sec.  
425.316(b)(2)(ii)(B) or (C) as a result of a compliance action due to 
the avoidance of at-risk beneficiaries, or the issuance of a revised 
initial determination based on a reopening of ACO shared savings or 
shared losses under Sec.  425.315--impact one of the 3 years prior to 
the start of the ACO's current agreement period, it is possible that 
the prior savings adjustment would no longer reflect the savings or 
losses achieved by the ACO during the applicable years. In the CY 2023 
PFS rulemaking, we did not adopt a mechanism to account for these 
changes in the prior savings adjustment, but

[[Page 79198]]

rather focused on changes to the prior savings adjustment related to 
changes in an ACO's participant list, changes to the ACO's assignment 
methodology selection, or changes to beneficiary assignment methodology 
under the Shared Savings Program as a whole.
(2) Revisions
    In the CY 2024 PFS proposed rule (88 FR 52474 through 52476), we 
proposed refinements to the prior savings adjustment calculation 
methodology, specified in 42 CFR part 425, subpart G, that would apply 
in the establishment of benchmarks for renewing ACOs and re-entering 
ACOs entering an agreement period beginning on January 1, 2024, and in 
subsequent years, to account for circumstances where the amount of 
savings or losses for a performance year used in the prior savings 
adjustment calculation changes retroactively. Specifically, we proposed 
to modify the list of circumstances for adjusting the historical 
benchmark in Sec.  425.652(a)(9) to include two additional scenarios: a 
change in savings earned by an ACO in a benchmark year in accordance 
with Sec.  425.316(b)(2)(ii)(B) or (C) due to compliance action to 
address avoidance of at-risk beneficiaries, or a change in the amount 
of savings or losses for a benchmark year as a result of a reopening of 
a prior determination of ACO shared savings or shared losses and the 
issuance of a revised initial determination under Sec.  425.315. In 
these situations, the amount of savings or losses that an ACO may have 
generated in the 3 performance years prior to the start of the current 
agreement period and that would have been eligible for inclusion in the 
calculation of the prior savings adjustment may change. The refinements 
we proposed would allow for the prior savings adjustment to be 
recalculated and the historical benchmark to be adjusted to reflect the 
any change in the amount of savings earned or losses incurred by the 
ACO in the 3 performance years prior to its current agreement period 
that are eligible for inclusion in the calculation of the prior savings 
adjustment.
    We proposed to modify the process described in Sec.  425.652(a)(9) 
for adjusting the historical benchmark. Under the current regulation, 
an ACO may receive an adjusted historical benchmark because of changes 
in the ACO's assigned beneficiary population in the benchmark years of 
the ACO's current agreement period due to the addition and removal of 
ACO participants or ACO providers/suppliers in accordance with Sec.  
425.118(b), a change to the ACO's beneficiary assignment methodology 
selection under Sec.  425.226(a)(1),\274\ or changes to the beneficiary 
assignment methodology specified in 42 CFR part 425, subpart E. We 
proposed to modify Sec.  425.652(a)(9) to indicate that an ACO would 
receive an adjusted historical benchmark for changes in values used in 
benchmark calculations in accordance with Sec.  425.316(b)(2)(ii)(B) or 
(C) due to compliance action to address avoidance of at-risk 
beneficiaries or as a result of issuance of a revised initial 
determination under Sec.  425.315. More specifically, an ACO would 
receive an adjusted benchmark for the following reasons: (1) a change 
in the amount of savings calculated for any of an ACO's 3 benchmark 
years eligible for inclusion in the prior savings adjustment in 
accordance with Sec.  425.316(b)(2)(ii)(B) or (C) due to compliance 
action taken to address avoidance of at-risk beneficiaries, or (2) CMS 
issues a revised initial determination under Sec.  425.315 that impacts 
the amount of savings or losses calculated for 1 of the ACO's benchmark 
years. In the proposed rule, we noted that a compliance action taken to 
address avoidance of at-risk beneficiaries may lead to a change in the 
amount of savings earned by an ACO for a previous performance year when 
CMS releases savings previously withheld under Sec.  
425.316(b)(2)(ii)(B) for a time period other than the time period 
during which the ACO avoided at-risk beneficiaries following completion 
of a CAP or CMS recoups shared savings previously disbursed to an ACO 
under Sec.  425.316(b)(2)(ii)(C) for a time period during which the ACO 
is later determined to have avoided at-risk beneficiaries.
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    \274\ Refer to section III.G.7.a of the proposed rule for a 
description of the proposal to revise the current reference to Sec.  
425.400(a)(4)(ii) in Sec.  425.652(a)(9)(iv) to a reference to Sec.  
425.226(a)(1).
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    Only ACOs whose current benchmark includes a prior savings 
adjustment or whose benchmark would include an adjustment for prior 
savings following a change in the amount of savings earned for a 
previous performance year that is a benchmark year for the ACO's 
current agreement period would receive an adjusted benchmark under 
these proposed changes. Furthermore, we proposed to modify the process 
described in Sec.  425.652(a)(9) to indicate that if either of these 
two conditions occur after the ACO has already received its historical 
benchmark for the first performance year of its agreement period, an 
ACO could receive an adjusted historical benchmark for the first year 
of its agreement period.
    We also proposed to add a new paragraph (e) to Sec.  425.658 to 
indicate that, when either of the two aforementioned scenarios occurs, 
the prior savings adjustment itself would be recalculated. We explained 
that without this addition there would be no mechanism for 
recalculating the prior savings adjustment to address changes in ACO's 
savings or losses for a performance year within an agreement period. 
Further, we proposed that, absent any other triggers for receiving an 
adjusted benchmark, an ACO would only receive an adjusted historical 
benchmark due to a change in the ACO's savings or losses for a 
performance year under Sec. Sec.  425.315 or 425.316(b)(2)(ii)(B) or 
(C) if the change would result in a change to the prior savings 
adjustment as determined under Sec.  425.652(a)(8). In other words, the 
ACO would not receive an adjusted historical benchmark following 
recalculation of the prior savings adjustment if the recalculation of 
the prior savings adjustment would not result in a change to the 
historical benchmark.
    In the CY 2024 PFS proposed rule (88 FR 52475), we explained our 
belief that, to issue adjusted benchmarks and complete financial 
reconciliation in a timely fashion, it would be necessary to establish 
a timing cutoff for when the determination to issue an adjusted 
historical benchmark for these two additional reasons would be made. 
Each of the two scenarios for which we proposed to recalculate the 
prior savings adjustment may occur at any point during any performance 
year of the ACO's agreement period, as well as after the end of that 
agreement period. We proposed that for an adjusted benchmark due to the 
two conditions being considered to be used in financial reconciliation 
for a performance year, any determination under Sec. Sec.  425.315 or 
425.316(b)(2)(ii)(B) or (C) that changes the amount of the ACO's 
savings or losses in any of the benchmark years must be issued no later 
than the date of the initial determination of shared savings or shared 
losses through financial reconciliation for the relevant performance 
year under Sec.  425.605(e) or Sec.  425.610(h). We noted, however, 
that if we become aware of a potential change under Sec.  
425.316(b)(2)(ii)(B) or (C) in the savings earned in a benchmark year 
by an ACO eligible for the prior savings adjustment or an upcoming 
revised initial determination under Sec.  425.315 that could impact the 
determination of the ACO's savings or losses for a benchmark year, we 
might delay the initial determination of shared savings or shared 
losses for the ACO for the

[[Page 79199]]

relevant performance year beyond when initial determinations would 
otherwise be issued in order to assess whether the ACO should receive 
an adjusted historical benchmark. Under this framework, changes to 
savings or losses for a benchmark year that are finalized after 
notification to the ACO of the initial determination of shared savings 
or shared losses for a given performance year would be reflected in the 
adjusted benchmark applied to any subsequent performance year during 
the relevant agreement period but would not be retroactively applied to 
completed performance years in the agreement period.
    We considered several alternatives to the timing of when we could 
incorporate new information about a change in savings earned by an ACO 
in accordance with Sec.  425.316(b)(2)(ii)(B) or (C) or a revised 
initial determination under Sec.  425.315 into the prior savings 
adjustment. The two primary alternatives we considered were: (1) 
requiring information about a change to the amount of savings 
calculated for a previous year in accordance with Sec.  
425.316(b)(2)(ii)(B) or (C) or a revised initial determination under 
Sec.  425.315 to become available by December 31st of the year prior to 
the performance year; and (2) considering this information at any time 
it becomes available. An advantage of the former option of requiring 
information by December 31st is that it would allow us to issue the 
adjusted benchmark in March of the performance year, consistent with 
when adjusted benchmarks are otherwise issued to ACOs. A disadvantage 
of this approach is that it would provide less flexibility for when new 
information impacting savings or losses in the benchmark years could be 
applied to the benchmark used in financial reconciliation for a given 
performance year. An advantage of the latter approach of considering 
such information at any time that it becomes available is that an ACO 
could receive an adjusted benchmark and a revised initial determination 
of shared savings or shared losses even after receiving its initial 
determination for a performance year. However, a disadvantage of this 
approach is that it would generate significant operational 
complexities. If, for instance, information becomes available during 
performance year four of an ACO's agreement period that would 
potentially impact financial reconciliation results in the first 3 
performance years of the agreement period, we would need to 
simultaneously issue adjusted benchmarks and revised initial 
determinations for several performance years. In the proposed rule, we 
stated that on balance, we believed it would be appropriate to consider 
new information that could impact the prior savings adjustment up to 
the point at which an ACO receives its initial determination for a 
particular performance year. We noted that we were continuing to 
consider the complexities surrounding reopening initial determinations 
for multiple prior performance years throughout the program's 
benchmarking and financial reconciliation methodologies and may address 
this issue in future rulemaking.
    We recognized that under Sec.  425.658(b)(1)(iii), for a new ACO 
identified as re-entering ACO, the prior savings adjustment is based on 
the prior savings or losses of the ACO in which the majority of the 
ACO's ACO participants were participating. Accordingly, in the case of 
a re-entering ACO, we proposed to consider whether this prior ACO is 
impacted by the following when determining whether to issue an adjusted 
benchmark: (1) a change in the amount of savings calculated for any of 
the ACO's benchmark years eligible for inclusion in the prior savings 
adjustment in accordance with Sec.  425.316(b)(2)(ii)(B) or (C) due to 
compliance action to address avoidance of at-risk beneficiaries; or (2) 
a revised initial determination issued under Sec.  425.315 that impacts 
the determination of the ACO's savings or losses for one of the 
benchmark years. In this case, other aspects of the proposal would 
apply similarly, including the timing cutoff for issuing an adjusted 
benchmark and issuing an adjusted benchmark only if the change in 
savings or losses determined for the applicable benchmark year would 
result in a change to the prior savings adjustment as determined under 
Sec.  425.652(a)(8).
    We included two examples to illustrate how an ACO could receive an 
adjusted historical benchmark that incorporates additional savings as a 
result of the changes we were proposing.
     Example 1: An ACO renews to begin a new agreement period 
on January 1, 2025 but is under a corrective action plan under Sec.  
425.316(b) for avoidance of at-risk beneficiaries during performance 
year 2023. In accordance with Sec.  425.316(b)(2)(ii)(B) the ACO did 
not receive a shared savings payment for performance year 2024, which 
represents the third benchmark year of its new agreement period. 
Therefore, the ACO's prior savings adjustment for its new agreement 
period would be calculated by setting the gross savings and losses for 
the third benchmark year equal to 0 as described in Sec.  
425.658(b)(1)(ii). However, in November of 2026 the corrective action 
plan for avoidance of at-risk beneficiaries is closed and CMS 
determines that the ACO is eligible to receive payment for shared 
savings for performance year 2024. In this example, the ACO would have 
previously received notification of the initial determination of shared 
savings or shared losses for performance year 2025. Because the change 
in the status of the corrective action plan occurred after the ACO 
received its initial determination of shared savings and shared losses 
for performance year 2025, savings from the ACO's third benchmark year 
would be included in the calculation of the prior savings adjustment 
beginning with the benchmark used to determine financial performance 
for performance year 2026. That is, the ACO would receive an adjusted 
historical benchmark for performance year 2026 reflecting the 
recalculated prior savings adjustment, and financial reconciliation for 
performance year 2026 and subsequent performance years of the ACO's 
current agreement period would reflect that adjusted historical 
benchmark. However, financial reconciliation for performance year 2025 
would not be reopened to reflect savings from the third benchmark year 
in the calculation of the prior savings adjustment because the 
corrective action plan was not lifted until after the ACO received its 
initial determination of shared savings or shared losses for that 
performance year.
     Example 2: An ACO begins a new agreement period on January 
1, 2026, and receives its historical benchmark, which includes a prior 
savings adjustment. In February of 2027, information is identified that 
leads to a revised initial determination of shared savings and shared 
losses for benchmark year 2 of the ACO's new agreement period. Because 
the issue was identified in February of the second performance year of 
the new agreement period, which is prior to the ACO receiving an 
initial determination of its shared savings and shared losses for 
performance year 2026, the ACO would receive an adjusted historical 
benchmark for performance year 2026. Shared savings and shared losses 
calculations for performance year 2026 would reflect the recalculated 
prior savings adjustment included in this adjusted benchmark. All 
subsequent performance years in the agreement period would also reflect 
the recalculated prior savings adjustment.
    In summary, we proposed revisions to Sec.  425.652(a)(9) to 
indicate that we

[[Page 79200]]

would adjust the benchmark for changes in values used in benchmark 
calculations in accordance with Sec.  425.316(b)(2)(ii)(B) or (C) due 
to compliance action to address avoidance of at-risk beneficiaries or 
as a result of the issuance of a revised initial determination under 
Sec.  425.315. We also proposed to add new paragraph (e) to Sec.  
425.658 to specify that the ACO's prior savings adjustment is 
recalculated for changes to the ACO's savings or losses for a 
performance year used in the prior savings adjustment calculation in 
accordance with Sec.  425.316(b)(2)(ii)(B) or (C) due to compliance 
action to address avoidance of at-risk beneficiaries or as a result of 
issuance of a revised initial determination under Sec.  425.315. 
Further, the new provision Sec.  425.658(e) would also establish that 
for new re-entering ACOs, the prior savings adjustment will be 
recalculated for changes in savings or losses for a performance year 
used in the prior savings adjustment for the ACO in which a majority of 
the new ACO's ACO participants were previously participating.
    We solicited comments on the proposal to adjust the historical 
benchmark to reflect changes in savings or losses for a performance 
year that constitutes a benchmark year for an ACO's current agreement 
period. These changes would be applicable for agreement periods 
beginning on or after January 1, 2024.
    We received public comments on this proposal. The following is a 
summary of the comments we received and our responses.
    Comment: We received several comments pertaining to the proposal to 
adjust the historical benchmark to reflect changes in savings or losses 
for a performance year that constitutes a benchmark year for an ACO's 
current agreement period. All comments supported the proposed changes, 
with several noting that the proposed policy increases program 
integrity without imposing undue burden on ACOs. We did not receive any 
comments opposing these changes.
    Response: We agree with the commenters that the proposed provisions 
will improve the accuracy of the prior savings adjustment without 
placing additional burden on ACOs.
    After consideration of the public comments, we are finalizing 
without modification the proposed refinements to the prior savings 
adjustment calculation methodology, specified in Sec.  425.658, to 
account for circumstances where the amount of savings or losses for a 
performance year used in the prior savings adjustment calculation 
changes retroactively. This change will apply in the establishment of 
benchmarks for renewing ACOs and re-entering ACOs entering an agreement 
period beginning on January 1, 2024, and in subsequent years.
    We are finalizing the proposed revisions to Sec.  425.652(a)(9) to 
include two additional circumstances under which we will adjust the 
historical benchmark: a change in savings earned by an ACO in a 
benchmark year in accordance with Sec.  425.316(b)(2)(ii)(B) or (C) due 
to compliance action to address avoidance of at-risk beneficiaries, or 
a change in the amount of savings or losses for a benchmark year as a 
result of a reopening of a prior determination of ACO shared savings or 
shared losses and the issuance of a revised initial determination under 
Sec.  425.315.
    We also refer readers to section III.G.8.c. of this final rule for 
a summary of comments received in response to the RFI in the CY 2024 
PFS proposed rule regarding potential increases to the prior savings 
adjustment.
e. Update How Benchmarks Are Risk Adjusted
(1) Overview of Risk Adjustment Within Shared Savings Program Benchmark 
Calculations
    When establishing, adjusting, and updating an ACO's historical 
benchmark, CMS makes certain adjustments to account for the severity 
and case mix of, and certain demographic factors for, the ACO's 
assigned beneficiary population and the assignable beneficiary 
population. We use prospective HCC risk scores and (as applicable) 
demographic risk scores to perform this risk adjustment.
    To follow is a summary of the calculations in which we will account 
for the severity and case mix of the ACO's assigned beneficiary 
population or the assignable beneficiary population when establishing, 
adjusting, and updating the historical benchmark, for agreement periods 
beginning on January 1, 2024, and in subsequent years, including as 
proposed elsewhere in the CY 2024 PFS proposed rule.
     We risk adjust benchmark year expenditures used to 
establish the historical benchmark for changes in severity and case mix 
using prospective HCC risk scores, in accordance with Sec.  
425.652(a)(3). In making this adjustment, we account for changes in 
severity and case mix in the ACO's assigned beneficiary population 
between the first and third benchmark years and between the second and 
third benchmark years.\275\
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    \275\ See, for example, Medicare Shared Savings Program, Shared 
Savings and Losses, Assignment and Quality Performance Standard 
Methodology Specifications (version #11, January 2023), available at 
https://www.cms.gov/files/document/medicare-shared-savings-program-shared-savings-and-losses-and-assignment-methodology-specifications.pdf-2 (see section 3.6, ``Risk Adjustment 
Policies'').
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     We calculate the ACO's regional FFS expenditures using 
risk adjusted county-level FFS expenditures, which are determined in 
accordance with Sec.  425.654(a)(4) by adjusting FFS expenditures for 
severity and case mix of assignable beneficiaries in the county using 
prospective HCC risk scores and by making separate expenditure 
calculations for populations of beneficiaries by Medicare enrollment 
type (ESRD, disabled, aged/dual eligible Medicare and Medicaid 
beneficiaries, and aged/non-dual eligible Medicare and Medicaid 
beneficiaries). The ACO's risk adjusted regional FFS expenditures are 
utilized in determining the regional adjustment to the historical 
benchmark (in accordance with Sec.  425.656), the regional component of 
the national-regional blended trend factor (in accordance with Sec.  
425.652(a)(5)), and the regional component of the three-way blended 
benchmark update factor (in accordance with Sec.  425.652(b)(2)).
     We calculate the regional adjustment to the historical 
benchmark in accordance with Sec.  425.656, including the following 
calculations to account for severity and case mix:
    ++ We adjust for differences in severity and case mix between the 
ACO's assigned beneficiary population for BY3 and the assignable 
population of beneficiaries for the ACO's regional service area for BY3 
in accordance with Sec.  425.656(b)(3).
    ++ In calculating the negative regional adjustment, we apply an 
offset factor based on the ACO's overall proportion of BY3 assigned 
beneficiaries who are dually eligible for Medicare and Medicaid 
(including dually eligible ESRD, disabled, and aged beneficiaries) and 
the ACO's weighted average prospective HCC risk score for BY3 taken 
across the four Medicare enrollment types, in accordance with Sec.  
425.656(c)(4).
     We adjust the ACO's historical benchmark to account for 
changes in severity and case mix in the ACO's assigned beneficiary 
population between BY3 and the performance year in accordance with 
Sec. Sec.  425.652(a)(10), 425.605(a)(1) and (2) (BASIC track), and 
425.610(a)(2) and (3) (ENHANCED track), at the time of financial 
reconciliation for a performance year. We use prospective HCC risk 
scores to adjust the historical benchmark for changes in severity and 
case mix for all assigned beneficiaries between BY3 and

[[Page 79201]]

the performance year, with positive adjustments subject to a cap equal 
to the ACO's aggregate growth in demographic risk scores between BY3 
and the performance year plus 3 percentage points (refer to Sec. Sec.  
425.605(a)(1)(ii) and 425.610(a)(2)(ii), and section III.G.4.b.(1) of 
the proposed rule).
     In calculating the regional component of the three-way 
blended update factor, we proposed to cap prospective HCC risk score 
growth in an ACO's regional service area between BY3 and the 
performance year by applying an adjustment factor, as discussed in 
section III.G.4.b.(2) of the proposed rule and the proposed new 
provision at Sec.  425.655.
     We adjust the flat dollar amounts of the ACPT component of 
the three-way blended update factor for each performance year, for 
differences in severity and case mix between the ACO's BY3 assigned 
beneficiary population and the national assignable FFS population for 
each Medicare enrollment type identified for the 12-month calendar year 
corresponding to BY3, in accordance with Sec.  425.660(b)(4).
(2) Background on Calculation of Prospective HCC Risk Scores Used to 
Risk Adjust Shared Savings Program Benchmark Calculations
(a) Historical Practices
    We detailed how CMS performs Shared Savings Program risk adjustment 
calculations in programmatic material, including publicly available 
specifications documents. See, for example, Medicare Shared Savings 
Program, Shared Savings and Losses, Assignment and Quality Performance 
Standard Methodology Specifications (version #11, January 2023), 
available at https://www.cms.gov/files/document/medicare-shared-savings-program-shared-savings-and-losses-and-assignment-methodology-specifications.pdf-2 (see section 3.6, ``Risk Adjustment Policies''). 
While we have specified the details of these practices in guidance, we 
have not previously codified these practices in regulation.
    In the CY 2024 PFS proposed rule (88 FR 52477), we described that 
CMS maintains the CMS-HCC risk adjustment models for the Medicare 
Advantage (MA) program. CMS maintains CMS-HCC risk adjustment models 
for populations of beneficiaries based on age, disability status, 
gender, institutional status, eligibility for Medicaid, and health 
status (see section 1853(a)(1)(C)(i) of the Act), including a separate 
MA risk adjustment model for the ESRD population, and a Part D risk 
adjustment model (known as the RxHCC model). Over time, CMS has 
implemented revised versions of the CMS-HCC risk adjustment models 
(also referred to generally as the ``CMS-HCC model''). Historically, 
transitions to a revised version of the CMS-HCC model have been 
gradually phased-in over time by blending the old risk adjustment model 
and the revised risk adjustment model. We specify the CMS-HCC risk 
adjustment models applicable for a calendar year in the annual MA Rate 
Announcement (see sections 1853(a)(1)(C) and (b)(1) of the Act). Prior 
to doing so, we solicited comments on the CMS-HCC risk adjustment 
methodology (see section 1853(b)(2) of the Act). Using the specified 
model, or blend of models (if applicable), we calculated prospective 
HCC risk scores for all Medicare beneficiaries, including FFS 
beneficiaries. These prospective HCC risk scores are then used to set 
MA capitation rates and Part C and D payment policies for the 
applicable calendar year.
    To perform risk adjustment calculations for the Shared Savings 
Program, we calculate prospective HCC risk scores for Medicare FFS 
beneficiaries for the relevant benchmark year or performance year. In 
doing so, we use the CMS-HCC risk adjustment model(s) that are 
applicable for the particular calendar year corresponding to the 
benchmark or performance year to identify a Medicare FFS beneficiary's 
prospective HCC risk score for that benchmark or performance year. 
Prospective HCC risk scores used in financial calculations for the 
Shared Savings Program have the MA coding pattern adjustment of 5.90 
percent removed, if applicable.\276\ Additionally, all prospective HCC 
risk scores are renormalized by Medicare enrollment type based on a 
national assignable FFS population to ensure that the mean risk score 
among assignable beneficiaries is equal to one. Renormalization helps 
to ensure consistency in risk scores from year to year, given changes 
made to the underlying risk score models. All risk adjustment 
calculations for the Shared Savings Program, including risk score 
renormalization, are performed separately for each Medicare enrollment 
type for the following populations of beneficiaries: ESRD, disabled, 
aged/dual eligible for Medicare and Medicaid, aged/non-dual eligible 
for Medicare and Medicaid.\277\
---------------------------------------------------------------------------

    \276\ The MA risk adjustment models used for beneficiaries 
classified as ESRD for the Shared Savings Program (that is, 
beneficiaries in long-term dialysis or transplant status, no more 
than three months post-graft) do not currently employ a coding 
intensity adjustment, therefore no adjustment is currently removed 
from risk scores for beneficiaries in the ESRD enrollment type.
    \277\ A beneficiary's final risk score for each month is the 
risk score determined for that beneficiary based on the 
beneficiary's risk adjustment model status for that month. There are 
risk adjustment models for MA subpopulations (for example, community 
model versus institutional model versus new enrollee model for aged/
non-dual eligible beneficiaries), and the risk scores used by the 
Shared Savings Program for beneficiaries in a Medicare enrollment 
type may be derived from more than one risk adjustment model.
---------------------------------------------------------------------------

    Under the Shared Savings Program, we calculate demographic only 
risk scores using a separate model than those used to calculate 
prospective HCC risk scores. For agreement periods beginning on January 
1, 2024, and subsequent years, CMS will use demographic risk scores to 
determine the cap on risk score growth between BY3 and the performance 
year. Demographic risk scores consider only certain specified patient 
demographic factors, such as age, sex, Medicaid status, and the basis 
for Medicare entitlement (that is, age, disability, or ESRD), without 
incorporating diagnostic information. As such, demographic risk scores 
are not subject to changes in coding intensity or coding accuracy in 
the same way that prospective HCC risk scores are. We note that while 
the Shared Savings Program uses the same demographic factors as those 
used in MA, Shared Savings Program demographic factor coefficients are 
calibrated based on the entire Medicare FFS population instead of new 
Medicare enrollees as is used by MA.
    Currently, when establishing, adjusting, and updating the 
benchmark, we account for changes in severity and case mix between 
benchmark years or between BY3 and the performance year by multiplying 
the expenditures for the applicable year by a quotient of two ACO-level 
renormalized risk scores, known as the risk ratio. For example, to risk 
adjust the expenditures for an ACO's assigned beneficiary population to 
account for changes in case mix and severity from the first benchmark 
year to the third, we multiply BY1 expenditures by a risk ratio equal 
to the mean renormalized risk score among the ACO's assigned 
beneficiaries in BY3 divided by the mean renormalized risk score among 
the ACO's assigned beneficiaries in BY1 for each Medicare enrollment 
type. For instance, a one percent rate of growth in renormalized risk 
scores between these benchmark years would be expressed by a risk ratio 
of 1.010. This ratio reflects growth in risk for the ACO's assigned 
beneficiary population relative to that of the national assignable 
population. Because the risk ratios used in benchmarking

[[Page 79202]]

calculations may be determined using risk scores calculated from 
different underlying CMS-HCC risk adjustment models, depending on the 
CMS-HCC risk adjustment model(s) applicable to the corresponding 
benchmark or performance year, this approach allows for the possibility 
that differences in risk models between the benchmark years and the 
performance year could impact an ACO's financial performance.
    Since the inception of the Shared Savings Program in 2012, there 
have been several CMS-HCC model changes. Several factors reduce the 
impact of using different risk adjustment models to calculate 
prospective HCC risk scores for benchmark and performance years when 
performing Shared Savings Program risk adjustment calculations. One 
factor is that the Shared Savings Program renormalizes prospective HCC 
risk scores by Medicare enrollment type, which ensures that the mean 
risk score for the national assignable FFS population for each 
enrollment type is equal to one. If a new CMS-HCC model leads to a 
shift in the mean of the distribution of prospective HCC risk scores 
for the national assignable FFS population for a particular Medicare 
enrollment type, then renormalizing the risk scores would 
counterbalance this effect. Because renormalization factors are 
calculated across the assignable beneficiary population for each 
enrollment type, any adverse or beneficial impact for an ACO from a 
change in CMS-HCC model would derive from the mean risk score for the 
ACO's assigned beneficiaries within a given enrollment type being 
impacted in a systematically different way than the mean for the 
national assignable population for that enrollment type.
    A second factor is that risk scores are used in multiple ways that 
balance their effects when establishing, adjusting, or updating a 
benchmark. Risk scores are used to adjust ACO expenditures and also to 
adjust regional expenditures used in calculating the regional 
adjustment to the benchmark and regional growth rates in benchmark 
calculations. Any impact of a new CMS-HCC model that could increase or 
decrease an ACO's risk scores used to establish, adjust, or update a 
benchmark may differ directionally from the impact that risk scores for 
the assignable FFS population in an ACO's regional service area might 
have on risk-adjusted regional expenditure calculations. For example, 
if a new CMS-HCC model lowers the risk ratio between BY3 and the PY, 
and therefore, lowers the benchmark for an ACO, all else equal, then 
the new risk adjustment model may also lower the risk scores for the 
ACO's regional service area assignable beneficiary population, which 
would increase risk-adjusted regional expenditures.\278\ This would put 
upward pressure on the benchmark by increasing the regional update 
factor. Any changes to the ACO's risk ratio may be thus reduced by 
changes to the ACO's regional update factor. This would reduce the 
impact of CMS-HCC model changes on ACO financial performance.
---------------------------------------------------------------------------

    \278\ For each county and Medicare enrollment type (ESRD, 
disabled, aged/dual eligible, and aged/non-dual eligible) in the 
ACO's regional service area, CMS divides average per capita county-
level FFS expenditures by the county average renormalized CMS-HCC 
risk score to obtain risk-adjusted county expenditures.
---------------------------------------------------------------------------

    A third factor is that CMS-HCC model transitions have been 
gradually phased-in over time by blending the old risk adjustment model 
and the new risk adjustment model, thereby constraining the magnitude 
of any change in risk ratios resulting from differences in the risk 
adjustment models used to calculate prospective HCC risk scores. That 
is, as a result of this blending, the risk ratios used to adjust 
expenditures between BY3 and the PY may have some degree of overlap in 
underlying risk adjustment models used to calculate both the numerator 
and denominator of the risk ratios.
(b) Introduction of the 2024 CMS-HCC Risk Adjustment Model, Version 28
    On March 31, 2023, CMS released the Announcement of CY 2024 MA 
Capitation Rates and Part C and Part D Payment Policies,\279\ which 
finalized the transition to a revised CMS-HCC risk adjustment model. 
The revised 2024 CMS-HCC risk adjustment model, Version 28 (V28), has 
the same structure as the 2020 CMS-HCC risk adjustment model currently 
used for payment in that it has eight model segments as first 
implemented for payment for CY 2017 and condition count variables as 
first implemented for payment for CY 2020. It incorporates the 
following technical updates: (1) updated data years used for model 
calibration, (2) updated denominator year used in determining the 
average per capita predicted expenditures to create relative factors in 
the model, and (3) a clinical reclassification of the hierarchical 
condition categories (HCCs) using the International Classification of 
Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes. In 
addition, as part of the clinical reclassification, CMS conducted an 
assessment on conditions that are coded more frequently in MA relative 
to FFS. This assessment is consistent with Principle 10 of CMS's 
longstanding model principles, described in more detail initially in 
the December 2000 report titled, ``Diagnostic Cost Group Hierarchical 
Condition Category Models for Medicare Risk Adjustment (Final Report)'' 
(available at https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Reports/downloads/pope_2000_2.pdf). As a 
result of this assessment, in addition to the technical updates, the 
revised model includes additional constraints and the removal of 
several HCCs to reduce the impact on risk score variation in coding 
between MA and FFS.\280\
---------------------------------------------------------------------------

    \279\ For more details, refer to Announcement of Calendar Year 
(CY) 2024 Medicare Advantage (MA) Capitation Rates and Part C and 
Part D Payment Policies (March 31, 2023) (herein CY 2024 Rate 
Announcement), available at https://www.cms.gov/files/document/2024-announcement-pdf.pdf.
    \280\ See Advance Notice of Methodological Changes for Calendar 
Year (CY) 2024 for Medicare Advantage (MA) Capitation Rates and Part 
C and Part D Payment Policies (February 1, 2023), available at 
https://www.cms.gov/files/document/2024-advance-notice-pdf.pdf.
---------------------------------------------------------------------------

    For CY 2024, MA risk scores will be calculated as a blend of 67 
percent of the risk scores calculated under the 2020 CMS-HCC risk 
adjustment model, Version 24 (V24), and 33 percent of the risk scores 
calculated with the 2024 CMS-HCC risk adjustment model (V28). CMS 
expects that for CY 2025, MA risk scores will be calculated using a 
blend of 33 percent of the risk scores calculated with V24 and 67 
percent of the risk scores calculated with V28, and for CY 2026, 100 
percent of risk scores will be calculated with V28.\281\
---------------------------------------------------------------------------

    \281\ See CY 2024 Rate Announcement, available at https://www.cms.gov/files/document/2024-announcement-pdf.pdf at 3.
---------------------------------------------------------------------------

    With the transition to the use of the V28 CMS-HCC model beginning 
in CY 2024 in MA, it is timely to revisit how we apply the CMS-HCC risk 
adjustment model(s) to calculate risk scores used in Shared Savings 
Program calculations. As summarized in the CY 2024 Rate Announcement, 
some commenters questioned if the updated MA risk adjustment model will 
affect lines of business outside of Medicare Advantage such as the ACO 
REACH Model and Medicare Shared Savings Program. In response to these 
comments, we explained that we were considering the implications of 
these changes to the CMS-HCC risk adjustment model for these 
initiatives.\282\
---------------------------------------------------------------------------

    \282\ See id. at 97.
---------------------------------------------------------------------------

    In the CY 2024 PFS proposed rule we described our initial analysis 
of the impact of the V28 CMS-HCC model on Shared Savings Program 
calculations, including modeling of an alternative approach to 
calculating benchmark year

[[Page 79203]]

risk scores (88 FR 52479 through 52481). We proposed an approach to 
making such calculations for agreement periods beginning on January 1, 
2024, and in subsequent years.
(3) Initial Analysis of the Impact of Risk Adjustment Model Changes on 
Shared Savings Program Calculations and Modeling of an Alternative 
Approach to Calculating Benchmark Year Risk Scores
    In the CY 2024 PFS proposed rule (88 FR 52479), we noted that to 
further evaluate the potential impact of the V28 CMS-HCC model 
transition on Shared Savings Program ACOs, we analyzed the following:
     Our current approach in which we apply the CMS-HCC risk 
adjustment model(s) applicable for a particular calendar year to 
calculate a Medicare FFS beneficiary's prospective HCC risk score for 
the corresponding benchmark or performance year. This approach could 
lead to different CMS-HCC risk adjustment models being used to 
calculate prospective HCC risk scores for the benchmark years as 
compared to a particular performance year of the ACO's agreement period 
when there is a transition to a new CMS-HCC risk adjustment model 
between one or more benchmark years and the performance year.
     An alternative approach in which we would use the CMS-HCC 
risk adjustment model(s) applicable to the calendar year corresponding 
to the performance year to calculate a Medicare FFS beneficiary's 
prospective HCC risk score for the performance year, and for each 
benchmark year of the ACO's agreement period.\283\ This approach 
ensures consistency between the CMS-HCC risk adjustment methodology 
used to calculate the prospective HCC risk scores for the benchmark 
years relative to a particular performance year.
---------------------------------------------------------------------------

    \283\ A similar approach was suggested by commenters in earlier 
rulemaking for the Shared Savings Program. See, for example, the 
December 2018 final rule (83 FR 68013), in which we summarize 
commenters' recommendation that CMS modify the current methodology 
to use the same CMS-HCC risk score model to calculate risk scores 
for both the benchmark years and the performance year.
---------------------------------------------------------------------------

    To conduct this analysis, we calculated prospective HCC risk scores 
and risk ratios for CY 2018 (treated as BY3) and CY 2021 (treated as 
the PY) for all 275 ACOs that participated in both PY 2018 and PY 2021. 
Risk ratios between BY3 and the PY were calculated under the current 
approach, in which we used the V24 CMS-HCC model to calculate BY3 
prospective HCC risk scores and the V28 CMS-HCC model to calculate PY 
prospective HCC risk scores, and under the alternative approach of 
calculating both BY and PY prospective HCC risk scores using V28.\284\
---------------------------------------------------------------------------

    \284\ The V24 CMS-HCC model was not applicable to CY 2018 but 
was used in this analysis to calculate BY3 prospective HCC risk 
scores under the current approach to measure the impact of the 
transition from V24 to V28 on Shared Savings Program ACOs.
---------------------------------------------------------------------------

    We performed this analysis to roughly estimate how V28 would have 
impacted payment to ACOs in PY 2021 using weighted average risk scores 
calculated across the three non-ESRD Medicare enrollment types 
(disabled, aged/dual eligible, aged/non-dual eligible). The analysis 
provides insight into the impact of a fully phased-in V28, which is 
expected to occur in PY 2026 (particularly for ACOs that would at that 
point have a BY3 prior to 2024). For the 275 ACOs in the sample, 
combined PY 2021 shared savings payments would have been about 11 
percent lower than actual payments if V28 had been fully phased-in for 
the performance year, when using V24 to calculate BY3 prospective HCC 
risk scores (reflecting the current approach to applying CMS-HCC risk 
adjustment models). Alternatively, combined shared savings payments 
would have been about 2 percent higher than actual if V28 were used for 
BY3 calculations, as well as for PY 2021 calculations (reflecting the 
alternative approach to applying CMS-HCC risk adjustment models).
    Table 44 compares the estimated impact on PY 2021 shared savings of 
the current approach, and the alternative approach to calculating BY3 
and PY prospective HCC risk scores.
[GRAPHIC] [TIFF OMITTED] TR16NO23.066

    Estimated decreases in PY 2021 shared savings payments are more 
extreme at the tail of the distribution when using the current 
approach. Over 10 percent of ACOs showed more than 1.4 percent in 
reduced shared savings payments relative to benchmark under the 
modeling of the current approach, in which we used V24 to calculate BY3 
prospective HCC risk scores and V28 to calculate PY prospective HCC 
risk scores. In contrast, about 3 percent of ACOs showed declines of 
such magnitude in shared savings payments relative to the benchmark 
using the alternative approach to calculating prospective HCC risk 
scores for BY3 and PY 2021 with the V28 CMS-HCC model. Compared to the 
alternative approach, the current approach is estimated to result in a 
reduction in shared savings of about 0.2 percent per ACO on average, 
relative to benchmark. These impacts would be smaller, potentially

[[Page 79204]]

one-third of the magnitude, if the use of V24 in BY3 was compared to 
the blend of 33 percent V28 and 67 percent V24 for the PY (reflecting 
the blend applicable for CY 2024).
    Table 45 compares the estimated impact on PY 2021 shared savings of 
the current approach, and the alternative approach to calculating BY3 
and PY risk scores (expressed as percentage of benchmark), based on the 
following ACO characteristics: ACO average renormalized prospective HCC 
risk scores for aged/disabled beneficiaries, ACO participation in 
performance-based risk, and year of entry into the Shared Savings 
Program. We observed that the current approach would have the greatest 
adverse effect on ACOs with the highest average risk scores (calculated 
with the V24 CMS-HCC model), ACOs participating in two-sided models, 
and ACOs that have been in the Shared Savings Program longer. ACOs that 
would not have been harmed by the current approach had an average 
renormalized risk score for their non-ESRD populations roughly equal to 
1.00. The 5 percent of ACOs in the modeling with the most adverse 
impact from the current approach had an average renormalized risk score 
for their non-ESRD populations of 1.22. For ACOs with the highest 
average risk scores, the modeling showed the current approach would 
have resulted in reduced shared savings of about 2 percent (relative to 
benchmark) per ACO, as compared to the alternative approach. The most 
adversely impacted ACOs in the modeling also were roughly 40 percent 
more likely to participate in a two-sided model and to have 
participated in the Shared Savings Program nearly 2 years longer than 
ACOs not harmed. The modeling demonstrates that the alternative 
approach would reduce the negative impact that the current approach 
shows for ACOs with high-risk scores, with earlier entry dates into the 
Shared Savings Program, and with participation in a two-sided model.
[GRAPHIC] [TIFF OMITTED] TR16NO23.067

    In the context of the transition to the V28 CMS-HCC model, the 
results of this analysis show that the current approach to calculating 
prospective HCC risk scores is expected to adversely impact ACO 
financial performance, particularly for ACOs that serve a high-risk 
beneficiary population, when compared to the stated alternative 
approach. We explained that factors discussed in the proposed rule (as 
described in section III.G.4.e.(2) of the proposed rule)--renormalizing 
risk scores to the national assignable FFS population, risk-adjusted 
regional expenditures providing a counterbalance to how risk ratios 
impact the benchmark, and the phased transition from V24 to V28 by 
means of a blended risk model--will reduce the impact of a risk 
adjustment model transition. However, these factors will be 
insufficient to prevent adverse effects on ACO financial performance 
due to the larger impact from the transition to V28 relative to prior 
CMS-HCC model transitions. The alternative policy under which CMS would 
apply the same CMS-HCC risk adjustment model used in the performance 
year to calculate prospective HCC risk scores for all benchmark years 
would strengthen risk adjustment in the Shared Savings Program and 
consistently apply the CMS-HCC model in the Shared Savings Program 
context as it is applied in MA.
(4) Revisions
    The adoption of the alternative approach to calculating prospective 
HCC risk scores for the performance year and each benchmark year of an 
ACO's agreement period would allow us to more accurately measure the 
change in severity and case mix for an ACO's assigned beneficiary 
population or the assignable beneficiary population. Under such an 
approach, there would be no potential for distortion from using 
different CMS-HCC risk adjustment models in calculating prospective HCC 
risk scores for benchmark years and the performance year that could 
occur under the current policy. For this reason, we proposed to modify 
our current use of the CMS-HCC risk adjustment model and adopt the 
alternative approach to calculating prospective HCC risk scores for a 
performance year and the relevant benchmark years for agreement periods 
beginning on January 1, 2024, and in subsequent years.
    We proposed to add a new section to our regulations at Sec.  
425.659, which would codify our existing framework for calculating risk 
scores used in Shared

[[Page 79205]]

Savings Program benchmark calculations and adopt the alternative 
approach to calculating prospective HCC risk scores for a performance 
year and the relevant benchmark years (88 FR 52481 through 52483). We 
proposed in paragraph (a) of Sec.  425.659 to codify our current 
practice of accounting for differences in severity and case mix of the 
ACO's assigned beneficiaries and assignable beneficiaries (as defined 
under Sec.  425.20) in calculations used in establishing, adjusting, 
and updating the ACO's historical benchmark.
    We proposed to set forth in paragraph (b) of Sec.  425.659 our 
approach to determining Medicare FFS beneficiary prospective HCC risk 
scores for Shared Savings Program benchmark and performance year 
calculations (88 FR 52481). In paragraph (b)(1) of Sec.  425.659, we 
proposed to codify our current policy under which CMS specifies the 
CMS-HCC risk adjustment methodology used to calculate prospective HCC 
risk scores for Medicare FFS beneficiaries (as defined under Sec.  
425.20) for use in Shared Savings Program calculations. Additionally, 
we proposed:
     To codify our current practice of calculating risk scores 
for Medicare FFS beneficiaries for a performance year, which provides 
that CMS uses the CMS-HCC risk adjustment methodology applicable for 
the corresponding calendar year.
     To codify our current practice for agreement periods 
beginning before January 1, 2024, of applying the CMS-HCC risk 
adjustment methodology for the calendar year corresponding to benchmark 
year in calculating risk scores for Medicare FFS beneficiaries for each 
benchmark year of the agreement period.
     For agreement periods beginning on January 1, 2024, and in 
subsequent years, CMS would apply the CMS-HCC risk adjustment 
methodology for the calendar year corresponding to the performance year 
in calculating risk scores for Medicare FFS beneficiaries for each 
benchmark year of the agreement period.
    We proposed at Sec.  425.659(b)(2) to codify our current practices 
for calculating prospective HCC risk scores for a benchmark or 
performance year (88 FR 52482). Specifically, in calculating 
prospective HCC risk scores, we would remove the MA coding intensity 
adjustment, if applicable. Further, we would renormalize prospective 
HCC risk scores by Medicare enrollment type (ESRD, disabled, aged/dual 
eligible Medicare and Medicaid beneficiaries, and aged/non-dual 
eligible Medicare and Medicaid beneficiaries) based on a national 
assignable FFS population for the relevant benchmark or performance 
year. We would calculate the average prospective HCC risk score by 
Medicare enrollment type (ESRD, disabled, aged/dual eligible Medicare 
and Medicaid beneficiaries, and aged/non-dual eligible Medicare and 
Medicaid beneficiaries) in order to risk adjust benchmark calculations 
also performed by Medicare enrollment type.
    We did not propose to modify the current approach to calculating 
demographic risk scores under the Shared Savings Program (88 FR 52482).
    We also proposed to adjust the benchmark to account for CMS-HCC 
risk adjustment model changes during the term of the agreement period 
to maintain uniformity between the calculation of prospective HCC risk 
scores for the performance year and each benchmark year (88 FR 52482). 
We proposed to revise the list of circumstances for adjusting the 
historical benchmark for the second and each subsequent performance 
year during the term of the agreement period at Sec.  425.652(a)(9) to 
include a change in the CMS-HCC risk adjustment methodology used to 
calculate prospective HCC risk scores under proposed, new Sec.  
425.659. We further proposed to add a new paragraph (a)(9)(vi) to Sec.  
425.652 to specify that we would redetermine factors based on 
prospective HCC risk scores calculated for benchmark years by 
calculating the prospective HCC risk scores using the CMS-HCC risk 
adjustment methodology that applies for the calendar year corresponding 
to the applicable performance year in accordance with proposed Sec.  
425.659(b)(1).
    We also proposed a technical and conforming change to Sec.  
425.650(a), which generally describes the organization of the sections 
on the benchmarking methodology within subpart G of the Shared Savings 
Program regulations (88 FR 52482). In the description of the 
benchmarking methodology applicable for agreement periods beginning 
before January 1, 2024, we proposed to update the list of referenced 
sections to include the proposed new Sec.  425.659.
    We stated in the CY 2024 PFS proposed rule (88 FR 52482), that this 
proposed policy would address the concerns of ACOs and other interested 
parties regarding the transition to the V28 CMS-HCC model or other 
similar future changes to CMS-HCC risk adjustment methodology that 
could occur during the term of an ACO's agreement period. Under the 
proposal, both the numerator and denominator in the PY/BY3 risk ratio 
would be calculated using a consistent risk model, and any 
distributional impacts should, on average, be balanced. This would 
prevent distortion to historical benchmarks resulting from model 
changes. This conclusion was informed by the data analysis described in 
the proposed rule (88 FR 52479 through 52481), which shows that on 
average ACOs would have earned roughly 0.2 percent in additional PY 
2021 shared savings payments relative to benchmark when both benchmark 
year and performance year prospective HCC risk scores are calculated 
under V28 compared to calculations under both V24 and V28.
    Our analysis showed that ACOs with higher than average risk scores 
would benefit from using the proposed approach to calculate BY and PY 
prospective HCC risk scores relative to the current policy. The 
proposal would therefore help the Shared Savings Program retain ACOs 
serving the highest risk beneficiaries. This is a priority for CMS as 
high-risk beneficiaries may benefit the most from better care 
coordination and quality improvement activities, particularly by ACOs 
with above average duration of participation in the program. Similarly, 
the proposed approach would support potential participation from new 
ACOs that would consider whether risk adjustment calculations in the 
Shared Savings Program benchmarking methodology would be adequate for 
beneficiaries with the highest risk.
    The proposal would not affect how prospective HCC risk scores are 
calculated for ACOs in agreement periods that began prior to January 1, 
2024, consistent with our historical practice of incorporating changes 
to the benchmarking methodology only at the start of an ACO's agreement 
period. We explained that ACOs in an existing agreement period that 
includes performance year 2024, 2025 or 2026 may benefit from the 
factors discussed in the proposed rule (88 FR 52478 through 52479)--
renormalizing risk scores to the national assignable FFS population, 
risk-adjusted regional expenditures providing a counterbalance to how 
risk ratios impact the benchmark, and the phased transition from V24 to 
V28 by means of a blended risk model. These factors would diminish 
adverse effects of using the new CMS-HCC risk adjustment methodology in 
Shared Savings Program calculations.
    In the CY 2024 PFS proposed rule (88 FR 52482), we stated that if 
we finalized the proposed approach for agreement periods beginning on 
January 1, 2024, and in subsequent years, an ACO in an existing 
agreement period could choose

[[Page 79206]]

to terminate its participation agreement early, to early renew under a 
new participation agreement to be under the revised approach. For 
instance, an ACO under an existing agreement period with the current 
methodology (with a 2022 or 2023 start date) could apply to early renew 
with the application cycle for the January 1, 2025 agreement period 
start date, which would occur during CY 2024. For an existing ACO that 
applied to early renew and enters a new agreement period beginning on 
January 1, 2024, the proposed policy, if finalized, would apply to the 
ACO's new agreement period. Any ACO that early renews would have its 
benchmark rebased at the start of the new agreement period.
    The following examples, based on the first 3 years of a 5-year 
agreement period beginning on January 1, 2024, illustrate the 
applicability of the current approach to calculating BY and PY 
prospective HCC risk scores using different CMS-HCC risk adjustment 
model(s), as compared to the proposed approach to calculating both BY 
and PY prospective HCC risk scores using the same CMS-HCC risk 
adjustment model(s). Under the current policy an ACO beginning a new 
agreement period on January 1, 2024, would have its prospective HCC 
risk scores for BY1 (2021) calculated using a blend of 25 percent under 
the 2014 CMS-HCC model, Version 22 (V22), and 75 percent V24,\285\ and 
for BY2 (2022) and BY3 (2023) calculated using V24.286 287 
For PY1 (2024), prospective HCC risk scores would be calculated using a 
blend of 67 percent V24 and 33 percent V28. For PY2 (2025), prospective 
HCC risk scores are expected to be calculated using a blend of 33 
percent V24 and 67 percent V28. For PY3 (2026), prospective HCC risk 
scores are expected to be calculated using V28. Under the current 
methodology, the risk ratios used to risk adjust expenditures would 
have the numerator and denominator calculated using different 
underlying CMS-HCC risk adjustment models. Specifically, to risk adjust 
BY1 expenditures to BY3 when establishing or adjusting the ACO's 
historical benchmark, the risk ratio would include risk scores 
calculated under V24 (BY3) and a blend of 25 percent V22 and 75 percent 
V24 (BY1). To risk adjust BY3 expenditures to the performance year when 
updating the historical benchmark during financial reconciliation, risk 
ratios would include risk scores calculated under V24 (as applicable to 
BY3) and either a blend of V24 and V28 (for PY1 and as expected for 
PY2) or fully calculated with V28 (as expected for PY3).
---------------------------------------------------------------------------

    \285\ For more details, refer to Announcement of Calendar Year 
(CY) 2021 Medicare Advantage (MA) Capitation Rates and Part C and 
Part D Payment Policies (April 6, 2020), available at https://www.cms.gov/files/document/2021-announcement.pdf.
    \286\ For more details, refer to Announcement of Calendar Year 
(CY) 2022 Medicare Advantage (MA) Capitation Rates and Part C and 
Part D Payment Policies (January 15, 2021), available at https://www.cms.gov/files/document/2022-announcement.pdf.
    \287\ For more details, refer to Announcement of Calendar Year 
(CY) 2023 Medicare Advantage (MA) Capitation Rates and Part C and 
Part D Payment Policies (April 4, 2022), available at https://www.cms.gov/files/document/2023-announcement.pdf.
---------------------------------------------------------------------------

    Under the proposed approach, BY and PY prospective HCC risk scores 
would be calculated under the CMS-HCC risk adjustment model(s) 
applicable to the calendar year corresponding to the relevant 
performance year. For an ACO beginning a new agreement period on 
January 1, 2024, in PY1 (2024) all benchmark year and PY1 prospective 
HCC risk scores would be calculated using a blend of 67 percent V24 and 
33 percent V28. In PY2 (2025), all benchmark year and PY2 prospective 
HCC risk scores are expected to be calculated using a blend of 33 
percent V24 and 67 percent V28. In PY3 (2026), all benchmark year and 
performance year prospective HCC risk scores are expected to be 
calculated using V28. In the case of an ACO in an existing agreement 
period that early renews for a new agreement period beginning on 
January 1, 2025, the calculations described in this paragraph regarding 
the blend of V24 and V28 for 2025 and the fully phased-in V28 CMS-HCC 
model for 2026 would be expected to apply for the ACO's first and 
second performance years (respectively).
    We solicited comments on these proposals regarding the prospective 
HCC risk scores to be used in risk adjustment for purposes of benchmark 
calculations under the Shared Savings Program.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Several commenters expressed general support for and 
appreciation of the proposed changes to how risk adjustment is 
performed for purposes of benchmark calculations under the Shared 
Savings Program. These commenters noted that they believe that using a 
consistent risk score model for both benchmark years and the 
performance year will improve predictability in risk scores, as well as 
prevent distortion to an ACO's historical benchmark resulting from 
changes in the risk score model.
    Response: We agree with commenters that using a consistent risk 
score model for both benchmark years and the performance year will more 
accurately assess changes in an ACO's assigned beneficiary population 
across years.
    Comment: Many commenters supported the proposed changes but urged 
CMS to apply the proposed changes to all ACOs and not just to ACOs in 
agreement periods beginning on or after January 1, 2024. Other 
commenters urged CMS to allow ACOs in existing agreement periods that 
began prior to January 1, 2024, be given an option to choose whether 
the proposed changes to the risk adjustment methodology will apply to 
them. Many commenters stated that the proposed rule was made public 
after the deadline to early renew to begin a new agreement period on 
January 1, 2024. They stated that knowledge of the proposed changes to 
risk adjustment methodology would have informed any decision to early 
renew. Several commenters referred to CMS' data analysis in section 
III.G.4.e.(3) of the proposed rule which showed that total PY 2021 
shared savings payments would have been 11 percent lower when 
performance year risk scores were calculated using V28. These 
commenters discussed that maintaining the current risk adjustment 
methodology for ACOs in agreement periods that began prior to January 
1, 2024, would unfairly harm such ACOs, especially those serving high-
risk beneficiary populations. A few commenters also noted that while 
there is an option to early renew to begin a new agreement period on 
January 1, 2025, there are administrative costs associated with the 
early renewal application process which may be prohibitive for some 
ACOs. Several commenters also noted that if an ACO decides to early 
renew, their benchmark will be rebased for the new agreement period and 
some ACOs may be harmed by the `ratchet effect' in which any savings 
generated in the current agreement period could lead to a lower 
benchmark in the new agreement period.
    Response: The data analysis presented in the proposed rule (88 FR 
52479 through 52481) examines the impact of adopting the full V28 CMS-
HCC risk adjustment model which is not expected to occur until 2026. 
While the results of the data analysis suggest combined PY 2021 shared 
savings payments would have been about 11 percent lower than actual 
payments if V28 had been fully phased-in for the performance year, this 
11 percent is larger in magnitude than the actual impact for PY 2024 
for ACOs continuing in an existing agreement

[[Page 79207]]

period under the current risk adjustment methodology. The impact will 
be significantly reduced since the risk adjustment model implemented 
for PY 2024 will be a blend of 67 percent V24 and 33 percent V28. The 
magnitude of the impact on ACOs for PY 2024 might only be one-third of 
what was estimated in the analyses included in the proposed rule, 
because those analyses looked at the fully implemented V28 risk model 
(88 FR 52480). Table 46 shows the estimated impacts of the PY 2024 
blended CMS-HCC model on PY 2021 Shared Savings under both the current 
and proposed risk adjustment methodologies (where the current approach 
will be applied for PY 2024 calculations only for ACOs with agreement 
periods that started before January 1, 2024).
[GRAPHIC] [TIFF OMITTED] TR16NO23.068

    Further, the analyses in the proposed rule only examined the impact 
of ACO risk scores on the risk ratios used to update the benchmark at 
the time of financial reconciliation. These risk ratios are calculated 
as the performance year prospective CMS-HCC risk scores divided by BY3 
prospective CMS-HCC risk scores. Under the current policy, which will 
only apply to ACOs in agreement periods that started before January 1, 
2024, the BY3 prospective CMS-HCC risk scores will not be recalculated 
using the new V28 model. The V28 model is expected to, on average, 
lower ACO prospective CMS-HCC risk scores which caused a fall in the 
risk ratios. Under the current approach, this then led to lower updated 
benchmarks which resulted in worsened average ACO financial performance 
in our analysis. However, as mentioned previously, there are other ways 
in which an ACO's prospective CMS-HCC risk scores impact financial 
calculations. One important way is in the calculation of an ACO's 
regional adjustment to their historical benchmark. When determining the 
amount of an ACO's regional adjustment, the ACO's BY3 prospective CMS-
HCC risk scores are used to multiply risk-adjusted regional 
expenditures. Under the proposed policy, all benchmark year risk scores 
will be calculated using the MA risk adjustment model applicable to the 
performance year. If the proposed policy were applied to ACOs in 
existing agreement periods, all BY3 risk scores for such ACOs would be 
recalculated using the PY 2024 blended model of 67 percent V24 and 33 
percent V28. As the blended model, through the V28 component, is 
expected to lower average ACO prospective CMS-HCC risk scores, this 
would tend to decrease the amount of the regional adjustment. This 
would in turn offset some (or potentially all) of the reduction in 
benchmark that some ACOs would receive by not extending the proposed 
policy to ACOs in agreement periods that started before January 1, 
2024. When we reviewed the ACOs that are most likely to see a decrease 
in their performance year risk scores, we also found these same ACOs 
would generally have the most favorable regional adjustments to their 
historical benchmarks, so the existing methodology would help them 
avoid negative impacts that would otherwise materialize from 
recalculation of those adjustments under the new risk model. Lastly, we 
note that risk scores continue to be renormalized across the assignable 
population in each eligibility group, which eliminates the risk that 
risk scores would be systematically biased against ACOs under either 
the current or proposed approaches described above. Due to these 
factors, we believe that the impact of the phased transition of V28 on 
financial performance for PY 2024 for ACOs in existing agreement 
periods will be lower than expressed by many commenters.
    We also note that while the analysis in the proposed rule showed 
that on average ACOs would benefit from the proposed risk adjustment 
policy, this was not universal. In comparing the current and 
alternative approaches to calculating prospective CMS-HCC risk scores, 
the median value for the difference between the two approaches was 0.0 
percent. While the mean impact on ACOs was negative, this was due to 
the larger impact on adversely affected ACOs rather than the number of 
ACOs that were adversely affected. In our analysis we found the 
proposed methodology would reduce benchmarks for at least 25 percent of 
ACOs in existing agreement periods. Due to this, applying the proposed 
policy to all ACOs in PY 2024 even those continuing in an existing 
agreement period, would slightly benefit some ACOs while marginally 
harming others. The Shared Savings Program's longstanding approach is 
to maintain a consistent benchmarking methodology for the duration of 
an ACO's agreement period because methodological changes can have 
varying impacts on ACO's benchmarks and performance.
    Further, we do not believe it is desirable to implement an approach 
that would allow each ACO to select from a menu of options for 
customizing the benchmark methodology that would apply in any given 
performance year during an agreement period. Historically, we have not 
applied changes to the benchmark methodology during an agreement 
period, and as we have discussed in prior rulemaking (see, for example, 
87 FR 69876), we have particular concern about allowing ACOs to ``opt 
in'' to certain benchmarking policies within an agreement period, as 
this creates an opportunity for selective behavior without the 
counterbalance of rebasing and introduces significant operational 
complexity. An approach

[[Page 79208]]

that allows an ACO to choose the more favorable of several 
methodologies for establishing its cost target would exacerbate our 
concerns about the potential for benchmarks to become overly inflated 
to the point where ACOs need to do little to maintain or change their 
care practices to generate savings. We are concerned that this 
flexibility could lead to opportunities for arbitrage and may dull 
incentives for ACOs to improve their performance under the Shared 
Savings Program. Further, doing so would introduce considerable 
operational complexity into the program's benchmarking methodology.
    During CY 2024, ACOs have the option to ``early renew'' for PY 
2025, meaning to terminate their current participation agreement under 
Sec.  [thinsp]425.220 and immediately enter a new agreement period to 
continue participation in the Shared Savings Program. (See paragraph 
(2) of the definition of ``renewing ACO'' in Sec.  [thinsp]425.20, and 
83 FR 67885 through 67890, and the application procedures set forth in 
Sec.  [thinsp]425.224.) Early renewal would allow a currently 
participating ACO to be subject to the modified financial benchmarking 
methodology policies described in sections III.G.4.b-d and to the 
modified risk adjustment methodology sooner than if the ACO were to 
wait to renew to continue its participation in the Shared Savings 
Program after completing its current agreement period of at least 5 
years. We believe that ACOs that elect to renew or early renew for PY 
2025 would have sufficient time to decide whether to renew for a new 
agreement period under the Shared Savings Program, for providers/
suppliers to consider the business case for forming or joining a Shared 
Savings Program ACO, and for CMS to prepare to implement these changes.
    Comment: One commenter appeared to misunderstand what was being 
proposed, stating that they interpreted the proposed policy as 
introducing the MA risk adjustment models to the Shared Savings 
Program. They also interpreted the data analysis in section 
III.G.4.e.(3) of the proposed rule showing the impact of using V24 to 
calculate benchmark year prospective HCC risk scores and V28 to 
calculate performance year prospective HCC risk scores as measuring the 
impact of our proposed policy. They expressed concern that the use of 
different risk score models would lead to deviations in the uniformity 
of risk assessment which might diminish trust in the Shared Savings 
Program.
    Response: We clarify that the current Shared Savings Program risk 
adjustment methodology calculates benchmark and performance year risk 
scores using the MA risk adjustment models that were applicable to the 
relevant calendar year. Under this approach, this may lead to 
situations in which benchmark and performance year risk scores are 
calculated under separate CMS-HCC risk score models. We proposed to 
revise the risk adjustment methodology to use the MA risk adjustment 
model that is applicable to the performance year to calculate both 
performance year and benchmark year prospective CMS-HCC risk scores. 
The proposed approach aims to ensure uniformity in risk assessment 
across multiple years by calculating prospective CMS-HCC risk scores 
using a consistent risk adjustment model.
    After consideration of the public comments, we are finalizing our 
proposal to apply the CMS-HCC risk adjustment methodology for the 
calendar year corresponding to the performance year in calculating risk 
scores for Medicare FFS beneficiaries for each benchmark year of the 
agreement period, for ACOs in agreement periods beginning on or after 
January 1, 2024. We are finalizing our proposal to add a new section to 
our regulations at Sec.  425.659 on calculating risk scores used in 
Shared Savings Program benchmark calculations, with minor modifications 
for grammar and clarity. We are also finalizing our proposal to revise 
the list of circumstances for adjusting the historical benchmark for 
the second and each subsequent performance year during the term of the 
agreement period at Sec.  425.652(a)(9) to include a change in the CMS-
HCC risk adjustment methodology used to calculate prospective CMS-HCC 
risk scores under new Sec.  425.659. Further, we are finalizing our 
proposal to add a new paragraph (a)(9)(vi) to Sec.  425.652 to specify 
that we will redetermine factors based on prospective HCC risk scores 
calculated for benchmark years by calculating the prospective HCC risk 
scores using the CMS-HCC risk adjustment methodology that applies for 
the calendar year corresponding to the applicable performance year in 
accordance with Sec.  425.659(b)(1). We are finalizing as proposed a 
technical and conforming change to Sec.  425.650(a), to revise the 
description of the benchmarking methodology applicable for agreement 
periods beginning before January 1, 2024, to include the new Sec.  
425.659 within the list of referenced sections.
5. Modifications to Advance Investment Payment Policies
a. Overview
    In the CY 2023 PFS final rule (87 FR 69782 through 69805), we 
finalized a new payment option for eligible Shared Savings Program ACOs 
entering agreement periods beginning on or after January 1, 2024, to 
receive advance shared savings payments. This payment option is 
referred to as advance investment payment (AIP) and the payments 
themselves are referred to as advance investment payments.
    In that final rule, we explained that section 1899(i) of the Act 
authorizes the Secretary to use other payment models instead of the 
one-sided model described in section 1899(d) of the Act so long as the 
Secretary determines that the other payment model would improve the 
quality and efficiency of items and services furnished to Medicare 
beneficiaries without additional program expenditures (87 FR 69783 and 
69784). In accordance with section 1899(i) of the Act, we determined 
that making advance investment payments to certain ACOs participating 
in the Shared Savings Program would improve the quality and efficiency 
of items and services furnished to Medicare beneficiaries by enhancing 
the accessibility of the Shared Savings Program (Id.).
    We established standards for an ACO's receipt and use of advance 
investment payments within the Shared Savings Program regulations at 
Sec.  425.630 and specified requirements in connection with AIP in 
other sections within 42 CFR part 425. Such standards include: 
eligibility criteria to limit AIP to new, low revenue ACOs that are 
inexperienced with performance-based risk; application procedures and 
contents, including submission of a spend plan; policies governing use 
and management of payments; amount and frequency of payments, which are 
comprised of a one-time $250,000 upfront payment and up to 8 quarterly 
payments; the methodology for calculation of the quarterly payment 
amount based on the ACO's assigned population; termination of advance 
investment payments, as well as recoupment and recovery of advance 
investment payments; policies to monitor ACO eligibility for AIP; and 
ACO public reporting requirements regarding the use of advance 
investment payments.
    In the CY 2024 PFS proposed rule (88 FR 52483), we proposed 
modifications to refine AIP policies to better prepare for initial 
implementation of AIP beginning with ACOs entering

[[Page 79209]]

agreement periods on January 1, 2024. In summary, we proposed to better 
support ACOs that are prepared to progress to performance-based risk by 
allowing ACOs to advance to two-sided model Levels within the BASIC 
track's glide path beginning in PY3 of the agreement period in which 
they receive advance investment payments (88 FR 52483). We also 
proposed to revise our policies for recoupment of advance investment 
payments from ACOs that wish to early renew and continue their 
participation in the Shared Savings Program (88 FR 52485). We proposed 
to specify that CMS would terminate quarterly advance investment 
payments in future quarters to ACOs that elect to terminate their 
participation in the Shared Savings Program (88 FR 52486). We proposed 
to require ACOs to report spend plan updates and actual spend 
information to CMS in addition to publicly reporting such information 
(88 FR 52484). Lastly, we proposed to codify that ACOs receiving 
advance investment payments may seek reconsideration review of all 
payment calculations (88 FR 52487). If finalized, we proposed that 
these policies would be effective beginning January 1, 2024 (88 FR 
52488).
b. Modifications to AIP Eligibility Requirements to Allow ACOs to 
Advance to Performance-Based Risk During the 5-Year Agreement Period
(1) Background
    The policies we finalized with the CY 2023 PFS final rule (87 FR 
69404) require an ACO to remain under a one-sided risk model for the 
duration of its agreement period in which it receives advance 
investment payments to remain compliant with AIP requirements. The ACO 
would otherwise face potential compliance action and may be required to 
repay all advance investment payments within 90 days of receiving 
written notification from CMS. This limits an ACO's ability to select 
participation options that include progression along the BASIC track's 
glide path to a performance-based two-sided risk model. This policy 
arises from the interaction of numerous standards.
    First, an ACO is eligible to receive advance investment payments if 
CMS determines that all of the following criteria are met: (1) the ACO 
is not a renewing or a re-entering ACO; (2) the ACO has applied to 
participate in the Shared Savings Program under any level of the BASIC 
track's glide path and is eligible to participate in the Shared Savings 
Program; (3) the ACO is inexperienced with performance-based risk 
Medicare ACO initiatives; and (4) the ACO is a low revenue ACO (Sec.  
425.630(b)). An eligible ACO will receive a one-time upfront payment of 
$250,000 and quarterly payments each quarter for the first 2 
performance years of the ACO's 5-year agreement period, totaling no 
more than 8 quarterly payments (Sec.  425.630(f)).
    Second, under Sec.  425.630(h), CMS will terminate an ACO's advance 
investment payments in accordance with Sec.  425.316(e) if the ACO is 
no longer inexperienced with performance-based risk Medicare ACO 
initiatives or is no longer a low revenue ACO. Section 425.316(e) 
specifies that if CMS determines during any performance year of the 
agreement period that an ACO receiving advance investment payments is 
experienced with performance-based risk Medicare ACO initiatives or is 
a high revenue ACO, and the ACO remains experienced with performance-
based risk Medicare ACO initiatives or a high revenue ACO after a 
deadline specified by CMS pursuant to compliance action, the ACO must 
repay all advance investment payments it received.
    An eligible ACO that joins the Shared Savings Program in Level A of 
the BASIC track and opts to receive advance investment payments will be 
eligible for all 8 quarterly payments to be paid over PY1 and PY2, so 
long as the ACO remains in Level A (or progresses to Level B) in PY2 
and remains inexperienced with performance-based risk Medicare ACO 
initiatives and a low revenue ACO. An ACO that joins the Shared Savings 
Program at Levels B through E of the BASIC track, however, will not be 
eligible to receive all 8 quarters of advance investment payments 
because current program regulations require that an ACO remain 
inexperienced with performance-based risk Medicare ACO initiatives 
while receiving advance investment payments (Sec.  425.630(h)(2)). More 
specifically, if an ACO receiving advance investment payments elects to 
participate at Level B of the BASIC track in PY1 progresses along the 
glide path to Level C for PY2, CMS would determine that the ACO is 
experienced with performance-based risk in PY2 and the ACO would no 
longer be eligible to receive advance investment payments during PY2.
    In the CY 2023 final rule (87 FR 69787), we stated that advance 
investment payments were intended to assist smaller, community-based 
providers in forming high-performing ACO networks by providing much-
needed startup capital that can be used to attract and maintain 
staffing, purchase healthcare delivery infrastructure and IT systems, 
and develop and implement a strategy to address the health needs of 
underserved communities. It is for this reason we restricted AIP 
eligibility to those ACOs that are inexperienced with performance-based 
risk. ACOs that are experienced with performance-based risk generally 
would not need advance investment payments to successfully participate 
in the Shared Savings Program as they have previously participated in 
the Shared Savings Program or certain Innovation Center models or CMS 
programs in which the ACO accepted risk for shared losses. In the CY 
2024 PFS proposed rule, we proposed to modify program regulations to 
permit an ACO to progress to two-sided risk along the BASIC track's 
glide path within the agreement period while the ACO continues to 
benefit from advance investment payments.
(2) Revisions
    We proposed to modify AIP eligibility requirements to allow an ACO 
receiving advance investment payments to transition to two-sided risk 
within its 5-year agreement period under the BASIC track's glide path. 
Specifically, we proposed to modify Sec.  425.630(b)(2) and (3) to 
allow an eligible ACO receiving advance investment payments to advance 
to performance-based risk (by advancing from Level A or B to Level C, 
D, or E of the BASIC track's glide path) beginning in PY3 of the ACO's 
agreement period. We also proposed to modify Sec.  425.316(e)(2) to 
specify that CMS will cease payment of advance investment payments if 
CMS determines that an ACO approved for AIP became experienced with 
performance-based risk Medicare ACO initiatives during the first or 
second performance year of its agreement period or became a high 
revenue ACO during any performance year of the agreement period in 
which it received advance investment payments. In accordance with Sec.  
425.316(e)(2)(ii), we may take compliance action against such ACOs. We 
also proposed to modify Sec.  425.316(e)(2)(i) to specify that CMS will 
cease payment of advance investment payments no later than the quarter 
after the ACO became experienced with performance-based risk Medicare 
ACO initiatives or became a high revenue ACO.
    Under the proposed approach, ACOs may choose to move into a two-
sided risk participation option within the Shared Savings Program's 
BASIC track beginning in PY3 (and in subsequent performance years). 
These ACOs would still be required to repay advance investment payments 
through earned

[[Page 79210]]

shared savings over the remaining performance years of their agreement 
period as prescribed in Sec.  425.630(g). We proposed that this policy 
would be effective January 1, 2024. Under this proposal, an ACO could 
not use advance investment payments to fund repayment mechanisms or 
repay shared losses. This limitation also reduces the risk that ACOs 
stretch themselves beyond their financial capacity while receiving 
advance investment payments by taking on large amounts of risk. Unlike 
other ACOs, ACOs receiving advance investment payments will have the 
additional financial obligation of repaying the advance investment 
payments if they misjudge their appetite for risk and leave the program 
mid performance period after incurring shared losses. These policies 
are intended to align with our goal to support the creation of new ACOs 
that need time and resource assistance to develop the infrastructure to 
operate an ACO that effectively manages patient care and lowers costs.
    After 2 years of participation, new ACOs may have sufficient 
experience to be capable of taking on downside risk available in levels 
C-E of the BASIC track. As proposed, these modifications balance the 
risk of a new ACO taking on too much risk too quickly while allowing 
them to take on moderate risk as they develop more experience with the 
program.
    Specifically, we proposed to amend the eligibility criteria 
specified in Sec.  425.630(b) as follows. We proposed to revise the 
eligibility criterion at Sec.  425.630(b)(2) to remove language stating 
that the ACO has applied to participate in the Shared Savings Program 
``under any level of the BASIC track's glide path;'' the revised 
provision would simply state that ``CMS has determined that the ACO is 
eligible to participate in the Shared Savings Program.'' Further, we 
proposed to amend the criterion in Sec.  425.630(b)(3) to specify that 
the ACO must be inexperienced with performance-based risk Medicare ACO 
initiatives during its first 2 performance years but may participate in 
Levels of the BASIC track that would make it experienced with 
performance-based risk Medicare ACO initiatives starting with the third 
year of its first agreement period. Specifically, we proposed to 
specify in revisions to Sec.  425.630(b)(3) that the ACO may 
participate in the Levels of the BASIC track's glide path as follows 
during the agreement period in which the ACO receives advance 
investment payments:
     For performance year 1, the ACO must participate in Level 
A of the BASIC track's glide path.
     For performance year 2, the ACO may participate in Level A 
of the BASIC track's glide path (in accordance with Sec.  
425.600(a)(4)(i)(C)(3)) or Level B.
     For performance years 3 through 5, the ACO may participate 
in Level A of the BASIC track's glide path (in accordance with Sec.  
425.600(a)(4)(i)(C)(3)), or Levels B through E.
    To illustrate the proposed policy, consider an ACO entering an 
agreement period beginning on January 1, 2024, that applies for and is 
determined to be eligible to receive advance investment payments. The 
ACO must participate in Level A for PY1. In PY2, the ACO may remain 
under Level A for all subsequent years of the agreement period in 
accordance with Sec.  425.600(a)(4)(i)(C)(3) or may move to Level B. 
The ACO would receive advance investment payments for PY1 and PY2, 
receiving the one-time payment of $250,000 and the 8 quarterly 
payments. If the ACO remained at Level A for PY2, it could then 
transition to a higher level of risk and potential reward within the 
glide path for PY3 (that is, Levels B, C, D, or E) in accordance with 
Sec.  425.600(a)(4)(i)(C)(3)(iii). If the ACO participated in Level B 
for PY2, it could automatically progress for PY3 to Level C (in 
accordance with Sec.  425.600(a)(4)(i)(C)(2)) or elect to transition to 
Level D (in accordance with Sec.  425.600(a)(4)(i)(C)(2)(i) and Sec.  
425.226(a)(2)(i)) or Level E (in accordance with Sec.  
425.600(a)(4)(i)(C)(2)(i) and Sec.  425.226(a)(2)(i)) beginning with 
PY3.
    Under this proposed modification, CMS will continue to recoup from 
future shared savings. In contrast to what is required under existing 
Sec.  425.316(e)(3), the ACO will not be immediately obligated to repay 
all advance investment payments it received by virtue of its transition 
to a two-sided model in its third performance year or any subsequent 
performance year. We noted that under our proposal if an ACO opts to 
progress to a two-sided risk model (BASIC track's glide path Levels C 
through Level E) in PY2, CMS will terminate the ACO's advance 
investment payments, the ACO may be subject to compliance actions 
specified in Sec. Sec.  425.216 and 425.218, and CMS may seek repayment 
of advance investment payments as set forth at Sec.  425.316(e).
    We solicited comments on our proposal to amend AIP policies and 
require that all ACOs receiving advance investment payments be 
inexperienced with performance-based risk Medicare ACO initiatives 
while the ACO receives advance investment payments--that is, during PY1 
and PY2 of the agreement period--and to allow ACOs to progress to 
performance-based risk under the BASIC track's glide path beginning 
with PY3 of the same agreement period.
    We received public comments on this proposal. The following is a 
summary of the comments we received and our responses.
    Comment: Commenters largely supported CMS' proposal to allow ACOs 
receiving advance investment payments to progress along the glide path 
and move into a two-sided risk model beginning in PY 3 of the ACO's 
agreement period. Many commenters noted that this policy refinement 
will strengthen and enhance the Shared Savings Program and assist in 
meeting CMS' goal of having 100 percent of traditional Medicare 
beneficiaries in an accountable care relationship by 2030. Other 
commenters encouraged CMS to finalize this policy refinement, 
contending that advance investment payments will likely increase access 
to equitable care and reduce disparities in health outcomes in rural 
and underserved communities.
    Response: We agree with commenters that this proposal will benefit 
the Shared Savings Program. Allowing ACOs receiving advance investment 
payments to move into a two-sided risk model beginning in PY 3 of their 
agreement period balances the risk of a new ACO taking on too much risk 
too quickly while allowing them to take on moderate risk as they 
develop more experience with the program, enabling ACOs receiving 
advance investment payments to progress along the BASIC track's glide 
path in a manner that works best for them. CMS expects this proposal 
will increase participation in the Shared Savings Program, especially 
among providers who practice in underserved communities, advance 
equitable access to quality care, and better health outcomes for ACOs' 
beneficiaries.
    Comment: One commenter noted that allowing ACOs receiving advance 
investment payments to move into two-sided risk during the first 
agreement period provides greater flexibility for physician-led ACOs to 
participate in the Shared Savings Program. The commenter stated that 
this policy refinement will allow smaller practices to move into two-
sided risk without the fear of having their advance investment payments 
immediately recouped.
    Response: We agree with the commenter that this proposal will 
afford ACOs receiving advance investment payments the flexibility to 
move into a two-sided risk model later in their agreement period while 
continuing to

[[Page 79211]]

use advance investment payments in the remaining performance years of 
their initial agreement period without fear of immediate recoupment by 
CMS, which will support all ACOs, including physician-led ACOs and 
smaller practices that are part of ACOs.
    Comment: One commenter shared that because ACOs receiving advance 
investment payments are required to repay all advance investment 
payments received in the first 2 years of their agreement period in 
their entirety, CMS should make the AIP payment option as expansive as 
possible. Other commenters encouraged CMS to consider expanding AIP 
eligibility to all ACOs regardless of their experience with 
performance-based risk Medicare ACO initiatives, whether they are a 
currently participating ACO or a renewing or re-entering ACO, or their 
status as a high revenue or low revenue ACO.
    Response: We agree with the commenter that eligibility for advance 
investment payments should be expanded. This proposal supports that 
expansion and provides ACOs with increased flexibilities that should 
better support newly participating ACOs in their efforts to build and 
maintain a high-performing ACO. However, we disagree with commenters 
who suggest that all ACOs should be eligible for advance investment 
payments. As we stated in the CY 2023 PFS final rule (87 FR 69783 
through 69785), expanding AIP eligibility to all ACOs or even all ACOs 
that can demonstrate need among their patient populations is not 
consistent with the purpose of AIP and would not be an appropriate use 
of the Trust Funds. AIP policy is based in part on the success of the 
ACO Investment Model, which primarily limited participation to ACOs who 
were (1) new to the Shared Savings Program; (2) did not include a 
hospital unless it was a critical access hospital or a small Inpatient 
Prospective Payment System (IPPS) hospital; and (3) were not owned or 
operated by a health plan. While these eligibility criteria do not 
exactly match the AIP eligibility criteria, the intent behind both sets 
of criteria is similar. In addition, advance investment payments are 
not intended to provide indefinite support to ACOs or to ACOs of all 
sizes, but to help provide start-up funding needed prior to earning 
shared savings for those ACOs that are most likely to face difficulty 
finding such funding.
    As we previously explained, ACOs that are experienced with 
performance-based risk generally would not need advance investment 
payments to successfully participate in the Shared Savings Program as 
they have previously participated in the Shared Savings Program or 
certain Innovation Center models or CMS programs in which the ACO 
accepted risk for shared losses. Our experience administering the 
Shared Savings Program suggests that re-entering and renewing ACOs have 
alternative payment model experience and would not need, or benefit as 
significantly from, the start-up funds that advance investment payments 
provide because they have already invested in creating an ACO (see 87 
FR 69784). They may also be able to leverage their experience to raise 
the necessary funds more easily than entities that are new and may 
primarily consist of ACO participants that are inexperienced with 
performance-based risk. Similarly, existing ACOs participating and 
earning shared savings have access to more resources to serve their 
aligned beneficiaries, and many existing ACOs already have health IT 
infrastructure in place to support and coordinate high quality care (87 
FR 69786).
    Advance investment payments are intended to advance shared savings 
to provide start-up funding for ACOs that are less well capitalized 
than a high revenue ACO, which should not need advance funding from CMS 
to increase staffing, improve healthcare infrastructure, and provide 
accountable care for underserved beneficiaries (87 FR 69786). By 
contrast, low revenue ACOs tend to be small, physician-led ACOs that 
are less well-capitalized organizations, and these ACOs may be 
encouraged to participate and remain in the program based on the 
availability of additional incentives, such as the opportunity to 
receive advance investment payments. For these reasons and the reasons 
stated elsewhere in this section, and to safeguard the Medicare Trust 
Funds, CMS will maintain more limited eligibility criteria at this 
time.
    Comment: Other commenters requested that CMS further modify AIP 
eligibility requirements to include ACOs who have been designated as 
experienced with performance-based risk by participating in the 
ENHANCED track. The commenters noted that these ACOs may still lack the 
significant resources and infrastructure required to meaningfully 
address patients' health and social needs.
    Response: We disagree with commenters that it would be appropriate 
to provide advance investment payments to an ACO that has been 
designated as experienced with performance-based risk Medicare ACO 
initiatives for the reasons stated previously in this section. We also 
disagree with commenters that it would be appropriate to provide 
advance investment payments to an ACO that is participating in the 
ENHANCED track. As we stated in the CY 2023 PFS final rule (87 FR 
69786), ACOs in the BASIC track are typically less experienced with 
risk and are more likely to benefit from upfront funding or ongoing 
financial assistance, while ACOs in the ENHANCED track, given the level 
of risk involved in that track, are generally well established and 
confident in their ability to coordinate care for their beneficiary 
population. However, as described in section III.G.5.c of this final 
rule, in the event than an ACO voluntarily terminates its participation 
agreement at the end of PY2 or later during the agreement period in 
which it received advance investment payments, and the ACO immediately 
enters into a new participation agreement with CMS under any level of 
the BASIC track's glide path or the ENHANCED track, CMS will not seek 
to collect all advance investment payments received from an ACO in 
accordance with Sec.  425.630(g)(4). CMS will carry forward any 
remaining balance of advance investment payments owed by the early 
renewing ACO into the ACO's new agreement period.
    These ACOs also benefit from effective management and planning, and 
such ACOs would not need advance investment payments from CMS to 
increase staffing, improve healthcare infrastructure, and provide 
accountable care for underserved beneficiaries. We also note that we 
solicited comments as part of the RFI in the CY 2024 PFS proposed rule 
regarding how ACOs could better work with CBOs to address the unmet 
health and social needs of beneficiaries, and we will take the comments 
we received in response to that solicitation into consideration for 
future rulemaking. See section III.G.8.e of this final rule.
    Comment: One commenter stated that all ACOs would benefit from AIP 
and would use the funds to invest in technology enhancements and 
account for resource expenditures resulting from the difficulty of 
keeping up with Shared Savings Program rules and guidance.
    Response: We disagree with commenters who suggest that all ACOs 
should be eligible for advance investment payments for the reasons 
stated elsewhere in this section of this final rule. We also note that 
CMS furnishes annual program guidance based upon annual CMS rulemaking 
and updates those guidance materials with important and necessary 
program information for each upcoming performance year. These materials 
are

[[Page 79212]]

available to all ACOs. CMS guidance materials include proposed and 
final rule fact sheets, detailed explanations of program requirements 
and financial calculations, and a number of other materials found in 
the Application toolkit and the ACO Management System (ACO-MS) 
knowledge library. ACOs may also submit inquiries to the Shared Savings 
Program helpdesk. We also note that investments in new technologies, 
including those required to meet program standards, are generally 
necessary among all healthcare providers, including those not 
participating in the Shared Savings Program, to keep pace with the 
current standards of medicine and deliver high-quality, coordinated 
care to patients.
    Comment: Other commenters suggested that CMS consider expanding AIP 
eligibility to existing ACOs that meet specific parameters. 
Specifically, commenters requested that CMS consider exceptions that 
would allow FQHCs, RHCs, and critical access hospitals (CAHs) to be 
eligible for AIP, even if they do not meet the current eligibility 
requirements regarding revenue and risk experience. Other commenters 
noted that the current eligibility criteria are overly limiting and 
exclude many safety net providers as a result. The commenters noted 
that these provider types still lack the significant resources and 
infrastructure required to meaningfully address patients' health-
related and social needs, even if they are deemed high-revenue by CMS.
    Response: We agree with commenters that FQHCs, RHCs, CAHs, and 
other safety net providers play an important role in addressing the 
healthcare and social needs of underserved communities. However, we 
disagree that revising the AIP eligibility criteria is necessary for 
FQHCs, RHCs, and CAHs to receive advance investment payments. AIP 
eligibility requirements are set forth at Sec.  425.630(b). Section 
425.630(b)(2) currently provides that an ACO must have applied to 
participate in the Shared Savings Program under any level of the BASIC 
track's glide path and be eligible to participate in the Shared Savings 
Program to be eligible to receive advance investment payments. Section 
425.102(a) states that CAHs that bill under Method II (as described in 
Sec.  413.70(b)(3)), FQHCs, and RHCs are eligible to apply to 
participate in the Shared Savings Program. We remind commenters the 
Shared Savings Program currently includes these provider types among 
the 456 ACOs participating in CY 2023 (2023 Shared Savings Program Fast 
Facts: https://www.cms.gov/files/document/2023-shared-savings-program-fast-facts.pdf).
    Moreover, as we explained in the CY 2023 PFS final rule (87 FR 
69786), we disagree that the AIP eligibility criteria should include an 
exception for high revenue ACOs that include safety-net providers, such 
as CAHs, FQHCs, and RHCs, as ACO participants. This would result in 
many ACOs receiving advance investment payments that do not need access 
to start-up capital. The vast majority of FQHCs and RHCs participating 
in Shared Savings Program ACOs without a hospital are in low revenue 
ACOs, so the AIP eligibility criteria should not preclude them from 
receiving advance investment payments. We plan to monitor the impact of 
advance investment payments on ACO formation and program participation, 
including the impact on CAHs.
    For the reasons explained in the previous discussion in this 
section of this final, we disagree with the commenters who suggested 
that CMS should revise the eligibility criteria to permit renewing or 
re-entering ACOs, currently participating ACOs, and ACOs that are 
experienced with performance-based risk Medicare ACO initiatives to 
receive advance investment payments.
    Comment: Multiple commenters recommended that CMS allow new, high 
revenue ACOs to be eligible for AIP regardless of their geographic 
location or status as a safety net provider, contending that this 
approach is aligned with CMS' goal to increase participation in the 
program through AIP. A few commenters stated that the distinction 
between high and low revenue is ``artificial.'' Another commenter cited 
analysis that found there was no significant difference in high revenue 
and low revenue ACO performance. One commenter shared that current AIP 
eligibility requirements exclude Medicare beneficiaries who may 
experience negative health outcomes due to socioeconomic factors simply 
because they are attributed to a high revenue ACO. These commenters 
urged CMS to remove the requirement that an ACO be considered low 
revenue to be eligible for advance investment payments.
    Response: We disagree with commenters about whether revenue status 
is an appropriate criterion to consider in determining AIP eligibility. 
As we explained previously in this section of this final rule, the 
intent of AIP is to advance shared savings to provide start-up funding 
for ACOs that are less well capitalized than a high revenue ACO. Low 
revenue ACOs tend to be small, physician-led ACOs that are less well 
capitalized than a high revenue ACO, and low revenue ACOs may be 
encouraged to participate and remain in the program based on the 
availability of additional incentives, such as the opportunity to 
receive advance investment payments.
    In contrast to low revenue ACOs, high revenue ACOs should not need 
advance funding from CMS to increase staffing, improve healthcare 
infrastructure, and provide accountable care for underserved 
beneficiaries, including Medicare beneficiaries who may experience 
negative health outcomes due to socioeconomic factors, because they are 
more likely to be sophisticated organizations with access to additional 
funding through parent organizations or capital markets and are more 
likely to already have the resources needed to provide accountable care 
for underserved beneficiaries. In addition to having access to more 
capital, ACOs identified as high revenue have a higher degree of 
control over the healthcare of their assigned beneficiaries. Relative 
to low revenue ACOs, high revenue ACOs provide a larger proportion of 
the healthcare their beneficiaries receive. This is because the 
services high revenue ACOs provide to their beneficiaries account for a 
larger amount of their assigned beneficiaries' total Medicare Parts A 
and B FFS expenditures (See Sec.  425.20, ``High revenue ACO'' and 
``Low revenue ACO''). They should therefore be in a better position to 
coordinate care for their beneficiaries. For further discussion of 
revenue status and other AIP eligibility criteria, we refer readers to 
our previous discussion in this section of this final rule and the CY 
2023 PFS final rule (87 FR 69784 through 69786).
    We also note that ACOs that meet the criteria set forth in Sec.  
425.630(b) are eligible to receive advance investment payments, 
regardless of their geographic location or status as a safety net 
provider. Separately, as we stated in the CY 2023 PFS final rule (87 FR 
69803), we will continue to monitor and collect program data on advance 
investment payments and the AIP eligibility requirements. After data on 
how advance investment payments impact ACOs and their beneficiaries, 
including underserved beneficiaries, become available, CMS may revisit 
the AIP eligibility criteria in future rulemaking.
    Comment: Some commenters noted that one barrier to increasing ACO 
participation in underserved communities is not including consideration 
of the level of need represented by their patient population in the AIP 
eligibility determination. Several commenters recommended CMS

[[Page 79213]]

consider other eligibility criteria which are more reflective of an 
ACO's level of capital and inclusive of the patient populations they 
serve. These commenters suggested that CMS consider the proportion of 
an ACO's assigned beneficiaries who meet the highest risk factors-based 
score when determining AIP eligibility (that is, those beneficiaries 
who are enrolled in the Medicare Part D LIS or are dually eligibility 
for Medicare and Medicaid, or whose mailing addresses are matched to 
ADIs at or above the 85th percentile).
    Response: We disagree with the comment that beneficiary need is not 
considered when we determine an ACO's eligibility for advance 
investment payments. As we explained in the CY 2023 PFS final rule 
(69785), re-entering and renewing ACOs are ineligible to receive 
advance investment payments partly because our experience administering 
the Shared Savings Program has shown us that these ACOs have already 
benefited from alternative payment model experience, and therefore, 
would be less likely to need financial support to develop programs 
targeting SDOH or to become operational. Similarly, as we explained 
previously in this section of this final rule, high revenue ACOs are 
ineligible to receive advance investment payments partly because, 
unlike low revenue ACOs, they are substantially better positioned to 
provide accountable care for underserved beneficiaries.
    Comment: One commenter urged CMS to consider extending AIP 
eligibility to renewing or re-entering ACOs who have never achieved 
shared savings due to not having access to this type of up-front 
investment. Another commenter urged CMS to consider offering AIP 
opportunities for renewing, low revenue ACOs that require additional 
investment to sustain participation in the Shared Savings Program. The 
commenter noted this would be especially helpful for ACOs that have yet 
to earn shared savings and are caring for underserved populations.
    Response: We remind commenters that advance investment payments are 
not intended to provide indefinite support to ACOs or to ACOs of all 
sizes, but to help provide start-up funding needed prior to earning 
shared savings for those ACOs that face difficulty finding such 
funding. Expanding AIP eligibility to all ACOs, including those that 
can demonstrate need among their beneficiary population, is not an 
appropriate use of the Medicare Trust Funds. For those reasons and the 
reasons explained previously in this section of this final rule, we 
disagree with the commenters who suggest we consider expanding AIP 
eligibility to certain renewing or re-entering ACOs.
    For the reasons discussed above, we are finalizing the revisions we 
proposed at Sec.  425.630(b) clarifying the AIP eligibility 
requirements and allowing the progression to performance-based risk for 
ACOs that receive advance investment payments beginning with PY 3 of 
the agreement period in which they received an advance investment 
payment. Under this finalized modification, CMS will continue to recoup 
from future shared savings. In contrast to what is required under 
existing Sec.  [thinsp]425.316(e)(3), the ACO would not be immediately 
obligated to repay all advance investment payments it received by 
virtue of its transition to a two-sided model in its third performance 
year or any subsequent performance year. We note that under our 
proposal if an ACO opts to progress to a two-sided risk model (BASIC 
track's glide path Levels C through Level E) in PY2, CMS would 
terminate the ACO's advance investment payments, the ACO may be subject 
to compliance actions specified in Sec. Sec.  [thinsp]425.216 and 
425.218, and CMS may seek repayment of advance investment payments as 
set forth at Sec.  [thinsp]425.316(e).
c. Modifications to AIP Recoupment and Recovery Policies for Early 
Renewing ACOs
(1) Background
    In the CY 2023 PFS final rule (87 FR 69803 through 69805), CMS 
finalized program policies regarding recoupment and recovery of advance 
investment payments. In accordance with Sec.  425.630(g)(4), if an ACO 
terminates its participation agreement during the agreement period in 
which it received an advance investment payment, the ACO must repay all 
advance investment payments it received. CMS would provide written 
notification to the ACO of the amount due and the ACO must pay such 
amount no later than 90 days after the receipt of such notification.
    Paragraph (2) of the definition of ``renewing ACO'' at Sec.  425.20 
includes an ACO that continues its participation in the Shared Savings 
Program for a consecutive agreement period, without a break in 
participation, because it is an ACO that terminated its current 
participation agreement under Sec.  425.220 and immediately enters a 
new agreement period to continue its participation in the program. In 
prior rulemaking (see, for example, 83 FR 67885 through 67890), we have 
referred to this provision as allowing for an ``early renewal'' option. 
In developing the AIP policies in the PFS rulemaking for CY 2023, we 
did not address the potential interactions between the policy on 
recovery of advance investment payments specified in Sec.  425.630(g) 
and a voluntary termination of the participation agreement by an ACO 
that is seeking to early renew.
(2) Revisions
    In the CY 2024 PFS proposed rule (88 FR 52485), we proposed to 
amend Sec.  425.630(g)(4) to create a limited exception to CMS's policy 
of recovering advance investment payments from an ACO that voluntarily 
terminates its participation agreement for the agreement period during 
which it received advance investment payments. Under this proposal, we 
would not seek to collect all advance investment payments received from 
an ACO in accordance with Sec.  425.630(g)(4) if the ACO voluntarily 
terminates its participation agreement at the end of PY2 or later 
during the agreement period in which it received advance investment 
payments, provided that the ACO immediately enters into a new 
participation agreement with CMS under any level of the BASIC track's 
glide path or the ENHANCED track. Rather, we would carry forward any 
remaining balance of advance investment payments owed by the early 
renewing ACO into the ACO's new agreement period. ACOs who participate 
in the Shared Savings Program participate in either the Basic or 
Enhanced track for their entire agreement period. While all ACOs 
receiving advance investment payments must participate in the Basic 
track for their first agreement period, they have flexibility to begin 
a new agreement period and participate in either track while CMS 
recoups the payments from earned shared savings.
    We proposed to allow an ACO approved for AIP to early renew its 
participation agreement before the expiration of its current agreement, 
as long as the ACO terminates its current participation agreement 
effective on or after December 31 of the ACO's second performance year. 
By requiring the ACO to maintain its current agreement period for the 
first 2 years, the ACO will receive all of its advance investment 
payments prior to renewing its participation agreement. We further 
proposed that in such circumstances, the early renewing ACO must 
continue to repay the advance investment payments through shared 
savings earned in the subsequent agreement period. If an ACO early 
renews prior to PY3, it will no longer comply with the eligibility 
requirements for receiving payments in Sec.  425.630(b)(1) and may be

[[Page 79214]]

subject to compliance actions under Sec. Sec.  425.216 and 425.218.
    Section 425.630(e)(3) specifies that an ACO may spend advance 
investment payments over its entire agreement period and must repay to 
CMS any unspent funds remaining at the end of the ACO's agreement 
period. We proposed to amend Sec.  425.630(e)(3) to permit an early 
renewing ACO to spend advance investment payments in its second 
agreement period so long as the advance investment payments are spent 
within 5 performance years of when it began to receive advance 
investment payments (that is, PY1 of its first agreement period). If 
the ACO does not spend all of the advance investment payments received 
by the end of the fifth performance year, the ACO must repay any 
unspent funds to CMS. The duration of spending advance investment 
payments was discussed in the CY 2023 PFS final rule (87 FR 69801).
    As we stated in the CY 2024 PFS proposed rule (88 FR 52485), we 
anticipate these policy proposals would be most relevant to an ACO that 
is receiving advance investment payments and seeks to early renew to 
enter a new participation agreement to participate under modified 
Shared Savings Program policies that are not applicable to the ACO's 
current agreement period. For such an ACO, any remaining balance of 
advance investment payments owed would continue to be recouped from any 
shared savings the ACO earns in its new agreement period. Further, such 
an ACO would continue its participation in the Shared Savings Program 
without a lapse in participation and would be required to continue to 
adhere to all AIP requirements. Continued program participation aligns 
with our goals to improve the quality and efficiency of care. These 
policies provide ACOs the flexibility to participate in the Shared 
Savings Program in a manner that may work best for their structure and 
patient population without having to choose between immediately paying 
back the advance investment payments they received and being able to 
enter a new agreement with the Shared Savings Program. Some policy 
changes are applicable only to new agreement periods, and ACOs approved 
for AIP should have the opportunity to enter a new agreement to 
experience those changes. We are finalizing this proposal without 
modification, and it will be effective January 1, 2024.
    We solicited comments on the proposed changes to Sec.  
425.630(e)(3) and (g)(4).
    We received public comments on this proposal. The following is a 
summary of the comments we received and our responses.
    Comment: Several commenters were supportive of CMS' proposal to 
provide these additional flexibilities to ACOs that receive advance 
investment payments and wish to early renew their participation in the 
Shared Savings Program. One commenter shared that they appreciate CMS' 
proposal to allow ACOs receiving advance investment payments to early 
renew and not require immediate repayment of all advance investment 
payments received. The commenter contended that allowing ACOs to repay 
advance investment payments in the ACO's new agreement period allows 
the ACO to participate in the Shared Savings Program in the manner that 
works best for their structure and patient population. The commenter 
also supported CMS' proposal to allow an early renewing ACO that 
received advance investment payments to continue to spend advance 
investment payments in its second agreement period, provided that the 
funds are spent within 5 performance years of when it began to receive 
advance investment payments. One commenter noted that this policy 
refinement could ensure continued Shared Savings Program participation 
by ACOs in their initial agreement periods.
    Response: We agree with commenters that allowing flexibility for 
early renewing ACOs that received advance investment payments in the 
agreement period they are terminating will provide incentives for 
continued participation in the Shared Savings Program. Allowing ACOs to 
carry advance investment payments over into a new agreement period will 
provide flexibility to these ACOs that they can use to maximize their 
shared savings potential and participate in the Shared Savings Program 
in a manner that may work best for their structure and patient 
population without having to choose between immediately paying back the 
advance investment payments they received and being able to enter a new 
agreement period.
    Comment: Several commenters were supportive of CMS's proposals to 
allow ACOs that receive advance investment payments to early renew but 
made recommendations to CMS on refining our AIP recoupment policies. 
These commenters urged CMS to consider modifications to AIP recoupment 
and recovery policies, which currently dictate that CMS will recoup 
advance investment payments from all earned shared savings by an ACO 
until all advance investment payments are repaid. Several commenters 
urged CMS to consider a longer time period for recoupment of advance 
investment payments. One commenter noted that if an ACO that received 
advance investment payments was unable to achieve shared savings 
payments for a significant period, this existing policy may jeopardize 
the ACO's ability to maintain its infrastructure and investments to 
support care coordination and performance improvement efforts. This 
commenter recommended a more gradual repayment that allows the ACO to 
retain a portion of earned shared savings during the performance year, 
noting that ACOs often reinvest earned shared savings to improve care 
quality and efficiency of care delivery.
    Response: As we explained in the CY 2023 PFS final rule (87 FR 
69804 through 69805), AIP recoupment begins the first performance year 
of the agreement period in which the ACO achieves shared savings, and 
any advance investment payments that are not recouped in the first 
agreement period would continue into the ACO's next agreement period 
and subsequent agreement periods if an AIP balance persists. We 
disagree with commenters that a longer recoupment period would be 
appropriate. As we explained in the CY 2023 PFS final rule, we view our 
AIP recoupment policy as a critical measure necessary to ensure the 
adequate protection of the Medicare Trust Funds regardless of the 
characteristics of the ACO's provider composition, aligned beneficiary 
population, and financial or quality performance. Immediately recouping 
these funds from earned shared savings should not disadvantage any ACOs 
as they will be receiving quarterly payments for the first 2 years. 
Regarding the commenters who advocated that ACOs should be able to 
retain a portion of their advance investment payments, we note that the 
advance investment payments are not intended to supplement FFS 
payments, but rather provide start-up capital out of expected future 
shared savings to be used by new ACOs to provide sufficient resources 
for staffing, providing accountable care for underserved beneficiaries, 
and investing in healthcare delivery infrastructure.
    After consideration of public comments, we are finalizing our 
proposed changes to AIP recoupment and recovery policies for early 
renewing ACOs. We are finalizing our proposed revisions to Sec.  
425.630(e)(3), with modifications for improved clarity. We are 
finalizing without modification our proposed revisions to Sec.  
425.630(g)(4).
    In summary, we anticipate these finalized policy changes would be 
most

[[Page 79215]]

relevant to an ACO that is receiving advance investment payments and 
seeks to early renew to enter a new participation agreement to 
participate under modified Shared Savings Program policies that are not 
applicable to the ACO's current agreement period. For such an ACO, any 
remaining balance of advance investment payments owed would continue to 
be recouped from any shared savings the ACO earns in its new agreement 
period. Further, such an ACO would continue its participation in the 
Shared Savings Program without a lapse in participation and would be 
required to continue to adhere to all AIP requirements. These finalized 
policies will be effective January 1, 2024.
d. Amendments to Termination Policies To Allow CMS To Cease 
Distribution of Advance Investment Payments Following an ACO's 
Notification of Voluntary Termination
(1) Background
    In the CY 2023 PFS final rule (87 FR 69803), we finalized policies 
for termination of advance investment payments at Sec.  425.630(h). 
Section 425.630(h)(1) specifies that CMS may terminate an ACO's advance 
investment payments if the ACO fails to comply with the requirements of 
Sec.  425.630 or meets any of the grounds for ACO termination set forth 
in Sec.  425.218(b). However, we did not address the termination of 
advance investment payments if an ACO voluntarily terminates its 
participation agreement in accordance with Sec.  425.220(a). This 
created ambiguity regarding whether CMS would continue to make 
quarterly advance investment payments to an ACO that voluntarily 
terminates its participation agreement in accordance with Sec.  
425.220(a) and does not immediately enter a new agreement period. We 
are concerned that the continued payment of advance investment payments 
in such a case would not serve the purpose for which CMS is making such 
payments and would create unnecessary program integrity risks for the 
Shared Savings Program. In such a case, CMS would be knowingly paying 
funds to the ACO that will need to be repaid upon termination.
(2) Revisions
    In the CY 2024 PFS proposed rule (88 FR 52485), we proposed to 
permit CMS to terminate advance investment payments for future quarters 
to an ACO that has provided CMS with notice of termination in 
accordance with Sec.  425.220(a) if the ACO will not immediately enter 
a new agreement period. This avoids distributing advance investment 
payments to an ACO from which CMS would subsequently need to recover 
such payments. Specifically, we proposed to add Sec.  
425.630(h)(1)(iii), which allows CMS to terminate an ACO's advance 
investment payments when the ACO voluntarily terminates its 
participation agreement in accordance with Sec.  425.220(a). We also 
proposed conforming changes to the punctuation of the list of factors 
in paragraphs (h)(1)(i) and (ii) of Sec.  425.630. These proposed 
changes would be effective January 1, 2024.
    We solicited comments on this proposal. We received public comments 
on this proposal. The following is a summary of the comments we 
received and our responses.
    Comment: Several commenters expressed appreciation of CMS' proposed 
policy revisions to terminate advance investment payments made to an 
ACO in the case of voluntary termination. Commenters noted that this 
revision aligns with the policy for ceasing advance investment payments 
for other causes of termination and protects the Medicare Trust Funds. 
One commenter suggested that CMS consider the reasons for termination 
and investments made by the ACO when requiring terminated ACOs to pay 
back all advance investment payments received.
    Response: We agree with commenters that ceasing advance investment 
payments to ACOs that inform CMS of their intent to terminate their 
participation agreement is necessary to safeguard the Medicare Trust 
Funds. We disagree with the commenter who suggested that CMS consider 
the reasons for the ACO's termination before requiring the repayment of 
all advance investment payments received. As we stated previously in 
this section of this final rule, recoupment of advance investment 
payments is a critical measure necessary to ensure the adequate 
protection of the Medicare Trust Funds regardless of the 
characteristics of the ACO's provider composition, aligned beneficiary 
population, and financial or quality performance. By requiring 
immediate repayment of advance investment payments upon early 
termination, we also reduce the risk that ACOs will voluntarily 
terminate their participation agreements to avoid repayment of advance 
investment payments.
    After consideration of public comments, we are finalizing this 
proposal without modification. Beginning January 1, 2024, CMS will 
cease paying advance investment quarterly payments to any ACO that 
voluntarily terminates its participation agreement in accordance with 
Sec.  425.220(a) if the ACO will not immediately enter a new agreement 
period. This policy revision is consistent with Sec.  425.630(g)(4), 
which requires such an ACO to repay all advance investment payments 
within the 90 days after receiving notice of the amount due to CMS.
e. Requirements for ACOs To Report to CMS Spend Plan Updates and Use of 
Advance Investment Payments
    In the CY 2023 PFS final rule (87 FR 69786 through 69788), CMS 
finalized program policies to require ACOs that receive advance 
investment payments to submit a spend plan to CMS as a part of their 
Shared Savings Program application (Sec.  425.630(d)(1)). In accordance 
with Sec.  425.630(d)(3), CMS may review an ACO's spend plan at any 
time and require the ACO to modify its spend plan to comply with the 
spend plan requirements specified at Sec.  425.630(d)(2) and the 
requirements for use and management of advance investment payments at 
Sec.  425.630(e).
    In the CY 2023 PFS final rule (87 FR 69801 and 69802), we also 
finalized requirements at Sec.  425.308(b)(8) that an ACO receiving 
advance investment payments must publicly report information, updated 
annually, about the ACO's use of advance investment payments for each 
performance year, including the following:
     The ACO's spend plan.
     The total amount of any advance investment payments 
received from CMS.
     An itemization of how advance investment payments were 
spent during the year, including expenditure categories, the dollar 
amounts spent on the various categories, any changes to the spend plan 
submitted under Sec.  425.630(d), and such other information as may be 
specified by CMS.
    These provisions do not require an ACO to submit this same 
information to CMS. To support CMS's ability to monitor AIP 
efficiently, in the CY 2024 PFS proposed rule (88 FR 52486), we 
proposed that an ACO must report to CMS the same information about its 
use of advance investment payments that it is required to publicly 
report under Sec.  425.308(b)(8).
    To ensure that Sec.  425.630 sets forth the complete requirements 
applicable to an ACO's obligation to report information on its receipt 
and use of advance investment payments, we proposed to add a new 
provision at Sec.  425.630(i) specifying that an ACO must (1) publicly 
report information about the ACO's use of advance investment

[[Page 79216]]

payments for each performance year in accordance with Sec.  
425.308(b)(8); and (2) in a form and manner and by a deadline specified 
by CMS, report to CMS the same information it is required to publicly 
report in accordance with Sec.  425.308(b)(8).
    We expect that these proposed changes would help ensure that CMS 
efficiently obtains information in a consistent manner from all ACOs 
receiving advance investment payments and thereby support CMS's 
monitoring and analysis of the use of advance investment payments. We 
anticipate that these proposed changes will impose little to no 
administrative burden on participating ACOs, which are already required 
to publicly report this information by Sec.  425.308(b)(8). Further, we 
expect to use the submitted data as the template that ACOs can use to 
populate their public reporting web page early in each performance year 
to minimize administrative burden for ACOs. These proposed changes 
would be effective January 1, 2024.
    We solicited comments on this proposal. We received public comments 
on this proposal. The following is a summary of the comments we 
received and our responses.
    Comment: Several commenters supported CMS' proposal to require ACOs 
receiving advance investment payments to report the same information to 
CMS as is reported publicly on the ACOs public reporting website page. 
Another commenter noted that AIP reporting will require additional 
steps for the ACOs who have elected to receive advance investment 
payments. The commenter cautioned CMS to consider ways to reduce any 
extra reporting steps and instead allow for increased flexibility for 
reporting on advance investment payments and AIP spend plans.
    Response: We agree with commenters that the information ACOs 
publicly report about their use of advance investment payments must be 
consistent with the information the ACOs provide to CMS. This proposal 
ensures that CMS receives the same information ACOs publicly account 
for advance investment payments received and their actual advance 
investment payment spending by category (that is, increased staffing, 
healthcare infrastructure and provisions of accountable care by 
underserved beneficiaries) and thereby supports CMS's monitoring of 
ACOs' use of advance investment payments. While CMS is mindful of 
reporting burden, this proposal supports our program integrity and 
monitoring efforts, and the administrative burden on participating ACOs 
should be minimal because they are already required to publicly report 
this information by Sec.  425.308(b)(8). We remind the commenters that 
we expect to use the submitted data as the template that ACOs can use 
to populate their public reporting web page early in each performance 
year to minimize administrative burden on ACOs. In the future, CMS will 
consider ways to further ease the reporting burden on ACOs receiving 
advance investment payments.
    Comment: One commenter shared that AIP could be leveraged by ACOs 
to enhance sociodemographic data collection, create targeted 
initiatives to reduce health disparities, and develop relationships 
with community-based organizations (CBOs) to address social needs. In 
short, the commenter suggested that advance investment payments could 
accelerate the investments and infrastructure for existing ACOs to 
build health equity programs, including data collection on the social 
determinants of health of beneficiaries.
    Response: We agree with the commenter that AIP could provide an 
opportunity to collect sociodemographic data on beneficiaries in the 
Shared Savings Program if necessary to implement initiatives focused on 
increased staffing, health care infrastructure, and the provision of 
accountable care for underserved beneficiaries, which may include 
addressing social determinants of health as required in Sec.  
425.630(e)(1). We note that advance investment payments must be used 
consistent with all applicable laws and regulations, including 
applicable anti-discrimination laws. We also agree with the commenter 
that advance investment payments could assist in providing coordinated 
care to underserved populations, and we agree that advance investment 
payments could be valuable in enabling clinical practices to partner 
with CBOs when identifying and providing care to underserved 
beneficiaries, which we note may include those who are impacted by SDOH 
factors that contribute to poor health outcomes. In the future, after 
advance investment payments are implemented in PY 2024, we will monitor 
how advance investment payments impact ACOs and their beneficiaries, 
including how ACOs use the funds. We intend to expand access to 
accountable care in underserved communities and will continue to refine 
and improve the Shared Savings Program to encourage ACO participation.
    After consideration of public comments, we are finalizing as 
proposed the addition of a new provision at Sec.  425.630(i). This 
finalized change will help ensure that CMS efficiently obtains 
information in a consistent manner from all ACOs receiving advance 
investment payments and thereby support CMS's monitoring and analysis 
of the use of advance investment payments.
f. Permitting Reconsideration Review of Quarterly Payment Calculations
(1) Background
    In the CY 2023 PFS final rule (87 FR 69795 and 69796), we specified 
that an ACO can request a reconsideration review if CMS does not make 
an advance investment payment to the ACO under subpart I of part 425 
(Sec.  425.630(f)). However, we did not specify that an ACO could 
request reconsideration of the amount of the advance investment 
payments.
(2) Revisions
    In the CY 2024 PFS proposed rule (88 FR 52487), we proposed to 
permit an ACO to request a reconsideration review for all AIP quarterly 
payment calculations, not just instances where no payments are 
distributed. We proposed to revise Sec.  425.630(f) to provide that CMS 
would notify in writing each ACO of its determination of the amount of 
the advance investment payments it will receive and that such notice 
would inform the ACO of its right to request reconsideration review in 
accordance with the procedures specified under 42 CFR part 425, subpart 
I. We solicited comments on this proposal.
    We received several public comments on this proposal. The following 
is a summary of the comments we received and our response.
    Comment: All commenters supported CMS' proposed policy refinement. 
Commenters also suggested that CMS provide payment details far enough 
in advance to allow sufficient time to resolve reconsideration reviews 
and avoid delayed payments to ACOs.
    Response: We appreciate the commenter's support of our proposed 
policy. CMS intends to provide payment details as quickly as 
operationally possible to avoid delays in payment of advance investment 
payments.
    After consideration of public comments, we are finalizing as 
proposed the revision of Sec.  425.630(f) without modification.
6. Shared Savings Program Eligibility Requirements
a. Overview
    We proposed two modifications to the Shared Savings Program 
eligibility

[[Page 79217]]

requirements that will be implemented on January 1, 2024. Specifically, 
we proposed the following, which are discussed in more detail in 
sections (b) and (c) below:
     Remove the option for ACOs to request an exception to the 
shared governance requirement that 75 percent control of an ACO's 
governing body must be held by ACO participants.
     Codify the existing Shared Savings Program operational 
approach to specify that CMS determines that an ACO participant TIN 
participated in a performance-based risk Medicare ACO initiative if it 
was or will be included on a participant list used in financial 
reconciliation for a performance year under performance-based risk 
during the 5 most recent performance years.
b. Shared Governance Requirement
(1) Background
    In the November 2011 final rule (76 FR 67819), we finalized 
policies that require an ACO to establish and maintain a governing body 
with adequate authority to execute the statutory functions of an ACO, 
and we codified the governing body policies at Sec.  425.106. 
Specifically, Sec.  425.106(c)(3) mandates that at least 75 percent 
control of an ACO's governing body must be held by ACO participants. An 
ACO's governing body is responsible for providing ACO leadership, 
strategic direction, and oversight for operational management towards 
meeting the goals of the ACO, including better care, healthy 
communities, and reduced spending. This responsibility incorporates not 
only the delivery of improved healthcare, but also the promotion of 
evidence-based healthcare practices, improved engagement of patients 
and caregivers, reporting on quality and cost, provision of high-
quality care to beneficiaries, and the distribution of shared savings, 
among other functions. In the November 2011 final rule (76 FR 67819), 
we indicated our belief that this requirement allowed for Medicare-
enrolled entities that directly provide health care services to 
beneficiaries to drive decision-making, while recognizing that 
partnerships with non-Medicare enrolled entities outside this 75 
percent composition allow these participants access to capital and 
infrastructure needed for an ACO. This physician-driven leadership is 
balanced by the remaining percentage of the governing body that is made 
up of patient advocates, accounting, legal and other professionals that 
support administrative duties and other functions of the ACO.
    We affirmed in the November 2011 final rule (76 FR 67820) our 
belief that the 75 percent participant control requirement is necessary 
to ensure that ACOs are provider-driven, innovative in care delivery 
and strike an appropriate balance to incentivize and empower ACO 
participants to be accountable for the success of the ACO's operations 
and improve the health outcomes of their beneficiaries. Previously, 
commenters expressed concern that the 75 percent participant control 
threshold is overly prescriptive and may hinder operations, conflict 
with IRS and State tax laws, and restrict access to capital for the 
ACO. ACOs requested flexibility to develop their own governing body 
composition to meet the unique leadership needs of the ACO. In response 
to these comments, CMS granted an exception process for an ACO that 
wishes to structure its governing body in a manner that does not meet 
the 75 percent participant control threshold as required under Sec.  
425.106(c)(3). Under the exception process defined at paragraph (c)(5), 
an ACO must describe why it seeks to differ from the 75 percent 
participant control threshold and how the ACO will involve ACO 
participants in innovative ways in ACO governance. If the exception is 
granted by CMS, an ACO can form a governing body with less than 75 
percent participant control.
    In the December 2014 Medicare Shared Savings Program proposed rule 
(79 FR 72776) we proposed to revise Sec.  425.106(c)(5) to remove the 
flexibility for ACOs to deviate from the requirement that at least 75 
percent control of an ACO's governing body must be held by ACO 
participants. We stated that, through program implementation, we 
learned that ACO applicants do not have difficulty meeting the 
requirements under Sec.  425.106(c)(3) that ACO participants maintain 
75 percent control of the governing body. We also noted that since CY 
2012, we had not denied participation to any ACO applicants solely 
based on failure to comply with this requirement and no exceptions have 
been granted by CMS under Sec.  425.106(c)(5). Furthermore, we affirmed 
the 75 percent participant control requirement to be ``necessary and 
protective of the ACO participant's interests'' and thus, that there 
was no reason to continue to offer an exception to the rule.
    During the public comment period for the December 2014 Medicare 
Shared Savings Program proposed rule, several commenters advocated for 
retaining the flexibility offered at Sec.  425.106(c)(5), stating that 
an ACO may elect to utilize the exception in the future. In our 
response, we noted that our program experience thus far had not 
suggested that commenters' concerns that laws concerning the 
composition of tax-exempt or State-licensed entities would interfere 
with their ability to meet the 75 percent participant control threshold 
would impact their compliance with this requirement. However, since 
implementation of the requirement remained in the early stages and we 
had limited applicability with ACOs in two-sided risk tracks, we 
declined to finalize the proposal in the June 2015 final rule (80 FR 
32719) and elected to retain the flexibility at Sec.  425.106(c)(5). In 
the final rule, we noted that we anticipated granting such exceptions 
only in limited circumstances (that is, an ACO being unable to meet the 
75 percent participant control requirement because it conflicts with 
other laws) and might revisit this issue in future rulemaking.
(2) Revisions
    We continue to believe that ACO participants should drive ACO 
leadership to move toward improved quality of care and patient 
outcomes, and that this is a key component of ACO success and ability 
to earn shared savings. The 75 percent participant control threshold is 
critical to ensuring that governing bodies are participant-led and best 
positioned to meet program goals, while allowing for partnership with 
non-Medicare enrolled entities to provide needed capital and 
infrastructure for ACO formation and administration.
    Over the years, a few ACOs have requested an exception to form a 
governing body with less than 75 percent participant control. CMS 
discussed the exemption requests with the interested ACOs and 
ultimately most ACOs adjusted to comply with the 75 percent participant 
control requirement. As noted in the proposed rule, we believed that no 
ACO had been granted an ACO an exception to this requirement, despite 
the flexibility provided in current regulation. Accordingly, we 
believed that there was no reason to continue to offer an exception to 
the requirement. Thus, we proposed to remove the option under Sec.  
425.106(c)(5) for ACOs to request an exception to the requirement 
specified in Sec.  425.106(c)(3) that 75 percent control of the ACO's 
governing body must be held by ACO participants. Additionally, we 
proposed a corresponding revision to Sec.  425.204(c)(3) to remove the 
option for ACOs to request an exception to the 75 percent control 
requirement under Sec.  425.106(c)(3) as part of their Shared Savings 
Program applications.

[[Page 79218]]

    We solicited comments on the appropriateness of our proposed policy 
refinement and elimination of the exception process. As stated in the 
CY 2024 PFS proposed rule, the proposed modification to Sec.  
425.106(c) would make no changes to paragraphs(c)(2), (3) and (4). We 
also proposed to amend Sec.  425.106(c)(5) to remove reference to 
paragraph (c)(3) and the procedure for submitting a request for an 
exception to the 75 percent requirement. Specifically, in our proposal 
the revised regulation text would state that in cases in which the 
composition of the ACO's governing body does not meet the requirements 
of paragraph (c)(2) of this section, the ACO must describe why it seeks 
to differ from these requirements and how the ACO will provide 
meaningful representation in ACO governance by Medicare beneficiaries. 
Additionally, we proposed to amend Sec.  425.204(c)(3) to remove 
references to Sec.  425.106(c)(3) and the procedure for submitting a 
request for an exception to the 75 percent requirement. We proposed 
that these amendments would become effective on January 1, 2024.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Commenters largely supported our proposal to remove the 
option for ACOs to request an exception to the requirement specified in 
Sec.  425.106(c)(3) that 75 percent control of the ACO's governing body 
must be held by ACO participants. Commenters noted they believe the 
threshold was appropriate, attainable, and important to ACO care 
delivery. Other commenters also noted that they believe that it is 
important to ACO participant involvement and supported centering 
practitioners in ACO governance.
    Response: We agree with the majority of commenters who stated that 
it was appropriate to remove the exception to meeting the requirement 
that 75 percent control of the ACO's governing body must be held by ACO 
participants. We agree with commenters about the importance of ACO 
participant governance and that it is attainable. We believe that this 
requirement is necessary and protective of the ACO participants' 
interests and does not believe that it is necessary to grant exceptions 
to this requirement.
    Comment: One commenter did not support removing the exception and 
wanted ACOs to retain the ability to make this request. Another 
commenter contested the statement that CMS has never issued an 
exception to the 75 percent control threshold, as they had worked with 
ACOs who believe they have received such an exception.
    Response: We disagree with the commenter who wants to retain the 
exception for the meeting the 75 percent participant control threshold 
as we do not believe it is necessary for ACO participation as noted 
above. However, in response to the comment regarding previously issued 
exceptions, we reviewed all previous application data and discovered 3 
ACOs operating with an exception to the 75 percent threshold and 2 that 
had an exception at the start of their agreement period but are 
currently meeting the threshold. While CMS failed to identify these 
ACOs in the proposed rule and the assertion that approvals had never 
occurred was cited by several supporting comments, these previously 
issued exceptions do not change our belief that exceptions to this 
requirement should no longer be permitted. To reduce disruption for the 
few ACOs who do not currently meet the requirement, we are finalizing 
this policy with the modification that the exception will be permitted 
only for agreement periods beginning before January 1, 2024.
    After consideration of the public comments, we are finalizing our 
proposal with modification, to specify that the option under Sec.  
425.106(c)(5) for ACOs to request an exception to the requirement 
specified in Sec.  425.106(c)(3) that 75 percent control of the ACO's 
governing body must be held by ACO participants is applicable only to 
agreement periods beginning before January 1, 2024.
    Additionally, we are finalizing with modification the proposed 
changes to Sec.  425.204(c)(3). We are finalizing revisions to Sec.  
425.204(c)(3)(iii) to limit the option for ACOs to request an exception 
to the 75 percent control requirement under Sec.  425.106(c)(3), as 
part of their Shared Savings Program applications, to agreement periods 
beginning before January 1, 2024. Further, we are finalizing a 
technical change to Sec.  425.204(c)(3)(ii), to provide a more complete 
cross-reference to Sec.  425.106(c)(2), for clarity and consistency.
c. Identifying ACOs Experienced With Risk Based on TINs' Prior 
Participation
(1) Background
    In the December 2018 final rule, we added a new paragraph (d) under 
Sec.  425.600 to set forth the participation options for ACOs that are 
experienced or inexperienced with ``performance-based risk Medicare ACO 
initiatives'' (which is defined at Sec.  425.20 to include certain 
Innovation Center ACO models, as well as two-sided risk tracks of the 
Shared Savings Program). We also finalized the definitions of 
``experienced with performance-based risk Medicare ACO initiatives'' 
and ``inexperienced with performance-based risk Medicare ACO 
initiatives'' (83 FR 68062). These definitions classify ACOs by 
experience level based on the percentage of ACO participant TINs that 
participated in performance-based risk Medicare ACO initiatives during 
a 5-year lookback period. However, current regulation text does not 
specify how CMS determines whether an ACO participant TIN has 
``participated'' in a performance-based risk Medicare ACO initiative. 
To improve clarity of the regulations, we proposed to codify our 
existing program policy under which an ACO participant TIN is 
considered to have participated in a performance-based risk Medicare 
ACO initiative if it was or will be included in financial 
reconciliation for a performance year under such initiative during any 
of the 5 most recent performance years.
    Under the December 2018 final rule, an ACO is ``inexperienced with 
performance-based risk Medicare ACO initiatives'' (and therefore, 
eligible to enter an agreement period under the BASIC track's glide 
path), if less than 40 percent of its ACO participants has participated 
in a performance-based risk Medicare ACO initiative in ``each'' of the 
5 most recent performance years prior to its Shared Savings Program 
agreement start date, and the ACO legal entity has not participated in 
any performance-based risk Medicare ACO initiative (83 FR 67895). 
Similarly, an ACO is ``experienced with performance-based risk Medicare 
ACO initiatives'' if 40 percent or more of its ACO participants has 
participated in a performance-based risk Medicare ACO initiative in 
``any'' of the 5 most recent performance years prior to its Shared 
Savings Program agreement start date (83 FR 67895). Thus, if 40 percent 
or more of the entities on an ACO participant list participated in a 
performance-based risk Medicare ACO initiative in a single performance 
year within the 5 most recent performance years, we would determine 
that the ACO meets the definition of ``experienced with performance-
based risk Medicare ACO initiatives.'' Conversely, we would determine 
that an ACO satisfies the definition of ``inexperienced with 
performance-based risk Medicare ACO initiatives'' only if it is below 
the 40 percent threshold in all of the 5 most recent performance years 
prior to the ACO's agreement start date. In other words, an ACO is

[[Page 79219]]

inexperienced with performance-based risk Medicare ACO initiatives as 
long as it does not meet the definition of ``experienced with 
performance-based risk Medicare ACO initiatives'' in any of the five 
most recent performance years prior to the ACO's agreement start date. 
We chose to use a 5-year lookback period for determining whether an ACO 
is experienced or inexperienced with performance-based risk Medicare 
ACO initiatives for a number of reasons, including that it could reduce 
the incentive for organizations to wait out the period in an effort to 
establish a new legal entity with the same or very similar composition 
of ACO participants for purposes of gaming program policies.
    We recognized that some ACOs or TINs in performance-based risk 
Medicare ACO initiatives participate for only part of a performance 
year, but our current regulation text does not specify the duration of 
participation required for CMS to determine that an ACO participant TIN 
has participated in a performance-based risk Medicare ACO initiative.
(2) Revisions
    We proposed to codify the current operational approach for 
determining whether an ACO participant has participated in a 
performance-based risk Medicare ACO initiative. Under our current 
operational approach, an ACO participant is considered to have 
participated in a performance-based risk Medicare ACO initiative if its 
TIN was or will be used to calculate financial reconciliation for the 
entity participating in such ACO initiative (``Initiative ACO''). In 
general, if an ACO participant was included on an Initiative ACO's 
participant list for a performance year during the 5 most recent 
performance years before the ACO's agreement start date, and the 
Initiative ACO is, or will be, financially reconciled for that 
performance year, the ACO participant will be considered to have 
participated in the Initiative ACO. This will generally be true 
regardless of whether the entity leaves the Initiative ACO mid-
performance year because its claims experience would still be used in 
the Initiative ACO's alignment and financial reconciliation for that 
performance year. If the ACO participant was included on an Initiative 
ACO's participant list for a performance year during the lookback 
period, but the ACO voluntarily terminates before the deadline for 
reconciliation or is otherwise not eligible for reconciliation, the ACO 
participant will not be considered to have experience with risk because 
its claims experience would not be used for financial reconciliation.
    Except for determinations made regarding AIP ACOs for purposes of 
Sec.  425.316(e)(2), we determine whether an ACO is experienced with 
performance-based risk Medicare ACO initiatives prior to the start of 
an ACO's agreement start date. At the time we make these 
determinations, the ACO may be in the middle of a PY for which 
reconciliation has not yet occurred. Nevertheless, we believe that at 
the time we make these determinations, we have the information 
necessary to determine whether an ACO or ACO participant TIN will be 
included in financial reconciliation for a PY in the relevant Medicare 
ACO initiative because this issue is addressed in the terms of each 
Medicare ACO initiative. For example, as outlined in Sec.  
425.221(b)(2)(ii)(A), if an ACO in a two-sided model terminates from 
the Shared Savings Program after June 30th of a PY, they will be held 
responsible for a pro-rated share of any shared losses determined for 
the performance year during which the termination becomes effective. 
Any ACO participant TIN that was included on the participant list for 
that performance year will have been included in beneficiary alignment 
and their claims experience used to calculate the benchmark and 
performance year expenditures. For other Medicare ACO initiatives, the 
terms of the participation agreement specify when the ACO is subject to 
reconciliation and which TINs will be included in reconciliation.
    We proposed to modify the existing definitions for ``experienced 
with performance-based risk Medicare ACO initiatives'' and 
``inexperienced with performance-based risk Medicare ACO initiatives'' 
at Sec.  425.20 to include the following new sentence at the end of 
each definition: An ACO participant is considered to have participated 
in a performance-based risk Medicare ACO initiative if the ACO 
participant TIN was or will be included in financial reconciliation for 
one or more performance years under such initiative during any of the 5 
most recent performance years. We also proposed a technical correction 
to remove the language ``as defined under this section'' from both 
definitions. We proposed that these amendments would become effective 
on January 1, 2024.
    We solicited comments on the proposed regulation text.
    The following is a summary of the comments received on the proposal 
to codify the existing Shared Savings Program operational approach to 
specify that CMS determines that an ACO participant TIN participated in 
a performance-based risk Medicare ACO initiative if it was or will be 
included on a participant list used in financial reconciliation for a 
performance year under performance-based risk during the 5 most recent 
performance years and our responses:
    Comment: Commenters supported the proposal to codify the existing 
Shared Savings Program operational approach to specify that CMS 
determines that an ACO participant TIN participated in a performance-
based risk Medicare ACO initiative if it was or will be included on a 
participant list used in financial reconciliation for a performance 
year under performance-based risk during the 5 most recent performance 
years. Multiple commenters appreciated CMS' transparency regarding 
program operations.
    Response: We thank the commenters for their support and agree that 
aligning the definitions of ``experienced with performance-based risk 
Medicare ACO initiatives'' and ``inexperienced with performance-based 
risk Medicare ACO initiatives'' with current operational methodologies 
will bring increased clarity and transparency around the determination 
of experience level.
    Comment: While multiple commenters appreciated the additional 
detail this proposal provides regarding TIN risk experience 
determination, they requested further clarification on the methodology 
described. One commenter asked how a determination of experience would 
be made if a portion of a TIN has participated in performance-based 
risk Medicare ACO initiatives during the 5 most recent performance 
years. In particular, they asked if a TIN would be classified as 
experienced if one participant in the TIN previously participated in 
ACO REACH, where participation is determined at the TIN/NPI level. 
Other commenters advocated for a process where ACOs could submit a 
reconsideration review if an ACO participant TIN has been determined to 
have participated in an Innovation Center ACO Model based on a small 
percentage of NPIs billing under the TIN for a split-TIN model. Both 
sets of commenters providing these additional suggestions advocated for 
CMS to align the experience thresholds at the ACO and TIN levels, 
meaning a TIN would only be considered experienced if 40 percent or 
more of the NPIs billing under the TIN participated in any performance-
based risk Medicare ACO initiatives.
    Response: We thank the commenters for their support to codify the 
existing operational approach around TIN

[[Page 79220]]

experience determination. As the commenters stated, the Shared Savings 
Program identifies participants using full TINs, which requires all 
individuals and entities that have reassigned their right to receive 
Medicare payment to the TIN of an ACO participant to participate in the 
ACO and comply with program requirements (82 FR 53689). As stated in 
the December 2018 final rule, we believe that defining ACO participants 
to include all NPIs that have reassigned their billing rights to the 
TIN is a means to allowing the ACO's redesigned care processes to more 
broadly reach all Medicare FFS beneficiaries that may receive care from 
ACO participants, including those that may not meet the program's 
assignment criteria, and provides incentives for lower performing 
providers within an ACO participant TIN to improve (83 FR 67874). 
Additionally, NPIs who have participated in a risk-based arrangement 
can help facilitate care redesign within their TIN, better preparing 
the TIN to join a ACO taking on risk. The impact of ACO participant 
experience can be seen in the shared savings results. Of the ACOs that 
newly joined the Shared Savings Program in 2022, 88 percent of the ACOs 
considered experienced with performance-based risk earned shared 
savings in the first performance year in comparison to 46 percent of 
the ACOs that were considered inexperienced with performance-based 
risk.
    After consideration of public comments, we are finalizing without 
modification the proposed changes to the definitions for ``experienced 
with performance-based risk Medicare ACO initiatives'' and 
``inexperienced with performance-based risk Medicare ACO initiatives'' 
at Sec.  425.20. We believe these changes will improve ACO 
understanding of our current operational policies.
7. Technical Changes to References in Shared Savings Program 
Regulations
a. References to an ACO's Assignment Methodology Selection
    Section 1899(c)(2)(A) of the Act, as amended by the Bipartisan 
Budget Act of 2018, provides all ACOs with a choice of prospective 
assignment for agreement periods beginning on or after January 1, 2020. 
In the December 2018 final rule (83 FR 67859 through 67863), we 
finalized modifications to the Shared Savings Program's regulations, to 
separate the choice of beneficiary assignment methodology from the 
choice of participation track (financial model). We also added a new 
section of the Shared Savings Program regulations at Sec.  425.226 to 
govern annual participation elections (see 83 FR 67857 through 67859). 
In accordance with Sec.  425.226, before the start of a performance 
year an ACO may make elections related to its participation in the 
Shared Savings Program, including selection of its beneficiary 
assignment methodology, which will be effective at the start of the 
applicable performance year and for the remaining years of the 
agreement period, unless superseded by a later election. Section 
425.226(a)(1) specifies that an ACO may select the assignment 
methodology that CMS employs for assignment of beneficiaries under 
subpart E of the Shared Savings Program regulations. An ACO may select 
either of the following: (i) preliminary prospective assignment with 
retrospective reconciliation, as described in Sec.  425.400(a)(2); or 
(ii) prospective assignment, as described in Sec.  425.400(a)(3).
    For consistency, in the December 2018 final rule (83 FR 67859 
through 67863), we also finalized conforming changes to regulations 
that previously identified assignment methodologies according to 
participation track. Among other changes to the Shared Savings Program 
regulations, we added Sec.  425.400(a)(4)(ii) to establish that for 
agreement periods beginning on July 1, 2019, and in subsequent years, 
the ACO may select the assignment methodology CMS employs for the 
assignment of beneficiaries. As specified in Sec.  
425.400(a)(4)(ii)(B), this selection of assignment methodology is made 
prior to the start of each agreement period and may be modified prior 
to the start of each performance year as specified in Sec.  425.226 (83 
FR 67863).
    Although Sec. Sec.  425.226(a)(1) and 425.400(a)(4)(ii) both 
reference assignment methodology selection, there are key differences 
in the purpose each section serves in directing action from the ACO 
versus action that CMS initiates. Section 425.226 states that the 
initial selection of, and any annual selection for a change in, 
beneficiary assignment methodology by an ACO must be made in the form 
and manner and according to the timeframe, that we establish. 
Therefore, Sec.  425.226(a)(1) is the relevant regulation for 
referencing the ACO's option to select and to change its selection of 
assignment methodology. That is, Sec.  425.226 describes actions for 
which the ACO is responsible because the ACO is selecting the 
assignment methodology that will be effective at the beginning of the 
ACO's agreement period or making a change to the ACO's prior assignment 
methodology selection that will become effective at the beginning of 
the next performance year.
    In comparison, Sec.  425.400 outlines how we employ the assignment 
methodology described in Sec. Sec.  425.402 and 425.404 for purposes of 
benchmarking, preliminary prospective assignment (including quarterly 
updates), retrospective reconciliation, and prospective assignment. 
Therefore, Sec.  425.400(a)(4)(ii) is the relevant regulation for 
referencing how we determine the assignment methodology to be used in 
the referenced program operations or program calculations. That is, 
Sec.  425.400(a)(4)(ii) governs actions undertaken by us because we are 
applying the ACO's selected assignment methodology when determining 
benchmarking, preliminary prospective assignment, retrospective 
reconciliation, and prospective assignment.
    Throughout the current Shared Savings Program regulations text, 
there are various references to Sec.  425.226(a)(1) or Sec.  
425.400(a)(4)(ii). We conducted a review of the Shared Savings Program 
regulations text to determine whether the existing 12 references to 
either Sec.  425.226(a)(1) or Sec.  425.400(a)(4)(ii) align with 
provisions' intended purposes. We also considered the intended purposes 
of the provisions in identifying the appropriate cross-reference to 
include in the proposed new regulation at Sec.  425.655, which is 
described in section III.G.4.b. of this final rule.
    We believe the following five references to Sec.  425.400(a)(4)(ii) 
are consistent with the intended purpose of Sec.  425.400(a)(4)(ii) 
because they refer to how we determine the ACO's chosen assignment 
methodology for purposes of determining beneficiary assignment or 
performing certain program calculations: Sec.  425.609(c)(1); Sec.  
425.652(a)(5)(v)(A) and (b)(2)(iv)(A); Sec.  425.654(a)(1)(i); and 
Sec.  425.656(b)(3).
    We believe the following two references to Sec.  425.226(a)(1) are 
consistent with the intended purpose of Sec.  425.226(a)(1) because the 
references are used when referring to the ACO's option to change its 
selection of assignment methodology: Sec.  425.601(a)(9) introductory 
text; and Sec.  425.652(a)(9) introductory text.
    We identified five inconsistencies in references to Sec. Sec.  
425.226(a)(1) and 425.400(a)(4)(ii) that we proposed to revise in the 
CY 2024 PFS proposed rule (see 88 FR 52490). To follow is a description 
of the five references that we proposed to revise in 42 CFR part 425, 
subpart G to ensure that the appropriate assignment selection reference 
is being cited, for clarity and consistency.
    For performance years starting on January 1, 2019, and subsequent

[[Page 79221]]

performance years, we add beneficiaries to an ACO's list of assigned 
beneficiaries based on a beneficiary's designation of an ACO 
professional as the provider or supplier they consider responsible for 
coordinating their overall care, if certain conditions are satisfied, 
including the conditions specified in Sec.  425.402(e)(2)(ii)(A). In 
accordance with Sec.  425.402(e)(2)(ii)(A), the beneficiary must meet 
the eligibility criteria established at Sec.  425.401(a) and must not 
be excluded by the criteria at Sec.  425.401(b). Further, Sec.  
425.402(e)(2)(ii)(A) specifies that the exclusion criteria at Sec.  
425.401(b) apply for purposes of determining beneficiary eligibility 
for alignment to an ACO based on the beneficiary's designation of an 
ACO professional as responsible for coordinating their overall care 
under Sec.  425.402(e), regardless of the ACO's assignment methodology 
selection under Sec.  425.400(a)(4)(ii). The citation to Sec.  
425.400(a)(4)(ii) in Sec.  425.402(e)(2)(ii)(A) is not consistent with 
the intended purpose of the reference, which is to refer to the ACO's 
option to change its assignment methodology selection. Therefore, in 
the CY 2024 PFS proposed rule (88 FR 52490), we proposed to amend Sec.  
425.402(e)(2)(ii)(A) by removing the reference to Sec.  
425.400(a)(4)(ii) and adding in its place a reference to Sec.  
425.226(a)(1), for clarity and consistency.
    The introductory text of Sec.  425.601(a) (applicable to agreement 
periods beginning on or after July 1, 2019, and before January 1, 2024) 
and of Sec.  425.652(a) (applicable to agreement periods beginning on 
January 1, 2024, and in subsequent years) specify that in computing an 
ACO's historical benchmark for its first agreement period under the 
Shared Savings Program, we determine the per capita Parts A and B FFS 
expenditures for beneficiaries that would have been assigned to the ACO 
in any of the 3 most recent years prior to the start of the agreement 
period using the ACO participant TINs identified before the start of 
the agreement period as required under Sec.  425.118(a) and the 
beneficiary assignment methodology selected by the ACO for the first 
performance year of the agreement period as required under Sec.  
425.226(a)(1). Accordingly, the introductory text in Sec.  425.601(a) 
and in Sec.  425.652(a) is describing how we will compute expenditures 
for beneficiaries that would have been assigned to the ACO based on the 
assignment methodology selected by the ACO. These provisions are 
referring to how we determine the assignment methodology to be used to 
identify the beneficiary population that would have been assigned in 
the three benchmark years, not to the ACO's act of selecting the 
assignment methodology. Therefore, in the CY 2024 PFS proposed rule 
(see 88 FR 52490), we proposed to amend the introductory text of Sec.  
425.601(a) and of Sec.  425.652(a) by removing the references to Sec.  
425.226(a)(1) and adding in their place references to Sec.  
425.400(a)(4)(ii), for clarity and consistency.
    Section 425.652(a)(9)(ii) specifies that for agreement periods 
beginning on January 1, 2024, and in subsequent years, when adjusting 
the benchmark for certain changes during the agreement period, we 
redetermine the regional adjustment amount under Sec.  425.656 
according to the ACO's assigned beneficiaries for BY3, and based on the 
assignable population of beneficiaries identified for the assignment 
window corresponding to BY3 that is consistent with the assignment 
window that applies under the beneficiary assignment methodology 
selected by the ACO for the performance year according to Sec.  
425.226(a)(1). In Sec.  425.652(a)(9)(ii), the reference to Sec.  
425.226(a)(1) is not consistent with the intended purpose of the 
reference, which is to specify how we determine the assignment 
methodology that will be used to identify the assigned beneficiary and 
assignable beneficiary populations for purposes of redetermining the 
regional adjustment amount in the event the ACO changes its selected 
assignment methodology for a performance year. Therefore, in the CY 
2024 PFS proposed rule (88 FR 52490), we proposed to amend Sec.  
425.652(a)(9)(ii) by removing the reference to Sec.  425.226(a)(1) and 
adding in its place the reference to Sec.  425.400(a)(4)(ii), for 
clarity and consistency.
    Section 425.652(a)(9)(iv) describes that for agreement periods 
beginning on January 1, 2024, and in subsequent years, when adjusting 
the benchmark for certain changes during the agreement period, we 
redetermine the proration factor used in calculating the prior savings 
adjustment under Sec.  425.658(b)(3)(ii) to account for changes in the 
ACO's assigned beneficiary population in the benchmark years of the 
ACO's current agreement period due to the addition and removal of ACO 
participants or ACO providers/suppliers in accordance with Sec.  
425.118(b), a change to the ACO's beneficiary assignment methodology 
selection under Sec.  425.400(a)(4)(ii), or changes to the beneficiary 
assignment methodology under 42 CFR part 425, subpart E. In Sec.  
425.652(a)(9)(iv), the reference to Sec.  425.400(a)(4)(ii), is not 
consistent with the intended purpose of the reference, which is to 
specify that we will redetermine the proration factor used in 
calculating the prior savings adjustment if the ACO changes its 
beneficiary assignment methodology selection. Therefore, we proposed to 
amend Sec.  425.652(a)(9)(iv) by removing the reference to Sec.  
425.400(a)(4)(ii) and adding in its place a reference to Sec.  
425.226(a)(1), for clarity and consistency.
    We solicited comments on these proposed technical changes.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: All commenters supported these proposals and provided no 
further elaboration or suggestions, stating that these technical 
changes will eliminate errors and inconsistencies and improve clarity 
in the regulatory text:
    Response: We agree with commenters that these technical changes 
will eliminate errors and inconsistencies and improve clarity in the 
regulatory text.
    We are finalizing the proposal to amend five inconsistencies in 
references to Sec. Sec.  425.226(a)(1) and 425.400(a)(4)(ii). 
Specifically, we are finalizing the following:
     Amend Sec.  425.402(e)(2)(ii)(A) by removing the reference 
to Sec.  425.400(a)(4)(ii) and adding in its place a reference to Sec.  
425.226(a)(1).
     Amend the introductory text of Sec.  425.601(a) and of 
Sec.  425.652(a) by removing the reference to Sec.  425.226(a)(1) and 
adding in its place a reference to Sec.  425.400(a)(4)(ii).
     Revise Sec.  425.652(a)(9)(ii) to remove the reference to 
Sec.  425.226(a)(1) and include a reference to Sec.  425.400(a)(4)(ii), 
among other revisions to this paragraph that we are finalizing with 
this final rule (see section III.G.3.a. of this final rule).
     Amend Sec.  425.652(a)(9)(iv) by removing the reference to 
Sec.  425.400(a)(4)(ii) and adding in its place a reference to Sec.  
425.226(a)(1).
b. Definition of Rural Health Clinic
    In the November 2011 final rule, we established a definition for 
the term ``Rural health center (RHC)'' for the Shared Savings Program 
at Sec.  425.20.\288\ The definition of ``Rural health center (RHC)'' 
at Sec.  425.20 states that this term has the same meaning given to 
this term under Sec.  405.2401(b). The term ``Rural health clinic 
(RHC)'' is defined at

[[Page 79222]]

Sec.  405.2401(b) to mean a facility that has--
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    \288\ See, for example, 76 FR 67930 through 67932 (discussion of 
our proposal to define FQHCs and RHCs as these terms are defined in 
Sec.  405.2401(b)), and 76 FR 67974 and 67975 (finalized regulations 
text for Sec.  425.20).
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     Been determined by the Secretary to meet the requirements 
of section 1861(aa)(2) of the Act and 42 CFR part 491 concerning RHC 
services and conditions for approval; and
     Filed an agreement with CMS that meets the requirements in 
Sec.  405.2402 to provide RHC services under Medicare.
    In the CY 2024 PFS proposed rule (88 FR 52490 and 52491), we 
explained that the inconsistency between Sec.  425.20, which 
inaccurately uses the word ``center,'' and Sec.  405.2401(b), which 
accurately uses the word ``clinic,'' had recently came to our 
attention. We noted that the term ``rural health clinic'' was in use 
and defined at Sec.  405.2401(b) when we established the term and 
definition for ``Rural health center (RHC)'' under part 425 with the 
November 2011 final rule. Furthermore, we noted that in the November 
2011 final rule (76 FR 67803), we separately established an acronym 
``RHCs'' for ``Rural Health Clinics'' in the acronyms list reflecting 
the accurate term.
    To ensure clarity and accuracy, we proposed to correct the error in 
the definition for ``Rural health center (RHC)'' at Sec.  425.20 by 
replacing the word ``center'' with the word ``clinic''. We also 
clarified that all uses of the acronym ``RHC'' or ``RHCs'' throughout 
part 425--including in the definition of ``primary care physician'' in 
Sec.  425.20, as well as in Sec. Sec.  425.102 and 425.304 and 
throughout 42 CFR part 425, subpart E--have been interpreted to refer 
to ``rural health clinic'' or ``rural health clinics'' as defined at 
Sec.  405.2401(b). Further, we proposed to revise the definition of 
rural health center in Sec.  425.20 to specify that the referenced 
provision at Sec.  405.2401(b) is within 42 CFR Chapter IV. We 
solicited comments on these proposed technical changes.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: All commenters supported these proposals and provided no 
further elaboration or suggestions, stating that these technical 
changes will eliminate errors and inconsistencies and improve clarity 
in the regulatory text.
    Response: We agree with commenters that these technical changes 
will eliminate errors and inconsistencies and improve clarity in the 
regulatory text.
    After consideration of public comments, we are finalizing as 
proposed.
c. Definition of At-Risk Beneficiary
    In the November 2011 final rule (see 76 FR 67974), we established 
the definition of ``At-risk beneficiary'' at Sec.  425.20, the meaning 
of which includes, but is not limited to, a beneficiary who--
     Has a high-risk score on the CMS-HCC risk adjustment 
model;
     Is considered high cost due to having two or more 
hospitalizations or emergency room visits each year;
     Is dually eligible for Medicare and Medicaid;
     Has a high utilization pattern;
     Has one or more chronic conditions;
     Has had a recent diagnosis that is expected to result in 
increased cost;
     Is entitled to Medicaid because of disability; or
     Is diagnosed with a mental health or substance abuse 
disorder.
    In the November 2011 final rule, we explained that we agreed with 
commenters that our proposed definition of at-risk beneficiary should 
be expanded to include patients who are entitled to Medicare (emphasis 
added) because of disability (see 76 FR 67950). However, in codifying 
the relevant regulation text at Sec.  425.20, we inadvertently referred 
to patients who are entitled to Medicaid because of disability 
(emphasis added). In the CY 2024 PFS proposed rule (88 FR 52491), we 
noted that an individual who is entitled to Medicare because of 
disability and who is also entitled to Medicaid, would be included 
under the category ``Is dually eligible for Medicare and Medicaid.''
    We proposed to correct the typographical error in the definition 
for ``At-risk beneficiary'' at Sec.  425.20 by replacing the word 
``Medicaid'' in paragraph (7) with the word ``Medicare''. We also 
proposed to adjust inaccurate punctuation in the list of paragraphs 
within this definition by replacing the period at the end of paragraphs 
(5) and (6) with a semi-colon. We solicited comments on these proposed 
changes.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: All commenters supported these proposals and provided no 
further elaboration or suggestions, stating that these technical 
changes will eliminate errors and inconsistencies and improve clarity 
in the regulatory text.
    Response: We agree with commenters that these technical changes 
will eliminate errors and inconsistencies and improve clarity in the 
regulatory text.
    After consideration of public comments, we are finalizing as 
proposed.
d. Updating Terminology in Regulations on Data Sharing with ACOs
    In the CY 2024 PFS proposed rule (88 FR 52491), we explained that 
it had come to our attention that certain terminology that is used in 
the data sharing regulations for the Shared Savings Program in 42 CFR 
part 425, subpart H is outdated or inconsistent with the terminology 
used elsewhere in the Medicare program and in the HIPAA regulations in 
45 CFR part 164. We proposed technical and conforming changes to Sec.  
425.702(c)(1)(ii)(A)(3) and Sec.  425.702(c)(1)(ii) for clarity and 
consistency.
    In accordance with the Medicare Access and CHIP Reauthorization Act 
of 2015 (MACRA), CMS discontinued the use of Social Security Number-
based Health Insurance Claim Numbers (HICNs) as the beneficiary 
identifier on Medicare cards and replaced that identifier type with 
Medicare Beneficiary Identifiers (MBIs) by April 2019. MBIs are now 
used for Medicare transactions like billing, eligibility status, and 
claim status. All claims with a date of service on or after January 1, 
2020, must use the beneficiary's MBI, rather than the 
HICN.289 290 To accommodate this change from HICN to MBI, 
starting in PY 2018 we revised Shared Savings Program reports that 
provide beneficiary-identifiable information under Sec.  425.702, and 
claim and claim line feed files with beneficiary identifiable claims 
data provided under Sec.  425.704, to include a field for the 
beneficiary's MBI. By the end of PY 2019, we discontinued populating 
data in the HICN fields. However, when we made this operational update, 
we did not make conforming changes to the regulations text at Sec.  
425.702(c)(1)(ii)(A) to revise the list of the four data elements we 
provide to ACOs on their FFS beneficiary population: (1) beneficiary 
name; (2) date of birth; (3) HICN; and (4) sex. Therefore, because we 
have discontinued use of the HICN, we proposed to revise Sec.  
425.702(c)(1)(ii)(A)(3) to refer to ``Beneficiary identifier'' instead 
of ``Health Insurance Claim Number (HICN).'' We explained that this 
change to the regulations text would not change

[[Page 79223]]

the information that is provided to ACOs pursuant to Sec.  
425.702(c)(1)(ii).
---------------------------------------------------------------------------

    \289\ CMS, MLN Matters, ``New Medicare Beneficiary Identifier 
(MBI) Get It, Use It''. Article number SE18006, revised March 19, 
2020. Available at https://www.cms.gov/outreach-and-education/medicare-learning-network-mln/mlnmattersarticles/downloads/se18006.pdf.
    \290\ CMS.gov website, Medicare Beneficiary Identifiers (MBIs), 
at https://www.cms.gov/Medicare/New-Medicare-Card.
---------------------------------------------------------------------------

    Further, we proposed to revise the list of purposes in Sec.  
425.702(c)(1)(ii) for which an ACO may request certain beneficiary-
identifiable data for purposes of population-based activities to better 
align with the terminology used in the first paragraph of the 
definition of health care operations at 45 CFR 164.501. Specifically, 
we proposed to remove the reference to ``process development'' and to 
add in its place a reference to ``protocol development.'' In prior 
rulemaking, we indicated that ACOs could request beneficiary-
identifiable data under Sec.  425.702(c)(1)(ii) for purposes of 
carrying out population-based activities, including process 
development, and we referred to care coordination processes and 
required process development under Sec.  425.112 (see 80 FR 32734 and 
32735). In the proposed rule, we stated that we did not believe the 
proposed revision would impact ACOs' ability to request data for these 
types of process development. Rather, activities related to care 
coordination processes and the development of required processes under 
Sec.  425.112 would continue to fall within the population-based 
activities listed in Sec.  425.702(c)(1)(ii) for which an ACO may 
request data, including protocol development (as added by this proposed 
revision) and care coordination. We also noted that this proposed 
revision would ensure that the terminology used in Sec.  
425.702(c)(1)(ii) is consistent with the language of the proposed new 
provision at Sec.  425.702(c)(1)(iii) (see section III.G.2.b.(2) of 
this final rule for a discussion of this proposal).
    We solicited comments on these proposed changes.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: All commenters supported these proposals and provided no 
further elaboration or suggestions, stating that these technical 
changes will eliminate errors and inconsistencies and improve clarity 
in the regulatory text.
    Response: We agree with commenters that these technical changes 
will eliminate errors and inconsistencies and improve clarity in the 
regulatory text.
    After consideration of public comments, we are finalizing as 
proposed.
8. Comment Solicitation on Potential Future Developments to Shared 
Savings Program Policies
a. Background
    As we described in the CY 2024 PFS proposed rule (88 FR 52492), in 
an article published on the New England Journal of Medicine's website 
on April 27, 2022,\291\ CMS articulated a vision for how ACOs 
participating in the Shared Savings Program and in Innovation Center 
models can help CMS achieve its goal of having all beneficiaries in 
Original Medicare cared for by health care providers who are 
accountable for the cost and quality of care by 2030. This article 
describes a vision for the Shared Savings Program and new Innovation 
Center models to expand participation in ACOs, strengthen incentives 
for savings for participants and for Medicare, and make access to ACOs 
more equitable, including: (1) aligning features of new Innovation 
Center models and features in the Shared Savings Program; (2) adopting 
lessons from the ACO Investment Model to help provide upfront 
investments for small ACOs that lack experience with performance-based 
risk; (3) examining benchmarking approaches that could support 
increased participation, including among organizations serving patients 
with high costs of care, and addressing the effects of rebasing and 
regional benchmark adjustments; and (4) examining the use of incentives 
to recruit health care providers that care for underserved populations 
to join ACOs, with the goal of closing gaps in outcomes, and asking 
health care providers to consider beneficiaries' social needs in care 
plans.
---------------------------------------------------------------------------

    \291\ Jacobs D, Rawal P, Fowler L, Seshamani M. Expanding 
Accountable Care's Reach among Medicare Beneficiaries. NEJM.org, 
April 27, 2022, available at https://www.nejm.org/doi/full/10.1056/NEJMp2202991.
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    In the CY 2023 PFS final rule (87 FR 69777 through 69968), we 
adopted several policies to advance these goals, including providing 
advance shared savings payments in the form of AIPs to certain new, low 
revenue ACOs that they can use to build the infrastructure needed to 
succeed in the Shared Savings Program and promote equity by 
holistically addressing beneficiary needs, including social needs; 
reinstating a sliding scale reflecting an ACO's quality performance for 
use in determining shared savings for ACOs and shared losses for 
ENHANCED track ACOs; modifying the benchmarking methodology to 
strengthen financial incentives for long-term participation by reducing 
the impact of ACOs' performance and market penetration on their 
benchmarks; supporting the business case for ACOs serving high-risk and 
a high proportion of dually eligible populations to participate; 
mitigating bias in regional expenditure calculations for ACOs electing 
prospective assignment; and expanding opportunities for certain low 
revenue ACOs participating in the BASIC track to share in savings.
    In the CY 2024 PFS proposed rule (88 FR 52492), we explained that 
we have also continued to receive significant input from interested 
parties regarding opportunities to increase participation in ACO 
initiatives. One such option would be to identify ways that the Shared 
Savings Program can support ACOs' efforts to strengthen primary care, 
such as by providing prospective payments for primary care that would 
reduce reliance on FFS payments and support innovations in care 
delivery that better meet beneficiary needs and increase access to 
primary care in underserved communities. Empirical data support the 
notion that primary care serves as the foundation of high-performing 
ACOs. ACO performance results have indicated that ACOs comprised of 75 
percent or more of primary care clinicians share in savings at almost 
twice the rate of those ACOs comprised of less than 75 percent primary 
care clinicians.\292\ Another option would be to offer a higher risk 
track in the Shared Savings Program.
---------------------------------------------------------------------------

    \292\ Refer to CMS, Press Release, ``Medicare Shared Savings 
Program Saves Medicare More Than $1.6 Billion in 2021 and Continues 
to Deliver High-quality Care'' (August 30, 2022), available at--As 
of August 30, 2022, available at https://www.cms.gov/newsroom/press-releases/medicare-shared-savings-program-saves-medicare-more-16-billion-2021-and-continues-deliver-high.
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    We solicited public comments on potential future developments to 
Shared Savings Program policies (88 FR 52492 through 52497).
b. Incorporating a Higher Risk Track Than the ENHANCED Track
    As described in the CY 2024 PFS proposed rule (88 FR 52492), CMS, 
over time, has considered a higher risk Shared Savings Program track 
under which the shared savings/loss rate would be somewhere between 80 
percent and 100 percent (that is, a rate higher than that currently 
offered under the ENHANCED track) that builds on the experience of the 
Next Generation ACO (NGACO) and ACO Realizing Equity, Access, and 
Community Health (ACO REACH) Models. ``Higher risk'' sharing provides a 
higher level of potential reward which may encourage ACOs that would 
not otherwise have participated in the Shared Savings

[[Page 79224]]

Program because of current limitations on potential upside to consider 
participating. Also, a higher risk sharing model may incentivize 
participating ACOs to take on more risk (and potential reward) and 
incentivize ACOs to improve performance in the program, which may 
result in reduced healthcare costs for Medicare, and more effective, 
efficient care for beneficiaries. In addition, higher risk sharing may 
incentivize ACOs to develop new care delivery strategies, such as a 
focus on specialty care integration and reduced care fragmentation. 
Offering a higher risk sharing track may also help CMS reach our goal 
of having all beneficiaries in Original Medicare in a care relationship 
with a health care provider who is accountable for the costs and 
quality of their care by 2030 by encouraging efficient ACOs to continue 
participation in the Shared Savings Program.
    Currently, under the Shared Savings Program, ACOs may enter 
participation agreements under one of two tracks--the BASIC track or 
the ENHANCED track. The BASIC track allows eligible ACOs to begin under 
a one-sided model and incrementally transition to higher levels of risk 
and potential reward through the BASIC track's glide path. The ENHANCED 
track is a two-sided model that represents the highest level of risk 
and potential reward currently offered under the Shared Savings 
Program. The rules governing the participation options available to 
ACOs and the progression from lower to higher risk for ACOs entering 
the program are described in Sec.  425.600 of the regulations.
    Under the BASIC track, eligible ACOs operate under either a one-
sided model or a two-sided model, either sharing savings only or 
sharing both savings and losses with the Medicare program. Under the 
BASIC track's glide path, the level of risk and potential reward phases 
in over the course of an agreement period with the ACO beginning 
participation under a one-sided model and progressing to incrementally 
higher levels of risk and potential reward, unless the ACO chooses to 
begin under a two-sided model and/or progresses more quickly than the 
glide path would require.\293\ The glide path includes five levels 
(Levels A through E). Levels A and B are one-sided models (shared 
savings only); \294\ and Levels C, D, and E are two-sided models 
(shared savings and shared losses) that provide for incrementally 
higher performance-based risk.\295\ An ACO in the ENHANCED track 
operates under a two-sided model, sharing both savings and losses with 
the Medicare program, for all five performance years of the agreement 
period.
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    \293\ Refer to Sec.  425.600(a)(4)(i).
    \294\ Refer to Sec. Sec.  425.600(a)(4)(i)(A)(1), 
425.605(d)(1)(i) (Level A); Sec. Sec.  425.600(a)(4)(i)(A)(2), 
425.605(d)(1)(ii) (Level B).
    \295\ Refer to Sec. Sec.  425.600(a)(4)(i)(A)(3), 
425.605(d)(1)(iii) (Level C); Sec. Sec.  425.600(a)(4)(i)(A)(4), 
425.605(d)(1)(iv) (Level D); Sec. Sec.  425.600(a)(4)(i)(A)(5), 
425.605(d)(1)(v) (Level E).
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    To qualify for a shared savings payment, an ACO must meet a minimum 
savings rate (MSR) requirement, meet the quality performance standard 
or alternative quality performance standard established under Sec.  
425.512, and otherwise maintain its eligibility to participate in the 
Shared Savings Program under 42 CFR part 425.\296\ For ACOs meeting the 
applicable quality performance standard established under Sec.  
425.512(a)(2), (4)(i) (for PY 2022 and PY 2023), or (5)(i) (for PY 2024 
and subsequent performance years), the final shared savings rate is 
equal to the maximum sharing rate specific to the ACO's track/level of 
participation as follows: 40 percent for ACOs participating in Level A 
or Level B of the BASIC track; \297\ 50 percent for ACOs participating 
in Levels C, D, or E of the BASIC track; \298\ and 75 percent for ACOs 
participating in the ENHANCED track.\299\ Beginning in PY 2023, ACOs 
meeting the MSR requirement that do not meet the applicable quality 
performance standard established under Sec.  425.512(a)(2), (4)(i) or 
(5)(i), as applicable, but meet the alternative quality performance 
standard described in Sec.  425.512(a)(4)(ii) (for PY 2023) or (5)(ii) 
(for PY 2024 and subsequent performance years) will have the 
opportunity to share in savings at a lower rate that is scaled by the 
ACO's quality performance. Additionally, beginning in PY 2024, certain 
ACOs participating in the BASIC track that do not meet the MSR have the 
opportunity to share in savings at a rate that is equal to half of the 
rate to which they would have otherwise been entitled had they met the 
MSR.\300\ CMS computes an ACO's shared savings payment by applying the 
final sharing rate to the ACO's savings on a first dollar basis 
(meaning the final sharing rate is applied to the ACO's full total 
savings amount), with the payment subject to a cap that is equal to 10 
percent of the updated benchmark for an ACO in the BASIC track or 20 
percent of the updated benchmark for an ACO in the ENHANCED track.\301\
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    \296\ Refer to Sec. Sec.  425.100(b), 425.604(c), 425.605(c), 
425.606(c), 425.610(c).
    \297\ Refer to Sec.  425.605(d)(1)(i)(A), (d)(1)(ii)(A).
    \298\ Refer to Sec.  425.605(d)(1)(iii)(A), (d)(1)(iv)(A), 
(d)(1)(v)(A).
    \299\ Refer to Sec.  425.610(d).
    \300\ Refer to Sec.  425.605(h).
    \301\ Refer to Sec.  425.605(d); Sec.  425.610(e).
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    ACOs that operate under a two-sided model and have losses that meet 
or exceed a minimum loss rate (MLR) must share losses with the Medicare 
program.\302\ Once this MLR is met or exceeded, the ACO will share in 
losses at a rate determined according to the ACO's track/level of 
participation, up to a loss recoupment limit (also referred to as the 
loss sharing limit).\303\ In determining shared losses, ACOs 
participating in Level C, D, or E of the BASIC track are subject to a 
fixed shared loss rate (also referred to as the loss sharing rate) of 
30 percent.\304\ ENHANCED track ACOs are subject to a loss rate that is 
scaled by the ACO's quality performance, subject to a minimum of 40 
percent and a maximum of 75 percent.\305\
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    \302\ Refer to Sec.  425.100(c).
    \303\ Refer to Sec.  425.605(d); Sec.  425.610(f), (g).
    \304\ Refer to Sec.  425.605(d)(1)(iii)(C), (d)(1)(iv)(C), 
(d)(1)(v)(C).
    \305\ Refer to Sec.  425.610(f).
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    For agreement periods beginning before January 1, 2024, certain 
ACOs were only allowed to enter the program in the ENHANCED track, and 
ACOs entering the program in the BASIC track were limited in how many 
agreement periods they could participate in the BASIC track before 
being required to transition to the ENHANCED track. Based on changes 
finalized in the CY 2023 PFS final rule (87 FR 69818 through 69821), 
for agreement periods starting on January 1, 2024, and in subsequent 
years, participation in the ENHANCED track will be optional.
    In the NGACO Model, NGACOs were offered the choice between two risk 
arrangements, partial risk or full risk. Under both arrangements, the 
NGACO was responsible for 100 percent of performance year expenditures, 
for services rendered to the NGACO's aligned beneficiaries.\306\ Under 
the

[[Page 79225]]

partial risk arrangement, the NGACO could receive or owe up to 80 
percent of savings/losses, whereas under the full risk arrangement, the 
NGACO could receive or owe up to 100 percent of savings/losses. To 
mitigate the ACO's risk of large shared losses, as well as to protect 
the Medicare Trust Funds against paying out excessive shared savings, 
NGACOs were required to choose a cap on gross savings/losses. The cap, 
expressed as a percentage of the benchmark, ranged from 5 percent to 15 
percent. The risk arrangement chosen by the NGACO (80 or 100 percent) 
was applied to gross savings or losses after the application of the 
cap. In PYs 1-3, a discount was applied to the NGACO's benchmark that 
was set at a standard 3 percent, with various adjustments, that allowed 
the final discount to vary from 0.5 percent to 4.5 percent. In PYs 4-6, 
a discount of 0.5 percent was applied to the benchmark under the 
partial risk arrangement, and a discount of 1.25 was applied to the 
benchmark under the full risk arrangement. The purpose of the discount 
was to ensure that CMS received a financial benefit from any savings 
achieved by the NGACOs participating in the model.
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    \306\ In 2020, due to the impacts of the COVID-19 pandemic, 
NGACOs were offered an optional amendment to the Participation 
Agreement (PA) for 2020 (PY5). For NGACOs that signed the amendment, 
CMS removed all beneficiary experience associated with COVID-19 
related admissions and retrospectively updated the prospective trend 
with a regional observed trend. For 2021, CMS modified the NGACO 
financial methodology to provide financial protection to all NGACOs 
continuing in the model for PY6. PY6 financial protections included: 
adoption of an extreme and uncontrollable circumstances policy, 
under which any shared losses were prorated based on the number of 
months during the PHE and the number of beneficiaries residing in an 
impacted area, and all expenses associated with COVID-19 related 
admissions were removed from both PY expenditures and retrospective 
trend.
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    Under the ACO REACH Model, REACH ACOs are offered the choice of 
participating under the Global or the Professional Risk Sharing 
Options. As in the NGACO Model, under both risk sharing options, the 
REACH ACO is responsible for 100 percent of performance year 
expenditures for services rendered to aligned beneficiaries. Because 
ACOs electing the Global Risk Sharing Option retain up to 100 percent 
of the savings/losses, a discount is applied to the benchmark to ensure 
savings are also generated for CMS. Consequently, for ACOs in the 
Global Risk Sharing Option, the benchmark is reduced by a fixed 
percentage based on the performance year.\307\ The benchmark for ACOs 
participating in the Professional Risk Sharing Option does not include 
this discount, and these ACOs are only eligible to retain 50 percent of 
savings or owe 50 percent of any losses.
---------------------------------------------------------------------------

    \307\ For more details, refer to CMS, ACO Realizing Equity, 
Access, and Community Health (REACH) Model, PY2023 Financial 
Settlement Overview, available at https://innovation.cms.gov/media/document/aco-reach-py2023-fncl-settlement (see Table 4: Schedule of 
Discounts by Risk Arrangement).
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    As we explained in the CY 2024 PFS proposed rule (see 88 FR 52493 
through 52494), when considering including a higher risk track in the 
Shared Savings Program, we must balance several factors to protect 
beneficiaries, ACOs, and the Medicare Trust Funds. One factor to 
consider is that there may be selective participation with regard to 
which ACOs would choose to participate in a higher risk track, if 
offered. For example, Shared Savings Program ACOs that have a history 
of high levels of shared savings or have received a favorable high 
regional adjustment to their benchmark may be more likely than other 
ACOs to switch to the higher risk track upon renewing or early renewing 
their participation in the program so they can receive additional 
benefit from the higher levels of potential reward offered in a higher 
risk track. Section 1899(i)(3) of the Act grants the Secretary the 
authority to use other payment models, if the Secretary determines that 
doing so would improve the quality and efficiency of items and services 
furnished under Medicare, and the alternative methodology would result 
in program expenditures equal to or lower than those that would result 
under the statutory payment model under section 1899(d) of the Act. In 
the proposed rule, we expressed concerns that introducing a higher risk 
track would lead to only select ACOs participating, creating benefits 
limited almost entirely to those ACOs and limited to no benefits for 
beneficiaries or CMS.
    Another consideration we explained in the proposed rule is that 
ACOs in a higher risk track could have an increased incentive (relative 
to existing Shared Savings Program risk models) to avoid high-cost 
beneficiaries in the performance year in order to maximize their 
potential shared savings payment or avoid or reduce potential shared 
losses. The Shared Savings Program truncates individual beneficiary 
expenditures at the 99th percentile of national Medicare FFS 
expenditures by enrollment type, which can help to protect ACOs from 
the impact of expenditure outliers (that is, to prevent a small number 
of extremely costly beneficiaries from significantly affecting the 
ACO's per capita expenditures) and reduce the incentive for ACOs to 
avoid high-cost beneficiaries. As described earlier in this section of 
this final rule, the Shared Savings Program also caps the amount of 
shared savings an ACO may receive or the amount of shared losses it may 
owe, which can further discourage beneficiary selection. If introducing 
a higher risk track to the program, we would need to consider whether 
the program's existing approach to expenditure truncation and capping 
shared savings and shared losses would be sufficient in curbing 
incentives for ACOs to engage in beneficiary selection in light of the 
higher potential risk and reward, while ensuring that the new risk 
model will still be attractive to ACOs and improve the quality and 
efficiency of the care their assigned beneficiaries receive.
    When considering a higher risk track, we would need to balance the 
incentives for ACOs to transition to higher levels of risk and 
potential reward only when they are very confident it is in their 
financial interest to do so, with the benefits of increasing ACO 
participation in the Shared Savings Program and in two-sided 
accountable care tracks, all while ensuring sufficient financial 
safeguards against inappropriately large shared losses for ACOs 
coordinating and improving quality of care for high-cost beneficiaries.
    In the proposed rule (88 FR 52492 through 52494), we sought comment 
on the following: (1) policies/model design elements that could be 
implemented so that a higher risk track could be offered without 
increasing program expenditures; (2) ways to protect ACOs serving high-
risk beneficiaries from expenditure outliers and reduce incentives for 
ACOs to avoid high-risk beneficiaries; and (3) the impact that higher 
sharing rates could have on care delivery redesign, specialty 
integration, and ACO investment in health care providers and practices.
    The following is a summary of the public comments we received in 
response to the comment solicitation on incorporating a higher risk 
track than the ENHANCED track and our response:
    Comment: Many commenters supported a higher risk track option in 
the Shared Savings Program. Commenters offered a variety of reasons for 
their support of a higher risk track, including that it would encourage 
more participation in the Shared Savings Program, bring more 
beneficiaries into an accountable care arrangement, improve care 
delivery, and could serve as a track for ACO REACH Model participants 
to transition into the Shared Savings Program, if the track is designed 
somewhat similarly to ACO REACH Model (for example, by offering options 
regarding the shared savings rate, options for waivers, and an option 
for paper-based voluntary alignment), after the ACO REACH Model expires 
at the end of 2026. Some commenters suggested that if CMS adopted 
certain design features, such as waivers to permit a home visit program 
and a tool that allows providers to receive advance payment for non-
primary care services, those design features could lead ACOs to 
generate more savings and spur innovation. Multiple commenters 
requested that the higher risk track be

[[Page 79226]]

optional. Several commenters requested that CMS use lessons learned 
from the NGACO Model and the ACO REACH Model when designing a higher 
risk track, specifically lessons relating to benefit enhancements and 
beneficiary engagement incentives, such as the post-discharge home 
visit waiver, care management home visit waiver, tailored Part B cost 
sharing support, SNF 3-day waiver, and telehealth waiver. One commenter 
recommended the higher risk track be offered within the Shared Savings 
Program, as opposed to being within a new ACO model offered by the 
Innovation Center.
    Many commenters provided input on financial model design elements 
for a higher risk track. One key design element discussed was the 
shared savings/shared losses rate. Several commenters supported a full 
risk model; that is, a model with a 100 percent shared savings/shared 
losses rate. Many of these commenters paired their support for a full 
risk model with other financial model design elements such as risk 
corridors, stop-loss insurance, caps on shared savings and shared 
losses, or discounts to the benchmark. Several commenters suggested 
that CMS should offer a choice between a full-risk model with a 
discount, or a shared savings rate of 85 or 90 percent, with some of 
these commenters specifically citing the ACO REACH Model and NGACO 
Model as precedent for these arrangements.
    A couple of commenters requested design elements that would result 
in asymmetrical upside versus downside financial risk. One commenter 
suggested a shared savings rate of at least 85 percent, with a cap on 
gross shared savings not to exceed 20 percent of the ACO's updated 
benchmark, along with a shared loss rate that is between 55 percent and 
75 percent, with a cap on gross shared losses not to exceed 15 percent 
of the ACO's updated benchmark. Another commenter suggested that CMS 
offer an asymmetric shared savings rate and shared loss rate, where the 
rates would start off as symmetrical but would be ``offset. . .in 
opposite directions based on an ACO's proportion of underserved 
beneficiaries,'' and explained their belief that this option could 
offer a higher shared savings rate while safeguarding ACOs from 
inappropriately large shared losses. As another option, the commenter 
suggested CMS explore an ``asymmetric MSR/MLR option, where the offset 
factor is based on the ACO's proportion of underserved beneficiaries,'' 
and explained their belief that such an option would protect ACOs with 
high proportion of underserved beneficiaries from being accountable for 
unforeseen losses, while increasing the likelihood of becoming eligible 
to share in savings.
    Multiple comments included input on the level of any discount to 
benchmark. A couple of commenters recommended the discount be capped at 
50 percent of the average shared savings rate among all ACOs 
participating in the Shared Savings Program. Several commenters 
expressed concerns that the level of the discount may end up being set 
too high for them to want to participate. One commenter stated that a 
discount of 3 percent would be a dealbreaker for many ACOs. Another 
commenter recommended that the discount be no more than 2 percent. A 
couple of commenters expressed concern that in the ACO REACH Model, 
ACOs had average net savings of less than 1 percent after the discount 
was incorporated. Several commenters stated that, for a full risk model 
with a 3 percent discount, they would need to generate savings of at 
least 12 percent to earn more than they would earn in the ENHANCED 
track.
    A few commenters recommended changing the benchmarking methodology 
for a higher-risk track. Suggestions included using regional-based 
benchmarks, using a fully administratively-set benchmark, removing the 
cap on regional adjustments, and applying an offset factor creating 
asymmetry between the MSR and MLR for an ACO based on its proportion of 
underserved beneficiaries. Some of these commenters stated that a track 
with higher risk should have more innovative benchmarking policies, and 
others stated that benchmark setting should reward risk-taking by ACOs 
whose assigned beneficiaries include high-needs populations.
    Many commenters recommended that providers participating in the 
higher risk track be paid using a payment methodology other than 
Medicare FFS payment, including ``prospective payments for primary 
care,'' ``prospective payments,'' primary care or total cost of care 
``capitation payments,'' ``population-based payments,'' payments for 
``team-based care,'' ``advanced payment option,'' ``bundled payments,'' 
and a ``hybrid payment option that includes primary care capitation.'' 
Some commenters suggested that payments under these alternative payment 
methods should be available as of January 1, 2025, so that primary care 
practices do not feel compelled to leave ACOs for the sole purpose of 
accessing prospective primary care payments in the Making Care Primary 
model. One commenter stated that a total cost of care capitation option 
would support ACOs interested in better engaging specialists through 
mechanisms such as shadow bundles.\308\ One commenter requested that 
flexibility be offered in selecting the level of capitation, including 
the selection of the specific services subject to capitation. The 
commenter stated that this flexibility would allow more small, 
independent, and new entrant practices to participate in a new higher 
risk track. A few commenters suggested that an alternative payment 
method be treated like any other Medicare Part B expenditure for 
purposes of benchmark and shared savings calculations.
---------------------------------------------------------------------------

    \308\ Shadow bundles are data that provide information on 
specialists' care patterns and clinical episodes of care. They are 
developed using existing assignment and claims data, and they assign 
services and associated payments to clinical episodes and provide 
additional information on procedural or condition-specific care.
---------------------------------------------------------------------------

    Commenters had differing views as to whether the new payments under 
a higher risk track should be made to ACOs or directly to providers and 
suppliers. A couple of commenters suggested that the ACO should have a 
choice of whether CMS makes prospective payments to the ACO or directly 
to the primary care practices, stating that ``ACOs composed of 
independent practices who have joined together to participate in the 
Shared Savings Program typically need to share services through the 
ACO'' and, in these cases, ``paying the prospective payment directly to 
the ACO makes the most sense.'' A few commenters suggested there be 
``safeguards to ensure investments,'' which we understand to mean 
prospective payments, reach primary care practices. One commenter 
stated that prospective payments to physicians are important so that 
physicians have the resources they need to proactively manage patients' 
care. Several commenters suggested that we establish clear guidelines 
for what portion of a capitated payment an ACO itself may retain, 
rather than share with its ACO participants. Commenters also requested 
that we ``require ACOs receiving capitated payments to help 
participating practices build the capacity to independently receive and 
effectively use prospective payments to support the provision of 
comprehensive primary care.'' One commenter mentioned that ACOs have 
varying organizational structures which will require CMS to take a very 
thoughtful approach to ensure payments intended to support primary 
care, including capitated or per patient per month payments, reach the 
primary care practices where physicians and care teams are delivering 
the care. Another

[[Page 79227]]

commenter preferred an approach under which CMS would make capitated 
payments directly to primary care practices, but also stated that 
another option would be to make capitated payments to ACOs with 
stipulations that establish the maximum level of retention of those 
payments by ACOs and to establish a strong audit mechanism and 
financial penalties for non-compliance.
    Several commenters provided input on the amount of payments for 
primary care services under a higher risk track. Some of these 
commenters requested that the ACO receive prospective primary care 
payments in an amount greater than Medicare's historical payments to 
the ACO's primary care providers to provide funds for innovative care 
delivery strategies. Another commenter suggested that monthly primary 
care capitation payments be set equal to 100 percent of an ACO's 
historical primary care spending, stating that this would provide 
important cash flow opportunities for ACOs looking to make proactive 
investments in primary care capacity to better manage patient care. One 
of the commenters requested CMS provide ACOs with the ability to 
gradually increase to higher levels of capitation payments, like 
Comprehensive Primary Care Plus Track 2.
    Many commenters suggested ways to protect ACOs serving high-risk 
beneficiaries from expenditure outliers and reduce incentives for ACOs 
to avoid high-risk beneficiaries. Several commenters suggested that CMS 
incorporate risk corridors or risk adjustment to account for treatment 
of complex and high-cost beneficiaries. A few commenters encouraged CMS 
to evaluate the applicability of some of the safeguards and policies in 
place under the ACO REACH Model that aim to reduce the potential for 
cherry-picking of beneficiaries, mitigate the potential of ``bad 
actors,'' and ensure appropriate resources for higher cost 
beneficiaries. A few commenters stated that there are already 
sufficient protections in place because there are several policies in 
place to identify and mitigate practices related to avoiding higher 
risk beneficiaries.
    Response: We appreciate the feedback we received in response to 
this comment solicitation. We will consider this information to inform 
future rulemaking.
c. Increasing the Amount of the Prior Savings Adjustment
    Under section 1899(d)(1)(B)(ii) of the Act, an ACO's benchmark must 
be reset at the start of each agreement period using the most recent 
available 3 years of expenditures for Parts A and B services for 
beneficiaries assigned to the ACO. Section 1899(d)(1)(B)(ii) of the Act 
provides the Secretary with discretion to adjust the historical 
benchmark by ``such other factors as the Secretary determines 
appropriate.'' Under this authority, as described in the CY 2023 PFS 
final rule (87 FR 69898 through 69915), we established a prior savings 
adjustment that will apply when establishing the benchmark for eligible 
ACOs entering an agreement period beginning on January 1, 2024, or in 
subsequent years, to account for the average per capita amount of 
savings generated during the ACO's prior agreement period.
    The prior savings adjustment adopted in the CY 2023 PFS final rule 
is designed to adjust an ACO's benchmark to account for the average per 
capita amount of savings generated by the ACO across the 3 performance 
years prior to the start of its current agreement period for re-
entering and renewing ACOs. In the final rule, we explained that 
reinstituting a prior savings adjustment would be broadly in line with 
our interest in addressing dynamics to ensure sustainability of the 
benchmarking methodology. Specifically, such an adjustment would help 
to mitigate the rebasing ratchet effect on an ACO's benchmark by 
returning to an ACO's benchmark an amount that reflects its success in 
lowering growth in expenditures while meeting the program's quality 
performance standard in the performance years corresponding to the 
benchmark years for the ACO's new agreement period. We also explained 
our belief that a prior savings adjustment could help address an ACO's 
effects on expenditures in its regional service area that result in 
reducing the regional adjustment added to the historical benchmark.
    In the CY 2023 PFS final rule (87 FR 69899), we explained that, in 
order to mitigate the potential for rebased benchmarks for ACOs that 
are lower-spending compared with their regional service area and that 
achieved savings in the benchmark period to become overinflated, we 
believed that adjusting an ACO's benchmark based on the higher of 
either the prior savings adjustment or the ACO's positive regional 
adjustment would be appropriate. In the CY 2024 PFS proposed rule, we 
also noted that we proposed to further mitigate the impacts of the 
negative regional adjustment when the overall adjustment to an ACO's 
historical benchmark is negative; however, the negative regional 
adjustments by enrollment type would continue to be factored in when 
the overall regional adjustment is positive. (Refer to 88 FR 52494, and 
88 FR 52465 through 52472.)
    In the CY 2023 PFS final rule (87 FR 69914 through 69915), we 
finalized a policy to apply a 50 percent scaling factor to the pro-
rated positive average per capita prior savings, because we believed it 
would be important to consider a measure of the sharing rate used in 
determining the shared savings payment the ACO earned in the applicable 
performance years under its prior agreement period(s). In response to 
discussion of this policy in the CY 2023 PFS proposed rule (87 FR 
69910), ACOs and other interested parties commented that we should 
consider using a higher scaling factor that may more closely match the 
maximum shared savings rate from an ACO's prior agreement period. 
However, in the CY 2023 PFS final rule, we reiterated our belief that a 
50 percent scaling factor would be appropriate because it represents a 
middle ground between the maximum sharing rate of 75 percent under the 
ENHANCED track and the lower sharing rates available under the BASIC 
track (for example, 40 percent). Additionally, we noted that if we were 
to finalize a scaling factor that would more closely match the average 
shared savings rate from an ACO's prior agreement period, many ACOs 
would have a scaling factor below 50 percent, which would be less 
advantageous than the policy that we finalized (see 87 FR 69910 through 
69911).
    In the CY 2023 PFS final rule (see 87 FR 69902), we also finalized 
a policy to calculate the final adjustment to the benchmark by adding 
the pro-rated average per capita prior savings to the ACO's negative 
regional adjustment for ACOs that are higher spending relative to their 
regional service area. Under this policy, we apply the 50 percent 
scaling factor after offsetting the negative regional adjustment to 
maximize the portion of the pro-rated average per capita savings that 
would be added to the negative regional adjustment in determining the 
final adjustment to the benchmark and strengthen incentives for ACOs to 
remain in the program.
    MedPAC commented on the CY 2023 PFS proposed rule that while the 
prior savings adjustment is a reasonable policy for mitigating 
ratcheting effects, implementing both the prior savings adjustment and 
the regional adjustment policies together would be duplicative. MedPAC 
also expressed concern that the prior savings adjustment and the 
regional adjustment could interact in a way that would perpetuate a

[[Page 79228]]

programmatic bias towards ACOs receiving a positive regional 
adjustment. In MedPAC's view, many ACOs would receive an inflated prior 
savings adjustment because the prior savings adjustment would be based 
on savings achieved using benchmarks already inflated by the regional 
adjustment. However, we explained in the CY 2023 PFS final rule (87 FR 
69913) that because for most ACOs, the positive regional adjustment 
would exceed the prior savings adjustment, our policy of applying the 
larger of the regional adjustment and the prior savings adjustment 
potentially mitigates this concern.
    In the CY 2024 PFS proposed rule (88 FR 52494 through 52495), we 
solicited comments on potential changes to the 50 percent scaling 
factor used in determining the prior savings adjustment. such as using 
an average of the ACO's shared savings rates from the 3 years prior to 
the start of its agreement period, increasing to 75 percent of shared 
savings achieved if the ACO participated in the ENHANCED track in the 3 
years prior to the start of the agreement period, or another value 
corresponding to the maximum shared savings rate the ACO was eligible 
to earn in the 3 years prior to the start of the agreement period. We 
also solicited comments on potential changes to the positive regional 
adjustment to reduce the possibility of inflating the benchmark, while 
still mitigating potential ratchet effects on ACO benchmarks.
    The following is a summary of the public comments we received in 
response to the comment solicitation on increasing the amount of the 
prior savings adjustment and our response:
    Comment: In response to the RFI regarding implementing changes to 
the prior savings adjustment and related changes to the positive 
regional adjustment to mitigate potential ratchet effects on ACOs' 
benchmarks, the majority of comments were supportive of increasing the 
prior savings adjustment in at least one of the ways described in the 
proposed rule, with several commenters specifically recommending using 
the maximum shared savings rate the ACO was eligible to receive during 
the benchmark years. We also received several comments regarding 
potential changes to the positive regional adjustment to reduce the 
possibility of inflating ACOs' benchmarks, while still mitigating 
potential ratchet effects on those benchmarks. Of those, most 
commenters favored increasing the cap on the positive regional 
adjustment to provide an additional incentive to ACOs that are already 
efficient relative to their region. One commenter noted that 
beneficiaries assigned based on primary care services furnished by 
specialists tend to have higher costs and suggested adjusting the cap 
on the positive regional adjustment based on the share of the ACO's 
assigned beneficiary population that is assigned based on step 2 of the 
step-wise beneficiary assignment methodology. One commenter recommended 
capping the positive regional adjustment using risk adjusted regional 
per-capita FFS expenditures in BY3 instead of national per-capita FFS 
expenditures, and also suggested incorporating an offset factor for the 
regional adjustment for ACOs that serve an unusually high proportion of 
underserved beneficiaries relative to other ACOs in their region.
    Two commenters, including MedPAC, were opposed to increasing the 
amount of the prior savings adjustment to align with the higher shared 
savings rate available under the ENHANCED track. MedPAC noted that 
using the sharing rate available under the ENHANCED track to increase 
the scaling factor of the prior savings adjustment would exacerbate the 
inflation of benchmarks due to the regional adjustment. As an 
alternative, MedPAC suggested that the prior savings adjustment should 
serve as a mechanism for phasing out the regional adjustment entirely. 
MedPAC also suggested that the prior savings adjustment could be scaled 
based on an ACO's own efficiency within its region, which would 
mitigate both the ratchet effect and benchmark inflation because the 
regional adjustment would be removed both from performance year 
benchmarks and the prior savings adjustment. Another commenter opined 
that the current 50 percent scaling factor is appropriate because it 
aligns with the weight used to determine positive regional adjustments 
for ACOs receiving a regional adjustment for their second or subsequent 
agreement periods.
    Several commenters recommended increasing the cap on the prior 
savings adjustment beyond 5 percent of national per-capita FFS 
expenditures. Several also recommended risk adjusting the capped amount 
to reflect differences in the health status of ACOs' beneficiary 
populations. A number of commenters also recommended allowing ACOs to 
receive the greater of the 50 percent factor and 5 percent of national 
per-capita FFS expenditures, and one commenter suggested allowing ACOs 
to retain 75 percent of the average savings achieved by the ACO over 
the three benchmark years. One commenter was opposed to increasing the 
5 percent cap, suggesting instead that the cap be based on a weighted 
average of national and risk-adjusted regional per-capita FFS 
expenditures as described in Sec.  425.652(a)(5)(iv).
    A few commenters recommended implementing a quartile-based 
benchmark system similar to Medicare Advantage, adjusting benchmarks 
relative to regional spending. Additionally, a few commenters suggested 
that ACOs transitioning from total cost of care models such as the ACO 
REACH Model be eligible for a prior savings adjustment based on savings 
achieved under those models. One commenter also suggested calculating 
the prior savings adjustment at the TIN level instead of the ACO level.
    Response: We appreciate the feedback we received in response to 
this comment solicitation. We will consider this information to inform 
future rulemaking.
d. Expanding the ACPT Over Time and Addressing Overall Market-wide 
Ratchet Effects
    As described in the December 2018 final rule (83 FR 68024 through 
68030), we used our statutory authority under section 1899(i)(3) of the 
Act to adopt the policy under which we update the historical benchmark 
using a blend of national and regional growth rates. In accordance with 
Sec.  [thinsp]425.601(b), for agreement periods beginning on July 1, 
2019, and before January 1, 2024, we update the historical benchmark 
for an ACO for each performance year using a blend of national and 
regional growth rates between BY3 and the performance year.
    In the CY 2023 PFS final rule (87 FR 69881 through 69898), we 
finalized a policy for agreement periods beginning on January 1, 2024, 
and in subsequent years, to incorporate a prospectively projected 
administrative growth factor, a variant of the United States Per Capita 
Cost (USPCC) that we refer to as the Accountable Care Prospective Trend 
(ACPT), into a ``three-way'' blend with national and regional growth 
rates to update an ACO's historical benchmark for each performance year 
in the ACO's agreement period. The three-way blend is calculated as the 
weighted average of the ACPT (one-third weight) and the existing 
national-regional ``two-way'' blend (two-thirds weight). The ACPT will 
be projected for an ACO's entire agreement period near the start of 
that agreement period, providing a degree of certainty to ACOs.
    We explained in the CY 2023 PFS final rule that the ACPT will 
insulate a portion of the annual benchmark update from any savings 
occurring as a result of

[[Page 79229]]

the actions of ACOs participating in the Shared Savings Program and 
address the impact of increasing market penetration by ACOs in a 
regional service area on the existing blended national-regional growth 
factor. Because the ACPT is prospectively set at the outset of an 
agreement period, any savings generated by ACOs during the agreement 
period would not be reflected in the ACPT component of the three-way 
blend. Accordingly, the incorporation of the ACPT may allow benchmarks 
to increase beyond actual spending growth rates as ACOs slow spending 
growth. By limiting ACOs' ability to slow spending growth for purposes 
of their own benchmarks, we noted that we believed the use of this 
three-way blend to update ACOs' benchmarks would incentivize greater 
savings by ACOs and greater program participation. Additionally, 
because incorporating the ACPT into the update would reduce the degree 
to which an ACO's savings negatively impact its benchmark through the 
regional trend component of the update, we also stated our belief that 
this change to the update methodology would help to address concerns 
raised by ACOs and other interested parties regarding the 
disproportionate impact of an ACO's savings on the benchmark update for 
ACOs with high market share.
    In the CY 2023 PFS final rule, we noted that it was possible that 
incorporating the ACPT into a three-way blended update factor would 
have the potential for mixed effects. For example, it might also lower 
an ACO's benchmark relative to the two-way blend if external factors 
lead to higher program spending growth than originally projected at the 
start of an ACO's agreement period. Consequently, we finalized that if 
an ACO generates losses for a performance year that meet or exceed its 
MLR (for two-sided model ACOs) or negative MSR (for one-sided model 
ACOs) under the three-way blend, we would recalculate the ACO's updated 
benchmark using the two-way blend and the ACO would receive whichever 
benchmark update minimizes shared losses. However, the ACO would not be 
eligible to share in savings resulting from use of the two-way blend in 
updating the benchmark. We also finalized that if unforeseen 
circumstances such as an economic recession, pandemic, or other factors 
cause actual expenditure trends to significantly deviate from 
projections, we would retain discretion to decrease the weight applied 
to the ACPT in the three-way blend.
    In their comments on the proposal to adopt the three-way blend in 
the CY 2023 PFS proposed rule (see 87 FR 69890), ACOs and other 
interested parties expressed concern that the three-way blend 
effectively increases the proportion of the benchmark update that is 
based upon national trends, as opposed to regional trends, noting that 
the blend may not adequately account for geographic variation in 
spending growth that is outside of an ACO's control. Over a 5-year 
agreement period, we recognize some ACOs may be disadvantaged or 
advantaged in the short term by benchmark updates that give greater 
weight to a national update factor. However, as we stated in the CY 
2023 PFS final rule (87 FR 69891), we expect that the net impact of 
these deviations will be modest in the context of offsetting 
considerations. For example, the three-way blend only incorporates the 
ACPT at a one-third weight and maintains the current two-way blend for 
the majority weight of the benchmark trend calculation, allowing for a 
significant proportion of the benchmark update to reflect expenditure 
growth in an ACO's regional service area. The ACPT itself is also 
expected to project spending above realized spending as ACOs generate 
savings, thereby providing a stable, predictable component of the 
update factor that will be beneficial for ACOs.
    Interested parties who commented on the proposal in the CY 2023 PFS 
proposed rule to incorporate the ACPT as part of a three-way blend 
suggested modifications to the three-way blend to further mitigate 
potential ratchet effects and to better reflect regional variation in 
spending. These included modifications such as: (1) keeping a two-way 
national-regional blend and substituting the national component of the 
two-way blend with the ACPT (see 87 FR 69890); and (2) adjusting the 
weight of the ACPT in the three-way blend to reflect each ACO's market 
penetration, as is done with the national component of the two-way 
blend (see 87 FR 69893). We declined to implement these suggestions in 
the CY 2023 PFS final rule.
    In the CY 2024 PFS proposed rule (88 FR 52495 through 52496), we 
sought comment on the following potential refinements to the ACPT and 
the three-way blended benchmark update factor as CMS works toward broad 
implementation of administrative benchmarks: (1) replacing the national 
component of the two-way blend with the ACPT; and (2) scaling the 
weight given to the ACPT in a two-way blend for each ACO based on the 
collective market share of multiple ACOs within the ACO's regional 
service area.
    The following is a summary of the public comments we received in 
response to the comment solicitation on expanding the ACPT over time 
and addressing overall market-wide ratchet effects, and our response:
    Comment: Many commenters supported replacing the national component 
of the two-way blend with the ACPT over use of the three-way blend 
finalized in the PY 2023 PFS final rule. MedPAC also supported the 
concept of scaling the weight given to the ACPT in a two-way blend for 
each ACO based on the collective market share of multiple ACOs within 
the ACO's regional service area. However, MedPAC also expressed a 
preference for phasing out the regional component of the update factor 
in favor of an administrative growth factor. Another commenter also 
supported scaling the weight of the ACPT in a blended update factor 
based on each ACO's market share, but only above a minimum threshold 
for market share.
    Several commenters were opposed to moving to a two-way blended 
update factor with the ACPT replacing the national component of the 
current two-way blend and favored keeping the three-way blend as 
finalized in the CY 2023 PFS final rule. Recommendations from these 
commenters included: (a) focusing on the longer-term goal of moving to 
an administrative benchmark; (b) providing additional details on how 
the three-way blend will be operationalized before making any changes; 
and (c) evaluating the impact of the three-way blend before making 
changes. A few commenters were also opposed to scaling the weight given 
to the ACPT in a two-way blend for each ACO based on the collective 
market share of multiple ACOs within the ACO's regional service area.
    Several commenters recommended that CMS remove an ACO's assigned 
beneficiaries from the assignable population for the region when 
calculating the update factor (the commenter did not specify if they 
were referencing the two-way or three-way blended update factor). Most 
of these commenters were also supportive of substituting the ACPT for 
the national component of the two-way blend, but commenters varied on 
whether removing assigned beneficiaries from the assignable population 
should be done in conjunction with, or as an alternative to, that 
approach.
    Several commenters favored calculating a two-way blended and three-
way blended update factor for each ACO and using the more advantageous 
factor when updating the benchmark in each performance year.

[[Page 79230]]

Some of these commenters favored using the national and regional two-
way blend, while others preferred an updated two-way blend including 
the ACPT in place of the national component.
    A number of commenters were concerned that the 5-year projection 
used in the ACPT, as finalized in the CY 2023 PFS final rule, would 
potentially be less accurate in later years of an ACO's agreement 
period and recommended only projecting the ACPT out for 3 years instead 
of 5. A few commenters also expressed general support for a longer-term 
move toward administrative benchmarks to address the ratchet effect 
experienced by renewing ACOs.
    Response: We appreciate the feedback we received in response to 
this comment solicitation. We will consider this information to inform 
future rulemaking.
e. Promoting ACO and CBO Collaboration
    Section 1899(b)(2)(G) of the Act requires an ACO participating in 
the Shared Savings Program to define processes to promote evidence-
based medicine and patient engagement, report on quality and cost 
measures, and coordinate care, such as through the use of telehealth, 
remote patient monitoring, and other enabling technologies. In the 
November 2011 final rule (76 FR 67827), we finalized policies to 
require that a participating Shared Savings Program ACO provide 
documentation in its application describing its plans to: (1) promote 
evidence-based medicine; (2) promote beneficiary engagement; (3) report 
internally on quality and cost metrics; and (4) coordinate care. We 
emphasized our belief that ACOs should retain the flexibility to 
establish processes that are best suited to their practice and patient 
population. As part of these required processes, we explained that ACOs 
should adopt a focus on patient-centeredness, which could include such 
activities as: a process for evaluating the needs of the ACO's 
population, including consideration of diversity in its patient 
populations, and a plan to address the needs of this population, 
including how the ACO intends to partner with other interested parties 
in the community to improve the health of its population; a plan to 
engage in shared decision-making with beneficiaries; and a plan to 
implement individualized care plans, including taking into account the 
community resources available to the individual beneficiary.
    When establishing these required processes and patient centeredness 
criteria in the November 2011 final rule (76 FR 67826), we stated that 
as we learn more about successful strategies in these areas, and as we 
gain more experience assessing specific critical elements for success, 
the Shared Savings Program eligibility requirements under section 
1899(b)(2)(G) of the Act may be revised. For example, in subsequent 
rules we underscored the importance of health information technology 
development and infrastructure within care coordination. In the June 
2015 final rule (80 FR 32725), we finalized two modifications to the 
care coordination processes required of ACOs under Sec.  
[thinsp]425.112(b)(4): (1) adding a new eligibility requirement under 
Sec.  [thinsp]425.112(b)(4)(ii)(C), which required an ACO to describe 
in its application how it will encourage and promote the use of 
enabling technologies for improving care coordination for 
beneficiaries, and (2) adding a new provision at Sec.  
[thinsp]425.112(b)(4)(ii)(D), which required the applicant to describe 
how the ACO intends to partner with long-term and post-acute care 
providers to improve care coordination for the ACO's assigned 
beneficiaries. In the CY 2018 PFS final rule (82 FR 53222), we shifted 
from requiring an ACO to submit documents detailing how it would meet 
the requirements of Sec.  [thinsp]425.112 as a narrative in its Shared 
Savings Program application to instead requiring it to certify at the 
time of application that it has defined the required processes and 
patient centeredness criteria consistent with the requirements 
specified in Sec.  [thinsp]425.112 and to furnish such documentation 
upon request--thereby reducing ACO burden while maintaining CMS's 
flexibility to obtain additional documentation when necessary (see 
Sec.  [thinsp]425.204(c)(ii)).
    Additionally, in our June 2015 final rule (80 FR 32722), we 
specified that the care coordination processes under Sec.  
[thinsp]425.112 could include coordination with CBOs that provide 
services that address social determinants of health. This coordination 
could include a plan to partner with interested parties in the 
community, a plan to engage in shared decision making with 
beneficiaries, and a plan to implement individualized care plans. In 
that rulemaking (80 FR 32722 and 32723), we also confirmed our 
understanding that ACOs differ in their ability to adopt the 
appropriate health information exchange technologies, but we continued 
to underscore the importance of robust health information exchange 
tools in effective care coordination.
    In the CY 2024 PFS proposed rule (88 FR 52496 through 52497), we 
solicited comments on ways to improve and incentivize collaboration 
between ACOs and interested parties in the community or CBOs. As 
explained in the CY 2023 PFS final rule (87 FR 69790), where we refer 
to CBOs, we mean public or private not-for-profit entities that provide 
specific services to the community or targeted populations in the 
community to address the health and social needs of those populations. 
They may include community-action agencies, housing agencies, area 
agencies on aging, or other non-profits that apply for grants to 
perform social services. They may receive grants from other agencies in 
the U.S. Department of Health and Human Services, including Federal 
grants administered by the Administration for Children and Families 
(ACF), Administration for Community Living (ACL), or the Centers for 
Disease Control, or from State-funded grants to provide social 
services. Generally, we believe such organizations are trusted entities 
that know the populations they serve and their communities, want to be 
engaged, and may have the infrastructure or systems in place to help 
coordinate supportive services that address social determinants of 
health or serve as a trusted source to share information.\309\ We 
recognize that ACOs wishing to address social needs may want to make 
investments in goods or social services that would enable their ACO 
participants and ACO providers/suppliers to work with CBOs that have 
expertise in identifying and providing the types of social services 
that the ACO's beneficiary population requires.
---------------------------------------------------------------------------

    \309\ U.S. Department of Health & Human Services, Office of the 
Assistant Secretary for Preparedness and Response, Community-Based 
Organizations during COVID-19, available at https://www.phe.gov/emergency/events/COVID19/atrisk/returning-to-work/Pages/default.aspx.
---------------------------------------------------------------------------

    It is important to note that the Shared Savings Program does not 
prohibit ACOs from partnering with CBOs. Currently, if a CBO is 
enrolled in Medicare, it may already be an ACO participant or an ACO 
provider/supplier. We believe CBOs could play an important role in 
identifying and addressing gaps in health equity. As we stated in the 
CY 2023 PFS final rule, we hope to encourage more ACOs to partner with 
CBOs whether they provide items and services reimbursed by Medicare or 
not. We recognized, however, that Federal and other sources of grant 
funding for social services may be insufficient to fully address the 
demand for services within a community or broader geography. As we 
noted in that final rule, contractual arrangements between the health 
care

[[Page 79231]]

sector and CBOs providing social services have increased in recent 
years to meet this demand.
    In the CY 2024 PFS proposed rule (88 FR 52496 through 52497), we 
solicited comments on approaches, generally, for encouraging or 
incentivizing increased collaboration between ACOs and CBOs, including 
any policies specifically designed to encourage ACOs to partner with 
CBOs and address unmet health-related social needs. We also solicited 
comments on potential changes CMS could make to the patient-centered 
care requirements in Sec.  [thinsp]425.112 to strengthen partnerships 
between ACOs and interested parties in the community, including CBOs, 
to address unmet health-related social needs.
    The following is a summary of the public comments we received in 
response to the comment solicitation on promoting ACO and CBO 
collaboration, and our response:
    Comment: Commenters generally supported increasing collaboration 
between ACOs and CBOs. Commenters noted that they appreciate the 
opportunity to highlight ways ACOs could increase collaboration with 
CBOs and strengthen partnerships between ACOs and interested parties in 
the community to address health equity and SDOH. Commenters stated that 
some ACOs are actively working with community partners to address SDOH 
and are working to close the loop between referrals to social services 
and follow-up interventions.
    Several commenters encouraged CMS to consider increased financial 
support to sustain ACO-CBO collaboration. The commenters stated that 
many CBOs are underfunded and lack connections to the health care 
system or the ability to share data effectively. Some commenters stated 
that they use shared savings to support partnerships with CBOs, but 
that more stable and predictable funding mechanisms that would support 
the long-term collaboration needed to improve care for beneficiaries 
may be needed. Some commenters suggested that CMS consider new and 
innovative payment methods for encouraging relationships between ACOs 
and CBOs, including advance payments to ACOs that agree to invest in 
CBO capacity to align with ACO providers to deliver targeted 
interventions to priority populations or a capitated payment 
methodology that would better support the capacity of CBOs, including 
systems and other infrastructure they can use to improve coordination 
of care.
    Commenters shared further suggestions with CMS (listed below) and 
stressed the need for non-financial support in increasing ACO-CBO 
collaborations.
     Commenters encouraged CMS to provide additional 
``technical assistance,'' as well as additional program guidance and 
resources to ACOs that they can use when establishing or expanding 
partnerships with CBOs in the community.
     Commenters encouraged CMS to conduct outreach and provide 
support to CBOs that may be interested in collaborating with ACOs.
     Commenters suggested that CMS expand payment mechanisms 
using a similar approach embedded in the Maryland Total Cost of Care 
(TCOC) Model for supporting collaboration with CBOs.
     Commenters suggested that CMS add an ACO quality measure 
to assess the percentage of the ACO population screened for health-
related social needs, and the percentage of the population that had an 
intervention delivered by a CBO.
     Commenters suggested that CMS improve SDOH data collection 
and expand and refine the use of payment methodologies that 
appropriately address the health, social, and equity goals of the 
community.
    Several commenters recommended changes to the Shared Savings 
Program's financial methodology to support ACO collaboration with CBOs. 
Specifically, they noted that increasing the financial benchmark to 
reflect assigned beneficiaries with social risk factors would provide 
resources for ACOs to develop robust community partnerships and allow 
flexibility for ACOs to provide supplemental benefits to those 
beneficiaries. Other commenters recommended that CMS leverage 
technology by providing ACOs with quality data reported via MIPS for 
purposes of identifying beneficiaries who have been screened for SDOH. 
One commenter encouraged CMS to consider a ``tiered level of ACO 
participation'' in the Shared Savings Program based on the degree to 
which the ACO collaborates with CBOs and integrates them into its 
governance structure and/or its ACO participant/ACO provider/supplier 
structure.
    In addition to the suggestions for increasing and incentivizing 
ACO-CBO collaboration as summarized above, commenters also shared a few 
potential program risks from advancing ACO-CBO collaboration. 
Commenters expressed concern regarding the capacity of CBOs to furnish 
care and shared that increasing collaboration between ACOs and CBOs 
would also increase referrals to the CBO, possibly straining the CBO's 
resources and increasing the demand on those resources. However, a few 
commenters noted that CMS could better evaluate the needs of 
communities to assist ACOs in meeting those needs. Lastly, commenters 
cautioned against any new regulations intended to increase ACO-CBO 
collaboration, noting that ACOs would benefit from the continued 
flexibility to form relationships that best meet the ACO's goals and 
the needs of the beneficiaries that they serve.
    Response: We thank commenters for their suggestions and appreciate 
the feedback we received for this solicitation. We will consider this 
information in future rulemaking.
f. Out of Scope Comments
    The following is a summary of the public comments that we received 
that went beyond the scope of the four RFIs in the CY 2024 PFS proposed 
rule (88 FR 52492 through 52497) and our response.
    Comment: A few commenters requested certain waivers of Medicare 
requirements for Shared Savings Program ACOs. One commenter requested 
that CMS allow wider use of telehealth by allowing all Shared Savings 
Program ACOs access to telehealth waivers, and expand what telehealth 
waivers cover (for example, to include patient cost-sharing, 
modalities, and covered services). Another commenter asked CMS to 
``waive the initiating face-to-face relationship requirement for the 
proposed and existing care management codes for partner organizations 
that have been designated by an ACO that accepts downside risk.'' This 
commenter also requested that ACOs be able to waive beneficiary co-pays 
and cost sharing requirements. One commenter requested that CMS change 
the ``eligibility requirements for beneficiaries for the Skilled 
Nursing Facility (SNF) 3-Day Rule Waiver which currently precludes the 
beneficiary from residing in a SNF or other long term care setting.'' 
Another commenter encouraged CMS to allow SNFs to be added to the ACO's 
SNF Affiliate List on a quarterly basis as well as ``reconsider the 
timing and star rating criteria so SNFs have an opportunity to 
correct'' their processes following an ``incident'' that reduced their 
star rating to ensure that the SNF would have an opportunity to attain 
their minimum star rating status in time for the following Shared 
Savings Program performance year. Other commenters suggested 
modifications to the Shared Savings Program's financial methodology 
unrelated to the RFIs or proposals in the CY 2024 PFS proposed rule, 
such as:

[[Page 79232]]

     Eliminating the distinction between low revenue ACOs and 
high revenue ACOs (refer to the definitions of ``High revenue ACO'' and 
``Low revenue ACO'' at Sec.  425.20);
     Setting regional-only benchmarks;
     Making equity adjustments in financial benchmarking;
     Removing the ACO's own assigned beneficiaries from 
regional expenditure calculations when adjusting and updating the ACO's 
benchmark;
     Retroactively applying the policy described at Sec.  
425.605(h) (Calculation of shared savings for certain BASIC track ACOs 
not meeting MSR requirement) to expand opportunities for certain ACOs 
to share in savings so that it will apply to PY 2023 and all prior 
years.
     Developing a pediatric risk algorithm; and
     Developing ``value-based arrangements'' (such as a nested 
bundled payment for skilled nursing facility, home health, or 
palliative care/serious illness management services) that ``are 
embedded within the ACO for non-physician participating providers or 
organizations.''
    Another commenter suggested CMS provide ``projected or year-to-date 
shared savings levels that include a single dollar amount without 
requiring template population.'' The commenter also requested that CMS 
allow an ACO to exclude a beneficiary from the ACO's assigned 
beneficiary population if the beneficiary declines data sharing. One 
commenter requested that CMS require ACOs to include geriatric 
expertise on their governing bodies or incentivize health systems to 
become ``Age-Friendly Health Systems.''
    Response: We appreciate the commenters' input but note that these 
suggestions go beyond the scope of the RFIs in the CY 2024 PFS proposed 
rule.

H. Medicare Part B Payment for Preventive Vaccine Administration 
Services (Sec. Sec.  410.10, 410.57, 410.152)

1. Statutory Background
    Under section 1861(s)(10) of the Act, Medicare Part B covers both 
the vaccine and vaccine administration for the specified preventive 
vaccines--the pneumococcal, influenza, hepatitis B and COVID-19 
vaccines. Section 1861(s)(10)(B) of the Act specifies that the 
hepatitis B vaccine and its administration is only covered for those 
who are at high or intermediate risk of contracting hepatitis B, as 
defined at Sec.  410.63. Under sections 1833(a)(1)(B) and (b)(1) of the 
Act, respectively, there is no applicable beneficiary coinsurance, and 
the annual Part B deductible does not apply for these vaccines or the 
services to administer them. Per section 1842(o)(1)(A)(iv) of the Act, 
payment for these vaccines is based on 95 percent of the Average 
Wholesale Price (AWP) for the vaccine product, except when furnished in 
the settings for which payment is based on reasonable cost, such as a 
hospital outpatient department (HOPD), rural health clinic (RHC), or 
Federally qualified health center (FQHC). Some other preventive 
vaccines, such as the zoster vaccine for the prevention of shingles, 
are not specified for Medicare Part B coverage under section 
1861(s)(10) of the Act and are instead covered and paid for under 
Medicare Part D.

2. Medicare Part B Payment for the Administration of Preventive 
Vaccines

a. Pneumococcal, Influenza and Hepatitis B Vaccine Administration
    In the CY 2022 PFS final rule (86 FR 65186), we finalized a uniform 
payment rate of $30 for the administration of a pneumococcal, influenza 
or hepatitis B vaccine covered under the Medicare Part B preventive 
vaccine benefit. We explained that since payment policies for the 
administration of the preventive vaccines described under section 
1861(s)(10) of the Act are independent of the PFS, these payment rates 
will be updated as necessary, independent of the valuation of any 
specific codes under the PFS. (Please see COVID-19 vaccine 
administration payment information in the next section.) The CY 2022 
PFS final rule (86 FR 65180 through 65182) provides a detailed 
discussion on the history of the valuation of the three Level II 
Healthcare Common Procedure Coding System (HCPCS) codes, G0008, G0009, 
and G0010, which describe the services to administer an influenza, 
pneumococcal, and hepatitis B vaccine, respectively.
    In the CY 2023 PFS final rule (87 FR 69984), we finalized a policy 
to annually update the payment amount for the administration of Part B 
preventive vaccines based upon the percentage increase in the Medicare 
Economic Index (MEI). Additionally, we finalized the use of the PFS 
Geographical Adjustment Factor (GAF) to adjust the payment amount to 
reflect cost differences for the geographic locality based upon the fee 
schedule area where the preventive vaccine is administered. These 
adjustments and updates apply to HCPCS codes G0008, G0009, G0010, and 
to the Level I Current Procedural Terminology (CPT) codes that describe 
the service to administer COVID-19 vaccines, which we discuss in the 
next section.\310\
---------------------------------------------------------------------------

    \310\ COVID-19 vaccine coding is available at https://www.cms.gov/medicare/payment/fee-for-service-providers/part-b-drugs/average-drug-sales-price/vaccine-pricing, under ``COVID-19 Vaccines 
& Monoclonal Antibodies''.
---------------------------------------------------------------------------

    The current payment rates for G0008, G0009, and G0010, as finalized 
in the CY 2023 PFS final rule, can be found on the CMS Vaccine Pricing 
website under ``Seasonal Flu Vaccines''.\311\ The payment rates for 
these services, with the annual update applied for CY 2024, are 
available in Tables 46A and 46B in section III.H.3.d. of this final 
rule.
---------------------------------------------------------------------------

    \311\ https://www.cms.gov/medicare/payment/fee-for-service-providers/part-b-drugs/average-drug-sales-price/vaccine-pricing, 
under ``Seasonal Flu Vaccines''.
---------------------------------------------------------------------------

b. COVID-19 Vaccine Administration
    In the CY 2022 PFS final rule (86 FR 65181 and 65182), we provided 
a detailed history regarding the determinations of initial payment 
rates for the administration of COVID-19 vaccines, and an explanation 
of how the payment policy evolved to a rate of $40 per dose. We noted 
that in the CY 2022 PFS proposed rule (86 FR 39220 through 39224), we 
included a comment solicitation requesting information that identifies 
the resource costs and inputs that should be considered when 
determining payment rates for preventive vaccine administration. As 
part of the comment solicitation, we requested feedback specifically 
related to the circumstances and costs associated with furnishing 
COVID-19 vaccines, to ensure that we took these into consideration when 
determining our payment policy. In the CY 2022 PFS final rule (86 FR 
65185), we stated that, after consideration of all the comments 
received, it was appropriate to establish a single, consistent payment 
rate for the administration of all four Part B preventive vaccines in 
the long term, but to pay a higher, $40 payment rate for administration 
of COVID-19 vaccines in the short term, while pandemic conditions 
persisted (86 FR 65185).
    In the CY 2023 PFS final rule (87 FR 69988 through 69993), we 
stated that due to timing distinctions between a PHE declared under 
section 319 of the Public Health Service (PHS) Act and an Emergency Use 
Authorization (EUA) declaration under section 564 of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act), we reconsidered the policies 
finalized in the CY 2022 PFS final rule in light of our goal to promote 
broad and timely access to COVID-19 vaccines. We explained that our 
goal would be better served if our policies with respect to payment for

[[Page 79233]]

administration of these products, as addressed in the November 2020 IFC 
and CY 2022 PFS final rule, continue until the EUA declaration for 
drugs and biological products with respect to COVID-19 (see 85 FR 
18250) is terminated. Therefore, we finalized that we would maintain 
the current payment rate of $40 per dose for the administration of 
COVID-19 vaccines through the end of the calendar year in which the 
March 27, 2020 EUA declaration under section 564 of the FD&C Act (EUA 
declaration) for drugs and biological products ends. Effective January 
1 of the year following the year in which the EUA declaration ends, the 
COVID-19 vaccine administration payment would be set at a rate to align 
with the payment rate for the administration of other Part B preventive 
vaccines, that is, approximately $30 per dose. As mentioned above, we 
also finalized that, beginning January 1, 2023, we would annually 
update the payment amount for the administration of all Part B 
preventive vaccines based upon the percentage increase in the MEI, and 
that we would use the PFS GAF to adjust the payment amount to reflect 
cost differences for the geographic locality based upon the fee 
schedule area where the vaccine is administered.
    The current payment rates for the CPT codes that describe the 
service to administer COVID-19 vaccines, as finalized in the CY 2023 
PFS final rule, are available on the CMS COVID-19 Vaccine Pricing 
website, under ``COVID-19 Vaccines & Monoclonal Antibodies''.\312\ The 
payment rates for these services, with the annual update applied for CY 
2024, are available in Tables 46A and 46B in section III.H.3.d. of this 
final rule.
---------------------------------------------------------------------------

    \312\ https://www.cms.gov/medicare/payment/fee-for-service-providers/part-b-drugs/average-drug-sales-price/vaccine-pricing, 
under ``COVID-19 Vaccines & Monoclonal Antibodies''.
---------------------------------------------------------------------------

    Comment: Some commenters requested CMS to clarify the Part B 
preventive vaccine administration payment amounts for CY 2024. 
Commenters specifically asked that, due to the uncertainty surrounding 
the ``commercialization'' of COVID-19 vaccines, and due to the 
additional expenses and operational complexity that COVID-19 vaccines 
still present in relation to other vaccines, CMS maintain the existing 
higher COVID-19 vaccine administration payment through CY 2024. These 
commenters expressed that they would appreciate additional 
clarification about the transition date for the COVID-19 vaccine 
administration payment amount from $40 to the $30. One commenter asked 
CMS to clarify payment amounts for both COVID-19 vaccine products and 
their administration, and the commenter also specifically requested a 
chart similar to Tables 85 and 86 published in the CY 2023 PFS final 
rule (87 FR 69993).
    Response: We acknowledge the commenters' requests for clarification 
regarding the transition date for the vaccine administration payment 
amount for COVID-19 vaccines. In the CY 2023 PFS final rule (87 FR 
69988 through 69993), we set this transition to occur on January 1 of 
the year following the year in which the Secretary ends the March 27, 
2020, EUA declaration under section 564 of the FD&C Act (EUA 
declaration) for drugs and biological products. In the CY 2023 PFS 
final rule (87 FR 70224), we also codified this policy in regulations 
at Sec.  410.152(h)(2) and (3).
    As discussed in the CY 2023 PFS final rule (87 FR 69987), an 
emergency declaration pursuant to section 564 of the FD&C Act (an ``EUA 
declaration'') continues until specifically terminated.\313\ When an 
EUA declaration is to be terminated, notice of termination will be 
published in the Federal Register to provide advance notice to the 
public that the EUA declaration is being terminated and provide for a 
transition period. This will permit manufacturers, health care 
facilities, providers, patients, and other interested parties time to 
transition from EUA products and the policies that support them. An EUA 
declaration under section 564 of the FD&C Act is distinct from, and not 
dependent on, an HHS PHE declaration under section 319 of the PHS Act. 
While the HHS PHE declaration under section 319 of the PHS Act for 
COVID-19 expired on May 11, 2023, the EUAs issued under the section 564 
EUA declarations for drugs and biological products with respect to 
COVID-19 continue to remain in effect.\314\
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    \313\ https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/faqs-what-happens-euas-when-public-health-emergency-ends, viewed September 19, 2023.
    \314\ Ibid.; https://www.hhs.gov/about/news/2023/05/09/fact-sheet-end-of-the-covid-19-public-health-emergency.html, viewed 
September 19, 2023.
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    Per commenters' suggestions, we have included Tables 46A and 46B, 
at the end of section III.H.3 of this final rule, that reflect the 
potential alternative payment amounts for Part B preventive vaccine 
administration for CY 2024. Table 47 displays the CY 2024 Part B 
payment rates for preventive vaccine administration if the EUA 
declaration continues into CY 2024, and Table 48 displays the CY 2024 
Part B payment rates for preventive vaccine administration if the EUA 
declaration ends on or before December 31, 2023.
    For more information on Part B payment for COVID-19 vaccines and 
their administration, please see the CMS COVID-19 Vaccine Pricing 
website at https://www.cms.gov/medicare/payment/all-fee-service-providers/medicare-part-b-drug-average-sales-price/vaccine-pricing, 
under ``COVID-19 Vaccines & Monoclonal Antibodies.'' The website 
includes Medicare Part B payment amounts for COVID-19 vaccine products. 
For more information on the end of the Centers for Disease Control and 
Prevention's (CDC) COVID-19 Vaccination Program and the transition to 
private purchasing of COVID-19 vaccines in the commercial marketplace, 
please see https://www.cdc.gov/vaccines/covid-19/vaccination-provider-support.html.
    Comment: Several commenters requested that CMS evaluate how the 
current Part B preventive vaccine administration payment amounts impact 
vaccination rates, and that CMS work with vaccine providers to ensure 
the in-home add-on payment is adequate, given the additional costs 
associated with at-home administration. Other commenters suggested CMS 
to continue the $40 payment amount for COVID-19 vaccine administration 
beyond the end of CY 2023, and extend that payment amount to the 
administration of all Medicare preventive vaccines. Some commenters 
noted that, while COVID-19 vaccines are somewhat easier for physician 
practices to manage than in previous years, the vaccines will still 
require unique practice considerations and additional expenses for 
those administering the vaccines.
    Response: The CY 2022 PFS final rule (87 FR 65184 through 65186) 
contains an extensive discussion on our rationale for initially setting 
the $40 COVID-19 vaccine administration rate, and for eventually 
aligning the COVID-19 vaccine administration rate with the rate for 
administration of the other Part B preventive vaccines, that is, $30 
per vaccine administered. In the CY 2023 final rule (87 FR 69988 
through 69993), we set this transition to occur on January 1 of the 
year following the year in which the Secretary ends the March 27, 2020, 
EUA declaration under section 564 of the FD&C Act (EUA declaration) for 
drugs and biological products.
    We acknowledged the unique circumstances that still surround the 
COVID-19 vaccine landscape, even now that the COVID-19 public health

[[Page 79234]]

emergency (PHE) has expired.\315\ We believe that our proposal to 
continue the higher COVID-19 vaccine administration rate through the 
end of the year in which the EUA declaration ends, rather than 
immediately aligning the COVID-19 vaccine administration payment amount 
with that of the other Part B preventive vaccines upon the expiration 
of the PHE, provides an appropriate transition period to recognize 
continued higher resource needs. We will continue to review payment 
policies for Part B preventive vaccines and their administration, as 
circumstances continue to evolve regarding COVID-19 specifically, and 
regarding public health in general. When the transition to a calendar 
year post-EUA declaration does arrive, we plan to provide both vaccine 
providers and Medicare enrollees with sufficient notice and thorough 
guidance regarding the transition.
---------------------------------------------------------------------------

    \315\ https://www.hhs.gov/about/news/2023/05/09/fact-sheet-end-of-the-covid-19-public-health-emergency.html, viewed on September 
19, 2023.
---------------------------------------------------------------------------

3. In-Home Additional Payment for Administration of COVID-19 Vaccines
a. Background
    In the CY 2022 PFS final rule (86 FR 65187 and 65190), we provide a 
detailed discussion on the payment policy for COVID-19 vaccine 
administration in the home. In summary, providers and suppliers that 
administer a COVID-19 vaccine in the home, under certain circumstances, 
can bill Medicare for one of the existing COVID-19 vaccine 
administration CPT codes along with HCPCS code M0201 (COVID-19 vaccine 
administration inside a patient's home; reported only once per 
individual home per date of service when only COVID-19 vaccine 
administration is performed at the patient's home).\316\ In CY 2022, 
the Medicare Part B payment amount paid to providers and suppliers 
administering a COVID-19 vaccine in the home was $75.50 dollars per 
dose ($40 for COVID-19 vaccine administration and $35.50 for the 
additional payment for administration in the home). These payment 
amounts were then geographically adjusted using PFS GPCIs (as discussed 
in the CY 2023 PFS final rule at 87 FR 69980 through 69983). We note 
that when a preventive vaccine that is covered and paid under section 
1861(s)(10) of the Act, is furnished in the settings for which payment 
is based on reasonable cost, such as a hospital outpatient department 
(HOPD), rural health clinic (RHC), or Federally qualified health center 
(FQHC), the in-home additional payment mechanism is not applicable, 
since vaccine administration in those settings is based on reasonable 
cost, and is paid through the cost report process.
---------------------------------------------------------------------------

    \316\ https://www.cms.gov/medicare/payment/fee-for-service-providers/part-b-drugs/average-drug-sales-price/vaccine-pricing, 
under ``COVID-19 Vaccines & Monoclonal Antibodies''.
---------------------------------------------------------------------------

    Since announcing the add-on payment for in-home COVID-19 vaccine 
administration in June 2021, we have noted that we established these 
policies on a preliminary basis to ensure access to COVID-19 vaccines 
during the public health emergency, and that we would continue to 
evaluate the needs of Medicare patients and these policies. In the CY 
2022 PFS proposed rule (86 FR 39224 through 39226), we included a 
comment solicitation to collect feedback on these policies and 
potential future changes. As part of the comment solicitation, we 
requested feedback related to our definition of ``home,'' program 
integrity concerns, changes that we should consider, costs associated 
with administering COVID-19 vaccines in the home, and whether outside 
of a PHE there is a need to vaccinate people in the home rather than 
going to a health care provider or supplier. In the CY 2022 PFS final 
rule (86 FR 65188 through 65190), we discussed the feedback received, 
and we noted that commenters overwhelmingly recommended that we 
continue making the additional payment for COVID-19 vaccines 
administered in the home beyond the end of the PHE. Many commenters 
also supported extending the payment to other preventive vaccines, 
either permanently or until the end of the PHE. Commenters emphasized 
the importance of increasing vaccination rates and making vaccines 
available to underserved homebound beneficiaries who face barriers 
including chronic illness, financial and social precarity, and lack of 
access to digital resources. We agreed with commenters that the added 
costs and compelling needs required CMS to adopt the in-home add-on 
payment rate for COVID-19 vaccine administration. In addition, we 
stated that since we did not expect those needs or costs to diminish 
immediately with the end of the PHE, we believed it would be 
appropriate to leave the in-home add-on payment rate in place through 
the end of the calendar year in which the PHE ends. We explained that 
this extension of payment past the end of the PHE would also afford CMS 
the opportunity to monitor vaccine uptake data (86 FR 65189).
    In the CY 2023 PFS final rule (87 FR 69984 through 69986), we 
discussed that we had received many comments and requests from 
interested parties that the in-home add-on payment be applied more 
broadly to all preventive vaccines. Commenters also expressed concerns 
that discontinuation of the in-home additional payment would negatively 
impact access to the COVID-19 vaccine for underserved homebound 
beneficiaries. We noted that while we agreed with these concerns, we 
also believed that we needed to learn more about the populations served 
through the current in-home add-on payment, and other potential 
populations that may not have been able to access a COVID-19 vaccine 
despite the availability of the in-home add-on payment, in order to 
understand the barriers experienced when receiving vaccinations in a 
home versus in the community. We also noted the need to consider 
potential program integrity concerns. Therefore, we finalized that we 
would continue the additional payment of $35.50 when a COVID-19 vaccine 
is administered in a beneficiary's home, under the certain 
circumstances, only for the duration of CY 2023. We explained that we 
were continuing the additional payment for at-home COVID-19 
vaccinations for another year to provide us time to track utilization 
and trends associated with its use, so to inform the Part B preventive 
vaccine policy on payments for in-home vaccine administration for CY 
2024.
    We also finalized the policy to adjust this payment amount for 
geographic cost differences as we do the payment for the preventive 
vaccine administration service, that is, based upon the fee schedule 
area where the COVID-19 vaccine is administered, by using the PFS GAF. 
In addition, we finalized an update to the $35.50 payment amount by the 
CY 2023 MEI percentage increase, consistent with the policy finalized 
for the other preventive vaccine administration services. We noted that 
in the CY 2023 PFS final rule (87 FR 69688 through 69710), we rebased 
and revised the MEI to a 2017 base year. Therefore, we finalized (87 FR 
69986) that for CY 2023, the in-home additional payment amount for 
COVID-19 vaccine administration described by HCPCS code M0201 was 
$36.85 ($35.50 x 1.038 = $36.85), and we established that payment for 
these services is adjusted for geographic cost differences using the 
relevant PFS GAF.
    We note that in section III.H.3 of this final rule, we are 
finalizing revisions to Sec.  410.152 that relate to these policies.
b. Conditions for Billing HCPCS Code M0201 Through CY 2023
    In establishing the additional payment for COVID-19 vaccine

[[Page 79235]]

administration in the home, we also established certain conditions for 
the add-on payment described by HCPCS code M0201. In the CY 2022 PFS 
final rule, we provided a detailed discussion on how we established the 
certain conditions under which the code can be used, and the situations 
we contemplated to arrive at our final payment policy (86 FR 65187 and 
65188).
    For purposes of this add-on payment for in-home COVID-19 vaccine 
administration, the following requirements have applied when billing 
for HCPCS code M0201: 317 318
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    \317\ https://www.cms.gov/medicare/payment/covid-19/medicare-covid-19-vaccine-shot-payment.
    \318\ https://www.cms.gov/files/document/vaccine-home.pdf.
---------------------------------------------------------------------------

     The patient has difficulty leaving the home to get the 
vaccine, which could mean any of these:
    ++ They have a condition, due to an illness or injury, that 
restricts their ability to leave home without a supportive device or 
help from a paid or unpaid caregiver;
    ++ They have a condition that makes them more susceptible to 
contracting a pandemic disease like COVID-19; or
    ++ They are generally unable to leave the home, and if they do 
leave home, it requires a considerable and taxing effort.
     The patient is hard-to-reach because they have a 
disability or face clinical, socioeconomic, or geographical barriers to 
getting a COVID-19 vaccine in settings other than their home. These 
patients face challenges that significantly reduce their ability to get 
vaccinated outside the home, such as challenges with transportation, 
communication, or caregiving.
     The sole purpose of the visit is to administer the COVID-
19 vaccine. Medicare will not pay the additional amount if the provider 
or supplier furnished another Medicare covered service in the same home 
on the same date.
     A home can be:
    ++ A private residence, temporary lodging (for example, a hotel or 
motel, campground, hostel, or homeless shelter);
    ++ An apartment in an apartment complex or a unit in an assisted 
living facility or group home (including assisted living facilities 
participating in the CDC's Pharmacy Partnership for Long-Term Care 
Program when their residents are vaccinated through this program);
    ++ A patient's home that is made provider-based to a hospital 
during the PHE for COVID-19; or
    ++ Communal spaces of a multi-unit or communal living arrangement.
     A home cannot be:
    ++ An institution that meets the requirements of sections 
1861(e)(1), 1819(a)(1), or 1919(a)(1) of the Act, which includes 
hospitals and skilled nursing facilities (SNFs), as well as most 
nursing facilities under Medicaid.\319\
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    \319\ 42 CFR 409.42(a).
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    To meet requirements for billing HCPCS code M0201, a COVID-19 
vaccine must be administered inside an individual's home. For this 
purpose, an individual unit in a multi-dwelling building is considered 
a home. For example, an individual apartment in an apartment complex or 
an individual bedroom inside an assisted living facility or group home 
is considered a home. HCPCS code M0201, as noted in the code 
descriptor, can be billed only once per individual home per date of 
service. Medicare pays the additional payment amount for up to a 
maximum of 5 vaccine administration services per home unit or communal 
space within a single group living location; but only when fewer than 
10 Medicare patients receive a COVID-19 vaccine dose on the same day at 
the same group living location.
c. Policies for CY 2024 and Subsequent Years
    As discussed in the CY 2024 PFS proposed rule (88 FR 52499 through 
52500), we have engaged in an in-depth analysis of the use of HCPCS 
billing code M0201, which specifically indicates that a COVID-19 
vaccine was furnished in the home on a Medicare claim. The analysis 
found that data for in-home COVID-19 vaccinations among Medicare fee-
for-service beneficiaries from June 2021 to June 2022 show the payment 
code was used at a disproportionately high rate by underserved 
populations, including persons who are dual eligible for both Medicare 
and Medicaid and those of advanced age. The data reflect that, between 
June 2021-June 2022, those 85 years of age and older were over 3 times 
more likely than younger beneficiaries to have received an in-home 
COVID-19 vaccination, and persons who are dual eligible for both 
Medicare and Medicaid were over 2 times more likely than those who are 
not dual eligible to have received a COVID-19 vaccine provided in their 
home. The data also showed higher usage of the in-home payment code 
among those with some common chronic conditions.\320\
---------------------------------------------------------------------------

    \320\ Common chronic conditions as identified by the CMS Chronic 
Conditions Data Warehouse, https://www2.ccwdata.org/web/guest/home/.
---------------------------------------------------------------------------

    Considering the results of our study, we concluded that the in-home 
additional payment improved healthcare access to vaccines for these 
often-underserved Medicare populations. From an analysis of the data, 
the in-home additional payment is billed significantly more frequently 
for beneficiaries that are harder to reach and that may be less likely 
to otherwise receive these preventive benefits. Therefore, we proposed 
to maintain the in-home additional payment for COVID-19 vaccine 
administration under the Part B preventive vaccine benefit. In 
addition, since our statutory authority at section 1861(s)(10) of the 
Act to regulate Part B preventive vaccine administration is identical 
for all four preventive vaccines, and since the payment has been shown 
to positively impact health equity and healthcare access, we proposed 
to extend the additional payment to the administration of the other 
three preventive vaccines included in the Part B preventive vaccine 
benefit--the pneumococcal, influenza, and hepatitis B vaccines. We 
proposed to provide the additional payment for pneumococcal, influenza, 
hepatitis B and COVID-19 vaccine administrations in the home when the 
conditions described in section III.H.3.b of the CY2024 PFS proposed 
rule are met. We noted that several of the conditions we established 
for the in-home additional payment refer specifically to COVID-19. We 
also stated in the CY 2024 PFS proposed rule, that if we finalize the 
proposal to expand the in-home additional payment to the other 
preventive vaccines, we would broaden the conditions for the payment to 
reflect preventive vaccines for the other diseases.
    In the CY 2024 PFS proposed rule (88 FR 52500), we explained that, 
for CY 2024, the proposed growth rate of the 2017-based MEI was 
estimated to be 4.5 percent, based on the IHS Global, Inc. (IGI) first 
quarter 2023 forecast with historical data through fourth quarter 2022. 
We also proposed that if more recent data subsequently became available 
(for example, a more recent estimate of the MEI percentage increase), 
we would use such data, if appropriate, to determine the CY 2024 MEI 
percentage increase in the CY 2024 PFS final rule; we would apply that 
new MEI percentage increase to update last year's $36.85 CY 2023 in-
home additional payment amount for Part B preventive vaccine 
administration.
    Since expanding this policy could mean that multiple vaccines are 
administered during the same visit to the home, we proposed to limit 
the additional payment to one payment per

[[Page 79236]]

home visit, even if multiple vaccines are administered during the same 
home visit. We emphasized that every vaccine dose that is furnished 
would still receive its own unique vaccine administration payment. We 
stated our intent of continuing to monitor utilization of the M0201 
billing code for the in-home additional payment, and that we plan to 
revisit the policy should we observe inappropriate use or abuse of the 
code. We proposed to modify the regulations at Sec.  410.152(h) to 
reflect these policies.
    We solicited comments on the policy condition regarding Medicare 
payment of the in-home additional payment amount for up to a maximum of 
five vaccine administration services per home unit or communal space 
within a single group living location, but only when fewer than 10 
Medicare patients receive a COVID-19 vaccine dose on the same day at 
the same group living location. We invited feedback on the 
applicability of this policy to the proposed policy to make the in-home 
additional payment available for the administration of all four Part B 
preventive vaccines.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Commenters were overwhelmingly supportive of our proposals 
to maintain the in-home additional payment for the administration of 
COVID-19 vaccine, and to extend the in-home additional payment to the 
administration of the other three Part B preventive vaccines. Many 
commenters remarked that this proposal, if finalized, would greatly 
improve access to vaccines for vulnerable, hard to reach and medically 
underserved populations. Commenters referenced increased access for the 
those with chronic illness, financial and social precarity, and for 
those who lack access to digital resources; those who face difficulty 
accessing transportation or who have limitations to mobility; minority 
and marginalized patients; older Americans; dually-eligible 
individuals; and generally, all those with barriers who rely on in-home 
care. Similarly, several commenters pointed to the positive impact the 
proposal would have on health equity. Other commenters voiced their 
belief that the policy will improve utilization of preventive vaccines, 
and therefore, help beneficiaries avoid serious illness. One commenter 
noted that the proposal would support primary care providers in their 
effort to combat vaccine hesitancy.
    Several comments voiced their support for our continued payment 
amount updates based on inflationary factors via the MEI, and for our 
geographic adjustments of payment amounts based on the PFS GAF.
    Many of the supportive commenters discussed the importance of 
vaccination in general. One commenter stated that the COVID-19 pandemic 
emphasized the need for an effective vaccine delivery infrastructure. 
The commenter also emphasized the importance of vaccination in 
pediatric and primary care. Another commenter discussed the barriers 
that Medicare enrollees face in obtaining vaccinations, and noted, with 
reference to an article published by the Assistant Secretary for 
Planning and Evaluation, that homebound older adults are more likely to 
be members of racial and ethnic minorities.\321\ Another commenter 
mentioned that, in addition to vaccines' contributions to the 
prevention of disease and lowering of healthcare costs, vaccines also 
contribute to treatment plans for certain conditions. Commenters 
encouraged CMS to continue incentivizing vaccination using every tool 
available, and to continue to believe creatively about ways to support 
vaccine access all parts of Medicare.
---------------------------------------------------------------------------

    \321\ Characteristics of Homebound Older Adults: Potential 
Barriers to Accessing the COVID-19 Vaccine Issue Brief. Office of 
the Assistant Secretary for Planning and Evaluation. U.S. Department 
of Health and Human Services. April 5, 2021. https://aspe.hhs.gov/reports/characteristics-homebound-older-adults-potential-barriers-accessing-covid-19-vaccineissue-brief.
---------------------------------------------------------------------------

    Response: We thank commenters for their support of our proposals 
and for partnering with CMS in our efforts to improve health access and 
equity. We agree that finalizing this proposal would improve access to 
preventive vaccines for all of the aforementioned groups of Medicare 
enrollees, including vulnerable, hard to reach and medically 
underserved populations, and those with chronic conditions and mobility 
challenges. We look forward to continuing our work with all of our 
partners in order to continue facilitating increased access to 
vaccinations for both Medicare enrollees and all Americans.
    Comment: Some commenters requested that CMS consider a wide 
expansion of the proposals regarding in-home additional payments for 
Part B vaccine administration. While virtually all commenters supported 
our proposals, some commenters requested that the Part B vaccine 
benefit cover all Medicare-covered vaccines, including those currently 
covered under Part D, such as the new respiratory syncytial virus (RSV) 
vaccine. One commenter specified that this move would likely minimize 
cost-sharing for patients. Others stated that the proposed in-home 
additional payment should apply to all vaccines recommended by the 
CDC's Advisory Committee on Immunization Practices (ACIP). One 
commenter stated that they believe that all vaccines should be 
available in all settings of care.
    A few commenters requested that CMS clarify that those furnishing 
vaccines in the home be permitted to bill for any additional unexpected 
services at the time of the visit.
    Another commenter voiced support for legislation that would allow 
pharmacists to bill for vaccine administration under Medicare Part B, 
as they believe that would help relieve constraints on primary care 
providers and other healthcare professionals. Similarly, another 
commenter requested that CMS address the types of health care providers 
that are permitted to bill for furnishing preventive vaccines, and this 
commenter specifically noted that CMS should consider allowing 
Emergency Medical Services (EMS) Providers, Nursing Technicians, 
Pharmacy Technicians, and other provider types to be paid for 
administering vaccines, in order to increase access to preventive care.
    One commenter requested that CMS use COVID-19 vaccine reporting 
requirements that were put in place during the pandemic to continue to 
prioritize vaccine reporting and suggested that this policy would 
support CMS' efforts to promote interoperability.
    Response: We thank commenters for their interest in and support of 
our policies. We note that, in accordance with the statute, Part B 
payment can be made only for the preventive vaccines specified at 
section 1861(s)(10) of the Act. Please see sections III.H.1 and III.H.2 
of this final rule for more information.
    We will not address each of these comments specifically, as they 
are outside of the scope of our proposals in the CY 2024 PFS proposed 
rule. We did not make any proposals regarding expanding the Part B 
preventive vaccine benefit to additional vaccines. We did not make any 
proposals regarding payment for vaccines covered under Part D, and we 
did not address vaccine administration in other health care settings. 
We also note that our proposals were limited to payment for in-home 
vaccine administration. We did not make any proposals regarding the 
scope of practice for those who would administer the vaccines, and we 
did not

[[Page 79237]]

address COVID-19 vaccination reporting.
    However, as noted above, CMS is dedicated to the goal of increasing 
vaccine access for Medicare enrollees. We appreciate that these 
commenters share CMS' priorities in this area. We are actively taking 
these comments into consideration for the future, as appropriate under 
our statutory authority.
    Comment: Some commenters requested specific expansions of our 
proposed policies. One commenter requested that we remove the 
requirement that a patient have difficulty leaving the home, or that 
patient must face barriers to getting a vaccine in settings other than 
their home, for the additional payment for in-home vaccine 
administration to apply. This commenter and others also suggested that 
we allow ``home'' to be defined to include skilled nursing facilities. 
Other commenters requested that CMS consider lifting the limit on the 
additional in-home payment to one payment per home visit, given the 
costs and operations associated with administering vaccines. A 
commenter explained that each vaccine administration involves unique 
work, time, and risk, and each vaccine administration has its own 
associated products.
    One commenter requested CMS to consider further incentivizing 
access to home-based care by revising the additional in-home vaccine 
administration payment to address travel-related expenses, including 
various factors such transportation options, transportation costs, 
geographic distance and traffic conditions. Similarly, other commenters 
requested CMS to consider an additional payment for an extended visit 
with a patient or an extended commute to a patient.
    Response: The proposals we included in the CY 2024 PFS proposed 
rule for the add-on payment for in-home administration of preventive 
vaccines are the first to establish payment for in-home vaccination 
under Part B outside the circumstances of the PHE for COVID-19. Our 
proposed regulations regarding the Part B preventive vaccine in-home 
additional payment are based on the payment conditions for the COVID-19 
in-home additional payment, and they allow beneficiaries to receive 
Part B preventive vaccines in a variety of circumstances. As stated 
earlier in this section, we intend to continue to monitor utilization 
of the HCPCS M0201 billing code for the in-home additional payment, and 
we plan to revisit the policy should we observe inappropriate use or 
abuse of the code. We are also carefully reviewing all the comments 
discussed above and will take them into consideration for potential 
future rulemaking regarding in-home vaccine administration payments.
    After consideration of public comments, we are finalizing these 
policies as proposed. The in-home additional payment for the 
administration of pneumococcal, influenza, and hepatitis B vaccines 
will be effective January 1, 2024, together with the current additional 
payment for the in-home administration of COVID-19 vaccines that is 
being extended. That is, providers and suppliers would continue to bill 
Medicare Part B for the additional payment for the in-home 
administration of COVID-19 vaccines, and beginning January 1, 2024, 
they would also be able to bill Medicare Part B for the in-home 
administration of pneumococcal, influenza, and hepatitis B vaccines. In 
addition, like the current in-home additional payment for COVID-19 
vaccine administration, the in-home additional payment for the 
administration of Part B preventive vaccines will be geographically 
adjusted based on the PFS GAF, and annually updated by the CY 2024 MEI 
percentage increase.
    We proposed in the CY 2024 PFS proposed rule (88 FR 52500) that if 
more recent data become available (for example, a more recent estimate 
of the CY 2024 MEI percentage increase), we would use such data, if 
appropriate, to determine the CY 2024 MEI percentage increase in the CY 
2024 PFS final rule, and would then apply that new MEI percentage 
increase to update last year's $36.85 CY 2023 in-home additional 
payment amount for Part B preventive vaccine administration. More 
recent data are now available, and we believe it is appropriate to use 
the updated data to update the in-home additional payment amount for CY 
2024. The MEI percentage increase for this CY 2024 final rule is 4.6 
percent, based on the most recent historical data through second 
quarter 2023. The CY 2024 in-home additional payment for Part B 
preventive vaccine administration is therefore $38.55 ($36.85 x 1.046 = 
$38.55).
    Thus, in this final rule, we are amending the Part B payment for 
preventive vaccine administration regulations at Sec.  410.152(h) to 
reflect the following:
     Effective January 1, 2022, the Medicare Part B additional 
payment amount paid to providers and suppliers administering a COVID-19 
vaccine in the home, under certain circumstances, is $35.50. For COVID-
19 vaccines administered in the home January 1, 2022, through December 
31, 2022, the additional payment amount under Medicare Part B is 
adjusted to reflect geographic cost variations using the PFS GPCIs.
     Effective January 1, 2023, the additional payment amount 
for the administration of a COVID-19 vaccine in the home is updated 
annually based upon the percentage change in the MEI. For COVID-19 
vaccines administered in the home January 1, 2023, through December 31, 
2023, the in-home vaccine administration payment amount is adjusted to 
reflect geographic cost variations using the PFS GAF.
     Effective January 1, 2024, the payment policy allowing for 
additional payment for the administration of a COVID-19 vaccine in the 
home is extended to include the other three preventive vaccines 
included in the Part B preventive vaccine benefit, and the in-home 
vaccine administration payment amount is the same for all four vaccines 
(though only one payment is made per home visit regardless of how many 
vaccines are administered). That is, beginning January 1, 2024, 
Medicare Part B will pay the same additional payment amount to 
providers and suppliers that administer a pneumococcal, influenza, 
hepatitis B, or COVID-19 vaccine in the home, under certain 
circumstances. This additional payment amount will be annually updated 
using the percentage increase in the MEI and adjusted to reflect 
geographic cost variations using the PFS GAF.
d. Summary of Payment Amounts for CY 2024 and Subsequent Years
    Due to the uncertainty surrounding the future of the EUA 
declaration for drugs and biological products for COVID-19, we are 
including Tables 46A and 46B that summarize Medicare Part B the 
potential alternative preventive vaccine administration payment amounts 
at the time of the publication of this final rule. If the EUA 
declaration continues in effect on January 1, 2024, the payment rates 
in Table 47 will apply. If the EUA declaration is terminated before 
January 1, 2024, the payment rates in Table 48 will apply.
BILLING CODE 4120-01-P

[[Page 79238]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.069


[[Page 79239]]


[GRAPHIC] [TIFF OMITTED] TR16NO23.070

BILLING CODE 4120-01-C
4. Other Amendments to Regulation Text
    In CY 2023 PFS final rule (87 FR 69987 through 69993), we finalized 
changes to our policies regarding Part B coverage and payment for 
COVID-19 monoclonal antibody products and their administration. In that 
final rule (87 FR 69987), we discussed that all COVID-19 monoclonal 
antibody products and their administration are covered and paid for 
under the Part B preventive vaccine benefit through the end of year in 
which the Secretary terminates the EUA declaration for drugs and 
biological products with respect to COVID-19. In addition, we explained 
that, under the authority provided by section 3713 of the CARES Act, we 
have established specific coding and payment rates for the COVID-19 
vaccine, as well COVID-19 monoclonal antibodies and their 
administration, through technical direction to Medicare Administrative 
Contractors (MACs) and information posted publicly on the CMS website 
(87 FR 69987). In Tables 46A and 46B, we do not list the unique 
payments rates for the administration of COVID-19 monoclonal antibodies 
since at the time of the publication of this final rule, there are no 
COVID-19 monoclonal antibodies approved or authorized for use against 
the dominant strains of COVID-19 in the United States.
    In the CY 2023 PFS final rule, we also established a policy to 
continue coverage and payment for monoclonal antibodies that are used 
for pre-exposure prophylaxis (PrEP) of COVID-19 under the Part B 
preventive vaccine benefit, if they meet applicable coverage 
requirements (87 FR 69992). We explained that we will continue to pay 
for these products and their administration even after the EUA 
declaration for drugs and biological products is terminated, so long as 
after the EUA declaration is terminated, such products have market 
authorization. Additionally, we established that payments for the 
administration of monoclonal antibodies that are used for PrEP of 
COVID-19 would be adjusted for geographic cost variations using the PFS 
GAF. However, we did not codify these policies in our regulations. In 
the CY 2024 PFS proposed rule (88 FR 52500), proposed revisions to the 
relevant regulations to include monoclonal antibodies that are used for 
PrEP of COVID-19 under the Part B preventive vaccine benefit. 
Specifically, we proposed to revise the following regulations to 
reflect policies for monoclonal antibodies for PrEP of COVID-19 that we 
finalized in the CY 2023 PFS final rule:
     At Sec.  410.10, in paragraph (l), we proposed to add a 
phrase regarding monoclonal antibodies used for pre-exposure 
prophylaxis of COVID-19, and their administration.
     At Sec.  410.57, in paragraph (c), we proposed to add a 
phrase regarding monoclonal antibodies used for pre-exposure 
prophylaxis of COVID-19, and their administration.
    We note again that at the time of the publication of this final 
rule, there are no COVID-19 monoclonal antibodies approved or 
authorized for use against the dominant strains of COVID-19 in the 
United States. Therefore, we did not finalize any payment regulations 
regarding monoclonal antibodies for PrEP of COVID-19 at this time. If 
and when a new monoclonal antibody for PrEP of COVID-19 becomes 
authorized for use, we will use the authority provided by section 3713 
of the CARES Act, as discussed in the CY 2023 PFS final rule (87 FR 
69987), to establish specific coding and payment rates for the 
administration of that product through technical direction to MACs and 
information posted publicly on the CMS website. We will subsequently 
proposed coding and payment rates for the administration of that 
product via rulemaking.

[[Page 79240]]

    We also note that, for the purposes of the in-home additional 
payment discussed above in section III.H.3 of this final rule, that 
additional payment is not applicable to the administration of 
monoclonal antibodies for PrEP of COVID-19. For monoclonal antibodies 
for PrEP of COVID-19, as displayed in Tables 46A and 46B, we set the 
coding and payment rates for the administration of COVID-19 monoclonal 
antibodies in the home to be higher than those in other health care 
settings, and therefore such amounts already account for the higher 
costs of administering the product in the home. More information on our 
coding and payment policies for COVID-19 monoclonal antibodies is 
available at https://www.cms.gov/monoclonal.
    Also, in the CY 2023 PFS final rule, we codified our payment rates 
for all four Part B preventive vaccines, and we finalized that the 
vaccine administration payment rates for all four Part B preventive 
vaccines would be annually updated by the MEI and geographically 
adjusted by the PFS GAF. We included these policies in regulation text 
at Sec.  410.152(h). However, we neglected to include the effective 
date for the MEI policy in the regulation text. Therefore, in the CY 
2024 PFS proposed rule (88 FR 52501), we proposed the following 
correction, and we reorganized other elements of the regulation text at 
Sec.  410.152(h) as we proposed to codify the in-home additional 
payment:
     At Sec.  410.152, at paragraph (h)(5), we proposed to add 
that the paragraph is effective beginning January 1, 2023.
     At Sec.  410.152, we proposed to combine the existing 
paragraphs (h)(2) and (3) into a new paragraph (h)(2), with paragraphs 
(h)(2)(i) and (h)(2)(ii).
     At Sec.  410.152, at a revised paragraph (h)(3), we 
proposed new regulations regarding the in-home additional payment for 
preventive vaccine administration, as described in section in section 
III.H.3.c of this final rule.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Commenters supported the proposed amendments to regulation 
text detailed above. Commenters reiterated their support for CMS' 
policy regarding monoclonal antibodies for PrEP of COVID-19, since 
these products provide certain patients, including immune-compromised 
patients, additional options for preventive care for COVID-19.
    Response: We thank commenters for their support of our proposals.
    Comment: One commenter requested CMS clarify guidance regarding 
payment for potential monoclonal antibodies that are indicated for both 
PrEP and treatment of COVID-19.
    Response: As previously stated, at the time of the publication of 
this final rule, there are no COVID-19 monoclonal antibodies approved 
or authorized for use against the dominant strains of COVID-19 in the 
United States. If and when a new monoclonal antibody for either PrEP or 
treatment of COVID-19 becomes authorized for use, we would use the 
authority provided by section 3713 of the CARES Act, as discussed in 
the CY 2023 PFS final rule (87 FR 69987), to establish specific coding 
and payment rates for the administration of that product through 
technical direction to MACs and information posted publicly on the CMS 
website. In the case of a monoclonal antibody for PrEP of COVID-19, we 
would subsequently propose coding and payment rates for the 
administration of that product via rulemaking.
    After consideration of public comments, we are finalizing these 
amendments to regulation text as proposed.

I. Medicare Diabetes Prevention Program (MDPP)

    The Centers for Medicare & Medicaid Services' (CMS) Medicare 
Diabetes Prevention Program Expanded Model (hereafter, ``MDPP'' or 
``expanded model'') is an evidence-based behavioral intervention that 
aims to prevent or delay the onset of type 2 diabetes for eligible 
Medicare beneficiaries diagnosed with prediabetes. MDPP is an expansion 
in duration and scope of the Diabetes Prevention Program (DPP) model 
test, which was initially tested by CMS through a Round One Health Care 
Innovation Award (2012-2016). MDPP was established in 2017 as an 
``additional preventive service'' covered by Medicare and not subject 
to beneficiary cost-sharing, in addition to being available once per 
lifetime to eligible beneficiaries. To facilitate delivery of MDPP in a 
non-clinical community setting (to align with the certified DPP model 
test), CMS created a new MDPP supplier type through rulemaking in the 
CY 2017 PFS final rule (81 FR 80471),\322\ in addition to requiring 
organizations that wish to participate in MDPP enroll in Medicare 
separately, even if they are already enrolled in Medicare for other 
purposes.
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    \322\ Centers for Medicare & Medicaid Services. Medicare 
Program; Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Part B for CY 2017; Medicare 
Advantage Bid Pricing Data Release; Medicare Advantage and Part D 
Medical Loss Ratio Data Release; Medicare Advantage Provider Network 
Requirements; Expansion of Medicare Diabetes Prevention Program 
Model; Medicare Shared Savings Program Requirements. 81 FR 80471. 
Accessed March 12, 2023. https://www.govinfo.gov/content/pkg/FR-2016-11-15/pdf/2016-26668.pdf.
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    MDPP is a non-pharmacological behavioral intervention consisting of 
up to 22 intensive sessions using a Centers for Disease Control and 
Prevention (CDC) approved National Diabetes Prevention Program 
(National DPP) curriculum. Sessions are furnished over 12 months by a 
trained Coach who provides training on topics that include long-term 
dietary change, increased physical activity, and behavior change 
strategies for weight control and diabetes risk reduction. Suppliers 
may use the CDC-developed PreventT2 curriculum \323\ or an alternate 
CDC-approved curriculum when delivering MDPP. The primary goal of the 
expanded model is to help Medicare beneficiaries reduce their risk for 
developing type 2 diabetes by achieving at least 5 percent weight loss.
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    \323\ https://www.cdc.gov/diabetes/prevention/resources/curriculum.html.
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    Eligible organizations seeking to furnish MDPP began enrolling in 
Medicare as MDPP suppliers on January 1, 2018, and began furnishing 
MDPP on April 1, 2018. Through the National Diabetes Prevention 
Recognition Program (DPRP), the CDC administers a national quality 
assurance program recognizing eligible organizations that furnish the 
National DPP through its evidence based DPRP Standards,\324\ which are 
updated every 3 years. The CDC established the DPRP in 2012 and 
possesses significant experience assessing the quality of program 
delivery by organizations throughout the United States, applying a 
comprehensive set of national quality standards. For further 
information on the DPP model test,\325\ the CDC's National DPP,\326\ 
and DPRP Standards,\327\ please refer to the CY 2017 \328\ (81 FR 
80471) and CY 2018

[[Page 79241]]

PFS \329\ (82 FR 52976) final rules and related websites.
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    \324\ Centers for Disease Control & Prevention Diabetes 
Prevention Recognition Program: Standards and Operating Procedures. 
May 1, 2021. https://www.cdc.gov/diabetes/prevention/pdf/dprp-standards.pdf.
    \325\ Health Care Innovation Awards. https://www.cms.gov/priorities/innovation/innovation-models/health-care-innovation-awards.
    \326\ https://www.cdc.gov/diabetes/prevention/index.html.
    \327\ https://www.cdc.gov/diabetes/prevention/pdf/dprp-standards.pdf.
    \328\ Centers for Medicare & Medicaid Services. Medicare 
Program; Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Part B for CY 2017; Medicare 
Advantage Bid Pricing Data Release; Medicare Advantage and Part D 
Medical Loss Ratio Data Release; Medicare Advantage Provider Network 
Requirements; Expansion of Medicare Diabetes Prevention Program 
Model; Medicare Shared Savings Program Requirements. 81 FR 80471. 
Accessed March 12, 2023. https://www.govinfo.gov/content/pkg/FR-2016-11-15/pdf/2016-26668.pdf.
    \329\ Centers for Medicare & Medicaid Services. Medicare 
Program; Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Part B for CY 2018; Medicare Shared 
Savings Program Requirements; and Medicare Diabetes Prevention 
Program. 82 FR 52976. https://www.govinfo.gov/content/pkg/FR-2018-11-23/pdf/2018-24170.pdf.
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    We proposed to amend Sec.  410.79(b),\330\ Conditions of coverage, 
to remove the definition for the core maintenance session interval 
while adding definitions for the following terms: Combination delivery, 
Distance learning, Extended flexibilities, Extended flexibilities 
period, Full-Plus CDC DPRP recognition, Online delivery, and Virtual 
sessions. In addition, we proposed to amend Sec.  410.79(c)(2)(i)(A) 
and (B) \331\ to update the maximum number of payable sessions during 
the MDPP core services period. We also proposed to amend Sec.  
410.79(e)(3) to extend certain flexibilities established through 
rulemaking as a result of the recent COVID-19 public health emergency 
(PHE) for a period of 4 years.\332\ Furthermore, we proposed to amend 
Sec.  414.84 Payment for MDPP Services \333\ to streamline the MDPP 
payment structure by adding service-based attendance payments while 
still retaining the diabetes risk reduction performance payments for 5 
percent and 9 percent weight loss. We also proposed to amend Sec.  
424.205(a) and (c) to remove ``MDPP interim preliminary recognition'' 
and replace it with ``CDC preliminary recognition''.\334\
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    \330\ Centers for Medicare & Medicaid Services. Medicare and 
Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment and Coverage Policies; 
Medicare Shared Savings Program Requirements; Medicare Advantage; 
Medicare and Medicaid Provider and Supplier Enrollment Policies; and 
Basic Health Program. 88 FR 52738. https://www.govinfo.gov/content/pkg/FR-2023-08-07/pdf/2023-14624.pdf.
    \331\ Centers for Medicare & Medicaid Services. Medicare and 
Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment and Coverage Policies; 
Medicare Shared Savings Program Requirements; Medicare Advantage; 
Medicare and Medicaid Provider and Supplier Enrollment Policies; and 
Basic Health Program. 88 FR 52739. https://www.govinfo.gov/content/pkg/FR-2023-08-07/pdf/2023-14624.pdf.
    \332\ Centers for Medicare & Medicaid Services. Medicare and 
Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment and Coverage Policies; 
Medicare Shared Savings Program Requirements; Medicare Advantage; 
Medicare and Medicaid Provider and Supplier Enrollment Policies; and 
Basic Health Program. 88 FR 52739. https://www.govinfo.gov/content/pkg/FR-2023-08-07/pdf/2023-14624.pdf.
    \333\ Centers for Medicare & Medicaid Services. Medicare and 
Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment and Coverage Policies; 
Medicare Shared Savings Program Requirements; Medicare Advantage; 
Medicare and Medicaid Provider and Supplier Enrollment Policies; and 
Basic Health Program. 88 FR 52740. https://www.govinfo.gov/content/pkg/FR-2023-08-07/pdf/2023-14624.pdf.
    \334\ Centers for Medicare & Medicaid Services. Medicare and 
Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment and Coverage Policies; 
Medicare Shared Savings Program Requirements; Medicare Advantage; 
Medicare and Medicaid Provider and Supplier Enrollment Policies; and 
Basic Health Program. 88 FR 52750. https://www.govinfo.gov/content/pkg/FR-2023-08-07/pdf/2023-14624.pdf.
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1. Changes to Sec.  410.79 by Amending Paragraphs (b), (c)(2)(i) and 
(e)(3)
    MDPP is a comprehensive behavior change intervention for people 
with pre-diabetes with the goal of preventing them from becoming 
diabetic. CMMI expanded this model in 2018 based on a Health Care 
Innovation Award (HCIA) to the National Young Men's Christian 
Association (YMCA) of the USA (Y-USA), who tested the Centers for 
Disease Control and Prevention's (CDC) National Diabetes Prevention 
Program (National DPP) in the Medicare population through their network 
of YMCAs in multiple US markets (DPP model test).\335\ The DPP model 
test successfully met statutory criteria for model expansion,\336\ 
demonstrating five percent weight loss by participants (a key metric of 
the program's success) along with statistically significant reductions 
in Medicare spending, ED visits and inpatient stays.\337\
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    \335\ L Hinnant, S Razi, R Lewis, A Sun, M Alva, T Hoerger et 
al. Evaluation of the Health Care Innovation Awards: Community 
Resource Planning, Prevention, and Monitoring, Annual Report 2015. 
RTI International. March 2016; https://www.cms.gov/priorities/innovation/files/reports/hcia-ymcadpp-evalrpt.pdf.
    \336\ Paul Spitalnic. Certification of Medicare Diabetes 
Prevention Program. Mar. 14, 2016. https://www.cms.gov/Research-Statistics-Data-and-Systems/Research/ActuarialStudies/Downloads/Diabetes-Prevention-Certification-2016-03-14.pdf.
    \337\ Rojas Smith. L., Amico, P., Hoerger, T. J., Jacobs, S., 
Payne. J., & Renaud, J.: Evaluation of the Health Care Innovation 
Awards: Community Resource Planning, Prevention, and Monitoring 
Third Annual Report Addendum -- August 2017 (https://downloads.cms.gov/files/cmmi/hcia-crppm-thirdannrptaddendum.pdf (pp. 
858-914).
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    The MDPP expanded model was implemented through the rulemaking 
process in two phases in the CY 2017 PFS final rule \338\ and in the CY 
2018 PFS final rule.\339\ In the CY 2017 PFS, we established MDPP to 
expand the duration and scope of the DPP model test, created a new 
supplier class, finalized the MDPP framework for expansion, and 
finalized details about the benefit such as beneficiary eligibility 
criteria, MDPP supplier eligibility criteria, enrollment policies, and 
the MDPP benefit period. In the CY 2018 PFS, we finalized additional 
policies necessary for suppliers to begin furnishing MDPP services 
nationally in 2018, including established the MDPP payment structure 
and amounts, provided additional supplier enrollment requirements and 
supplier compliance standards. In addition, we updated CY 2017 policies 
regarding MDPP services and beneficiary eligibility, established an 
MDPP-specific supplier enrollment application and an effective date for 
MDPP billing privileges.
---------------------------------------------------------------------------

    \338\ Centers for Medicare & Medicaid Services. Medicare 
Program; Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Part B for CY 2017; Medicare 
Advantage Bid Pricing Data Release; Medicare Advantage and Part D 
Medical Loss Ratio Data Release; Medicare Advantage Provider Network 
Requirements; Expansion of Medicare Diabetes Prevention Program 
Model; Medicare Shared Savings Program Requirements. 81 FR 80170. 
https://www.govinfo.gov/content/pkg/FR-2016-11-15/pdf/2016-26668.pdf.
    \339\ Centers for Medicare & Medicaid Services. Medicare 
Program; Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Part B for CY 2018; Medicare Shared 
Savings Program Requirements; and Medicare Diabetes Prevention 
Program. 82 FR 52976. https://www.govinfo.gov/content/pkg/FR-2017-11-15/pdf/2017-23953.pdf.
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    Although MDPP was established through the 2017 PFS, it went into 
effect in 2018, with supplier enrollment starting January 1, 2018, and 
beneficiary enrollment starting April 1, 2018. After nearly 6 years of 
implementation, we are finalizing updates to MDPP based on lessons 
learned since the expanded model's launch, including updates to 
definitions and the core services period as well as extending the 
flexibilities allowed under the COVID-19 Public Health Emergency for a 
period of 4 years.
    The core maintenance session interval, as defined in the CY 2018 
PFS, means one of the two consecutive 3-month time periods during 
months 7 through 12 of the MDPP services period, during which an MDPP 
supplier offers an MDPP beneficiary at least one core maintenance 
session per month.\340\ The core maintenance session interval 
represents a performance interval for attendance-based payments in the 
current payment structure. Because we proposed that beneficiary 
attendance be paid on a fee-for-service basis, we proposed removing the 
core maintenance session interval to make the payment structure less 
confusing.
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    \340\ Centers for Medicare & Medicaid Services. Medicare 
Program; Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Part B for CY 2018; Medicare Shared 
Savings Program Requirements; and Medicare Diabetes Prevention 
Program. 82 FR 53359. https://www.govinfo.gov/content/pkg/FR-2017-11-15/pdf/2017-23953.pdf.

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[[Page 79242]]

    In prior rulemaking, we did not formally define the MDPP delivery 
modalities that are considered virtual. In this final rule, we proposed 
adding definitions for distance learning and online delivery modalities 
in Sec.  410.79(b) to better clarify which virtual modalities can be 
used in the proposed Extended flexibilities period.\341\
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    \341\ Centers for Medicare & Medicaid Services. Medicare and 
Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment and Coverage Policies; 
Medicare Shared Savings Program Requirements; Medicare Advantage; 
Medicare and Medicaid Provider and Supplier Enrollment Policies; and 
Basic Health Program. 88 FR 52738. https://www.govinfo.gov/content/pkg/FR-2023-08-07/pdf/2023-14624.pdf.
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    We also proposed to modify the definitions for Make-up session, 
MDPP services period, and MDPP session as defined in Sec.  410.79(b) to 
remove most references to ongoing maintenance sessions.\342\ In the 
finalized CY 2022 PFS, we removed eligibility for the ongoing 
maintenance sessions for those beneficiaries who started the Set of 
MDPP services on or after January 1, 2022.\343\ Given that the 2-year 
MDPP services period for those beneficiaries who started MDPP on or 
before December 31, 2021, will end on or before December 30, 2023, 
eligibility for ongoing maintenance services will end December 31, 2023 
for all beneficiaries.
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    \342\ Centers for Medicare & Medicaid Services. Medicare and 
Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment and Coverage Policies; 
Medicare Shared Savings Program Requirements; Medicare Advantage; 
Medicare and Medicaid Provider and Supplier Enrollment Policies; and 
Basic Health Program. 88 FR 52738. https://www.govinfo.gov/content/pkg/FR-2023-08-07/pdf/2023-14624.pdf.
    \343\ Centers for Medicare & Medicaid Services. Medicare 
Program; CY 2022 Payment Policies Under the Physician Fee Schedule 
and Other Changes to Part B Payment Policies; Medicare Shared 
Savings Program Requirements; Provider Enrollment Regulation 
Updates; and Provider and Supplier Prepayment and Post-Payment 
Medical Review Requirements. 86 FR 64996. https://www.govinfo.gov/content/pkg/FR-2021-11-19/pdf/2021-23972.pdf.
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    The core services period, as defined in Sec.  410.79(c)(2)(i)(A) 
and (B), consists of at least 16 core sessions offered at least one 
week apart during the months 1 through 6 of the MDPP services period, 
and two 3-month core maintenance session intervals offered during 
months 7 through 12 of the MDPP services period. In order to conform to 
the proposed revisions to the payment structure in Sec.  414.84, we 
proposed to amend the expanded model regulations to allow for fee-for-
service payments for beneficiary attendance during the core services 
period.
    MDPP's performance-based payment structure was established in the 
CY 2018 PFS final rule \344\ to pay for the Set of MDPP services that 
makes up the periodic performance payments to MDPP suppliers during the 
MDPP services period. The aggregate of all MDPP performance payments 
constitutes the total performance-based payment amount for the Set of 
MDPP services. Although beneficiaries may currently attend at least 16 
weekly sessions in months 1-6 and at least 6 monthly sessions in months 
7-12, MDPP suppliers are only paid five times for beneficiary 
attendance: after a beneficiary attends the 1st, 4th and 9th sessions 
in months 1-6, and after attending the second core maintenance session 
in months 7-9 and in months 10-12.\345\
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    \344\ Centers for Medicare & Medicaid Services. Medicare 
Program; Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Part B for CY 2018; Medicare Shared 
Savings Program Requirements; and Medicare Diabetes Prevention 
Program. 82 FR 52976. https://www.govinfo.gov/content/pkg/FR-2017-11-15/pdf/2017-23953.pdf.
    \345\ Centers for Medicare & Medicaid Services. Medicare 
Program; Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Part B for CY 2018; Medicare Shared 
Savings Program Requirements; and Medicare Diabetes Prevention 
Program. 82 FR 53280. https://www.govinfo.gov/content/pkg/FR-2017-11-15/pdf/2017-23953.pdf.
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    Since this payment structure went into effect in 2018, feedback was 
received from suppliers and interested parties that the MDPP 
performance-based payment structure is confusing to suppliers, 
including those new to Medicare and existing Medicare-enrolled 
suppliers. Confusion with claims submission has been due in part to the 
MDPP payment structure, which pays for attendance and diabetes risk-
reduction performance-based milestones instead of paying for an 
individual service. Paying for an individual service delivery is 
typical in Medicare.\346\ Public comments in response to the CY 2018 
PFS proposed rule have indicated that CMS should modify its payment 
structure such that it allows for an adequate and predictable payment 
stream to cover the cost of providing services as long as beneficiaries 
attend sessions.
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    \346\ What Part B Covers. https://www.medicare.gov/what-medicare-covers/what-part-b-covers.
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    After 5 years of testing the current performance-based payment 
structure, we have determined that the structure is inadequate to meet 
MDPP supplier needs and beneficiary retention. For example, there are 
currently five attendance-based performance payments over the 12-month 
MDPP service period, with a potential 4- to 5-month lag between the 
third payment and the fourth payment. We believe that our current 
payment structure does not incentivize beneficiary retention. As a 
result, we proposed fee-for-service payments for beneficiary attendance 
in this final rule, allowing for up to 22 attendance-based payments 
versus the five that are currently in place. Thus, we proposed allowing 
beneficiaries to attend a maximum of 22 sessions during the core 
services period, including up to 16 sessions in months 1-6 and up to 6 
sessions in months 7-12.\347\
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    \347\ Centers for Medicare & Medicaid Services. Medicare and 
Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment and Coverage Policies; 
Medicare Shared Savings Program Requirements; Medicare Advantage; 
Medicare and Medicaid Provider and Supplier Enrollment Policies; and 
Basic Health Program. 88 FR 52739. https://www.govinfo.gov/content/pkg/FR-2023-08-07/pdf/2023-14624.pdf.
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    We proposed to amend the MDPP expanded model to revise certain MDPP 
policies finalized in the CY 2021 PFS final rule.\348\ We proposed to 
extend the flexibilities allowed under the COVID-19 PHE for a period of 
4 years until December 31, 2027. These Extended flexibilities are 
described in Sec.  410.79(e)(3)(iii), and (iv) of this final rule. The 
MDPP regulations provide for the following flexibilities during the PHE 
or an applicable 1135 waiver event:
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    \348\ Centers for Medicare & Medicaid Services. Medicare 
Program; CY 2021 Payment Policies Under the Physician Fee Schedule 
and Other Changes to Part B Payment Policies; Medicare Shared 
Savings Program Requirements; Medicaid Promoting Interoperability 
Program Requirements for Eligible Professionals; Quality Payment 
Program; Coverage of Opioid Use Disorder Services Furnished by 
Opioid Treatment Programs; Medicare Enrollment of Opioid Treatment 
Programs; Electronic Prescribing for Controlled Substances for a 
Covered Part D Drug; Payment for Office/Outpatient Evaluation and 
Management Services; Hospital IQR Program; Establish New Code 
Categories; Medicare Diabetes Prevention Program (MDPP) Expanded 
Model Emergency Policy; Coding and Payment for Virtual Check-in 
Services Interim Final Rule Policy; Coding and Payment for Personal 
Protective Equipment (PPE) Interim Final Rule Policy; Regulatory 
Revisions in Response to the Public Health Emergency (PHE) for 
COVID-19; and Finalization of Certain Provisions from the March 
31st, May 8th and September 2nd Interim Final Rules in Response to 
the PHE for COVID-19. 85 FR 85027. https://www.govinfo.gov/content/pkg/FR-2020-12-28/pdf/2020-26815.pdf.
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     Alternatives to the requirement for in-person weight 
measurement (Sec.  410.79(e)(3)(iii)). Section 410.79(e)(3)(iii) 
permits an MDPP supplier to obtain weight measurements for MDPP 
beneficiaries for the baseline weight and any weight loss-based 
performance achievement goals in the following manner: (1) via digital 
technology, such as scales that transmit weights securely via wireless 
or cellular transmission; or (2) via self-reported weight measurements 
from the at-home digital scale of the MDPP beneficiary.

[[Page 79243]]

We stated that self-reported weights must be obtained during live, 
synchronous online video technology, such as video chatting or video 
conferencing, wherein the MDPP Coach observes the beneficiary weighing 
themselves and views the weight indicated on the at-home digital scale. 
Alternatively, the MDPP beneficiary may self-report their weight by 
submitting to the MDPP supplier a date-stamped photo or video recording 
of the beneficiary's weight, with the beneficiary visible in their 
home. The photo or video must clearly document the weight of the MDPP 
beneficiary as it appears on the digital scale on the date associated 
with the billable MDPP session. This flexibility allows suppliers to 
bill for participants achieving weight loss performance goals.
     Elimination of the maximum number of virtual 
services (Sec.  410.79(e)(3)(iv): The virtual session limits described 
in Sec.  410.79(d)(2), and (d)(3)(i) and (ii) do not apply, and MDPP 
suppliers may provide all MDPP sessions virtually during the PHE as 
defined in Sec.  400.200 of this chapter or applicable 1135 waiver 
event. MDPP suppliers were permitted to provide the Set of MDPP 
services virtually during the PHE for COVID-19, as long as the virtual 
services were furnished in a manner that is consistent with the CDC 
DPRP standards for virtual sessions, follow the CDC-approved National 
DPP curriculum requirements, and the supplier has an in-person DPRP 
organizational code.
    We proposed that during the Extended flexibilities period, MDPP 
suppliers may provide virtual services as long as they are provided in 
a manner consistent with the CDC DPRP standards for distance 
learning.\349\ The extension of these flexibilities under Sec.  
410.79I(3)(v) will allow beneficiaries to obtain the Set of MDPP 
services either in-person, through distance learning, or through a 
combination of in-person and distance learning for a period of 4 years.
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    \349\ Centers for Medicare & Medicaid Services. Medicare and 
Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment and Coverage Policies; 
Medicare Shared Savings Program Requirements; Medicare Advantage; 
Medicare and Medicaid Provider and Supplier Enrollment Policies; and 
Basic Health Program. 88 FR 52739. https://www.govinfo.gov/content/pkg/FR-2023-08-07/pdf/2023-14624.pdf.
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    In the May 2, 2023, Federal Register (88 FR 27413), we published a 
notice extending PHE flexibilities for MDPP suppliers, providing them 
the opportunity to deliver the Set of MDPP services either virtually or 
in-person (or a combination of both) from May 12, 2023, through 
December 31, 2023. As a result, MDPP suppliers can continue delivering 
the Set of MDPP services on a virtual basis during this period to allow 
MDPP suppliers additional time to resume in-person services. For more 
information on the Federal Register Notice, please see https://www.federalregister.gov/d/2023-09188. For more information on the 
flexibilities that MDPP suppliers were permitted to implement during 
the PHE, please see https://www.ms.gov/files/document/participants-medicare-diabetes-prevention-program-cms-flexibilities-fight-covid-19.pdf. The CDC's 2021 DPRP Standards allow two types of virtual 
delivery modalities: ``Distance learning'' and ``online'' 
delivery.\350\ According to CDC, Distance learning involves ``a 
yearlong National DPP lifestyle change program delivered 100 percent by 
trained Lifestyle Coaches via remote classroom or telehealth. The 
Lifestyle Coach provides live (synchronous) delivery of session content 
in one location and participants call-in or video-conference from 
another location.''\29\ Although ``telehealth'' is included in CDC's 
definition of distance learning, CMS stated in the CY 2017 PFS final 
rule (82 FR 52976) that MDPP services delivered via a 
telecommunications system or other remote technologies do not qualify 
as telehealth services.\351\
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    \350\ Centers for Disease Control and Prevention. Diabetes 
Prevention Recognition Program: Standards and Operating Procedures. 
May 1, 2021. https://www.cdc.gov/diabetes/prevention/pdf/dprp-standards.pdf.
    \351\ Centers for Medicare & Medicaid Services. Medicare 
Program; Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Part B for CY 2017; Medicare 
Advantage Pricing Data Release; Medicare Advantage and Part D 
Medical Low Ratio Data Release; Medicare Advantage Provider Network 
Requirements; Expansion of Medicare Diabetes Prevention Program 
Model. 82 FR 52976, November 15, 2017. https://www.govinfo.gov/content/pkg/FR-2017-11-15/pdf/2017-23953.pdf.
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    Additionally, CDC defines online delivery as a yearlong National 
DPP lifestyle change program delivered 100 percent online for all 
participants. \29\ The program is experienced through the internet via 
smart phone, tablet, or laptop in an asynchronous classroom where 
participants are experiencing the content on their own time without a 
live Lifestyle Coach teaching the content. However, live Lifestyle 
Coach interaction should be provided to each participant no less than 
once per week during the first 6 months and once per month during the 
second 6 months. Emails and text messages can count toward the 
requirement for live coach interaction as long as there is bi-
directional communication between coach and participant.\352\
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    \352\ Centers for Disease Control & Prevention Diabetes 
Prevention Recognition Program: Standards and Operating Procedures. 
May 1, 2021. https://www.cdc.gov/diabetes/prevention/pdf/dprp-standards.pdf.
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    In the CY 2021 PFS final rule (85 FR 84472),\353\ we established 
that virtual sessions performed under flexibilities finalized in that 
rule could only be performed by suppliers who offered in-person 
services. For the proposed Extended flexibilities period,\354\ we 
proposed to limit virtual delivery to the CDC DPRP definition of 
``distance learning.'' This proposal was based on internal data from 
the PHE for COVID-19, including anecdotal, monitoring, evaluation, 
claims, and CDC DPRP data, suggesting that the majority of the MDPP 
virtual sessions delivered during the PHE for COVID-19 1135 waiver 
event were distance learning sessions.
---------------------------------------------------------------------------

    \353\ Centers for Medicare & Medicaid Services. Medicare 
Program; CY 2021 Payment Policies Under the Physician Fee Schedule 
and Other Changes to Part B Payment Policies; Medicare Shared 
Savings Program Requirements; Medicaid Promoting Interoperability 
Program Requirements for Eligible Professionals; Quality Payment 
Program; Coverage of Opioid Use Disorder Services Furnished by 
Opioid Treatment Programs; Medicare Enrollment of Opioid Treatment 
Programs; Electronic Prescribing for Controlled Substances for a 
Covered Part D Drug; Payment for Office/Outpatient Evaluation and 
Management Services; Hospital IQR Program; Establish New Code 
Categories; Medicare Diabetes Prevention Program (MDPP) Expanded 
Model Emergency Policy; Coding and Payment for Virtual Check-in 
Services Interim Final Rule Policy; Coding and Payment for Personal 
Protective Equipment (PPE) Interim Final Rule Policy; Regulatory 
Revisions in Response to the Public Health Emergency (PHE) for 
COVID-19; and Finalization of Certain Provisions from the March 
31st, May 8th and September 2nd Interim Final Rules in Response to 
the PHE for COVID-19. (85 FR 84472), December 28, 2020. https://www.federalregister.gov/d/2020-26815.
    \354\ Centers for Medicare & Medicaid Services. Medicare and 
Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment and Coverage Policies; 
Medicare Shared Savings Program Requirements; Medicare Advantage; 
Medicare and Medicaid Provider and Supplier Enrollment Policies; and 
Basic Health Program. 88 FR 52503. https://www.govinfo.gov/content/pkg/FR-2023-08-07/pdf/2023-14624.pdf.
---------------------------------------------------------------------------

    Although the MDPP was certified and established as an in-person 
service, in response to the PHE for COVID-19, we established and 
implemented policies that allowed MDPP suppliers to provide MDPP 
services virtually during the PHE for COVID-19, as long as the virtual 
services: were furnished in a manner that is consistent with the CDC 
DPRP standards for virtual sessions, the curriculum furnished during 
the virtual sessions addressed the same curriculum topics as the CDC-
approved National DPP curriculum, the supplier had an in-person DPRP 
organizational code, and other requirements specified at

[[Page 79244]]

Sec.  410.79(e)(3)(iv) were satisfied.\355\ We believe that distance 
learning allows for a similar live group experience for beneficiaries 
but only when delivered in a synchronous virtual manner through 
telephonic or video conference. Through utilizing distance learning, 
participants may still interact with their Coach and other participants 
in their cohort in real-time, allowing for relationship building and 
peer support, unlike online delivery which is delivered asynchronously. 
Therefore, the proposed Extended flexibilities do not include online 
delivery (or asynchronous virtual), as defined in the CDC DPRP 
Standards through the ``online'' modality, including virtual make-up 
sessions.
---------------------------------------------------------------------------

    \355\ Centers for Medicare & Medicaid Services. Medicare 
Program; CY 2021 Payment Policies Under the Physician Fee Schedule 
and Other Changes to Part B Payment Policies; Medicare Shared 
Savings Program Requirements; Medicaid Promoting Interoperability 
Program Requirements for Eligible Professionals; Quality Payment 
Program; Coverage of Opioid Use Disorder Services Furnished by 
Opioid Treatment Programs; Medicare Enrollment of Opioid Treatment 
Programs; Electronic Prescribing for Controlled Substances for a 
Covered Part D Drug; Payment for Office/Outpatient Evaluation and 
Management Services; Hospital IQR Program; Establish New Code 
Categories; Medicare Diabetes Prevention Program (MDPP) Expanded 
Model Emergency Policy; Coding and Payment for Virtual Check-in 
Services Interim Final Rule Policy; Coding and Payment for Personal 
Protective Equipment (PPE) Interim Final Rule Policy; Regulatory 
Revisions in Response to the Public Health Emergency (PHE) for 
COVID-19; and Finalization of Certain Provisions from the March 
31st, May 8th and September 2nd Interim Final Rules in Response to 
the PHE for COVID-19. (85 FR 85027), December 28, 2020. https://www.federalregister.gov/d/2020-26815.
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    We previously stated that the MDPP expanded model was certified for 
expansion by the Chief Actuary of CMS, based on a model test that used 
in-person delivery.\356\ Given the 3-year duration of the PHE for 
COVID-19 and the feedback received from MDPP suppliers, beneficiaries, 
MA plans, interested parties, and comments submitted during the CY 2022 
rulemaking, there is interest in extending the flexibilities offered 
during the PHE for COVID-19 to reduce the burden of traveling to an in-
person class on a weekly basis, as beneficiaries experienced 
transportation as well as child/elder care challenges with in-person 
delivery. Additionally, we have heard interest in a hybrid or 
combination delivery option where participants could attend some in-
person classes as well as virtual classes. As a result of this 
feedback, we proposed to extend the flexibilities allowed under Sec.  
410.79(e)(3)(iii) (regarding use of alternative methods for obtaining 
weight measurements during virtual services) and Sec.  410.79(e)(3)(iv) 
(regarding elimination of the maximum number of virtual services) for 4 
years, to give us time to test and evaluate the distance learning 
delivery of MDPP.
---------------------------------------------------------------------------

    \356\ Centers for Medicare & Medicaid Services. Medicare 
Program; CY 2021 Payment Policies Under the Physician Fee Schedule 
and Other Changes to Part B Payment Policies; Medicare Shared 
Savings Program Requirements; Medicaid Promoting Interoperability 
Program Requirements for Eligible Professionals; Quality Payment 
Program; Coverage of Opioid Use Disorder Services Furnished by 
Opioid Treatment Programs; Medicare Enrollment of Opioid Treatment 
Programs; Electronic Prescribing for Controlled Substances for a 
Covered Part D Drug; Payment for Office/Outpatient Evaluation and 
Management Services; Hospital IQR Program; Establish New Code 
Categories; Medicare Diabetes Prevention Program (MDPP) Expanded 
Model Emergency Policy; Coding and Payment for Virtual Check-in 
Services Interim Final Rule Policy; Coding and Payment for Personal 
Protective Equipment (PPE) Interim Final Rule Policy; Regulatory 
Revisions in Response to the Public Health Emergency (PHE) for 
COVID-19; and Finalization of Certain Provisions from the March 
31st, May 8th and September 2nd Interim Final Rules in Response to 
the PHE for COVID-19. (85 FR 84833), December 28, 2020. https://www.federalregister.gov/d/2020-26815.pdf.
---------------------------------------------------------------------------

    Since MDPP was established in the CY 2017 PFS final rule, CMS and 
interested parties have considered whether fully virtual services could 
be included as part of the expanded model. For example, in the CY 2017 
PFS proposed rule, we proposed that MDPP suppliers be allowed to 
provide MDPP services via remote technologies, even though the majority 
of CDC DPRP organizations provided in-person delivery at that 
time.\357\ However, we also recognized that the virtual delivery of the 
Set of MDPP services may introduce additional risk of fraud and abuse. 
CMS stated that if that provision was to be finalized, we will propose 
specific policies in future rulemaking to mitigate these risks. In the 
CY 2017 PFS final rule (81 FR 80459), we deferred establishing policies 
related to organizations delivering the Set of MDPP services virtually.
---------------------------------------------------------------------------

    \357\ Centers for Medicare & Medicaid Services. Centers for 
Medicare & Medicaid Services. Medicare Program; Revisions to Payment 
Policies Under the Physician Fee Schedule and Other Revisions to 
Part B for CY 2017; Medicare Advantage Pricing Data Release; 
Medicare Advantage and Part D Medical Low Ratio Data Release; 
Medicare Advantage Provider Network Requirements; Expansion of 
Medicare Diabetes Prevention Program Model. 81 FR 46417. July 15, 
2016. https://www.govinfo.gov/content/pkg/FR-2016-07-15/pdf/2016-16097.pdf.
---------------------------------------------------------------------------

    In the subsequent CY 2018 PFS proposed rule, we explained our 
rationale for proposing not to allow fully virtual delivery of MDPP, 
but did propose to allow, consistent with CDC DPRP Standards, a limited 
number of virtual make-up sessions for participants who missed a 
regularly scheduled session.\36\ ``Virtual make-up session'' was 
defined in Sec.  410.79(d)(2) as a make-up session that is not 
furnished in-person and that is furnished in a manner consistent with 
the requirements in paragraph Sec.  410.79(d)(1). In the CY 2018 PFS 
final rule,\358\ we finalized that the Set of MDPP services would be 
primarily delivered in-person, in a classroom-based setting, and within 
an established timeline.
---------------------------------------------------------------------------

    \358\ Centers for Medicare & Medicaid Services. Medicare 
Program; Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Part B for CY 2017; Medicare 
Advantage Pricing Data Release; Medicare Advantage and Part D 
Medical Low Ratio Data Release; Medicare Advantage Provider Network 
Requirements; Expansion of Medicare Diabetes Prevention Program 
Model. 82 FR 53359, November 15, 2017. https://www.govinfo.gov/content/pkg/FR-2017-11-15/pdf/2017-23953.pdf.
---------------------------------------------------------------------------

    We prioritized establishing a service that, when delivered within 
this framework, would create the least risk of fraud, waste, and abuse; 
increase the likelihood of success for beneficiaries; and maintain the 
integrity of data. Furthermore, we believed at that time that in-person 
administration of beneficiaries' weight measurements was the most 
reliable and appropriate approach to monitoring beneficiary-level 
progress toward the 5 percent weight loss programmatic goal.
    However, circumstances have changed since the start of the expanded 
model. We have received comments from interested parties in response to 
the CY 2018 PFS proposed rule and thereafter regarding increasing the 
limited virtual delivery of MDPP. Commenters noted that increased 
virtual options could expand access to MDPP for beneficiaries in rural 
areas, those who lack access to healthcare providers, specifically 
minority beneficiaries living within underserved communities, 
beneficiaries who are homebound or who lack transportation options, as 
well as increase beneficiary choice of delivery modality and 
flexibility of location. Commenters also noted that virtual National 
DPP delivery has been successful in reaching beneficiaries in certain 
locations. Ultimately, we finalized our policy that suppliers could 
offer no more than four virtual makeup sessions during months 1-6 and 
two virtual makeup sessions during months 7-12.
    On March 13, 2020, less than 2 years after MDPP went into effect, 
COVID-19 was declared a national emergency by Proclamation 9994.\359\ 
By mid-March 2020, MDPP suppliers were largely

[[Page 79245]]

unable to deliver in-person classes due to national and local 
restrictions resulting from the national emergency. On April 6, 2020, 
CMS established MDPP PHE-related flexibilities in the first interim 
final rule with comment (IFC-1),\360\ to allow for temporary 
flexibilities that prioritized availability and continuity of services 
for MDPP suppliers and MDPP beneficiaries impacted by extreme and 
uncontrollable circumstances during the PHE for COVID-19. These 
flexibilities allowed an unlimited number of virtual sessions, waived 
the once-per-lifetime limit for those participating in MDPP when the 
PHE for COVID-19 started, and waived the 5 percent weight loss 
requirement to continue with ongoing maintenance sessions.
---------------------------------------------------------------------------

    \359\ https://www.whitehouse.gov/briefing-room/presidential-
actions/2023/02/10/notice-on-the-continuation-of-the-national-
emergency-concerning-the-coronavirus-disease-2019-covid-19-pandemic-
3/
#:~:text=On%20March%2013%2C%202020%2C%20by,(COVID%2D19)%20pandemic.
    \360\ Centers for Medicare & Medicaid Services, HHS. Medicare 
and Medicaid Programs; Policy and Regulatory Revisions in Response 
to the COVID-19 Public Health Emergency. (85 FR 19230, Monday, April 
6, 2020) https://www.federalregister.gov/documents/2020/04/06/2020-06990/medicare-and-medicaid-programs-policy-and-regulatory-revisions-in-response-to-the-covid-19-public.
---------------------------------------------------------------------------

    However, we did not waive the requirement for in-person weigh-ins 
at that time, leaving suppliers unable to obtain the 5 percent weight 
loss performance payment given the local and State restrictions that 
may have kept individuals at home during the initial months of the PHE 
for COVID-19. This prevented suppliers from collecting an in-person 
weight from beneficiaries at each MDPP session as described in Sec.  
424.205(g)(2)(v) to document the 5 percent weight loss.
    In the CY 2021 PFS final rule,\361\ we finalized the MDPP Emergency 
Policy and updated the PHE flexibilities established in the IFC-1 in 
the following ways: allowing for virtual weigh-ins and new cohorts to 
begin virtually; reinstating the 5 percent weight loss requirement 
during an 1135 waiver event; and reinstating the once-per-lifetime 
limit during an 1135 waiver event starting with beneficiaries who 
started the Set of MDPP services in 2021 or thereafter. These changes 
sought to address interruptions in services caused by CMS not waiving 
the in-person weigh-in in IFC-1, which prevented MDPP suppliers from 
starting new cohorts and getting reimbursed for participants who 
achieved and maintained the 5 percent weight loss goals. Additionally, 
beneficiaries who began sessions on or before December 31, 2020, were 
able to re-start MDPP sessions at a later date. Similarly, we allowed 
suppliers to pause, then resume MDPP sessions at a later date.
---------------------------------------------------------------------------

    \361\ Centers for Medicare & Medicaid Services. Medicare 
Program; CY 2021 Payment Policies Under the Physician Fee Schedule 
and Other Changes to Part B Payment Policies; Medicare Shared 
Savings Program Requirements; Medicaid Promoting Interoperability 
Program Requirements for Eligible Professionals; Quality Payment 
Program; Coverage of Opioid Use Disorder Services Furnished by 
Opioid Treatment Programs; Medicare Enrollment of Opioid Treatment 
Programs; Electronic Prescribing for Controlled Substances for a 
Covered Part D Drug; Payment for Office/Outpatient Evaluation and 
Management Services; Hospital IQR Program; Establish New Code 
Categories; Medicare Diabetes Prevention Program (MDPP) Expanded 
Model Emergency Policy; Coding and Payment for Virtual Check-in 
Services Interim Final Rule Policy; Coding and Payment for Personal 
Protective Equipment (PPE) Interim Final Rule Policy; Regulatory 
Revisions in Response to the Public Health Emergency (PHE) for 
COVID-19; and Finalization of Certain Provisions from the March 
31st, May 8th and September 2nd Interim Final Rules in Response to 
the PHE for COVID-19. (85 FR 84831), December 28, 2020. https://www.federalregister.gov/d/2020-26815.pdf.
---------------------------------------------------------------------------

    During the PHE for COVID-19, we allowed full virtual delivery of 
MDPP. In making that policy change in the CY 2021 PFS final rule, we 
stated that ``Because MDPP services are covered under Medicare only 
when they are furnished at least in-part in-person, a supplier that 
does not have an organizational code authorizing in-person services 
(``virtual-only suppliers'') may not provide MDPP services, either 
virtually or in-person.''\362\ We indicated that it is not appropriate 
to permit virtual-only suppliers, such as suppliers with CDC DPRP 
recognition in the distance learning, online, or combination only 
modalities, to furnish MDPP services when the Emergency Policy is in 
effect. This is due to the requirement that MDPP suppliers remain 
prepared to resume in-person delivery of the Set of MDPP services to 
start new cohorts and to serve beneficiaries who wish to return to in-
person services when the Emergency Policy is no longer in effect.
---------------------------------------------------------------------------

    \362\ Centers for Medicare & Medicaid Services. Medicare 
Program; CY 2021 Payment Policies Under the Physician Fee Schedule 
and Other Changes to Part B Payment Policies; Medicare Shared 
Savings Program Requirements; Medicaid Promoting Interoperability 
Program Requirements for Eligible Professionals; Quality Payment 
Program; Coverage of Opioid Use Disorder Services Furnished by 
Opioid Treatment Programs; Medicare Enrollment of Opioid Treatment 
Programs; Electronic Prescribing for Controlled Substances for a 
Covered Part D Drug; Payment for Office/Outpatient Evaluation and 
Management Services; Hospital IQR Program; Establish New Code 
Categories; Medicare Diabetes Prevention Program (MDPP) Expanded 
Model Emergency Policy; Coding and Payment for Virtual Check-in 
Services Interim Final Rule Policy; Coding and Payment for Personal 
Protective Equipment (PPE) Interim Final Rule Policy; Regulatory 
Revisions in Response to the Public Health Emergency (PHE) for 
COVID-19; and Finalization of Certain Provisions from the March 
31st, May 8th and September 2nd Interim Final Rules in Response to 
the PHE for COVID-19. (85 FR 84830), December 28, 2020. https://www.federalregister.gov/d/2020-26815.pdf.
---------------------------------------------------------------------------

    As stated earlier, we proposed in the CY 2024 PFS proposed rule to 
extend the flexibilities allowed during the PHE for COVID-19 under 
Sec.  410.79(e)(3)(iii), and (iv) for 4 years, or through December 31, 
2027.\363\ Next, we proposed that the Extended flexibilities under 
Sec.  410.79(e)(3)(iii) and (iv) continue to apply only to MDPP 
suppliers that have and maintain CDC DPRP in-person recognition.\364\ 
We recognized that organizations and interested parties may be 
disappointed that we did not propose to allow organizations with CDC 
recognition in distance learning delivery modalities to participate in 
MDPP unless they also have and maintain their in-person CDC 
recognition. In the CY 2021 PFS final rule,\365\ we stated that virtual 
only suppliers are not permitted to provide the Set of MDPP services 
because MDPP beneficiaries may elect to return to in-person services 
after the PHE for COVID-19 or other applicable 1135 waiver event ends, 
and MDPP suppliers need to be able to accommodate their request.
---------------------------------------------------------------------------

    \363\ Centers for Medicare & Medicaid Services. Medicare and 
Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment and Coverage Policies; 
Medicare Shared Savings Program Requirements; Medicare Advantage; 
Medicare and Medicaid Provider and Supplier Enrollment Policies; and 
Basic Health Program. 88 FR 52503. https://www.govinfo.gov/content/pkg/FR-2023-08-07/pdf/2023-14624.pdf.
    \364\ Centers for Medicare & Medicaid Services. Medicare and 
Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment and Coverage Policies; 
Medicare Shared Savings Program Requirements; Medicare Advantage; 
Medicare and Medicaid Provider and Supplier Enrollment Policies; and 
Basic Health Program. 88 FR 52504. https://www.govinfo.gov/content/pkg/FR-2023-08-07/pdf/2023-14624.pdf.
    \365\ Centers for Medicare & Medicaid Services. Medicare 
Program; CY 2021 Payment Policies Under the Physician Fee Schedule 
and Other Changes to Part B Payment Policies; Medicare Shared 
Savings Program Requirements; Medicaid Promoting Interoperability 
Program Requirements for Eligible Professionals; Quality Payment 
Program; Coverage of Opioid Use Disorder Services Furnished by 
Opioid Treatment Programs; Medicare Enrollment of Opioid Treatment 
Programs; Electronic Prescribing for Controlled Substances for a 
Covered Part D Drug; Payment for Office/Outpatient Evaluation and 
Management Services; Hospital IQR Program; Establish New Code 
Categories; Medicare Diabetes Prevention Program (MDPP) Expanded 
Model Emergency Policy; Coding and Payment for Virtual Check-in 
Services Interim Final Rule Policy; Coding and Payment for Personal 
Protective Equipment (PPE) Interim Final Rule Policy; Regulatory 
Revisions in Response to the Public Health Emergency (PHE) for 
COVID-19; and Finalization of Certain Provisions from the March 
31st, May 8th and September 2nd Interim Final Rules in Response to 
the PHE for COVID-19. (85 FR 84831), December 28, 2020. https://www.federalregister.gov/d/2020-26815.pdf.
---------------------------------------------------------------------------

    During the PHE for COVID-19, we allowed greater flexibility with 
the use of virtual sessions, but the virtual delivery was primarily 
furnished as a virtual classroom or through distance

[[Page 79246]]

learning. In the CY 2024 PFS proposed rule,\366\ we proposed that 
suppliers may offer a combination delivery of MDPP, including both in-
person and distance learning. After almost 4 years of having the option 
to deliver the Set of MDPP services through distance learning, between 
the PHE for COVID-19 and the Federal Register Notice to extend the PHE 
flexibilities through December 31, 2023, allowing MDPP suppliers to 
have the option to continue delivering the Set of MDPP services in the 
same manner will be the least disruptive to both suppliers and 
beneficiaries. We also proposed that MDPP suppliers may no longer 
suspend the Set of MDPP services as described in paragraph (e)(3)(v) in 
this section on or after January 1, 2024.\45\ We believe we have given 
MDPP suppliers ample time, through the Federal Register Notice to 
extend the PHE flexibilities through December 31, 2023, to adequately 
prepare to resume MDPP services from an operational perspective.
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    \366\ Centers for Medicare & Medicaid Services. Medicare and 
Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment and Coverage Policies; 
Medicare Shared Savings Program Requirements; Medicare Advantage; 
Medicare and Medicaid Provider and Supplier Enrollment Policies; and 
Basic Health Program. 88 FR 52505. https://www.govinfo.gov/content/pkg/FR-2023-08-07/pdf/2023-14624.pdf.
---------------------------------------------------------------------------

    Furthermore, we also believe that our proposal to extend the PHE 
flexibilities for 4 years, or through December 31, 2027, will make MDPP 
more equitable and accessible for all eligible beneficiaries by 
providing both suppliers and beneficiaries more flexibility in how the 
Set of MDPP services are delivered, including in-person, distance 
learning, or a combination of in-person and distance learning. For 
example, allowing virtual sessions will make MDPP more accessible to 
beneficiaries who reside in rural or urban communities or urban 
underserved communities, and who may have transportation and other 
barriers to attending in-person classes. We anticipate that the 
combination of a simplified payment structure in addition to more 
flexibilities regarding how MDPP is delivered will encourage more 
organizations to engage in and deliver MDPP, making MDPP more 
accessible to more beneficiaries.
    Additionally, extending the PHE flexibilities for 4 years would 
provide CMS an opportunity to evaluate the impact of the Extended 
flexibilities over a longer period of time. To better track the use of 
distance learning through claims, we proposed the creation of a new 
HCPCS G-code specific to ``distance learning,\367\'' that will more 
accurately track sites from which distance learning occurs, the number 
of MDPP sessions delivered by distance learning, monitor the expanded 
model for fraud, waste, or abuse, and evaluate the impact of distance 
learning and in-person delivery modalities of MDPP relative to cost-
savings and diabetes risk reduction among participants.
---------------------------------------------------------------------------

    \367\ Centers for Medicare & Medicaid Services. Medicare and 
Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment and Coverage Policies; 
Medicare Shared Savings Program Requirements; Medicare Advantage; 
Medicare and Medicaid Provider and Supplier Enrollment Policies; and 
Basic Health Program. 88 FR 52506. https://www.govinfo.gov/content/pkg/FR-2023-08-07/pdf/2023-14624.pdf.
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    In previous rulemaking, we received comments about how to best 
monitor the use of virtual make-up sessions, and whether CMS would use 
an additional HCPCS code or modifier to indicate virtual sessions since 
there was a limit to the number of virtual make-up sessions a 
beneficiary can attend.\368\ In response, we finalized the use of the 
virtual make-up sessions in Sec.  410.79(d)(2) and stated that MDPP 
suppliers must include the virtual modifier (VM) on claims to indicate 
the use of the virtual make-up session.\369\ As part of the MDPP 
flexibilities established in response to the PHE for COVID-19, we 
eliminated the maximum number of virtual make-up sessions that could be 
delivered by MDPP suppliers, described in Sec.  410.79(d)(2) and 
(d)(3)(i) and (ii), but still required MDPP suppliers to use the VM to 
indicate when a beneficiary received MDPP virtually.
---------------------------------------------------------------------------

    \368\ Centers for Medicare & Medicaid Services. Medicare 
Program; Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Part B for CY 2017; Medicare 
Advantage Pricing Data Release; Medicare Advantage and Part D 
Medical Low Ratio Data Release; Medicare Advantage Provider Network 
Requirements; Expansion of Medicare Diabetes Prevention Program 
Model. 82 FR 52976, November 15, 2017. https://www.govinfo.gov/content/pkg/FR-2017-11-15/pdf/2017-23953.pdf.
    \369\ Centers for Medicare & Medicaid Services. Medicare 
Program; Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Part B for CY 2017; Medicare 
Advantage Pricing Data Release; Medicare Advantage and Part D 
Medical Low Ratio Data Release; Medicare Advantage Provider Network 
Requirements; Expansion of Medicare Diabetes Prevention Program 
Model. 82 FR 53254, November 15, 2017. https://www.govinfo.gov/content/pkg/FR-2017-11-15/pdf/2017-23953.pdf.
---------------------------------------------------------------------------

    Given the inconsistent use of the VM as it was described in the CY 
2018 PFS final rule to document the virtual make-up sessions allowed 
during the PHE for COVID-19 as described in Sec.  410.79(e)(2)(iii), we 
proposed to add a HCPCS code for distance learning to better track the 
synchronous virtual delivery of the Set of MDPP services to be used 
instead of the VM when submitting MDPP claims, including claims for 
make-up sessions since we are not permitting online (asynchronous 
virtual) delivery of the Set of MDPP services.\370\ At this time, we 
did not propose to remove use of the VM entirely in-case we need it in 
future rulemaking, for example, should we allow online make-up sessions 
in future rulemaking.
---------------------------------------------------------------------------

    \370\ Centers for Medicare & Medicaid Services. Medicare and 
Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment and Coverage Policies; 
Medicare Shared Savings Program Requirements; Medicare Advantage; 
Medicare and Medicaid Provider and Supplier Enrollment Policies; and 
Basic Health Program. 88 FR 52507. https://www.govinfo.gov/content/pkg/FR-2023-08-07/pdf/2023-14624.pdf.
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    MDPP supplier locations have traditionally clustered proximate to 
large metropolitan areas, leaving significant gaps throughout rural 
communities.\371\ Given that the MDPP curriculum consists of no fewer 
than 16 weekly sessions in months 1-6, and 6 monthly sessions in months 
7-12 months, the participation commitment may pose significant 
challenges to beneficiaries with limited mobility or access to reliable 
transportation. Based on findings from the 2nd evaluation report of the 
MDPP expanded model,\372\ we believe that in-person requirements have 
contributed to significant MDPP underutilization, not only for those 
who reside in rural communities, but also populations that experience 
excessive diabetes-related disparities, including populations of color, 
low-income beneficiaries, those living in Tribal and rural communities, 
and the disabled.
---------------------------------------------------------------------------

    \371\ RTI International. Evaluation of the Medicare Diabetes 
Prevention Program (MDPP): Second Evaluation Report. November 2022. 
https://www.cms.gov/priorities/innovation/data-and-reports/2022/mdpp-2ndannevalrpt.
    \372\ RTI International. Evaluation of the Medicare Diabetes 
Prevention Program: Second Evaluation Report. November 2022. https://innovation.cms.gov/data-and-reports/2022/mdpp-2ndannevalrpt.
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    To date, beneficiary uptake of MDPP has been low, with 4,848 
beneficiaries participating as of December 31, 2021, and approximately 
half of those participants were Medicare FFS beneficiaries, and the 
remaining MA beneficiaries. White women account for the majority of 
MDPP participants to date, with the both the National DPP and MDPP 
having enrolled a similar high proportion of non-Hispanic white women. 
The evaluator estimated that 97 percent of participants travel less 
than 25 miles to attend in-person services, with the average distance 
to the nearest MDPP supplier location being 5 to 7

[[Page 79247]]

miles \373\. At the time of the second annual evaluation report, which 
was released in November 2022 and includes data through December 31, 
2021, 39 percent of all Medicare beneficiaries live more than 25 miles 
from the nearest MDPP location. Extending the PHE flexibilities to 
allow distance learning will make MDPP more accessible to beneficiaries 
who live more than 25 miles from the nearest MDPP location or lack 
transportation \374\. Additionally, the second annual evaluation report 
(p. 32) \375\ noted that suppliers tried to make MDPP services 
accessible to Medicare beneficiaries by scheduling sessions at 
locations that were most convenient to Medicare beneficiaries. It was 
also noted that while beneficiary engagement and connection tend to be 
stronger with in-person cohorts, moving to distance learning delivery 
reduced participant barriers (p. 34). While some suppliers and 
beneficiaries experienced initial challenges migrating to fully virtual 
delivery, the report noted an overwhelming support from MDPP suppliers 
for the continued opportunity to administer MDPP through distance 
learning or a combination of in-person and synchronous virtual 
delivery. We proposed in the CY 2024 PFS proposed rule \376\ the use of 
synchronous virtual delivery as an acceptable modality for MDPP 
delivery, because our goal is to use the Extended flexibilities period 
to increase beneficiary access to and uptake of MDPP while 
demonstrating that the beneficiaries receiving the Set of MDPP services 
through distance learning experience similar or better outcomes 
compared to in-person delivery concerning attendance, achievement of 
the 5 percent weight loss goal, and cost savings.
---------------------------------------------------------------------------

    \373\ RTI International. Evaluation of the Medicare Diabetes 
Prevention Program (MDPP): Second Evaluation Report. November 2022. 
https://www.cms.gov/priorities/innovation/data-and-reports/2022/mdpp-2ndannevalrpt.
    \374\ RTI International. Evaluation of the Medicare Diabetes 
Prevention Program (MDPP): Second Evaluation Report. November 2022. 
https://www.cms.gov/priorities/innovation/data-and-reports/2022/mdpp-2ndannevalrpt.
    \375\ RTI International. Evaluation of the Medicare Diabetes 
Prevention Program (MDPP): Second Evaluation Report. November 2022. 
https://www.cms.gov/priorities/innovation/data-and-reports/2022/mdpp-2ndannevalrpt.
    \376\ Centers for Medicare & Medicaid Services. Medicare and 
Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment and Coverage Policies; 
Medicare Shared Savings Program Requirements; Medicare Advantage; 
Medicare and Medicaid Provider and Supplier Enrollment Policies; and 
Basic Health Program. 88 FR 52503.https://www.govinfo.gov/content/pkg/FR-2023-08-07/pdf/2023-14624.pdf.
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    We anticipate the proposed programmatic updates will boost supplier 
enrollment, with the goal of increasing beneficiary participation and 
retention due to increased access to the Set of MDPP services. 
Moreover, we believe that extending the PHE flexibilities will increase 
equitable access to diabetes preventive services among rural and at-
risk populations, as well as minority beneficiaries who reside in 
communities underserved by healthcare providers. For example, for 
beneficiaries with transportation challenges or child/elder care 
obligations, the ability to participate in MDPP through a live virtual 
classroom, or distance learning, may encourage uptake and retention 
among those participants. Also, for beneficiaries living in rural areas 
or regions with a limited number of MDPP suppliers, the distance 
learning option will allow beneficiaries to enroll in programs further 
away from their homes, making MDPP accessible to more beneficiaries. 
Finally, we believe that increased participation in the Set of MDPP 
services through distance learning may provide data necessary to 
conduct an impactful evaluation of the synchronous virtual delivery of 
MDPP.
    In the CY 2024 PFS proposed rule,\377\ we proposed to amend Sec.  
410.79(b), (c), and (d) to remove most references to, and requirements 
of, the Ongoing Maintenance phase described in these sections. In the 
CY 2022 PFS final rule,\378\ we removed eligibility for the ongoing 
maintenance sessions for those beneficiaries who started the Set of 
MDPP services on or after January 1, 2022. Eligibility for these 
services will end December 31, 2023.
---------------------------------------------------------------------------

    \377\ Centers for Medicare & Medicaid Services. Medicare and 
Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment and Coverage Policies; 
Medicare Shared Savings Program Requirements; Medicare Advantage; 
Medicare and Medicaid Provider and Supplier Enrollment Policies; and 
Basic Health Program. 88 FR 52502. https://www.govinfo.gov/content/pkg/FR-2023-08-07/pdf/2023-14624.pdf.
    \378\ Centers for Medicare & Medicaid Services. Medicare 
Program; CY 2022 Payment Policies Under the Physician Fee Schedule 
and Other Changes to Part B Payment Policies; Medicare Shared 
Savings Program Requirements; Provider Enrollment Regulation 
Updates; and Provider and Supplier Prepayment and Post-Payment 
Medical Review Requirements. 86 FR 64996. https://www.govinfo.gov/content/pkg/FR-2021-11-19/pdf/2021-23972.pdf.
---------------------------------------------------------------------------

    We proposed to amend Sec.  410.79(b), (c)(2)(i) and (e)(2), and 
solicited comments on these proposals.\379\
---------------------------------------------------------------------------

    \379\ Centers for Medicare & Medicaid Services. Medicare and 
Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment and Coverage Policies; 
Medicare Shared Savings Program Requirements; Medicare Advantage; 
Medicare and Medicaid Provider and Supplier Enrollment Policies; and 
Basic Health Program. 88 FR 52506. https://www.govinfo.gov/content/pkg/FR-2023-08-07/pdf/2023-14624.pdf.
---------------------------------------------------------------------------

    We received public comments on these proposals. Overall, commenters 
were very supportive of the proposed changes. The following is a 
summary of the comments we received and our responses.
    Comment: Several commenters encouraged CMS to consider adopting the 
same definitions for MDPP as CDC uses for the National DPP, including 
distance learning, online delivery, and combination modalities to 
better align the two programs. Commenters indicated that the addition 
of these definitions that are consistent with the CDC's definitions 
will reduce confusion about MDPP.
    Response: We agree that MDPP and the National DPP should align 
terminology where applicable. Although CMS works closely with CDC to 
coordinate the National DPP and MDPP, there are times when the National 
DPP and MDPP will naturally diverge given that CMS is a payer of the 
MDPP Set of services, and CDC sets the quality standards for 
organizations that deliver the National DPP. CMS and CDC have worked 
closely to update the National DPP and MDPP for CY 2024, as MDPP 
updates were proposed in this provision, and CDC is updating its 
standards in 2024. To the extent possible, CMS may make conforming 
changes in future rulemaking, including applicable definitions.
    Comment: Commenters were overwhelmingly supportive of the proposed 
changes to streamline the MDPP payment structure. Commenters indicated 
that improvements to the payment schedule may increase both supplier 
and beneficiary access to MDPP. MDPP coaches commented that the 
proposed changes are more streamlined and less burdensome to those 
responsible for billing.
    Regarding the new HCPCS G-codes, commenters were very supportive of 
our creation of a new G-code for in-person delivery (G9886), distance 
learning (G9887), and maintenance of 5 percent weight loss from 
baseline in months 7 to 12 (G9888). Commenters agreed that these new G-
codes will enable CMS to track trends related to the distance learning 
service delivery. One commenter recommended that instead of CMS 
allowing for six monthly claims for maintaining the 5 percent weight 
loss from baseline (G9888), CMS should consider a one-time payment of 
$48 for maintenance of 5 percent weight loss in months 7 to 12 that is 
paid at the time

[[Page 79248]]

of program completion. Finally, commenters appreciated CMS simplifying 
the number of HCPCS G-codes from 15 to 6, reducing the administrative 
burden while allowing suppliers to collect payments more frequently.
    Response: We appreciate comments and support of the proposed rule 
provisions. Although out of scope for this rule, depending upon the 
outcomes we observe, we may consider alternative performance payments 
for maintenance of 5 percent weight loss in future rulemaking.
    Comment: Commenters were unanimously supportive of the proposed 
changes to extend the PHE flexibilities for 4 years. They commented 
that these flexibilities will allow the MDPP to continue to grow and 
offer beneficiaries flexibility when determining how they would like to 
receive services. These flexibilities will allow MDPP to continue to 
grow and offer beneficiaries increased flexibility when it comes to how 
they would like to receive services. Such flexibility is important in 
promoting equity, as well as reaching underserved communities, or 
individuals who face challenges making in-person appointments, 
including those lacking access to transportation or those with mobility 
issues.
    Additionally, multiple commenters indicated that they were able to 
reach more participants through distance learning compared to in-person 
delivery during the PHE for COVID-19, and that the flexibilities 
increased access to MDPP for both coaches and participants by removing 
barriers related to transportation and time. Similarly, another 
commenter indicated that the Extended flexibilities would help reduce 
the financial and physical hardship for patients by being able to 
attend MDPP through distance learning. Another commenter reminded us 
that distance learning delivery of MDPP does require technological 
competency and access, so it may not be appropriate for all 
participants.
    Concerning participation, one commenter indicated that the 4-year 
extension of the flexibilities utilized during the PHE for COVID-19 may 
incentivize rural beneficiaries to participate with an MDPP supplier 
that is not local. The commenter further reasoned that CMS could use 
this 4-year extension to monitor the uptake of the program and make an 
evidence-based decision on permanently extending virtual services.
    Although there is overwhelming support of extending the 
flexibilities utilized during the PHE for COVID-19, multiple commenters 
were disappointed that CMS is not allowing virtual-only providers to 
enroll in Medicare as MDPP suppliers. Virtual-only providers include 
those that deliver the National DPP services solely by distance 
learning or online delivery. Commenters indicated that the lack of full 
alignment between the MDPP expanded model and the CDC's National DPP 
continues to severely limit supplier participation, thus contributing 
to increased health inequities by limiting opportunities for the MDPP 
to reach the most vulnerable Medicare beneficiaries.
    Finally, multiple commenters recommended CMS remove the requirement 
to maintain in-person recognition for distance learning only suppliers, 
while allowing CDC-defined online providers of CDC's DPRP recognized 
program to apply to become MDPP suppliers.
    One commenter questioned CMS' rationale for excluding virtual-only 
suppliers, arguing that the proposed rule conflicts with the belief 
that peer support is less effective when people are not together in 
person.
    Response: We appreciate the widespread support of the proposed 
changes and are encouraged by the comments received for our proposed 
changes, in-particular the extension of the PHE flexibilities utilized 
during COVID-19 to allow distance learning delivery. Although we 
understand the disappointment of commenters representing distance 
learning and online delivery organizations, we hope that they will 
continue to work with CMS to increase the recruitment and retention of 
beneficiaries to help expand MDPP access and uptake.
    Although we updated our definitions in this rule to better align 
with the National DPP, we will continue to work with CDC to align its 
National DPP with MDPP to the greatest extent possible. As such, we 
encourage National DPP organizations, MDPP suppliers, and interested 
parties to review the updated 2024 DPRP Standards when they are 
published in 2024. CMS will consider conforming changes, as 
appropriate, in future rulemaking.
    As we stated earlier, MDPP was established as a primarily in-person 
service since the original DPP test and data used in the certification 
were based on in-person delivery. At the time of certification, 
although we did have minimal online delivery data provided to us by CDC 
and industry, these data did not meet the thresholds required for 
certification. The PHE for COVID-19 was a unique circumstance that 
required CMS to quickly establish MDPP pandemic-related flexibilities 
in the IFC-1, which was released in early April of 2020 to allow for 
temporary flexibilities that prioritized availability and continuity of 
services for MDPP suppliers and MDPP beneficiaries impacted by 
uncontrollable circumstances during the PHE for COVID-19.
    In the CY 2021 PFS final rule, we updated and finalized the 
policies from the IFC-1. We did not expect the PHE for COVID-19 to last 
over 3 years, with MDPP suppliers able to deliver services virtually 
for longer than they delivered services in-person prior to the PHE for 
COVID-19. Therefore, the PHE for COVID-19 was a unique circumstance 
that afforded us the opportunity to deliver the MDPP Set of services 
virtually over the past 3.5 years.
    When we established the MDPP flexibilities in the IFC-1, we could 
not predict when the PHE for COVID-19 would end. In the CY 2021 
PFS,\380\ we indicated that virtual-only suppliers may not have 
sufficient time to obtain the CDC's authorization to furnish in-person 
services. Therefore, permitting virtual-only suppliers to furnish MDPP 
services during the PHE for COVID-19 could disrupt the provision of 
MDPP Set of services when services were to resume on an in-person 
basis. Consequently, virtual only suppliers are not permitted to 
provide the set of MDPP services because MDPP suppliers need to 
accommodate beneficiary requests for in-person services.
---------------------------------------------------------------------------

    \380\ Centers for Medicare & Medicaid Services. Medicare 
Program; CY 2021 Payment Policies Under the Physician Fee Schedule 
and Other Changes to Part B Payment Policies; Medicare Shared 
Savings Program Requirements; Medicaid Promoting Interoperability 
Program Requirements for Eligible Professionals; Quality Payment 
Program; Coverage of Opioid Use Disorder Services Furnished by 
Opioid Treatment Programs; Medicare Enrollment of Opioid Treatment 
Programs; Electronic Prescribing for Controlled Substances for a 
Covered Part D Drug; Payment for Office/Outpatient Evaluation and 
Management Services; Hospital IQR Program; Establish New Code 
Categories; Medicare Diabetes Prevention Program (MDPP) Expanded 
Model Emergency Policy; Coding and Payment for Virtual Check-in 
Services Interim Final Rule Policy; Coding and Payment for Personal 
Protective Equipment (PPE) Interim Final Rule Policy; Regulatory 
Revisions in Response to the Public Health Emergency (PHE) for 
COVID-19; and Finalization of Certain Provisions from the March 
31st, May 8th and September 2nd Interim Final Rules in Response to 
the PHE for COVID-19. (85 FR 84830), December 28, 2020. https://www.federalregister.gov/d/2020-26815.pdf.
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    Our internal data explain that suppliers halted in-person sessions 
at the beginning of the PHE for COVID-19, with their pauses varying in 
length. However, most suppliers resumed offering the Set of MDPP 
services via virtual delivery. Currently, we do not have sufficient 
data from the PHE for COVID-19 to certify the distance

[[Page 79249]]

learning delivery of MDPP. We hope that after the Extended 
flexibilities period we will have enough data to fully evaluate the 
impact of distance learning delivery of MDPP on diabetes risk 
reduction, as well as cost-savings to Medicare.
    We also understand that distance learning delivery of MDPP may not 
be appropriate for every beneficiary. For example, beneficiaries may 
not have the required technological competency and access to 
participate in MDPP through distance learning. Given this, we want to 
remind suppliers that they are required to maintain capacity to deliver 
MDPP Set of services in-person.
    Although commenters expressed concern about MDPP's lack of full 
alignment with the CDC's National DPP in terms of allowing fully 
virtual organizations--or organizations that deliver diabetes 
prevention services solely through distance learning or online 
delivery--to become MDPP suppliers, we want to remind commenters that 
MDPP continues to be an expanded model test of in-person delivery of 
diabetes prevention services. In the CY 2018 final rule,\381\ we stated 
that CDC began recognizing Virtual DPP organizations in 2015. The MDPP 
certification \382\ was publicly released in March 2016 and was based 
on in-person data from the DPP clinical trial, the DPP test, CDC DPRP 
data, and a large national DPP provider.
---------------------------------------------------------------------------

    \381\ Centers for Medicare & Medicaid Services. Medicare 
Program; Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Part B for CY 2017; Medicare 
Advantage Pricing Data Release; Medicare Advantage and Part D 
Medical Low Ratio Data Release; Medicare Advantage Provider Network 
Requirements; Expansion of Medicare Diabetes Prevention Program 
Model. 82 FR 53253, November 15, 2017. https://www.govinfo.gov/content/pkg/FR-2017-11-15/pdf/2017-23953.pdf.
    \382\ Paul Spitalnic. Certification of Medicare Diabetes 
Prevention Program. Mar. 14, 2016. https://www.cms.gov/Research-Statistics-Data-and-Systems/Research/ActuarialStudies/Downloads/Diabetes-Prevention-Certification-2016-03-14.pdf.
---------------------------------------------------------------------------

    The PHE for COVID-19 was a special circumstance that allowed MDPP 
suppliers to deliver the MDPP Set of Services virtually, but there 
remains a lack of data on virtual delivery during the PHE for COVID-19 
because many suppliers appear to have paused or stop delivery of MDPP 
Set of services during the PHE for COVID-19. Although we understand 
that the exclusion of fully virtual suppliers may limit supplier 
participation, we do not agree that this exclusion will contribute to 
increased health inequities among Medicare's most vulnerable 
beneficiaries. Although virtual delivery of MDPP may make MDPP more 
accessible for most beneficiaries, it is not appropriate for every 
Medicare beneficiary. We appreciate this commenter's feedback and will 
assess the health equity impact of excluding fully virtual suppliers 
once we have updated data from the PHE for COVID-19 time period.
    Additionally, we understand the commenter's concern about the 
proposed rule conflicting with the belief that peer support is less 
effective when people are not together in person. We have confidence 
that distance learning possesses similar elements to in-person delivery 
such as live instruction from a coach and live interactive peer 
support, both which we believe will contribute to beneficiary 
understanding of pre-diabetes management tactics and strategies.
    Comment: As part of MDPP's Emergency Policy finalized in the CY 
2021 PFS final rule, we allowed for virtual weight collection. In this 
final rule, we summarized our policies for alternatives to the 
requirement for in-person weight collection (Sec.  410.79(e)(3)(iii)), 
which include virtual weight collection.\383\ Overall, commenters were 
very supportive of CMS continuing to allow virtual weight collection. 
However, we received several comments regarding barriers suppliers 
experienced relating to virtual weight collection during the PHE for 
COVID-19.
---------------------------------------------------------------------------

    \383\ Centers for Medicare & Medicaid Services. Medicare and 
Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment and Coverage Policies; 
Medicare Shared Savings Program Requirements; Medicare Advantage; 
Medicare and Medicaid Provider and Supplier Enrollment Policies; and 
Basic Health Program. 88 FR 52502. https://www.govinfo.gov/content/pkg/FR-2023-08-07/pdf/2023-14624.pdf.
---------------------------------------------------------------------------

    For example, several commenters recommended that CMS no longer 
require date-stamped photos to document the self-reported beneficiary 
weights. The commenters reported that many of their beneficiaries are 
unable to take a picture while standing on their home scales due to 
risk of injury and physical health limitations. Thus, this risk has 
prevented organizations from submitting claims accurately, since they 
have several participants that live alone and attend sessions via 
distance education.
    Additionally, some participants join virtual sessions from 
different locations and do not have access to a scale to record their 
measurement each session. The commenter urged CMS to consider allowing 
submission of weight photos without the date and time stamp, allowing 
participants to submit official weights less frequently for example, 
every 2-3 sessions).
    Finally, we received a comment indicating that some participants 
may not be able to purchase Bluetooth-enabled scales, and the MDPP 
payment structure does not enable the program to purchase scales 
without additional funding.
    Response: We acknowledge that some MDPP beneficiaries may lack the 
technology or capacity to provide a date-stamped photograph to document 
their body weight measurements. In situations in which beneficiaries 
may be unable to self-report their weight according to the MDPP 
conditions of coverage, suppliers may want to consider collecting 
weight measurements from the MDPP beneficiary in-person.
    In terms of allowing MDPP participants to submit their weight less 
frequently, the current CDC DPRP Standards \384\ state that the 
participant's body weight must be recorded at all sessions. In 
addition, in Sec.  424.25(g)(2)(v),\385\ we state that documentation 
for each MDPP session must include each MDPP's beneficiary's weight and 
date weight taken in a form and manner specified by CMS. Given that we 
aim to align with the DPRP Standards as much as possible, we are 
requiring participant body weight to be collected at each MDPP session 
so that weight loss can be tracked during the MDPP service period.
---------------------------------------------------------------------------

    \384\ Centers for Disease Control and Prevention Diabetes 
Prevention Recognition Program Standards and Operating Procedures. 
May 1, 2021. https://www.cdc.gov/diabetes/prevention/pdf/dprp-standards.pdf.
    \385\ Centers for Medicare & Medicaid Services. Medicare 
Program; Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Part B for CY 2017; Medicare 
Advantage Pricing Data Release; Medicare Advantage and Part D 
Medical Low Ratio Data Release; Medicare Advantage Provider Network 
Requirements; Expansion of Medicare Diabetes Prevention Program 
Model. 82 FR 53366, November 15, 2017. https://www.govinfo.gov/content/pkg/FR-2017-11-15/pdf/2017-23953.pdf.
---------------------------------------------------------------------------

    Suppliers may also consider urging beneficiaries to identify a 
household member, friend, or family member who could assist the 
participant with relaying their body weight to the supplier. However, 
we want to remind MDPP suppliers that beneficiaries may report their 
weight using scales that securely transmit their weight to the MDPP 
supplier. Unfortunately, CMS cannot provide funds for a Bluetooth-
enabled scale per one commenter request. However, we want to remind 
suppliers that in the CY 2018 PFS rulemaking, we finalized the use of 
beneficiary engagement incentives under Sec.  424.210, and suppliers 
may review the requirements of that regulation.

[[Page 79250]]

    Comment: One commenter indicated their appreciation of allowing 
unlimited make-up sessions and the ability to hold the make-up sessions 
on the same day as a different session (so that a participant who 
missed the previous week, can attend the make-up session immediately 
before the next session). This allows for flexibility for both the 
participant and the Coach.
    Response: In the CY 2018 PFS final rule, we finalized that 
suppliers may furnish a maximum of one virtual make-up session on the 
same day as a regularly scheduled in-person session. However, we stated 
that the intent of this policy was to allow most make-up sessions to be 
scheduled on different days than regularly scheduled session, since 
beneficiaries may not be able to attend a make-up session on the same 
day as a regularly scheduled session.
    In the CY 2021 PFS final rule, we finalized in paragraph Sec.  
410.79(e)(3)(iv)(B) that the MDPP supplier may furnish to the MDPP 
beneficiary a maximum of one virtual make-up session on the same day as 
a regularly scheduled session and that under paragraph (e)(3)(iv)(C), 
the MDPP supplier may furnish a maximum of one virtual make-up session 
per week. In the proposed rule, we proposed to no longer require 
suppliers to indicate whether the session was delivered as a make-up 
session or a regularly scheduled session when submitting claims for 
services. Instead of using the virtual modifier on claims to indicate a 
virtual make-up session, we proposed to replace the virtual modifier 
with one of two MDPP G-codes (G9886 or G9887) to indicate whether the 
session was delivered in-person (G9886) or through distance learning 
(G9887) \386\.
---------------------------------------------------------------------------

    \386\ Centers for Medicare & Medicaid Services. Medicare and 
Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment and Coverage Policies; 
Medicare Shared Savings Program Requirements; Medicare Advantage; 
Medicare and Medicaid Provider and Supplier Enrollment Policies; and 
Basic Health Program. 88 FR 52507. https://www.govinfo.gov/content/pkg/FR-2023-08-07/pdf/2023-14624.pdf.
---------------------------------------------------------------------------

    In the current payment schedule (CY 2018 to CY 2023), attendance is 
paid on a performance basis, after attending the 1st, 4th, and 9th 
sessions in months 1 to 6, and after the 2nd monthly session in months 
7 to 12. Additionally, there is a non-payable session code (G9891) to 
track attendance. Under the current performance-based schedule,\387\ 
same day make-up sessions were permitted because it did not necessarily 
impact payments. In contrast, under the CY 2024 PFS \388\ proposed 
payment schedule, which pays for up to 22 sessions on a fee-for-service 
(FFS) basis over the 12-month MDPP service period, participants have 6 
months to attend the first 16 weekly sessions and another 6 months to 
attend 6 monthly sessions Theoretically, in months 1 to 6, participants 
can reach 16 sessions at some point in month 4 if they attend most of 
the weekly sessions and sooner if they attend same-day make-up 
sessions.
---------------------------------------------------------------------------

    \387\ Centers for Medicare & Medicaid Services. Medicare and 
Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment and Coverage Policies; 
Medicare Shared Savings Program Requirements; Medicare Advantage; 
Medicare and Medicaid Provider and Supplier Enrollment Policies; and 
Basic Health Program. 88 FR 52508. https://www.govinfo.gov/content/pkg/FR-2023-08-07/pdf/2023-14624.pdf.
    \388\ Centers for Medicare & Medicaid Services. Medicare and 
Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment and Coverage Policies; 
Medicare Shared Savings Program Requirements; Medicare Advantage; 
Medicare and Medicaid Provider and Supplier Enrollment Policies; and 
Basic Health Program. 88 FR 52507. https://www.govinfo.gov/content/pkg/FR-2023-08-07/pdf/2023-14624.pdf.
---------------------------------------------------------------------------

    Although Sec.  410.79(e)(3)(iv)(B) and (C) does permit a 
beneficiary one virtual makeup session on the same day as a regularly 
scheduled session, and a beneficiary may only have one virtual make-up 
session per week, we want to encourage suppliers to schedule make-up 
sessions on days other than the same day of a regularly scheduled 
session to avoid claims being rejected or denied under the new payment 
schedule and to allow beneficiaries to receive the benefit as intended 
by having access to the full 12 months MDPP service period to build the 
skills needed to reduce their risk for diabetes.
    Comment: One commenter requested that CMS affirm that MA plans may 
use virtual MDPP to meet network adequacy requirements and satisfy the 
requirements to provide MDPP services by allowing virtual providers to 
register as Medicare suppliers for this purpose.
    Response: We appreciate the commenter's request for clarification 
regarding allowing virtual providers to enroll in Medicare as MDPP 
suppliers for the purpose of meeting MA Plan network adequacy 
requirements. Given that we proposed that MDPP suppliers must have and 
maintain CDC in-person DPRP recognition, it does not make sense to 
allow this requirement to be waived for organizations that serve 
beneficiaries in MA plans.
    Comment: Several commenters requested that CMS waive the once per 
lifetime requirement to allow for multiple attempts at weight loss. 
Moreover, several commenters expressed concern over the high-risk 
designation requirements for organizations enrolling in Medicare as 
MDPP suppliers.
    Response: We appreciate the commenters' support and interest in 
MDPP. These suggested changes are outside the scope of this final rule. 
The provisions we are finalizing in this rule are to extend the PHE 
flexibilities for 4 years, update the MDPP payment structure from a 
performance-based attendance and weight loss structure to a hybrid 
structure that pays for attendance on an FFS basis and diabetes risk 
reduction (weight loss), on a performance basis, and remove most 
references to and requirements of, the Ongoing Maintenance phase.
    After consideration of public comments, we are finalizing Sec.  
410.79(b), (c)(2)(i), (e)(2), and (e)(3)(iv) as proposed.
2. Changes to Sec.  414.84
    Although MDPP has over 300 suppliers representing over 1,000 
locations across the US, based on fee-for-service claims analysis, only 
one-third of them have submitted claims since MDPP launched in April 
2018. We have heard anecdotally from suppliers, CDC, and interested 
parties that our payment structure is complex, which has created 
barriers to organizations wanting to participate in the MDPP. As a 
result, the lack of suppliers has contributed to limited beneficiary 
access to the preventive services offered under this expanded model. 
Challenges inherent in the current payment structure include irregular 
flow of operating funds due to the performance-based payment structure, 
claims denials due to the complicated payment structure, and a lack of 
incentive to retain participants after the 9th core session due to the 
potential 4 to 5-month payment lag between the 9th session attended and 
the 2nd session attended in months 7-9. Consistent with this last 
challenge, our monitoring data show a sharp drop in claims after the 
first quarter.
    In the proposed rule,\389\ we proposed to update the payment 
structure from a performance-based attendance and weight loss structure 
to a hybrid structure that pays for attendance on a

[[Page 79251]]

FFS basis and diabetes risk reduction (weight loss), on a performance 
basis.
---------------------------------------------------------------------------

    \389\ Centers for Medicare & Medicaid Services. Medicare and 
Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment and Coverage Policies; 
Medicare Shared Savings Program Requirements; Medicare Advantage; 
Medicare and Medicaid Provider and Supplier Enrollment Policies; and 
Basic Health Program. 88 FR 52506. https://www.govinfo.gov/content/pkg/FR-2023-08-07/pdf/2023-14624.pdf.
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    Given consistent supplier and interested party feedback regarding 
the complexity of this payment structure and necessary up-front costs 
incurred by suppliers, we proposed to simplify the payment structure 
and pay for attendance on a FFS basis. We proposed creating an 
Attendance Payment, which we proposed to define as a payment that is 
made to an MDPP supplier for furnishing services to an MDPP beneficiary 
when the MDPP beneficiary attends an MDPP core or core maintenance 
session. We also proposed that suppliers may receive an Attendance 
Payment after they submit a claim for each MDPP session, starting with 
the first core session, using a new HCPCS G-code, Behavioral counseling 
for diabetes prevention, in-person, group, 60 minutes, or Behavioral 
counseling for diabetes prevention, distance learning, 60 minutes, for 
MDPP dates of service on or after January 1, 2024.\390\
---------------------------------------------------------------------------

    \390\ Centers for Medicare & Medicaid Services. Medicare and 
Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment and Coverage Policies; 
Medicare Shared Savings Program Requirements; Medicare Advantage; 
Medicare and Medicaid Provider and Supplier Enrollment Policies; and 
Basic Health Program. 88 FR 52506. https://www.govinfo.gov/content/pkg/FR-2023-08-07/pdf/2023-14624.pdf.
---------------------------------------------------------------------------

    This proposed payment structure aligns closely to that of similar 
benefits such as the Intensive Behavioral Counseling for Obesity (IBTO) 
and Diabetes Self-Management Training (DSMT), and also allows suppliers 
to receive regular payments for service for up to a year during a 12-
month MDPP service period. We proposed paying for up to 22 sessions of 
either in-person or distance learning, or a combination of the two, for 
MDPP dates of services within a 12-month MDPP services period. In 
months 1 to 6, payments are allowed for one in-person or distance 
learning session every week up to a maximum of 16 sessions. During 
months 7 to 12, payments are allowed for one in-person or distance 
learning session every month up to a maximum 6 sessions.
    We proposed to update the performance goal to depict a weight loss 
goal that an MDPP beneficiary must achieve during the MDPP services 
period for an MDPP supplier to be paid a performance payment and 
removing the performance-based payments for attendance from the 
performance goal.\391\ We retained the diabetes risk-reduction 
performance payments, which include payments for 5 percent and 9 
percent weight loss because we want to continue to pay for outcomes, 
and the MDPP certification includes a diabetes risk-reduction 
component, the achievement of 5 percent weight loss from baseline. 
Although we proposed to remove the attendance-based performance goal 
and pay for attendance on a FFS basis, we want to continue rewarding 
suppliers for achieving successful outcomes for beneficiaries (weight 
loss), while motivating suppliers to retain participants and deliver a 
high-quality program.
---------------------------------------------------------------------------

    \391\ Centers for Medicare & Medicaid Services. Medicare and 
Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment and Coverage Policies; 
Medicare Shared Savings Program Requirements; Medicare Advantage; 
Medicare and Medicaid Provider and Supplier Enrollment Policies; and 
Basic Health Program. 88 FR 52506. https://www.govinfo.gov/content/pkg/FR-2023-08-07/pdf/2023-14624.pdf.
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    As part of the performance payments, MDPP suppliers must still 
submit a claim when 5 percent weight loss from baseline weight is 
achieved and will receive a one-time payment for this claim (weight 
loss G-code). We proposed to create a new HCPCS G-code, ``Maintenance 
of 5 percent weight loss from baseline, months 7-12'' to be submitted 
along with the monthly session claim for beneficiaries who have met the 
5 percent weight loss performance goal, for whom the one-time claim for 
5 percent weight loss has been submitted. This maintenance of 5 percent 
weight loss code replaces the attendance plus 5 percent weight loss 
HCPCS G-codes, G9878 and G9879, in months 7-12.
    The one-time claim for 5 percent weight loss must be submitted 
prior to submitting a claim for the enhanced payment in months 7 to 12 
for maintaining the 5 percent weight loss. Additionally, suppliers must 
continue to submit a claim when 9 percent weight loss from baseline 
weight is achieved per Sec.  414.84(b)(7), so they may receive a one-
time payment for this claim.
    This proposed payment structure increases the maximum attendance-
based payments a supplier may receive in the first 6 months by $56 per 
MDPP beneficiary, while allowing for similar maximum attendance 
payments in months 7-12 and maintaining the maximum total payment of 
$768 per person during the MDPP services period.\392\ Also, this 
proposed payment structure takes into consideration the Extended 
flexibilities, by adding a distance learning HCPCS G-code. The new 
structure simplifies the claims submission process because it no longer 
requires that suppliers submit 11 to 15 G-codes for different 
attendance-based sessions at irregular intervals.
---------------------------------------------------------------------------

    \392\ Centers for Medicare & Medicaid Services. Medicare and 
Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment and Coverage Policies; 
Medicare Shared Savings Program Requirements; Medicare Advantage; 
Medicare and Medicaid Provider and Supplier Enrollment Policies; and 
Basic Health Program. 88 FR 52507. https://www.govinfo.gov/content/pkg/FR-2023-08-07/pdf/2023-14624.pdf.
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    This proposed payment structure allows suppliers to submit one of 
two G-codes (depending on whether the MDPP session was delivered in 
person or via distance learning) for each session. In months 7-12, 
suppliers may also add the proposed maintenance of the 5 percent weight 
loss from baseline G-code to their claim once the 5 percent weight loss 
has been achieved. The proposed payment structure allows suppliers to 
indicate which sessions were held via distance learning without needing 
to provide additional information in the claim submission process. The 
proposed new payment structure reduces complexity by reducing the 
number of G-codes from 15 to 6.
    Table 49 displays the proposed MDPP payment structure and Table 50 
indicates the current CY 2023 performance payments.

[[Page 79252]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.071

[GRAPHIC] [TIFF OMITTED] TR16NO23.072

    During the CY 2018 PFS rulemaking process,\393\ we received 
comments regarding how to best monitor the use of virtual make-up 
sessions, and whether we would use an additional HCPCS code or modifier 
to indicate virtual sessions since there is a limit to the number of 
virtual make-up sessions a beneficiary can attend. In response, we 
finalized the use of the virtual make-up

[[Page 79253]]

sessions in Sec.  410.79(d)(2) and stated in the preamble to the CY 
2018 PFS final rule that MDPP suppliers must include the virtual 
modifier on claims to indicate the use of the virtual make-up 
session.\394\ As part of the flexibilities established in response to 
the COVID-19 PHE, in the CY 2021 PFS final rule, we eliminated the 
maximum number of virtual make-up sessions that could be delivered by 
MDPP suppliers, described in Sec.  410.79(d)(2), and (d)(3)(i) and 
(ii),\395\ but still required MDPP suppliers to use the virtual 
modifier to indicate when a beneficiary received MDPP virtually.
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    \393\ Centers for Medicare & Medicaid Services. Medicare 
Program; Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Part B for CY 2018; Medicare Shared 
Savings Program Requirements; and Medicare Diabetes Prevention 
Program. 82 FR 53255. https://www.govinfo.gov/content/pkg/FR-2018-11-23/pdf/2018-24170.pdf.
    \394\ Centers for Medicare & Medicaid Services. Medicare 
Program; Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Part B for CY 2018; Medicare Shared 
Savings Program Requirements; and Medicare Diabetes Prevention 
Program. 82 FR 53255. https://www.govinfo.gov/content/pkg/FR-2018-11-23/pdf/2018-24170.pdf.
    \395\ Centers for Medicare & Medicaid Services. Medicare 
Program; CY 2021 Payment Policies Under the Physician Fee Schedule 
and Other Changes to Part B Payment Policies; Medicare Shared 
Savings Program Requirements; Medicaid Promoting Interoperability 
Program Requirements for Eligible Professionals; Quality Payment 
Program; Coverage of Opioid Use Disorder Services Furnished by 
Opioid Treatment Programs; Medicare Enrollment of Opioid Treatment 
Programs; Electronic Prescribing for Controlled Substances for a 
Covered Part D Drug; Payment for Office/Outpatient Evaluation and 
Management Services; Hospital IQR Program; Establish New Code 
Categories; Medicare Diabetes Prevention Program (MDPP) Expanded 
Model Emergency Policy; Coding and Payment for Virtual Check-in 
Services Interim Final Rule Policy; Coding and Payment for Personal 
Protective Equipment (PPE) Interim Final Rule Policy; Regulatory 
Revisions in Response to the Public Health Emergency (PHE) for 
COVID-19; and Finalization of Certain Provisions from the March 
31st, May 8th and September 2nd Interim Final Rules in Response to 
the PHE for COVID-19. (85 FR 84838), December 28, 2020. https://www.govinfo.gov/content/pkg/FR-2020-12-28/pdf/2020-26815.pdf.
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    In the CY 2024 PFS proposed rule, we proposed to amend our policies 
on payment for MDPP services Sec.  414.84(a), (b), (c), and newly 
redesignated paragraphs (d)(1) and (e). We solicited comments on these 
proposals.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Commenters supported the proposal to move from a 
performance-based attendance and outcomes (weight loss of 5 and 9 
percent) payment structure to a hybrid structure that pays for 
attendance on an FFS basis, indicating it would reduce the 
administrative burden associated with billing. Overall, commenters 
supported allowing payment for up to 22 sessions during the 12-month 
core services period and indicated that finalizing these proposals 
should increase efficiency from a timeliness perspective of payments 
due to an increase of attendance payments for MDPP suppliers, many of 
whom have been operating MDPP at a loss.
    Several commenters added that the National DPP is reimbursable in 
their States through Medicaid and the Medicaid billing per attendance 
has been much more efficient than the MDPP billing. Therefore, the FFS 
changes will be a welcome advancement for suppliers that provide 
billing management for their community-based partner organizations that 
furnish the MDPP Set of services.
    Additionally, commenters indicated that finalizing these proposals 
may also help reduce health inequities by reducing disincentives in the 
current outcomes-based reimbursement approach as many MDPP suppliers 
serve populations that may be less likely to achieve the 5 percent 
weight loss threshold, and therefore, would be operating at a financial 
loss.
    For example, several commenters indicated that the streamlined MDPP 
payment schedule may increase participation in MDPP of community-based 
settings with limited cash flow and capital. It is critical that MDPP 
delivered in these types of settings receive payment in a timely 
manner, so that they may pay staff, rent, and other direct operating 
expenses.
    Concerning Medicare FFS attendance payments, commenters supported 
CMS moving from performance-based attendance to service-based 
attendance. Commenters noted that this would create greater consistency 
for payments. Commenters also appreciated the simplified billing 
process, as one commenter suggested that it may expand the potential 
pool of organizations who will be able to provide MDPP Set of services 
due to more frequent payments. Others commented that the updated 
payment structure is consistent with other Medicare services, 
simplifies billing, and assures payment for services that are rendered.
    Comments regarding MDPP diabetes risk-reduction one-time 
performance payments for achievement of 5 percent and 9 percent weight 
loss were also positive. Commenters indicated that payments for 
positive health outcomes, including 5 percent and 9 percent weight loss 
are worthwhile and should be maintained. One commenter agreed with 
incentivizing weight loss outcomes given that weight loss drives 
diabetes risk reduction.
    Interestingly, comments regarding performance payments consisted 
mostly of recommendations to CMS concerning including additional 
performance payments for consideration. Several commenters recommended 
weight loss performance payments be provided for lesser, yet clinically 
relevant weight loss such as 3 to 5 percent weight loss, while 
maintaining a small payment for achieving 9 percent weight loss. 
Several commenters recommended CMS establish an additional performance 
payment for 4 percent weight loss, as this would align with the CDC 
weight loss performance outcomes. One commenter further explained that 
for National DPPs that serve historically underserved communities, a 4 
percent weight loss benchmark is based on evidence that achieving a 5 
percent goal is more difficult in these communities and that lower 
levels of weight loss are associated with improved health.
    Several commenters recommended that CMS consider adding a 0.2% 
reduction in Hemoglobin A1C (HbA1c) as an additional performance 
measure for diabetes risk reduction. One commenter in particular 
further clarified that the proposed CY 2024 payment structure, which 
only accounts for 5 or 9 percent weight loss to receive a performance 
payment, does not reward suppliers for individuals who have maintained 
weight or gained muscle mass while reducing HbA1c. Commenters discussed 
the limitations of body weight and BMI as they do not take into account 
changes in body composition type such as muscle mass versus fat mass. 
Commenters referred to an American Medical Association published 
statement on considering body composition measures in addition to BMI 
for better indicators of health. (https://www.ama-assn.org/press-center/press-releases/ama-adopts-new-policy-clarifying-role-bmi-measure-medicine).
    One commenter recommended that given MDPP's role in preventing the 
onset of type 2 diabetes, the known underutilization of this service, 
and the enormous cost to care for patients who transition from 
prediabetes into full type 2 diabetes, CMS should consider either (1) 
incentivizing clinicians to facilitate MDPP through increased payment 
for the program or, (2) creating an incentive for clinician referral to 
MDPP or oversight of MDPP via a billable CPT code. This commenter 
clarified that incentivizing clinicians to refer to or oversee the MDPP 
program via a billable code or increasing payment to administer the 
MDPP as a clinician would increase program implementation.
    Several commenters also recommended that CMS increase the payment 
rates, indicating that the

[[Page 79254]]

proposed rates do not cover the costs to deliver MDPP set of services 
to participants with adverse social determinants. Commenters suggested 
that the proposed rates do not fully cover staff time, coordination, 
and follow-up. One commenter indicated that the payment amount is 
insufficient to incentivize rural providers to enroll and provide MDPP 
Set of services.
    Several commenters recommended that CMS consider paying for up to 
26 sessions versus the proposed 22 sessions. One commenter further 
explained that when they initiated the program, they offered the 
minimally required 22 sessions (16 sessions followed by monthly 
meetings once a month). After reviewing their data, they found that 
participants had significantly better attendance when the sessions were 
offered weekly compared to monthly. Based on that observation they 
moved to offering sessions twice a month after the first 16 weeks of 
the program, which improved program attendance and outcomes.
    Regarding our proposed G-Code for the ``Maintenance of 5 percent 
weight loss from baseline, months 7-12,'' one commenter commended the 
intent of the G-code, but recommended CMS consider a larger one-time 
payment for ``Maintenance of 5 percent weight loss in months 7 to 12.'' 
The commenter recommended this one-time payment take place at the time 
of program completion, to encourage participant retention.
    Response: We appreciate the interest and comments regarding the 
revised MDPP payment structure, the FFS attendance payments, and the 
weight loss performance payments. We note that the one-time performance 
payments for 5 percent and 9 percent weight loss from baseline as well 
as the monthly performance payments for maintenance of 5 percent weight 
loss from baseline weight in months 7 to 12 are out of scope of this 
rule. However, we will review and consider commenters' recommendations 
for future rulemaking, as appropriate, regarding a second performance 
measure that considers lower thresholds for weight loss performance 
payments such as 4 percent weight loss, as well as HbA1c reduction as a 
performance payment. Historically, CMS has not covered HbA1c as part of 
the diabetes screening benefit, thus we could not consider it as a 
performance measure. In a section of the proposed rule \396\ that was 
not specific to MDPP, CMS is finalizing to expand diabetes screening 
and diabetes definitions, including the addition of HbA1c test as part 
of the diabetes screening benefit, and we thank commenters for 
separately supporting this proposal. We may consider an additional 
performance payment option in future rulemaking. We may also consider 
other recommendations including suggestions on how to create incentives 
for clinician referral.
---------------------------------------------------------------------------

    \396\ Centers for Medicare & Medicaid Services. Medicare and 
Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment and Coverage Policies; 
Medicare Shared Savings Program Requirements; Medicare Advantage; 
Medicare and Medicaid Provider and Supplier Enrollment Policies; and 
Basic Health Program. 88 FR 52715. https://www.govinfo.gov/content/pkg/FR-2023-08-07/pdf/2023-14624.pdf.
---------------------------------------------------------------------------

    Per the commenters that recommended we increase the MDPP payment 
rates, we appreciate this feedback. Unfortunately, we run the risk of 
jeopardizing our certification as an expanded model test if we increase 
the total payment amount to the rates recommended by these commenters. 
Moreover, we believe that the current payment schedule aligns with 
similar Medicare preventive services payment rates such as IBTO and 
DSMT in terms of per session payment and maximum payment amounts. Per 
Sec.  414.84(e) we annually adjust the MDPP performance payments, 
attendance payments, and bridge payments by the percent change in the 
Consumer Price Index and publish the updated MDPP payment schedule at 
the beginning of the calendar year.\397\
---------------------------------------------------------------------------

    \397\ Centers for Medicare & Medicaid Services. Medicare and 
Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment and Coverage Policies; 
Medicare Shared Savings Program Requirements; Medicare Advantage; 
Medicare and Medicaid Provider and Supplier Enrollment Policies; and 
Basic Health Program. 88 FR 52713. https://www.govinfo.gov/content/pkg/FR-2023-08-07/pdf/2023-14624.pdf.
---------------------------------------------------------------------------

    We appreciate the comments regarding the number of sessions CMS 
should cover in the new payment schedule. We applaud the commenter who 
found that offering the program twice a month in the second 6 months 
instead of monthly increased attendance and improved outcomes. However, 
should we increase the total number of sessions to 26 versus 22, the 
maximum payment amount would still have to remain the same given our 
certification, but the session payment amounts would decrease. In 
addition, paying for up to 22 sessions allows more flexibility in how 
sessions are scheduled, encouraging suppliers to retain participants 
since more sessions will be covered, and allow more suppliers to meet 
the maximum attendance payments. We are concerned that if we increase 
the number of payable sessions to 26, fewer suppliers will be able to 
reach that goal with their participants, and they would not be able to 
reach the maximum attendance payments for MDPP. We believe that paying 
for up to 22 sessions provides the right balance between per session 
payments, supplier success in reaching the maximum attendance payments 
for beneficiaries, and flexibility with scheduling sessions.
    After consideration of public comments, we are finalizing as 
proposed.
3. Changes to Sec.  424.205 (a), (b)(1), (c), and Newly Designated 
Paragraphs (c)(1), (d)(14), (f)(2)(i), (g)(1)(i)(C)
    The Centers for Disease Control and Prevention (CDC), which 
administers the Diabetes Prevention Recognition Program (DPRP), is 
responsible for implementing the quality assurance function of the 
National DPP at the national level, including for MDPP.\398\ The DPRP 
awards four categories of recognition: Pending, preliminary, full, and 
full-plus.\399\ Organizations may participate in MDPP with preliminary, 
full, or full-plus CDC recognition. Organizations may advance in CDC 
DPRP recognition by demonstrating their ability to effectively deliver 
the behavioral change program (preliminary) and achieve the outcomes 
shown to prevent or delay type 2 diabetes (full and full-plus). To 
achieve full CDC recognition, organizations must demonstrate a 
reduction in risk of developing type 2 diabetes among completers in the 
evaluation cohort by showing that at least 60 percent of all completers 
achieved at least one of the following outcomes:
---------------------------------------------------------------------------

    \398\ Centers for Medicare & Medicaid Services. Medicare 
Program; Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Part B for CY 2018; Medicare Shared 
Savings Program Requirements; and Medicare Diabetes Prevention 
Program. 82 FR 53301. https://www.govinfo.gov/content/pkg/FR-2018-11-23/pdf/2018-24170.pdf.
    \399\ Centers for Disease Control & Prevention Diabetes 
Prevention Recognition Program: Standards and Operating Procedures. 
May 1, 2021. https://www.cdc.gov/diabetes/prevention/pdf/dprp-standards.pdf.
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     At least 5 percent weight loss 12 months after the cohort 
began; or
     At least 4 percent weight loss and at least 150 minutes/
week on average of physical activity 12 months after the cohort began; 
or
     At least a 0.2 percent reduction in HbA1C.
    Organizations are granted an additional 2 years of full recognition 
(full-plus), for a total of 5 years if, at the time full recognition is 
achieved, organizations meet the following retention criteria:

[[Page 79255]]

     A minimum of 50 percent at the beginning of the fourth 
month since the cohorts held their first sessions;
     A minimum of 40 percent at the beginning of the seventh 
month since the cohorts held their first sessions; and
     A minimum of 30 percent at the beginning of the tenth 
month since the cohorts held their first sessions.\400\
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    \400\ Centers for Disease Control & Prevention Diabetes 
Prevention Recognition Program: Standards and Operating Procedures. 
May 1, 2021. https://www.cdc.gov/diabetes/prevention/pdf/dprp-standards.pdf.
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    In the CY 2017 PFS final rule,\401\ we indicated that we would 
align the CDC's DPRP and MDPP to the greatest extent possible. When the 
CY 2018 PFS final rule went into effect on January 1, 2018, CDC's 2018 
DPRP Standards had neither been publicly released nor gone into effect. 
For these reasons, we had to establish an interim MDPP preliminary 
recognition so that eligible organizations could begin enrolling in 
Medicare to become MDPP suppliers starting January 1, 2018, and 
approved suppliers could start serving Medicare beneficiaries on April 
1, 2018.
---------------------------------------------------------------------------

    \401\ Centers for Medicare & Medicaid Services. Medicare 
Program; Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Part B for CY 2018; Medicare Shared 
Savings Program Requirements; and Medicare Diabetes Prevention 
Program. 82 FR 53298. https://www.govinfo.gov/content/pkg/FR-2018-11-23/pdf/2018-24170.pdf.
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    When the CY 2018 PFS final rule was issued, the CDC 2015 DPRP 
Standards were still in effect, and the CDC only recognized 
organizations with pending or full DPRP recognition. Consequently, CMS 
and CDC developed an interim solution that would allow organizations 
that met the MDPP interim preliminary recognition standard, which went 
into effect on January 1, 2018, to become eligible to enroll in 
Medicare as an MDPP supplier.
    Because CMS and the CDC understood that there would be a 2- to 4-
month gap between when the CY 2018 PFS went into effect for MDPP 
(January 1, 2018) and when the CDC 2018 DPRP Standards would be cleared 
and go into effect, CMS worked with CDC to establish an interim 
solution so that eligible organizations with MDPP interim preliminary 
or CDC DPRP full recognition could apply to Medicare to become MDPP 
suppliers before the CDC's 2018 Standards went into effect on March 1, 
2018. The CY 2018 PFS final rule \402\ at established at Sec.  
[thinsp]424.205(c)(2)(ii) that CDC-recognized organizations with 
pending CDC DPRP recognition could meet additional criteria for an 
``interim preliminary recognition'' standard and enroll as MDPP 
suppliers. With the MDPP new supplier type going into effect on January 
1, 2018, and beneficiary enrollment starting on April 1, 2018, CMS 
wanted suppliers to be able to enroll in Medicare to become MDPP 
suppliers in time for the April 1 MDPP launch.
---------------------------------------------------------------------------

    \402\ Centers for Medicare & Medicaid Services. Medicare 
Program; Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Part B for CY 2018; Medicare Shared 
Savings Program Requirements; and Medicare Diabetes Prevention 
Program. 82 FR 53298. https://www.govinfo.gov/content/pkg/FR-2018-11-23/pdf/2018-24170.pdf.
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    With the CDC DPRP Standards for preliminary recognition in effect, 
in the CY 2024 PFS proposed rule,\403\ we proposed to remove Sec.  
[thinsp]424.205(c) and retire the MDPP ``interim preliminary 
recognition'' standard. We also proposed to amend Sec.  
[thinsp]424.59(a)(1) (redesignated Sec.  [thinsp]424.205(b)(1)) to 
require that, at the time of enrollment, organizations have 
preliminary, full, or full-plus CDC DPRP recognition. As described in 
the CY 2018 PFS final rule,\404\ MDPP suppliers who received MDPP 
interim preliminary recognition during the 4-month time period between 
when the CY 2018 PFS final rule was published and when the CDC 2018 
Standards went into effect, have achieved CDC preliminary recognition.
---------------------------------------------------------------------------

    \403\ Centers for Medicare & Medicaid Services. Medicare and 
Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment and Coverage Policies; 
Medicare Shared Savings Program Requirements; Medicare Advantage; 
Medicare and Medicaid Provider and Supplier Enrollment Policies; and 
Basic Health Program. 88 FR 52501. www.govinfo.gov/content/pkg/FR-2023-08-07/pdf/2023-14624.pdf">https://-www.govinfo.gov/content/pkg/FR-2023-08-07/pdf/2023-14624.pdf.
    \404\ Centers for Medicare & Medicaid Services. Medicare 
Program; Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Part B for CY 2018; Medicare Shared 
Savings Program Requirements; and Medicare Diabetes Prevention 
Program. 82 FR 53298. https://www.govinfo.gov/content/pkg/FR-2018-11-23/pdf/2018-24170.pdf.
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    To maintain compliance with the current CDC DPRP Standards, 
organizations that enrolled in Medicare as MDPP suppliers based on 
their MDPP interim preliminary recognition \405\ between January 1, 
2018, and February 28, 2018, would have had at least two CDC DPRP 
evaluations given the 5-year time lapse. Per CDC DPRP Standards, 
organizations are required to submit data to CDC every 6 months, and 
undergo evaluation every 12 to 18 months, depending upon the timing of 
new cohorts.
---------------------------------------------------------------------------

    \405\ Centers for Medicare & Medicaid Services. Medicare 
Program; Revisions to Payment Policies Under the Physician Fee 
Schedule and Other Revisions to Part B for CY 2018; Medicare Shared 
Savings Program Requirements; and Medicare Diabetes Prevention 
Program. 82 FR 53364. https://www.govinfo.gov/content/pkg/FR-2018-11-23/pdf/2018-24170.pdf.
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    Since the CDC DPRP Standards were updated in 2018 and 2021 and are 
due to be updated in Spring 2024, suppliers are required to meet the 
most current CDC DPRP Standards for preliminary, full, or full-plus 
recognition to maintain their eligibility to enroll and participate in 
MDPP as MDPP suppliers. Organizations that are interested in enrolling 
in Medicare as MDPP suppliers should refer to the CDC DPRP's most 
current standards \406\ to understand how to obtain preliminary, full, 
or full-plus CDC recognition, and consult Sec.  424.205 for all other 
enrollment conditions that need to be met, in advance of submitting 
their application to become a MDPP supplier.
---------------------------------------------------------------------------

    \406\ Centers for Disease Control & Prevention Diabetes 
Prevention Recognition Program: Standards and Operating Procedures. 
May 1, 2021. https://www.cdc.gov/diabetes/prevention/pdf/dprp-standards.pdf.
---------------------------------------------------------------------------

    We proposed to amend Sec.  424.205 newly designated paragraphs (c) 
and (f) to remove reference to and requirements of the Ongoing 
Maintenance phase described in these sections with the exception of the 
newly designated requirement at Sec.  424.205(d)(14), which we are 
retaining for historical recordkeeping and crosswalk purposes.\407\ In 
the CY 2022 PFS final rule,\408\ CMS removed eligibility for the 
Ongoing Maintenance Sessions for those beneficiaries who started the 
Set of MDPP services on or after January 1, 2022. Eligibility for these 
services will end December 31, 2023.
---------------------------------------------------------------------------

    \407\ Centers for Medicare & Medicaid Services. Medicare and 
Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment and Coverage Policies; 
Medicare Shared Savings Program Requirements; Medicare Advantage; 
Medicare and Medicaid Provider and Supplier Enrollment Policies; and 
Basic Health Program. 88 FR 52750. https://www.govinfo.gov/content/pkg/FR-2023-08-07/pdf/2023-14624.pdf.
    \408\ Centers for Medicare & Medicaid Services. Medicare 
Program; CY 2022 Payment Policies Under the Physician Fee Schedule 
and Other Changes to Part B Payment Policies; Medicare Shared 
Savings Program Requirements; Provider Enrollment Regulation 
Updates; and Provider and Supplier Prepayment and Post-Payment 
Medical Review Requirements. 86 FR 65668. https://www.govinfo.gov/content/pkg/FR-2021-11-19/pdf/2021-23972.pdf.
---------------------------------------------------------------------------

    We proposed to amend Sec.  424.205(a), (b)(1),\409\ newly 
redesignated paragraphs (c)(1) and (g)(1)(i)(C). We solicited comments 
on these proposals.
---------------------------------------------------------------------------

    \409\ Centers for Medicare & Medicaid Services. Medicare and 
Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment and Coverage Policies; 
Medicare Shared Savings Program Requirements; Medicare Advantage; 
Medicare and Medicaid Provider and Supplier Enrollment Policies; and 
Basic Health Program. 88 FR 52508. https://www.govinfo.gov/content/pkg/FR-2023-08-07/pdf/2023-14624.pdf.
---------------------------------------------------------------------------

    We received public comments on these proposals. The following is a

[[Page 79256]]

summary of the comments we received and our responses.
    Comment: Commenters were unanimous in their support of CMS' 
proposal to remove the requirement for MDPP interim preliminary 
recognition and replace it with CDC preliminary recognition.
    Response: We appreciate the public comments in support of the 
proposed revisions. After consideration of public comments, we are 
finalizing as proposed.
4. Changes to Sec.  424.210(b) and (d)
    We proposed to amend Sec.  424.210(b) and (d) \410\ to remove 
reference to, and requirements of, the Ongoing Maintenance phase 
described in these sections. In the CY 2022 PFS final rule,\411\ CMS 
removed eligibility for the Ongoing Maintenance Sessions for those 
beneficiaries who started the Set of MDPP services on or after January 
1, 2022. Eligibility for these services will end December 31, 2023.
---------------------------------------------------------------------------

    \410\ Centers for Medicare & Medicaid Services. Medicare and 
Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment and Coverage Policies; 
Medicare Shared Savings Program Requirements; Medicare Advantage; 
Medicare and Medicaid Provider and Supplier Enrollment Policies; and 
Basic Health Program. 88 FR 52509. https://www.govinfo.gov/content/pkg/FR-2023-08-07/pdf/2023-14624.pdf.
    \411\ Centers for Medicare & Medicaid Services. Medicare 
Program; CY 2022 Payment Policies Under the Physician Fee Schedule 
and Other Changes to Part B Payment Policies; Medicare Shared 
Savings Program Requirements; Provider Enrollment Regulation 
Updates; and Provider and Supplier Prepayment and Post-Payment 
Medical Review Requirements. 86 FR 65668. https://www.govinfo.gov/content/pkg/FR-2021-11-19/pdf/2021-23972.pdf.
---------------------------------------------------------------------------

    We proposed to amend its regulation at Sec.  424.210 by amending 
paragraphs (b) and (d). We solicited comments on these proposals.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: We received several comments regarding CMS removing 
reference to, and requirements of, the Ongoing Maintenance phase were 
supportive of this change.
    Response: We appreciate the comments regarding this provision.
    After consideration of public comments, we are finalizing as 
proposed.

J. Appropriate Use Criteria for Advanced Diagnostic Imaging

    Section 1834(q) of the Act, as added by section 218(b) of the 
Protecting Access to Medicare Act (Pub. L. 113-93, April 1, 2014) 
(PAMA), directs CMS to establish a program to promote the use of 
appropriate use criteria (AUC) for advanced diagnostic imaging 
services. Since the bill was passed, we have taken steps to implement 
this program and codified the AUC program in our regulations at 42 CFR 
414.94. In CY 2020, we began conducting an educational and operations 
testing period for the claims-based reporting of AUC consultation 
information and the program currently operates in this phase.
    In the CY 2024 PFS proposed rule (88 FR 52262, at 52509 through 
52515), we proposed to pause efforts to implement the AUC program for 
reevaluation and to rescind the current AUC program regulations at 
Sec.  414.94. We did not propose a timeframe within which 
implementation efforts may recommence. We stated that we will continue 
efforts to identify a workable implementation approach and will propose 
to adopt any such approach through subsequent rulemaking.
1. Background
    AUC are evidence-based guidelines that assist clinicians in 
selecting the imaging studies most likely to improve health outcomes 
for patients based on their individual clinical presentation. AUC 
present information in a manner that links a specific clinical 
condition or presentation; one or more services; and an assessment of 
the appropriateness of the service(s). For purposes of this program, 
AUC are a set or library of individual AUC. Each individual criterion 
is an evidence-based guideline for a particular clinical scenario based 
on a patient's presenting symptoms or condition. Under this program, 
any clinician who orders an advanced diagnostic imaging service must 
consult AUC for the imaging service ordered. Examples of advanced 
diagnostic imaging services include computed tomography, positron 
emission tomography, nuclear medicine and magnetic resonance imaging.
    To consult AUC, clinicians use clinical decision support mechanisms 
(CDSMs). CDSMs are the electronic portals through which clinicians 
access the AUC during the patient workup. They can be standalone 
applications that require direct entry of patient information; however, 
may be more effective when they are integrated into electronic health 
records (EHRs). Ideally, clinicians would interact directly with the 
CDSM through their primary user interface, thus minimizing interruption 
to the clinical workflow.
    Under the AUC program, clinicians and facilities that furnish the 
imaging service are responsible for reporting information about the 
ordering clinician's AUC consultation on the imaging service claim. The 
furnishing clinician and facility are not paid if the ordering 
clinician fails to consult and/or if the consultation information is 
not correctly included on the imaging service claim.
2. Statutory Authority
    Section 218(b) of the PAMA added a new section 1834(q) of the Act 
entitled, ``Recognizing Appropriate Use Criteria for Certain Imaging 
Services,'' which directed the Secretary to establish a program to 
promote the use of AUC. Section 1834(q)(4) of the Act requires ordering 
professionals to consult with specified applicable AUC through a 
qualified CDSM for applicable imaging services furnished in an 
applicable setting and paid for under an applicable payment system; and 
payment for such service may only be made if the claim for the service 
includes information about the ordering professional's consultation of 
specified applicable AUC through a qualified CDSM.
3. Discussion of Statutory Requirements and Implementation
    There are four major components of the AUC program under section 
1834(q) of the Act, and each component has its own implementation date: 
(1) establishment of AUC by November 15, 2015 (section 1834(q)(2) of 
the Act); (2) identification of mechanisms for consultation with AUC by 
April 1, 2016 (section 1834(q)(3) of the Act); (3) AUC consultation by 
ordering professionals, and reporting on AUC consultation by January 1, 
2017 (section 1834(q)(4) of the Act); and (4) annual identification of 
outlier ordering professionals (based on low adherence to AUC) for 
services furnished after January 1, 2017 (section 1834(q)(5) of the 
Act). These four components are precursors to the requirement that, 
beginning for CY 2017, we establish mandatory prior authorization 
procedures for outlier ordering professionals when ordering advanced 
diagnostic imaging services (section 1834(q)(6) of the Act).
a. Establishment of AUC
    We addressed the first component of the Medicare AUC program under 
section 1834(q)(2) of the Act, establishment of AUC, in the CY 2016 PFS 
final rule with comment period (80 FR 70886). With this rule, we began 
to codify the statutory requirements in our regulations at 42 CFR 
414.94. We also defined provider-led entity (PLE), as well as 
additional definitions under section 1834(q)(1) of the Act in our 
regulations at Sec.  414.94(b). In Sec.  414.94(c)(1) and (2), 
respectively, we

[[Page 79257]]

set forth the requirements and process by which PLEs become qualified 
by CMS to develop, modify, or endorse AUC. We qualified the first group 
of PLEs under the AUC program and posted them to the CMS website in 
June 2016 at which time their AUC libraries became specified applicable 
AUC for purposes of section 1834(q)(2)(A) of the Act.
b. Identification of Mechanisms for Consultation With AUC
    We addressed the second component under section 1834(q)(3) of the 
Act, identification of mechanisms for consultation with AUC, in the CY 
2017 PFS final rule (81 FR 80170). In this rule we defined clinical 
decision support mechanism (CDSM) in Sec.  414.94(b). In Sec.  
414.94(g)(1) and (2), respectively, we set forth the requirements CDSMs 
must meet and established a process by which CDSMs may become qualified 
by CMS in accordance with the statutory requirements under section 
1834(q)(3)(B)(ii) of the Act. We qualified the first group of CDSMs 
under the AUC program and posted them to the CMS website in July 2017.
c. AUC Consultation and Reporting
    We addressed the third component under section 1834(q)(4) of the 
Act, AUC consultation by ordering professionals, and reporting on AUC 
consultation, primarily in the CY 2018 PFS final rule (82 FR 53190). 
Additionally, in the CY 2017 PFS final rule, we defined terms in Sec.  
414.94(b) (81 FR 80405 and 80406) and identified exceptions to the AUC 
consultation and reporting requirements under section 1834(q)(4) of the 
Act in Sec.  414.94(i) (81 FR 80422 through 80424) which are pertinent 
to the third component. We also continued to revise the regulation at 
Sec.  414.94 as needed and in response to comments from interested 
parties in subsequent rulemaking cycles. These updates, revisions, and 
clarifications, which continued through annual PFS rulemaking for CYs 
2018, 2019, and 2020, are discussed throughout this section as they 
directly relate to the AUC consultation requirement under section 
1834(q)(4)(A) of the Act and reporting requirement under section 
1834(q)(4)(B) of the Act.
    In the CY 2017 PFS final rule, we defined applicable payment 
systems consistent with section 1834(q)(4)(D) of the Act to include the 
PFS established under section 1848(b) of the Act, the prospective 
payment system for hospital outpatient department services under 
section 1833(t) of the Act, and the ambulatory surgical center payment 
system under section 1833(i) of the Act (81 FR 80406). In the CY 2016 
PFS final rule with comment period, we defined applicable setting 
consistent with section 1834(q)(1)(D) of the Act to include a 
physician's office, a hospital outpatient department (including an 
emergency department), and an ambulatory surgical center (80 FR 71105). 
We later added independent diagnostic testing facility (IDTF) to the 
definition of applicable setting in the CY 2019 PFS final rule (83 FR 
59690 and 59691).
    Also in the CY 2017 PFS final rule, consistent with section 
1834(q)(4)(C) of the Act, we identified exceptions to the AUC 
consultation and reporting requirements under section 1834(q)(4) of the 
Act in the case of: a service ordered for an individual with an 
emergency medical condition, a service ordered for an inpatient and for 
which payment is made under Medicare Part A, and a service ordered by 
an ordering professional for whom the Secretary determines that 
consultation with applicable AUC would result in a significant hardship 
(81 FR 80422 through 80424). The significant hardship exception 
criteria and process under Sec.  414.94(i)(3) was later updated in the 
CY 2019 PFS final rule (83 FR 59697 through 59700).
    In the CY 2018 PFS final rule, we established a voluntary period 
from July 2018 through the end of 2019 during which ordering 
professionals who were ready to participate in the AUC program could 
consult specified applicable AUC through qualified CDSMs and 
communicate the results to furnishing professionals (82 FR 53193 
through 53195). Furnishing professionals who were ready to do so could 
report AUC consultation information on the claim. To incentivize early 
use of qualified CDSMs for consulting AUC, we established in the CY 
2018 Updates to the Quality Payment Program; and Quality Payment 
Program: Extreme and Uncontrollable Circumstances Policy for the 
Transition Year final rule with comment period and interim final rule a 
high-weight improvement activity for ordering professionals who consult 
specified AUC using a qualified CDSM for the Merit-based Incentive 
Payment System (MIPS) performance period that began January 1, 2018 (82 
FR 54193).
    In addition, in the CY 2018 PFS final rule, we established the 
start date of January 1, 2020, for the Medicare AUC program for 
advanced diagnostic imaging services in Sec.  414.94(j)(1) (82 FR 53189 
through 53195). Specifically, for services ordered on and after January 
1, 2020, we established that ordering professionals must consult 
specified applicable AUC using a qualified CDSM when ordering 
applicable imaging services in Sec.  414.94(j) and furnishing 
professionals must report AUC consultation information on the Medicare 
claim in Sec.  414.94(k). In the CY 2019 PFS final rule, we specified 
under Sec.  414.94(j)(2) that when delegated by the ordering 
professional, clinical staff under the direction of the ordering 
professional may perform the AUC consultation with a qualified CDSM. In 
the CY 2018 PFS final rule, we further specified that the AUC program, 
including the claims denial payment penalty phase, would begin on 
January 1, 2020, with a year-long educational and operations testing 
period for CY 2019 during which AUC consultation information was 
expected to be reported on claims, but claims would not be denied for 
failure to include proper AUC consultation information (82 FR 53193 
through 53195). As discussed in further detail below, the educational 
and operations testing period was subsequently extended multiple times 
and the program currently operates in the educational and operations 
testing period.
    In the CY 2018 PFS final rule and consistent with section 
1834(q)(4)(B) of the Act, we established in Sec.  414.94(k) that the 
following information must be reported on Medicare claims for advanced 
diagnostic imaging services: (1) the qualified CDSM consulted by the 
ordering professional; (2) whether the service ordered would or would 
not adhere to specified applicable AUC, or whether the specified 
applicable AUC consulted was not applicable to the service ordered; and 
(3) the NPI of the ordering professional (if different from the 
furnishing professional) (82 FR 53190 through 53193). Section 
1834(q)(4)(B) of the Act specifies that payment for advanced diagnostic 
imaging service claims under the AUC program may only be made if the 
claim submitted by the furnishing professional (of which there can be 
more than one if the professional component is furnished by a different 
entity than the technical component) includes this information about 
the ordering professional's AUC consultation. This statutory 
requirement establishes a real-time claims-based reporting requirement 
whereby payment for the imaging service is contingent upon specific 
information being present on the claim. We worked to operationalize the 
real-time claims-based reporting requirement by announcing our 
intention to use G-codes and HCPCS modifiers to report AUC consultation 
information on the Medicare claims in the CY 2019 PFS final rule.

[[Page 79258]]

    In the CY 2022 PFS final rule (86 FR 64996), we provided further 
clarification around the scope of the AUC program specifically 
pertaining to updates or modifications to orders for advanced 
diagnostic imaging services (86 FR 65227 through 65229), the extreme 
and uncontrollable circumstances significant hardship exception (86 FR 
65229 and 65230) and specified claims processing solutions, including 
creation and use of a new HCPCS modifier intended to accurately 
identify claims that are and are not subject to the AUC program 
requirements. We also discussed special circumstances related to: 
services furnished by a critical access hospital (CAH) (86 FR 65231 and 
65232), services paid under the Maryland Total Cost of Care Model (86 
FR 65232 and 65233), inpatients converted to outpatients (86 FR 65233 
and 65234), Medicare as the secondary payer (86 FR 65234 and 65235), 
and imaging services ordered prior to the start of the claims denial 
payment penalty phase but furnished on or after the start of the 
payment penalty phase (86 FR 65235). We addressed where to identify the 
ordering professional on practitioner claims for imaging services (86 
FR 65231) (we addressed where to identify ordering professionals on 
institutional claims in educational materials following the CY 2019 PFS 
final rule claims-based reporting discussion (83 FR 59696)) and 
confirmed that claims that do not properly append AUC consultation 
information will be returned for correction and resubmission, rather 
than denied, when the payment penalty phase begins (86 FR 65234). We 
did not specify how long claims would be returned before the payment 
penalty phase would shift to claim denials. Finally, we established 
that the payment penalty phase would begin on the later of January 1, 
2023, or the January 1 that follows the declared end of the PHE for 
COVID-19. Under this specification and with the declared end of the PHE 
for COVID-19 on May 11, 2023, the payment penalty phase would have been 
scheduled to begin on January 1, 2024. However, as announced via the 
AUC website in 2022 and discussed further below in this section of the 
proposed rule, the educational and operations testing period will 
continue until further notice. We did not include provisions pertaining 
to the AUC program in the CY 2023 PFS final rule (87 FR 69404).
d. Identification of Outlier Ordering Professionals
    We began to address the fourth component under section 1834(q)(5) 
of the Act, identification of outlier ordering professionals, in the CY 
2017 PFS final rule by finalizing the first list of priority clinical 
areas (PCAs) in Sec.  414.94(e)(5) (81 FR 80406 through 80412) which 
were intended to ultimately guide identification of outlier ordering 
professionals who would eventually be subject to prior authorization 
when ordering advanced diagnostic imaging services. Section 1834(q)(5) 
of the Act directs CMS to: (1) determine on an annual basis no more 
than 5 percent of total ordering professionals who are outlier ordering 
professionals; and (2) base the determination of an outlier ordering 
professional on low adherence to AUC which may be based on comparisons 
to other ordering professionals and include data for ordering 
professionals for whom prior authorization applies; and (3) use 2 years 
of data to identify outlier ordering professionals; and (4) consult 
with physicians, practitioners and other interested parties in 
developing methods to identify outlier ordering professionals. To date, 
we have not proposed or codified the methods for identifying outlier 
ordering professionals as prescribed by section 1834(q)(5) of the Act, 
and thus, we have not subjected any ordering professionals to prior 
authorization when ordering advanced diagnostic imaging services as 
prescribed by section 1834(q)(6) of the Act.
4. Timeline
    As evident from the description of our regulatory activities to 
date, we have not met the statutory implementation time frame for the 
AUC program components. The educational and operations testing period 
began January 1, 2020, and the AUC program continues to operate in this 
phase currently. In this phase, there are no payment penalties for 
advanced diagnostic imaging service claims that do not append AUC 
consultation information. The provisions in section 1834(q) of the Act 
repeatedly stress the importance of engagement with interested parties 
in developing the Medicare AUC program. Throughout our implementation 
activities, we have intentionally taken a diligent, stepwise 
implementation approach to maximize the opportunity for public comment 
and engagement with interested parties, and allow for adequate advance 
notice to physicians and practitioners, beneficiaries and other AUC 
interested parties of any programmatic changes or updates. These 
efforts to maximize engagement included speaking and answering live 
questions at multiple CMS Open Door Forums, participating in external 
meetings sponsored by and at the request of interested parties like 
medical specialty societies and health care practitioners, and meeting 
in person and virtually with interested parties upon request to receive 
feedback and answer questions to the best of our ability and within the 
context of already publicly available information. All of these 
interactions were critical to inform our proposals during each round of 
notice and comment rulemaking. This approach has allowed us to be 
comprehensive in our assessment of implementation options and 
regulatory proposals, responsive to concerns expressed by interested 
parties, and agile in reacting to unexpected events, like the PHE for 
COVID-19. Since the CY 2022 PFS final rule was released, we have used 
the AUC website \412\ to publicly announce updates to the AUC program. 
In July 2022, we updated the AUC website to inform interested parties 
that the payment penalty phase of the AUC program would not begin on 
January 1, 2023, even if the PHE for COVID-19 ended in 2022. This 
update also stated that the educational and operations testing period 
would continue and that we are not able to forecast when the payment 
penalty phase will begin. In October 2022, we updated the AUC website 
again to announce that applications for CDSM and PLE initial 
qualification and re-qualification would not be accepted for the 2023 
application cycle and that all CDSMs and PLEs qualified as of July 2022 
would remain qualified through this cycle.
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    \412\ https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/appropriate-use-criteria-program.
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5. Proposal To Pause Program for Reevaluation
    Since 2015, we have taken a thoughtful, stepwise approach that 
maximized engagement and involvement of interested parties to implement 
the statutory provisions set forth in section 1834(q), as added by 
section 218(b) of the PAMA, using notice and comment rulemaking. As 
discussed previously in this section of the final rule, we established 
the first two components of the AUC statutory requirements--
establishment of AUC and mechanisms for consultation. We began to build 
the parameters for the fourth component, outlier identification, 
leading to prior authorization, by establishing the PCAs. And we began 
implementing the third component, the AUC consultation and reporting 
requirement, using the ongoing educational and operations testing 
period. At this time, however, we have

[[Page 79259]]

exhausted all reasonable options for fully operationalizing the AUC 
program consistent with the statutory provisions as prescribed in 
section 1834(q)(B) of the Act directing CMS to require real-time 
claims-based reporting to collect information on AUC consultation and 
imaging patterns for advanced diagnostic imaging services to ultimately 
inform outlier identification and prior authorization. As a result, we 
proposed to pause implementation of the AUC program for reevaluation, 
and proposed to rescind the current AUC program regulations from Sec.  
414.94. We expected this to be a hard pause to facilitate thorough 
program reevaluation and, as such, we did not propose a time frame 
within which implementation efforts may recommence.
a. Real-Time Claims-Based Reporting
    Section 1834(q)(4)(A) of the Act requires ordering professionals to 
consult AUC using a qualified CDSM. Section 1834(q)(4)(B) of the Act 
requires furnishing professionals to report information about the 
ordering professional's AUC consultation with a qualified CDSM on the 
Medicare claim for the advanced diagnostic imaging service the ordering 
professional ordered. This section dictates that payment to the 
furnishing professional is contingent on reporting the ordering 
professional's AUC consultation information, which must include the 
ordering professional's NPI, the qualified CDSM that was consulted, and 
whether the service ordered adheres or does not adhere to the AUC 
consulted, or if there were no AUC applicable to the order available 
for consultation via the qualified CDSM that was consulted as described 
above.
    While each component of the statutory requirements has presented 
unique challenges to implement, the greatest challenge has been in 
fully implementing and operationalizing the real-time claims-based 
reporting requirement consistent with section 1834(q)(4)(B) of the Act 
to ensure accurate reporting, claims processing and, ultimately, 
outlier identification and prior authorization. We formally solicited 
public comment and feedback from interested parties in notice and 
comment rulemaking in the CY 2017 PFS rulemaking cycle, and have 
welcomed and encouraged feedback and information from interested 
parties less formally throughout the duration of our implementation 
efforts in each successive year. In the CY 2017 PFS final rule, we 
discussed the importance of developing and operationalizing a 
meaningful solution for collecting AUC consultation information on 
Medicare claims. We explained that ``we must diligently evaluate our 
options taking into account the vast number of claims impacted and the 
limitations of the legacy claims processing system.'' We further noted 
that ``[m]oving too quickly to satisfy the reporting requirement could 
inadvertently result in technical and operational problems that could 
cause delays in payments'' (81 FR 80420). In addition to consulting 
with claims processing experts outside of and between rulemaking 
cycles, we continued to clearly and intentionally solicit feedback and 
suggestions from interested parties to assist us in developing workable 
claims processing edits and solutions to operationalize the AUC 
reporting requirement consistent with section 1834(q)(4)(B) of the Act 
in rulemaking cycles for the CY 2018, 2019 and 2022 PFS.
    Having considered many rounds of input from interested parties, 
including internal and external experts, and diligent exploration of 
options, we have come to believe that the real-time claims-based 
reporting requirement prescribed by section 1834(q)(4)(B) of the Act 
presents an insurmountable barrier for CMS to fully operationalize the 
AUC program. To properly apply the statutory provisions of the AUC 
program, including specifications around settings in which services are 
furnished and payment systems under which Medicare payments are made, 
it is critical that claims are accurately identified in the Medicare 
claims processing system and accurately subjected to system's edits to 
ensure AUC consultation information is properly reported on the claim. 
Equally important is ensuring that claims not subject to the AUC 
program are not inappropriately subjected to claims system's edits. We 
consider a process where the Medicare claims processing system properly 
and accurately identifies only claims for services subject to the AUC 
program requirements, without manual action by practitioners/facilities 
that submit claims, to be a fully automated process. The existing 
Medicare claims processing system does not have the capacity to fully 
automate the process for distinguishing between advanced diagnostic 
imaging claims that are or are not subject to the AUC program 
requirement to report AUC consultation information as prescribed by 
section 1834(q)(4)(B) of the Act. This means that the Medicare claims 
processing system is not able to ensure that claims for services that 
are not subject to the AUC consultation information reporting 
requirement will not be improperly denied for failure to append AUC 
consultation information. We note here that our intention, as announced 
in the CY 2022 PFS final rule, was to begin the payment penalty phase 
of the AUC program by returning, rather than denying, claims for 
advanced diagnostic imaging services that do not contain AUC 
consultation information for correction and resubmission; however, 
section 1834(q)(4)(B) of the Act specifies that payment for advanced 
diagnostic imaging services under the AUC program may only be made if 
the claim for the imaging service includes specific AUC consultation 
information. Consequently, the payment penalty phase would eventually 
need to shift from returning claims for correction and resubmission to 
denying claims. As such, and without the practicable capacity to fully 
automate the process for editing claims to ensure only appropriate 
claims are edited for AUC consultation information, there is a 
significant risk that full implementation of the penalty phase of the 
AUC program would result in inappropriate claims denials.
    To avoid these inappropriate denials, we considered requiring 
claims to include certain modifiers that would identify them as not 
being subject to the AUC consultation and reporting requirements under 
section 1834(q)(4)(A) and (B) of the Act. However, this would add an 
extra layer of burden on furnishing professionals, including 
freestanding and hospital-based imaging facilities, requiring them to 
append information to the claims even for services that are not subject 
to the AUC consultation and reporting requirement in order to allow us 
to identify which imaging services are and are not subject to the AUC 
consultation and reporting requirements under section 1834(q)(4)(A) and 
(B) of the Act, and allow us to appropriately process claims.
    Additionally, the AUC program is designed to target a subset of 
advanced diagnostic imaging services furnished in specific settings and 
paid under specific payment systems, as opposed to, for example, all 
Medicare part B advanced diagnostic imaging service claims, and 
includes multifaceted criteria for identifying which services are 
subject to the program. As such, ordering professionals would need to 
know, at the time of the order, where each imaging service will be 
furnished and under which payment system the claim will be paid to 
determine whether AUC consultation, and transmission of AUC 
consultation information with the order, is required. Furnishing 
professionals, including freestanding and hospital-

[[Page 79260]]

based imaging facilities, would need to be able to delineate which 
orders received without AUC consultation information are not subject to 
the AUC program from those that are subject to the program and its 
requirements. If they are able to confirm that a service is not subject 
to the AUC program, then they would need to identify the appropriate 
modifier to append to the claim so it can be processed and be paid 
without AUC consultation information. Alternatively, if they find that 
the order is subject to the AUC program, they would need to take steps 
to obtain AUC consultation information from the ordering professional, 
decline to furnish the service, or risk denial of the claim for a 
furnished service.
    An example that highlights the practical complexity and 
unwieldiness of the AUC program is the, not uncommon, scenario where an 
advanced diagnostic imaging service is furnished in two settings--only 
one of which is an applicable setting. For example, this occurs when 
the technical component (TC) of an imaging service is furnished in a 
setting, like a critical access hospital (CAH), that is not an 
applicable setting. As we discussed in the CY 2022 PFS final rule, 
because the service was not furnished in an applicable setting, the 
entirety of the service (both the technical and professional component 
(PC)), is not subject to the AUC consultation requirement. Therefore, 
neither of the separate claims for the TC and PC for the service are 
required to include AUC consultation information. However, there is no 
way in real-time claims processing for us to identify that the PC claim 
is for an imaging service that was not furnished in an applicable 
setting. For the claim to process and be paid when it does not include 
AUC consultation information, the furnishing professional for the PC 
would need to append a modifier to the claim to identify it as not 
being subject to the AUC consultation and reporting requirement.
b. Accuracy of Claims Data
    Because, as previously noted, the CMS claims processing system is 
unable to fully automate editing advanced diagnostic imaging claims, 
risks around reporting accuracy are inherent to the AUC program 
prescribed by section 1834(q)(4)(B) of the Act. These risks directly 
impact furnishing professionals, including free-standing and hospital-
based facilities, by affecting payment for advanced diagnostic imaging 
services they furnish, in some cases based on conduct of ordering 
professionals with whom they have little or no affiliation. Beyond the 
potential for inappropriate claims denials as previously discussed, by 
manually appending information to their claims as supplied by ordering 
professionals, furnishing professionals are attesting to the 
credibility and accuracy of that information and may find themselves 
subject to audits or post-pay review. Considering that the AUC program 
ultimately involved the identification of outlier ordering 
professionals and imposing a prior authorization procedure for them as 
prescribed in sections 1834(q)(5) and (6) of the Act, reliance on 
manual reporting by one party of information supplied by another party 
presents a serious risk to data accuracy and integrity. Since section 
1834(q)(5) of the Act directs CMS to use these data from claims-based 
AUC consultation information collection to identify outlier ordering 
professionals, and section 1834(q)(6) of the Act directs CMS to require 
prior authorization for outlier ordering professionals, the quality and 
accuracy of the data used to make these determinations is critical to 
ensure the AUC program leads to appropriate application of prior 
authorization for advanced diagnostic imaging services.
c. Effect on Medicare Beneficiaries
    We recognize that a program to promote the use of AUC for advanced 
diagnostic imaging could improve imaging utilization patterns for 
Medicare beneficiaries. Ideally, beneficiaries would undergo fewer and 
more appropriate imaging procedures to inform more efficient treatment 
plans and address medical conditions more quickly and without 
unnecessary tests. In the CY 2019 PFS final rule, we estimated how 
adding AUC consultation to an ordering professional's workload would 
directly impact a Medicare beneficiary based on the additional office 
visit time needed for consultation and ordering. We estimated this 
impact by calculating the cost to beneficiaries associated with the 
additional consultation time to be $68,001,000 annually (83 FR 60040), 
representing the opportunity cost of time spent in the office. In the 
CY 2022 PFS final rule, we updated this estimate based on Medicare 
claims data and changes in wage estimates to $54,789,518 annually. We 
estimated that potential savings would offset this opportunity cost of 
time spent by beneficiaries in the office by $27,394,759 annually based 
on process efficiencies that may be implemented over time by ordering 
professionals (86 FR 65626). In the CY 2019 PFS final rule, we 
estimated other impacts associated with the AUC program including 
potential savings to the Medicare program. We estimated potential 
savings of $700,000,000 annually by extrapolating savings from a 
clinical decision support pilot project performed by the Institute for 
Clinical Systems Improvement in Bloomington, Minnesota.\413\ (83 FR 
60043) Since this estimate was based on information from previous 
clinical decision support experiences and not Medicare claims data or 
wage estimates, we did not update this estimate in the CY 2022 PFS 
final rule. The prior savings estimate is no longer an accurate 
reflection of savings that could be achieved and CMS will not realize 
the estimated $700,000,000 annual savings because, as described in the 
final rule, the AUC program cannot be implemented as written in 
statute; therefore, expected savings are negligible.
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    \413\ Miliard, M. Nuance, ICSI aim to prevent unnecessary 
imaging tests. Healthcare IT News. November 10, 2010.
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    While the incorporation of any new process into workflows can be 
expected to impart burden that eventually lessens, we have additional 
concerns about risks for beneficiaries stemming from the real-time 
claims-based reporting requirement prescribed by section 1834(q)(4)(B) 
of the Act. Beyond the burden of adding to the workload of the ordering 
and furnishing professionals for advanced diagnostic imaging services, 
the AUC consultation program can produce risk to beneficiaries in 
receiving timely imaging services, and potentially being financially 
liable for advanced diagnostic imaging service claims denied by the 
Medicare program, whether properly or due to omissions or errors in 
conveying AUC consultation information on claims. Beneficiaries may 
experience delays in scheduling and receiving imaging if AUC 
information is not properly provided with the order from the ordering 
professional to furnishing professionals/facilities. This may happen, 
even if the imaging service is not subject to the AUC program 
requirements, in any circumstance where the furnishing professional/
facility is unclear whether the AUC consultation and reporting 
requirements apply (for example if Medicare is the secondary payer, or 
under other circumstances as discussed in the CY 2022 PFS final rule). 
Section 1834(q) of the Act does not separately establish protections to 
Medicare beneficiaries from financial liability for advanced diagnostic 
imaging service claims not paid by Medicare as required under the AUC 
program. As discussed above, because the Medicare claims processing 
system cannot fully automate

[[Page 79261]]

a process to ensure only claims for advanced diagnostic imaging 
services subject to the AUC program reporting requirement under section 
1834(q)(4)(B) of the Act are edited as such, there is a risk of 
inappropriate claims denials. Additionally, in the event that an 
ordering professional fails to consult AUC or neglects to communicate 
AUC consultation information (or relevant exception information) to the 
furnishing professional/facility and the furnishing professional/
facility proceeds with furnishing the imaging service despite the 
absence of this information, the beneficiary may incur unwarranted 
financial liability for the imaging service.
d. Summary
    Taken together and, in particular, due to the inability of the 
Medicare claims processing system to automate claims processing edits 
that ensure only claims subject to the AUC program requirements as 
prescribed in section 1834(q) of the Act will be processed as such, 
returned or denied accordingly, we believe the inherent risks in terms 
of data integrity and accuracy, beneficiary access, and potential 
beneficiary financial liability for advanced diagnostic imaging 
services render the AUC program impracticable, and have led us to our 
proposal to pause efforts to implement the AUC program for reevaluation 
and rescind current regulations. Working within the parameters 
prescribed under section 1834(q) of the Act, we have not identified any 
practical way to move the AUC program forward beyond the educational 
and operations testing period. Further, without a way forward to fully 
implement the AUC program, we believe there is no utility in continuing 
the educational and operations testing period. We will continue efforts 
to identify a workable implementation approach and will propose to 
adopt any such approach through subsequent rulemaking. We note, and 
discuss further below in this section of the final rule, that clinical 
decision support tools can be beneficial in assisting with clinical 
decision making and we encourage continued use of clinical decision 
support in a manner that best serves and assists clinicians.
6. Summary of Other Quality Initiatives
    As discussed above, section 218(b) of the PAMA of 2014 entitled 
``Promoting Evidence-Based Care'' established the Medicare AUC program. 
The statute was designed to promote the use of AUC for advanced 
diagnostic imaging services with enforcement through immediate non-
payment of claims for which there was no AUC consultation and, 
eventually, prior authorization for ``outliers'' that more frequently 
neglect to consult AUC. Promoting the use of AUC in clinical practice 
is an activity that encourages the use of evidence-based information/
guidelines/recommendations to guide patient care thus resulting in 
improved value and quality. Subsequent to PAMA, the Medicare Access and 
CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10, April 16, 
2015) established the Quality Payment Program, which is an incentive 
program to tie Medicare PFS payment to performance by rewarding high-
value, high-quality care. After enactment of these laws, we worked to 
implement both programs by successfully establishing and fully 
operationalizing the Quality Payment Program (both the Merit-based 
Incentive Payment System (MIPS) and Advanced Alternative Payment Models 
(APMs)) and, as discussed above, taking steps to implement each 
component of the AUC program up to and through the ongoing educational 
and operations testing period. We have developed outreach and 
educational materials and made all AUC program-related information 
available on the CMS AUC website.\414\ We believe that many goals of 
the AUC program have been met by the QPP and other more comprehensive 
accountable care initiatives such as the Medicare Shared Savings 
Program, advances in electronic clinical quality measures (eCQMs) and 
interoperability requirements of Certified Electronic Health Record 
Technology (CEHRT), and new Innovation Center models such as ACO REACH 
and Kidney Care Choices where physicians and other health care 
providers join together to take responsibility for both the quality of 
care and total cost of care their patients experience. These quality 
and value-based care programs are designed to achieve quality of care 
goals by addressing issues of utilization, cost and quality 
holistically instead of via claim-by-claim examination and improvement 
initiatives for specific types of services.
---------------------------------------------------------------------------

    \414\ https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/appropriate-use-criteria-program.
---------------------------------------------------------------------------

    While these initiatives, including the Shared Savings Program, do 
not specifically target advanced diagnostic imaging, we expect that 
this more global approach to improving quality and accountable care 
would broadly affect all services, including advanced diagnostic 
imaging utilization. Both ACO participation and episode of care payment 
models promote accountability for beneficiary cost of care as well as 
improving or maintaining quality of care according to applicable 
quality measures. Similarly, the MIPS ties together quality and costs 
by measuring and scoring performance in four performance categories: 
quality, cost, improvement activities, and promoting interoperability. 
MIPS uses measures and activities in each of these categories, such as 
the Total Per Capita Cost (TPCC) specialty measure, which focuses on 
effective primary care management to support Medicare savings. While 
also not specific to advanced diagnostic imaging, improvements in 
primary care management including ordering of diagnostic tests may 
involve consideration of appropriate imaging orders.
    More specific to advanced diagnostic imaging, MIPS includes 10 
specific quality measures pertaining to imaging or under the 
``Diagnostic Radiology'' Specialty Measure Set. Additionally, the 
Meaningful Measures 2.0 Framework includes a priority area for safety 
with the goal of ``Reduced Preventable Harm'' (https://edit.cms.gov/files/document/cascade-meaningful-measures-framework.xlsx). An 
objective under this goal is ``Diagnostic Accuracy/Error'' which 
includes a cascade measure concept/family of ``Appropriate use of 
radiology and lab testing.'' An example of an existing measure within 
this concept is ``Appropriate Follow-up Imaging for Incidental 
Abdominal Lesions'' (https://www.cms.gov/files/document/cascade-measures.xlsx).
    While a standalone program specifically requiring AUC consultation 
when ordering advanced diagnostic imaging services would directly 
target goals of improving advanced diagnostic imaging ordering 
patterns, our experience in recent years has demonstrated that the 
goals of appropriate, evidence based, coordinated care can be achieved 
more effectively, efficiently and comprehensively through other CMS 
quality initiatives.
7. Summary of the Proposal To Rescind (Sec.  414.94)
    We provided clarity to interested parties as we proposed to amend 
our regulations to rescind the current regulations by removing the text 
of Sec.  414.94 and reserve it for future use. This section contains 
the entirety of the regulations we adopted in the course of 
implementing elements of section 1834(q) of the Act. We believe the 
removal of these regulations is consistent with our proposal to pause

[[Page 79262]]

efforts to implement the AUC program for reevaluation, and would avoid 
the potential confusion that could result if we were merely to retain 
or amend the regulation text at Sec.  414.94.
    We acknowledge and emphasize the value of clinical decision support 
to bolster efforts to improve the quality, safety, efficiency and 
effectiveness of health care. We welcome and encourage the continued 
voluntary use of AUC and/or clinical decision support tools in a style 
and manner that most effectively and efficiently fits the needs and 
workflow of the clinician user. Across many specialties and services, 
not just advanced diagnostic imaging, clinical decision support 
predates the enactment of the PAMA and, given its utility when accessed 
and used appropriately, we expect it to continue being used to 
streamline and enhance decision making in clinical practice and improve 
quality of care. Resources on clinical decision support are available 
on HHS Agency websites including the following:
     Office of the National Coordinator--https://www.healthit.gov/topic/safety/clinical-decision-support.
     Agency for Healthcare Research and Quality--https://www.ahrq.gov/cpi/about/otherwebsites/clinical-decision-support/index.html.
     Centers for Disease Control and Prevention--https://www.cdc.gov/opioids/healthcare-admins/ehr/clinical-decision-support.html.
8. Summary
    In conclusion, we proposed to pause efforts to implement the AUC 
program for reevaluation and to rescind the current AUC program 
regulations at Sec.  414.94 and reserve this section in the CFR. We did 
not propose a timeframe within which implementation efforts may 
recommence. We will continue efforts to identify a workable 
implementation approach and will propose to adopt any such approach 
through subsequent rulemaking.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Many commenters supported our proposal to pause efforts to 
implement the AUC program for reevaluation. The majority of these 
commenters also supported our proposal to rescind and reserve the 
current AUC program regulations at Sec.  414.94. Most commenters cited 
their agreement with our explanations of the insurmountable barriers 
presented in the discussion on the real-time claims-based reporting 
requirement and claims processing issues, as well as other operational 
challenges. Many stakeholders that represent health care providers who 
would be considered ordering professionals expressed support for the 
proposals because they believe the AUC program imposes undue burdens 
and administrative costs on providers. Many discussed aspects of the 
time, training effort, and costs of complying with the regulations. A 
few health systems and providers discussed their specific technical 
challenges with integrating CDSMs into their clinical workflow, 
disrupting patient care. Others noted that after years of the 
educational and operations testing period, they continue to have 
significant problems with reviewing orders received from outside their 
system and challenges in contacting ordering professionals to get 
correct information. One also noted technical challenges getting their 
electronic systems to correctly include AUC information on claims. One 
commenter stated that the regulatory requirement to implement a 
clinical decision support tool ``focused solely on imaging 
appropriateness creates a large burden on health systems and 
clinicians, without evidence that the program reduces high-cost 
imaging.'' Many commenters agreed with CMS's concerns about unintended 
costs to beneficiaries for improperly denied claims, as well as 
potential delays in accessing needed imaging services. Many commenters 
that represent professionals who furnish imaging services also thanked 
CMS for recognizing their concerns that the penalty portion included in 
the statute would penalize furnishing professionals who are unable to 
control the behaviors of ordering professionals. Several commenters 
agreed with CMS's concerns that the claims processing systems 
challenges present substantial risks for data integrity and accuracy. 
Many commenters expressed hope that CMS would permanently forgo the AUC 
program and/or that Congress would repeal or substantially change the 
PAMA statute. Many commenters recommended that CMS should provide 
clarity as to the status of the AUC program and not take steps to 
continue future implementation except through additional public 
engagement and public notice and comment. Several commenters thanked 
CMS for engaging with stakeholders and being responsive to comments and 
concerns of all interested parties over the last 8 years.
    Response: We thank commenters for their support.
    Comment: Some commenters provided mixed comments and a few 
commenters noted that they were unclear about their support or 
opposition to the proposal. Of the commenters that had mixed views, 
several expressed support for pausing the program for reevaluation and 
working toward a redesigned program but were either silent about 
rescinding the regulations or believed that rescinding the regulations 
at Sec.  414.94 is premature. A few commenters noted they believed that 
the PAMA statute must be changed in order to successfully implement an 
AUC program that eases utilization and does not inappropriately deny 
claims.
    Response: As discussed in the CY 2024 PFS proposed rule (88 FR 
52514 through 52515), we acknowledge and emphasize the value of 
clinical decision support to bolster efforts to improve the quality, 
safety, efficiency, and effectiveness of health care. We welcome and 
encourage the continued voluntary use of AUC and/or clinical decision 
support tools in a style and manner that most effectively and 
efficiently fits the needs and workflow of the clinician user. Across 
many specialties and services, not just advanced diagnostic imaging, 
clinical decision support predates the enactment of the PAMA and, given 
its utility when accessed and used appropriately, we expect it to 
continue being used to streamline and enhance decision-making in 
clinical practice and improve quality of care.
    While we are finalizing our proposal to pause the AUC program for 
reevaluation and to rescind the regulations at Sec.  414.94 at this 
time, reserving it for future use, we will continue efforts to identify 
a workable implementation approach and will propose to adopt any such 
approach through subsequent rulemaking, including implementing any 
amendments Congress might make to the AUC program statutory provisions. 
We appreciate some commenters' concerns that rescinding all or part of 
Sec.  414.94 is premature; however, given the need for clarity on the 
status of the program, we believe rescinding the regulations and 
reserving Sec.  414.94 is the most appropriate and straightforward 
option.
    Comment: Some commenters stated opposition to the proposal to both 
pause the AUC program and to rescind the regulations. Generally, most 
of these commenters cited the benefits of using AUC such as promoting 
cost containment and better test results. A few commenters expressed 
concern about the time, effort, money, and staff training resources 
they have spent to implement AUC consultation within their health 
system or practices. Several commenters that represent EHR

[[Page 79263]]

vendors, developers of clinical decision support tools, and a developer 
of AUC expressed strong concerns over delaying progress in development 
and use of AUC and CDSMs to advance use of high-quality imaging 
services as well as the potential chilling effect a pause could have on 
innovation within Medicare and across health care as a whole including 
Medicare Advantage and commercial plans. One commenter stated that CMS 
is concentrating too much on the payment mechanism in PAMA rather than 
focusing on the quality improvement aspect which in their view is the 
foundational aspect of the program. Three commenters stated that CMS 
has incorrectly interpreted various sections of the statute, including 
the requirement for AUC real-time claims-based reporting. Two 
commenters suggested that CMS is not interpreting enough flexibility 
into the PAMA or subsequent authorizing statutes; and if we follow 
commenters' interpretations instead, then we would have the authority 
already to incorporate the AUC program into other quality and value-
based care programs. Several commenters also expressed concerns 
regarding the time and resources spent developing, qualifying, and 
marketing clinical decision support tools and AUC; and the revenue they 
fear losing if CMS does not mandate use of AUC within the Medicare 
program. One commenter requested that CMS at minimum keep the PLE and 
CDSM subsections of Sec.  414.94. One commenter urged CMS to set a 
timeline for reevaluation and promulgation of new regulations so that 
phases of the program can continue.
    Response: As previously mentioned, use of clinical decision support 
in the healthcare industry predates the enactment of the PAMA across 
many specialties, not just advanced diagnostic imaging. Given its 
utility when accessed and used appropriately, we expect it to continue 
being used to streamline and enhance decision making in clinical 
practice and improve quality of care. We disagree with commenters' 
suggestions that we could and should simply ignore or reinterpret the 
PAMA statute to disregard the real-time claims-based processing 
requirement in section 1834(q)(4)(B) of the Act. We also disagree with 
interpretations of the statute that read a flexibility into the PAMA or 
subsequent authorizing statutes that would allow CMS to incorporate AUC 
into other quality and value-based care programs without additional 
amendments to the statute. As noted in the previous response, we are 
finalizing our proposal to pause the AUC program for reevaluation and 
to rescind the regulations at Sec.  414.94 at this time, reserving it 
for future use. We will continue efforts to identify a workable 
implementation approach and will propose to adopt any such approach 
through subsequent rulemaking, including implementing any amendments 
Congress might make to the AUC program statutory provisions. We 
appreciate comments recommending that we keep certain parts of Sec.  
414.94; however, we believe it would be confusing for all interested 
parties if CMS were to continue annually reviewing and qualifying PLE 
and CDSM applications while the rest of the program is paused. As noted 
in the proposed rule and previous comment response, the use of AUC and 
clinical decision support pre-dates the statutory AUC program for 
advanced diagnostic imaging. We note that many commenters indicated 
that they may continue to incorporate AUC and/or clinical decision 
support tools into their clinical decision making. Therefore, we 
expect, and encourage, that clinicians may continue to use clinical 
decision support, likely including mechanisms that had been qualified 
CDSMs under the AUC program, in a style and manner that best fits their 
needs and workflow. As such, while CMS will not be qualifying PLEs or 
CDSMs, we expect the industry and market for them will continue. We did 
not propose and cannot specify a timeframe within which implementation 
efforts may recommence, as that depends on the time needed for 
reevaluation and findings, as well as any potential Congressional 
action to revise the statute.
    Comment: Some commenters recommended that CMS hire a third-party 
contractor (technology vendor) to make any necessary changes to the 
claims processing system in order to avoid pausing the program for 
reevaluation. One commenter stated their ``surprise'' at learning for 
the first time of the claims processing difficulties as a reason for 
pausing the program. Other commenters disagreed with our descriptions 
of the claims processing barriers and questioned the accuracy of our 
explanations of the risks for improperly denied claims and inaccurate 
claims data. One commenter stated their belief that we over-estimated 
the numbers of inaccurate claims and improperly denied claims. This 
commenter believed instead that the worst result of implementing the 
program as is would be ``occasional incidents of a consultation 
occurring that was not required.''
    Response: We thank commenters for their suggestion that we contract 
for additional technical assistance, and will take it into further 
consideration. In the CY 2024 PFS proposed rule (88 FR 52510 through 
52512), we explained that since 2015, we have taken a thoughtful, 
stepwise approach to implementing the statute that maximized engagement 
and involvement of interested parties. In the proposed rule (88 FR 
52512 through 52513), we detailed the years of effort and public 
engagement to solve the claims processing aspects required by the 
statute. As described in the proposed rule on pages 52512 through 
52514, we considered many factors and believe we have exhausted all 
reasonable options for fully operationalizing the AUC program and 
resolving the issues with the real-time claims-based reporting 
requirement. We disagree with assertions that implementing the payment 
penalty portion of the statute with the current capabilities would not 
result in the potential for millions of improperly denied claims and 
would not implicate beneficiary liability for those denied claims. We 
also disagree with assertions that the only negative impacts would be 
occasional incidences of ordering professionals consulting AUC when it 
is not required. In the CY 2022 PFS final rule we updated the 
regulatory impact analysis based, in part, on updated claims data for 
advanced diagnostic imaging. Using only services billed on the 
professional claim type, we estimated over 30 million advanced 
diagnostic imaging services to be subject to the AUC program (86 FR 
65626). Since only professional claims were used for these estimates, 
the number of claims only increases once institutional claims for the 
same services are considered. Because we cannot fully automate the 
claims processing system to accurately identify the claims for services 
that are and are not subject to the real-time claims-based reporting 
requirement as discussed above, millions of claims are in fact at risk 
of improper processing, including unwarranted denials. As noted in a 
previous response, while we are finalizing our proposal to pause the 
AUC program for reevaluation and will rescind the regulations at Sec.  
414.94 (reserving this section) at this time. We will continue efforts 
to identify a workable implementation approach and will propose to 
adopt any such approach through subsequent rulemaking, including 
implementing any amendments Congress might make

[[Page 79264]]

to the AUC program statutory provisions.
    Comment: One commenter recommended that CMS should require the 
CDSMs to provide CMS data on compliance and problem areas that may 
exist. Another commenter similarly recommended that CMS change the AUC 
program to transfer responsibility for reporting and auditing on CDSM/
Guideline usage to the CDSMs. This commenter stated the CDSM reports 
could then be used ``on an ex post facto basis'' to enforce the program 
as originally envisioned, leading outlier physicians to have to follow 
pre-certification steps until their usage of AUC was within established 
limits.
    Response: This suggestion would require a change in the statute to 
remove the current real-time claims-based reporting requirement in 
section 1834(q)(4)(B) of the Act. As noted in the proposed rule, we 
would use the public notice and comment rulemaking process to reinstate 
any regulations and make future changes to the AUC program, including 
to implement any amendments Congress might make to the AUC program 
statutory provisions.
    Comment: A few commenters indicated that in recent years they have 
made efforts to work directly with Congress to revise or rescind the 
PAMA statute and will continue to do so given the discussion in the 
proposed rule. Several commenters requested that CMS partner directly 
with Congress; some suggested that this partnership work toward 
removing the requirements for the AUC program from the statute, others 
suggested CMS and Congress should modify the statute to remove the 
real-time claims-based reporting requirements and provide CMS with more 
flexibility in how to implement AUC within Medicare. Several suggested 
modifying the statute to align or incorporate the AUC program with 
other quality improvement and value-focused programs authorized under 
other sections of the statute. One commenter requested that CMS work to 
advance legislation with Congress that enables implementation of an 
advanced payment model for advanced diagnostic imaging based on the use 
of AUC embedded in CDSMs and to consider other opportunities in Federal 
policy making to use CDSMs.
    Response: As noted, the commenters are suggesting legislative 
changes to the AUC program, which would require Congressional action. 
We appreciate these suggestions and will respond appropriately to any 
amendments to the statute that impact the AUC program.
    Comment: One commenter wished to ``. . . remind CMS that, in July 
2021, the House Appropriations Committee approved the Fiscal Year (FY) 
2022 Labor, Health and Human Services, Education spending bill and 
included an accompanying report that called on CMS to report to 
Congress on the implementation of the AUC Program, including program 
challenges and successes. The report language further directed CMS to 
consider existing quality improvement programs and relevant CMS 
Innovation Center models and their influence on appropriate use of 
advanced diagnostic imaging.''
    Response: We provided a response to this Appropriations Committee 
request in February 2023. Additionally, in the proposed rule (88 FR 
52514 through 52515) in section 6. ``Summary of Other Quality 
Initiatives'', we discussed that, subsequent to PAMA, in accordance 
with the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) 
(Pub. L. 114 10, April 16, 2015) we established and fully 
operationalized the Quality Payment Program (both the Merit-based 
Incentive Payment System (MIPS) and Advanced Alternative Payment Models 
(APMs)). We discussed the Quality Payment Program and stated that we 
believe that many goals of the AUC program have been met by the Quality 
Payment Program and other more comprehensive accountable care 
initiatives such as the Medicare Shared Savings Program, advances in 
electronic clinical quality measures (eCQMs) and Interoperability 
requirements of Certified Electronic Health Record Technology (CEHRT), 
and new Innovation Center models such as ACO REACH and Kidney Care 
Choices where physicians and other health care providers join together 
to take responsibility for both the quality of care and total cost of 
care their patients experience. These quality and value-based care 
programs are designed to achieve quality of care goals by addressing 
issues of utilization, cost, and quality holistically instead of via 
claim-by-claim examination and improvement initiatives for specific 
types of services. While a standalone program specifically requiring 
AUC consultation when ordering advanced diagnostic imaging services 
would directly target goals of improving advanced diagnostic imaging 
ordering patterns, our experience in recent years has demonstrated that 
the goals of appropriate, evidence based, coordinated care can be 
achieved more effectively, efficiently, and comprehensively through 
other CMS quality initiatives.
    Comment: Many commenters noted that other quality and efficiency 
programs may have a greater impact on improving quality of care and 
promoting high-value care. Several commenters stated that the current 
AUC program does not consider patient outcomes, or other important 
factors related to quality, which they believe are more appropriately 
addressed in APMs. Additionally, one commenter stated that physicians 
participating in APMs are ``already accountable for the quality and 
cost of their care, including strong incentives to reduce unnecessary 
utilization of costly imaging services, rendering the AUC program 
unnecessary.'' Another commenter stated that their organization has 
always been concerned that implementation of the AUC program would 
detract from the developments of the Quality Payment Program made in 
the years since the AUC program was signed into law. One commenter 
recommended adjusting the MIPS to better serve as an incentive for use 
of AUC; they noted that practices and customers have difficulty gauging 
the benefit of AUC contribution to their MIPS credit scoring and have 
concerns that including AUC in their submissions could actually reduce 
their MIPS credits if used as an alternative.
    Response: We thank commenters for these comments and suggestions 
and will keep them in consideration as we reevaluate the AUC program. 
As noted in the previous responses, we are finalizing our proposal to 
pause the AUC program for reevaluation and to rescind the regulations 
at Sec.  414.94 at this time, reserving it for future use. We will 
continue efforts to identify a workable implementation approach and 
will propose to adopt any such approach through subsequent rulemaking, 
including implementing any amendments Congress might make to the AUC 
program statutory provisions. As noted in the proposed rule, and in 
responses above, our experience in recent years has demonstrated that 
the goals of appropriate, evidence based, coordinated care can be 
achieved more effectively, efficiently, and comprehensively through 
other CMS quality initiatives. However, as discussed in the proposed 
rule (88 FR 52514 through 52515) in section 6. ``Summary of Other 
Quality Initiatives'', those other programs have different authorizing 
statutes.
    Comment: A few commenters commended CMS for reinforcing the 
beneficial role of clinical decision support tools and commended CMS 
for welcoming and supporting voluntary use of AUC and clinical decision 
support tools even as we pause efforts to implement the AUC program for

[[Page 79265]]

reevaluation and rescind the current AUC program regulations. Several 
commenters wrote of their commitment to the AUC program's overarching 
goal of enhancing patient safety and reducing healthcare costs by 
curbing unnecessary imaging studies, even without the AUC program.
    Response: We thank commenters for their support.
    Comment: One commenter requested that CMS take steps to limit prior 
authorization burden for any impacted clinicians as CMS reevaluates the 
AUC program and designs any future quality or AUC related program. 
Another commenter stated that AUC is necessary for targeting prior 
authorization to practitioners who ordered diagnostic imaging services 
inconsistent with appropriate, evidence-based care to reduce the amount 
of ``low-value'' care in the traditional Medicare program.
    Response: We thank the commenter for their suggestions and will 
note these concerns as we continue to reevaluate the program.
    Comment: One commenter recommended that CMS audit the current eight 
priority clinical areas to assess the impact of clinical decision 
support on quality of care.
    Response: We thank the commenter for their recommendation and will 
consider this suggestion as part of our reevaluation.
    Comment: Several commenters expressed their willingness to provide 
help to CMS in its reevaluation, for example, ``insights on how 
automated tools in the EHR can support CMS's goals of implementing the 
program in a manner that does not increase provider burden.'' Several 
commenters representing various sectors of the healthcare industry 
urged CMS to engage with representatives of their respective industries 
while reevaluating the program, including but not limited to various 
physician specialties, the radiology and revenue cycle communities, the 
EHR industry, and independent guideline authors.
    Response: We thank commenters for their offers to assist with 
reevaluation and to continue to engage with CMS and provide feedback. 
We continue to welcome and encourage feedback and information from 
interested parties. While we did not propose and are not finalizing a 
timeframe within which implementation efforts may recommence, we will 
continue efforts to identify a workable implementation approach and 
will include stakeholder engagement as part of that process and will 
propose to adopt any such approach through subsequent rulemaking, 
including implementing any amendments Congress might make to the AUC 
program statutory provisions.
    Comment: One commenter stated their primary concern with the AUC 
program continues to be the regulatory definition of Provider Led 
Entity, which they believe continues to be inconsistent with the 
statute and prevents independent evidence-based guideline authors from 
participating in the AUC program. The commenter took issue with our 
previous responses to this comment in past rulemaking cycles.
    Response: As discussed in prior responses, we are finalizing our 
proposal to pause the program and rescind the current regulations at 
Sec.  414.94, including the regulatory definition of a Provider Led 
Entity.
    After consideration of public comments, we are finalizing our 
proposal to pause the AUC program for reevaluation and to rescind the 
regulations at Sec.  414.94, keeping this section reserved for future 
use.

K. Medicare and Medicaid Provider and Supplier Enrollment

1. Medicare Enrollment
a. Background
    Section 1866(j)(1)(A) of the Act requires the Secretary to 
establish a process for the enrollment of providers and suppliers into 
the Medicare program. The overarching purpose of the enrollment process 
is to help confirm that providers and suppliers seeking to bill 
Medicare for services and items furnished to Medicare beneficiaries 
meet all applicable Federal and State requirements to do so. The 
process is, to an extent, a ``gatekeeper'' that prevents unqualified 
and potentially fraudulent individuals and entities from entering and 
inappropriately billing Medicare. Since 2006, we have undertaken 
rulemaking efforts to outline our enrollment procedures. These 
regulations are generally codified in 42 CFR part 424, subpart P 
(currently Sec. Sec.  424.500 through 424.575 and hereafter 
occasionally referenced as subpart P). They address, among other 
things, requirements that providers and suppliers must meet to obtain 
and maintain Medicare billing privileges.
    As outlined in Sec.  424.510, one such requirement is that the 
provider or supplier must complete, sign, and submit to its assigned 
Medicare Administrative Contractor (MAC) the appropriate enrollment 
form, typically the Form CMS-855 (OMB Control No. 0938-0685). The Form 
CMS-855, which can be submitted via paper or electronically through the 
internet-based Provider Enrollment, Chain, and Ownership System (PECOS) 
process (SORN: 09-70-0532, PECOS), collects important information about 
the provider or supplier. Such data includes, but is not limited to, 
general identifying information (for example, legal business name), 
licensure and/or certification data, and practice locations. The 
application is used for a variety of provider enrollment transactions, 
including the following:
     Initial enrollment--The provider or supplier is--(1) 
enrolling in Medicare for the first time; (2) enrolling in another 
Medicare contractor's jurisdiction; or (3) seeking to enroll in 
Medicare after having previously been enrolled.
     Change of ownership--The provider or supplier is reporting 
a change in its ownership.
     Revalidation--The provider or supplier is revalidating its 
Medicare enrollment information in accordance with Sec.  424.515. 
(Suppliers of durable medical equipment, prosthetics, orthotics, and 
supplies (DMEPOS) must revalidate their enrollment every 3 years; all 
other providers and suppliers must do so every 5 years.)
     Reactivation--The provider or supplier is seeking to 
reactivate its Medicare billing privileges after it was deactivated in 
accordance with Sec.  424.540.
     Change of information--The provider or supplier is 
reporting a change in its existing enrollment information in accordance 
with Sec.  424.516.
    After receiving the provider's or supplier's initial enrollment 
application, CMS or the MAC reviews and confirms the information 
thereon and determines whether the provider or supplier meets all 
applicable Medicare requirements. We believe this screening process has 
greatly assisted CMS in executing its responsibility to prevent 
Medicare fraud, waste, and abuse.
    As previously mentioned, over the years we have issued various 
final rules pertaining to provider enrollment. These rules were 
intended not only to clarify or strengthen certain components of the 
enrollment process but also to enable us to take further action against 
providers and suppliers: (1) engaging (or potentially engaging) in 
fraudulent or abusive behavior; (2) presenting a risk of harm to 
Medicare beneficiaries or the Medicare Trust Funds; or (3) that are 
otherwise unqualified to furnish Medicare services or items. Consistent 
with this, and as we discuss in this section III.K of this final rule, 
we proposed several changes to our existing Medicare provider 
enrollment regulations.

[[Page 79266]]

    (We note that section III.K of this final rule also addresses a 
proposed change to one of our Medicaid provider enrollment provisions.)
b. Legal Authorities
    There are two principal categories of legal authorities for our 
proposed Medicare provider enrollment provisions:
     Section 1866(j) of the Act furnishes specific authority 
regarding the enrollment process for providers and suppliers.
     Sections 1102 and 1871 of the Act provide general 
authority for the Secretary to prescribe regulations for the efficient 
administration of the Medicare program.
c. Medicare Provider Enrollment Provisions
i. Revocation and Denial Reasons and Revisions to Other Revocation 
Policies
(A) Revocations
    Under Sec.  424.535(a), we may revoke a Medicare provider's or 
supplier's enrollment for any of the reasons specified within that 
paragraph. (The revocation grounds are currently identified as Sec.  
424.535(a)(1) through (22), with paragraphs (a)(15) and (16) designated 
as reserved.) These reasons include, for instance, the provider's or 
supplier's: (i) failure to adhere to Medicare enrollment requirements; 
(ii) exclusion by the HHS Office of Inspector General (OIG); (iii) 
felony conviction within the previous 10 years; (iv) pattern of 
improper or abusive billing, prescribing of Part B or Part D drugs, or 
ordering/referring/certifying of Medicare services or items; and (v) 
termination by another Federal health care program. A revocation is 
designed to safeguard the Medicare program, the Trust Funds, and 
beneficiaries by removing (and preventing payment to) Medicare 
providers and suppliers that have engaged in problematic or otherwise 
non-compliant behavior. When a provider or supplier is revoked, they 
are generally barred from reenrolling in Medicare for a period of 1 to 
10 years. The length of this ``reenrollment bar'' is predicated upon 
the severity of the basis of the revocation. The maximum reenrollment 
bar is typically restricted to egregious acts of misconduct.
    We have previously finalized a number of regulations adding new 
revocation reasons to Sec.  424.535(a) to address particular program 
integrity vulnerabilities and types of provider or supplier behavior. 
We have also used rulemaking to refine other policies regarding 
revocations, such as the reenrollment bar and the effective dates of 
certain revocations. Given our continuing obligation to assess 
potential vulnerabilities and establish payment safeguard measures, we 
proposed several additions and revisions to our revocation policies in 
Sec.  424.535(a).
(1) Non-Compliance Revocation Ground (Sec.  424.535(a)(1))
    Existing Sec.  424.535(a)(1), in part, permits revocation if the 
provider or supplier is determined to not be in compliance with the 
enrollment requirements described in subpart P or in the enrollment 
application applicable to its provider or supplier type. We proposed to 
change the language therein that reads ``described in this subpart P or 
in the enrollment application'' to ``described in this title 42, or in 
the enrollment application . . .'' This is because there are enrollment 
requirements located outside of 42 CFR part 424, subpart P; for 
instance, certain enrollment requirements pertaining to opioid 
treatment programs are in Sec.  424.67(b). All enrollment requirements, 
regardless of their placement in title 42, must be adhered to, which is 
why we believed the scope of Sec.  424.535(a)(1) should be expanded.
    We received the following comments on this proposal:
    Comment: A commenter expressed support for our proposed expansion 
of Sec.  424.535(a)(1).
    Response: We appreciate the commenter's support.
    Comment: A commenter asked CMS to outline the enrollment provisions 
outside of subpart P to which this new revocation authority could 
apply; otherwise, the commenter stated, CMS should not finalize this 
proposal because commenters would not have had adequate opportunity to 
comment on this change.
    Response: As noted above, the proposed rule cited as an example 
certain enrollment requirements pertaining to opioid treatment programs 
that are found in Sec.  424.67(b). Other examples include conditions 
for Medicare diabetes prevention program enrollment in Sec.  424.205 
and certain enrollment requirements for home infusion therapy suppliers 
in Sec.  424.68. However, as the provider community is largely familiar 
with the enrollment provisions outside of subpart P, we do not believe 
it is necessary to list all of them aside from citing examples of the 
expanded applicability of Sec.  424.535(a)(1). Each enrollment section 
of title 42 outside of subpart P, moreover, is denoted as applying to 
enrollment either in the title or the text of the section; for 
instance, Sec.  424.68(c) is titled ``Specific requirements for 
enrollment.'' We hence believe that adequate notice was furnished to 
stakeholders regarding the scope of our proposal.
    After consideration of these comments, we are finalizing this 
provision as proposed.
(2) Misdemeanor Convictions
    As already alluded to, a provider or supplier can be revoked under 
Sec.  424.535(a)(3)(i) if the provider, supplier, or any owner, 
managing employee, officer, or director of the provider or supplier 
was, within the preceding 10 years, convicted of a Federal or State 
felony that CMS determines is detrimental to the best interests of the 
Medicare program and its beneficiaries. Section 424.535(a)(3)(ii) lists 
examples of such felonies, though they are not limited in scope and 
severity to these offenses.
    Section 424.535(a)(3) does not include misdemeanor convictions, and 
there currently is no regulatory authority to revoke a provider or 
supplier based solely on a misdemeanor. We noted in the proposed rule 
that we have become aware of and increasingly concerned about providers 
and suppliers convicted of misdemeanors for conduct that could endanger 
the Trust Funds' integrity and Medicare beneficiaries' health and 
safety. To this end, we proposed in new Sec.  424.535(a)(16)(i) that 
CMS may revoke a provider's or supplier's enrollment if they, or any 
owner, managing employee or organization, officer, or director thereof, 
has been convicted (as that term is defined in 42 CFR 1001.2) of a 
misdemeanor under Federal or State law within the previous 10 years 
that CMS deems detrimental to the best interests of the Medicare 
program and its beneficiaries. Proposed Sec.  424.535(a)(16)(ii) stated 
that offenses under Sec.  424.535(a)(16) include, but are not limited 
in scope or severity to, the following:
     Fraud or other criminal misconduct involving the 
provider's or supplier's participation in a Federal or State health 
care program or the delivery of services or items thereunder.
     Assault, battery, neglect, or abuse of a patient 
(including sexual offenses).
     Any other misdemeanor that places the Medicare program or 
its beneficiaries at immediate risk, such as a malpractice suit that 
results in a conviction of criminal neglect or misconduct.
    We solicited comments on this proposal. We specifically sought 
feedback on: (1) whether there are any potential unintended 
consequences of our proposal that we are not

[[Page 79267]]

considering; or (2) any guardrails we should consider so as not to 
create unintended impacts on persons with misdemeanor convictions.
    Comment: We received numerous comments opposing our proposed 
misdemeanor revocation authority. Among the principal concerns 
expressed, commenters noted:
     The purview of our proposal was too broad in that it could 
encompass many types of misdemeanors involving comparatively modest 
conduct.
     Physicians with misdemeanor convictions for violating 
State laws restricting gender-affirming care or reproductive rights 
(particularly in States with near-total bans on abortion) could have 
their enrollments unfairly revoked.
     The provision could negatively impact equity given that 
some individuals with misdemeanors for minor offenses could be denied 
the opportunity to work in the health care field because provider 
organizations may be reluctant to hire them out of concern that they 
may be revoked.
    Response: After reviewing the comments received, we are not 
finalizing proposed Sec.  424.535(a)(16). We will nonetheless continue 
to monitor cases of misdemeanor convictions involving significant 
misconduct and may pursue future rulemaking to address them. We 
emphasize that many misdemeanors, especially those involving assault, 
battery, neglect, or abuse of a patient (including sexual offenses), 
can pertain to activity that remains of concern to us.
(3) False Claims Act Civil Judgments
    The False Claims Act (FCA) (31 U.S.C. 3729-3733) is the Federal 
government's principal civil remedy for addressing false or fraudulent 
claims for Federal funds. Section 3729(a)(1) of the FCA lists specific 
actions that can result in an FCA judgment against a defendant, such as 
knowingly presenting, or causing to be presented, a false or fraudulent 
claim for payment or approval.
    Although the FCA's scope is not restricted to the health care arena 
and applies to all types of Federal government programs, the FCA has 
proven effective in helping to stem Medicare fraud. However, an FCA 
civil judgment against a provider or supplier does not, in and of 
itself, impact the latter's Medicare enrollment. Even if, for example, 
a provider is found to have knowingly submitted fraudulent claims and 
is liable for $100,000 in damages, we have no ability to revoke the 
provider's enrollment exclusively on this basis. This concerns us, for 
the actions identified in section 3729(a)(1) of the FCA involve serious 
misbehavior. We believe we must address this vulnerability to protect 
the Medicare program and its beneficiaries.
    We accordingly proposed in Sec.  424.535(a)(15) that we could 
revoke enrollment if the provider or supplier, or any owner, managing 
employee or organization, officer, or director thereof, has had a civil 
judgment under the FCA imposed against them within the previous 10 
years. (Strictly for purposes of (a)(15), the term ``civil judgment'' 
would not include FCA settlement agreements. The provision would 
require a judgment against the provider or supplier.) Recognizing that 
the specific facts and circumstances of each case will differ, we 
proposed to consider the following factors in our decision:
     The number of provider or supplier actions that the 
judgment incorporates (for example, the number of false claims 
submitted).
     The types of provider or supplier actions involved.
     The monetary amount of the judgment.
     When the judgment occurred.
     Whether the provider or supplier has any history of final 
adverse actions (as that term is defined in Sec.  424.502).
     Any other information that CMS deems relevant to its 
determination.
    We noted that we would include FCA civil judgments against owners, 
managing employees and organizations, and officers and directors (as 
those terms are defined in Sec.  424.502) of the provider or supplier 
within the scope of this revocation basis. This is consistent with our 
approach to several other revocation reasons in Sec.  424.535(a) and 
reflects our recognition that certain owning and managing parties 
exercise great influence over the provider or supplier organization and 
its daily operations. Should such a party have an FCA civil judgment 
against them, this could present a program integrity risk. We therefore 
stated our belief that Sec.  424.535(a)(15) should encompass such 
situations. However, we would consider the degree of the owning or 
managing party's control over the provider or supplier (for example, 
percentage of ownership, scope of day-to-day operational authority) as 
a factor in our determination.
    We received the following comments on this proposal:
    Comment: A commenter expressed support for our proposed revocation 
authority regarding FCA judgments.
    Response: We appreciate the commenter's support.
    Comment: Several commenters opposed our proposed FCA authority. 
They were concerned that it could: (1) harm good-faith providers and 
suppliers that inadvertently submitted false claims; and (2) compel 
providers and suppliers to settle their case--even though the provider 
or supplier believes it committed no wrongdoing and wishes to contest 
the government's claims--to maintain their Medicare enrollment. One 
commenter stated that this second scenario could impose serious 
financial costs on such providers and suppliers, hence diverting 
resources from patient care. This commenter added that if CMS 
nonetheless finalizes its proposal, the 10-year window should apply 
prospectively. This would prevent CMS from revoking enrollment for 
judgments that occurred many years ago when the provider or supplier 
could not have accounted for Medicare enrollment in determining whether 
to settle or contest the case.
    Response: We appreciate these comments. We first note that our 
authority under Sec.  424.535(a)(15) will be purely discretionary and 
not mandatory. We would only take action after a careful assessment of 
the factors outlined in Sec.  424.535(a)(15) and the circumstances of 
the case. However, we respectfully do not believe our new authority 
will compel providers and suppliers to settle FCA cases rather than 
challenge them. In our view, the provider's or supplier's decision on 
this matter will be based on many considerations, some of which may be 
more critical to the provider or supplier than Medicare enrollment. We 
are unaware, for example, of situations where providers and suppliers 
have pled guilty to a misdemeanor charge instead of contesting a felony 
charge out of concern that their Medicare enrollment would be revoked 
if convicted of a felony. We believe the same will hold true regarding 
Sec.  424.535(a)(15).
    Concerning the final comment, we only intend to apply Sec.  
424.535(a)(15) prospectively--that is, to FCA judgments occurring on or 
after the effective date of this final rule.
    Comment: Several commenters stated that situations involving false 
claims already fall under: (1) CMS' existing revocation authority; or 
(2) OIG or DOJ authorities. Consequently, there is no need for proposed 
Sec.  424.535(a)(15).
    Response: At this time, we believe we lack explicit authority to 
revoke enrollment in every possible instance where a false claim is 
implicated. The closest authority is Sec.  424.535(a)(8)(ii), but this 
requires a pattern or practice of submitting non-compliant claims and 
does not allow us to take action based solely on the FCA judgment 
itself. Had

[[Page 79268]]

we believed we had the legal authority to revoke in all false claim 
situations, we would not have proposed Sec.  424.535(a)(15). Moreover, 
while we partner with OIG and DOJ to protect the Medicare program and 
its beneficiaries, we also have an independent responsibility to do so. 
Consequently, we must have administrative means at our disposal to 
promptly act in Medicare's best interests.
    Comment: A commenter asked CMS to explain what an FCA 
``settlement'' is.
    Response: We refer the commenter to the DoJ False Claims Act web 
link at https://www.justice.gov/civil/false-claims-act for information 
concerning FCA settlements.
    After consideration of these comments, we are finalizing this 
proposal without modification.
(4) Violation of Provider and Supplier Standards
    As alluded to previously, Sec.  410.33(g) lists detailed enrollment 
standards that IDTFs must meet to enroll and maintain enrollment in 
Medicare. Likewise, Sec.  424.57(c) identifies 30 enrollment standards 
that DMEPOS suppliers must meet as conditions of enrollment. These IDTF 
and DMEPOS standards address matters such as the maintenance of 
liability coverage, solicitation of patients, and customer service 
requirements. In addition, Sec. Sec.  424.67(b) and (e), 424.68(c) and 
(e), and 424.205(b) and (d) contain enrollment standards and conditions 
for, respectively, opioid treatment programs (OTPs), home infusion 
therapy (HIT) suppliers, and Medicare diabetes prevention programs 
(MDPPs). The standards and conditions in Sec. Sec.  410.33(g), 
424.57(c), 424.67(b) and (e), 424.68(c) and (e), and 424.205(b) and (d) 
are in addition to, and not in lieu of, the more general enrollment 
requirements in subpart P with which IDTFs, DMEPOS suppliers, OTPs, HIT 
suppliers, MDPPs, and all other provider and supplier types must 
comply.
    We proposed to add new paragraph (a)(23) to Sec.  424.535 that 
would permit CMS to revoke an IDTF's, DMEPOS supplier's, OTP's, HIT 
supplier's, or MDPP's enrollment based on a violation of any standard 
or condition in, respectively, Sec. Sec.  410.33(g), 424.57(c), 
424.67(b) or (e), 424.68(c) or (e), or 424.205(b) or (d). No revocation 
reason in existing Sec.  424.535(a) specifically references these 
regulatory paragraphs or violations thereof. Although we have sometimes 
applied a comparatively broad revocation basis in Sec.  424.535(a)(1) 
to certain non-compliant IDTFs, DMEPOS suppliers, OTPs, HIT suppliers, 
and MDPPs (for example, an invalid practice location under Sec.  
424.535(a)(5)), we believed that a narrower approach that allows us to 
target violations of these standards and conditions is preferable. That 
is, our proposal would more directly tie these regulatory paragraphs to 
Sec.  424.535(a) by establishing a new revocation reason restricted to 
non-compliance with any of them.
    We received the following comments on this proposal:
    Comment: A commenter stated that proposed Sec.  424.535(a)(23) is 
unnecessary because CMS can currently deactivate providers and 
suppliers for non-compliance.
    Response: We respectfully disagree. As we will discuss further in 
this section III.K., there are varying degrees of non-compliance and 
some of them are substantial enough to warrant a revocation as opposed 
to a deactivation. In other words, the non-compliance is of a 
sufficiently serious nature that we believe revocation--and a 
consequent reenrollment bar to keep the provider or supplier out of the 
Medicare program for a period of time--are needed to protect Medicare 
and its beneficiaries. We accordingly must retain the ability to take 
such action as circumstances dictate.
    Comment: Several commenters stated that CMS should only apply Sec.  
424.535(a)(23) when the provider or supplier has a pattern of non-
compliance and refuses to remedy the matter when requested to do so; 
one commenter explained that isolated instances of minor non-compliance 
can inadvertently occur.
    Response: We respectfully do not believe a pattern or multiple acts 
of non-compliance should be required to invoke Sec.  424.535(a)(23). 
While we acknowledge that an isolated instance of non-compliance can 
take place, this can nonetheless involve a serious violation of an 
enrollment condition or standard. We do not believe we should be 
compelled to wait for the provider or supplier in such cases to commit 
additional violations (and, in the process, potentially further 
threaten the Medicare program) before taking revocation action.
    After reviewing the comments received, we are finalizing our 
proposal without modification.
(5) Scope of Sec.  424.535(a)(17)
    Under Sec.  424.535(a)(17), we may revoke enrollment if the 
provider or supplier has an existing debt that CMS appropriately refers 
to the United States Department of Treasury. In determining whether a 
revocation is appropriate, we consider the six factors outlined in 
Sec.  424.535(a)(17)(i) through (vi); these include, for instance, the 
reason for the provider's or supplier's failure to pay the debt. The 
purpose of Sec.  424.535(a)(17) is to spur providers and suppliers to 
repay their financial obligations to Medicare. In our view, their 
failure to do so raises doubts as to whether the provider or supplier 
can be a reliable partner of the Medicare program.
    We received inquiries from interested parties concerning the scope 
of this provision, such as whether paragraph (a)(17) applies to debts 
that are no longer being collected or are being appealed. We proposed 
to revise paragraph (a)(17) to address these issues.
    First, and to help accommodate our revisions, existing Sec.  
424.535(a)(17)(i) through (vi) would be re-designated as paragraphs 
(a)(17)(i)(A) through (F).
    Second, in new paragraph (a)(17)(ii), we proposed to exclude from 
paragraph (a)(17)(i)'s purview those cases where: (1) the provider's or 
supplier's Medicare debt has been discharged by a bankruptcy court; or 
(2) the administrative appeals process concerning the debt has not been 
exhausted or the timeline for filing such an appeal, at the appropriate 
appeal level, has not expired. We believed the debts in these two 
situations have not been finally and fully adjudicated for purposes of 
paragraph (a)(17)(i)'s applicability. For this reason, we believed 
basic fairness to the provider or supplier justifies revised paragraph 
(a)(17)(ii).
    Third, in Sec.  424.535(a)(17)(i) we proposed to change the term 
``existing debt'' to ``failure to repay a debt''. This would allow us 
to potentially use our revocation authority even if collection action 
has ceased and the debt was ultimately terminated as a result, since 
the provider or supplier had still failed to repay it.
    We received the following comments on our proposal:
    Comment: Several commenters expressed concerns about our proposed 
terminology change in Sec.  424.535(a)(17) to ``failure to repay a 
debt.'' The commenters stated that there are many circumstances where a 
debt may be ``written off'' that do not involve a provider's or 
supplier's intent to avoid its legal obligations under Medicare. One 
commenter requested that CMS clarify: (1) the circumstances under which 
a provider or supplier would be revoked under our proposal; and (2) the 
length of time that must elapse before a provider or supplier is deemed 
as having failed to repay the debt,

[[Page 79269]]

including how many points of contact CMS will attempt before moving a 
provider or supplier into such a status.
    Response: We appreciate these comments and address them in turn. 
First, we recognize that failures to repay certain debts may not 
involve any nefarious intent by the provider or supplier. Yet the core 
issue is not the provider's or supplier's state of mind but the 
repayment failure itself. As we explained at length in the proposed 
rule, any non-payment, whether deliberate or not, harms the Trust Funds 
and the taxpayers, and we must have means to address such situations, 
hence our change to Sec.  424.535(a)(17). However, this change will not 
alter the criteria we consider in determining whether a revocation is 
appropriate or the care and conscientiousness with which we review the 
facts and circumstances of the case. Providers and suppliers should 
also not assume they will now be more likely to be revoked under Sec.  
424.535(a)(17). Nonetheless, we cannot outline fact patterns for which 
CMS will always invoke Sec.  424.535(a)(17) due to the need to retain 
our flexibility to address each case on its own unique characteristics.
    Regarding the latter commenter's second request for clarification, 
CMS Publication 100-06, Medicare Financial Management, Chapter 4 
(hereafter Chapter 4) outlines CMS procedures for recovering debts, 
referring unpaid debts to the Department of Treasury, and determining 
when debts are written-off or closed out. This includes information 
regarding the timeframes in which debts are placed in certain debt 
statuses and the steps that occur (such as demands for repayment) prior 
thereto. We: (1) will continue to follow these procedures upon 
implementation of revised Sec.  424.535(a)(17); and (2) encourage the 
commenter and other interested stakeholders to review Chapter 4 for 
more information regarding the operational aspects of debt collection, 
including the number of attempted contacts before a provider or 
supplier is moved into a certain status.
    After reviewing the comments received, we are finalizing our 
proposal without modification.
(B) Reasons for Denial
    As previously discussed, we proposed new revocation authorities in 
Sec.  424.535(a)(15), (16), and (23), as well as expanded the scope of 
Sec.  424.535(a)(1) to include non-compliance with any enrollment 
provision in title 42. Since we believed that the rationales for these 
revocation reasons (and our associated program integrity concerns) were 
equally applicable to newly enrolling providers and suppliers, we 
proposed corresponding denial reasons on these bases. Specifically, 
proposed denial reasons Sec.  424.530(a)(16), (a)(17), and (18) 
involved, respectively, misdemeanor convictions, FCA judgments, and 
supplier standard/condition violations, with revised Sec.  
424.530(a)(1) addressing violations of enrollment provisions in title 
42.
    In general, the previously identified comments in section 
III.K.1.c.i.(A) did not distinguish between revocations and denials. 
The commenters' concerns were the same irrespective of whether, for 
example, a misdemeanor conviction resulted in a denial or revocation. 
For this reason, we will not repeat these comments in this section 
III.K.1.c.i.(B). Yet we fully considered these comments and will take 
the same approach for our denial reasons that we did for our revocation 
grounds; that is, the rationales behind our responses to those 
revocation-related comments are equally applicable to our proposed 
denial bases. We are accordingly finalizing proposed Sec.  
424.530(a)(17) and (18) (respectively, FCA judgments and supplier 
standard/condition violations), as well as our proposed change to Sec.  
424.530(a)(1) without modification. We are not finalizing proposed 
Sec.  424.530(a)(16) concerning denials for misdemeanor convictions.
(C) Effective Date of Revocation
    Section 424.535(g) addresses revocation effective dates. It states 
that a revocation becomes effective 30 days after CMS or the contractor 
mails notice of its determination to the provider or supplier. Yet 
there are exceptions. If the revocation is based on a Federal exclusion 
or debarment, felony conviction, license suspension or revocation, or 
non-operational practice location, the revocation is effective with the 
date of exclusion or debarment, felony conviction, license suspension 
or revocation, or the date that CMS or its contractor determined that 
the provider or supplier was non-operational. The purpose of these 
exceptions is to prevent payment to a provider or supplier while it is 
out of compliance with Medicare enrollment requirements.
    With this overarching principle in mind, we proposed several 
organizational changes to and expansions of Sec.  424.535(g).
    First, we would split existing Sec.  424.535(g) into several 
paragraphs. Paragraph (g)(1) would include the previously mentioned 30-
day effective date policy, though with the following language at its 
beginning, ``Except as described in paragraphs (g)(2) and (g)(3) of 
this section''. New paragraph (g)(2) would list the four retroactive 
revocation situations in existing Sec.  424.535(g). Each situation (and 
its associated revocation effective date) would be incorporated into a 
separate paragraph to make paragraph (g)(2) clearer and more readable.
    Second, paragraph (g)(2) would include the following additional 
situations where a retroactive effective date would be warranted:
     Revocations under proposed Sec.  424.535(a)(16) (regarding 
misdemeanor convictions): the effective date would be the date of the 
misdemeanor conviction.
     Revocations based on a State license surrender in lieu of 
further disciplinary action: the effective date would be the date of 
the license surrender.
     Revocations based on termination from a Federal health 
care program other than Medicare (for example, Medicaid): the effective 
date would be the date of the termination.
     Revocations based on termination of a provider agreement 
under 42 CFR part 489: the effective date would be, as applicable to 
the type of provider involved, the later of the following: (1) the date 
of the provider agreement termination; or (2) as applicable, the date 
that CMS establishes under 42 CFR 489.55. (Section 489.55 permits 
payments beyond the provider agreement termination date in certain 
instances and for a certain period.)
     Revocations based on proposed Sec.  424.535(a)(23) would 
be as follows:
    ++ If the standard or condition violation involved the suspension, 
revocation, or termination (or surrender in lieu of further 
disciplinary action) of the provider's or supplier's Federal or State 
license, certification, accreditation, or MDPP recognition, the 
revocation effective date would be the date of the license, 
certification, accreditation, or MDPP recognition suspension, 
revocation, termination, or surrender.
    ++ If the standard or condition violation involved a non-
operational practice location (for example, an IDTF's failure to 
maintain a physical facility on an appropriate site per Sec.  
410.33(g)(3)), the revocation effective date would be the date the non-
operational status began.
    ++ If the standard violation involved a felony conviction of an 
individual or entity described in Sec.  424.67(b)(6)(i), the revocation 
effective date would be the date of the felony conviction.
    For all other standard violations, the effective date in paragraph 
(g)(1) would apply if the effective date in new Sec.  424.535(g)(3) 
does not. Under

[[Page 79270]]

Sec.  424.535(g)(3), we proposed that if the action that triggered the 
revocation occurred before the provider's or supplier's enrollment 
effective date, the revocation effective date would be the enrollment 
effective date that CMS assigned to the provider or supplier. The aim 
of Sec.  424.535(g)(3) was to merely reiterate that we could not apply 
a revocation effective date that is earlier than the date the provider 
or supplier is enrolled.
    We received the following comments on this proposal.
    Comment: A commenter expressed support for our proposed retroactive 
revocation effective dates.
    Response: We appreciate the commenter's support.
    Comment: A commenter stated that retroactive revocations can result 
in the imposition of an overpayment for services that were medically 
reasonable and necessary and delivered in good faith. The commenter 
expressed concern that, given the discretionary nature of revocations, 
a supplier who becomes aware of a potential retroactive revocation must 
decide whether to: (1) stop billing Medicare (which in many cases, the 
commenter believed, would result in the supplier going out of 
business); or (2) take their chances that they will not receive a 
retroactive revocation notice many months in the future, which could 
leave the supplier with a six or seven-figure overpayment. The 
commenter thus requested that CMS place a cap on the overpayment period 
for retroactive revocations, such as a maximum 30-days after CMS became 
aware of the action resulting in the revocation; this policy, the 
commenter added, should also apply to retroactive deactivation grounds 
under Sec.  424.540(b).
    In support of their request, the commenter noted that under 
existing Sec.  424.535(g) (and as referenced previously in section 
III.K of this final rule), a revocation based on a felony conviction, 
license suspension or revocation, or a non-operational practice 
location is applied retroactively. Because these three revocation 
grounds (like other revocation bases) are discretionary, CMS might not 
revoke a provider or supplier for these reasons, meaning the provider 
or supplier can continue to be paid. Consequently, the commenter 
stated, CMS cannot justify retroactive revocation and deactivation 
effective dates on the contention that it is unable to pay for services 
while a provider or supplier is non-compliant, since CMS is doing so 
when it elects not to impose a revocation or deactivation when it has 
the authority to do so.
    Response: We respectfully do not believe an overpayment cap is 
warranted. Providers and suppliers must always remain compliant with 
Medicare enrollment requirements, and any failure to do so can result 
in CMS action. Merely because CMS might decline in a particular 
instance to impose, for example, a revocation for non-compliance does 
not mean CMS should be barred from ever assessing overpayments in cases 
where it does apply a revocation. That is, it does not follow that CMS 
non-action in a potential revocation situation mandates similar non-
action (and subsequent non-assessment of overpayments) in every other 
situation where the same revocation reason under Sec.  424.535(a) is 
involved. As discussed further in section III.K.1.c.ii of this final 
rule, there are varying degrees of non-compliance. When we impose a 
revocation instead of, for instance, a deactivation or a stay of 
enrollment, it is generally because the conduct involved was of such 
significance that we believe the provider or supplier should be removed 
from the Medicare program. Given, accordingly, the seriousness of the 
provider's or supplier's action or inaction in revocation cases, we do 
not believe we should be prohibited from assessing overpayments to the 
extent we deem appropriate. It is ultimately the provider's or 
supplier's responsibility to: (1) maintain compliance; (2) take rapid 
measures to resume adherence if they fall out of compliance or suspect 
that they have; and (3) not engage in the applicable misconduct, such 
as felonious behavior. Doing so will avoid the situation the commenter 
describes in their first paragraph concerning physicians who believe 
they might be revoked.
    After reviewing the comments received, we are finalizing them as 
proposed excluding the language in paragraph (g)(2) referencing 
misdemeanor convictions. We are not finalizing this paragraph because 
we are not finalizing Sec.  424.535(a)(16).
(D) Timeframes for Reversing a Revocation Under Sec.  424.535(e)
    Section 424.535(e) states that if a revocation was due to adverse 
activity (sanction, exclusion, felony) by one of the parties listed in 
Sec.  424.535(e) (for example, owner, managing employee, authorized or 
delegated official, supervising physician), the revocation can be 
reversed if the provider or supplier terminates and submits proof that 
it has terminated its business relationship with that party within 30 
days of the revocation notification. As we explained in the proposed 
rule, we have been concerned about this 30-day period. We do not 
believe a provider or supplier should be afforded so much time to 
terminate this business relationship. Each day the revoked provider or 
supplier remains affiliated with the party in question, the more 
Medicare dollars that could be paid until the 30-day timeframe expires. 
It is the provider's or supplier's constant responsibility to ensure 
that its owning and managing personnel present no program integrity 
risks to the Medicare program. To give the provider or supplier 30 days 
to terminate a relationship that should have been promptly ended upon 
the commission of the adverse action (for example, when the owner 
became excluded) would be inconsistent with our obligation to protect 
the Trust Funds. It could also convey a false impression that 
maintaining affiliations with problematic parties is acceptable so long 
as the relationship ceases within a month of the revocation notice.
    To this end, we proposed to revise Sec.  424.535(e) to reduce the 
30-day period therein to 15 days. We did not propose, for instance, a 
5-day period because we recognized that it might be administratively 
and financially difficult to immediately terminate the business 
relationship in question, especially an owner's interest in the 
provider or supplier. Still, the reduction from 30 days to 15 days 
evidences our concern about making Medicare payments to providers and 
suppliers that have relationships with parties presenting program 
integrity risks.
    We received the following comments on our proposal:
    Comment: Several commenters opposed our proposed reduction from 30 
days to 15 days. They stated that this is insufficient time to 
terminate the affiliation and submit proof thereof, especially since 
there could be administrative and legal processes to complete before 
the relationship can be severed. They noted that revocation letters can 
take 5 or more days to reach the provider (and even longer to reach the 
appropriate person within the provider organization), leaving the 
latter no more than 10 days to comply with Sec.  424.535(g)'s 
requirements. They stated the current 30-day period should remain, 
adding that merely because the provider or supplier can appeal the 
revocation does not make the proposed reduction to 15 days more 
palatable. Some commenters recommended that if CMS finalizes this 
proposal: (1) a provider or supplier should have 15 days (business or 
calendar, though preferably the former) from the documented date of 
receipt of the

[[Page 79271]]

revocation letter to end the affiliation and furnish proof thereof; and 
(2) CMS should send all revocation notices via certified mail.
    Response: We recognize that affected providers and suppliers will 
need to act expeditiously to comply with revised Sec.  424.535(g). 
However, and as explained in the proposed rule and this final rule, it 
is imperative that providers and suppliers always take quick measures 
to resume compliance with enrollment requirements. The overriding 
concern, in our view, must be the protection of the Trust Funds from 
improper payments, even if this means the provider or supplier has less 
time to satisfy Sec.  424.535(g)'s requirements. The longer the 
provider or supplier remains non-compliant, the more taxpayer monies 
that can be inappropriately paid; this is especially true with respect 
to excluded providers, suppliers, owners, etc., for we are prohibited 
by statute from paying for services furnished by such parties. While 
Days 16-30 (that is, the difference between current and proposed Sec.  
424.535(g)) may only represent two weeks of payments, many thousands of 
dollars could still be paid to non-compliant providers. In sum, while 
we understand the commenters' contentions, our foremost obligation is 
to safeguard the Trust Funds, and we respectfully believe this must 
take precedence over the inconvenience of a shorter period under 
proposed Sec.  424.535(g).
    In terms of the stakeholders' suggestions, we do not believe the 
15-day timeframe should commence upon the provider's receipt of the 
revocation notice. Such a policy could amount to a reduction in 
existing Sec.  424.535(g)'s timeframe from 30 days to 20 days, which 
would still not address to our satisfaction the need to reduce improper 
payments as much as possible; five extra days of payments (Days 16-20) 
could, again, involve thousands of dollars. We maintain our position 
that 15 days is the appropriate period. As for sending revocation 
notices via certified mail, we appreciate this suggestion and may 
consider it as a future enhancement to the enrollment process.
    Comment: A commenter did not believe that retaining the 30-day 
period (and foregoing the proposed reduction to 15 days) substantially 
increases the risk to the Medicare program. Another commenter stated 
that keeping the existing timeframe will support patient care by 
reducing the potential for unnecessary disruption.
    Response: As previously explained, each additional day where the 
provider is non-compliant with enrollment requirements threatens the 
Medicare program due to the potentially significant volume of payments 
that could be made to the provider or supplier. Regarding the second 
comment, we do not believe our revision to Sec.  424.535(g) will have a 
deleterious effect on patient care. It has been our experience that 
patients whose treating physicians, practitioners, and providers have 
been revoked were able to obtain care from other parties, and we do not 
foresee this changing because of a mere 15-day reduction in Sec.  
424.535(g)'s timeframe. We also note that rebuttals of deactivations 
under Sec.  424.540 and payments suspensions under Sec.  405.371 must 
be submitted within 15 days. Providers and suppliers have generally 
been able to meet this timeframe, and we believe this will be true 
regarding Sec.  424.535(g) new timeframe, too.
    Comment: A commenter asked whether the timeframe in Sec.  
424.535(g) begins on the day that the offending owner, manager, etc., 
was notified of the adverse action or the day when the organization 
with which he or she is affiliated was notified.
    Response: The timeframe under Sec.  424.535(g) commences on the 
date of the revocation notice to the organization with which the owner, 
manager, etc., is associated. This has long been our operational policy 
and is consistent with the current language in Sec.  424.535(g) that 
requires provider compliance within ``30 days of the revocation 
notification.''
    Comment: Several commenters disagreed with our belief in the 
proposed rule that a 30-day period could convey the false impression 
that maintaining affiliates who have engaged in improper conduct is 
acceptable.
    Response: We respectfully do not concur with the commenters' 
position. We believe that reducing the period to 15 days will expedite 
provider action and make clear that allowing, for example, 28 or 29 
days to pass before compliance is reached (especially when it could 
have accomplished in 10-15 days) is inappropriate. It is critical for 
revoked providers under Sec.  424.535(g) to understand that they cannot 
take their time in resuming compliance but must act quickly to remedy 
the situation.
    After reviewing the comments received, we are finalizing our 
proposal without modification.
ii. Stay of Enrollment
    Pursuant to Sec.  424.540, we may deactivate a provider's or 
supplier's Medicare billing privileges for any of the reasons specified 
in paragraph (a) of that section. A deactivation differs from a 
revocation in that the former: (1) merely involves the stoppage, rather 
than the termination, of the provider's or supplier's billing 
privileges; and (2) does not entail any reenrollment bar under Sec.  
424.535(c). The latter is a particularly important distinction, for a 
deactivated provider or supplier can reactivate its billing privileges 
by following the procedures in Sec.  424.540(b). A deactivated provider 
or supplier need not wait (as a revoked provider or supplier must) for 
the expiration of the 1 to 10-year bar period referenced in Sec.  
424.535(c) before attempting to restore its ability to bill Medicare.
    Nevertheless, we explained in the proposed rule that: (1) a 
deactivation can still impose burden on a provider or supplier; and (2) 
a middle ground between deactivation and non-action on our part is 
needed. In our view, we need as much flexibility as possible to take 
appropriate, fair, and reasonable measures that are commensurate with 
the degree of the provider's or supplier's non-compliance.
    For these reasons, we proposed in new Sec.  424.541 a new 
enrollment status labeled a ``stay of enrollment.'' This would be a 
preliminary, interim status--prior to any subsequent deactivation or 
revocation--that would represent, in a sense, a ``pause'' in 
enrollment, during which the provider or supplier would remain enrolled 
in Medicare; in this vein, CMS would neither formally nor informally 
treat the stay as a sanction or adverse action for purposes of Medicare 
enrollment. We would also notify the affected provider or supplier in 
writing of the stay.
    We proposed two prerequisites for a stay's implementation. First, 
the provider or supplier must be non-compliant with at least one 
enrollment requirement in Title 42. Second, CMS ascertains that the 
provider or supplier can remedy the non-compliance by submitting, as 
applicable to the situation, a Form CMS-855, Form CMS-20134, or Form 
CMS-588 change of information or revalidation application (hereafter 
collectively and occasionally referenced ``Form CMS-855 change 
request,'' ``change of information application,'' or similar term). 
This change request could involve, for instance, reporting a new street 
number (to illustrate, a provider's address changed from 10 Smith 
Street to 15 Smith Street) that the provider previously failed to 
disclose to CMS. We believed these two comparatively bright-line 
standards would clearly articulate when a stay can be implemented and 
the specific vehicle for remedial action.

[[Page 79272]]

    We proposed that when a stay is imposed, the provider or supplier 
could not receive payment for services or items furnished during this 
period because the provider or supplier is non-compliant with 
enrollment requirements. Although we acknowledged that this denial of 
payment mirrors what occurs with a deactivation under Sec.  424.540, we 
explained that there are critical differences between the two actions. 
First, Sec.  424.541 made clear that a stay lasts no more than 60 days. 
A deactivation, on the other hand, has no finite timeframe, meaning 
that services and items may not be payable for a long period of time if 
the provider or supplier does not submit the required reactivation 
application. Second, MACs can generally process Form CMS-855 change 
requests more rapidly than reactivation applications. A provider or 
supplier subject to a stay could therefore begin receiving payments 
again sooner than would a deactivated provider or supplier. Third, 
while a reactivation application typically involves the provider's or 
supplier's completion of the entire Form CMS-855, a change of 
information application may only involve the submission of a limited 
amount of data (such as the information that is changing and basic 
identifying data). Completion of a change of information application 
is, in short, considerably less burdensome for providers and suppliers 
than completion of a reactivation application.
    Indeed, the issue of burden was the core consideration behind our 
proposal. As previously indicated, we do not wish to have to proceed to 
a deactivation (much less a revocation) in all cases of non-compliance. 
This is especially true if CMS believes the non-adherence can be 
promptly corrected via the provider's or supplier's submission of 
updated enrollment data. We again acknowledged that payments for 
services and items furnished during the stay would not be covered, but 
we noted that this would also occur if CMS imposed a deactivation or 
revocation, with the important distinction that the period of non-
payment would often be significantly shorter with a stay than with a 
deactivation and certainly a revocation. In all, we believed that our 
stay provision would ultimately reduce the burden on providers and 
suppliers that would otherwise be deactivated or revoked for non-
compliance.
    Notwithstanding this, we believed the affected provider or supplier 
should have an opportunity to raise a concern about a stay by 
submitting a rebuttal. The rebuttal process would generally mirror that 
for deactivations and payment suspensions (outlined in Sec. Sec.  
424.546 and 405.374, respectively), the two actions most akin to a 
stay. We recognized that given the comparatively short period of a 
stay, the stay may have expired by the time CMS makes its rebuttal 
determination. In addition, if the provider or supplier can quickly 
return to compliance, they may likely pursue this course rather than 
submit a rebuttal (although the provider or supplier may still do so). 
Yet merely because some providers and suppliers may forego submitting a 
rebuttal does not mean the process should be unavailable to them.
    Consistent with all the foregoing, we proposed several provisions 
in Sec.  424.541. In paragraph (a)(1), we proposed that CMS may stay an 
enrolled provider's or supplier's enrollment if the provider or 
supplier:
     Is non-compliant with at least one enrollment requirement 
in title 42; and
     Can remedy the non-compliance via the submission of, as 
applicable to the situation, a Form CMS-855, Form CMS-20134, or Form 
CMS-588 change of information or revalidation application.
    We emphasized that our authority to impose a stay would be 
discretionary. More specifically, our authority to apply a revocation, 
deactivation, or a stay lies within our discretion. Our decision as to 
which of these actions is most appropriate would depend upon the facts 
and circumstances of the case in question. We emphasize that we may 
impose a deactivation or revocation (if grounds exist for either) 
without first applying a stay; that is, a stay is not a mandatory 
prerequisite for a subsequent deactivation or revocation. Too, there 
may be situations where we impose a stay and, if the non-compliance is 
not addressed, we would then exercise our discretion to impose a 
deactivation or revocation. The effective date of the deactivation or 
revocation will be applied in accordance with the applicable 
regulations in 42 CFR part 424, subpart P, and could, depending on the 
specific regulatory provision involved, be retroactive to the date of 
the non-compliance.
    In paragraphs (a)(2)(i) and (ii), respectively, we would state that 
during the stay period:
     The provider or supplier remains enrolled in Medicare; and
     Claims submitted by the provider or supplier with dates of 
service within the stay period will be denied.
    In paragraph (a)(3), we proposed that a stay would last no longer 
than 60 days from the postmark date of the notification letter.
    In paragraph (a)(4), we proposed that CMS must notify the affected 
provider or supplier in writing of the stay's imposition.
    In paragraph (b), we outlined our proposed rebuttal process, which, 
as stated, would largely align with that for deactivations and payment 
suspensions.
    In paragraph (b)(1), we proposed that if a provider or supplier 
receives written notice from CMS or its contractor that the provider or 
supplier is subject to a stay under Sec.  424.541, the provider or 
supplier has 15 calendar days from the date of the written notice to 
submit a rebuttal to the stay.
    In paragraph (b)(2), we proposed that CMS may, at its discretion, 
extend the 15-day time-period referenced in paragraph (b)(1).
    In paragraphs (b)(3)(i) through (iv), we proposed that the rebuttal 
must:
     Be in writing.
     Specify the facts or issues about which the provider or 
supplier disagrees with the stay's imposition and/or the effective 
date, and the reasons for disagreement.
     Submit all documentation the provider or supplier wants 
CMS to consider in its review of the stay.
     Be submitted in the form of a letter that is signed and 
dated by the individual supplier (if enrolled as an individual 
physician or non-physician practitioner), the authorized official or 
delegated official (as those terms are defined in Sec.  424.502), or a 
legal representative (as defined in Sec.  498.10). If the legal 
representative is an attorney, the attorney must include a statement 
that he or she has the authority to represent the provider or supplier; 
this statement is sufficient to constitute notice of such authority. If 
the legal representative is not an attorney, the provider or supplier 
must file with CMS written notice of the appointment of a 
representative; this notice of appointment must be signed and dated by, 
as applicable, the individual supplier, the authorized official or 
delegated official, or a legal representative.
    In paragraph (b)(4), we proposed that the provider's or supplier's 
failure to submit a rebuttal that is both timely under paragraph (b)(1) 
of this section and fully compliant with all the requirements of 
paragraph (b)(3) of Sec.  424.541 constitutes a waiver of all rebuttal 
rights under this section.
    In paragraph (b)(5), we proposed that upon receipt of a timely and 
compliant stay rebuttal, CMS reviews the rebuttal to determine whether 
the imposition of the stay and/or the effective date thereof are 
correct.
    In paragraph (b)(6), we proposed that a determination made under 
paragraph

[[Page 79273]]

(b) is not an initial determination under Sec.  498.3(b), and therefore 
not appealable.
    In paragraph (b)(7), we proposed that nothing in paragraph (b) 
requires CMS to delay the imposition of a stay pending the completion 
of the review described in paragraph (b)(5).
    We proposed in paragraph (b)(8) to clarify the interaction between 
a stay and a subsequent deactivation or revocation.
    In paragraph (b)(8)(i), we proposed that nothing in paragraph (b) 
would require CMS to delay the imposition of a deactivation or 
revocation pending completion of the review described in paragraph 
(b)(5) of this section.
    In paragraph (b)(8)(ii)(A), we proposed that if CMS deactivates the 
provider or supplier during the stay, any rebuttal to the stay the 
provider or supplier submits that meets the requirements of Sec.  
424.541 will be combined and considered with the provider's or 
supplier's rebuttal to the deactivation under Sec.  424.546 if CMS has 
not yet made a determination on the stay rebuttal. (This is meant to 
facilitate efficiency and simplicity in the review process of both 
rebuttals.) In paragraph (b)(8)(ii)(B), however, we proposed that in 
all cases other than that described in paragraph (b)(8)(ii)(A), a stay 
rebuttal that was submitted in compliance with Sec.  424.541 would be 
considered separately and independently of any review of any other 
rebuttal or provider enrollment appeal.
    Finally, existing Sec.  424.555(b) states that payment may not be 
made for Medicare services and items furnished to a Medicare 
beneficiary by a deactivated, denied, or revoked provider or supplier. 
The paragraph further states that the beneficiary has no financial 
liability for such services and items provided by these providers and 
suppliers. To clarify the issues of payment and beneficiary liability 
for purposes of Sec.  424.541, we proposed to add providers and 
suppliers currently under a stay of enrollment to the categories of 
providers and suppliers falling within Sec.  424.555(b).
    We received the following comments on our proposal:
    Comment: Several commenters supported the basic concept of a stay 
of enrollment in lieu of deactivating or revoking a provider or 
supplier for minor instances of non-compliance.
    Response: We appreciate the commenters' support.
    Comment: Notwithstanding the previous comments, numerous commenters 
opposed the prohibition against payment for services and items 
furnished during the stay. At a minimum, they requested that these 
services and items be payable retroactively; that is, once the provider 
or supplier has resumed compliance and the stay has been lifted, 
payment can be made for services and items provided during the stay. 
They noted that it would be unfair to deny payment--which could, more 
importantly, seriously harm providers' cash flow and hinder patient 
access to care--for inconsequential cases of non-compliance that CMS 
did not even deem significant enough to warrant a deactivation or 
revocation. Some commenters added that they saw little difference 
between the provider burden imposed by a stay and that by a 
deactivation.
    Response: We agree with these commenters on two principal grounds. 
First, and above all, the central purpose of the stay proposal was to 
ameliorate provider burden. We believe, upon further reflection and 
after reviewing these comments, that this objective would be largely 
unmet if we applied to stays the same policy of ``no retroactive 
payment'' that we use for deactivations. Second, we stated in the 
proposed rule that a stay would prove less burdensome for providers 
than a deactivation because, for instance: (a) completion of a Form 
CMS-855 change of information application generally entails less 
provider burden (and takes less time for a MAC to process) than a 
reactivation application; and (b) a stay would last a maximum of 60 
days whereas a deactivation lasts until the provider complies with the 
reactivation requirements. While (a) and (b) are true, we do not 
believe these burden differences are so substantial as to offset the 
provider burden associated with prohibiting retroactive payments. In 
other words, we concur with commenters who did not see an appreciable 
difference in burden between stays and deactivations notwithstanding 
(a) and (b). Another way, in our view, to materially distinguish 
between stays and deactivations in terms of provider impact is to 
permit retroactive payment in the former instance.
    We acknowledge our statement in the proposed rule whereby we deemed 
retroactive payment prohibitions for stays to be necessary because 
``(t)o permit payment for these services and items [while the provider 
was non-compliant with enrollment requirements] would be contrary to 
our obligation to safeguard the Trust Funds.'' \415\ Yet, upon further 
consideration, we do not believe that allowing retroactive payments in 
stay situations would be inherently inconsistent with this statement. 
During the stay period, the non-compliant provider or supplier would 
indeed not be receiving payment for services furnished therein, as the 
above-quoted language indicates. Once the stay ends, these payments 
could be retroactively made if the requirements outlined in this final 
rule are met. We raise this matter because we do not want stakeholders 
to believe that, by permitting retroactive payments in stay cases, we 
are now allowing all non-complaint providers and suppliers--whether 
stayed, deactivated, revoked, etc.--to receive continuous payments for 
services and items furnished while out of adherence. This is untrue, as 
evidenced by our stoppage of payments for services furnished during the 
stay. We emphasize that we remain fully committed to ensuring that 
providers remain in full and constant compliance with enrollment 
requirements and will take measures, such as imposing a stay, if they 
are not.
---------------------------------------------------------------------------

    \415\ 88 FR 52520.
---------------------------------------------------------------------------

    Considering the foregoing, proposed Sec.  424.541 will be revised 
as follows:
     As proposed, paragraph (a)(2)(ii) states that during the 
stay period, claims submitted by the provider or supplier with dates of 
service within the stay period will be denied. We will change this 
paragraph in two principal ways.
    First, the paragraph will be redesignated as paragraph 
(a)(2)(ii)(A), though with the insertion of the following caveat at its 
beginning: ``Except as stated in paragraph (a)(2)(ii)(B) of this 
section''. We will also change ``denied'' to ``rejected,'' which we 
believe will make it easier for the provider or supplier to later 
resubmit the claims.
    Second, new paragraph (a)(2)(ii)(B) will state that these claims 
are eligible for payment (and may be resubmitted by the provider or 
supplier within applicable timeframes specified in title 42) if: (1) 
CMS or its contractor determines that the provider or supplier has 
resumed compliance with all Medicare enrollment requirements in Title 
42; and (2) the stay ends on or before the 60th day of the stay period. 
This will clarify that retroactive payment is permissible (assuming all 
other requirements for payment of the claim are met) but only if the 
provider or supplier returned to compliance within the stay period. The 
purpose of this latter proviso is to spur the stayed provider or 
supplier to resume compliance quickly. Without this condition, the 
provider or supplier might indefinitely continue its non-compliance 
beyond the 60-day stay period because it knows it may

[[Page 79274]]

eventually receive retroactive payments. This, in our view, is 
unacceptable, and we believe that providers must understand they cannot 
disregard their obligation to always adhere to enrollment requirements. 
If they wish to receive retroactive payments, they must fulfill this 
obligation in a timely manner.
     As indicated previously, and with respect to payment 
prohibitions, we proposed to add the language ``if the provider or 
supplier is currently under a stay of enrollment'' to Sec.  424.550(b). 
We will add the following parenthetical to end of this language: 
``(except as stated in paragraph (a)(2)(ii)(B) of this chapter).'' This 
means that payments can be made when the circumstance in paragraph 
(a)(2)(ii)(B) applies.
    Comment: A commenter stated that if compliance is not reached 
within the 60-day stay timeframe, CMS should extend the period an 
additional 60 days rather than deactivate the provider or supplier.
    Response: We respectfully disagree for two reasons. First, we 
believe 60 days is adequate time for a provider or supplier to remedy 
its non-compliance, particularly considering the relatively minor 
nature thereof. Second, if we were to permit a subsequent 60-day 
period, providers and suppliers might be less incentivized to come into 
compliance within the initial 60-day timeframe. In our view, it is 
imperative that providers and suppliers resume compliance promptly, and 
we believe the commenter's recommendation, while appreciated, is 
contrary to this.
    Comment: A commenter stated that the 15-day rebuttal period should 
be extended to 30 days because it may take 5 or more days for the stay 
notice to reach the provider or supplier, leaving little time to 
prepare and submit the rebuttal.
    Response: We respectfully disagree. As previously noted, rebuttals 
of deactivations under Sec.  424.540 and payments suspensions under 
Sec.  405.371 are subject to a 15-day period, and it has been our 
experience that providers and suppliers have generally been able to 
meet this timeframe. We believe the same will occur for stay rebuttals.
    Comment: A commenter stated that a stay should not be imposed for 
mere clerical or administrative errors that result in non-compliance. 
The commenter stated this would be overly punitive.
    Response: While we are respectfully uncertain what the commenter 
considers to be simple clerical or administrative errors for enrollment 
purposes, we believe that any form of non-compliance is cause for 
concern. To permit even minor non-compliance to go unremedied could 
threaten the Trust Funds, and we respectfully do not believe the 
commenter's apparent suggestion for CMS to merely dismiss such non-
adherence is a feasible solution. Yet we recognize that there are 
degrees of non-compliance, and it is with this in mind that we proposed 
the stay provision. We sought a measure that could address minor cases 
of non-compliance without involving a more significant action, such as 
a deactivation. We believe an enrollment stay, particularly given our 
above-mentioned change to Sec.  424.541(a)(2)(ii), is a suitable 
remedy.
    Comment: Several commenters sought clarification about the 
operational aspects of the stay process, including the commencement 
date of any stay, when the stay ends, and how providers will be 
notified of the stay. One commenter asked whether the stay would end on 
the date the contractor processes the changed information, which we 
interpret to mean the date on which the contractor completes its 
application processing and approves the application submission.
    Response: We appreciate these questions and address them in Sec.  
424.541 as follows:
     Commencement--Paragraph (a)(3) states that a stay lasts no 
longer than 60 days from the postmark date of the notification letter. 
The effective date is therefore the notification letter's postmark 
date. To clarify this point, we will add the following language at the 
end of paragraph (a)(3): ``which is the effective date of the stay.''
     End-Date of the Stay--We will clarify in paragraph (a)(5) 
that the stay's end-date will be the date on which CMS or the 
contractor determines that the provider or supplier has resumed 
compliance with all Medicare enrollment requirements in Title 42 or the 
day after the 60-day stay period expires, whichever occurs first. We 
believe this is consistent with our aforementioned change concerning 
paragraph (a)(2)(ii)(B).
     Notification of the Stay--Per paragraph (a)(4), CMS 
notifies the affected provider or supplier in writing of the stay's 
imposition.
    Other operational matters of the stay process will be addressed 
via, as appropriate, subregulatory guidance or future rulemaking.
    Comment: A commenter stated that CMS should outline the types of 
conduct that would result in (1) a deactivation, (2) a stay of 
enrollment, or (3) no CMS action at all. The commenter expressed 
concern that a stay could be a more punitive option in situations where 
CMS previously would not have taken any action against the provider or 
supplier.
    Response: We are unable in this final rule or in subregulatory 
guidance to provide further detail about the forms of non-compliance 
that fall within these three categories for two principal reasons. 
First, there are many types of non-compliance involving many different 
regulatory requirements and data elements. To list them all is not 
feasible. Second, we cannot publicly commit ourselves to a specific 
course of action in these cases because there could be different facts 
and circumstances associated with each situation. We must always retain 
the flexibility to address them on an individual basis. As for the 
stakeholder's remaining comment, the stay provision is not primarily 
intended to now penalize providers for matters that previously would 
not have involved CMS action. It is instead to reduce the severity of 
CMS action for minor cases of non-compliance that would ordinarily have 
triggered a deactivation. In other words, the goal is to reduce the 
level of burden rather than create new, harsher penalties for certain 
actions.
    Comment: A commenter asked CMS to explain the resources it will 
dedicate to the MACs to ensure that: (1) they will expedite the 
processing of ``stay of enrollment'' changes of information; and (2) 
such applications will indeed be processed within 60 days. The 
commenter also appeared to ask whether CMS will explicitly direct MACs 
to process these applications within the stay period. The commenter 
stated that if the MAC does not timely process the change, the provider 
or supplier should not be penalized with deactivation. The commenter 
also expressed concern that the 60-day stay period may not be 
sufficient time for: (1) the MACs and providers to resolve complex 
issues; and (2) the rebuttal process to be completed.
    Response: We will work very closely with the MACs regarding the 
implementation of this final rule's stay provisions and will issue 
detailed subregulatory guidance to them. We are confident the MACs 
will: (1) be able to process these Form CMS-855 applications within the 
stay period; and (2) have the resources to do so. We will also 
establish timeliness standards that MACs must meet when processing 
applications submitted pursuant to a stay.
    We cannot commit in this final rule to never impose a subsequent 
deactivation if the application is not timely processed; this is 
because of the

[[Page 79275]]

variety of factual scenarios that can arise. Yet we understand the 
commenter's concern regarding cases where the 60-day period expires 
without a contractor decision, and we will account for such 
circumstances in determining whether to proceed with a deactivation or 
revocation.
    We also acknowledge the commenter's remaining concern that the 60-
day period may be too brief to resolve all potential issues. However, 
we reiterate that the provider or supplier is out of compliance with 
enrollment requirements during this time, and it is imperative that 
providers and suppliers act rapidly to resume adherence. We believe 60 
days appropriately balances the need for the latter while giving 
providers and suppliers adequate time to do so.
    After reviewing the comments received, we are finalizing our stay 
provisions in Sec.  424.541 as proposed except for the previously 
noted.
     Modification to paragraph (a)(2)(ii);
     Addition of new paragraph (a)(5); and
     Addition of the parenthetical ``(except as stated in Sec.  
424.541(a)(2)(ii)(B) of this chapter)'' to the end of the first 
sentence of Sec.  424.550(b).
iii. Reporting Changes in Practice Location
    Consistent with Sec. Sec.  424.57(c)(2), 410.33(g)(2), and 
424.516(d)(1)(iii), respectively, the following provider and supplier 
types must report a change in practice location within 30 days of the 
change: (1) DMEPOS suppliers; (2) IDTFs; and (3) physicians, 
nonphysician practitioners, and physician and nonphysician practitioner 
organizations. All other provider and supplier types are required per 
Sec.  424.516(e)(2) to report practice location changes within 90 days 
of the change. We proposed two sets of regulatory revisions regarding 
practice location changes. First, we proposed to revise Sec.  
424.516(e)(1) to require such location changes involving providers and 
suppliers other than the categories previously described to be reported 
within 30 days of the change. Second, we proposed to clarify in 
Sec. Sec.  410.33(g)(2), 424.516(d)(1)(iii), and 424.516(e)(1) that a 
change of practice location includes adding a new location or deleting 
an existing one.
    There were two main reasons for our proposals. One is that Medicare 
payments are often based on the provider's or supplier's specific 
geographic location. If we are not timely informed of the change in 
location, we could be making incorrect payments to the provider or 
supplier for an extended period (for instance, 90 days); this would be 
inconsistent with CMS's obligation to protect the Trust Funds. The 
other reason is that we would be unable to promptly determine whether 
the new site is compliant with Medicare provider enrollment 
requirements (for example, via a site visit) because we would not yet 
know of the change. The provider or supplier may be furnishing services 
from an invalid location, hence resulting in improper payments.
    We also noted that for purposes of reporting practice location 
changes, we have always included additions and deletions of locations 
within the scope of such changes. We sought to reemphasize this 
interpretation via our proposed revisions.
    We received the following comments on our proposal:
    Comment: A commenter stated that the list of providers and 
suppliers in Sec.  424.516 that are subject to the 30- or 90-day 
reporting timelines is not exhaustive, which could create confusion 
among providers outside these categories (particularly pharmacies 
enrolled as DMEPOS suppliers). The commenter recommended that CMS 
elucidate which timeframes are applicable to providers and suppliers 
that are enrolled as multiple provider or supplier types (for example, 
pharmacy and DMEPOS).
    Response: All provider and supplier types are addressed in Sec.  
424.516. Those types not explicitly referenced (such as home health 
agencies (HHAs), community mental health centers, etc.) fall within 
Sec.  424.516(e). The applicable timeframe category is determined by 
the provider or supplier type involved. For instance, suppose an entity 
is enrolled as an HHA and an IDTF. The timeframes in Sec. Sec.  
424.516(b) and 410.33(g)(2) apply to the IDTF enrollment and those in 
Sec.  424.516(e) to the HHA enrollment. Using the commenter's example, 
since the pharmacy is enrolled as a DMEPOS supplier, the applicable 
reporting timeframes are those for DMEPOS suppliers (addressed in 
Sec. Sec.  424.516(c) and 424.57(c)(2)).
    Comment: A commenter stated that our practice location reporting 
proposal should be coordinated with the DEA's telehealth requirements 
to avoid subjecting suppliers to conflicting standards.
    Response: While we appreciate this comment, we are respectfully 
uncertain as to the specific DEA standard to which the commenter is 
referring. We further note that we must adopt policies that are best-
suited to protect the Medicare program.
    Comment: Several commenters opposed our practice location reporting 
proposal, stating that the existing burden and difficulty in meeting 
timeframes for reporting changes in enrollment data would be 
exacerbated if all practice location changes must be disclosed within 
30 days.
    Response: We note that over 2 million currently enrolled physicians 
and non-physicians are required under Sec.  424.516(d)(1)(iii) (as are 
over 60,000 enrolled DMEPOS suppliers per Sec.  424.57(c)(2)) to report 
practice location changes within 30 days. This requirement has been 
effective for over a decade, and we are unaware of any significant, 
wide-ranging challenges these supplier types have encountered in 
meeting the timeframe. We accordingly and respectfully do not believe 
that providers and suppliers that must now report practice location 
changes within 30 days will have great difficulty doing so.
    Comment: A commenter asked: (1) how providers should report 
required changes of information when the contractor is currently 
processing a pending application from the provider; and (2) whether a 
provider can report a change of information 30 days prior to the change 
becoming effective.
    Response: Providers and suppliers must report changes of 
information within required timeframes irrespective of whether the 
contractor is processing a pending application. They are welcome to 
submit such changes prior to the change's effective date.
    After reviewing the comments received, we are finalizing our 
proposal without modification.
iv. Definitions
    We also proposed several new and clarified definitions to help 
explain the meaning of certain provider enrollment concepts.
(A) ``Pattern or Practice''
    The following current Medicare enrollment revocation reasons are 
based upon the provider or supplier engaging in a pattern or practice 
of conduct:
     Section 424.535(a)(8)(ii): The provider or supplier has a 
pattern or practice of submitting claims that fail to meet Medicare 
requirements.
     Section 424.535(a)(14): The physician or eligible 
professional has a pattern or practice of prescribing Part B or D drugs 
that is abusive, represents a threat to the health and safety of 
Medicare beneficiaries, or fails to meet Medicare requirements.
     Section 424.535(a)(21): The physician or eligible 
professional has a pattern or practice of ordering,

[[Page 79276]]

certifying, referring, or prescribing Medicare Part A or B services, 
items, or drugs that is abusive, represents a threat to the health and 
safety of Medicare beneficiaries, or otherwise fails to meet Medicare 
requirements.
    We have received questions from interested parties over the years 
as to what constitutes a pattern or practice under these provisions. 
Accordingly, we proposed to define ``pattern or practice'' in Sec.  
424.502. It would mean:
     For purposes of Sec.  424.535(a)(8)(ii), at least three 
submitted non-compliant claims.
     For purposes of Sec.  424.535(a)(14), at least three 
prescriptions of Part B or Part D drugs that are abusive, represent a 
threat to the health and safety of Medicare beneficiaries, or otherwise 
fail to meet Medicare requirements.
     For purposes of Sec.  424.535(a)(21), at least three 
orders, certifications, referrals, or prescriptions of Medicare Part A 
or B services, items, or drugs that are abusive, represent a threat to 
the health and safety of Medicare beneficiaries, or otherwise fail to 
meet Medicare requirements.
    To accommodate our definition, we also proposed to make several 
minor technical changes to Sec.  424.535(a)(8)(ii), (14), and (21).
    We received several comments on our proposed ``pattern or 
practice'' definition.
    Comment: Some commenters opposed the definition. They noted that 
the threshold of three non-compliant claims, orders, etc. (1) is too 
low, (2) cannot adequately establish a pattern or practice of 
intentional or harmful behavior, and (3) could be arbitrarily applied 
by CMS. One commenter stated that the term ``pattern or practice'' is 
typically understood to require more than three instances and means 
activity done in a systematic way. The commenter stated that our 
proposed definition in inconsistent with this standard meaning.
    Response: After reviewing the comments received, we are not 
finalizing our proposed definition of ``pattern or practice'' or the 
corresponding technical revisions to Sec.  424.535(a)(8)(ii), (14), and 
(21). We may reconsider this issue for future rulemaking.
(B) Indirect Ownership
    We also proposed to define ``indirect ownership interest'' in Sec.  
424.502. Some interested parties have expressed uncertainty about what 
indirect ownership is. An understanding of indirect ownership is 
important for providers and suppliers because they are required to 
report on their enrollment application all their 5 percent or greater 
indirect owners. Section 420.201 defines an ``indirect ownership 
interest'' as ``any ownership interest in an entity that has an 
ownership interest in the disclosing entity. The term includes an 
ownership interest in any entity that has an indirect ownership 
interest in the disclosing entity.'' We believed this definition 
(albeit with certain modifications for purposes of clarity and to 
conform to the terminology of subpart P) would provide the desired 
elucidation. Consequently, our proposed definition of ``indirect 
ownership interest'' would state:
     Any ownership interest in an entity that has an ownership 
interest in the enrolling or enrolled provider or supplier.
     Any ownership interest in an indirect owner of the 
enrolling or enrolled provider or supplier.
    We proposed to designate this portion of our definition as 
paragraphs (1)(i) and (ii). To further elucidate the concept of 
indirect ownership, we proposed in paragraph (2) to mirror an example 
contained in Sec.  420.202(a). Paragraph (2) would state: ``The amount 
of indirect ownership interest is determined by multiplying the 
percentages of ownership in each entity. For example, if A owns 10 
percent of the stock in a corporation that owns 80 percent of the 
provider or supplier, A's interest equates to an 8 percent indirect 
ownership interest in the provider or supplier and must be reported on 
the enrollment application. Conversely, if B owns 80 percent of the 
stock of a corporation that owns 5 percent of the stock of the provider 
or supplier, B's interest equates to a 4 percent indirect ownership 
entity in the provider or supplier and need not be reported.''
    We received the following comment on our proposal to define 
``indirect ownership'' in Sec.  424.502.
    Comment: A commenter supported our proposed definition.
    Response: We appreciate the commenter's support.
    After reviewing the comment received, we are finalizing our 
proposed definition of ``indirect ownership'' without modification.
(C) PTs and OTs in Private Practice and Speech-Language Pathologists
    Physical therapists in private practice (PTPPs), occupational 
therapists in private practice (OTPPs), and speech-language 
pathologists (SLPs) are permitted under the Act to receive payment for 
furnished Medicare services. However, they do not fall within the 
regulatory definition of ``supplier'' under Sec.  400.202. The reason 
is that while the services they provide are payable under Medicare 
(thus allowing these individuals to enroll in the program), PTPPs, 
OTPPs, and SLPs are not formally recognized in either the Act or the 
CFR as types of ``suppliers.'' Nevertheless, we have applied the 
provisions of subpart P to PTPPs, OTPPs, and SLPs via current guidance. 
We have also afforded PTPPs, OTPPs, and SLPs the same appeal rights 
(for example, appeals of enrollment denials and revocations) as all 
other enrolling or enrolled individuals and entities. To codify these 
practices in the CFR, we proposed several regulatory provisions.
    First, we proposed to define ``supplier'' in Sec.  424.502 as 
follows: ``Supplier means, for purposes of this subpart, all of the 
following: (1) the individuals and entities that qualify as suppliers 
under Sec.  400.202; (2) physical therapists in private practice; (3) 
occupational therapists in private practice; and (4) speech-language 
pathologists.'' Second, we included within new Sec.  405.800(d) the 
same definition of ``supplier'' we proposed in Sec.  424.502. This is 
because subpart H of part 405 addresses various types of provider 
enrollment appeals under Medicare Part B. Third, 42 CFR part 498, too, 
contains various provisions concerning provider enrollment appeals. 
Section 498.2 defines ``supplier'' for purposes of part 498 by 
outlining several categories of suppliers. One such category, codified 
in paragraph (6) of this definition, reads, ``Physical therapist in 
independent practice.'' We proposed to revise paragraph (6) to state: 
``For purposes of this part, physical therapist in private practice, 
occupational therapist in private practice, or speech-language 
pathologist.''
    We received the following comment on this proposal:
    Comment: A commenter supported our proposed inclusion of PTPPs, 
OTPPs, and SLPs within Sec.  498.2, as well as our proposed definition 
of supplier in Sec.  424.502.
    Response: We appreciate the commenter's support.
    After reviewing this comment, we are finalizing these proposals 
without modification.
(D) Authorized Officials
    Under Sec.  424.510(d)(3), an authorized official or delegated 
official must sign the Medicare enrollment application (for example, 
Form CMS-855A) on behalf of the provider or supplier if the latter is a 
corporation, partnership, group, limited liability company, or other 
organization. The terms

[[Page 79277]]

authorized official and delegated official are defined in Sec.  
424.502. The former is ``an appointed official (for example, chief 
executive officer, chief financial officer, general partner, chairman 
of the board, or direct owner) to whom the organization has granted the 
legal authority to enroll it in the Medicare program, to make changes 
or updates to the organization's status in the Medicare program, and to 
commit the organization to fully abide by the statutes, regulations, 
and program instructions of the Medicare program.'' A delegated 
official is defined as an individual ``who is delegated by the 
`Authorized Official' the authority to report changes and updates to 
the enrollment record. The delegated official must be an individual 
with ownership or control interest in, or be a W-2 managing employee 
of, the provider or supplier.''
    With respect to the authorized official definition, interested 
parties have asked CMS whether the term ``organization'' as used 
therein means: (1) the entity listed in Section 2 of the Form CMS-855 
as identified by its legal business name (LBN) and tax identification 
number (TIN); or (2) the provider or supplier type that is enrolling. 
To illustrate, suppose Entity A (with its unique LBN and TIN) submits 
three separate Form CMS-855A initial enrollment applications to enroll 
an HHA, a hospice, and a skilled nursing facility (SNF), all of which 
have Entity A's LBN and TIN. In this type of situation, the question is 
whether ``organization'' refers to Entity A or instead to three 
separate ones--that is, the HHA, hospice, and the SNF.
    We proposed to add a sentence to the conclusion of the ``authorized 
official'' definition clarifying that the term ``organization'' 
therein--and exclusively for purposes of applying the ``authorized 
official'' definition--means the enrolling entity as identified by its 
LBN and TIN and not the provider or supplier type(s) that the entity is 
enrolling as. Using our previous illustration, this is because the HHA, 
hospice, and the SNF are not legal entities (such as corporations) 
separate and distinct from Entity A but are, in effect, part of Entity 
A itself; Entity A, in other words, is enrolling as an HHA, hospice, 
and SNF. In practical terms, this means an authorized official serves 
in that role on behalf of the enrolling entity (Entity A). Per our 
example, the individual could sign CMS provider enrollment applications 
concerning the HHA, hospice, and the SNF.
    We received no comments on our proposed change and are therefore 
finalizing it without modification.
2. Medicaid and CHIP Enrollment
a. Background
    The Medicaid program (title XIX of the Act) is a joint Federal and 
State health care program that, as of June 2023, covers more than 85 
million low-income individuals. States have considerable flexibility 
with respect to the design of their Medicaid programs within a broad 
Federal framework, and programs vary from State to State. The 
Children's Health Insurance Program (CHIP) (Title XXI of the Act) is a 
joint Federal and State health care program that (as of June 2023) 
provides health care coverage to nearly 7 million children in families 
with incomes too high to qualify for Medicaid, but too low to afford 
private coverage.
    In operating Medicaid and CHIP, and as required by sections 
1902(a)(78) and 2107(e)(1)(D) of the Act, respectively, each State 
requires providers to enroll if the providers wish to furnish, order, 
prescribe, refer, or certify eligibility for Medicaid or CHIP items or 
services in that State.\416\ States may also establish their own 
provider enrollment requirements which must be met in addition to the 
applicable Federal provider enrollment requirements, outlined in 42 CFR 
part 455. Similar to Medicare provider enrollment, the purpose of the 
Medicaid and CHIP provider enrollment processes is to ensure that 
providers: (1) meet all Medicaid or CHIP requirements (and any other 
State-specific or Federal requirements); (2) are qualified to furnish, 
order, prescribe, refer, or certify Medicaid and CHIP services, items, 
and drugs; and (3) are eligible to receive payment, where applicable.
---------------------------------------------------------------------------

    \416\ Section 1902(kk)(7) also requires physicians and other 
eligible professionals who order or refer Medicaid services and 
items to be enrolled in Medicaid. This requirement is made 
applicable to CHIP via section 2107(e)(1)(G) of the Act.
---------------------------------------------------------------------------

    The provider enrollment provisions in part 455 to which States must 
adhere include requirements relating to denial or termination of 
enrollment. Under Sec.  455.416, the State must deny or terminate a 
provider's Medicaid or CHIP enrollment for reasons specified therein. 
These include, for example:
     Any person with a 5 percent or greater direct or indirect 
ownership interest in the provider fails to: (1) submit timely and 
accurate information; and (2) cooperate with any screening methods 
required under part 455, subpart E.
     Any person with a 5 percent or greater direct or indirect 
ownership interest in the provider has been convicted of a criminal 
offense related to that person's involvement with Medicare, Medicaid, 
or CHIP in the last 10 years.
    Of particular relevance to this rulemaking is that, under section 
1902(a)(39) of the Act and Sec.  455.416(c), the State must deny or 
terminate the provider's enrollment if the provider is terminated under 
the Medicare program, or the Medicaid program or CHIP of any other 
State.
b. The 21st Century Cures Act's Medicaid and CHIP Provider Enrollment 
Requirements
    Section 5005 of the 21st Century Cures Act (Pub. L. 114-255; 
hereafter referred to as the Cures Act) addresses, in part, Medicaid 
and CHIP provider enrollment and provider terminations. For purposes of 
our proposals discussed in section of this final rule, section 5005's 
most pertinent provisions are:
     Section 5005(a)(1) of the Cures Act added a new paragraph 
(8) to section 1902(kk) of the Act requiring the State to report the 
termination of a provider under Medicaid or CHIP to the Secretary 
within 30 days after the effective date of the termination. Section 
5005(a)(1) of the Cures Act also outlines data that must be included in 
the termination notification that the State sends to CMS. However, 
paragraph (8)(A) limits this reporting requirement to terminations for 
reasons specified in Sec.  455.101 as in effect on November 1, 2015, 
which are limited to terminations ``for cause'' (including, but not 
limited to, terminations for reasons relating to fraud, integrity, or 
quality). Paragraph (8)(B) provides that, for purposes of the reporting 
requirement, the effective date of a Medicaid termination is the later 
of: (1) the effective date specified in the notice of termination; or 
(2) the date on which applicable appeal rights have been exhausted or 
the timeline for appeal has expired.
     Section 5005(a)(3) of the Cures Act added a new paragraph 
(ll) to section 1902 of the Act stating that within 30 days of 
receiving notification of a Medicaid or CHIP provider termination, the 
Secretary shall review such termination and, if the Secretary 
determines appropriate, include such termination in any database or 
similar system developed under section 6401(b)(2) of the Affordable 
Care Act.
     Section 5005(a)(4)(A) of the Cures Act added a new 
paragraph (D) to section 1903(i)(2) of the Act providing that, except 
for emergency items or services (but not including items or services 
furnished in a hospital emergency department), no Federal financial 
participation (FFP) funds may be paid for items and services furnished 
by a provider terminated under

[[Page 79278]]

Medicaid or CHIP (as described in section 1902(kk)(8)) beginning 60 
days after the date the termination is included in the termination 
database.
    We have issued extensive subregulatory guidance to assist States in 
implementing Medicaid and CHIP screening and enrollment provisions 
outlined in 42 CFR part 455. This guidance is compiled in a document 
titled ``Medicaid Provider Enrollment Compendium'' (MPEC) (https://www.medicaid.gov/sites/default/files/2021-05/mpec-3222021.pdf), 
originally issued in May 2016 and subsequently updated several times. 
After the enactment of the Cures Act, CMS again updated the MPEC to 
clarify the operational details concerning several of the statutory 
provisions amended by section 5005.
    Under CMS' existing process (under the statute and MPEC guidance), 
when a State reports a ``for cause'' termination, CMS determines 
whether: (1) the State submitted the required termination data in 
accordance with section 1902(kk)(8) of the Act; and (2) the termination 
is, indeed, ``for cause.'' If CMS concludes that the reported 
termination is ``for cause'' and is thus appropriate to be included in 
the database referenced in section 1902(ll) of the Act, the information 
is uploaded into a CMS-managed database. This database contains 
information on Medicaid and CHIP terminations and Medicare revocations, 
the latter of which is updated at least monthly. The database enables a 
State to review Medicaid and CHIP terminations in other States, as well 
as Medicare revocations, and, under Sec.  455.41(c), to deny enrollment 
or take its own termination action against a provider if the latter is 
also enrolled in the State. Moreover, the database gives CMS access to 
information on Medicaid and CHIP provider terminations nationwide, 
which permits us to take a Medicare revocation action against the 
provider under Sec.  424.535(a)(12)(i), if appropriate, based on the 
Medicaid or CHIP termination.
c. Proposed Provisions
i. Termination Lengths--Background
    There are two termination database-related matters that have 
generated uncertainty during our implementation of the Sec.  455.416(c) 
termination requirement. They involve: (1) the length of time for which 
a termination remains active in the termination database; and (2) the 
interaction of different termination periods imposed by the States and/
or the Medicare program.
    Under Sec.  424.535(c), if a Medicare provider or supplier is 
revoked from Medicare, they are barred from participating in the 
Medicare program from the effective date of the revocation until the 
end of the reenrollment bar, which, under existing Sec.  424.535(c), is 
generally for a period of 1 to 10 years. This 1- to 10-year period 
typically constitutes: (1) the period for which the provider or 
supplier is revoked from Medicare; and (2) the amount of time that the 
Medicare revocation will remain in the termination database.
    Many States have similar reenrollment bars for terminated Medicaid 
and CHIP providers. (Hereafter, and for purposes of consistency, the 
terms ``termination period'' and ``reenrollment bar'' as used in this 
section III.K.2 of this final rule, refer to a Medicaid or CHIP 
reenrollment bar, unless otherwise noted.) Yet these termination 
periods often differ among the States. For instance, State A may 
terminate a provider for 3 years for a particular transgression while 
State B might do so for 10 years for the same conduct. As noted in the 
proposed rule, we recognize the traditional deference given to States 
regarding the establishment of reenrollment bars. However, the 
interplay between varying termination period lengths (especially as 
they relate to the termination database and the termination requirement 
in Sec.  455.416(c)) has caused confusion among the States, provider 
communities, and other interested parties. Accordingly, we proposed to 
specify in regulation the length of time for which ``for cause'' 
provider terminations will remain in the database and, by extension, 
the period for which other States must deny or terminate the provider 
under Sec.  455.416(c).
ii. Revision to Sec.  455.416(c)
    We proposed to add the following clause to the end of Sec.  
455.416(c): ``and is currently included in the termination database 
under Sec.  455.417.'' This would clarify that the denial and 
termination requirement under Sec.  455.416(c) is predicated on the 
provider's inclusion in the termination database.
    iii. Length of Inclusion in Database (Sec.  455.417)
    For the reasons outlined above and in the proposed rule, we 
proposed several provisions in new Sec.  455.417 as follows:
     In paragraph (a)(1), we proposed that a provider would 
remain in the termination database referenced in section 1902(ll) of 
the Act for a period that is the lesser of:
    ++ The length of the termination period imposed by the initially 
terminating State Medicaid program or CHIP, or the reenrollment bar 
imposed by the Medicare/program; or
    ++ 10 years (for those Medicaid or CHIP terminations that are 
greater than 10 years).
     Under proposed paragraph (a)(2,) all other State Medicaid 
programs or CHIPs in which the provider is enrolled or seeking to 
enroll would be required to terminate or deny the provider's enrollment 
from their respective programs (under Sec.  455.416(c)) for at least 
the same length of time as the termination database period).
     In paragraphs (b)(1)(i) and (ii), respectively, we 
proposed that nothing in paragraph (a) would prohibit:
    ++ The initially terminating State from imposing a termination 
period of greater than 10 years consistent with that State's laws, or
    ++ Another State from terminating the provider, based on the 
original State's termination, for a period: (A) of greater than 10 
years; or (B) that is otherwise longer than that imposed by the 
initially terminating State.
    In paragraph (b)(2), however, we proposed to clarify that the 
period established under paragraph (b)(1)(ii) must be no shorter than 
the period in which the provider is to be included in the termination 
database under paragraph (a).
    In paragraph (c)(1), we proposed that if the initially terminating 
State agency or the Medicare program reinstates the provider prior to 
the end of the termination period originally imposed by the initially 
terminating State program or Medicare, CMS would remove the provider 
from the termination database after the reinstatement has been reported 
to CMS.
    In paragraph (c)(2), we proposed that if the provider is removed 
from the database due to reinstatement by the originally terminating 
State agency, nothing prohibits CMS from immediately re-including the 
provider in the database if a separate basis for doing so exists under 
42 CFR part 455 or 424.
    In paragraph (d), we proposed that, for purposes of Sec.  455.417 
only, terminations under Sec.  455.416(c) (which, as previously 
discussed, are based on another State's termination of the provider) 
are not themselves considered ``for cause'' terminations, and 
therefore, need not be separately reported to CMS for inclusion in the 
termination database.
    We received the following comments on our termination database 
proposal:
    Comment: Several commenters supported our termination database

[[Page 79279]]

provisions, believing that they would furnish needed elucidation.
    Response: We appreciate the commenters' support.
    After reviewing the comments received, we are finalizing our 
termination database proposals without modification.
3. Miscellaneous Comments
    We also received the following miscellaneous comments concerning 
our proposals, as well as on provider enrollment in general.
    Comment: Several commenters asked us to: (1) provide detailed 
public guidance for providers and suppliers regarding our new 
revocation reasons and how they will affect providers and suppliers; 
and (2) monitor the impact of our revocation policies on providers' and 
suppliers' workforces.
    Response: As we typically do upon issuing new provider enrollment 
regulatory provisions, we will: (1) release subregulatory guidance to 
stakeholders explaining our new requirements and the provider activity 
involved; and (2) keep abreast of any impacts these provisions may have 
on the provider community.
    Comment: A commenter stated that in proposing our enrollment 
provisions, we failed to justify why our existing regulatory authority 
is insufficient to protect program integrity. The commenter urged CMS 
to engage with the provider community via town hall discussions, 
requests for comments, and other modes of dialogue before initiating 
what the commenter believed was a sweeping expansion of administrative 
authority. Another commenter recommended that CMS not finalize its 
enrollment proposals and instead obtain feedback from stakeholders 
(including via conferences with provider groups and State medical 
boards, as well as requests for information (RFI) published in the 
Federal Register) to better understand the proposals' potential 
consequences, including with respect to patient care.
    Response: We respectfully disagree that we did not sufficiently 
justify our proposals or the need for them. We detailed in the proposed 
rule the reasons for our provisions and the gaps in our current 
authority that we were attempting to close. For instance, we explained 
why an across-the-board 30-day practice location reporting period was 
critical, how the current 90-day period for some provider types can 
leave CMS without accurate practice location information for months, 
and the program integrity risks this posed. Insofar as public 
consultation, CMS regularly communicates with stakeholders, such as 
provider organizations, on provider enrollment issues, including at 
conferences, chatrooms, etc., and solicits recommendations on means of 
improving the provider enrollment process and addressing important 
payment safeguard issues. Part of this also involves the notice-and-
comment process in rulemaking, wherein we receive valuable observations 
and suggestions from interested parties, such as occurred with our 
enrollment proposals in this rule. We believe the comments we received 
helped us make informed decisions regarding our provisions, which, 
except as otherwise noted, we are finalizing as proposed.
    Comment: Several commenters stated that CMS should: (1) revoke 
providers and suppliers only for severe infractions involving clear 
potential harm to Medicare beneficiaries or financial malfeasance and 
not for minor errors unrelated to patient care; (2) outline the 
criteria it will use when determining whether to revoke and explain 
when providers and suppliers can anticipate a revocation, including the 
degree of improper conduct necessary for such an action; (3) always 
give providers and suppliers an opportunity to correct any errors and 
to present their side before revocation; (4) ensure that all providers 
and suppliers are treated equally when considering whether revocation 
is necessary; (5) clarify the expertise of the personnel making such 
determinations; and (6) recognize and ameliorate the impact that 
revocations (include those we are finalizing) can have on longstanding 
physician-patient relationships and beneficiary access to care. 
Regarding the fourth recommendation, a commenter requested that CMS 
explicitly confirm that it will adopt this approach.
    Response: In reviewing some of these comments, it was unclear 
whether the stakeholders were referring only to our proposed revocation 
reasons or to all revocation grounds under Sec.  424.535(a). To ensure 
that these comments are fully addressed, our responses will jointly 
pertain to our existing revocation bases and those we are finalizing in 
this rule.
    We are very cognizant of the impact a revocation can have on 
providers and suppliers. We do not take this decision without a careful 
and thorough analysis of the facts and circumstances of the case. For 
many revocations, we also diligently consider specific factors outlined 
in regulation. Revocation is always the least desired step for CMS in 
addressing a particular provider enrollment situation. But it is 
sometimes the necessary one if circumstances warrant. As already 
explained in this final rule, our primary obligation is to safeguard 
the Medicare program and its beneficiaries, and revocation action may 
occasionally be required to facilitate this goal. It is not possible 
for us in this rule, as the commenters appeared to request, to: (1) 
articulate every type of conduct that will automatically result in a 
revocation; or (2) establish a minimum threshold or bright-line test 
regarding the severity of behavior or impact on Medicare (or 
beneficiary care) that is required for revocation action. While we 
always ensure that providers and treated fairly and consistently in our 
reviews, which (in response to the commenter's fifth issue) are 
conducted by experienced enrollment personnel, every case is and must 
be considered on its own unique facts. Nevertheless, CMS typically does 
not revoke providers for modest errors but instead may deactivate the 
provider or, per this final rule, impose a stay of enrollment.
    Concerning the request for an opportunity to correct or for a 
hearing before any revocation is imposed, we reiterate that we 
generally take revocation action only when the non-compliance or 
conduct is of a sufficiently significant nature that we must move 
quickly to protect the (1) Trust Funds and (2) Medicare beneficiaries. 
The longer we wait to act (such as via a pre-revocation hearing), the 
greater the threat to both. Moreover, if we were to furnish corrective 
opportunities and hearings before each revocation, providers and 
suppliers would have little incentive to consistently adhere to 
enrollment requirements because they would know they could avoid 
revocation by waiting until the pre-revocation period to remedy the 
problem. It would, in our view, negate the provider's or supplier's 
obligation to always remain compliant with our requirements.
    Comment: A commenter stated that the ``any other information that 
CMS deems relevant to its determination'' criterion CMS uses in some of 
its denial and revocation determinations (including in its FCA 
proposal) should include mitigating factors (for example, efforts the 
provider took to address the concern, cooperation in the investigation, 
etc.)
    Response: CMS always considers mitigating factors under this 
criterion in its denial and revocation determinations and will continue 
to do so.
    Comment: Several commenters stated that our proposals, such as the 
revision to Sec.  424.535(g), give CMS the opportunity to eliminate the 
use of standard mail when communicating with providers and instead 
adopt more

[[Page 79280]]

reliable and cost-efficient means of communication, such as electronic 
delivery, PECOS, or certified mail. The commenters believed this would 
help providers and suppliers meet strict timeframes for responding to 
CMS requests for information.
    Response: We appreciate this comment but believe it is outside the 
scope of this final rule.
    Comment: A commenter expressed concern about the 10-year maximum 
length of the reenrollment bar, stating that: (1) this period is longer 
than most OIG exclusions and has the same effect as an exclusion; and 
(2) there is no published guidance as to how CMS determines the length 
of a reenrollment bar (that is, how it ascertains the severity of the 
conduct resulting in the revocation).
    Response: We believe this comment is outside the scope of this 
final rule.
    Comment: A commenter stated that CMS' original justification for 
not extending appeal rights to deactivations--that a deactivation 
carried no payment consequences and thus no appeal rights were 
warranted--is invalid because Sec.  424.540(e) states that a provider 
or supplier may not receive payment while deactivated.
    Response: We believe this comment is outside the scope of this 
final rule.
    Comment: A commenter contended that there should be an expedited 
right of judicial review (we assume the commenter was referring to 
enrollment revocations and denials) as exists in the Medicare claims 
and the Provider Reimbursement Review Board processes. The commenter 
stated that a provider or supplier seeking to raise a constitutional or 
regulatory procedural or arbitrary and capricious challenge currently 
must go through several years of the enrollment appeals process before 
being able to present such challenge in court. The commenter added that 
notice-and-comment procedures are not required to implement a 
procedural rule such as an expedited appeals process.
    Response: We believe this comment is outside the scope of this 
final rule.
    Comment: A commenter stated that CMS should eliminate gaps in 
payment stemming from provider enrollment actions, particularly with 
respect to deactivations. The commenter stated that the definition of 
``deactivate'' in Sec.  424.502 states that a provider's or supplier's 
billing privileges can be ``restored'' (which, the commenter contended, 
means to be put back in the original state) and that CMS, at one time, 
did not have payment gaps for deactivations. Eliminating such gaps 
would be consistent with both the definition of deactivate, as well as 
previous CMS policy.
    Response: We believe this comment is outside the scope of this 
final rule.

L. Expand Diabetes Screening and Diabetes Definitions

    In the CY 2024 PFS proposed rule (88 FR 52262), we proposed to: (1) 
expand coverage of diabetes screening tests to include the Hemoglobin 
A1C test (HbA1c) test; (2) expand and simplify the frequency 
limitations for diabetes screening; and (3) simplify the regulatory 
definition of ``diabetes'' for diabetes screening (Sec.  410.18(a)), 
Medical Nutrition Therapy (MNT) (Sec.  410.130) and Diabetes Outpatient 
Self-Management Training Services (DSMT) (Sec.  410.140).
    Medicare coverage for diabetes screening tests under Part B are 
described in statute (sections 1861(s)(2)(Y), 1861(ww)(2)(K), 1861(yy), 
and 1862(a)(1)(M) of the Act) and in regulation at 42 CFR 410.18. The 
statute and regulations allow for diabetes screening tests:
     The Fasting Plasma Glucose (FPG) test (section 
1861(yy)(1)(A) of the Act and Sec.  410.18(c)(1));
     The Post Glucose Challenge Test, also called the Glucose 
Tolerance Test (GTT) (Sec.  410.18(c)(2)); and
     Such other tests, and modifications to tests, as the 
Secretary determines appropriate, in consultation with appropriate 
organizations (section 1861(yy)(1)(B) of the Act) and that may be 
determined through a national coverage determination (Sec.  
410.18(c)(3)).\417\
---------------------------------------------------------------------------

    \417\ The Secretary, as of the date of this final rule, has not 
approved additional diabetes screening tests by through a national 
coverage determination.
---------------------------------------------------------------------------

    We proposed to exercise our authority in section 1861(yy)(1) of the 
Act to add the HbA1c test to the types of diabetes screening tests 
covered under Sec.  410.18(c), after consultation with appropriate 
organizations.
    Section 1861(yy)(3) of the Act limits the frequency of diabetes 
screening tests to not more often than twice within the 12-month period 
following the date of the most recent diabetes screening test of that 
individual. Our regulations currently allow two screening tests per 
calendar year if the patient was previously diagnosed with pre-diabetes 
and one screening test per year for patients who were previously tested 
who were not diagnosed with pre-diabetes, or who were never tested 
before (Sec.  410.18(d)). We proposed to exercise our authority in 
section 1861(yy)(1)(3) of the Act to simplify our frequency limitations 
for diabetes screening by aligning to the statutory limitation of not 
more often than twice within the 12-month period following the date of 
the most recent diabetes screening test of that individual.
    We also proposed to simplify the regulatory definitions of 
``diabetes'' for the purpose of diabetes screening at Sec.  410.18(a) 
to remove the codified clinical test requirements from the definition 
of ``diabetes.'' We also proposed to remove the definition of ``pre-
diabetes'' at Sec.  410.18(a). The diabetes and prediabetes definitions 
at Sec.  410.18(a) supported existing regulatory frequency limitations 
in Sec.  410.18(d), which describe separate frequency limitations 
between individuals previously diagnosed, and those terms would no 
longer be needed under our proposed updates. We recognized that it is 
unnecessary to codify clinically specific test criteria into the 
regulatory definition of diabetes, which reduces flexibility for the 
agency and health care system to adapt to evolving clinical standards 
without potentially producing programmatic benefit. The proposed 
revised definition of diabetes for screening purposes will be shortened 
to describe diabetes as diabetes mellitus, a condition of abnormal 
glucose metabolism.
    Medicare coverage for MNT under Part B is described in statute 
(primarily sections 1861(s)(2)(V), 1861(vv), and 1861(ww)(2)(I) of the 
Act, in regulations at 42 CFR part 410, subpart G, and in National 
Coverage Determination (NCD) (Section 180.1 of the Medicare National 
Coverage Determinations Manual (NCD Manual)). Section 410.130 currently 
describes a number of definitions for purposes of the MNT benefit, 
including ``diabetes.'' The regulatory definition of diabetes for MNT 
purposes at Sec.  410.130 is currently identical to the existing 
regulatory definition of diabetes for screening purposes at Sec.  
410.18(a). We proposed to simplify the regulatory definitions of 
``diabetes'' for the purpose of MNT at Sec.  410.130 to remove the 
codified clinical test requirements. The proposed revised definition of 
diabetes for MNT purposes will be shortened to simply describe diabetes 
as diabetes mellitus, a condition of abnormal glucose metabolism. NCD 
180.1 refers to the regulatory definition of diabetes at Sec.  410.130, 
so no modifications would be required to the NCD.
    Medicare coverage for DSMT under Part B is described in statute 
(sections 1861(s)(2)(S), 1861(qq), 1861(ww)(2)(F) of the Act) and in 
regulation at part 410 subpart H. Section 410.140 currently describes a 
number of definitions for the purposes of the DSMT benefit,

[[Page 79281]]

including ``diabetes''. The regulatory definition of diabetes for DSMT 
purposes at Sec.  410.140 is identical to the existing regulatory 
definition of diabetes for MNT purposes at Sec.  410.130 and the 
existing regulatory definition of diabetes for screening purposes at 
Sec.  410.18(a). We proposed to exercise our authority to simplify the 
regulatory definitions of ``diabetes'' for the purpose of DSMT at Sec.  
410.140 to remove the codified clinical test requirements. The proposed 
revised definition of diabetes for DSMT purposes will be shortened to 
simply define diabetes as diabetes mellitus, a condition of abnormal 
glucose metabolism.
1. Background
    Diabetes is a chronic disease that affects how the body turns food 
into energy and includes three main types: Type 1, Type 2 and 
gestational diabetes. The Centers for Disease Control and Prevention 
(CDC) reports that approximately 37.3 million Americans are living with 
diabetes and an additional 96 million Americans are living with 
prediabetes.\418\ CDC reports that 326,000 persons age 65 years and 
older are newly diagnosed with diabetes each year. CDC also estimates 
that among persons age 65 years and older, 21 percent have been 
diagnosed with diabetes while 5 percent have undiagnosed diabetes.\419\ 
Diabetes is the leading cause of kidney failure and new cases of 
blindness among adults, and the sixth leading cause of death among 
adults age 65 years and older in the US.\420\ Screening is performed on 
persons who may not exhibit symptoms to identify persons with either 
prediabetes or diabetes, who can then be referred for appropriate 
prevention or treatment, with the intention of improving health 
outcomes.
---------------------------------------------------------------------------

    \418\ CDC website on diabetes at https://www.cdc.gov/diabetes/basics/index.html.
    \419\ Centers for Disease Control and Prevention. National 
Diabetes Statistics Report, 2020. Accessed March 9, 2023. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf.
    \420\ Heron M. Deaths: Leading causes for 2019. National Vital 
Statistics Reports; vol 70 no 9. Hyattsville, MD: National Center 
for Health Statistics. 2021. DOI: https://dx.doi.org/10.15620/cdc:107021.
---------------------------------------------------------------------------

    In October 2015, the United States Preventive Services Task Force 
(USPSTF) issued a revised final recommendation statement, with a grade 
of B, for screening for abnormal blood glucose as part of 
cardiovascular risk assessment in adults aged 40 to 70 years who are 
overweight or obese and again identified the FPG, GTT and HbA1c tests 
as appropriate for diabetes screening.\421\ In August 2021, the USPSTF 
issued a revised final recommendation statement, with a grade of B, 
that expanded recommended screening for prediabetes and type 2 diabetes 
in adults aged 35 to 70 years who have overweight or obesity, and that 
clinicians should offer or refer patients with prediabetes to effective 
preventive interventions, which are discussed in their report. The 
USPSTF again recommended the FPG, GTT and HbA1c tests as appropriate 
for diabetes screening and noted, ``Because HbA1c measurements do not 
require fasting, they are more convenient than using a fasting plasma 
glucose level (FPG) or an oral glucose tolerance test (GTT).'' \422\ 
The grade of B is indicated when the USPSTF has high certainty that the 
net benefit is moderate or moderate certainty that the net benefit is 
moderate to substantial.
---------------------------------------------------------------------------

    \421\ USPSTF website: https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/screening-for-abnormal-blood-glucose-and-type-2-diabetes-october-2015.
    \422\ USPSTF website: https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/screening-for-prediabetes-and-type-2-diabetes.
---------------------------------------------------------------------------

    Both the USPSTF and specialty societies have identified the HbA1c 
test as clinically appropriate for diabetes screening. In addition, the 
HbA1c test has certain unique advantages and disadvantages compared to 
the FPG and GTT tests that should be considered by the practitioner and 
patient when choosing a diabetes screening test. The American Diabetes 
Association (ADA) Standards of Care in Diabetes--2023 reads, 
``Generally, FPG, 2-h PG during 75-g OGTT (aka GTT), and A1C (aka 
HbA1c) are equally appropriate for diagnostic screening . . . The same 
tests may be used to screen for and diagnose diabetes and to detect 
individuals with prediabetes . . . A1C (aka HbA1c) has several 
advantages compared with FPG and OGTT (aka GTT), including greater 
convenience (fasting not required), greater preanalytical stability, 
and fewer day-to-day perturbations during stress, changes in nutrition, 
or illness. However, these advantages may be offset by the lower 
sensitivity of A1C (aka HbA1c) at the designated cut point, greater 
cost, limited availability of A1C (aka HbA1c) testing in certain 
regions of the developing world, and the imperfect correlation between 
A1C (aka HbA1c) and average glucose in certain individuals . . . 
Despite these limitations with A1C (aka HbA1c), in 2009, the 
International Expert Committee added A1C (aka HbA1c) to the diagnostic 
criteria with the goal of increased screening.'' \423\ We also 
recognized that the American Association of Clinical Endocrinology 
(AACE) also recommends screening for diabetes and prediabetes with 
similar tests, including HbA1c.\424\
---------------------------------------------------------------------------

    \423\ Diabetes Care 2023;46(Suppl. 1):S19-S40: https://doi.org/10.2337/dc23-S002.
    \424\ Lawrence Blonde, Guillermo E. Umpierrez, S. Sethu Reddy, 
et al. American Association of Clinical Endocrinology Clinical 
Practice Guideline: Developing a Diabetes Mellitus Comprehensive 
Care Plan--2022 Update. Endocrine Practice, 2023; 28: 923-1049, 
https://doi.org/10.1016/j.eprac.2022.08.002.
---------------------------------------------------------------------------

    The regulatory texts for diabetes screening, MNT, and DSMT 
currently include a clinically specific test-based definition for 
``diabetes'' that has since been overtaken by evolving clinical 
standards. Since 2020, the ADA has revised and expanded its criteria 
for the diagnosis of diabetes to also include the HbA1c test and a 
random plasma glucose test for a patient appearing to have 
hyperglycemia or hyperglycemic crisis.\425\
---------------------------------------------------------------------------

    \425\ Diabetes Care 2020;43(Supplement_1):S14-S31, https://diabetesjournals.org/care/article/43/Supplement_1/S14/30640/2-Classification-and-Diagnosis-of-Diabetes.
---------------------------------------------------------------------------

2. Statutory Authority
    Section 613 of the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (MMA) (Pub. L. 108-173) added section 
1861(yy) to the Act and mandated coverage of diabetes screening tests 
in the Medicare Part B program. Section 1861(yy)(1) of the Act 
describes diabetes screening tests as testing furnished to an 
individual at risk for diabetes for the purpose of early detection of 
diabetes, including the FPG test and such other tests, and 
modifications to tests, as the Secretary determines appropriate, in 
consultation with appropriate organizations. Section 1861(yy)(2) of the 
Act describes ``individual at risk for diabetes'' as an individual who 
has any of a number of listed risk factors, including obesity, defined 
as a body mass index greater than or equal to 30 kg/m\2\ as an 
independent qualifying factor and overweight, defined as a body mass 
index greater than 25 kg/m\2\, but less than 30, kg/m\2\ (when present 
with a second qualifying factor including a family history of diabetes, 
a history of gestational diabetes and an age of 65 years or older. 
Section 1861(yy)(3) of the Act mandates that the Secretary shall 
establish standards, in consultation with appropriate organizations, 
regarding the frequency of diabetes screening tests, except that such 
frequency may not be more often than twice within the 12-month period 
following the date of the most recent diabetes screening test of

[[Page 79282]]

that individual. Section 1861(yy) of the Act does not include a 
definition of diabetes.
    Section 105 of the Medicare, Medicaid, and SCHIP Benefits 
Improvement and Protection Act of 2000 (Pub. L. 106-554) added section 
1861(vv) to the Act and mandated coverage of MNT under Part B. Section 
1861(s)(2)(V) of the Act limits coverage of MNT to patients with 
diabetes or a renal disease. Section 1861(vv)(1) of the Act describes 
MNT, in pertinent part, as nutritional diagnostic, therapy, and 
counseling services for the purpose of disease management. Sections 
1861(s)(2)(V) and (vv) of the Act do not include a codified definition 
of diabetes.
    Section 4105(a) of the Balanced Budget Act of 1997 (Pub. L. 105-33) 
added section 1861(qq) to the Act and mandated coverage of DSMT. 
Section 1861(qq) of the Act describes DSMT, in part, as educational and 
training services furnished to an individual with diabetes by a 
certified provider in an outpatient setting by an individual or entity, 
but only if the physician who is managing the individual's diabetic 
condition certifies that such services are needed under a comprehensive 
plan of care related to the individual's diabetic condition to ensure 
therapy compliance or to provide the individual with necessary skills 
and knowledge to participate in the management of the individual's 
condition. Section 1861(qq) of the Act does not establish a definition 
of diabetes.
3. Regulatory Authority and National Coverage Determinations
    Our implementing regulations for diabetes screening tests are 
codified at Sec.  410.18. The current regulatory definition of diabetes 
and prediabetes for the purposes of diabetes screening were created, in 
part, to distinguish separate frequency limitations for each. Section 
410.18(d) allows two diabetes screening tests per calendar year for 
individuals diagnosed with pre-diabetes and one diabetes screening test 
per calendar year for individuals previously tested who were not 
diagnosed with pre-diabetes, or who were never tested before. Section 
410.18(e) limit diabetes screening to ``individual at risk for 
diabetes'' with a list of qualifying eligibility factors, including 
obesity, defined as a body mass index greater than or equal to 30 kg/
m\2\ as an independent qualifying factor (Sec.  410.18(e)(3)) and 
overweight, defined as a body mass index greater than 25 kg/m\2\, but 
less than 30, kg/m\2\ (when present with a second qualifying factor 
including a family history of diabetes, a history of gestational 
diabetes and an age of 65 years or older) (Sec.  410.18(e)(5)).
    Our implementing regulations for MNT are codified at part 410 
subpart G. Section 410.130 describes a number of definitions for 
purposes of the MNT benefit, including ``diabetes.'' MNT is also 
described as a covered service at section 180.1 of the NCD Manual. NCD 
180.1 does not include a codified definition of diabetes but does refer 
to ``diabetes, as defined at Sec.  410.130.'' Our implementing 
regulations for DSMT are codified at part 410 subpart H. Section 
410.140 describes a number of definitions for the purposes of the DSMT 
benefit, including ``diabetes.''
    NCD 190.20, Blood Glucose Testing, describes the indications and 
limitations of blood glucose testing generally but refers to Sec.  
410.18 and the Claims Processing Manual for specific policies on 
diabetes screening. NCD 190.21, Glycated Hemoglobin/Glycated Protein, 
authorizes coverage of the HbA1c test for the management of diabetes 
but does not address screening for diabetes.
    In the CY 2004 PFS final rule (68 FR 63195), we finalized proposals 
to adopt regulatory definitions of diabetes for the purposes of MNT and 
DSMT. We codified in regulatory text at Sec. Sec.  410.130 and 410.140 
that diabetes is defined as ``diabetes mellitus, a condition of 
abnormal glucose metabolism diagnosed using the following criteria: A 
fasting blood sugar greater than or equal to 126 mg/dL on two different 
occasions; a 2 hour post-glucose challenge greater than or equal to 200 
mg/dL on 2 different occasions; or a random glucose test over 200 mg/dL 
for a person with symptoms of uncontrolled diabetes.'' The definition 
of diabetes was based, in part on a clinical recommendation submitted 
by the American Association of Clinical Endocrinologists. In the CY 
2005 PFS final rule (69 FR 66235), we finalized proposals to adopt 
implementing regulations for diabetes screening, which was recently 
added as a Medicare covered benefit in the Section 613 of the MMA. We 
adopted a new regulatory definition of prediabetes as condition of 
abnormal glucose metabolism diagnosed using the following criteria: a 
fasting glucose level of 100-125 mg/dL, or a 2-hour post-glucose 
challenge of 140-199 mg/dL, as well as including the conditions of 
impaired fasting glucose and impaired glucose tolerance. We also 
adopted the regulatory definition of diabetes finalized in the CY 2004 
PFS for MNT and DSMT. Neither the statutes nor the regulatory text for 
diabetes screening, MNT and DSMT distinguish between different types of 
diabetes.
4. Revisions to the Final Rule
    We proposed to exercise our authority in section 1861(yy)(1)(B) of 
the Act to add the HbA1c test to the types of diabetes screening tests 
covered under Sec.  410.18(c), consistent with a recently revised 
recommendation by the USPSTF. The USPSTF recommended the HbA1C test for 
diabetes screening in their October 2015 and August 2021 revised final 
recommendation statements. We also engaged in meetings with appropriate 
organizations while developing our proposal to expand diabetes 
screening coverage, including the ADA, the Association of Diabetes Care 
& Education Specialists (ADCES), the National Clinical Care Commission 
(NCCC) and the Diabetes Advocacy Alliance (DAA). In addition, we 
consulted the published clinical recommendations from the USPSTF 
(described earlier), the ADA \426\ and the AACE \427\ in developing our 
proposal. We also solicited comments from other organizations through 
the notice and comment rulemaking process.
---------------------------------------------------------------------------

    \426\ https://diabetesjournals.org/care/article/45/Supplement_1/S17/138925/2-Classification-and-Diagnosis-of-Diabetes.
    \427\ https://www.endocrinepractice.org/article/S1530-891X(22)00576-6/fulltext.
---------------------------------------------------------------------------

    We received public comments on these proposals. Overall, commenters 
expressed broad support and approval of our proposal to exercise our 
authority in section 1861(yy)(1)(B) of the Act to add the HbA1c test to 
the types of diabetes screening tests covered under Sec.  410.18(c). 
The following is a summary of the comments we received and our 
responses.
    Comment: Commenters agreed that adding the HbA1c test to the types 
of diabetes screening tests covered under Sec.  410.18(c) will make 
available a screening option that will reduce patient burdens. Many 
commenters agreed that a screening option with reduced patient burden 
will be especially impactful for patients with diabetes, a disease that 
disproportionally impacts minority and disadvantaged populations. Many 
commenters agreed that expanding coverage of diabetes screening to 
include the HbA1c test will allow measurement of different aspects of 
diabetes pathology compared to the already covered FPG and GTT tests. 
Commenters also expressed appreciation that our proposal to cover the 
HbA1c test for diabetes screening will support increased patient 
referral to the Medicare Diabetes Prevention Program. Commenters also 
supported aligning Medicare coverage policies

[[Page 79283]]

with USPSTF and ADA clinical recommendations.
    Response: We thank the commenters for their support of our proposal 
to add the HbA1c test to the types of diabetes screening tests covered 
under Sec.  410.18(c) and we are adopting those changes in this final 
rule We are also finalizing corresponding updates to regulatory text as 
proposed.
    Comment: Many commenters recommended that CMS eliminate Part B 
cost-sharing (deductible and coinsurance) for the HbA1c test when 
furnished as a diabetes screening test.
    Response: We are happy to clarify that Congress has made Part B 
coinsurance (section 1833(a)(1)(Y) of the Act, Sec.  410.152(l)(9)) and 
deductibles (section1833(b)(1) of the Act) not applicable for covered 
prevention services recommended with a grade of A or B by the USPSTF. 
As described earlier in our rule, in August 2021, the USPSTF issued a 
revised final recommendation statement, with a grade of B, that 
expanded recommended screening for prediabetes and type 2 diabetes in 
adults aged 35 to 70 years who have overweight or obesity, and that 
clinicians should offer or refer patients with prediabetes to effective 
preventive interventions, which are discussed in their report. The 
USPSTF recommended the FPG, GTT and HbA1c tests as appropriate for 
diabetes screening. Thus, the HbA1c test will require no Part B 
coinsurance and deductible when furnished as a covered diabetes 
screening test. We clarify that the HbA1c test will continue to require 
Part B coinsurance and deductible when furnished for diabetes 
management.
    We also proposed to exercise our authority in section 
1861(yy)(1)(3) of the Act to expand and simplify our frequency 
limitations for diabetes screening by aligning to the statutory 
limitation of not more often than twice within the 12-month period 
following the date of the most recent diabetes screening test of that 
individual. We also proposed to remove the current regulatory 
definition of pre-diabetes for the purposes of diabetes screening at 
Sec.  410.18(a), which functionally served, in part, to distinguish the 
separate frequency limitations of diabetes screening at two diabetes 
screening tests per calendar year for individuals diagnosed with pre-
diabetes and one diabetes screening test per calendar year for 
individuals previously tested who were not diagnosed with pre-diabetes, 
or who were never tested before (Sec.  410.18(d)). We noted in the PFS 
proposed rule that our proposal to remove the regulatory definition of 
pre-diabetes was intended to simplify and expand diabetes screening 
while reducing unnecessary regulatory complexity. We also noted that we 
recognize that pre-diabetes and diabetes exist on a continuum, and both 
are screened and identified through common diabetes screening tests. 
Our proposal to remove the regulatory definition of pre-diabetes did 
not reflect a change in our position on pre-diabetes screening and 
treatment as a Medicare benefit. In making this proposal we recognized 
that the FPG, GTT and HbA1c tests include different levels of burden 
for the patient and also measure different aspects of diabetes 
pathology. The August 2021 USPSTF revised final recommendation 
statement states ``HbA1c is a measure of long-term blood glucose 
concentration and is not affected by acute changes in glucose levels 
caused by stress or illness. Because HbA1c measurements do not require 
fasting, they are more convenient than using a fasting plasma glucose 
level or an oral glucose tolerance test. Both fasting plasma glucose 
and HbA1c levels are simpler to measure than performing an oral glucose 
tolerance test. The oral glucose tolerance test is done in the morning 
in a fasting state; blood glucose concentration is measured 2 hours 
after ingestion of a 75-g oral glucose load. The diagnosis of 
prediabetes or type 2 diabetes should be confirmed with repeat testing 
before starting interventions.'' \428\ We noted we had engaged in 
meetings with appropriate organizations while developing our proposal 
to expand diabetes screening coverage, including the ADA, the ADCES, 
the NCCC, and the DAA. We noted we also consulted with the written 
recommendations of a number of specialty societies and the USPSTF in 
developing our proposal. We acknowledged that the USPSTF, ADA and AACE 
recommend diabetes screening frequency screening of once every 3 
years.429 430 431 We proposed expanding the frequency 
limitations for diabetes screening to twice in a 12-month period under 
the theory that additional flexibility in screening frequency will 
remove barriers and empower clinicians to apply screening by multiple 
types of tests or with increased frequency where the circumstances of 
the patient demonstrate a medical necessity. We noted in the PFS 
proposed rule that we looked forward to further consultation with 
organizations through the public notice and comment rulemaking process 
and solicited comments on our proposal.
---------------------------------------------------------------------------

    \428\ USPSTF website: https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/screening-for-prediabetes-and-type-2-diabetes.
    \429\ https://diabetesjournals.org/care/article/43/Supplement_1/S14/30640/2-Classification-and-Diagnosis-of-Diabetes.
    \430\ https://www.endocrinepractice.org/article/S1530-891X(22)00576-6/fulltext.
    \431\ https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/screening-for-prediabetes-and-type-2-diabetes#bootstrap-panel--10.
---------------------------------------------------------------------------

    The following is a summary of the comments we received and our 
responses.
    Comment: We received numerous public comments expressing approval 
of our proposal to exercise our authority in section 1861(yy)(1)(3) of 
the Act to expand and simplify our frequency limitations for diabetes 
screening by aligning to the statutory limitation of not more often 
than twice within the 12-month period following the date of the most 
recent diabetes screening test of that individual. Many commenters 
agreed that expanding frequency limitations for diabetes screening to 
not more often than twice within the 12-month period following the date 
of the most recent diabetes screening test of that individual will 
remove barriers, expand access and empower clinicians to apply multiple 
types of tests or with increased frequency when the circumstances of 
the patient demonstrate a medical necessity.
    Response: We thank commenters for their support and in this final 
rule we are expanding and simplifying our frequency limitations for 
diabetes screening as proposed. We are also finalizing corresponding 
updates to regulatory text as proposed.
    Comment: One commenter disagreed with our proposal to expand and 
simplify our frequency limitations for diabetes screening and suggested 
that diabetes screening frequency be determined by the furnishing 
clinician (with no statutory or regulatory frequency limitations 
imposed by CMS).
    Response: We disagree with the commenter's recommendation that 
diabetes screening frequency be entirely determined by the furnishing 
clinician without any frequency limitations. First, we have no 
authority to disregard or remove the frequency limitation for diabetes 
screening included in section 1861(yy)(1)(3) of the Act. Second, 
frequency limitations are important to protect beneficiaries from 
clinically inappropriate services and protect beneficiaries and the 
Medicare program from fraud, waste, and abuse. We are not adopting the 
commenter's suggestion.
    Comment: We received numerous comments expressing support for our 
proposal to remove the regulatory definition of pre-diabetes from

[[Page 79284]]

Sec.  410.18(a). Many commenters agreed that pre-diabetes and diabetes 
exist on a continuum, are detected by the same screening tests, and 
that removing the definition of pre-diabetes from diabetes screening 
regulations will remove barriers and expand access to care for patients 
and providers. Many commenters agreed that our proposal will simplify 
claims processing and reduce the risk of denied claims due to frequency 
limitations.
    Response: We thank commenters for their support and will remove the 
regulatory definition of pre-diabetes for the purposes of diabetes 
screening at Sec.  410.18(a). We are also finalizing corresponding 
updates to regulatory text as proposed.
    We also proposed to simplify the regulatory definitions of 
``diabetes'' for the purpose of diabetes screening at Sec.  410.18(a), 
MNT at Sec.  410.130 and DSMT at Sec.  410.140. In all three instances, 
we proposed to remove the codified clinical test requirements from the 
definition of ``diabetes'' and keep a shorted version of the existing 
definition that would define diabetes as diabetes mellitus, a condition 
of abnormal glucose metabolism. We noted in the proposed rule that we 
now recognize that regulatorily codifying clinically specific test 
criteria into the regulatory definition of diabetes for screening, MNT 
and DSMT benefit reduces flexibility for the agency and health care 
system to adapt to evolving clinical standards without potentially 
producing programmatic benefit. We noted that we believe that our 
proposal will empower practitioners to apply clinically accurate and 
appropriate criteria and that we can ensure certain safeguards through 
medical coding and claims processing instructions. By analogy, we 
considered that end stage renal disease (ESRD) is not described with 
specific clinical test criteria in section 226A and 1881 of the Act, 
nor in regulations at Sec.  406.13. We noted in the proposed rule that 
we generally believe that scientific advancements in understanding and 
measuring disease pathology outpace the lengthy and formal notice and 
comment rulemaking process. In the instance of diabetes screening, MNT 
and DSMT, the regulatory codification of clinical test criteria into 
disease definitions may not be necessary nor ideal. We noted that even 
without clinical test criteria codified in the regulatory definitions 
of diabetes and pre-diabetes, a Medicare claim that includes a 
diagnosis of diabetes or pre-diabetes would still need to include 
appropriate coding, substantiation in the medical record and compliance 
with claims processing instructions from CMS and Medicare 
Administrative Contractors (MACs).
    In the alternative, we considered not removing the clinical test 
criteria for the regulatory definitions of diabetes or removing the 
regulatory definition of pre-diabetes. We considered adding the HbA1c 
test criteria result of 6.5 percent or greater into the regulatory 
definition of diabetes for screening, MNT and DSMT and the HbA1c test 
criteria result of 5.7 percent to 6.4 percent to the regulatory 
definition of pre-diabetes for screening. The alternative would be 
consistent with our proposal to expand coverage of diabetes screening 
by adding the HbA1c test, and would also be consistent with clinical 
recommendations by the USPSTF \432\ and the ADA.\433\ However, we did 
not propose this alternative because, while currently clinically 
appropriate, we believed it would further, unnecessarily complicate the 
regulatory definition of diabetes and pre-diabetes. As noted earlier, 
we noted in the proposed rule that we now recognize that regulatorily 
codifying clinically specific test criteria into the regulatory 
definition of ``diabetes'' and ``pre-diabetes'' for screening, and 
``diabetes'' for the MNT and DSMT benefits reduces flexibility for the 
agency and health care system to adapt to evolving clinical standards 
without potentially producing programmatic benefit. We solicited 
comments on our proposal and alternative considered.
---------------------------------------------------------------------------

    \432\ https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/screening-for-prediabetes-and-type-2-diabetes#bootstrap-panel-6.
    \433\ https://diabetesjournals.org/care/article/43/Supplement_1/S14/30640/2-Classification-and-Diagnosis-of-Diabetes.
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    The following is a summary of the comments we received and our 
responses. No commenters opposed our proposed rule and no commenters 
favored the alternative.
    Comment: Numerous public commenters expressed approval and support 
for our proposal to simplify the regulatory definitions of ``diabetes'' 
for the purpose of diabetes screening at Sec.  410.18(a), MNT at Sec.  
410.130 and DSMT at Sec.  410.140 by removing the codified clinical 
test requirements from the definition of ``diabetes'' and keeping a 
shorted version of the existing definition that will define diabetes as 
diabetes mellitus, a condition of abnormal glucose metabolism. Many 
commenters expressed that our proposal will increase patient access to 
care to diabetes screening and related services by improving the 
referral process and reduce the risk of claims being denied. Many 
commenters also expressed support and appreciation that our simplified 
regulatory definition of ``diabetes'' for diabetes screening, MNT and 
DSMT would remove potential future misalignment between specific 
clinical test criteria in regulations and evolving standards of care.
    Response: We thank the commenters for their support and will 
simplify the regulatory definitions of ``diabetes'' for the purpose of 
diabetes screening at Sec.  410.18(a), MNT at Sec.  410.130 and DSMT at 
Sec.  410.140 by defining diabetes as diabetes mellitus, a condition of 
abnormal glucose metabolism. We are also finalizing corresponding 
updates to regulatory text as proposed.
    Comment: We received several comments that were outside the scope 
of the proposals made in the CY 2024 PFS proposed rule. Comments 
included removing the clinical test criteria from the definition of 
``Chronic renal insufficiency'' in the MNT regulations at 410.130, to 
expand the regulatory definition of Chronic Kidney Disease, to allow 
the HbA1c test for diabetes screening to be furnished at pharmacies and 
allowing for coverage of diabetes screening regardless of the licensure 
of the ordering physician.
    Response: Although we are not summarizing and responding to these 
comments in the final rule, the have been informative and we will take 
them into consideration for possible future rulemaking.
    After considering public comments, we are finalizing the proposals 
made in the CY 2024 PFS proposed rule to (1) expand coverage of 
diabetes screening tests to include the Hemoglobin A1C test (HbA1c) 
test; (2) expand and simplify the frequency limitations for diabetes 
screening; and (3) simplify the regulatory definition of ``diabetes'' 
for diabetes screening (Sec.  410.18(a)), Medical Nutrition Therapy 
(MNT) (Sec.  410.130) and Diabetes Outpatient Self-Management Training 
Services (DSMT) (Sec.  410.140).
    We noted in the CY 2024 PFS proposed rule that we believe that our 
proposal to expand and simplify coverage for diabetes screening aligns 
with the administration's strategic pillar to advance health equity by 
addressing the health disparities that underlie our health system. The 
August 2021 updated USPSTF final recommendation statement reads, ``The 
prevalence of diabetes is higher among American Indian/Alaska Native 
(14.7 percent), Asian (9.2 percent), Hispanic/Latino (12.5 percent), 
and non-Hispanic Black (11.7 percent) persons than among non-Hispanic 
White (7.5 percent) persons. Disparities in diabetes prevalence are the 
result of a variety of factors. A large

[[Page 79285]]

body of evidence demonstrates strong associations between prevalence of 
diabetes and social factors such as socioeconomic status, food 
environment, and physical environment.'' \434\ The HbA1c test does not 
require fasting or drinking an unappetizing glucose solution. We noted 
in the CY 2024 PFS proposed rule that expanding coverage for diabetes 
screening to include the HbA1c test will reduce screening burdens for a 
disease that disproportionally impacts minority and disadvantaged 
populations. In addition, earlier identification of diabetes and 
prediabetes among minorities and disadvantaged persons may lead to 
improved diabetes control and reduce its complications, which currently 
occur disproportionately in those groups.
---------------------------------------------------------------------------

    \434\ USPSTF website: https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/screening-for-prediabetes-and-type-2-diabetes.
---------------------------------------------------------------------------

    We recognize that expanded access and appropriate utilization of 
diabetes screening is critical to mitigating and avoiding downstream 
health complications that significantly impact beneficiary wellbeing, 
as well as being costly and burdensome to the healthcare system. We 
also note that the National Institute of Diabetes and Digestive and 
Kidney Diseases (NIDDK) website states, ``diabetes can cause serious 
health problems, such as heart disease, stroke, and eye and foot 
problems. Prediabetes also can cause health problems. The good news is 
that type 2 diabetes can be delayed or even prevented. The longer you 
have diabetes, the more likely you are to develop health problems, so 
delaying diabetes by even a few years will benefit your health.'' \435\ 
The U.S. Department of Health and Human Services Office of the 
Assistant Secretary for Planning and Evaluation recently published a 
Report to Congress on the Affordability of Insulin that included a 
number of generalized findings on costs and downstream impacts of 
serious diabetes related complications on health care use.\436\ We 
believe our final rules will expand access to quality care and improve 
health outcomes for patients through prevention, early detection, and 
more effective treatment.
---------------------------------------------------------------------------

    \435\ National Institute of Diabetes and Digestive and Kidney 
Diseases (NIDDK), part of the National Institutes of Health, 
website: https://www.niddk.nih.gov/health-information/diabetes/overview/preventing-type-2-diabetes.
    \436\ Office of the Assistant Secretary for Planning and 
Evaluation, U.S. Department of Health & Human Services. Report on 
the Affordability of Insulin. December 16, 2022. https://aspe.hhs.gov/reports/insulin-affordability-rtc.
---------------------------------------------------------------------------

M. Requirement for Electronic Prescribing for Controlled Substances for 
a Covered Part D Drug Under a Prescription Drug Plan or an MA-PD Plan

1. Previous Regulatory Action
    In the CY 2021, CY 2022, and CY 2023 PFS final rules, we finalized 
policies for the CMS EPCS Program requirements specified in section 
2003 of the SUPPORT Act (Pub. L. 115-271, October 24, 2018). We refer 
readers to 85 FR 84802 through 84807, 86 FR 65361 through 65370, and 87 
FR 70008 through 70014 for the details of the statutory requirements 
and those finalized policies. Specifically, in the CY 2022 PFS final 
rule, we extended the date of compliance actions to no earlier than 
January 1, 2023 and, for prescribers writing Part D controlled 
substances prescriptions for beneficiaries in long-term care (LTC) 
facilities, January 1, 2025 (86 FR 65364 and 65365). We also finalized 
a proposal requiring prescribers to electronically prescribe at least 
70 percent of their Schedule II, III, IV, and V controlled substances 
that are Part D drugs, except in cases where an exception or waiver 
applies (86 FR 65366); finalized multiple proposals related to the 
classes of exceptions specified by section 2003 of the SUPPORT Act (86 
FR 65366 through 65369); and finalized our proposal to limit compliance 
actions with respect to compliance through December 31, 2023 to a non-
compliance notice (86 FR 65370).
    In the CY 2023 PFS final rule (87 FR 70012 through 70013), we 
extended the existing non-compliance action of sending notices to non-
compliant prescribers, which we had finalized for the CY 2023 CMS EPCS 
Program implementation year (January 1, 2023 through December 31, 
2023), to the CY 2024 Program implementation year (January 1, 2024 
through December 31, 2024). We also finalized a change to the data 
sources used to identify the geographic location of prescribers for 
purposes of the recognized emergency exception at Sec.  
[thinsp]423.160(a)(5)(iii) (87 FR 70011 through 70012) and finalized 
our proposal to use the Prescription Drug Event (PDE) data from the 
current evaluated year instead of the preceding year when CMS 
determines whether a prescriber qualifies for an exception based on 
issuing 100 or fewer Part D controlled substance prescriptions per 
calendar year (87 FR 70009 through 70011).
2. CMS EPCS Program Terminology
    In the CY 2021, CY 2022, and CY 2023 PFS final rules (85 FR 84802 
through 84807, 86 FR 65361 through 65370, and 87 FR 70008 through 
70013), we used various terminology to describe aspects of the 
requirements for EPCS. In order to provide consistency and clarity 
throughout the CMS EPCS Program and future rules, we will use the 
following terms going forward.
     CMS EPCS Program. We will refer to the program 
requirements for EPCS at Sec.  423.160(a)(5) as the ``CMS EPCS 
Program.'' We believe this provides an appropriate distinction from the 
prescriber's act of electronically submitting individual prescriptions 
for controlled substances, which is also referred to as EPCS.
     Non-compliance action or action for non-compliance. We 
will use ``non-compliance action'' or ``action for non-compliance'' to 
refer to a consequence for not meeting the CMS EPCS Program compliance 
threshold, as described at Sec.  423.160(a)(5), after exceptions have 
been applied.
     Measurement year. When we refer to ``measurement year,'' 
we mean the time period (beginning on January 1 and ending on December 
31 of each calendar year) during which data is collected to calculate 
outcomes for the CMS EPCS Program. In prior rules, we have used the 
term ``current year'' or ``evaluated year,'' but moving forward we will 
use the term ``measurement year.''
     Compliance threshold. For the CMS EPCS Program, 
``compliance threshold'' is the requirement at Sec.  423.160(a)(5) that 
prescribers must conduct prescribing for at least 70 percent of their 
Schedule II, III, IV, and V controlled substances that are Part D drugs 
electronically, after exceptions, each measurement year.
     Compliance analysis period. The ``compliance analysis 
period'' is the time period after the measurement year where data is 
analyzed to determine whether prescribers have met the compliance 
threshold for the CMS EPCS Program.
     Notification period. The ``notification period'' is the 
time period during which we notify a prescriber of the prescriber's 
initial compliance status and any associated review or waiver process 
that may be available prior to CMS determining the prescriber's final 
compliance status.
     Measurement cycle. The ``measurement cycle'' is generally 
a period of 24 months, consisting of a measurement year, the compliance 
analysis period, and the notification period.
3. Standard for CMS EPCS Program
a. Updates to the NCPDP Standards
    In the CY 2021 PFS final rule (85 FR 84804), we finalized a 
requirement for

[[Page 79286]]

Part D prescribers to use the NCPDP SCRIPT standard version 2017071 
standard for electronic prescribing of Schedule II, III, IV, and V 
controlled substances covered under Medicare Part D. In the CY 2021 PFS 
proposed rule, we had stated our belief that because prescribers were 
already required to use this standard when e-prescribing for covered 
Part D drugs for Part D eligible individuals, prescribers should use 
this same standard when e-prescribing controlled substances (85 FR 
50261).
    In the CY 2024 PFS proposed rule (88 FR 52532), we noted that on 
December 27, 2022, as part of the Medicare Program; Contract Year 2024 
Policy and Technical Changes to the Medicare Advantage Program, 
Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, 
Medicare Parts A, B, C, and D Overpayment Provisions of the Affordable 
Care Act and Programs of All-Inclusive Care for the Elderly; Health 
Information Technology Standards and Implementation Specifications 
proposed rule (herein referred to as the ``CY 2024 Medicare Advantage 
and Part D Policy and Technical Changes proposed rule'') (87 FR 79550), 
we proposed to update provisions related to e-prescribing standards at 
Sec.  423.160(b), including, after a transition period, requiring the 
NCPDP SCRIPT standard version 2022011 proposed for adoption at 45 CFR 
170.205(b), and retiring the current NCPDP SCRIPT standard version 
2017071, as the e-prescribing standard for covered Part D drugs for 
Part D eligible individuals. The CY 2024 Medicare Advantage and Part D 
Policy and Technical Changes final rule appeared in the April 12, 2023 
Federal Register (88 FR 22120). We noted that we did not address 
comments received on the provisions of the proposed rule related to e-
prescribing standards as these provisions were not finalized in the 
final rule. We also noted that we will address provisions of the 
proposed rule that we did not finalize at a later time, such as in 
possible future rulemaking, as appropriate.
    As stated in the CY 2021 PFS proposed rule (85 FR 50261), our 
intent with the CMS EPCS Program is for prescribers to use the same 
version of the NCPDP SCRIPT standard for their electronic prescribing 
of Schedule II-V controlled substances that are Part D drugs as for 
other electronic prescribing for Part D eligible individuals. Although 
we finalized the NCPDP SCRIPT standard version 2017071 as the standard 
in the CY 2021 PFS final rule, we want to clarify that, based on the 
existing regulatory text at Sec.  423.160(a)(5), the CMS EPCS Program 
will automatically adopt the electronic prescribing standards at Sec.  
423.160(b) as they are updated. This is based on the requirement at 
Sec.  423.160(a)(5) that prescribers conduct prescribing for at least 
70 percent of their Schedule II, III, IV, and V controlled substances 
that are Part D drugs electronically using the applicable standards in 
paragraph (b) of Sec.  423.160. Therefore, any proposals from the CY 
2024 Medicare Advantage and Part D Policy and Technical Changes 
proposed rule to standards at Sec.  423.160(b) that are finalized will 
apply to electronic prescribing for the CMS EPCS program as well.
    Although we did not make a formal proposal in this section, we did 
receive public comments requesting clarification on when the new NCPDP 
SCRIPT standard version would be adopted and the implications for 
measuring long-term care (LTC) compliance. Because we did not make a 
proposal in regard to the date on or after which compliance actions 
will commence against prescribers who do not meet the compliance 
threshold based on prescriptions written for a beneficiary in a LTC 
facility, the responses that follow are for clarification purposes 
only.
    Comment: A few commenters supported our clarification that the CMS 
EPCS Program will require use of the same NCPDP SCRIPT standard version 
that is required for Part D e-prescribing. One commenter noted their 
belief that the following preamble text from the CY 2024 PFS proposed 
rule was confusing: ``In the final rule, we did not address comments 
received on the provisions of the proposed rule related to e-
prescribing standards as these provisions were not finalized in the 
final rule. Rather, we will address provisions of the proposed rule 
that we did not finalize at a later time, such as in possible future 
rulemaking, as appropriate.'' The commenter recommended removing that 
statement and substituting the following: ``Therefore, any proposals 
from the CY 2024 Medicare Advantage and Part D Policy and Technical 
Changes proposed rule to standards at Sec.  [thinsp]423.160(b) that are 
finalized will apply to electronic prescribing for the CMS EPCS program 
as well.''
    Response: We appreciate this feedback. We are further clarifying 
that the CMS EPCS Program will require use of the same version (or 
versions) of standards that are finalized through rulemaking for 
Medicare Part D e-prescribing by virtue of the cross reference in Sec.  
423.160(a)(5) to ``the applicable standards in paragraph (b) of this 
section,'' which refers to the standards in Sec.  423.160(b). In 
particular, the CMS EPCS Program will require use of the same version 
(or versions) of standards that are required for prescribers, 
dispensers, and Part D sponsors transmitting prescriptions and 
prescription-related information for covered Part D drugs for Part D 
eligible individuals using electronic media consistent with the general 
rules governing requirements for electronic prescribing at Sec.  
423.160(a)(1) and (2).
    Comment: A few commenters sought clarification for when the 
Medicare Part D standards for electronic prescribing would be finalized 
and noted the implications for LTC. Commenters noted that the proposed 
NCPDP SCRIPT standard version 2022011 offered new and important 
functionality that addresses longstanding challenges with implementing 
e-prescribing in the post-acute care sector. These commenters sought 
clarification as to CMS' timeline for adopting and implementing this 
new standard, given that prescriptions written for a beneficiary in an 
LTC facility were excluded from compliance until January 1, 2025 and 
compliance actions against prescribers who do not meet the compliance 
threshold based on prescriptions written for a beneficiary in an LTC 
facility will commence on or after January 1, 2025.
    Response: As of publication of this final rule, we acknowledge that 
we have not finalized our proposal to update the standard that was 
proposed in the CY 2024 Medicare Advantage and Part D Policy and 
Technical Changes proposed rule (88 FR 22120).
    In the 2022 PFS final rule (86 FR 65364), we noted that the intent 
of extending the date on or after which we will pursue compliance 
actions for prescriptions written for beneficiaries in LTC facilities 
to January 1, 2025 was to strike a balance between being responsive to 
stakeholder concerns surrounding the increased implementation barriers 
faced by LTC facilities, while at the same time helping to ensure that 
these facilities eventually implement EPCS, given the benefits of EPCS. 
Furthermore, we noted that we were not persuaded to further delay 
commencing compliance actions to await publication of the NCPDP SCRIPT 
2022011 standard. We acknowledged that three-way communication is not 
as seamless in the 2017071 version of the standard as it may be in 
upcoming versions. We also stated that it is still possible with some 
modifications to EPCS, and therefore, we did not believe it would be 
appropriate to adopt a further delay on this basis alone. We know that 
some prescribers prescribing for beneficiaries in LTC facilities have

[[Page 79287]]

adopted EPCS, but that others have waited for the standard to be 
updated. Our current policy is to start including prescriptions written 
for a beneficiary in a LTC facility in compliance calculations starting 
January 1, 2025. However, if the updated NCPDP SCRIPT standard is 
finalized for a date after January 1, 2025, we may explore whether a 
waiver is appropriate for prescribers who are not compliant solely as a 
result of prescriptions they have written for beneficiaries in LTC 
facilities or we may revisit the compliance start date, if needed, 
through future rulemaking.
b. Standards for Same Legal Entity
    In the CY 2022 PFS final rule (86 FR 65366), we finalized an 
exception at Sec.  423.160(a)(5)(i) for prescriptions issued where the 
prescriber and dispensing pharmacy are the same entity (hereafter 
called the same entity exception). We stated our belief that a 
requirement to use the NCPDP SCRIPT standard version 2017071 within a 
closed system could increase costs and the rate of performance errors, 
such as data corruption and patient matching errors, which we 
understand often happens when a unified database is split into a 
transaction system that relays information to and from the same entity.
    As we have implemented the same entity exception, our experience 
has been that the Prescription Drug Event (PDE) data, which we use for 
CMS EPCS Program compliance calculations, does not have a field that 
consistently and accurately identifies prescribers and dispensing 
pharmacies that are part of the same entity, making it impossible to 
exclude these prescriptions from the compliance calculations using PDE 
data. Additionally, we realized that we can include prescriptions where 
the prescriber and dispensing pharmacy are the same entity without 
triggering the concerns that led us to us to finalize the same entity 
exception, if we remove the requirement to use the NCPDP SCRIPT 
standard listed in Sec.  423.160(b), as described below.
    Medicare Part D has an existing electronic prescribing regulation 
that permits the use of either HL7 messages or the NCPDP SCRIPT 
standard to transmit prescriptions or prescription-related information 
internally when the sender and the beneficiary are part of the same 
legal entity while still maintaining the requirement for e-prescribing. 
The Medicare Program; E-Prescribing and Prescription Drug Program final 
rule (70 FR 67581), which appeared in the November 7, 2005 Federal 
Register, codified at Sec.  423.160(a)(3)(ii), that either HL7 messages 
or the NCPDP SCRIPT standard could be used when all parties to a 
transaction are, for example, employed by and part of the same legal 
entity. We subsequently finalized a proposal to move the provision to 
Sec.  423.160(a)(3)(iii) in the CY 2008 PFS final rule (72 FR 66405).
    In the CY 2024 PFS proposed rule (88 FR 52532), we proposed to 
integrate this regulation into the CMS EPCS Program, as it provides 
alignment across electronic prescribing policies for prescriptions 
prescribed and dispensed within the same legal entity without forcing 
these entities to adopt the NCPDP SCRIPT standard for such 
transmittals. We are finalizing this proposal. As a result, prescribers 
in the same legal entities as the dispensing pharmacy will have 
multiple methods to conduct internal electronic transmittals for 
Schedule II, III, IV, and V controlled substances that are Part D 
drugs, as permitted in Sec.  423.160(a)(3)(iii). Therefore, we believe 
that these prescribers' prescriptions can be included in the CMS EPCS 
Program compliance calculation so long as prescribers' electronic 
prescriptions are transmitted consistent with the exemption in Sec.  
423.160(a)(3)(iii).
    By finalizing this proposal, we will no longer need to separately 
identify and apply different methodologies based on whether the 
prescriber and dispensing pharmacy are the same entity. We will 
identify electronic prescriptions for Schedule II-V controlled 
substances that are Part D drugs using the Prescription Origin Code 
data element in the PDE record, where a value of three indicates 
electronic transmission. Additionally, this proposal will expand the 
available standards for prescribers that are within the same legal 
entities as the dispensing pharmacy under the CMS EPCS Program, as 
defined by the Medicare Program; E-Prescribing and Prescription Drug 
Program final rule (70 FR 67581), by cross-referencing the standards at 
Sec.  423.160(a)(3)(iii), which broadens the requirements of the e-
prescribing standard that can be used to meet CMS EPCS Program 
requirements. We believe that by aligning with the regulation at Sec.  
423.160(a)(3)(iii), we are advancing e-prescribing standardization and 
addressing potential concerns about burdening prescribers within the 
same legal entity, including workflow and data errors.
    Therefore, to address our data limitations and to provide 
flexibility where prescriptions are transmitted within the same legal 
entity, we are finalizing our proposals to remove the same entity 
exception at Sec.  [thinsp]423.160(a)(5)(i) from the CMS EPCS Program 
requirements and to redesignate paragraphs (a)(5)(ii) through (iv) as 
paragraphs (a)(5)(i) through (iii), respectively. We also are 
finalizing our proposal to add ``subject to the exemption in paragraph 
(a)(3)(iii) of this section'' to Sec.  423.160(a)(5). As a result, 
prescriptions that are prescribed and dispensed within the same legal 
entity will be included in CMS EPCS Program compliance calculations as 
part of the 70 percent compliance threshold at Sec.  
[thinsp]423.160(a)(5), and prescribers will not be exempt from the 
requirement to prescribe electronically at least 70 percent of their 
Schedule II-V controlled substances that are Part D drugs--but such 
prescriptions will only have to meet the applicable standards in Sec.  
423.160(b) subject to the exemption in Sec.  423.160(a)(3)(iii).
    We solicited comments on the proposals to remove the same entity 
exception and expand the available standards for same legal entities 
within the CMS EPCS Program.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Several commenters supported the proposal to remove the 
same entity exception and use HL7 messages or the NCPDP SCRIPT 
standard, which is identified in the exemption at Sec.  
423.160(a)(3)(iii), because it reduces administrative burden and 
promotes interoperability and data sharing which can improve patient 
outcomes.
    Response: We thank the commenters for their support of the proposal 
to remove the same entity exception and align e-prescribing practices 
with Medicare Part D.
    Comment: One commenter did not support the proposal to remove the 
same entity exception and use HL7 messages or the NCPDP SCRIPT standard 
as they believed broader flexibility would not solve this issue because 
some prescribers, especially those in rural communities, may use 
proprietary codes rather than HL7 messages or the NCPDP SCRIPT 
standard, which is identified in the exemption at Sec.  
423.160(a)(3)(iii), and LTC participants have unique requirements. The 
commenter suggested that CMS consider alternative options for excluding 
same entity prescriptions and allow some level of exception.
    Response: Generally speaking, we intend to align CMS EPCS Program 
requirements with the Medicare Part D electronic prescribing standards, 
as we do not want to create different

[[Page 79288]]

requirements regarding the use of electronic prescribing standards 
between the Medicare Part D program as a whole and the CMS EPCS 
Program. The concerns the commenter identified with respect to EPCS 
within the same entity would also be applicable to electronic 
prescriptions for non-controlled Part D drugs. However, as noted in the 
CY 2024 PFS proposed rule and as we reiterate above, due to the 
limitations in the data we have already described, we intend to 
identify electronic prescribing through the Prescription Origin Code 
with a value of three found in the PDE record, which is based on the 
NCPDP definitions for electronic transmission.\437\
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    \437\ https://www.ncpdp.org/NCPDP/media/pdf/VersionD-Questions.pdf.
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    After consideration of public comments, we intended to finalize 
these policies as proposed.
4. Definition of Prescriptions for Compliance Calculation
    In the CY 2022 PFS final rule, we finalized the compliance 
threshold requirement for the CMS EPCS Program such that prescribers 
are required to prescribe at least 70 percent of their Schedule II, 
III, IV, and V controlled substances that are Part D drugs 
electronically, except in cases where an exception or waiver applies 
(86 FR 65366). Additionally, we indicated that the compliance threshold 
for each prescriber would be calculated by examining PDE data at the 
end of the measurement year and dividing the number of Part D 
controlled substances that were e-prescribed by the total number of 
Part D controlled substance prescriptions (excluding from both the 
numerator and denominator any prescriptions issued while a prescriber 
falls within an exception or is subject to a waiver) (86 FR 65365). 
Previously, we did not define how prescriptions with multiple fills 
would affect the compliance threshold calculation. We proposed to 
specify how the compliance threshold is affected by multiple fills 
within the same year.
    For purposes of CMS EPCS Program, we will count unique 
prescriptions in the measurement year using the prescription number 
assigned by the pharmacy and included in the Part D claims data. All 
prescriptions, regardless of how they are transmitted, may include a 
number of refills so that the pharmacy may provide additional fills of 
the prescribed medication without the need for a new prescription from, 
or visit to, a prescriber. Refills are not separately transmitted 
prescriptions; they are documented as part of the original prescription 
transmittal, which includes any refills issued against the original 
prescription (by the pharmacy). However, renewals of prescriptions 
(such as those for maintenance medications) require prescribers to 
generate a new prescription along with a new set of refills. Because of 
this distinction, we will count renewals as an additional prescription 
in the CMS EPCS Program compliance threshold calculation, and we will 
not count refills as an additional prescription in the CMS EPCS Program 
compliance threshold calculation unless the refill is the first 
occurrence of the unique prescription in the measurement year.
    We believe, if we were to include every fill in the compliance 
threshold calculation, an increased burden could be placed on small 
prescribers, as they would potentially no longer qualify for the small 
prescriber exception at Sec.  423.160(a)(5)(ii) (which we proposed to 
be redesignated to Sec.  423.160(a)(5)(i), as described in the 
regulation text in this rule). If we were to count every single fill, 
preliminary analysis of 2021 Part D data shows that approximately 
23,000 prescribers would no longer qualify for the small prescriber 
exception and that approximately 6,900 additional prescribers would be 
considered non-compliant. For this reason, we will count only the 
unique prescriptions in the measurement year for the purposes of CMS 
EPCS Program compliance threshold calculations.
    We received public comments on the definition of prescriptions for 
the CMS EPCS program compliance calculation. The following is a summary 
of the comments we received and our responses.
    Comment: A few commenters supported counting prescription renewals, 
but not refills, toward the CMS EPCS program's compliance threshold 
calculation and to only include a refill in the calculation if it is 
the first occurrence of that unique prescription within a measurement 
year. One commenter noted that many prescribers who currently qualify 
for the small prescriber exception would be at risk of no longer 
qualifying if each refill of a prescription counted towards the 
compliance threshold calculation.
    Response: We agree with commenters that if we were to include every 
fill in the compliance threshold calculation, an increased burden could 
be placed on small prescribers, as they would potentially no longer 
qualify for the small prescriber exception.
    After consideration of public comments, we are finalizing the 
policy as proposed to count only the unique prescriptions in the 
measurement year for the purposes of CMS EPCS Program compliance 
threshold calculations.
5. Updates to CMS EPCS Program Exceptions for Cases of Recognized 
Emergencies and Extraordinary Circumstances
a. Background
    In the CY 2022 PFS final rule (86 FR 65367 through 65368), we 
finalized two exceptions related to exceptional circumstances that may 
prevent prescribers from being able to conduct EPCS. The first 
exception, codified at Sec.  [thinsp]423.160(a)(5)(iii), is for 
prescribers who are prescribing during a recognized emergency, such as 
a natural disaster, a pandemic, or a similar situation where there is 
an environmental hazard. Prescribers in a geographic area of an 
emergency or disaster declared by a Federal, State, or local government 
entity are excluded from the CMS EPCS Program requirements. In the CY 
2023 PFS final rule (87 FR 70012), we modified the exception to use the 
prescriber's PECOS address or, in situations where a prescriber does 
not have a PECOS address, the prescriber's address in the National Plan 
and Provider Enumeration System (NPPES) data, to determine whether the 
exception at Sec.  [thinsp]423.160(a)(5)(iii) is applicable.
    The second exception, codified at Sec.  [thinsp]423.160(a)(5)(iv), 
is for prescribers who request and receive from CMS a waiver, which we 
grant to prescribers who are facing extraordinary circumstances that 
prevent them from electronically prescribing a controlled substance to 
a Part D beneficiary, but who are not in an emergency or disaster area. 
We defined ``extraordinary circumstance'' for purposes of this 
exception to mean a situation, other than an emergency or disaster, 
outside of the control of a prescriber that prevents the prescriber 
from electronically prescribing a controlled substance to a Part D 
beneficiary (86 FR 65367).
    In the CY 2024 PFS proposed rule (88 FR 52533), we proposed to 
further modify the recognized emergency exception and extraordinary 
circumstances waiver (which we codified at Sec.  
[thinsp]423.160(a)(5)(ii) and (iii), respectively, as described in 
section III.M.3.b of this rule). We proposed to modify the rules for 
when these exceptions apply by enabling prescribers to apply for 
waivers in times of an emergency and disaster and by limiting the 
emergencies or disasters that would trigger the recognized emergency 
exception. Additionally, we proposed to modify the duration of both

[[Page 79289]]

exceptions and proposed timing requirements for submitting a waiver 
application.
b. Updating the Circumstances Applicable for the Recognized Emergency 
and Extraordinary Circumstances Waiver Exceptions
    At the time we made proposals in the CY 2024 PFS proposed rule (88 
FR 52533 through 52534), the exception for recognized emergencies 
applied to all prescribers with an address in PECOS, or alternatively 
in NPPES, in the geographic area of an emergency or disaster declared 
by a Federal, State, or local government entity. As we explained in 
that proposed rule, we have realized there may be unintended 
consequences to our policy based on our experience implementing it. 
First, while we can identify emergencies recognized by the Federal 
Emergency Management Agency (FEMA) or pandemics recognized by the 
Department of Health and Human Services (HHS), we may not be able to 
identify every local or state emergency. Because we excluded 
emergencies and disasters from our extraordinary circumstances waiver 
policy, some prescribers may not be able to receive an exception for an 
emergency or disaster we did not identify. Second, we realized that not 
every emergency may impact the ability of prescribers to conduct EPCS, 
and thus it may not be appropriate to automatically apply the exclusion 
to all prescribers in the affected geographic area of some emergencies. 
Third, we realized that some of our policies do not align with other 
emergency policies of CMS programs for quality reporting and 
performance. Therefore, in order to address these concerns, we looked 
to the Quality Payment Program Merit-based Incentive Payment System 
(MIPS) automatic policy for extreme and uncontrollable circumstances 
and to the extraordinary circumstances exceptions (ECE) for many of our 
quality reporting and value-based purchasing programs for hospitals and 
other types of facilities to see other examples of when we apply 
automatic exceptions versus when we ask clinicians or facilities to 
apply for a waiver.
    In the FY 2018 IPPS/LTCH PPS final rule (82 FR 38410) and CY 2018 
OPPS/ASC final rule (82 FR 52584), we worked to align common processes 
for our ECE policies across many of our quality programs including the 
Hospital IQR Program, Hospital OQR Program, IPFQR Program, ASCQR 
Program, and PCHQR Program, as well as the Hospital VBP Program, HAC 
Reduction Program, and the Hospital Readmissions Reduction Program. 
Using the Hospital IQR Program as an example, generally, CMS may grant 
an exception with respect to quality data reporting requirements in the 
event of extraordinary circumstances beyond the control of the hospital 
(42 CFR 412.140(c)(2)). A hospital may submit such a request in the 
form and manner described on QualityNet.org. CMS may also grant an 
exception to one or more hospitals that have not requested an exception 
if: CMS determines that a systemic problem with CMS data collection 
systems directly affected the ability of the hospital to submit data; 
or if CMS determines that an extraordinary circumstance, such as an act 
of nature (for example, hurricane), has affected an entire region or 
locale (see Sec.  412.140(c)(2)(ii) and 76 FR 51651). We stated that if 
we make the determination to grant an ECE to hospitals in a region or 
locale, we would communicate this decision through routine 
communication channels (76 FR 51652).
    Separately, in the context of clinicians participating in MIPS, we 
established another ECE policy. In the Medicare Program; CY 2018 
Updates to the Quality Payment Program; and Quality Payment Program: 
Extreme and Uncontrollable Circumstance Policy for the Transition Year 
(CY 2018 Quality Payment Program final rule), we adopted in an interim 
final rule with comment period an automatic extreme and uncontrollable 
circumstances policy for one performance period due to several 
hurricanes (82 FR 53895 through 53900). In discussing the triggering 
events for this policy (82 FR 53897), we stated that we have discretion 
not to require MIPS eligible clinicians to submit an application for 
reweighting the performance categories in cases where an extreme and 
uncontrollable circumstance, such as an act of nature (for example, 
hurricane), affects an entire region or locale. We noted that we 
anticipate the types of events that could trigger this policy would be 
events designated by the Federal Emergency Management Agency (FEMA) as 
major disasters or a public health emergency declared by the Secretary, 
although we will review each situation on a case-by-case basis. We also 
noted our intention to align the automatic extreme and uncontrollable 
circumstance policy with the ECE policies for other Medicare programs 
such that events that trigger ECE policies would also trigger the 
automatic extreme and uncontrollable circumstance policy (82 FR 53897). 
In the CY 2019 PFS final rule (83 FR 59875), we finalized a similar 
policy for all future years, which we codified at Sec.  
414.1380(c)(2)(i)(A)(8) and (C)(3).
    As we stated in the CY 2024 PFS proposed rule (88 FR 52534), we 
believe that it will be beneficial to interested parties for the CMS 
EPCS Program to have a similar policy as it relates to applying for an 
exception versus having an automatic exception for all prescribers in 
an affected region. This will streamline communications across CMS 
programs, as well as ensure that CMS can, where appropriate, except all 
prescribers for an appropriate circumstance beyond their control, 
including disasters or emergencies. In order to facilitate this 
transition, for the waiver exception at Sec.  423.160(a)(5)(iv) (which 
we proposed to codify at Sec.  423.160(a)(5)(iii), as described in the 
regulation text in this rule), we are finalizing our proposal to modify 
the definition of ``extraordinary circumstance'' to mean a situation 
outside of the control of a prescriber that prevents the prescriber 
from electronically prescribing a Schedule II-V controlled substance 
that is a Part D drug. This updated definition will drop the 
restriction ``other than an emergency or disaster,'' that we previously 
included when discussing this exception. This modification will allow 
prescribers the ability to request a waiver regardless of whether we 
trigger the recognized emergency exception.
    Additionally, we proposed to modify the recognized emergency 
exception at Sec.  423.160(a)(5)(iii) (which is codified at Sec.  
423.160(a)(5)(ii), as described in the regulation text in this rule) so 
that we will identify which events trigger the recognized emergency 
exception. We believe the ability to identify triggering events will 
allow us to ensure that the emergency affects widespread EPCS 
functionality. In applying this determination of which emergencies or 
disasters would trigger this exception, we will review each emergency 
situation on a case-by-case basis but will generally look to events 
designated as a FEMA major disaster or a public health emergency 
declared by the Secretary. We also intend to align the determination of 
the emergency exception with the MIPS automatic extreme and 
uncontrollable circumstances policy, such that events that would 
trigger this policy, in most instances, will also qualify under the CMS 
EPCS Program exception for recognized emergencies. We expect any 
deviation from MIPS automatic extreme and uncontrollable circumstances 
policies would be rare and only in circumstances which may cause 
disruption for MIPS performance but should not affect a prescriber's 
ability to

[[Page 79290]]

electronically prescribe Schedule II-V controlled substances that are 
Part D drugs, or vice versa.
    We will inform prescribers of which emergencies or disasters 
qualify for the exception, as determined by CMS, using normal 
communication channels such as listservs and the CMS EPCS Program 
website.
    We solicited comments on the proposals related to circumstances 
applicable for the recognized emergency and extraordinary circumstances 
waiver exceptions.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Several commenters supported the proposal to modify the 
definition of extraordinary circumstances by dropping the phrase 
``other than an emergency or disaster.'' Commenters noted the policy 
allows prescribers to apply for a waiver for all circumstances beyond 
their control, even in cases where a recognized emergency is not 
declared. One commenter noted their belief that this policy promotes 
climate change resiliency by providing EPCS flexibilities during a 
natural disaster. Commenters also supported the alignment of policies 
with MIPS and other CMS programs and noted how that promotes continuity 
and reduces burden.
    Response: We thank these commenters for their support. We agree 
that this policy provides the most flexibility to prescribers and 
reduces burden by aligning with other CMS programs.
    Comment: A few commenters supported our proposal for CMS to review 
emergency situations and offer blanket exceptions by region on a case-
by-case basis using FEMA-designated emergencies and HHS-declared public 
health emergencies as a baseline because it aligns with MIPS program 
policies.
    Response: We agree that it is important that we have flexibility in 
establishing exceptions for recognized emergencies and that it is 
desirable to align the CMS EPCS Program with other CMS programs where 
practicable and appropriate.
    Comment: One commenter did not support the proposal for CMS to 
identify the emergencies and disasters that would trigger the 
recognized emergency exception. The commenter noted that CMS did not 
provide any examples of when such emergencies may not be applicable, 
and the commenter was also concerned that disconnecting emergency and 
disaster declarations from the recognized emergency exception may lead 
to confusion.
    Response: As discussed earlier in this section, we will review each 
emergency situation on a case-by-case basis and will generally look to 
events designated as a FEMA major disaster or a public health emergency 
declared by the Secretary. Further, by permitting prescribers to 
request a waiver regardless of whether we trigger the recognized 
emergency exception, we are providing prescribers greater certainty 
that, regardless of whether we recognize an emergency under the 
exception at Sec.  423.160(a)(5)(ii), a prescriber can still request a 
waiver identifying the extraordinary circumstance preventing the 
prescriber from complying with the CMS EPCS Program requirements.
    Finally, we believe our proposal will reduce confusion rather than 
increase confusion by aligning with other CMS programs. One potential 
example for this policy is the multi-year public health emergency 
related to COVID-19 that ended May 11, 2023. Some prescribers may 
continue to be affected by the emergency in calendar year 2023, while 
others are not. Under the policy we are finalizing, we would have the 
ability to make an assessment if the recognized emergency applies for 
the measurement year for the entire nation and align this assessment, 
if appropriate, to other programs. After consideration of public 
comments, we are finalizing these policies as proposed.
c. Duration of Recognized Emergency Exceptions
    In the CY 2022 PFS final rule (86 FR 65367), we clarified that the 
recognized emergency exception would be applicable only if the 
dispensing date of the medication occurs during the time period that 
the declared disaster is occurring. In an effort to continue aligning 
the CMS EPCS Program with the Quality Payment Program, we proposed 
that, as a default, prescribers impacted by the CMS EPCS Program 
recognized emergency exception at Sec.  423.160(a)(5)(iii) (which we 
codified at Sec.  423.160(a)(5)(ii), as described in the regulation 
text in this rule) would be excepted for the entire measurement year, 
and not just for the duration of the emergency. We believe this would 
protect prescribers who may not be able to monitor their compliance 
status over multiple periods of time.
    We solicited comments on the proposed duration for exceptions due 
to recognized emergencies.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: A few commenters supported the proposal that any 
prescriber impacted by a recognized emergency exception would be 
excepted for the whole measurement year instead of the length of the 
emergency. One commenter noted that they believed this would help 
reduce administrative burden for practices.
    Response: We thank the commenters for their support. We agree this 
proposal will reduce administrative burden.
    After consideration of public comments, we are finalizing this 
policy as proposed.
d. Duration and Timing of Extraordinary Circumstances Waiver Exception
    In the CY 2022 PFS final rule (86 FR 65367 through 65368), we 
finalized an attestation process for prescribers to request a 
waiver.\438\ In the CY 2024 PFS proposed rule (88 FR 52535), we did not 
propose any modifications on the information needed to request a 
waiver, but we proposed the timeframe that would be covered by a waiver 
that is authorized under the CMS EPCS Program and the timing of waiver 
requests.
---------------------------------------------------------------------------

    \438\ The waiver application is currently going through the 
Paperwork Reduction Act approval process under the document 
identifier CMS-10834, and the proposed collection comment request 
appeared in the March 10, 2023 Federal Register (88 FR 15037).
---------------------------------------------------------------------------

    Section 1860D-4(e)(7)(B)(iii) of the Act, as added by section 2003 
of the SUPPORT Act, refers to a waiver or a renewal thereof for a 
period of time, not to exceed 1 year, as determined by the Secretary. 
We proposed that approved waivers for the CMS EPCS Program would apply 
to the entire measurement year. Prescribers who receive a waiver and 
continue to experience exceptional circumstances that extend beyond 
December 31 of a measurement year would be required to complete a new 
waiver application for the subsequent measurement year.
    In the CY 2022 PFS proposed rule (86 FR 39332), we signaled that we 
would include more information about the waiver process in subsequent 
rulemaking. One issue that was not clearly defined is the timing of 
when a prescriber can request a waiver. In the CY 2022 PFS final rule 
(86 FR 65370), we finalized that we would notify prescribers that they 
are violating the EPCS requirement with information about how they can 
come into compliance, the benefits of EPCS, an information solicitation 
as to why they are not conducting EPCS, and a link to the CMS portal to 
request a waiver. In the CY 2024 PFS proposed rule (88 FR 52535), we 
proposed that a prescriber

[[Page 79291]]

has a period of 60 days from the date of the notice of non-compliance 
to request a waiver. Approved waivers would apply to prescriptions 
written by a prescriber for the entire measurement year, and the waiver 
would expire on December 31 of the applicable measurement year.
    We solicited comments on the proposed waiver duration and the 
proposal for the timing and process of applying for a waiver in cases 
of extraordinary circumstances.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: A few commenters supported our proposal to apply the 
extraordinary circumstance exception for the entire measurement year 
and for prescribers to reapply if the emergency goes beyond the 
measurement year. Commenters noted this reduces burden.
    Response: We agree this policy reduces burden.
    Comment: One commenter requested clarification regarding how CMS 
will determine the length of an extraordinary circumstance for which a 
prescriber requests a waiver, especially if it occurs close to the end 
of the year, given that a granted exception would apply for the full 
measurement year. The commenter noted it is critical for providers to 
understand this information when CMS grants a waiver in response to an 
application to avoid inadvertent noncompliance.
    Response: We realize that prescribers will not be able to apply for 
waivers until after the measurement period has ended and this may 
result in the prescriber not being able to modify their behavior based 
on the denial of a waiver. As part of the waiver request process, we 
provide an opportunity for a prescriber to describe the reasons for 
non-compliance. If the waiver is not accepted, there is an opportunity 
for educational outreach.
    We also hope to minimize inadvertent non-compliance by allowing 
prescribers to apply for a waiver after they know their compliance 
status for the year. In some cases, we believe prescribers who 
experience an extraordinary circumstance may still be compliant 
because, even with the extraordinary circumstance, they were able to 
achieve the 70 percent compliance threshold.
    After consideration of public comments, we are finalizing these 
policies as proposed.
6. Actions for Non-Compliance
    In the CY 2022 PFS final rule (86 FR 65370), we limited compliance 
actions with respect to compliance from January 1, 2023 through 
December 31, 2023, to a non-compliance notice sent to prescribers who 
are violating the CMS EPCS Program requirement. In the CY 2023 PFS 
final rule (87 FR 70013), we extended the existing compliance action of 
sending notices to non-compliant prescribers from the CY 2023 CMS EPCS 
Program implementation year (January 1, 2023 through December 31, 2023) 
to the CY 2024 EPCS Program implementation year (January 1, 2024 
through December 31, 2024). The content of the notices will remain 
unchanged and continue to consist of a notice to prescribers that they 
are violating the CMS EPCS Program requirements, information about how 
they can come into compliance, the benefits of EPCS, and a link to the 
CMS EPCS Program dashboard where the prescriber may request a waiver 
and provide information as to why they are not conducting EPCS.
    We proposed to continue the practice of issuing a prescriber a 
notice of non-compliance as a non-compliance action for subsequent 
measurement years. As stated in the CY 2023 PFS final rule (87 FR 
70013), we believe prescriber use of EPCS encourages the use of 
interoperable technology, produces a verifiable and traceable history, 
prevents fraud and abuse, and reduces burden. We believe that 
continuing to send non-compliance notices would support increased EPCS 
adherence and encourage increased EPCS adoption rates, which could be 
more effective than imposing more restrictive non-compliance actions or 
penalties that may increase burden on prescribers.
    In the CY 2023 PFS proposed rule (87 FR 46240 through 46241), we 
solicited ideas of possible non-compliance actions with the goal of 
identifying one that would be operationally feasible (for example, can 
be accomplished without requiring modifications to the data available 
through the PDE file) and support the nation's ongoing fight against 
drug abuse and diversion without adding administrative burden to 
prescribers or hindering beneficiary access to needed medications. We 
did not receive a large number of comments. However, we did receive one 
comment specifically noting that non-compliance alone is not a 
definitive indicator of fraud, waste, or abuse. We agree with the 
commenter that non-compliance alone is not a definitive indicator of 
fraud, waste, or abuse; however, we maintain that one risk to public 
safety is potential fraud, waste, and abuse and intend that a 
prescriber's non-compliance under the CMS EPCS program may be 
considered in our processes for assessing potential fraud, waste, and 
abuse. We may use this information in our processes for assessing 
potential fraud, waste, and abuse, which, in some instances, could 
result in a referral to law enforcement or revocation of billing 
privileges, in the event that evidence of fraud, waste, or abuse is 
present. At this time, we believe the risk of fraud, waste, or abuse 
can be mitigated without the need for further penalties for CMS EPCS 
program non-compliance. Literature suggests a correlation between use 
of EPCS and reduction in fraud, waste, and abuse related to opioid 
prescriptions.439 440 Prescriber use of EPCS is directly 
related to improving prescription security, decreasing prescription 
forgery, and reducing the overall chance of fraud and alteration 
associated with paper prescribing.\441\ Also notable are studies 
demonstrating reductions in opioid overdoses when EPCS use is increased 
and general findings that e-prescribing can improve coordination of 
care, reduce fraud and abuse, and contribute to public health safety.
---------------------------------------------------------------------------

    \439\ Abuok, Rahi, and David Powell. ``Can Electronic 
Prescribing Mandates Reduce Opioid-Related Overdoses?'' Science 
Direct, JOURNAL of ECONOMICS & HUMAN BIOLOGY, Elsevier B.V., 14 Apr. 
2021, https://doi.org/10.1016/j.ehb.2021.101000.
    \440\ Achar, Suraj, et al. ``Adoption and Increased Use of 
Electronic Prescribing of Controlled Substances.'' Journal of 
Medical Regulation, Federation of State Medical Boards, 27 Aug. 
2021, https://doi.org/10.30770/2572-1852-107.2.8.
    \441\ Achar, Suraj, et al. ``Adoption and Increased Use of 
Electronic Prescribing of Controlled Substances.'' Journal of 
Medical Regulation, Federation of State Medical Boards, 27 Aug. 
2021, https://doi.org/10.30770/2572-1852-107.2.8.
---------------------------------------------------------------------------

    Although we did not propose further non-compliance actions beyond 
the extension of sending notices at this time, we will continue to 
evaluate compliance and prescriber performance under the CMS EPCS 
Program and will consider whether to propose changes in future years. 
We solicited comments on our proposal to continue the action of sending 
notice to prescribers who are identified as non-compliant.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Many commenters supported the proposal to send non-
compliance notices to prescribers who do not meet the CMS EPCS Program 
requirements in subsequent years without imposing additional penalties. 
Several commenters noted that continuing to send the notices would 
promote increased EPCS adoption, especially for those who require 
additional time to update their technological abilities, and any added 
provider penalties for non-compliance

[[Page 79292]]

beyond the notice and education could be counterproductive. A few 
commenters noted that CMS should not impose restrictions, penalties, or 
other limitations that may interfere with beneficiary access and 
instead should work with practices to support compliance efforts.
    Response: We agree that continuing to send non-compliance notices 
in subsequent years will encourage adoption and compliance without 
adding prescriber burden or restricting patient access.
    Comment: A few commenters agreed with CMS's belief that public 
safety concerns related to fraud, waste and abuse for prescribers who 
do not use EPCS can be mitigated without additional penalties in the 
CMS EPCS Program.
    Response: We agree with commenters. We believe that considering a 
prescriber's non-compliance under the CMS EPCS program in our processes 
for assessing potential fraud, waste, and abuse could help identify 
prescribers who may be avoiding CMS EPCS Program compliance for harmful 
reasons. We believe doing so promotes proper prescribing patterns.
    Comment: A few commenters did not support the proposal to issue a 
notice of non-compliance as a non-compliance action for the CMS EPCS 
program requirement in subsequent measurement years; these commenters 
expressed concerns that additional penalty mechanisms would be needed 
in addition to the notice in order to increase prescriber adoption and 
compliance in the CMS EPCS program. One commenter noted that stronger 
compliance actions might be needed to increase prescriber compliance in 
the future, but did not provide specific suggestions. One commenter 
specifically supported further consideration of corrective action 
plans, public notice of noncompliance, and referral to applicable state 
regulators. One commenter suggested that the CMS EPCS requirement be 
connected to the Promoting Interoperability performance category under 
the MIPS program. Another commenter suggested that CMS consider 
offering incentives as a future mechanism for those who comply, as a 
method to encourage implementation. A few commenters acknowledged CMS' 
authority to refer non-compliant prescribers to other enforcement 
agencies for investigation. One commenter recommended that CMS provide 
a ``series of escalating notices'' that would allow prescribers 
appropriate time to correct non-compliance.
    Response: We considered multiple actions for CMS EPCS Program non-
compliance but believe continuing to provide non-compliant prescribers 
with notices, along with using CMS EPCS Program non-compliance 
information in our processes for identifying fraud, waste, and abuse, 
is sufficient incentive to encourage EPCS adoption. We will continue to 
evaluate previously considered actions for non-compliance and their 
applicability for the future as we evaluate and monitor CMS EPCS 
Program compliance in subsequent years. We considered the use of 
corrective action plans, public notice of non-compliant prescribers, 
referral to state regulators, and believed these options to be 
logistically complex for the value they would bring. We also considered 
alignment with existing MIPS reporting options and other financial 
incentives but do not believe those are feasible at the present time.
    We will send notices of non-compliance for each measurement year a 
prescriber is non-compliant and will provide educational opportunities 
to support prescribers in becoming compliant. We plan to monitor CMS 
EPCS program compliance rates and may revisit the use of further non-
compliance actions in future rulemaking.
    After consideration of public comments, we are finalizing this 
policy as proposed.

N. Changes to the Regulations Associated With the Ambulance Fee 
Schedule and the Medicare Ground Ambulance Data Collection System 
(GADCS)

1. Background on Ambulance Services
    Section 1861(s)(7) of the Act establishes an ambulance service as a 
Medicare Part B service where the use of other methods of 
transportation is contraindicated by the individual's condition, but 
only to the extent provided in regulations. Since April 1, 2002, 
payment for ambulance services has been made under the ambulance fee 
schedule (AFS), which the Secretary established, as required by section 
1834(l) of the Act, in 42 CFR part 414 subpart H. Payment for an 
ambulance service is made at the lesser of the actual billed amount or 
the AFS amount, which consists of a base rate for the level of service, 
a separate payment for mileage to the nearest appropriate facility, a 
geographic adjustment factor (GAF), and other applicable adjustment 
factors as set forth at section 1834(l) of the Act and Sec.  414.610 of 
the regulations. In accordance with section 1834(l)(3) of the Act and 
Sec.  414.610(f), the AFS rates are adjusted annually based on an 
inflation factor. The AFS also incorporates two permanent add-on 
payments in Sec.  414.610(c)(5)(i) and three temporary add-on payments 
to the base rate and/or mileage rate, which are discussed in the next 
section of this final rule.
    Our regulations relating to coverage of and payment for ambulance 
services are set forth at 42 CFR part 410, subpart B, and 42 CFR part 
414, subpart H.
2. Ambulance Extender Provisions
a. Amendment to Section 1834(l)(13) of the Act
    Section 146(a) of the Medicare Improvements for Patients and 
Providers Act of 2008 (Pub. L. 110-275, enacted July 15, 2009) (MIPPA), 
amended section 1834(l)(13) of the Act to specify that, effective for 
ground ambulance services furnished on or after July 1, 2008, and 
before January 1, 2010, the ambulance fee schedule amounts for ground 
ambulance services shall be increased as follows:
     For covered ground ambulance transports that originate in 
a rural area or in a rural census tract of a metropolitan statistical 
area, the fee schedule amounts shall be increased by 3 percent.
     For covered ground ambulance transports that do not 
originate in a rural area or in a rural census tract of a metropolitan 
statistical area, the fee schedule amounts shall be increased by 2 
percent.
    The payment add-ons under section 1834(l)(13) of the Act have been 
extended several times. Most recently, division FF, section 4103 of the 
Consolidated Appropriations Act, 2023 (Pub. L. 117-328, December 29, 
2022) amended section 1834(l)(13) of the Act to extend the payment add-
ons through December 31, 2024. Thus, these payment add-ons apply to 
covered ground ambulance transports furnished before January 1, 2025. 
In the CY 2024 PFS proposed rule (88 FR 52536), we proposed to revise 
Sec.  414.610(c)(1)(ii) to conform the regulations to this statutory 
requirement. (For a discussion of past legislation extending section 
1834(l)(13) of the Act, please see the CY 2014 PFS final rule with 
comment period (78 FR 74438 through 74439), the CY 2015 PFS final rule 
with comment period (79 FR 67743), the CY 2016 PFS final rule with 
comment period (80 FR 71071 through 71072) and the CY 2019 PFS final 
rule with comment period (83 FR 59681 through 59682)).
    This statutory requirement is self-implementing. A plain reading of 
the statute requires only a ministerial

[[Page 79293]]

application of the mandated rate increase and does not require any 
substantive exercise of discretion on the part of the Secretary.
    We received one comment regarding this proposal. The following is 
the summary of the comment we received and our response.
    Comment: One commenter supported the proposal and agreed with CMS 
that the statutory provision is self-implementing and that these 
provisions are critically important to ground ambulance services.
    Response: We appreciate the commenter's support of these 
provisions.
    After consideration of the public comment that we received, we are 
finalizing our proposal to revise Sec.  414.610(c)(1)(ii) to conform 
the regulations to this statutory requirement.
b. Amendment to Section 1834(l)(12) of the Act
    Section 414(c) of the Medicare Prescription Drug, Improvement and 
Modernization Act of 2003 (MMA) (Pub. L. 108-173, December 8, 2003) 
added section 1834(l)(12) to the Act, which specified that, in the case 
of ground ambulance services furnished on or after July 1, 2004, and 
before January 1, 2010, for which transportation originates in a 
qualified rural area (as described in the statute), the Secretary shall 
provide for a percent increase in the base rate of the fee schedule for 
such transports. The statute requires this percent increase to be based 
on the Secretary's estimate of the average cost per trip for such 
services (not taking into account mileage) in the lowest quartile of 
all rural county populations as compared to the average cost per trip 
for such services (not taking into account mileage) in the highest 
quartile of rural county populations. Using the methodology specified 
in the July 1, 2004 interim final rule (69 FR 40288), we determined 
that this percent increase was equal to 22.6 percent. As required by 
the MMA, this payment increase was applied to ground ambulance 
transports that originated in a ``qualified rural area,'' that is, to 
transports that originated in a rural area comprising the lowest 25th 
percentile of all rural populations arrayed by population density. For 
this purpose, rural areas included Goldsmith areas (a type of rural 
census tract). This rural bonus is sometimes referred to as the ``Super 
Rural Bonus'' and the qualified rural areas (also known as ``super 
rural'' areas) are identified during the claims process via the use of 
a data field included in the CMS-supplied ZIP code file.
    The Super Rural Bonus under section 1834(l)(12) of the Act has been 
extended several times. Most recently, division FF, section 4103 of the 
CAA, 2023 amended section 1834(l)(12)(A) of the Act to extend this 
rural bonus through December 31, 2024. Therefore, we are continuing to 
apply the 22.6 percent rural bonus described in this section (in the 
same manner as in previous years) to ground ambulance services with 
dates of service before January 1, 2025 where transportation originates 
in a qualified rural area. Accordingly, in the CY 2024 PFS proposed 
rule (88 FR 52536), we proposed to revise Sec.  414.610(c)(5)(ii) to 
conform the regulations to this statutory requirement. (For a 
discussion of past legislation extending section 1834(l)(12) of the 
Act, please see the CY 2014 PFS final rule with comment period (78 FR 
74439 through 74440), CY 2015 PFS final rule with comment period (79 FR 
67743 through 67744), the CY 2016 PFS final rule with comment period 
(80 FR 71072) and the CY 2019 PFS final rule with comment period (83 FR 
59682)).
    This statutory provision is self-implementing. It requires an 
extension of this rural bonus (which was previously established by the 
Secretary) through December 31, 2024, and does not require any 
substantive exercise of discretion on the part of the Secretary.
    We received one comment regarding this proposal. The following is 
the summary of the comment we received and our response.
    Comment: One commenter supported the proposal and agreed with CMS 
that the statutory provision is self-implementing and that these 
provisions are critically important to ground ambulance services.
    Response: We appreciate the commenter's support of these 
provisions.
    After consideration of the public comment that we received, we are 
finalizing our proposal to revise Sec.  414.610(c)(5)(ii) to conform 
the regulations to this statutory requirement.
3. Medicare Ground Ambulance Data Collection System
a. Background
    Section 50203(b) of the BBA of 2018 added paragraph (17) to section 
1834(l) of the Act, which requires ground ambulance providers of 
services and suppliers (ground ambulance organizations) to submit cost 
and other information. Specifically, section 1834(l)(17)(A) of the Act 
requires the Secretary to develop a data collection system (which may 
include use of a cost survey) to collect cost, revenue, utilization, 
and other information determined appropriate by the Secretary for 
providers and suppliers of ground ambulance services. Section 
1834(l)(17)(B)(i) of the Act required the Secretary to specify the data 
collection system by December 31, 2019, and to identify the ground 
ambulance providers and suppliers that would be required to submit 
information under the data collection system. Section 1834(l)(17)(D) of 
the Act required that beginning January 1, 2022, the Secretary apply a 
10 percent payment reduction to payments made under section 1834(l) of 
the Act for the applicable period to a ground ambulance provider or 
supplier that is required to submit information under the data 
collection system and does not sufficiently submit such information. 
The term ``applicable period'' is defined under section 
1834(l)(17)(D)(ii) of the Act to mean, for a ground ambulance provider 
or supplier, a year specified by the Secretary not more than 2 years 
after the end of the period for which the Secretary has made a 
determination that the ground ambulance provider or supplier has failed 
to sufficiently submit information under the data collection system. 
Division P, section 311 of the CAA, 2022 (Pub. L. 117-103) amended 
section 1834(l)(17)(F)(i) of the Act to delay the deadline for MedPAC 
to submit its report to Congress on the ground ambulance data 
collection system study until the second June 15th following the date 
the Secretary transmits data for the first representative sample of 
ground ambulance organizations. Section 1834(l)(17)(I) of the Act 
states that the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.) 
does not apply to the collection of information required under section 
1834(l)(17) of the Act.
    In the CY 2020 PFS final rule (84 FR 62864 through 62897), we 
implemented section 1834(l)(17) of the Act and codified regulations 
governing data reporting by ground ambulance organizations at 
Sec. Sec.  414.601, 414.605, 414.610(c)(9), and 414.626. We also 
finalized a data collection system that collects detailed information 
on ground ambulance provider and supplier characteristics including 
service areas, service volume, costs, and revenue through a data 
collection instrument, commonly referred to as the Medicare Ground 
Ambulance Data Collection Instrument, via a web-based system. We refer 
the reader to our CY 2020 PFS final rule (84 FR 62864 through 62897) 
for

[[Page 79294]]

more specifics on the establishment of the Medicare Ground Ambulance 
Data Collection System.
    In the CY 2022 PFS final rule (86 FR 65306 through 65317), we 
finalized a number of updates to the Medicare Ground Ambulance Data 
Collection System, including: (1) a new data collection period 
beginning between January 1, 2023, and December 31, 2023, and a new 
data reporting period beginning between January 1, 2024, and December 
31, 2024, for selected ground ambulance organizations in Year 3; (2) 
aligning the timelines for the application of penalties for not 
reporting data with our new timelines for data collection and reporting 
and a notice that the data collected will be publicly available 
beginning in 2024; and (3) revisions to the Medicare Ground Ambulance 
Data Collection Instrument that include better accounting for labor 
hours across different categories of personnel and better 
distinguishing between accrual and cost basis accounting methodologies. 
We refer the reader to our CY 2022 PFS final rule (86 FR 65306 through 
65317) for more specifics on the revisions to the Medicare Ground 
Ambulance Data Collection System.
    In the CY 2023 PFS final rule (87 FR 70014) we finalized a series 
of changes to the Medicare Ground Ambulance Data Collection System. 
First, we finalized our proposal to update our regulations at Sec.  
414.626(d)(1) and (e)(2) to provide the necessary flexibility to 
specify how ground ambulance organizations should submit hardship 
exemption requests and informal review requests, including to our web-
based portal once that portal is operational. Second, we finalized our 
proposed changes and clarifications to the Medicare Ground Ambulance 
Data Collection Instrument to reduce burden on respondents, improve 
data quality, or both. We refer the reader to our CY 2023 PFS final 
rule (87 FR 70014) for more specifics on the revisions to the Medicare 
Ground Ambulance Data Collection System.
b. Revisions to the Medicare Ground Ambulance Data Collection 
Instrument
    As described in the CY 2022 PFS final rule (86 FR 65307) and the CY 
2023 PFS Final Rule (87 FR 70014), we made several changes to the 
instrument instructions and questions to improve clarity and reduce 
burden for respondents. A printable version of the current instrument 
instructions and questions is available in English and Spanish on the 
CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AmbulanceFeeSchedule/Ground-Ambulance-Services-Data-Collection-System.
    We continue to receive ad hoc questions and feedback related to the 
Medicare Ground Ambulance Data Collection System and the Medicare 
Ground Ambulance Data Collection Instrument via four primary channels. 
First, we receive email and other written communication from ground 
ambulance organizations via the CMS Ambulance Data Collection email 
inbox ([email protected]) and through other channels 
(for example, inquiries sent by organizations to Medicare 
Administrative Contractors (MACs) and then forwarded to CMS). These 
emails and other communications often include questions seeking 
clarification of instrument questions and their applicability to 
specific ground ambulance organization scenarios and context. We 
continue to update a Medicare Ground Ambulance Data Collection System 
Frequently Asked Questions (FAQ) document with answers and the GADCS 
User Guide to commonly asked questions. These documents are available 
on the CMS website at https://www.cms.gov/medicare/medicare-fee-for-
service-payment/ambulancefeeschedule/ground-ambulance-services-data-
collection-system. Through review of questions and feedback, we 
identified some instances where a clarification to the instrument 
language itself will likely be more useful and less burdensome to 
respondents than having to respond with reference to the FAQ document, 
the GADCS User Guide, or to other resources. Second, we answer 
questions live from interested parties during webinars, dedicated 
question and answer sessions, and other educational sessions. As with 
the emailed questions described above, live question and answer 
exchanges sometimes identify opportunities for clarifying instrument 
language. Third, we have begun analyzing initial data responses 
submitted via the GADCS portal by selected organizations in Year 1 and 
Year 2. Findings from this initial analysis, including inconsistent 
response patterns, unusual combinations of responses across questions, 
and investigation of outlier results were helpful to identify some 
additional opportunities for clarification. Fourth, we continue to 
identify opportunities to clarify instructions and correct a small 
number of typos through the final development and launch of the web-
based GADCS.
    Based on information that we received via the four sources 
described above, we proposed in CY 2024 PFS proposed rule (88 FR 
52537), the following further changes and clarifications to the 
Medicare Ground Ambulance Data Collection Instrument. The changes and 
clarifications aimed to reduce burden on respondents, improve data 
quality, or both.
1. Addressing Partial-Year Responses
    Ground ambulance organizations selected to participate in the GADCS 
that are in operation for only part of their continuous, 12-month data 
collection period are, following the GADCS instructions, still required 
to collect and report data. However, there is not a field for these 
organizations to report that they were in operation, and therefore 
collecting data, for less than a full 12-month period via the GADCS. In 
these cases, we would not know that the costs, revenue, and utilization 
reported by these partial-year organizations are comparatively smaller 
than those reported by similar organizations in operation for an entire 
12-month period. As a result, some statistics from analyses of GADCS 
data, for example total annual expenditures per ground ambulance 
organization, would be biased downward.
    To address this limitation, we proposed in the CY 2024 PFS proposed 
rule (88 FR 52538) to add a response option to Section 2 
(Organizational Characteristics), Question 1 which asks whether the 
selected national provider identifier (NPI) linked to the organization 
was used to bill Medicare for ground ambulance services during its data 
collection period. The current response options are ``Yes (1)'' and 
``No (0)''. We proposed to split the existing ``Yes (1)'' response into 
two separate responses, one reading ``Yes, throughout the 
organization's continuous, 12-month data collection period (1)'' and 
``Yes, but for only part of the organization's continuous, 12-month 
data collection period (2).'' The ``No (0)'' response would not change. 
Respondents from organizations that billed for ground ambulance 
services during part of, but not all of, its continuous, 12-month data 
collection period, would select ``Yes, but for only part of the 
organization's continuous, 12-month data collection period (2)''. Those 
that did so would be prompted to enter the date they started and/or 
stopped operations during the continuous, 12-month data collection 
period in a pop-up box, followed by an instruction to proceed through 
the remainder of the GADCS reporting process.
    Organizations selecting ``Yes, throughout the organization's 
continuous, 12-month data collection period (1)'' would proceed through 
the

[[Page 79295]]

rest of the GADCS reporting process as would respondents answering 
``Yes (1)'' to this question currently. Organizations selecting ``No 
(0)'' would, as is currently the case, be prompted with several follow-
up questions which result in either: outreach to the GADCS helpdesk for 
assistance if the listed NPI does not match their organization, or if 
they answer that none of the scenarios in the follow-up questions apply 
or to the completion of the organization's data reporting requirement.
    This approach allows CMS to understand when reported costs, 
revenue, and utilization are measured over a period of time less than a 
full 12 months and, if necessary, to adjust partial-year responses so 
that they are more comparable to most responses that will cover a 
continuous full 12-month data collection period. Furthermore, we 
believe this approach will reduce confusion and burden for 
organizations in operation for only part of their 12-month data 
collection periods.
    We solicited comments on this proposal to address partial-year 
responses.
    We received public comments on this proposal. The following is a 
summary of the comments we received and our responses.
    Comment: Two commenters stated their overall support for our 
proposals to the Medicare Ground Ambulance Data Collection Instrument 
in the CY 2024 PFS proposed rule. The commenters appreciated CMS' 
efforts to educate, as well as to listen to input from interested 
parties and revise the data collection instrument based on this 
feedback.
    Response: We appreciate the commenters' support of our proposals.
    After consideration of the public comments we received, we are 
finalizing our proposal to add the ability to address partial- year 
responses as proposed.
2. Programming Logic for Hospitals and Other Medicare Providers of 
Services
    Section 2 of the GADCS printable instrument includes a programming 
note after Question 9 reading: ``For the remainder of the data 
collection instrument, instructions and items related to fire, police, 
or other public safety department-based ground ambulance organizations 
are shown to organizations that answer Section 2, Question 7= ``a'' or 
``b'' OR Question 8 = Yes (1) OR answer Question 9 = Yes (1) to one or 
both of a and b.'' The intent of this programming note is to ensure 
questions in Section 7 (Labor Costs) present instructions and response 
fields appropriate to organizations with staff having both ground 
ambulance and fire, police, or other public safety responsibilities. In 
other words, a for-profit, ground ambulance-only organization should 
not be asked whether they have ground ambulance staff with fire, 
police, or other public safety responsibilities, while a fire 
department-based ground ambulance organization should.
    Section 2, Question 8 asks whether organizations reporting to be 
fire department-based (response ``a'' in Section 2, Question 7), police 
or other public safety department-based (response ``b'' in Section 2, 
Question 7), or hospital or other Medicare provider of services-based 
(response ``d'' in Section 2, Question 7) share operational costs 
between ground ambulance and the respective other reported function. A 
programming note for Section 2, Question 8 states that the question 
should be asked of organizations responding a, b, or d to Section 2, 
Question 7. As a result, hospitals and other Medicare provider of 
services-based organizations responding ``d'' in Section 2, Question 7 
are presented with Section 2, Question 8, and many may respond ``Yes'' 
to Section 2, Question 8. As discussed above, answering ``Yes'' to 
Section 2, Question 8 triggers the appearance of table columns in 
Section 7, Question 1 related to fire, police, and other public safety 
staff (``Section 2, Question 7= ``a'' or ``b'' OR Question 8 = Yes (1) 
OR answer Question 9 = Yes (1) to one or both of a and b).
    As a result of these programming notes, many hospital-based 
organizations answering ``d'' to Section 2, Question 7 and ``Yes'' to 
Section 2, Question 8, and any options other than ``a'' or ``b'' in 
Section 2, Question 9 will see columns for fire, police, and other 
public safety staff in Section 7, Question 1, which was not intended. 
We believe that no ground ambulance organizations with this response 
pattern will have fire, police, or other public safety staff to report 
via the GADCS. Furthermore, we are concerned that this will result in 
confusion for hospital-based organizations.
    In the CY 2024 PFS proposed rule (88 FR 52538), we proposed to 
change the programming note after Section 2, Question 9 to read as 
follows: ``. . .instructions and items related to fire, police, or 
other public safety department-based ground ambulance organizations are 
shown to organizations that: (A) answer Section 2, Question 7= ``a'' or 
``b'' AND answering Question 8 = Yes (1); OR, (B) answer Question 9 = 
Yes (1) to one or both of ``a'' or ``b''.'' This change to the 
programming logic will result in provider-based ground ambulance 
organizations seeing only two columns in Section 7, Question 1, one for 
paid and the other, if applicable, for volunteer staff, and not columns 
specific to staff with fire, police, or other public safety 
responsibilities.
    We solicited comments on this proposal to change the programming 
note after Section 2, Question 9 in the GADCS printable instrument.
    We received public comments on this proposal. The following is a 
summary of the comments we received and our responses.
    Comment: Two commenters stated their overall support for our 
proposals to the Medicare Ground Ambulance Data Collection Instrument 
in the CY 2024 PFS proposed rule. The commenters appreciated CMS' 
efforts to educate, as well as to listen to input from interested 
parties and revise the data collection instrument based on this 
feedback.
    Response: We appreciate the commenters' support of our proposals.
    After consideration of the public comments we received, we are 
finalizing our proposal to change the programming note after Section 2, 
Question 9 in the GADCS printable instrument as proposed.
3. Typos and Technical Corrections
    In the CY 2024 PFS proposed rule (88 FR 52538), we proposed to make 
four corrections to the GADCS printable instrument.
     Section 2, Question 1a.ii is missing the word ``period'' 
after ``data collection'' in the text. Therefore, we proposed the 
question to read as: ``The NPI was in operation during the data 
collection period but was not used during the data collection to bill 
Medicare for ground ambulance services.''
     Section 2, Question 3 in the printable instrument 
questions ``What is the name of your organization? For the remainder of 
the instrument, the term ``organization'' refers to the NPI for which 
we are requesting data. (enter name)'' while the web-based GADCS asks 
``Is [ORGANIZATION NAME] the name of your organization? For the 
remainder of the instrument, the term `organization' refers to the NPI 
for which we are requesting data. Yes (1)/No (0).'' The web-based GADCS 
asks the question in this way because organization name is pre-
populated in the system and not entered directly. We proposed to change 
the language in the printable instrument to match the text in the web-
based GADCS for consistency.

[[Page 79296]]

     Section 9.1 (Ground Ambulance Vehicle Costs), Question 5 
current wording states ``Do not report ground ambulance acquisition 
costs related to an annual depreciation expense for the same 
ambulance'' which does not make sense. We proposed Question 5 to read 
as: ``Do not report an acquisition cost and an annual depreciation 
expense for the same ground ambulance.''
     Section 9.2 (Other Vehicle Costs (Non Ambulance)), 
Question 5 current wording includes the same error as noted above for 
Section 9.1, Question 5, and also mistakenly refers to ground 
ambulances rather than non-ambulance vehicles: ``Do not report non-
ambulance vehicle acquisition costs related to an annual depreciation 
expense for the same ground ambulance.'' We proposed to change the 
question to read as: ``Do not report an acquisition cost and an annual 
depreciation expense for the same ground non-ambulance vehicle.''
    We solicited comments on these proposals related to GADCS typos and 
technical corrections.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Two commenters stated their overall support for our 
proposals to the Medicare Ground Ambulance Data Collection Instrument 
in the CY 2024 PFS proposed rule.
    Response: We appreciate the commenters' support of our proposals.
    After consideration of the public comments we received, we are 
finalizing our typos and technical corrections as proposed.

O. Hospice: Changes to the Hospice Conditions of Participation

1. Background and Statutory Authority
    We have broad statutory authority for most provider and supplier 
types to establish health and safety regulations, which includes the 
authority to establish health and safety requirements that advance 
health equity for underserved communities. Certain statutes explicitly 
give CMS the authority to enact regulations that the Secretary finds 
necessary in the interest of the health and safety of individuals who 
are furnished services in an institution, while others give CMS the 
authority to prescribe regulations as may be necessary to carry out the 
administration of the program. Section 122 of the Tax Equity and Fiscal 
Responsibility Act of 1982 (Pub. L. 97-248) (TEFRA), added section 
1861(dd) to the Act to provide coverage for hospice care to terminally 
ill Medicare beneficiaries who elect to receive care from a Medicare-
participating hospice. Under the authority of section 1861(dd)(2)(G) of 
the Act, the Secretary established the Conditions of Participation 
(CoPs) that a hospice must meet to participate in Medicare and/or 
Medicaid, and these conditions are set forth at 42 CFR part 418. The 
CoPs apply to the hospice as an entity, as well as to the services 
furnished to each individual under hospice care. Under section 
1861(dd), the Secretary is responsible for ensuring that the CoPs and 
their enforcement, are adequate to protect the health and safety of the 
individuals under hospice care. To implement this requirement, State 
survey agencies conduct surveys of hospices to assess their compliance 
with the CoPs.
    The Consolidated Appropriations Act of 2023 (Pub. L. 117-328) (CAA 
2023), was signed into law on December 29, 2022. Division FF, section 
4121 of the CAA 2023 establishes a new Medicare benefit category for 
marriage and family therapist (MFT) services and mental health 
counselor (MHC) services furnished by and directly billed by MFTs and 
MHCs, respectively. Section 4121(b)(2) of CAA 2023 specifically adds 
these services to covered hospice care services under section 
1861(dd)(2)(B)(i)(III) of the Act. To implement division FF, section 
4121 of the CAA 2023, we proposed to modify the requirements for the 
hospice CoPs at Sec.  418.56 ``Interdisciplinary group, care planning 
and coordination of service,'' and Sec.  418.114 ``Personnel 
qualifications.'' This statutorily-required modification allows MFTs 
and MHCs to serve as members of the interdisciplinary group (IDG). 
Specifically, the CAA 2023 revised section 1861(dd) of the Act to state 
that the hospice interdisciplinary group is required to include a 
social worker, MFT, or MHC. In addition, we proposed to modify the 
hospice personnel qualification at Sec.  418.114(c) to also include 
qualifications for an MFT and an MHC.
2. Summary of the Hospice Proposed Provisions, Public Comments, and 
Responses to Comments
    In this section, we discuss the public comments received on the 
inclusion of an MFT and MHC as part of the IDG for hospice care and 
personnel requirements. We received a total of 13 unique comments from 
patient advocacy groups, national associations, and individuals with a 
personal or professional interest in this proposed rule. Overall, 
commenters were generally supportive of the addition of the MFT and MHC 
to the hospice IDG. Several of the comments sought additional 
information and clarification on the implementation of these proposals. 
In addition, many comments expressed burden concerns related to 
staffing shortages and highlighted the challenges rural areas 
experience with limited access to behavioral health professionals. A 
few commenters believed CMS misinterpreted the Statute and that the 
proposed provisions do not align with congressional intent.
    The following is a summary of the comments we received, our 
responses, and the policies we are finalizing for hospices.
a. General Comments
    Comment: A commenter asked if an MFT and MHC will be able to admit 
a hospice patient, stating that social workers are able to admit 
patients. They stated that because (based on the commenter's 
understanding) social workers can admit a hospice patient, the MFT and 
MHC should also be able to do the same. Further, a commenter asked if 
the hospice MSW would supervise the MFT and MHC.
    Response: We thank the commenter for the question regarding 
admitting a patient to hospice. We believe the commenter is referring 
to the hospice's initial visit with the patient. The initial and 
comprehensive assessment requirements for hospices have not changed and 
can be found at Sec.  418.54. Specifically, at Sec.  418.54(a), we 
require the hospice registered nurse to complete an initial assessment 
within 48 hours after the election of hospice care in accordance with 
Sec.  418.24 (unless the physician, patient, or representative requests 
that the initial assessment be completed in less than 48 hours.) There 
are no requirements in the assessment CoPs that require the social 
worker (SW) to be included in the initial assessment visit. However, we 
understand that many hospices utilize both the nurse and the SW for the 
initial assessment. Therefore, it would be within the individual 
hospice's purview to allow for the MFT or MHC to accompany the nurse to 
complete the initial assessment.
    There are no regulatory requirements for the supervision of the MFT 
and MHC other than what is referenced in the Condition of 
participation: Interdisciplinary group, care planning, and coordination 
of services, Sec.  418.56(a)(1). The role of the IDG is to meet the 
physical, medical, psychosocial, emotional, and spiritual needs of the 
hospice patients and families facing terminal illness and bereavement; 
``Interdisciplinary group members must provide the care and services 
offered by the hospice, and the

[[Page 79297]]

group, in its entirety, must supervise the care and services.''\442\
---------------------------------------------------------------------------

    \442\ https://www.govinfo.gov/content/pkg/FR-2008-06-05/pdf/08-1305.pdf.
---------------------------------------------------------------------------

    Comment: A commenter asked for clarification on the billing 
requirements for MFTs and MHCs, and if CMS will communicate this 
through a change request. In addition, the commenter asked if this 
information will be communicated in the Physicians Fee Schedule final 
rule or in a hospice final rule. The commenter recommended that this 
information be included in the 2024 hospice final rule to ensure that 
the target audience is aware of these proposals and for continuity. 
Lastly, a commenter asked for additional clarification regarding the 
language in this proposed rule, specifically, ``Division FF, Section 
4121 of the CAA 2023 and the establishment of a new Medicare benefit 
category for MFT and MHC services furnished and directly billed by MFTs 
and MHCs respectively.''
    Response: The referenced language in the CAA 2023 refers to the 
establishment of MFT and MHC as providers under Medicare. This rule set 
forth certain requirements for MFT and MHC enrollment, qualifications, 
and billing as Part B providers. However, the billing of these services 
under Part B does not apply to hospices. Hospices are paid at a daily 
rate for each patient based on the patient's level of care. Similar to 
other hospice services, the services of MFTs and MHCs are included in 
that daily rate. There are no separate billing provisions for MFT and 
MHC services, and an MFT or MHC cannot independently bill Medicare for 
services rendered to a hospice patient.
    While we understand publishing the proposed rule and finalizing 
these requirements in a hospice rule may have been more apparent to the 
hospice industry, due to the hospice wage index publication dates and 
the CAA 2023 implementation requirements; it was determined that the CY 
2024 PFS rule was the best rulemaking vehicle to propose and finalize 
the CAA requirements. Therefore, all the hospice CoP information and 
requirements related to MHCs and MFTs are published in this final rule, 
and there are no plans to republish this information in a separate 
hospice rule.
    Comment: One commenter stated that it was their understanding that 
the MFT and MHC appear to be missing from other applicable regulations, 
specifically that MFTs and MHCs are not listed as medical social 
service providers in the way in which social workers are listed at 
Sec. Sec.  418.64 and 418.202. One commenter suggested that the MFT and 
MHC be added to medical social services, or that the mention of the SW 
be removed from this provision.
    Response: We thank this commenter for their feedback. While the 
social worker is a member of core services, a MFT and MHC are not. The 
CAA 2023 did not modify the Statute to include the MFT or MHC under 
medical social services. The Hospice Benefit Policy Manual defines 
medical social services as, ``services which contribute meaningfully to 
the treatment of a patient's condition. Such services include, but are 
not limited to: Assessment of the social and emotional factors related 
to the patient's illness, need for care, response to treatment, and 
adjustment to care in the facility; Appropriate action to obtain case 
work services to assist in resolving problems in these areas; and 
Assessment of the relationship of the patient's medical and nursing 
requirements to their home situation, financial resources, and the 
community resources available to them in making the decision regarding 
their discharge.'' \443\ In addition, the hospice 2008 final rule 
entitled, ``Medicare and Medicaid Programs: Hospice Conditions of 
Participation'' (73 FR 32088) stated, ``It is essential that the 
individuals providing medical social services to hospice patients be 
qualified to provide these services.''\444\ Section Sec.  418.114 
addresses the personnel qualifications that social workers must meet in 
order ``to provide services to hospice patients.'' Longstanding CMS 
regulations and policies across multiple provide types including 
hospice, home health agencies, and hospitals considers medical social 
services, also referred to as social services, to be linked directly to 
the scope of practice and duties of the social 
worker.445 446 447 For example, Chapter 9 of the Medicare 
Benefit Policy Manual, ``Coverage of Hospice Services Under Hospital 
Insurance,'' states that ``Medical social services must be provided by 
a person who meets the criteria given in the Conditions of 
Participation at Sec.  418.114(b)(3).'' \448\ Section Sec.  
418.114(b)(3) defines a ``social worker'' as, a person who has a Master 
of Social Work (MSW) degree from a school of social work accredited by 
the Council on Social Work Education; or has a baccalaureate in social 
work from an institution accredited by the Council on Social Work 
Education; or a baccalaureate degree in psychology, sociology, or other 
field related to social work and is supervised by an MSW as described 
in paragraph (b)(3)(i)(A) of this section; and has 1 year of social 
work experience in a healthcare setting; or Has a baccalaureate degree 
from a school of social work accredited by the Council on Social Work 
Education, is employed by the hospice before December 2, 2008, and is 
not required to be supervised by a MSW.\449\ Therefore, it would not be 
appropriate to add MFT and MHC to the medical social service 
requirement.
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    \443\ https://www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/bp102c01.pdf.
    \444\ https://www.federalregister.gov/documents/2008/06/05/08-1305/medicare-and-medicaid-programs-hospice-conditions-of-participation.
    \445\ www.cms.gov/regulations-and-guidance/guidance/manuals/downloads/bp102c09.pdf.
    \446\ https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c07.pdf.
    \447\ https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-B/part-409/subpart-E/section-409.45.
    \448\ https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-B/part-418.
    \449\ https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-B/part-418.
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    Comment: Multiple commenters expressed concern over the staffing 
shortages and lack of mental health professionals in certain areas of 
the country, including rural areas. Specifically, commenters stated 
that rural areas may not have access to MFTs and MHCs and asked how 
hospices should address this access issue. A commenter also asked if 
hospices will be able to contract these professionals for remote visits 
and if this would still meet the intent of the regulation. The 
commenter expressed concern over transporting the patient to these 
professionals due to their illness and explained that they were unaware 
of MFTs or MHCs making home visits.
    Response: We acknowledge the presence of staffing shortages and 
recognize the importance of increasing the presence of and access to 
behavioral health professionals. We are aware that hospices in rural 
areas experience challenges in recruiting and retaining staff and that 
there is a shortage of behavioral health providers. We also recognize 
the value of telehealth services in improving access to health care 
services. However, the final rule, ``Medicare Program; FY 2024 Hospice 
Wage Index and Payment Rate Update, Hospice Conditions of Participation 
Updates, Hospice Quality Reporting Program Requirements, and Hospice 
Certifying Physician Provider Enrollment Requirements'' published 
August 2, 2023, (88 FR 51164) clarifies that the hospice regulations at 
Sec.  418.204 were amended on an interim basis during the COVID-19 
Public Health Emergency (PHE). This amendment of the requirements 
allows for a waiver for hospices to provide services via

[[Page 79298]]

telecommunications if it was feasible and appropriate to ensure that 
Medicare patients could continue receiving services that were 
reasonable and necessary for the palliation and management of a 
patient's terminal illness and related conditions without jeopardizing 
the patient's health and or the health of those who are providing such 
services during the COVID-19 PHE. This amendment only authorized the 
Secretary to extend this flexibility through December 31, 2024. 
Additionally, the authors of the Hospice Wage Index Final Rule note 
that the hospice benefit is best when provided in person and stress the 
importance of in-person services.\450\
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    \450\ https://www.federalregister.gov/documents/2023/08/02/2023-16116/medicare-program-fy-2024-hospice-wage-index-and-payment-rate-update-hospice-conditions-of.
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    Comment: A commenter expressed support for the IDG changes and 
suggested that CMS should allow PAs and NPs to substitute in the place 
of a physician as a required member of the IDG.
    Response: We appreciate the commenters support on the IDG 
provision. We note that the IDG member requirements at Sec.  
418.56(a)(1) are statutorily-mandated at section 1861(dd)(2)(B)(i) of 
the Act. Therefore, there would need to be a change in the law for CMS 
to amend the hospice regulations in the manner suggested by the 
commenter.
    Comment: One commenter sought additional information regarding 
HCPCS codes, quality reporting programs, and the hospice cost report. 
Specifically, this commenter asked if CMS will add HCPCS codes to 
hospice claims for identification of visits made by MFTs and MHCs. They 
also asked if there were plans to include MFT and MHC visits in the 
hospice quality reporting program. Lastly, this commenter asked how 
hospices should record MFT and MHC visits in the hospice cost report.
    Response: We thank this commenter for their thoughtful questions. 
However, these topics are outside the scope of the CoPs. We will 
consider this feedback and share it with our CMS colleagues so that it 
may be taken into consideration in future rulemaking.
b. Sec.  418.56 Condition of Participation: Interdisciplinary Group, 
Care Planning, and Coordination of Services
    At Sec.  418.56(a)(1)(iii) we proposed to require that the IDG must 
include a social worker (SW), MFT, or MHC depending on the preferences 
and needs of the patient. Section 4121 of the CAA 2023 specifically 
modified the statute to require the hospice interdisciplinary team to 
include one SW, MFT, or MHC. However, we emphasized that each hospice 
patient and family are different in their needs and goals. We explained 
how the services SWs, MFTs, and MHCs provide are not interchangeable, 
and that each offers unique support that may be valuable to the patient 
and family based on the situation. Therefore, it is important for the 
hospice to assess and determine what care and services best support the 
needs of the patient. This information would be included in the 
individualized patient plan of care in accordance with Sec.  418.56(c), 
as well as which discipline(s) (SW, MFT, or MHC) will be caring for the 
hospice patient. We note that the IDG must develop an individualized 
plan of care for each patient that is based on the needs of the 
patient, so we expect that the needs of the patient will be addressed 
regardless of whether a SW, MFT, of MHC serves on the IDG.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Several commenters expressed concern that CMS was 
misinterpreting the statute and that the proposed provisions do not 
align with congressional intent. Specifically, the commenters noted 
that they do not believe that the patient preferences and needs of the 
of the patient should drive the IDG membership. These commenters 
pointed out that the provision in the CAA 2023 was meant to be 
optional, allowing the choice of which practitioner will sit on the 
IDG. They stated that making it mandatory would create a significant 
burden for hospices and be difficult to comply with. Commenters 
emphasized the use of the word ``or'' in the amended language of the 
CAA 2023 indicates that the hospice IDG includes at least one SW, one 
MFT, or one MHC, not all three disciplines. The hospice community 
interpreted the language in the CAA to mean that hospices have the 
choice of using a SW, MFT, or MHC, and would not be required to employ 
or contract with a MFT or MHC. One commenter urged CMS to underscore 
that it is not a requirement to make them available, even when 
counseling services are in the plan of care. The commenters emphasized 
that requiring every hospice to add an MFT or MHC would deprive 
beneficiaries of access to hospice care. Commenters explained that the 
statute indicates the disciplines from which a hospice must choose IDG 
members to, ``provide or supervise the provision of,'' covered hospice 
services. The commenters noted that the statute does not address the 
needs and preferences of the patient, and one commenter expressed their 
belief that CMS was exceeding their statutory authority by adding 
``depending on the preferences and needs of the patient'' to this 
requirement. They explained that their interpretation on the use of 
this language would require the hospice to have all three disciplines 
as part of the IDG and that this would eliminate the intended 
flexibility for hospices to choose the IDG members. They also noted 
that regulations implementing the statutory language regarding IDG 
membership have not been connected to patient needs and preferences in 
the past. Commenters stated it will be necessary to revise the proposed 
provisions to accurately and completely implement this statutory 
amendment.
    Response: The hospice IDG will only be required to include one SW, 
one MFT, or one MHC. The hospice is not required to include all three 
of these professions as members of the IDG. We note that the hospice 
may choose (although is not required) to select more than one of these 
professions to serve as member(s) of the IDG. The MFT or MHC must be 
hired as a direct employee which would include the options of hiring 
full time, part time or per diem. This may alleviate some of the 
staffing challenges that hospices may experience by allowing more 
flexibility in the recruitment and hiring process. In addition, the 
2008 hospice final rule (73 FR 32088) implemented section 946 of the 
MMA (Medicare Modernization Act).\451\ In accordance with section 946 
of the MMA, a hospice (the primary hospice) may enter into arrangements 
with another Medicare-certified hospice to obtain core hospice 
services. The MMA provided that this could be done under extraordinary 
or other nonroutine circumstances. The Act specifically states 
``substantially all'' in recognition of the fact that there are times 
when hospices must contract for core services. Section 1861(dd)(5)(D) 
of the Act identifies the circumstances in which hospices are permitted 
to contract for core services as those that are ``extraordinary'' or 
otherwise ``nonroutine'' such as unanticipated periods of high patient 
loads, temporary staffing shortages, and travel of a patient outside of 
the hospice's service area. The provision at Sec.  418.64(d) requires 
counseling services to be available to the patient and family to assist 
the patient and family in minimizing the stress and problems that arise 
from the

[[Page 79299]]

terminal illness, related conditions, and the dying process. We believe 
the MFT and MHC primarily provide counseling services and that 
counseling services are considered core services of the hospice. The 
``extraordinary circumstance'' provision is generally a short-term 
temporary event that was unanticipated. This may allow hospices the 
flexibility to contract for the MFT or MHC during temporary staffing 
shortages. If a hospice chooses to contract with another Medicare-
certified hospice or a non-hospice entity, the contracting hospice or 
non-hospice entity must maintain professional management responsibility 
for the services provided, in accordance with Sec.  418.100(e). During 
a survey to determine the hospice's compliance with the CoPs, the 
hospice should be able to explain why it is using the ``extradentary 
circumstance'' to mitigate the staffing shortages and how it is working 
towards hiring direct staff. The survey process for Medicare and 
Medicaid participating hospices provides an opportunity for them to 
demonstrate compliance with all of the applicable CoPs. The methods 
used by CMS to determine compliance with the hospice regulations 
include surveys conducted by a State survey agency and surveys 
conducted by AOs that have deeming authority for Medicare and Medicaid 
participating hospices. Currently, the professionals (physician, 
registered nurse, social worker, pastoral or other counselor) that 
comprise the IDG are responsible for providing and supervising the 
provision of the care and services for each patient. The CAA 2023 has 
now provided hospices with the option to select between multiple 
professionals. In the past, the IDG structure did not require hospices 
to distinguish between different disciplines, each with their own 
unique scope of practice, when determining IDG membership. As stated 
earlier, and commenters agreed, the services provided by SWs, MFTs, and 
MHCs are not interchangeable. Each offers unique support that may be 
valuable to the patient and family based on the situation. For example, 
a SW may assist the patient and their family with issues regarding 
finances or connecting the family to valuable community resources. 
Conversely, therapy and counseling services traditionally may help 
patients cope with mental distress.
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    \451\ https://www.federalregister.gov/documents/2008/06/05/08-1305/medicare-and-medicaid-programs-hospice-conditions-of-participation.
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    We believe it is important for the hospice IDG to consider the 
patients' assessed needs to ensure IDG member, whether it be a SW, MFT 
or MHC, have the appropriate knowledge and scope of practice to share 
and recommend care options related to the services that patient is 
receiving or may need. We agree the hospice has the choice to select 
either a SW, MFT or MHC. We also understand that hospice may have IDG 
team members pre-selected to serve on specific teams, and it may be 
administratively impractical to change a member based on the needs of 
one patient. Therefore, we are not finalizing the requirement that the 
SW, MFT, or MHC be a member of the IDG ``based on the needs and 
preferences of the patient.'' While we are modifying the proposed 
requirement, we stress that hospices have always had the option to have 
non-IDG staff that provide care for the patient to attend the IDG 
meetings to share patient status, issues/concerns, and recommendations. 
For example, if the patient is receiving care and services from a SW 
and MFT, and the MFT is the designated member of the IDG; the SW could 
attend the IDG meeting and provide the IDG team with updates related to 
social work services. Additionally, if the patient is receiving 
volunteer services, the volunteer may attend the IDG meeting to share 
information that will assist with informing the plan of care.
    The provisions at Sec.  418.56(e) requires the hospice to develop 
and maintain a system of communication and integration, in accordance 
with the hospice's own policies and procedures. The provision also 
requires the hospice IDG to maintain responsibility for directing, 
coordinating, and supervising the care and services provided; ensure 
that the care and services are provided in accordance with the plan of 
care (which is based on the needs of the patient); ensure that the care 
and services provided are based on all assessments of the patient and 
family needs, and to provide for and to ensure the ongoing sharing of 
information between all disciplines providing care and services in all 
settings, whether the care and services are provided directly or under 
arrangement.\452\ The hospice model has always been based on an 
interdisciplinary care model, which requires frequent communication 
between care disciplines across settings, as well as between the 
hospice, the patient and the family. The hospice relies on 
communication between and integration of providers to effectively plan 
and furnish care to patients and families. Over time, hospices have 
developed methods within their policies and procedures to ensure that 
all members of a patient's care team receive timely information about 
patients. Therefore, we expect that the hospices' ``system of 
communication'' would include how information is communicated and 
shared during the IDG meetings; ensuring pertinent patient care 
information from each discipline caring for each patient are 
communicated with the IDG, according to the hospices own policies.
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    \452\ https://www.federalregister.gov/documents/2008/06/05/08-1305/medicare-and-medicaid-programs-hospice-conditions-of-participation.
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    Comment: Several commenters shared their support for the inclusion 
of the MFT and MHC in the interdisciplinary group and in the personnel 
qualifications. A few commenters stated they appreciate CMS' 
acknowledgment of the importance of collaborative decision-making 
between provider, client, and family in providing the best care aligned 
to that patient's needs and preferences. Beneficiaries' access to 
robust care provider options to meet their needs is pivotal in 
providing quality care, during what can be a particularly difficult 
time, and help to decrease distress. Another commenter supported the 
proposed changes and suggested that additional information regarding 
implementing these provisions be included in the State Operations 
Manual/interpretive guidance. This commenter also sought guidance on 
whether the hospice would need to document their decision-making 
process in selecting which practitioner (MFT, MHC, or SW) will serve as 
a member of the IDG, as they consider the patient's needs and 
preferences. The commenter stated that this could lead to an additional 
administrative burden.
    Response: We thank the commenters for their support of these new 
proposals. Additional information regarding the implementation and 
execution of these proposals will be provided in the hospice 
interpretive guidance, which will be published following the 
publication of this final rule. It is important for the hospice to 
assess and determine, along with the input from the patient and family, 
which care and services are most appropriate/ensure the health and 
safety of the patient. Therefore, we expect that during the care 
planning process, the hospice IDG would consider the patient's needs 
and preferences will provide services to meet the needs of the patient. 
As stated earlier, the information from the patient's assessment would 
be included in the individualized patient plan of care, as well as 
which professional(s) (SW, MFT or MHC) will be caring for the hospice 
patient.
    Comment: Several commenters found the language ``at least one 
social worker, MFT, or MHC'' in the proposed rule unclear. This 
language led these commenters to seek clarification regarding whether 
the hospice IDG must

[[Page 79300]]

include a SW and MFT, SW and MHC, all three professionals, or just one 
of these professionals. Additionally, a few comments shared that it was 
their interpretation that the addition of the MFT and MHC was optional, 
not mandatory.
    Response: The statutory language of division FF, section 4121 of 
the CAA 2023 states that section 1861(dd)(2)(B)(i)(III) of the Act (42 
U.S.C. 1395x(dd)(2)(B)(i)(III)) is amended by inserting `, marriage and 
family therapist, or mental health counselor' after social worker,''' 
and that, ``The amendments made by this section shall apply with 
respect to services furnished on or after January 1, 2024.'' This 
language clarifies that hospices have the ability to discern which 
professional to choose to serve as a member of the IDG. The language 
``at least'' was used in the proposed rule to qualify that there must 
be, at minimum, one of these three professionals who serve as members 
of the IDG. As previously discussed, we emphasize the hospice 
interdisciplinary care model, which relies on communication between and 
integration of providers to effectively plan and furnish care to 
patients and families.
    Comment: Many commenters concurred with CMS that the needs, 
preferences, and goals of each hospice patient and family should be 
considered when determining which professional (SW, MFT, or MHC) should 
serve on a hospice IDG. Commenters also noted that grief and 
bereavement counseling that hospice patients and their families may 
need should be from a counselor with a master's or higher degree and 
should be distinguished from the case management services provided by 
social workers on a hospice interdisciplinary team. Further, the 
commenter stated these different types of supportive services may both 
be needed, and hospice programs should be encouraged to ensure access 
to both, to the extent possible.
    Response: We appreciated the commenters support on this provision. 
We note that bereavement counseling is out of scope for this rule and 
is a separate requirement in the hospice CoPs at Sec.  418.64(d)(1). 
The bereavement counseling provision requires the hospice to have an 
organized bereavement program furnished under the supervision of a 
qualified professional with experience or education in grief or loss 
counseling. We note the commenters recommendations and will consider 
this for future rulemaking.
    Comment: One commenter noted that MFT and MHC services may 
potentially be needed more often in areas with larger populations.
    Response: We thank the commenter for providing insight into areas 
that will benefit from our proposed provisions. We believe all 
populations, including areas with larger populations, may benefit from 
MFT and MHC services.
    Comment: We received one comment that discussed that the MFT and 
MHC are not defined as ``non-core services'' like physical therapy, 
occupational therapy, and speech-language pathology, which are defined 
at Sec.  418.70. The commenter noted that these ``non-core'' services 
have clearly defined expectations for hospices in contracting and 
providing services, including waivers for when the professionals are 
not available in a hospice's service area.
    Response: We are aware that hospices in rural areas experience 
challenges in recruiting and retaining staff and that there is a 
shortage of behavioral health providers. Hospices have the option to 
directly employee MFTs and MHCs full time, part time or per diem, which 
provides additional flexibility to the hospice in their recruitment and 
hiring practices. This may help to hire the most qualified 
professionals, as well as increase employee retention. Further, Sec.  
418.74 allows hospice to waive the requirement to provide physical 
therapy, occupational therapy, speech-language pathology, and dietary 
counseling 24 hours a day for hospices located in non-urbanized areas. 
This waiver does not eliminate the requirement that the hospice must 
provide these services, it waives the requirement to provide the 
services 24 hours a day. At this time, we are not proposing revisions 
to these ``non-core services'' CoPs but will consider this for future 
rulemaking.
    Comment: Several commenters were concerned about the enforcement of 
these provisions. These commenters asked if there would be consequences 
if the hospice is unable to comply with these regulations.
    Response: We acknowledge that there is an increased need for 
behavioral and mental health services. However, we understand that many 
regions, particularly rural areas, may not be able to fulfill this 
need. We will follow the standard survey and enforcement process and 
additional information regarding the implementation of these provisions 
will be available in interpretative guidance that will be published 
following the publication of this final rule.
    After consideration of public comments on this provision, we are 
finalizing the proposed requirements with modification at Sec.  418.56 
by removing the phrase ``depending on the preferences and needs of the 
patient.'' We believe this modification will provide additional 
flexibility for the hospice to choose the members of the IDG while also 
utilizing the hospice's system of communication (Sec.  418.56(e)) to 
ensure information is communicated during the IDG meetings, according 
to the hospices own policies.
    The inclusion of an MFT or MHC as members of the hospice IDG helps 
to provide hospices with greater flexibility in IDG membership in 
meeting the mental health needs of their patients. The provisions 
support our responsibility to protect patient health and safety by 
encouraging the patients' and their family members to act as active 
participants in decision-making processes. We believe that this action 
strengthens our response to the need for increased access to behavioral 
and mental health services.
b. Personnel Qualifications (Sec.  418.114)
    With the introduction of MFT and MHC into the hospice CoPs, it is 
important to also include these new disciplines into the personnel 
qualifications at Sec.  418.114. Currently the requirement at Sec.  
418.114 establishes the requirements for several disciplines that work 
in hospices including but not limited to social worker, registered 
nurse and the therapist. We proposed to add both MFT and MHC to the 
provider requirements under 42 CFR subpart B, Medical and Other Health 
Services at Sec. Sec.  410.53 and 410.54. Therefore, to avoid 
duplication and confusion between the CoP and the Medical and Other 
Health Services requirements, we proposed to add both MFT and MHC to 
the requirements as new standards at Sec.  418.114(c)(3) and (4) and 
reference the new requirements at Sec. Sec.  410.53 and 410.54, 
respectively.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Several commenters shared their support for the inclusion 
of the MFT and MHC in the personnel qualifications.
    Response: We thank this commenter for their support for the 
inclusion of MFT and MHC in the hospice personnel requirements. We 
believe this provision will help support the introduction of MFTs and 
MHCs to hospice.
    Comment: One commenter that suggested that the MFT and MHC should 
be cited at Sec.  418.114(a) instead of the proposed Sec.  418.114(c). 
This commenter clarified that this change is needed to ensure that MFTs 
and MHCs

[[Page 79301]]

can effectively serve as hospice providers.
    Response: We thank the commenter for bringing this to our attention 
and we agree that it would be more appropriate for the MFT and MHC 
personnel requirements to be located at a different regulation citation 
to accurately reflect the licensure requirements for these professions. 
However, we believe it is more appropriate to redesignate the proposed 
personnel requirements at Sec.  418.114(b)(9) and (10) with the 
personnel qualifications for certain disciplines in order to reflect 
the State licensure requirements that the MFT and MHC have. We have 
collaborated with our colleagues to accurately align the personnel 
requirements for the MFT and MHC with the proposed definitions for 
these professions at Sec. Sec.  410.53 and 410.54.
    Comment: One commenter noted that States define MFTs and MHCs 
differently, and that this may result in hospices being unable to 
utilize MFTs and MHCs in some States.
    Response: We refer to the definitions of the MFT and MHC at 
Sec. Sec.  410.53 and 410.54. If State requirements for MFT and MHC are 
stricter than our Federal requirements, then those stricter State 
requirements would take precedence. If State requirements are less 
stringent than Federal requirements, then the Federal requirements will 
take precedence. We believe that the scope of this final rule are the 
minimum health and safety requirements with which facilities could 
reasonably be expected to comply.
    After consideration of the public comments we received, we are 
finalizing this provision with modification by redesignating the 
personnel qualifications at Sec.  418.114(c)(3) and (4) to Sec.  
418.114(b)(9) and (10) referencing requirements at Sec. Sec.  410.53 
and 410.54, respectively. The inclusion of an MFT and MHC in the 
personnel requirements will clarify for hospices the qualifications 
required for MFT and MHC.

P. Request for Information: Histopathology, Cytology, and Clinical 
Cytogenetics Regulations Under the Clinical Laboratory Improvement 
Amendments (CLIA) of 1988

1. Background
    The Clinical Laboratory Improvement Advisory Committee (CLIAC), 
CMS, interested parties, and State Agency (SA) surveyors have 
identified areas in the CLIA requirements that may need updating.
a. Histopathology
    The Clinical Laboratory Improvement Amendments of 1988 (CLIA) (Pub. 
L. 100-578, October 31, 1988) regulations related to histopathology 
have not been updated since 1992. The current Histopathology 
requirements may not represent new innovations and technology performed 
in laboratories.
(1) Slide Preparation and Staining
    Facilities only collecting or preparing specimens (or both) or only 
serving as a mailing service but not performing testing are not 
considered laboratories \453\. Slide staining and tissue processing 
have not been subject to the CLIA regulations. However, we received 
inquiries from interested parties stating that slide staining and 
tissue processing are an essential part of the testing process for 
histopathology. Absent these steps, the tissue cannot be prepared, 
mounted onto a slide, or accurately evaluated by a pathologist to make 
an assessment for diagnosis.
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    \453\ See definition of ``laboratory'', https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493#493.2.
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    Slide staining in histopathology includes routine Hematoxylin and 
Eosin (H&E) staining, special stains, and immunohistochemical (IHC) 
stains. Routine slide staining in histopathology provides simple 
cellular identification and requires minimal steps with solutions, 
dyes, and clearing reagents (for example, Hematoxylin & Eosin stains, 
Giemsa stain). An individual trained under the supervision of a 
qualified technical supervisor can perform these staining techniques. 
An independent facility (for example, a processing center, that 
performs slide staining) is not required to hold a CLIA certificate. 
IHC stains are complex stains designed to identify specific antigens 
and targets within the cells. These targets can include ribonucleic 
acid (RNA) and deoxyribonucleic acid (DNA) specific reactivity. The 
U.S. Food and Drug Administration (FDA) has categorized instruments 
that perform automated IHC staining as high complexity. Therefore, 
individuals that perform IHC staining in a CLIA certified laboratory 
(for example, histotechnicians, histotechnologists, and pathology 
assistants) must meet the personnel requirements for facilities 
carrying out high complexity testing. The facility must also hold a 
CLIA certificate in the subspecialty of testing performed.
(2) Gross Tissue Examination Review
    Testing in histopathology includes both gross tissue examination 
(macroscopic) and the microscopic evaluation of the stained slide(s) 
with evaluation and diagnostic interpretations, and the reporting of 
diagnostic findings by qualified personnel. Gross examination means the 
manipulation, orientation, and selection of the desired representative 
pieces of excised tissue from the total specimen received. This 
includes the physical examination and description, color, weight, 
measurements, and other characteristics of the tissue. Selected 
portions of the tissue are placed into a tissue cassette, subjected to 
a fixative, processed and infiltrated with paraffin wax, placed onto a 
slide(s), and stained before being reviewed and evaluated by a 
technical supervisor.
    The CLIA State Operations Manual (SOM), Appendix C (``Interpretive 
Guidelines'')\454\ for 42 CFR 493.1489(b)(7) state that gross 
examinations may be performed by individuals qualified under Sec.  
493.1489 as delegated by the technical supervisor. The technical 
supervisor is not required to provide on-site supervision, but is 
responsible for the review, accuracy, and confirmation of the 
macroscopic gross examination in the patient report. The documentation 
of the review of the results of the macroscopic gross examination by 
the technical supervisor must be included in the signed microscopic 
examination report, as required at Sec.  493.1273(d). The CLIA 
regulations do not cover the acceptable timeframe in which the review 
of the gross tissue examination must be completed. The discussion 
surrounding the review of the gross tissue examination includes CLIA's 
oversight at this phase of the histopathology testing process. CLIA 
supports an acceptable timeframe to permit a pathologist to review the 
tissue specimen prepared during the gross examination by a qualified 
technical supervisor. This review can be delegated by the technical 
supervisor to a qualified individual. Gross examination is a critical 
part of the tissue analysis process to ensure subsequent pathology 
tests are accurate and reliable. The review of the gross tissue is 
important to protect the patient's specimen identification during the 
testing process.
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    \454\ CLIA Interpretive Guidelines: https://www.cms.gov/regulations-and-guidance/legislation/clia/interpretive_guidelines_for_laboratories.
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b. Cytology
(1) CLIA Statute and Regulations
    CLIA revised section 353 of the Public Health Service Act (42 U.S.C 
263a) to authorize the regulation of all clinical

[[Page 79302]]

laboratories. Section 353(4)(B)(vi) of the Public Health Service Act 
requires that all cytological screening be done on the premises of a 
laboratory that is certified under this section.
    The CLIA regulations for cytology state that cytology slide 
preparations must be evaluated on the premises of a laboratory 
certified to conduct testing in the subspecialty of cytology at Sec.  
493.1274(a).
(2) Clinical Laboratory Improvement Amendments (CLIA) Guidance for 
Temporary Testing Sites Under the Multiple Site Exception \455\, CMS 
Policy Memo (QSO-22-13-CLIA)
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    \455\ QSO-22-13-CLIA:
    https://www.cms.gov/medicareprovider-enrollment-and-certificationsurveycertificationgeninfopolicy-and-memos-states-and/clinical-laboratory-improvement-amendments-clia-guidance-temporary-testing-sites-under-multiple-site.
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    The intent of the CLIA program is to ensure that test results 
provided to individuals and their healthcare providers are accurate, 
timely, and reliable. During the COVID-19 public health emergency 
(PHE), we issued memo QSO-22-13-CLIA that informed interested parties 
that we exercised enforcement discretion to allow pathologists the 
ability to examine histopathology and cytology slides/images remotely, 
under the following conditions:
     The primary laboratory's CLIA certificate must include the 
specialty of pathology with the subspecialties of histopathology and 
cytology, as appropriate.
     The remote location complies with other applicable Federal 
laws, including the Health Insurance Portability and Accountability Act 
of 1996 (HIPAA).
     The primary laboratory's written procedure manuals for 
tests, assays, and examinations are available to the pathologists at 
the remote location.
     Retention time for histopathology slides (10 years), 
specimen blocks (2 years), preserved tissue remnants (until a diagnosis 
was made), and cytology slides (5 years) were maintained.
     The use of equipment, supplies and reagents, and similar 
items needed at the remote location are not allowed to be permanently 
stored on site.
    Under the memorandum, QSO-22-13-CLIA, the remote location could 
allow pathologists the opportunity to examine histopathology and 
cytology slides during the PHE.
    Pathologists that held a current CLIA certificate were exempt from 
this enforcement discretion. The pathology community has expressed 
their desire to make this enforcement discretion a permanent provision 
after the end of the PHE for COVID-19.
c. Clinical Cytogenetics
    We require any testing facility that meets the CLIA regulatory 
definition of a ``laboratory'' (per Sec.  493.2, Definitions \456\) to 
have a CLIA certificate. A laboratory may choose to outsource a test or 
a portion of their test procedure because it lacks the equipment, 
personnel with the expertise in the subject, or is considered more 
cost-efficient. The CLIA regulations at Sec.  493.1242(c) require the 
laboratory to only refer a test (for example, reflex, confirmatory, or 
distributive testing) to another laboratory that is CLIA certified or 
to a laboratory meeting equivalent requirements as determined by CMS. 
Therefore, each laboratory or testing facility that performs clinical 
testing must have its own CLIA certificate and comply with the 
regulations for the complexity of the testing it performs.
---------------------------------------------------------------------------

    \456\ See definition of ``laboratory'', https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493#493.2.
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    Clinical cytogenetics testing is generally categorized as a CLIA 
high complexity test. A cytogenetics test may be conducted at one 
facility or involve a testing workflow model in which one facility 
performs the analytical bench testing activities (for example, sample 
processing, extraction, chemical reaction, slide preparation, imaging) 
and another facility conducts the non-bench testing activities (for 
example, review of images, analysis, interpretation or reporting of the 
results). When any part of a test is performed by more than one 
facility, this testing model is considered distributive testing. CLIA 
defines distributive testing under Sec.  493.2, Definitions, as 
``laboratory testing performed on the same specimen, or an aliquot of 
it, that requires sharing it between two or more laboratories to obtain 
all data required to complete an interpretation or calculation 
necessary to provide a final reportable result for the originally 
ordered test. When such testing occurs at multiple locations with 
different CLIA certificates, it is considered distributive testing.'' 
Therefore, any facility performing clinical cytogenetics testing 
activities must be CLIA certified and meet high complexity testing 
requirements.
    During the PHE for COVID-19, we exercised enforcement discretion 
regarding clinical cytogenetics distributive testing models. Under the 
enforcement discretion, we allowed clinical cytogenetics personnel the 
opportunity to examine clinical cytogenetics digital images (that is, 
non-bench testing activities) at a remote testing location without 
obtaining a separate CLIA certificate for the remote site under certain 
conditions. Some interested parties have requested we make this 
enforcement discretion permanent. Changes to the current CLIA 
regulations would be necessary to allow the examination of clinical 
cytogenetics images at a different, remote location from the primary 
CLIA-certified site without a separate CLIA certificate. Please note 
that a remote location not associated with or covered by a primary 
CLIA-certified laboratory would be required to obtain its own CLIA 
certificate. The primary site laboratory director would be responsible 
for the overall operation and administration of the laboratory 
including the employment of personnel who are competent to perform test 
procedures, record and report test results promptly, accurately, and 
proficiently; for assuring compliance with applicable regulations in 
their primary laboratory; and for the supervision of the personnel 
reviewing digital laboratory data, digital results, and digital images 
remotely.
2. Solicitation of Public Comments
    We solicited comments on the following areas of CLIA: 
Histopathology; Cytology; and Clinical cytogenetics. The topics listed 
in this RFI are areas that CMS, CDC, interested parties, and SA 
surveyors have identified that may potentially be used by CMS for 
future rulemaking.
a. Histopathology
    We solicited comments on the following:
     Whether, and how, CLIA should provide oversight of 
histopathology preparation and processing of tissue samples for slide 
staining, specifically related to guidance for routine histopathology 
slide staining and complex IHC staining.
     What criteria (for example, training programs, on-the-job 
training, experience, or academic degree) would interested parties 
recommend for personnel performing high complexity automated IHC 
staining?
     How does the categorization of automated staining systems 
impact personnel who are currently performing this task but do not meet 
the qualifications for performing high complexity testing?
     What is an acceptable timeframe between the review of the 
macroscopic gross tissue examination, and the review and confirmation 
of these tissue findings by a pathologist prior to the microscopic 
review of slides to protect the integrity of the macroscopic tissue?

[[Page 79303]]

     What education and experience or training requirements 
should be required for individuals to qualify as a general supervisor 
(GS) for histopathology? If qualified, what is an acceptable timeframe 
for the GS to review and evaluate gross examinations under the 
specialty of histopathology?
     What education and professional experience, or training 
requirements should be required for individuals performing gross tissue 
examination that have an associate degree from a histotechnician 
program or a PA who has training from an accredited program and is 
certified as a PA?
b. Histopathology and Cytology Testing at Remote Locations
    We solicited comments on the following:
     How should ``remote testing location'' be defined?
     How should the CLIA regulations be revised to allow 
pathologists to examine histopathology and cytology slides/images at a 
remote testing location?
     What conditions (including, location(s)) should apply for 
a pathologist to examine histopathology or cytology slides/images 
remotely without obtaining a separate CLIA certification?
     Under what conditions should a primary location cease 
permitting testing at the remote location?
     How should the remote location be included on the final 
patient report?
     How should CMS, SAs, or Accreditation Organizations 
perform onsite surveys at remote locations?
c. Clinical Cytogenetics
    We solicited comments on the following:
     Under what circumstances should CLIA allow remote 
locations or testing facilities to examine clinical cytogenetics images 
without obtaining a separate CLIA certification?
     Under what circumstances would the examination of clinical 
cytogenetics images be unacceptable for the remote location scenario?
     What clinical cytogenetics testing processes should the 
primary laboratory have in place to ensure the remote site complies 
with the CLIA requirements?
     What ``conditions'' or ``criteria'' would be necessary for 
the remote location to ensure quality testing for the examination of 
clinical cytogenetics images?
    We thank the commenters for their submissions. We received 52 
comments.
    Commentors were in favor of updating the CLIA '88 regulations in 
Histopathology, Cytology, and Clinical cytogenetics to reflect 
advancements in technology and current laboratory practices. We will 
consider the input received as we continue to evaluate possible future 
changes to the CLIA regulations.

Q. Changes to the Basic Health Program Regulations

    Section 1331 of the Patient Protection and Affordable Care Act 
(Pub. L. 111-148, enacted March 23, 2010), as amended by the Health 
Care and Education Reconciliation Act of 2010 (Pub. L. 111-152, enacted 
March 30, 2010) (collectively referred to as the Affordable Care Act or 
ACA), provides States with the option to operate a Basic Health Program 
(BHP). In the States that elect to operate a BHP, the State's BHP makes 
affordable health benefits coverage available for lawfully present 
individuals under age 65 with household incomes between 133 and 200 
percent of the Federal poverty level (or in the case of a lawfully 
present non-citizen, ineligible for Medicaid or the Children's Health 
Insurance Program (CHIP) due to immigration status, whose household 
income is between zero and 200 percent of the FPL) who are not eligible 
for Medicaid, CHIP, or other minimum essential coverage. As of the date 
of this final rule, only New York and Minnesota have implemented a BHP.
    Federal funding for BHP is based on 95 percent of the value of the 
premium tax credits (PTC) and cost sharing reduction (CSR) subsidies 
that BHP enrollees would have received had they instead enrolled in 
Qualified Health Plans (QHPs) through the Exchange in accordance with 
section 1331(d)(3)(A)(i) of the ACA. These funds are paid to trusts 
established by the States and dedicated to the BHP, and the States then 
administer the payments to BHP standard health plans within the BHP. 
Under section 1331(d)(2) of the ACA, Federal funding for the BHP can 
only be used to reduce the premiums and cost-sharing of, or to provide 
additional benefits for, eligible individuals enrolled in standard 
health plans within the State.
1. Allowing States To Suspend a BHP
    Current regulations require States to operate a BHP under a 
certified Blueprint approved by CMS, and to operate the BHP as long as 
their approved certified Blueprint is in place. Under 42 CFR 600.140, a 
State may terminate its BHP, which requires that the BHP trust fund 
balance be refunded to the Federal government. The regulations do not 
contemplate ``suspending'' a BHP, and, as such, in the CY 2024 PFS 
proposed rule, we proposed to give a State the option of temporarily 
suspending its BHP program, while retaining funds that were accrued 
prior to suspending the program in the BHP trust fund for a limited 
period of time. Specifically, we proposed at Sec.  600.140(b)(1) that 
States wishing to suspend their BHP program must submit an application 
to HHS. Under proposed Sec.  600.140(b)(1), States could also seek 
approval to extend a BHP suspension previously approved by HHS. In 
Sec.  600.140(b)(1)(vi), we proposed that the application must be 
submitted at least 9 months in advance of the proposed effective date 
of the suspension or extension. However, for States seeking to suspend 
a BHP in the first plan year that begins following publication of a 
final rule adopting this proposal, we proposed that States must submit 
an application within 30 days of the publication of such a final rule 
and HHS would approve or deny such application as expeditiously as 
possible. We proposed in Sec.  600.140(b)(2) that a suspension 
application would need to be approved prior to the effective date of 
suspension, except in the case of a State seeking to suspend a BHP in 
the first plan year that begins following publication of a final rule 
adopting this proposal.
    The proposed substantive requirements for the suspension 
application are described in proposed Sec.  600.140(b)(1)(i) through 
(v). Under the proposed requirements, for the period of suspension, BHP 
enrollees must receive comparable coverage that is as comprehensive and 
affordable as, or more comprehensive and affordable than, BHP coverage 
during the period of suspension. Therefore, in Sec.  600.140(b)(1)(i) 
through (iii), we proposed to require that the suspension and extension 
application demonstrates that the benefits that would be provided to 
individuals that meet the BHP eligibility criteria are at least 
equivalent to the benefits offered in the State's BHP. We proposed that 
the cost sharing and premiums that would be charged to such individuals 
under the new coverage option could not exceed the amounts charged 
under the BHP to reduce the risk that these individuals are harmed by 
the transition to other coverage.
    Finally, in developing our proposal we believed that the suspension 
period should not result in individuals losing coverage solely due to a 
change in eligibility criteria for the program. Therefore, we proposed 
in Sec.  600.140(b)(1)(iv) that a State must demonstrate in its 
application that the eligibility criteria for coverage during

[[Page 79304]]

the suspension would not more restrictive than the criteria described 
in Sec.  600.305.
    We believed that the suspension period should be long enough to 
allow the State to evaluate the alternative coverage provided to BHP-
eligible individuals but should not be indefinite. Therefore, we 
proposed in Sec.  600.140(b)(1)(v) that a State could request a 
suspension of up to 5 years in an initial suspension application, after 
which a State could request an extension of up to 5 additional years. 
Additional extension periods would not be allowed. We proposed at Sec.  
600.140(b)(7) that at least 9 months before the end of the suspension 
period, a State would be required to submit a transition plan to HHS 
that explains how the State would reinstate its BHP, or terminate the 
program under Sec.  600.140(a) of the current regulations.
    Under proposed Sec.  600.140(b)(1)(vii), States requesting an 
extension of a previously-approved BHP suspension also would need to 
provide an evaluation of the alternative coverage in its application.
    If individuals and/or standard health plans would experience a 
change in the terms of the coverage, including receiving additional 
benefits or being charged different cost sharing amounts, in Sec.  
600.140(b)(3), we proposed to require that the State provide notice to 
them at least 90 days prior to the effective date of the suspension. 
The notices would need to include information regarding the State's 
assessment of their eligibility for all other insurance affordability 
programs in the State, and meet the accessibility and readability 
standards at 45 CFR 155.230(b).
    We proposed to require in Sec.  600.140(b)(4) that States that 
suspend their BHP must submit the data necessary to complete the BHP 
payment reconciliation process within 12 months of the effective date 
of the suspension. We believed that 12 months was a reasonable amount 
of time for a State to submit the actual enrollment data for the 
periods it was operating a BHP.
    We proposed in Sec.  600.140(b)(6) that while the State is not 
providing BHP coverage, any accrued interest on the trust fund would 
have to be remitted to HHS on an annual basis in the form and manner 
set out by HHS.
    States currently submit the balance of their trust fund and any 
interest accrued through the BHP annual report described in Sec.  
600.170. We proposed revisions to Sec. Sec.  600.140(b) and 600.170(a) 
to require States that suspend their BHP continue to submit an annual 
report in order to document the interest earned and to provide 
assurance that the coverage provided to BHP-eligible individuals meets 
the standards discussed previously in this section.
    If a State does not meet the proposed requirements (that is, 
completing the financial reconciliation process, remitting interest on 
the trust fund, continuing to meet the standards that the alternative 
coverage provides coverage as comprehensive and affordable as the BHP, 
and submitting the required information in its annual report), we 
proposed in Sec.  600.140(d), redesignated as Sec.  600.140(c) in this 
final rule, that the Secretary could withdraw approval of the 
suspension. We received four public comments on these proposals. The 
following is a summary of the comments we received and our responses.
    Comment: All commenters supported allowing States to suspend their 
BHP, with some commenters mentioning specific changes they would like 
to see which are discussed later in this section. One commenter noted 
that flexibility to suspend a BHP while maintaining the trust fund may 
encourage more States to consider implementing a BHP.
    Response: We appreciate the commenters support of our proposal, and 
for reasons discussed below, we are finalizing the regulation changes 
as proposed, with only minor modifications.
    Comment: One commenter suggested that CMS require States to outline 
in the application for suspension a plan to notify physicians who 
provide care to BHP enrollees about the suspension; share information 
with physician practices and other clinicians and facilities about how 
and where patients will receive or can seek alternative comprehensive, 
affordable coverage; and work with physician practices to minimize any 
resulting administrative burden.
    Response: We appreciate this commenter's suggestion. While we will 
not be requiring States to provide a specific plan to notify physicians 
who provide care to BHP enrollees about the suspension in the 
suspension application, we anticipate informally asking States for how 
they will notify providers, including physicians, of this change. We 
will encourage States to communicate any changes that may impact 
patient care networks to providers. We proposed and are finalizing a 
requirement that would apply if individuals and/or standard health 
plans will experience a change in the terms of the coverage during the 
suspension, including receiving additional benefits or being charged 
different cost sharing amounts, States would be required to provide 
notice to them at least 90 days prior to the effective date of the 
suspension. We also proposed and are finalizing that BHP enrollees must 
receive comparable coverage that is as comprehensive and affordable as, 
or more comprehensive and affordable than, BHP coverage during the 
period of suspension. Therefore, as individuals will be receiving 
coverage that is as comprehensive and affordable as the BHP coverage, 
and will have been notified at least 90 days prior to the effective 
date of the suspension of any changes, we do not believe it necessary 
to require that States explicitly provide information to physicians 
regarding where individuals can receive alternative care.
    Comment: One commenter specifically requested that CMS require that 
the Secretary must approve an application for the suspension of BHP 
submitted by the State.
    Response: We proposed in Sec.  600.140(b)(2) that the State could 
not implement the suspension or extension of the suspension without 
prior approval by the Secretary, unless the State is proposing to 
suspend their BHP in the first plan year following publication of such 
a final rule. Additionally, for States seeking to suspend a BHP in the 
first plan year that begins following publication of a final rule 
adopting this proposal, we proposed that States must submit an 
application within 30 days of the publication of such a final rule and 
that HHS would approve or deny such application as expeditiously as 
possible. We are finalizing this requirement as proposed, with minor 
modifications.
    We are finalizing the requirement that a State cannot implement the 
suspension or extension of the suspension without prior approval by the 
Secretary unless the State is proposing to suspend their BHP in 2024. 
This is a minor change from the proposed regulation, which stated that 
a State cannot implement a suspension or extension of a suspension 
without prior approval by the Secretary, unless the State is proposing 
to suspend their BHP in the first plan year after this rule is 
finalized. We are finalizing that, for States proposing to suspend 
their BHP in 2024, the suspension application must be submitted within 
30 days of the effective date of this final rule. This is a minor 
change from the proposed regulation, which stated that a State 
proposing to suspend their BHP in the first plan year after this rule 
is finalized, must submit their suspension

[[Page 79305]]

application within 30 days of publication of the final rule.
    Comment: One commenter specifically requested that CMS establish 
requirements for States to ensure safeguards are in place for 
individuals that are enrolled in BHP. Another commenter noted support 
for the proposal to ensure formerly BHP-eligible consumers are not 
subject to more restrictive eligibility rules under an alternative 
coverage plan while the BHP is suspended.
    Response: We share the commenters' desire to ensure there are 
safeguards for individuals that are enrolled in BHP. We proposed in 
Sec.  600.140(b)(1)(i) through (iii), that, during the period of 
suspension, former BHP enrollees should receive coverage that is as 
comprehensive and affordable as, or more comprehensive and affordable 
than, BHP coverage during the period of suspension. Specifically, we 
proposed to require that the suspension and any suspension extension 
applications demonstrate that the benefits that will be provided to 
individuals who meet the BHP eligibility criteria are at least 
equivalent to the benefits offered in the State's BHP. We also proposed 
that the cost sharing and premiums that will be charged to such 
individuals under the new coverage option do not exceed the amounts 
charged under the BHP to reduce the risk that these individuals are 
harmed by the transition to other coverage. We are finalizing these 
requirements as proposed.
    Comment: One commenter suggested that States be allowed to suspend 
their BHP beyond 10 years, if the circumstances in States could 
reasonably justify longer suspension periods, subject to CMS approval.
    Response: We appreciate the commenter's suggestion, but we believe 
that our proposal to allow a suspension for 5 years with a one-time 
extension of an additional 5 years, is sufficient time for a State to 
evaluate whether or not it should resume its BHP. As discussed in the 
proposed PFS rule, we chose 5 years for the initial approval period 
because this aligns with the duration of initial waivers and 
demonstration projects approved under section 1332 of the ACA and 
section 1115 of the Act. We believe these are the most likely 
authorities under which States could seek to provide alternative 
coverage to BHP enrollees. Similarly, we chose 5 years for the 
extension period because it aligns with the duration of typical 
extensions or amendment periods under section 1332 waiver and section 
1115 demonstration projects.
    Comment: One commenter suggested that if a State proposes to 
suspend its BHP and implement a section 1332 waiver, that the State be 
allowed to leverage relevant parts of their section 1332 waiver 
application and actuarial and economic analysis to provide the 
necessary supporting evidence for their BHP suspension application 
since aspects of the 1332 application serve a similar purpose.
    Response: We believe it is likely a State would be able to use 
relevant parts of its section 1332 waiver application and actuarial and 
economic analysis to provide supporting evidence for the BHP suspension 
application. As discussed in the CY 2024 PFS proposed rule, to 
determine that the cost sharing required of individuals under the new 
coverage option does not exceed the BHP cost sharing levels, we 
proposed at Sec.  600.140(b)(1)(ii) to require that the actuarial value 
of the new coverage option must meet or exceed the actuarial value of 
the BHP standard health plans in effect immediately prior to the 
suspension period. If there are multiple health plans being offered 
under the new coverage option and/or multiple standard health plans in 
effect in the State, we proposed that the median actuarial value of the 
health plans offered under the new coverage option must meet or exceed 
the median actuarial value of the BHP standard health plans. To the 
extent this information is required for the State's 1332 waiver 
application, it could also be utilized for the suspension application 
and be submitted as part of the suspension application.
    Comment: One commenter recommended that States be required to 
submit only the sections of the BHP Annual Report pertaining to 
financial management and audit findings while the BHP is suspended.
    Response: In the CY 2023 PFS proposed rule, we proposed to add a 
new paragraph Sec.  600.170(a)(2) to require that States that have 
suspended their BHP under Sec.  600.140(b) submit an annual report that 
includes (1) the balance of the BHP trust fund and any interest accrued 
on that balance; (2) an assurance that the coverage provided to 
individuals who would be eligible for a BHP under Sec.  600.305 
continues to meet the standards described in Sec.  600.140(b)(1)(i) 
through (iii); and (3) any additional information specified by the 
Secretary at least 120 days prior to the date that the annual report is 
due. We believe it is important for States to continue to provide 
assurances that any coverage changes under the alternative program 
continue to meet the BHP suspension requirements.
    Comment: One commenter requested that States be allowed to use BHP 
trust funds for the duration of the suspension on, at a minimum, the 
same uses that were permissible when BHP-eligible consumers were still 
enrolled in the BHP, and not the alternative coverage program.
    Response: As discussed in the CY 2024 PFS proposed rule, under 
section 1331(d)(2) of the ACA and current regulations at Sec.  
600.705(c), Federal funding for BHP can only be used to reduce the 
premiums and cost-sharing, or to provide additional benefits, for BHP-
eligible individuals enrolled in standard health plans within the 
State. When a State suspends its BHP, individuals will no longer be 
enrolled in standard health plans. Therefore, Federal funding is not 
available for costs associated with providing new coverage after the 
transition has occurred.
    After consideration of public comments, we are finalizing the 
requirements for a suspension of a State's BHP as proposed, with minor 
changes. We are removing proposed paragraph Sec.  600.140(c), because 
it was duplicative of the requirement in proposed Sec.  600.140(b)(2). 
As such, proposed paragraph Sec.  600.140(d) is redesignated to Sec.  
600.140(c) in this final rule.
    We are finalizing the requirement that a State cannot implement the 
suspension or extension of the suspension without prior approval by the 
Secretary unless the State is proposing to suspend their BHP in 2024. 
This is a minor change from the proposed regulation, which stated that 
a State cannot implement a suspension or extension of a suspension 
without prior approval by the Secretary, unless the State is proposing 
to suspend their BHP in the first plan year after this rule is 
finalized. We are finalizing that for States proposing to suspend their 
BHP in 2024, the suspension application must be submitted within 30 
days of the effective date of this final rule. This is a minor change 
from the proposed regulation, which stated that a State proposing to 
suspend their BHP in the first plan year after this rule is finalized 
must submit their suspension application within 30 days of publication 
of the final rule.
2. Submission and Review of BHP Blueprints
    In developing the BHP proposals included in the proposed rule, we 
determined that additional parameters were necessary to ensure 
effective and efficient operation of the BHPs and HHS review of a 
revised Blueprint, consistent with section 1331(a)(1) of the ACA. 
Therefore, we proposed changes to Sec.  600.125 to establish timeframes 
and

[[Page 79306]]

procedures for the submission and review of BHP Blueprints, similar to 
the Medicaid and CHIP State plan amendment (SPA) submission and review 
processes. We noted that these proposed timeframes only apply to the 
submission and review of revised Blueprints; we did not propose changes 
to the timeframes for the submission and review of an initial 
Blueprint, set forth in current regulations at Sec.  600.120, in the 
event additional States seek to establish BHPs.
    Additionally, we believed States needed flexibility to receive 
approval of a retroactive effective date for changes to their BHP 
Blueprint, similar to flexibilities allowed under regulations at 
Sec. Sec.  430.20(b) and 457.60 for the submission of Medicaid and CHIP 
SPAs. We noted, that in the event that a State implements a change to 
its BHP Blueprint that is ultimately disapproved by HHS, the State 
could be required to implement a corrective action plan under Sec.  
[thinsp]600.715.
    Specifically, under existing regulations at Sec.  600.125(a), 
States must submit a revised Blueprint whenever they seek to make 
significant change(s) that alter program operations the BHP benefit 
package, enrollment, disenrollment and verification policies described 
in its certified BHP Blueprint. Under the proposed revisions to Sec.  
600.125(a), we would broaden the circumstances requiring submission of 
a revised Blueprint to include States' significant changes that alter 
any core program operations under Sec.  600.145(f). States also would 
be required to submit a revised Blueprint to HHS whenever necessary to 
reflect changes in Federal law, regulations, policy interpretations, or 
court decisions that affect provisions in their certified Blueprint. 
States would continue to be required to submit a revised Blueprint to 
make changes to the BHP benefit package or to enrollment, 
disenrollment, and verification policies described in the certified 
Blueprint, as currently required under Sec.  600.125(a).
    At Sec.  600.125, we also proposed to redesignate paragraph (b) as 
paragraph (d) and to add new paragraph (b) to provide that the 
effective date of a revised Blueprint may be as early as, but not 
earlier than, the first day of the quarter in which an approvable 
revision is submitted to HHS. This policy mirrors the standards for 
submission of a Medicaid SPA at Sec.  430.20(b). The current 
regulations do not specify as to when a revised Blueprint is considered 
received by HHS. We believe that it is reasonable to consider a revised 
Blueprint to be received when HHS receives an electronic copy of a 
cover letter signed by the Governor or Governor's designee and a copy 
of the currently approved Blueprint with proposed changes indicated in 
track changes. In the event a State is unable to submit a revised 
Blueprint electronically, due to a disaster or other event outside of 
the State's control, we proposed that CMS could consider other modes of 
submission on a case-by-case basis. Under current regulations at Sec.  
600.125(b), redesignated at Sec.  600.125(d) in the proposed rule, the 
State is responsible for continuing to operate under the terms of the 
existing certified Blueprint until the State adopts a revised 
Blueprint, the State terminates or suspends the BHP, or the Secretary 
withdraws certification for the BHP.
    We also proposed to redesignate paragraph (c) of current Sec.  
600.125 as paragraph (g) and to add a new paragraph (c) to create clear 
timelines for HHS's review, approval, and disapproval of revised 
Blueprints similar to the timelines currently applicable to CHIP SPAs 
under Sec.  457.150. Under proposed Sec.  600.125(c)(1), a revised 
Blueprint would be deemed approved unless HHS, within 90 days after 
receipt of the revised Blueprint, sends the State written notice of 
disapproval or written notice of additional information HHS needs in 
order to make a final determination. If HHS requests additional 
information, the 90-day review period would be stopped and would resume 
the day after HHS receives all of the requested additional information 
from the State. Under proposed paragraph (c)(2), if 90 days from the 
date a Blueprint revision is received does not fall on a business day, 
the 90-day review period would end on the next business day. Under 
proposed paragraph (c)(3), HHS may send written requests for additional 
information as many times as needed to obtain all information necessary 
to certify the revised Blueprint. This mirrors the process used by 
CHIP, of having one 90-day review period that can start and stop 
multiple times with a request for additional information and response. 
This process differs from Medicaid, which has a 90-day review period 
that can be stopped once by a request for additional information, 
followed by a second 90-day review period when the State responds. At 
paragraph (c), we proposed that HHS may disapprove a Blueprint 
amendment if the Secretary determines that the Blueprint revision is 
not consistent with section 1331 of the ACA or the regulations set 
forth in this part at any time during the review process, including 
when the 90-day review clock is stopped due to a request for additional 
information.
    Once a Blueprint is approved, current Sec.  600.125(b) specifies 
that the State is responsible for continuing to operate under the terms 
of the existing certified Blueprint until and unless a revised 
Blueprint that seeks to make significant change(s) is certified, as 
described in paragraph (c), except during a public health emergency. We 
proposed to revise paragraph (b) of Sec.  600.125, redesignated as 
paragraph (d) in this rulemaking, redesignated as paragraph (d) in this 
rulemaking, to provide that the State must continue to operate under 
the terms of an existing certified Blueprint until the State adopts a 
revised Blueprint, terminates the BHP following the procedures 
described in Sec.  600.140(a), suspends the BHP following the 
procedures described in Sec.  600.140(b), or the Secretary withdraws 
certification of the BHP under Sec.  600.142.
    Finally, we proposed to apply some of the existing parameters for 
initial Blueprint submissions to Blueprint revisions. In paragraph (e), 
we proposed that a State may withdraw the proposed revised Blueprint 
during HHS review if the State has not yet implemented the proposed 
changes and provides written notice to HHS. This proposal mirrors 
current Sec.  600.130 for initial BHP Blueprints. In paragraph (f), we 
proposed that HHS will accept a State's request for reconsideration of 
a decision not to certify a revised Blueprint and provide an impartial 
review against standards for certification if requested. This proposal 
mirrors current Sec.  600.135(c) for initial BHP Blueprints.
    Under current Sec.  600.135, HHS must act on all initial BHP 
Blueprint certification and revision requests in a timely matter. 
Because we proposed to specify timeframes for the submission and review 
of revised BHP Blueprints under Sec.  600.125, we proposed to revise 
Sec.  600.135 to apply only to the submission of initial BHP 
Blueprints. Specifically, we proposed to revise the title to clearly 
state that this section is applicable to only initial Blueprints and to 
remove the reference to BHP Blueprint revisions in paragraph (a).
    For a full discussion of this proposal, please see the CY 2024 PFS 
proposed rule (88 FR 52545).
    We received one public comment on these proposals.
    Comment: The commenter supported the proposed regulations allowing 
for retroactive approval of Blueprint revisions and aligning the review 
process for Blueprint revisions more closely with that for Medicaid 
State plan amendments. This commenter stated the changes would provide 
States

[[Page 79307]]

with further clarity regarding the review process for revising 
Blueprints as well as more flexibility to implement changes to their 
BHPs.
    Response: We appreciate this commenter's support and are finalizing 
the regulation changes as proposed.
3. BHP Notices
    Under current Sec.  600.330, States must provide written notice to 
beneficiaries conveying final determination of eligibility or 
ineligibility. The regulation does not require States to provide those 
notices in a manner that is accessible to individuals with disabilities 
or limited English proficiency (LEP). Therefore, we proposed to add 
paragraph (f) to Sec.  600.330 to require that BHP eligibility notices 
be written in plain language and be provided in a manner which ensures 
that eligible individuals with LEP are provided with meaningful 
language access and individuals with disabilities are provided with 
effective communication.
    For a full discussion of this proposal, please see the CY 2024 PFS 
proposed rule (88 FR 52546).
    We received one public comment on this proposal.
    Comment: One commenter supported the proposed changes requiring 
that eligibility notices be written in plain language.
    Response: We appreciate this commenter's support and are finalizing 
our regulations as proposed.
4. BHP Appeals
    Under current Sec.  600.335(b), individuals must be given the 
opportunity to appeal BHP eligibility determinations through the 
appeals rules of the State's Medicaid program or the Exchange, as 
indicated in the State's Blueprint. Current BHP and Exchange 
regulations do not provide for appeals of health services matters. 
Therefore, we proposed in paragraph (b) to remove the option for States 
to conduct their BHP appeals process according to Exchange rules. In 
paragraph (b)(2), we proposed to require States to provide individuals 
an opportunity to appeal a delay, denial, reduction, suspension, or 
termination of health services, in whole or in part, including a 
determination about the type or level of service, after individuals 
exhaust appeals or grievances through the BHP standard health plans. 
Because current BHP regulations do not include provisions related to 
the appeal of health services matters, these appeals are not currently 
included in the list of core operations of a BHP in Sec.  600.145. 
Therefore, in proposed Sec.  600.145(f)(2), we included appeals of 
health services matters as specified in Sec.  600.335 as a core 
operation of a BHP.
    For a full discussion of these proposal, please see the CY 2024 PFS 
proposed rule (88 FR 52546).
    The following is a summary of the comments we received and our 
responses.
    Comment: One commenter supported the proposal changes to the 
regulations for appeals of health care services.
    Response: We appreciate this commenter's support and are finalizing 
our regulations as proposed, with one modification described later in 
this section.
    Comment: One commenter requested clarification on whether an 
appellant must exhaust utilization review and external appeals before 
filing a health service appeal through the proposed BHP appeal process.
    Response: As stated in the preamble of the proposed rule, 
individuals must first exhaust appeals or grievances through the BHP 
standard health plans prior to appealing to the State. We have added 
this requirement to the regulation text, to provide further clarify 
this requirement.
    Comment: One commenter requested that States be permitted 
flexibility to establish the health service appeals process in a manner 
that takes individual States' needs into account, such as being able to 
choose the department that will oversee the appeals.
    Response: We appreciate the comment and agree that individual 
States' needs should be taken into account, including being able to 
choose the department that will oversee the appeals. We have revised 
Sec.  600.335(b) and added Sec.  600.335(c) to specify that subject to 
HHS approval, a State may request to follow an appeals process for BHP 
eligibility determinations and health service matters that differs from 
the State's Medicaid program. We specify that the State must 
demonstrate in its request that the BHP agency has oversight of any 
entity delegated the authority to administer appeals and provide a 
clear description of the responsibilities and functions delegated to 
such an entity. In addition, the State must ensure that the agency to 
which eligibility determinations or appeals decisions are delegated: 
complies with all relevant Federal and State law, regulations, and 
policies; and informs applicants and beneficiaries how they can 
directly contact and obtain information from the agency.
    We expect this request to be submitted via a Blueprint revision. In 
determining whether the BHP agency has sufficient oversight, CMS will 
consider whether:
     The delegated agency has been provided sufficient training 
to make appeals decisions and apply BHP laws and policies correctly;
     The responsibilities of the delegated agency have been 
clearly articulated, including the scope of review, whether the 
delegated entity has final decision making authority, and how the 
delegated entity coordinates with the BHP agency regarding processing 
requests and other functions necessary to conduct appeals;
     A written agreement is in place between the delegated 
entity and the BHP agency regarding the responsibilities of the 
delegated entity; and
     A process has been established to monitor the accuracy and 
quality of decisions made by the delegated entity.
    Comment: One commenter requested that the effective date for the 
requirement to follow the Medicaid process for appeals of health 
services matters be extended into the future by 3-5 years.
    Response: We believe that by allowing a State to request to follow 
an appeals process for health service matters that differs from the 
State's Medicaid program, as discussed previously in this section, that 
the effective date of the policy does not need to be extended.
    After consideration of public comments, we are finalizing this 
proposal as proposed, with one change as described previously in this 
section. We have revised Sec.  600.335(b) and added Sec.  600.335(c) to 
specify that subject to HHS approval, a State may request to follow an 
appeals process for BHP eligibility determinations and health service 
matters that differs from the State's Medicaid program.

R. Updates to the Definitions of Certified Electronic Health Record 
Technology

1. Background
    The American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5, 
enacted February 17, 2009) (ARRA), authorized incentive payments to 
eligible professionals, eligible hospitals and critical access 
hospitals (CAHs), and Medicare Advantage (MA) organizations to promote 
the adoption and meaningful use of certified electronic health record 
(EHR) technology (CEHRT). In 2010, the Office of the National 
Coordinator for Health Information Technology (ONC) launched the Health 
IT Certification Program (ONC Health IT Certification Program) to 
provide for the certification of health information technology (IT),

[[Page 79308]]

including EHRs. Requirements for certification are based on standards, 
implementation specifications, and certification criteria adopted by 
the Secretary pursuant to section 3004 of the Public Health Service 
Act. The ONC Health IT Certification Program supports the use of 
certified health IT under the programs that we administer, including, 
but not limited to, the Medicare Promoting Interoperability Program 
(previously known as the Medicare and Medicaid EHR Incentive Programs), 
the Shared Savings Program, and the Quality Payment Program, which 
includes the MIPS Promoting Interoperability performance category and 
the Advanced Alternative Payment Models (Advanced APMs). While these 
programs continue to require the use of CEHRT, the use of certified 
health IT has expanded to other government and non-government programs.
    For CY 2019 and subsequent years, the definitions of CEHRT for the 
Promoting Interoperability Programs at Sec.  495.4, the Quality Payment 
Program at Sec.  414.1305, and the Shared Savings Program at Sec.  
425.20 require the use of EHR technology that meets the 2015 Edition 
Base EHR definition at 45 CFR 170.102 and is certified to 2015 Edition 
health IT certification criteria under the ONC Health IT Certification 
Program. In addition, the CEHRT definitions in our regulations for 
these programs require technology to be certified to certain specific 
2015 Edition health IT certification criteria, as specified in each of 
the definitions, including criteria necessary to be a meaningful EHR 
user under the Medicare Promoting Interoperability Program, and 
criteria necessary to report on applicable objectives and measures 
specified under the MIPS Promoting Interoperability performance 
category under the Quality Payment Program. Prior Editions of health IT 
certification criteria were associated with ``stages'' of the EHR 
Incentive Programs (now the Medicare Promoting Interoperability Program 
and the MIPS Promoting Interoperability performance category), which 
linked new and updated functionality in certified health IT to 
significant revisions to the objectives and measures in the programs.
    In the CY 2021 PFS final rule (85 FR 84815 through 84825), we 
finalized that the technology used by health care providers to satisfy 
the definitions of CEHRT at Sec. Sec.  495.4 and 414.1305 must be 
certified under the ONC Health IT Certification Program, in accordance 
with the updated 2015 Edition certification criteria (2015 Edition 
Cures Update), as finalized i\n\ the ONC 21st Century Cures Act: 
Interoperability, Information Blocking, and the ONC Health IT 
Certification Program (Cures Act) final rule (85 FR 25642). We further 
finalized aligning the transition period during which health care 
providers participating in the Medicare Promoting Interoperability 
Program, the MIPS Promoting Interoperability performance category, and 
Advanced APMs may use technology certified to either the existing or 
updated 2015 Edition certification criteria, with the December 31, 2022 
date established in the ONC interim final rule, Information Blocking 
and the ONC Health IT Certification Program: Extension of Compliance 
Dates and Timeframes in Response to the COVID-19 Public Health 
Emergency (85 FR 70064), for health IT developers to make updated 
certified health IT available (85 FR 84815 through 84825). After this 
date, health care providers were required to use only certified 
technology updated to the 2015 Edition Cures Update for an EHR 
reporting period or performance period beginning with CY 2023.
    In the ONC ``Health Data, Technology, and Interoperability: 
Certification Program Updates, Algorithm Transparency, and Information 
Sharing'' proposed rule (88 FR 23746 through 23917) (hereafter referred 
to as ``ONC HTI-1 proposed rule''), which appeared in the Federal 
Register on April 18, 2023, ONC proposed to discontinue the year themed 
``editions,'' which ONC first adopted in 2012, to distinguish between 
sets of health IT certification criteria finalized in different rules 
(88 FR 23758). In the proposed rule, ONC noted public comments stating 
that the continued use and reference to the 2015 Edition inaccurately 
implies an age and outdatedness to the certification criteria ONC has 
adopted. Given these concerns, ONC stated that it believes there should 
be a single set of certification criteria, which will be updated in an 
incremental fashion in closer alignment to standards development cycles 
and regular health IT development timelines (88 FR 23750).
    ONC further stated its belief that maintaining a single set of 
``ONC Certification Criteria for Health IT'' would create more 
stability for the ONC Health IT Certification Program and for Federal 
partners who reference the ONC Health IT Certification Program, as well 
as make it easier for developers of certified health IT to maintain 
their product certificates over time (88 FR 23759). ONC stated this 
proposal to remove ``editions'' from the ONC Health IT Certification 
Program would also help users of certified health IT identify which 
certification criteria are necessary for their participation in 
programs, such as the Medicare Promoting Interoperability Program, the 
Shared Savings Program, and the Quality Payment Program's MIPS 
Promoting Interoperability performance category and Advanced APMs (88 
FR 23760). For example, users would only need to know that their Health 
IT Module is certified to 45 CFR 170.315(b)(3), electronic prescribing, 
for successful participation in the MIPS Promoting Interoperability 
performance category related to electronic prescribing, as compared to 
the current state, where they must also know if the Health IT Module 
supports electronic prescribing as part of the 2014 Edition 
Certification Criteria or the 2015 Edition Certification Criteria, or 
2015 Edition Cures Update Certification Criteria. To implement this 
approach, ONC has proposed to rename all criteria within the ONC Health 
IT Certification Program simply as ``ONC Certification Criteria for 
Health IT,'' proposing associated changes to the regulations at 45 CFR 
part 170 (88 FR 23759).
    Similar to ONC's proposal to move away from ``editions'' and toward 
incremental changes to its certification criteria, we also have focused 
in recent years on implementing incremental changes to individual 
measures under, but not limited to, the Medicare Promoting 
Interoperability Program, the Shared Savings Program, and the Quality 
Payment Program, which includes the MIPS Promoting Interoperability 
performance category and the Advanced APMs. We expect to continue to 
prioritize incremental changes in future years to reduce burden on 
participants in these programs (including eligible hospitals and CAHs 
and MIPS eligible clinicians), and build on the established base of 
available certified health IT capabilities. We believe our approach is 
consistent with the strategy discussed in the ONC HTI-1 proposed rule, 
in which ONC proposes to pursue a framework for the ONC Health IT 
Certification Program that focuses on incremental updates to a single 
set of certification criteria.
2. Updates to the Definition of Certified Electronic Health Record 
Technology in the Medicare Promoting Interoperability Program and the 
Quality Payment Program
a. Background and Previously Finalized Certification Requirements
    In consideration of the updates made to the 2015 Edition 
certification criteria as described in the CY 2021 PFS final rule (85 
FR 84815 through 84828), we finalized that health care providers 
participating in the Medicare Promoting

[[Page 79309]]

Interoperability Program and eligible clinicians participating in the 
Quality Payment Program must use certified health IT that satisfies the 
definitions of CEHRT at Sec. Sec.  495.4 and 414.1305, respectively, 
and is certified under the ONC Health IT Certification Program, in 
accordance with the 2015 Edition Cures Update certification criteria, 
as finalized in the ONC 21st Century Cures Act final rule (85 FR 
25642). We explained this included technology used to meet the 2015 
Edition Base EHR definition at 45 CFR 170.102, technology certified to 
the criteria necessary to be a meaningful EHR user under the Medicare 
Promoting Interoperability Program and the MIPS Promoting 
Interoperability performance category, and technology certified to the 
criteria necessary to report on applicable objectives and measures. In 
this final rule, we are finalizing revisions to the CEHRT definitions 
in the Medicare Promoting Interoperability Program and the Quality 
Payment Program (on which the Shared Savings Program's definition of 
CEHRT at Sec.  425.20 also relies) to support the proposed transition 
from the historical state of year themed ``editions'' to the ``edition-
less state'' in the ONC HTI-1 proposed rule.
    We included Table IX.F.-04 in the Hospital Inpatient Prospective 
Payment System for Acute Care Hospitals and the Long-Term Care Hospital 
Prospective Payment System and Fiscal Year 2024 Rates final rule (88 FR 
59278 through 59279), which includes some, but not all, certification 
criteria for the Medicare Promoting Interoperability Program's measures 
and eCQMs for eligible hospitals and CAHs, and Table 57 in section 
IV.A.4.f.(4)(e)(iv) of this final rule, which includes some, but not 
all, certification criteria for measures under the MIPS Promoting 
Interoperability performance category. These tables are only applicable 
for the measures under the Medicare Promoting Interoperability Program 
and the MIPS Promoting Interoperability performance category, and do 
not include all of the updated certification criteria included in the 
CEHRT definition as discussed in the CY 2021 PFS proposed rule (85 FR 
50265 through 50270). For further discussion on the complete list of 
changes to the certification criteria under the CEHRT definition, we 
refer readers to the ONC 21st Century Cures Act final rule (85 FR 
25667), the CY 2021 PFS proposed rule (85 FR 50265), and the CY 2021 
PFS final rule (85 FR 84818 through 84825).
b. Revisions to Certified Electronic Health Record Technology 
Definitions in Regulatory Text
    We proposed to revise the definitions of CEHRT in Sec. Sec.  495.4 
and 414.1305 for the Medicare Promoting Interoperability Program and 
for the Quality Payment Program respectively (88 FR 52547 through 
52548) so these definitions would be consistent with the ``edition-
less'' approach to health IT certification as proposed in the ONC HTI-1 
proposed rule, should the ONC proposal be finalized. First, for 
references to the ``2015 Edition Base EHR definition'' defined at 45 
CFR 170.102, we proposed to add a reference to the revised name ``Base 
EHR definition,'' proposed in the ONC HTI-1 proposed rule, to ensure, 
if ONC's definition is finalized, it is applicable for the CEHRT 
definitions going forward (88 FR 23759, 23905). Next, we proposed to 
replace our references to ``2015 Edition health IT certification 
criteria,'' with ``ONC health IT certification criteria'' and to add 
the regulatory citation for ONC health IT certification criteria in 45 
CFR 170.315. We are finalizing these proposals as proposed. By revising 
our regulations to account for ONC's proposed discontinuation of 
references to the ``2015 Edition,'' and pointing to the regulations at 
45 CFR 170.102 and 170.315, we believe these changes will ensure the 
CEHRT definitions do not need to be updated to reflect modified 
terminology unless ONC changes the location of these certification 
criteria.
    While these proposed revisions will allow us to maintain more 
permanent cross-references to ONC's regulations and terminology, we 
recognize that ONC has historically updated, and will likely in the 
future continue to update over time, the underlying certification 
criteria contained in 45 CFR 170.315.
    Previously under the year-themed ``editions'' construct, we 
periodically revised the language in our regulatory CEHRT definitions 
to refer to a new Edition in order to incorporate ONC's updates to 
health IT certification criteria. Then, in the CY 2021 PFS final rule 
(85 FR 84818 through 84825), to incorporate ONC's updates to 
certification criteria in its 2015 Edition Cures Update, which ONC 
finalized under the ONC 21st Century Cures Act final rule (85 FR 25642 
through 25961), we did not revise the language of the CEHRT definitions 
for the Medicare Promoting Interoperability Program and the Quality 
Payment Program. Instead, we finalized that technology used to satisfy 
the CEHRT definitions must be certified under the ONC Health IT 
Certification Program, in accordance with the 2015 Edition Cures Update 
certification criteria as finalized in the ONC 21st Century Cures Act 
final rule.
    Consistent with ONC's proposal to move away from year-themed 
``editions,'' and to further simplify our regulatory approach, we 
proposed revisions to our definitions of CEHRT to ensure we would not 
necessarily be required to update our regulatory text each time ONC 
proposed or finalized any updates to its definition of Base EHR or 
certification criteria.
    We proposed to establish that any certification criteria adopted or 
updated in 45 CFR 170.315 would be applicable for the CEHRT definitions 
in our programs' regulations at Sec. Sec.  495.4 and 414.1305, if ONC's 
applicable regulations are referenced directly in our CEHRT 
definitions. We stated that if finalized, this proposal would allow the 
CEHRT definitions in our regulations to automatically incorporate ONC's 
updates to relevant certification criteria without pursuing additional 
rulemaking.
    In the proposed rule, we stated that any update to a certification 
criterion finalized by ONC would not necessarily be immediately 
required for use in CEHRT for our Medicare Promoting Interoperability 
Program, Quality Payment Program, and Shared Savings Program. We remind 
readers that ONC sets timelines through their rulemaking for when 
health IT developers must ensure their health IT products meet ONC's 
new or updated certification criteria to maintain certification under 
the ONC Health IT Certification Program, including time for health IT 
developers to implement these updates for their customers who may 
participate in programs that require use of CEHRT (88 FR 23761). We 
also noted that CMS will continue to determine when new or revised 
versions of measures that require the use of certified health IT would 
be required for participation under the Medicare Promoting 
Interoperability Program and the Quality Payment Program. In 
determining requirements for any potential new or revised measures, we 
will consider factors such as implementation time and provider 
readiness to determine when we propose requiring participants to 
complete measures that require the use of certified health IT.
    We believe this approach will provide us with more flexibility to 
finalize updates and is more consistent with the incremental approach 
to revising measures and technology requirements described above. 
Moreover, this additional flexibility will allow eligible hospitals, 
CAHs, and eligible clinicians

[[Page 79310]]

to adopt, implement, and use ONC's updated certification criteria for 
health IT, including EHRs, as it becomes available from their chosen 
vendor, without the need to wait for us to first amend the regulations 
at Sec. Sec.  495.4 and 414.1305 through separate rulemaking.
    In summary, we proposed to revise the definitions of CEHRT for the 
Medicare Promoting Interoperability Program at Sec.  495.4, and for the 
Quality Payment Program at Sec.  414.1305 (88 FR 52548). Specifically, 
we proposed to add a reference to the revised name of ``Base EHR 
definition,'' proposed in the ONC HTI-1 proposed rule, to ensure, if 
that rule is finalized, the revised name of ``Base EHR definition'' is 
applicable for the CEHRT definitions going forward (88 FR 23759). We 
also proposed to replace our references to the ``2015 Edition health IT 
certification criteria'' with ``ONC health IT certification criteria'' 
and add the regulatory citation for ONC health IT certification 
criteria in 45 CFR 170.315. We proposed to specify that technology 
meeting the CEHRT definitions must meet ONC's certification criteria in 
45 CFR 170.315 ``as adopted and updated by ONC.'' We believe that these 
revisions to the CEHRT definitions, which we are finalizing as 
proposed, will ensure that updates to the definition at 45 CFR 170.102 
and updates to applicable health IT certification criteria in 45 CFR 
170.315 will be incorporated into the CEHRT definitions, without 
additional regulatory action by CMS.
    Finally, we noted that while this proposal is consistent with the 
approach in ONC's HTI-1 proposed rule (88 FR 23746 through 23917), we 
do not believe that ONC must finalize its proposed revisions for us to 
be able to finalize the changes proposed in this section for our 
regulatory definitions of CEHRT.
    We solicited comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Many commenters supported the proposal to revise and 
streamline the CEHRT definitions and the proposed cross-references for 
the Medicare Promoting Interoperability Program at Sec.  495.4, and for 
the Quality Payment Program at Sec.  414.1305, with ONC's regulations 
and terminology. Some commenters supported the alignment because 
disparate definitions for the same terms across different health IT and 
other health care regulations can cause confusion and administrative 
burdens to ensure compliance. Some commenters agreed with the proposal 
and approach to offer flexibility to clinicians and hospitals to adopt 
and implement ONC's updated certification criteria as they become 
available without having to wait on CMS to amend related regulations. 
Commenters also agreed with our assertion that CMS will determine when 
to incorporate any new or revised measures requiring new ONC Health IT 
Certification Program certification criteria--taking into account 
implementation timelines and readiness.
    Response: We agree that the revisions will help to reduce potential 
confusion by clarifying references to certification criteria under the 
ONC Health IT Certification Program. We believe these revisions are 
consistent with the strategy described in the ONC HTI-1 proposed rule 
to move away from year-themed ``editions,'' including updates to the 
Base EHR definition and establishment of a single set of ONC health IT 
certification criteria (88 FR 52547). We believe this alignment, 
whether or not ONC finalizes its proposals, will simplify participation 
and reduce confusion for CMS program participants. In determining 
requirements for any potential new or revised measures, we will 
consider factors such as implementation time and provider readiness to 
determine when we propose requiring participants to complete measures 
that require the use of any new health IT certification criteria.
    Comment: Some commenters requested more information regarding 
specific requirements to meet the ONC health IT certification criteria. 
One commenter recommended that CMS work with ONC to educate providers 
on the certification process to convey what providers need to know, 
actions to take now and in future years, and the anticipated costs 
associated with adopting and implementing certified EHR technology. 
Another commenter suggested that CMS ensure proper disclosures and 
plain language be included from EHR vendors to avoid confusion 
regarding EHR updates so that medical groups remain fully aware of 
whether the products they are using meet the CMS requirements. Another 
commenter recommended that CMS work with ONC to ensure health IT 
developers support awareness of proposed policies that impact 
healthcare providers.
    Response: We thank commenters for their suggestion to work with ONC 
in development of educational materials for providers so they better 
understand the certification process. We also appreciate the need to 
help users of ONC-certified products understand whether those products 
meet the definition of CEHRT, as well as the need to ensure clear and 
concise communications when describing the certification status of 
their products. We note that ONC maintains the Certified Health IT 
Product List (https://chpl.healthit.gov/), which is a comprehensive 
source of information for all health IT products certified by the ONC 
Health IT Certification Program. We may take these recommendations into 
consideration as we engage in continued educational activities. We will 
also work with ONC to explore the role health IT developers can play in 
effectively communicating policy changes to healthcare providers.
    Comment: Other commenters expressed concern that the proposal would 
create financial and clinician burden in terms of implementation 
without providing clear or defined advantages and benefits. One 
commenter noted that many EHR developers charge physicians for 
``upgrades'' and software updates to support new certified ``editions'' 
of the ONC health IT certification criteria. These fees often signify a 
required change in EHR versions to support federal reporting 
requirements, therefore, leaving it up to the EHR developer to 
``provide'' ongoing certified EHRs to physicians. This results in the 
EHR developer charging physicians for updates without sufficiently 
communicating why the update is necessary, which could result in the 
physician declining the update to save money without realizing this 
action could result in the physician not possessing certified health IT 
necessary for participation in CMS' programs. To address this, the 
commenter recommended a joint ONC-CMS educational campaign to clearly 
communicate to physicians what an EHR developer's ``provided product'' 
means and what declining the product means for the EHR's ability to 
support provider participation in Federal programs. The commenter also 
expressed concern that shifting the responsibility to the physician, 
rather than requiring explicit use of a specific certified ``edition'' 
of ONC health IT certification criteria, as ONC and CMS have required 
for years, will disadvantage physicians.
    Response: We understand that financial and other implementation 
burden for providers may be associated with updates to certified health 
IT products required for participation in CMS programs. We note that 
ONC's focus on moving to incremental updates from the large-scale 
updates associated with year-themed Editions is intended in part to 
help mitigate the burden

[[Page 79311]]

associated with updates. We also appreciate the recommendation to have 
joint educational resources that underscore the importance of having 
health IT products that meet the CEHRT definition, and we may take this 
into consideration as we engage in continued educational activities. 
Additionally, we agree it is important to support the broader adoption 
and use of interoperable certified health IT, and we refer readers to 
several existing resources and technical assistance information that 
HHS disseminates to support the broader care 
continuum.457 458 459 We do not believe that this approach 
will disadvantage health care providers, relative to our prior focus on 
year-themed Editions. Rather, we believe this approach will simplify 
compliance and reduce the burden on healthcare providers who were 
previously required to ascertain the requirements and complete a large-
scale update from one Edition to the next every few years. For a given 
capability required under the Medicare Promoting Interoperability 
Program or the Quality Payment Program, a health care provider will 
only need to know that their health IT product is certified to the 
appropriate criterion or criteria at 45 CFR 170.315, rather than the 
appropriate Edition. As previously mentioned, ONC maintains the 
Certified Health IT Product List (https://chpl.healthit.gov/), which is 
a comprehensive and authoritative listing of all certified Health IT 
Modules that have been successfully tested and certified by the ONC 
Health IT Certification program. We believe this will also help 
healthcare providers to have confidence that their health IT is kept up 
to date as their developer supports compliance with the ONC Health IT 
Certification Program requirements.
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    \457\ https://www.healthit.gov/topic/health-it-health-care-settings/long-term-and-post-acute-care.
    \458\ https://www.healthit.gov/topic/behavioral-health.
    \459\ https://www.healthit.gov/sites/default/files/page/2020-07/Care%20Continuum%20Tipsheet.pdf.
---------------------------------------------------------------------------

    Comment: One commenter expressed concern with the updates providers 
would need to implement for criteria that are part of the CEHRT 
definition, such as those under the Base EHR definition. Specifically, 
the commenter noted since the CEHRT definition (both current and 
revised in this rule) directly references the Base EHR definition at 45 
CFR 170.102, any such criteria would be updated as part of the Base EHR 
definition as of a date defined by ONC, and therefore, also updated 
automatically as part of the CEHRT definition given that direct 
citation. The commenter urged CMS to revise the CEHRT definition in a 
way that clarifies a date by which such new or revised criteria would 
become effective for purposes of Medicare Promoting Interoperability 
Program and the Quality Payment Program, for instance, by codifying a 
standard delay of 12 months from ONC's own effective dates intended for 
applicability for developers. One commenter recommended the timelines 
related to CEHRT definitions and requirements in this proposed rule not 
be effective any sooner than 24 months following the publication of the 
final rule. One commenter recommended that CMS set a date by which it 
expects all EHRs to achieve certification, requesting that CMS afford 
EHR vendors and health care providers a transition period of 3 to 5 
years to develop, adopt, and integrate certified products. Other 
commenters requested the proposed timelines be clarified and delayed or 
extended, and prioritization be given to reducing provider burden 
across the whole healthcare continuum when implementing provisions of 
the 21st Century Cures Act and updating ONC's Health IT Certification 
Program.
    Response: As noted by the commenter, under this final policy, 
technology meeting the CEHRT definitions must meet ONC's certification 
criteria in 45 CFR 170.315 ``as adopted and updated by ONC.'' As a 
result, updates to the definition at 45 CFR 170.102 of a ``Base EHR'' 
and updates to applicable health IT certification criteria in 45 CFR 
170.315 would be incorporated into the CEHRT definitions of our 
programs, without additional regulatory action by CMS. ONC sets 
timelines through their rulemaking for when health IT developers must 
ensure their health IT products meet new or updated certification 
criteria in order to maintain certification under the ONC Health IT 
Certification Program, including time for health IT developers to 
implement these updates for their customers (88 FR 23761). We decline 
to finalize separate effective dates in the CEHRT definitions for the 
use of updated certified health IT products within the Medicare 
Promoting Interoperability Program or the Quality Payment Program, as 
recommended by commenters. We believe that emphasizing the timelines 
ONC adopts through notice and comment rulemaking for health IT 
developers to update and provide certified technology to their 
customers will reduce burden on participants in the Medicare Promoting 
Interoperability Program and the Quality Payment Program. Conversely, 
we believe that developing separate deadlines for program participants 
to ensure their technology has been appropriately updated would 
increase the regulatory burden for participants. As stated in the CY 
2024 PFS proposed rule (88 FR 52548), we will continue to determine 
when new or revised versions of measures that require the use of 
certified health IT would be required for participation under the 
Medicare Promoting Interoperability Program and the Quality Payment 
Program. In determining requirements for any potential new or revised 
measures, we will consider factors such as implementation time and 
provider readiness to determine when we propose requiring participants 
to complete measures that require the use of certified health IT.
    Finally, we refer readers to ONC's HTI-1 proposed rule, which 
includes two important proposals to further ensure that developers of 
certified health IT have certified products available for their 
customers to implement by specific dates. First, ONC proposes across 
several certification criteria,\460\ and across several standards that 
are incorporated into certification criteria,\461\ an expiration date 
after which a certification criterion and standard would no longer be 
available for certification under the ONC Health IT Certification 
Program.\462\ Second, ONC proposes a new requirement (88 FR 23828 
through 23830) as part of the Assurances Condition and Maintenance of 
Certification requirements in 45 CFR 170.402(b)(3) that would require a 
health IT developer to (1) update their products to the most recently 
adopted capabilities and standards included in a revised certification 
criterion and (2) provide to its customers such updated products by 
dates specified according to the revised criterion or standard.\463\
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    \460\ For example, ONC proposed in 45 CFR 170.315(f)(5) that a 
Health IT Module must conform to the revised requirements of the 
electronic case reporting certification criterion on an after 
December 31, 2024 (88 FR 23769 through 23774).
    \461\ For example, ONC proposed that adoption of the United 
States Core Data for Interoperability (USCDI) version 1 standard in 
45 CFR 170.213(a) would expire on January 1, 2025 (88 FR 23764).
    \462\ See also 45 CFR 170.315(a)(9)(vi) where ONC proposed that 
adoption of the CDS criterion for purposes of the ONC Health IT 
Certification Program expires on January 1, 2025 (88 FR 23782).
    \463\ For example, several new standards were proposed for the 
standardized API for patient and population level services 
certification criterion in 45 CFR 170.315(g)(10), and under the 
proposed Assurances requirements in 45 CFR 170.402(b)(3) a developer 
of certified health IT with a Health IT Module certified to 45 CFR 
170.315(g)(10) would need to update their products to use the newer 
standards and provide those updated products to its customers by 
dates specified in 45 CFR 170 subpart B. In the case of 45 CFR 
170.315(g)(10), by January 1, 2025 (88 FR 23828 through 23830).

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[[Page 79312]]

    After consideration of public comments, we are finalizing our 
proposals to revise the definitions of CEHRT for the Medicare Promoting 
Interoperability Program at Sec.  495.4, and for the Quality Payment 
Program at Sec.  414.1305, to add a reference to the revised name of 
``Base EHR definition''; to replace our references to the ``2015 
Edition health IT certification criteria'' with ``ONC health IT 
certification criteria''; and to add the regulatory citation for ONC 
health IT certification criteria in 45 CFR 170.315.

S. A Social Determinants of Health Risk Assessment in the Annual 
Wellness Visit

    Medicare coverage for the Annual Wellness Visit (AWV) under Part B 
is primarily described in statute at section 1861(hhh) of the Act, and 
in regulation at 42 CFR 410.15. In the CY 2024 PFS proposed rule (88 FR 
52262), we proposed to exercise our authority in section 
1861(hhh)(2)(I) of the Act to add other elements to the AWV by adding a 
new Social Determinants of Health (SDOH) Risk Assessment as an 
optional, additional element with an additional payment. We noted that 
the proposed new SDOH Risk Assessment would enhance patient-centered 
care and support effective administration of an AWV. There are no 
deductible requirements or Part B coinsurance for the AWV. See 
Sec. Sec.  410.160(b)(12) and 410.152(l)(13). Our proposal built upon 
our separate proposal described earlier to establish a stand-alone G 
code (G0136) for SDOH Risk Assessment furnished in conjunction with an 
Evaluation and Management (E/M) visit (see section II.E. of this final 
rule).
1. Background
    The AWV includes the establishment (or update) of the patient's 
medical and family history, application of a health risk assessment and 
the establishment (or update) of a personalized prevention plan. The 
AWV also includes an optional Advance Care Planning (ACP) service. The 
AWV is covered for eligible beneficiaries who are no longer within 12 
months of the effective date of their first Medicare Part B coverage 
period and who have not received either an Initial Preventive Physical 
Examination (IPPE) or AWV within the past 12 months. The goals of AWV 
are health promotion, disease prevention and detection and include 
education, counseling, a health risk assessment, referrals for 
prevention services, and a review of opioid use. Additional information 
about the AWV is available on the CMS website at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/preventive-services/medicare-wellness-visits.html.
    It is estimated \464\ that around 50 percent of an individual's 
health is directly related to SDOH, which is defined by Healthy People 
2030 \465\ as, ``The conditions in the environment where people are 
born, live, work, play, worship, and age that affect a wide range of 
health, functioning, and quality-of-life outcomes and risks.'' Healthy 
People 2030 also defines the broad groups of SDOH as: economic 
stability, education access and quality, healthcare access and quality, 
neighborhood and built environment, and social and community context. 
These parameters include factors like housing, food and nutrition 
access, and transportation needs. Given the large impact on health 
these factors have, the health care system broadly has been working to 
take these factors into account when providing care and rendering 
services.
---------------------------------------------------------------------------

    \464\ https://aspe.hhs.gov/sites/default/files/documents/e2b650cd64cf84aae8ff0fae7474af82/SDOH-Evidence-Review.pdf.
    \465\ https://health.gov/healthypeople.
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    Several Federal agencies, including the CDC, AHRQ, ACL, ACF, 
SAMHSA, HRSA, ONC, and ASPE are developing policies and implementation 
frameworks to better address the impact SDOH has on patients, in 
support of HHS's Strategic Approach to Addressing Social Determinants 
of Health to Advance Health Equity.\466\ At CMS, addressing SDOH is an 
essential piece of the CMS Framework for Health Equity,\467\ and it is 
tied in heavily with the CMS Strategic Pillar to advance equity. SDOH 
was also a foundational concept with the CMS Innovation Center 
Accountable Health Communities (AHC) Model that ended in 2022. Given 
the importance of and focus surrounding SDOH and enhancing equity, CMS 
is exploring ways to recognize and quantify practitioner work currently 
being done in this area, and to provide support to enable practitioners 
to assess and intervene when SDOH is relevant to the assessment, 
prevention and treatment plan of a Medicare patient.
---------------------------------------------------------------------------

    \466\ https://aspe.hhs.gov/sites/default/files/documents/aabf48cbd391be21e5186eeae728ccd7/SDOH-Action-Plan-At-a-Glance.pdf.
    \467\ https://www.cms.gov/files/document/cms-framework-health-equity-2022.pdf.
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    CMS tested the AHC Model between 2017 and 2022. One element of the 
model test was the development and application of the AHC Health-
Related Social Needs (HRSN) Screening Tool, which helps providers to 
identify patients' SDOH related needs, including housing instability, 
food insecurity, family and community support and mental health. 
Additional information on the AHC model is available on the CMS website 
at (https://innovation.cms.gov/innovation-models/ahcm).
    We have heard from many health care professionals and beneficiary 
groups that there are barriers to completing the AWV, including, but 
not limited to, language and communication, differences in cultural 
perspectives and expectations regarding engagement with the healthcare 
system. We described in the PFS proposed rule that we increasingly 
understand the importance that SDOH be considered in an assessment of 
patient histories, patient risk, and in informing medical decision 
making, prevention, diagnosis, care and treatment.
    In February 2018, Health Affairs published an article titled, 
``Practices Caring for the Underserved Are Less Likely to Adopt 
Medicare's Annual Wellness Visit,'' which described findings from a 
statistical study of Medicare primary care providers and AWV's from 
2011 to 2015. The article states, ``One of our most striking results 
was that while underserved patients were less likely to receive an 
annual wellness visit regardless of where they sought care, practices 
in rural areas and those caring for underserved and sicker populations 
were less likely to provide such visits to any of their patients--which 
suggests these practices may face resource constraints or have 
priorities that compete with adoption of the visit.'' \468\
---------------------------------------------------------------------------

    \468\ Ganguli I, Souza J, McWilliams JM, Mehrotra A. Practices 
Caring For The Underserved Are Less Likely To Adopt Medicare's 
Annual Wellness Visit. Health Aff (Millwood). 2018 Feb;37(2):283-
291. doi: 10.1377/hlthaff.2017.1130. PMID: 29401035; PMCID: 
PMC6080307.
---------------------------------------------------------------------------

    In August 2022, the Journal of the American Geriatrics Society 
published an article titled, ``Medicare's annual wellness visit: 10 
years of opportunities gained and lost.'' The article expresses the 
concern, ``currently AWVs are a `one size fits all','' approach. This 
uniform approach does not sufficiently take into consideration the 
medical, psychological, functional, racial, cultural and socio-economic 
diversity of older adults. Updated AWVs should be tailored to meet the 
needs and priorities of older adults receiving them.'' It goes on to 
recommend, ``Medicare AWVs should include screening and

[[Page 79313]]

counseling for social determinants of health as a means of mitigating 
the growing disparities in health and longevity for underserved older 
adults.'' \469\
---------------------------------------------------------------------------

    \469\ Coll PP, Batsis JA, Friedman SM, Flaherty E. Medicare's 
annual wellness visit: 10[thinsp]years of opportunities gained and 
lost. J Am Geriatr Soc. 2022 Oct;70(10):2786-2792. doi: 10.1111/
jgs.18007. Epub 2022 Aug 17. PMID: 35978538.
---------------------------------------------------------------------------

2. Statutory and Regulatory Authority
    Section 4103 of The Patient Protection and Affordable Care Act 
(ACA) (Pub. L. 111-148) expanded Medicare coverage by adding the AWV 
benefit at section 1861(hhh) of the Act, effective for services 
furnished on or after January 1, 2011. We subsequently implemented the 
AWV in CMS regulations at Sec.  410.15. The AWV is a wellness visit 
that focuses on identification of certain risk factors, personalized 
health advice, and referral for additional preventive services and 
lifestyle interventions (which may or may not be covered by Medicare). 
The elements included in the AWV differ from comprehensive physical 
examination protocols with which some providers may be familiar since 
it is a visit that is specifically designed to provide personalized 
prevention plan services as defined in the Act. The AWV includes a 
health risk assessment (HRA) and the AWV takes into account the results 
of the HRA. The AWV is covered for eligible beneficiaries who are no 
longer within 12 months of the effective date of their first Medicare 
Part B coverage period and who have not received either an IPPE or AWV 
within the past 12 months. Section 1861(hhh)(2) of the Act describes a 
number of elements included in the AWV and section 1861(hhh)(2)(I) of 
the Act authorizes the addition of any other element determined 
appropriate by the Secretary.
    Section 410.15(a) requires that the first AWV include the 
following:
     Review (and administration if needed) of a health risk 
assessment (as defined in Sec.  410.15).
     Establishment of an individual's medical and family 
history.
     Establishment of a list of current providers and suppliers 
that are regularly involved in providing medical care to the 
individual.
     Measurement of an individual's height, weight, body-mass 
index (or waist circumference, if appropriate), blood pressure, and 
other routine measurements as deemed appropriate, based on the 
beneficiary's medical and family history.
     Detection of any cognitive impairment that the individual 
may have, as that term is defined in Sec.  410.15.
     Review of the individual's potential (risk factors) for 
depression, including current or past experiences with depression or 
other mood disorders, based on the use of an appropriate screening 
instrument for persons without a current diagnosis of depression, which 
the health professional may select from various available standardized 
screening tests designed for this purpose and recognized by national 
medical professional organizations.
     Review of the individual's functional ability and level of 
safety, based on direct observation or the use of appropriate screening 
questions or a screening questionnaire, which the health professional 
as defined in Sec.  410.15 may select from various available screening 
questions or standardized questionnaires designed for this purpose and 
recognized by national professional medical organizations.
     Establishment of the following:
    ++ A written screening schedule for the individual such as a 
checklist for the next 5 to 10 years, as appropriate, based on 
recommendations of the United States Preventive Services Task Force 
(USPSTF) and the Advisory Committee on Immunization Practices, and the 
individual's health risk assessment (as that term is defined in Sec.  
410.15), health status, screening history, and age- appropriate 
preventive services covered by Medicare.
    ++ A list of risk factors and conditions for which primary, 
secondary or tertiary interventions are recommended or are underway for 
the individual, including any mental health conditions or any such risk 
factors or conditions that have been identified through an IPPE (as 
described under Sec.  410.16), and a list of treatment options and 
their associated risks and benefits.
    ++ Furnishing of personalized health advice to the individual and a 
referral, as appropriate, to health education or preventive counseling 
services or programs aimed at reducing identified risk factors and 
improving self- management, or community-based lifestyle interventions 
to reduce health risks and promote self-management and wellness, 
including weight loss, physical activity, smoking cessation, fall 
prevention, and nutrition.
    ++ At the discretion of the beneficiary, furnish advance care 
planning services to include discussion about future care decisions 
that may need to be made, how the beneficiary can let others know about 
care preferences, and explanation of advance directives which may 
involve the completion of standard forms.
    ++ Furnishing of a review of any current opioid prescriptions as 
that term is defined in this section.
    ++ Screening for potential substance use disorders including a 
review of the individual's potential risk factors for substance use 
disorder and referral for treatment as appropriate.
    ++ Any other element determined appropriate through the national 
coverage determination process.
    We noted in the PFS proposed rule that Sec.  410.15(a) requires 
that a subsequent AWVs include the following:
     Review (and administration, if needed) of an updated 
health risk assessment (as defined in Sec.  410.15).
     An update of the individual's medical and family history.
     An update of the list of current providers and suppliers 
that are regularly involved in providing medical care to the individual 
as that list was developed for the first AWV providing personalized 
prevention plan services or the previous subsequent AWV providing 
personalized prevention plan services.
     Measurement of an individual's weight (or waist 
circumference), blood pressure and other routine measurements as deemed 
appropriate, based on the individual's medical and family history.
     Detection of any cognitive impairment that the individual 
may have, as that term is defined in Sec.  410.15.
     An update to the following:
    ++ The written screening schedule for the individual as that 
schedule is defined in paragraph (a) of Sec.  410.15 for the first AWV 
providing personalized prevention plan services.
    ++ The list of risk factors and conditions for which primary, 
secondary or tertiary interventions are recommended or are underway for 
the individual as that list was developed at the first AWV providing 
personalized prevention plan services or the previous subsequent AWV 
providing personalized prevention plan services.
    ++ Furnishing of personalized health advice to the individual and a 
referral, as appropriate, to health education or preventive counseling 
services or programs as that advice and related services are defined in 
paragraph (a) of Sec.  410.15.
    ++ At the discretion of the beneficiary, furnish advance care 
planning services to include discussion about future care decisions 
that may need to be made, how the beneficiary can let others know about 
care

[[Page 79314]]

preferences, and explanation of advance directives which may involve 
the completion of standard forms.
    ++ Furnishing of a review of any current opioid prescriptions as 
that term is defined in this section.
    ++ Screening for potential substance use disorders including a 
review of the individual's potential risk factors for substance use 
disorder and referral for treatment as appropriate.
    ++ Any other element determined appropriate through the national 
coverage determination process.
    In the CY 2016 PFS final rule (80 FR 70885), we included ACP as an 
optional element (at beneficiary discretion) within the AWV. We stated 
in the final rule we added ACP as a voluntary, separately payable 
element of the AWV. We provided the instruction that when ACP is 
furnished as an optional element of AWV as part of the same visit with 
the same date of service, CPT codes 99497 and 99498 should be reported 
and will be payable in full in addition to payment that is made for the 
AWV under HCPCS code G0438 or G0439, when the parameters for billing 
those CPT codes are separately met, including requirements for the 
duration of the ACP services. Under these circumstances, ACP should be 
reported with modifier -33 and there will be no Part B coinsurance or 
deductible, consistent with the AWV (80 FR 70958). We also added this 
policy to the regulatory text at Sec.  410.15(a).
3. Proposal
    In the CY 2024 PFS proposed rule (88 FR 52262), we proposed to 
exercise our authority in section 1861(hhh)(2)(I) of the Act to add 
elements to the AWV by adding a new SDOH Risk Assessment as an 
optional, additional element of the AWV with an additional payment. We 
recognized that, for some patients, identification and consideration of 
SDOH is critical to furnishing a fully informed health assessment and 
personalized prevention plan in the AWV. Interested parties had 
reported that the current elements of the AWV may not directly or 
adequately identify those SDOH challenges. We proposed that the SDOH 
Risk Assessment be separately payable with no beneficiary cost sharing 
when furnished as part of the same visit with the same date of service 
as the AWV. We proposed that the SDOH Risk Assessment service include 
the administration of a standardized, evidence-based SDOH risk 
assessment tool, furnished in a manner that all communication with the 
patient be appropriate for the patient's educational, developmental, 
and health literacy level, and be culturally and linguistically 
appropriate. We stated that services that are culturally and 
linguistically appropriate are critical to providing effective, 
equitable, understandable, and respectful quality care that are 
responsive to diverse cultural health beliefs and practices, preferred 
languages, health literacy, and other communication needs of each 
patient. We recognized that patients with SDOH risks and challenges may 
often also experience communication barriers of various kinds when 
interacting with the health care system. We further noted that we 
believe that the SDOH Risk Assessment would only be effective in 
informing the greater AWV (including the health assessment and 
personalized prevention plan) when furnished in a manner that is 
intelligible and appropriate to the individualized characteristics and 
circumstances of the patient. Additional information on culturally and 
linguistically appropriate services in healthcare can be found at 
(https://thinkculturalhealth.hhs.gov/clas). In addition, we described 
our belief that the SDOH Risk Assessment Tool would be most effective 
and actionable when furnished in a setting with staff-assisted supports 
in place to ensure follow-up for health-related social needs associated 
to the visit. We also encouraged partnerships with community-based 
organizations such as Area Agencies on Aging to help address identified 
social needs. We proposed that the SDOH Risk Assessment be furnished as 
part of the same visit and on the same date of service as the AWV, so 
as to inform the care the patient is receiving during the visit, 
including taking a medical and social history, applying health 
assessments and prevention services education and planning. We 
suggested our proposal would directly reduce barriers, expand access, 
promote health equity and improve care for populations that have 
historically been underserved by recognizing the importance that SDOH 
be considered and assessed, where appropriate, in support of the 
existing AWV. In addition, we expressed our hope that our proposal 
would help spread general awareness among health professionals about 
the importance of providing cultural and linguistically appropriate 
services, which in turn will encourage clinicians to adopt language 
services and technologies to achieve high quality communication between 
the practitioner and patient. Our goal was the development of a 
personalized prevention plan that takes SDOH into account and is truly 
tailored to the individual patient. We solicited comments on our 
proposal, including whether a SDOH Risk Assessment would ultimately 
inform and result in the development of steps to address and integrate 
SDOH in the patient's AWV health assessment and personalized prevention 
plan.
    We recognized in the PFS proposed rule that SDOH risk assessments 
are an emerging and evolving tool in healthcare and so we did not 
restrict our proposal to a specific list of approved assessments. In 
selecting an evidence-based tool, we encourage clinicians to explore 
the many widely adopted and validated tools available, including the 
CMS Accountable Health Communities \470\ tool, the Protocol for 
Responding to & Assessing Patients' Assets, Risks & Experiences 
(PRAPARE) tool,\471\ and instruments identified for Medicare Advantage 
Special Needs Population Health Risk Assessment.\472\ We also 
encouraged clinicians, where feasible, to select screening instruments 
that maximize opportunities to collect and analyze standardized, 
quantifiable, and actionable data. For instance, clinicians were 
encouraged to utilize screening instruments where questions and 
responses are computable and mapped to health IT vocabulary standards 
(that is, have available LOINC[supreg] coding terminology), to ensure 
that data captured through assessments is interoperable and can be 
shared, analyzed and evaluated across the care continuum.
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    \470\ https://innovation.cms.gov/files/worksheets/ahcm-screeningtool.pdf.
    \471\ https://www.nachc.org/research-and-data/prapare/.
    \472\ CMS-10825.
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    Our proposal built upon our separate proposal described earlier in 
the PFS proposed rule to establish a stand-alone G code (G01365) for 
SDOH Risk Assessment furnished in conjunction with an E/M visit. See 
section II.E. of this final rule for additional information on coding, 
pricing, and additional conditions of payment for the proposed new SDOH 
Risk Assessment service. We indicated that once the rule was final, CMS 
would issue public guidance in the Medicare Learning Network, the 
Medicare & You Handbook, and other policy and payment instructions in 
the Medicare Benefit Policy Manual and the Medicare Claims Processing 
Manual on the CMS website.
    CMS has worked to develop payment mechanisms under the PFS to 
improve the accuracy of valuation and payment for the services 
furnished by physicians and other health care professionals, especially 
in the context of evolving models of care. Section 1862(a)(1)(A) of the 
Act generally excludes from

[[Page 79315]]

coverage services that are not reasonable and necessary for the 
diagnosis or treatment of illness or injury or to improve the 
functioning of a malformed body member. Practitioners across 
specialties have opined and recognized the importance of SDOH on the 
health care provided to their patients by recommending the assessment 
of SDOH through position or discussion papers,473 474 475 
organizational strategic plans,\476\ and provider training 
modules,\477\ among others. We have discussed how the practice of 
medicine currently includes assessment of health-related social needs 
or SDOH in taking patient histories, assessing patient risk, and 
informing medical decision making, diagnosis, care and treatment. The 
taking of a social history is generally performed by physicians and 
other health professionals in support of patient-centered care to 
better understand and help address relevant problems that are impacting 
medically necessary care. Practitioners are expending resources to 
obtain information from the patient about health-related social needs, 
and to formulate diagnosis and treatment plans that take these needs 
into account as part of a person-centered care plan for the treatment 
of medical problems. This work currently is reported and paid for, in 
part, under the PFS under E/M visit codes, and we believe as such, is 
undervalued and not optimized to allow the health professional and 
patient to benefit from the full value of a dedicated SDOH assessment 
and have that assessment immediately inform the health assessment and 
prevention planning services in the AWV.
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    \473\ https://www.aafp.org/about/policies/all/social-determinants-health-family-medicine-position-paper.html.
    \474\ https://doi.org/10.7326/M17-2441.
    \475\ https://nam.edu/social-determinants-of-health-201-for-health-care-plan-do-study-act/.
    \476\ https://www.ama-assn.org/system/files/2021-05/ama-equity-strategic-plan.pdf.
    \477\ https://edhub.ama-assn.org/steps-forward/module/2702762.
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    We proposed that Medicare would pay 100 percent of the fee schedule 
amount for the SDOH Risk Assessment service (beneficiary cost sharing 
would not be applicable) when this risk assessment is furnished to a 
Medicare beneficiary as an optional element within an AWV (as part of 
the same visit with the same date of service as the AWV). Our proposal 
was analogous to our approach to the ACP service, which is an optional 
service for which beneficiary cost sharing is not applicable when 
furnished as part of the same visit and on the same date of service as 
the AWV. Beneficiary cost sharing (coinsurance and deductible) is not 
applicable to the AWV and, because the SDOH Risk Assessment will be an 
optional element within the AWV, there will not be any beneficiary cost 
sharing for the SDOH Risk Assessment either. See Sec. Sec.  
410.160(b)(12) and 410.152(l)(13). We noted that beneficiary cost 
sharing would apply to the SDOH Risk Assessment if furnished in 
conjunction with another service (outside of the AWV) that is subject 
to beneficiary cost sharing. We proposed that the SDOH Risk Assessment 
would be optional for both the health professional and the beneficiary 
to empower clinicians and patients to employ this assessment only when 
appropriate and desired.
    We proposed to add regulatory text at Sec.  410.15 that will 
include the new SDOH Risk Assessment service as an optional element 
within the AWV, at the discretion of the health professional and 
beneficiary. Furthermore, we proposed to add regulatory text that the 
SDOH Risk Assessment be standardized, evidence-based, and furnished in 
a manner that all communication with the patient be appropriate for the 
beneficiary's educational, developmental, and health literacy level, 
and be culturally and linguistically appropriate. We solicited comments 
on our proposal.
    Because we had previously received feedback from interested parties 
that the AWV may be more effectively furnished if elements were allowed 
to be completed over multiple visits and days, or prior to the AWV 
visit, we also solicited comments on this issue for consideration in 
future rulemaking.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Overall, public commenters expressed broad support and 
approval of our proposal to exercise our authority in section 
1861(hhh)(2)(I) of the Act to add elements to the AWV by adding a new 
SDOH Risk Assessment as an optional, additional element of the AWV with 
an additional payment and no applicable beneficiary cost sharing. Many 
commenters agreed with our position described in the PFS proposed rule 
that, for some patients, a Social Determinates of Health Risk 
Assessment would be critical to furnishing a fully informed Health Risk 
Assessment and Personalized Prevention Plan in the Annual Wellness 
Visit, and thus, an appropriate additional, optional element in the 
AWV.
    Response: We thank the commenters for their support of our proposal 
to exercise our authority in section 1861(hhh)(2)(I) of the Act to add 
elements to the AWV by adding a new SDOH Risk Assessment as an 
optional, additional element of the AWV with an additional payment and 
no applicable beneficiary cost sharing.
    Comment: Many commenters expressed agreement with our proposal to 
make the SDOH Risk Assessment optional for the patient and clinician. A 
few comments disagreed with our proposal that the SDOH Risk Assessment 
be optional for the provider and beneficiary and, instead, the 
commenters recommended that the SDOH Risk Assessment be a mandatory 
additional element in the AWV.
    Response: We disagree with the commenters' recommendation that the 
SDOH Risk Assessment should be a mandatory element of the AWV at this 
time. We recognize that a SDOH Risk Assessment is an emerging tool in 
healthcare and that some clinicians and patients may be reluctant to 
collect and share sensitive information about health-related social 
needs until this tool becomes more established and familiar. We are not 
adopting the recommendation by public commenters that the SDOH Risk 
Assessment be a mandatory element of the AWV, but we may consider it in 
future rulemaking.
    Comment: We received a few comments requesting clarification on the 
type of clinician that would be eligible to furnish the SDOH Risk 
Assessment as an additional element of the AWV.
    Response: We clarify in the PFS final rule that as an additional 
element of the AWV, the clinicians identified within the definition of 
``Health Professional'' (42 CFR 410.15(a)) as eligible to furnish to 
AWV would also be eligible to furnish the SDOH Risk Assessment as an 
additional element of the AWV. This would include a physician who is a 
doctor of medicine or osteopathy (as defined in section 1861(r)(1) of 
the Act); A physician assistant, nurse practitioner, or clinical nurse 
specialist (as defined in section 1861(aa)(5) of the Act); and a 
medical professional (including a registered nurse, a licensed clinical 
social worker, a health educator, a registered dietitian, or nutrition 
professional, or other licensed practitioner) or a team of such medical 
professionals, working under the direct supervision (as defined in 
Sec.  410.32(b)(3)(ii)) of a physician.
    Comment: A few commenters requested clarification on the 
eligibility of the beneficiary and frequency limitations of the SDOH 
Risk Assessment as an additional element in the AWV.

[[Page 79316]]

    Response: We clarify the PFS final rule that as an additional 
element of the AWV, the SDOH Risk assessment would be subject to the 
same limitations on coverage for the AWV described at Sec.  410.15(c). 
Specifically, the beneficiary must be eligible for an AWV and have not 
had either an initial preventive physical examination or an AWV within 
the past 12 months. We note earlier in our final rule in section II.E. 
that the SDOH Risk Assessment may also be furnished in conjunction with 
an E/M visit, though in this instance different frequency limitations 
and other conditions of payment would apply, and Part B coinsurance and 
deductible would be applicable.
    Comment: Numerous commenters requested clarification on whether 
elements of the AWV, including the health risk assessment described at 
Sec.  410.15(a), and the SDOH Risk Assessment described in the PFS 
proposed rule, could be initiated by the patient prior to the date of 
the AWV, and if so, whether it would fit within the requirement of the 
PFS proposed rule that it be furnished on the same date of service and 
as part of the same visit as the AWV.
    Response: We clarify in the PFS final rule that in some cases, for 
various reasons, elements of the AWV may be initiated and furnished 
over a period of multiple days. In these situations, the date of 
service that should be reported on the claim is the date of service on 
which the entirety of the AWV (including applicable additional 
elements) (based on CPT code description) is completed. For example, 
there could be a scenario where a patient would provide their input for 
a SDOH Risk Assessment through an online portal on a Monday and the 
health professional interprets the patient's SDOH Risk Assessment input 
and applies that information toward the establishment or update of a 
personalized prevention plan as part of the remainder of the AWV on a 
Tuesday. In this scenario, the date of service for both the SDOH Risk 
Assessment and the AWV would be the date of service on which the 
entirety of the AWV is completed. We further clarify that medical 
record documentation should reflect that the service began on one day 
and was completed on another day (the date of service reported on the 
claim). If documentation is requested, medical records for both days 
should be submitted. In scenarios where elements of the AWV are 
initiated on one day and completed on another day, the services are to 
be billed based on the time involved as described by CPT code and the 
date of service the entire AWV is completed. This clarification is 
consistent with our implementing regulations for the health risk 
assessment element of the AWV, which allow that the health risk 
assessment may be administered independently by the beneficiary or 
administered by a health professional prior to or as part of the AWV 
encounter (Sec.  410.15(a) ``Health risk assessment''). This 
clarification is consistent with prior CMS guidance on coding and 
billing date of service on professional Medicare claims. See MLN 
article # SE17023.\478\
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    \478\ CMS website: https://www.cms.gov/regulations-and-guidance/guidance/transmittals/2017-transmittals-items/se17023.
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    Comment: Numerous commenters requested clarification on 
implications of our proposal for Federal Qualified Health Centers 
(FQHCs) and Rural Health Clinics (RHCs). First, commenters requested 
clarification on whether FQHCs and RHCs would be eligible to furnish 
the SDOH Risk Assessment as an additional element of the AWV. Second, 
many commenters also requested clarification on coding and payment 
calculations and mechanics for the SDOH Risk Assessment as an 
additional element of the AWV in relation to the FQHC and RHC bundled 
payment mechanisms.
    Response: First, we clarify in the PFS final rule that as FQHCs and 
RHCs are currently eligible to furnish the AWV, they will also be 
eligible to furnish a SDOH Risk Assessment as an additional element of 
the AWV. Second, regarding comments requesting clarification on payment 
calculations and mechanics for the SDOH Risk Assessment within the AWV 
in relation to the bundled payment mechanisms of the FQHC Prospective 
Payment System and the RHC facility-specific all-inclusive rate (AIR), 
see section III.B. of this final rule for additional information on 
coding, pricing, and additional conditions of payment for the proposed 
new SDOH Risk Assessment service in regards to FQHCs and RHCs.
    Comment: One commenter requested that CMS add screening for chronic 
kidney disease and rare kidney disease as additional elements in the 
AWV.
    Response: While adding screening for chronic kidney disease and 
rare kidney disease as additional elements in the AWV is out of scope 
for this rule, we will take it into consideration for possible future 
rulemaking.
    After consideration of public comments, we are finalizing our 
proposal made in the CY 2024 PFS proposed rule to exercise our 
authority in section 1861(hhh)(2)(I) of the Act to add elements to the 
AWV by adding a new SDOH Risk Assessment as an optional, additional 
element of the AWV with an additional payment and no applicable 
beneficiary cost sharing. We are also finalizing corresponding updates 
to regulatory text as proposed.

IV. Updates to the Quality Payment Program

A. CY 2024 Modifications to the Quality Payment Program

1. Executive Summary
a. Overview
    This section of the final rule outlines changes to the Quality 
Payment Program starting January 1, 2024, except as otherwise noted for 
specific provisions. We continue to move the Quality Payment Program 
forward, including focusing more on our measurement efforts and 
refining how clinicians would be able to participate in a more 
meaningful way, to achieve continuous improvement in the quality of 
health care services provided to Medicare beneficiaries and other 
patients through the Quality Payment Program's Merit-based Incentive 
Payment System (MIPS) and Advanced Alternative Payment Models (APMs) 
for the CY 2024 performance period/2026 MIPS payment year.
    Authorized by the Medicare Access and CHIP Reauthorization Act of 
2015 (MACRA) (Pub. L. 114-10, April 16, 2015), the Quality Payment 
Program is a payment incentive program, by which the Medicare program 
rewards clinicians who provide high-value, high-quality services in a 
cost-efficient manner. The Quality Payment Program includes two 
participation tracks for clinicians providing services under the 
Medicare program: MIPS and Advanced APMs. The statutory requirements 
for the Quality Payment Program are set forth in section 1848(q) and 
(r) of the Act for MIPS and section 1833(z) of the Act for Advanced 
APMs.
    For the MIPS participation track, MIPS eligible clinicians (defined 
in 42 CFR at 414.1305) are subject to a MIPS payment adjustment 
(positive, negative, or neutral) based on their performance in four 
performance categories: cost, quality, improvement activities, and 
Promoting Interoperability. We assess each MIPS eligible clinician's 
total performance according to our established performance standards 
with respect to the applicable measures and activities specified in 
each of these four performance categories during a performance period 
to compute a final composite performance score (a ``final score'' as 
defined at Sec.  414.1305). In

[[Page 79317]]

calculating the final score, we must apply different weights for the 
four performance categories, subject to certain exceptions, as set 
forth in section 1848(q)(5) of the Act and at Sec.  414.1380. Unless we 
assign a different scoring weight pursuant to these exceptions, for CY 
2024 performance period/2026 MIPS payment year, the scoring weights are 
as follows: 30 percent for the quality performance category; 30 percent 
for the cost performance category; 15 percent for the improvement 
activities performance category; and 25 percent for the Promoting 
Interoperability performance category.
    Once calculated, each MIPS eligible clinician's final score is 
compared to the performance threshold we have established in prior 
rulemaking for that performance period to calculate the MIPS payment 
adjustment factor as specified in section 1848(q)(6) of the Act, such 
that the MIPS eligible clinician will receive in the applicable MIPS 
payment year: (1) a positive adjustment, if their final score exceeds 
the performance threshold; (2) a neutral adjustment, if their final 
score meets the performance threshold; or (3) a negative adjustment, if 
their final score is below the performance threshold. The actual amount 
paid to the MIPS eligible clinician in MIPS payment year, once the MIPS 
payment adjustment factor is applied, is subject to further 
calculations such as application of the scaling factor and budget 
neutrality requirements, as further specified in section 1848(q)(6) of 
the Act.
    Section 1848(q) of the Act sets forth other requirements applicable 
to MIPS, including opportunities for feedback and targeted review and 
public reporting of MIPS eligible clinicians' performance. Section 
1848(r) of the Act sets forth more specific requirements for 
development of measures for the cost performance category under MIPS.
    If an eligible clinician participates in an Advanced APM and 
achieves Qualifying APM Participant (QP) or Partial QP status, they are 
excluded from the MIPS reporting requirements and payment adjustment 
(though eligible clinicians who are Partial QPs may elect to be subject 
to the MIPS reporting requirements and payment adjustment). Eligible 
clinicians who are QPs for the CY 2023 performance year receive a 3.5 
percent APM Incentive Payment in the 2025 payment year, and, beginning 
with the CY 2024 performance year (payment year 2026), a higher PFS 
payment rate (calculated using the differentially higher ``qualifying 
APM conversion factor'') than non-QPs. QPs will continue to be excluded 
from MIPS reporting and payment adjustments for the applicable year.
    Participation in the Quality Payment Program (defined as clinicians 
with a final score greater than 0, including both those who submitted 
data and those who did not submit data) decreased slightly to 97.59 
percent in the sixth year (CY 2022 performance period/2024 MIPS payment 
year) with 609,148 MIPS eligible clinicians receiving a final score 
other than zero out of 624,209 MIPS total eligible clinicians. In the 
CY 2021 performance period/2023 MIPS payment year, all 698,859 MIPS 
eligible clinicians received a final score other than zero. Therefore, 
participation rates in MIPS decreased slightly between the CY 2021 and 
CY 2022 MIPS performance periods.
    In addition, 78.76 percent of MIPS eligible clinicians received a 
positive payment adjustment for the CY 2024 MIPS payment year based on 
their performance in the CY 2022 performance period. Please note that 
results for the CY 2022 performance period/CY 2024 MIPS payment year 
described herein are subject to change as a result of the targeted 
review process which began on August 10, 2023, and will conclude on 
October 9, 2023. For more information on the targeted review process 
for the CY 2022 performance period/2024 MIPS payment year, please see 
our targeted review guide at https://qpp-cm-prod-content.s3.amazonaws.com/uploads/2511/2022MIPSTargetedReviewGuide.pdf.
    Regarding performance in Advanced APMs, for the CY 2022 QP 
Performance Period, 384,105 eligible clinicians (TIN-NPIs) earned 
Qualifying APM Participant (QP) status while another 2,528 eligible 
clinicians earned partial QP status.
    We plan to continue developing policies for the Quality Payment 
Program that more effectively reward high-quality of care for patients 
and increase opportunities for Advanced APM participation. We are 
moving forward with implementing MIPS Value Pathways (MVPs) to allow 
for a more cohesive participation experience by connecting activities 
and measures from the four MIPS performance categories that are 
relevant to a specialty, medical condition, or a particular population.
    As we move into the seventh year of the Quality Payment Program, we 
are finalizing the updates set forth in this section of this final 
rule, encouraging continued improvement in clinicians' performance with 
each performance year and driving improved quality of health care 
through payment policy.
    In developing and putting forth these proposed and final policies, 
we intend to continue our efforts to align the Quality Payment Program 
with broader CMS initiatives, such as the establishment of the 
Universal Foundation (https://www.nejm.org/doi/full/10.1056/NEJMp2215539) and the CMS National Quality Strategy (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/Legacy-Quality-Strategy). These 
initiatives unify strategic efforts across our programs, including the 
Quality Payment Program, to adopt measures most critical to providing 
high quality care and accelerate strategic improvements for quality 
programs and measures.
    The vision for the CMS National Quality Strategy is to shape a 
resilient, high-value American health care system to achieve high-
quality, safe, equitable, and accessible care for all. This strategy 
aims to promote the highest quality outcomes and safest care for all 
individuals. It also focuses on a person-centered approach as 
individuals journey across the continuum of care, care settings, and 
across payer types. The goals of this strategy incorporate lessons 
learned from the COVID-19 public health emergency (PHE) to inform both 
short- and long-term direction for our health care system.
    The Universal Foundation moves toward a building-block approach to 
advance the overall vision of the National Quality Strategy and 
increase alignment across CMS quality programs by capturing measures 
that are meaningful, broadly applicable, and capable of being digitally 
reported and stratified, to identify and track disparities over time. 
The Universal Foundation seeks to improve health outcomes, reduce 
provider burden, improve standardization of measurement, and promote 
interoperability by prioritizing measures to transition to 
interoperable digital data.
    The implementation of MVPs aligns with many of the objectives and 
goals the CMS National Quality Strategy and the Universal Foundation 
strive to achieve. For example, to align implementation of the measures 
in the Universal Foundation across MIPS and APMs, we are finalizing as 
proposed the updates to consolidate the Promoting Wellness and Managing 
Chronic Conditions MVPs into the Value in Primary Care MVP to align 
with the adult Universal Foundation measure set. We also explored the 
expansion of the APM Performance Pathway (APP) reported by clinicians 
in the Shared

[[Page 79318]]

Savings Program and Advanced APMs to include the primary care universal 
measure set in the future. In our continued strategy to incentivize 
improved equity as well as advancing value, in Performance Year 2023, 
the Shared Savings Program will implement an upside-only adjustment to 
reward ACOs that provide excellent care for underserved populations (87 
FR 69838 through 69857).
    To support our goal to accelerate interoperability, we are 
finalizing with modification our proposal to align the Shared Savings 
Program CEHRT requirement with the MIPS Promoting Interoperability 
performance category's requirements. We also are finalizing as proposed 
to modify our certified electronic health record (EHR) technology 
(CEHRT) use criterion for Advanced APMs to promote flexibility in 
adopting CEHRT that is clinically relevant to participants, emphasizing 
the importance of interoperability and health information technology. 
Moreover, we are finalizing as proposed the expansion of our portfolio 
of available MVPs for the CY 2024 performance period and remain 
committed to our goal of ensuring more meaningful participation in the 
Quality Payment Program through MVPs.
b. Summary of Major Provisions
(1) Transforming the Quality Payment Program
    The CMS National Quality Strategy addresses the urgent need for 
transformative action to advance towards a more equitable, safe, and 
outcomes-based health care system for all individuals. This vision is 
supported by the alignment of policies and quality measures in MIPS and 
APMs within the Quality Payment Program. Priorities for the Quality 
Payment Program include: achieving more equitable outcomes; utilizing 
clinically relevant measures for specialty performance that inform 
clinicians and beneficiaries; enhancing quality, patient safety, and 
efficiency through use of CEHRT; reducing burden and simplifying 
quality performance reporting; articulating meaningful outcomes, 
promoting alignment where possible, and moving to all digital 
reporting.
    The Quality Payment Program allows eligible clinicians to engage in 
patient-centered care via two tracks: MIPS and APMs. We believe the 
Quality Payment Program should continuously support the measurement and 
improvement of specialty and primary care. To this end, we are 
implementing MVPs to allow clinicians to report on measures that are 
directly relevant to their clinical practice. MVPs provide more 
clinically relevant performance measurement, engage more specialists in 
performance measurement, and reduce barriers to APM participation. CMS 
has recently laid out multiple steps intended to fulfill the potential 
of APMs. The CMS Innovation Center strategy refresh acknowledges that 
whole person care requires the depth and scope of services that 
includes both primary and specialty care and aims to provide ACOs with 
tools to better engage specialists, test ways to better link primary 
and specialty care upstream in the patient journey, and further 
movement into value-based care.\479\
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    \479\ CMMI Strategy Refresh. October 20, 2021. https://innovation.cms.gov/strategic-direction-whitepaper.
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(2) Major MIPS Provisions
    We requested comment on how the Quality Payment Program can 
facilitate continuous improvement of Medicare beneficiaries' healthcare 
and best build on existing CMS Innovation Center model policies and 
Medicare programs, such as the Medicare Shared Savings Program. We 
sought feedback on how we might modify our policies, requirements, and 
performance standards to encourage clinicians to continuously improve 
the quality of care, particularly for clinicians with little room for 
improvement in MIPS.
(a) MIPS Value Pathways Development and Maintenance
    In an effort to promote high-quality, safe, and equitable care and 
to implement the vision outlined in the CMS National Quality Strategy, 
we are finalizing as proposed five new MVPs around the topics of: 
Women's Health; Infectious Disease, Including Hepatitis C and HIV; 
Mental Health and Substance Use Disorder; Quality Care for Ear, Nose, 
and Throat (ENT); and Rehabilitative Support for Musculoskeletal Care. 
In addition, we are finalizing as proposed MVP maintenance updates to 
our MVP inventory that are in alignment with the MVP development 
criteria, and in consideration of the feedback from interested parties 
we have received through the maintenance process.
(b) Subgroup Reporting
    We are finalizing our proposal to codify previously finalized 
subgroup policies in the preamble to regulation text. Additionally, we 
are finalizing updates to previously finalized subgroup policies to 
help guide clinicians and groups to meaningfully participate in MVPs 
through subgroup reporting. Specifically, we are finalizing to 
eliminate the policy allowing a subgroup to submit a separate 
reweighting application request independent of its affiliated group, to 
not calculate the facility-based score for a subgroup, to assign the 
affiliated group's complex patient bonus score for subgroups under 
final score calculation, and to allow subgroups to submit a targeted 
review request.
(c) MIPS Performance Category Measures and Activities
(i) Quality Performance Category
    We proposed six modifications to the quality performance category. 
First, we are finalizing the proposal to expand the definition of the 
collection type to include Medicare Clinical Quality Measures for 
Accountable Care Organizations Participating in the Medicare Shared 
Savings Program (Medicare CQMs). Second, we are finalizing the proposal 
to establish the quality performance category data submission criteria 
for eCQMs that requires the utilization of CEHRT. Third, we are 
finalizing the proposal to establish the data submission criteria for 
Medicare CQMs. Fourth, we are finalizing the proposal to require the 
administration of the Consumer Assessment of Healthcare Providers and 
Systems (CAHPS) for MIPS Survey in the Spanish translation. Fifth, we 
are finalizing the proposal to maintain the data completeness criteria 
threshold to at least 75 percent for the CY 2026 performance period/
2028 MIPS payment year, and not finalizing the proposal to increase the 
data completeness criteria threshold to at least 80 percent for the CY 
2027 performance period/2029 MIPS payment year. Sixth, we are 
finalizing, with modification, the proposal to establish the data 
completeness criteria threshold for Medicare CQMs to at least 75 
percent for the CY 2024, CY 2025, and CY 2026 performance periods/2026, 
2027, and 2028 MIPS payment years, and not finalizing the proposal to 
increase the data completeness criteria threshold for Medicare CQMs to 
at least 80 percent for the CY 2027 performance period/2029 MIPS 
payment year. Finally, we are finalizing, with modification, the 
proposal to establish a measure set inventory of 198 MIPS quality 
measures.
(ii) Cost Performance Category
    We are finalizing our proposal to add five new episode-based 
measures to the cost performance category beginning with the CY 2024 
performance period/2026 MIPS payment year: Depression,

[[Page 79319]]

Emergency Medicine, Heart Failure, Low Back Pain, and Psychoses and 
Related Conditions. We are also finalizing our proposal to use a 20-
episode case minimum for each of these new measures, and to clarify our 
policy regarding case minimums for cost measures, as codified at Sec.  
414.1350(c). Additionally, we are finalizing our proposal to remove the 
Simple Pneumonia with Hospitalization episode-based measure beginning 
with the CY 2024 performance period/2026 MIPS payment year. Lastly, we 
are finalizing our proposal to update the operational list of care 
episode and patient condition groups and codes to add all five new 
measures and remove the Simple Pneumonia with Hospitalization episode-
based measure from the operational list of care episode and patient 
condition groups and codes.
(iii) Improvement Activities Performance Category
    We are finalizing as proposed to add five new, modify one existing, 
and remove three existing improvement activities from the Inventory. 
The new and modified activities help fill gaps we have identified in 
the Inventory as well as seek to ensure that activities reflect current 
clinical practice across the category. Four of the new activities 
relate to CMS Health Equity, Increase All Forms of Accessibility to 
Health Care Services and Coverage. We are also finalizing the removal 
of three improvement activities, both to align with current clinical 
guidelines and practice as well as to eliminate duplication, so that 
the inventory offers flexibility and choice without potentially causing 
burden with too many activities to choose from.
(iv) Promoting Interoperability Performance Category
    We are finalizing as proposed five policy modifications for the 
Promoting Interoperability performance category. Specifically, we are 
finalizing to: (1) lengthen the performance period for this category 
from 90 days to 180 days; (2) modify one of the exclusions for the 
Query of Prescription Drug Monitoring Program (PDMP) measure; (3) 
provide a technical update to the e-Prescribing measure's description 
to ensure it clearly reflects our previously finalized policy; (4) 
modify the Safety Assurance Factors for Electronic Health Record 
Resilience (SAFER) Guide measure to require MIPS eligible clinicians to 
affirmatively attest to completion of the self-assessment of their 
implementation of safety practices; and (5) continue to reweight this 
performance category at zero percent for clinical social workers for 
the CY 2024 performance period/2026 MIPS payment year. In section III.R 
of this final rule, we are finalizing the revision of our regulatory 
definition of CEHRT for the MIPS Promoting Interoperability performance 
category to be more flexible in reflecting any changes the Office of 
the National Coordinator for Health Information Technology (ONC) may 
make to its Base EHR definition, certification criteria, and other 
standards for health information technology.
(d) MIPS Final Scoring Methodology
(i) Performance Category Scores
    We are finalizing as proposed updates to our scoring flexibilities 
policy. We are finalizing to update the criteria by which we assess the 
scoring impacts of coding changes and apply our scoring flexibilities.
(ii) Cost Improvement Scoring
    We are finalizing as proposed with modification two amendments to 
the cost improvement scoring methodology that was established in the CY 
2018 Quality Payment Program final rule. First, we are finalizing to 
change improvement scoring from a measure-level to a category-level 
method and to remove the statistical significance requirement and amend 
the cost improvement scoring calculation, with a modification to amend 
the final step of the cost improvement scoring calculation. Second, we 
are finalizing that the maximum cost improvement score is zero 
percentage points for the CY 2020 through CY 2024 MIPS payment years, 
and one percentage point beginning with the 2025 MIPS payment year.
(e) MIPS Payment Adjustments
    We are not finalizing our proposed policy to identify the ``prior 
period'' by which we will establish the performance threshold as three 
performance periods, instead of a single prior performance period, 
beginning with the CY 2024 performance period/2026 MIPS payment year. 
To determine the performance threshold for the CY 2024 performance 
period/2026 MIPS payment year, we are finalizing that we will use the 
CY 2017 performance period/2019 MIPS payment year. Based on the mean 
final score from that prior period, we are finalizing the performance 
threshold as 75 points for the CY 2024 performance period/2026 MIPS 
payment year and codifying this policy at Sec.  414.1405(b)(9)(iii).
(f) MIPS Targeted Review
    We are finalizing as proposed to add virtual groups and subgroups 
as being eligible to submit a request for targeted review. We are 
finalizing to codify this addition at Sec.  414.1385(a).
    In addition, we are finalizing as proposed an amendment at Sec.  
414.1385(a)(2) with respect to the timeline for MIPS eligible 
clinicians, virtual groups, subgroups, groups, and APM entities to 
request a targeted review of our calculation of their MIPS payment 
adjustment factor(s). Specifically, we are finalizing an amendment to 
permit submission of a request for targeted review beginning on the day 
we make available the MIPS final score and ending 30 days after 
publication of the MIPS payment adjustment factors for the MIPS payment 
year. This will modify the current time period to submit a request for 
targeted review, which is 60 days beginning on the day that CMS makes 
available the MIPS payment adjustment factors for the MIPS payment 
year.
    We also are finalizing to amend Sec.  414.1385(a)(5). Specifically, 
we are finalizing an amendment to require that, if CMS requests 
additional information under the targeted review process, then that 
additional information must be provided to and received by CMS within 
15 days of receipt of such request. This will modify the current 
timeline to respond to CMS' request set forth at Sec.  414.1385(a)(5), 
which is within 30 days of receipt of such request.
(g) Third Party Intermediaries
    In this final rule, in addition to codifying previously finalized 
policies and proposing to make technical updates for clarity, we are 
finalizing proposals to: (1) Add requirements for third party 
intermediaries to obtain documentation of their authority to submit on 
behalf of a MIPS eligible clinician; (2) Specify the use of a 
simplified self-nomination process for existing QCDRs and qualified 
registries; (3) Add requirements for QCDRs and qualified registries to 
provide measure numbers and identifiers for performance categories; (4) 
Add a requirement for QCDRs and qualified registries to attest that the 
information contained in the qualified posting about them is correct; 
(5) Modify requirements for QCDRs and qualified registries to support 
MVP reporting to increase flexibility for measures supported; (6) 
Specify requirements for a transition plan for QCDRs and qualified 
registries withdrawing from the program; (7) Specify requirements for 
data validation audits; (8) Add additional criteria for rejecting QCDR 
measures; (9) Add a requirement for QCDR measure specifications to be 
displayed

[[Page 79320]]

throughout the performance period and data submission period; (10) 
Eliminate the Health IT vendor category; (11) Add failure to maintain 
updated contact information as criteria for remedial action; (12) 
Revise corrective action plan requirements; (13) Allow CMS to terminate 
third party intermediaries that are on remedial action for 2 
consecutive years; (14) Specify the process for publicly posting 
remedial action; and (15) Specify the criteria for audits.
(h) Public Reporting on Compare Tools
    In an effort to expand the information available to patients and 
caregivers when choosing a doctor or clinician, we are finalizing our 
proposals to modify existing policies for public reporting on 
individual clinician and group profile pages, including:
     The telehealth indicator, such that, we would use the most 
recent CMS coding policies at the time the information is updated to 
identify the telehealth services provided on clinician profile pages 
instead of only using specific Place of Service (POS) and claims 
modifier codes.
     Utilization data, such that we have additional procedure 
code grouping flexibility; can address procedure volume limitations and 
provide a more complete scope of a clinician's experience by adding 
Medicare Advantage (MA) data to procedure counts; and align the data in 
the Provider Data Catalog (PDC) with the procedural groupings shown on 
profile pages.
    Additionally, we solicited feedback from interested parties through 
a request for information on ways to publicly report data submitted on 
measures under the MIPS cost performance category on the Compare tool.
(3) Major APM Provisions
(a) APM Performance Pathway
    In section IV.A.4.e. of the proposed rule, we are finalizing as 
proposed to include the Medicare Clinical Quality Measure (Medicare 
CQM) for Accountable Care Organizations Participating in the Medicare 
Shared Savings Program collection type in the APM Performance Pathway 
(APP) measure set.
(b) Overview of the APM Incentive
    In section IV.A.4.m. of the proposed rule, we are not finalizing 
our proposal to end the use of APM Entity-level QP determinations and 
instead make all QP determinations at the individual eligible clinician 
level. We also are not finalizing our proposal to modify the ``sixth 
criterion'' under the definition of ``attribution-eligible 
beneficiary,'' which is listed at Sec.  414.1305.\480\ Specifically, we 
are not finalizing our proposal to include as attribution-eligible any 
beneficiary who has received a covered professional service furnished 
by the NPI for the purpose of making QP determinations. We are 
finalizing our proposal to amend Sec.  414.1430 to reflect the 
statutory QP and Partial QP threshold percentages for both the payment 
amount and patient count methods under the Medicare Option and the All-
Payer Option with respect to payment year 2025 (performance year 2023) 
in accordance with amendments made by the CAA, 2023. Relatedly, we are 
finalizing our proposal to amend Sec.  414.1450 to reflect the 
statutory APM Incentive Payment amount for the 2025 payment year 
(performance year 2023) of 3.5 percent of the eligible clinician's 
estimated aggregate payments for covered professional services in 
accordance with amendments made by the CAA, 2023. As described in the 
proposed rule (88 FR 52601 through 52603), we are finalizing as 
proposed an amendment Sec.  414.1385 to adjust the Targeted Review 
period to address operational challenges that have arisen ahead of the 
required transition beginning for payment year 2026 (performance year 
2024) from the APM Incentive Payment to the higher PFS payment rate for 
QPs (calculated using the differentially higher ``qualifying APM 
conversion factor).
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    \480\ Currently, there are six criteria required for a 
beneficiary to be an ``attribution-eligible beneficiary'' during the 
QP Performance Period, which can be found at Sec.  414.1305. The 
sixth criterion provides that an ``attribution-eligible 
beneficiary'' must have ``a minimum of one claim for evaluation and 
management services furnished by an eligible clinician who is in the 
APM Entity for any period during the QP Performance Period or, for 
an Advanced APM that does not base attribution on evaluation and 
management services and for which attributed beneficiaries are not a 
subset of the attribution-eligible beneficiary population based on 
the requirement to have at least one claim for evaluation and 
management services furnished by an eligible clinician who is in the 
APM Entity for any period during the QP Performance Period, the 
attribution basis determined by CMS based upon the methodology the 
Advanced APM uses for attribution, which may include a combination 
of evaluation and management and/or other services.''
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(c) Advanced APMs
    In section IV.A.4.n. of the proposed rule, we are finalizing as 
proposed our proposal to modify the CEHRT use criterion for Advanced 
APMs to provide greater flexibility for APMs to tailor CEHRT use 
requirements to the APM and its participants. We also had proposed to 
amend the CEHRT use criterion for Advanced APMs at Sec.  
414.1415(a)(1)(i) effective beginning for CY 2024 to remove the 75 
percent CEHRT use threshold, and to instead specify that the APM must 
require all APM participants to use CEHRT as defined in a proposed 
revised definition of CEHRT under Sec.  414.1305. We are finalizing 
this proposal with a modification in the effective date, to retain the 
75 percent CEHRT use threshold in CY 2024 and instead remove that 
threshold effective beginning for CY 2025. We also finalizing our 
proposal to amend the Other-Payer Advanced APM CEHRT use criterion at 
Sec.  414.1420(b) to conform to the proposed changes at Sec.  
414.1415(a)(1)(i).
2. Definitions
    At Sec.  414.1305, we are finalizing as proposed to revise the 
definitions of the following terms:
     Certified Electronic Health Record Technology (CEHRT); and
     Collection type.
     Qualified posting
    These terms and definitions are discussed in detail in the relevant 
sections of this final rule.
3. Transforming the Quality Payment Program
a. Advancing CMS National Quality Strategy Goals
(1) Increasing Alignment Across Value-Based Programs
    The CMS National Quality Strategy \481\ addresses the urgent need 
for transformative action to advance towards a more equitable, safe, 
and outcomes-based health care system for all individuals. One of the 
CMS National Quality Strategy goals is to improve quality and health 
outcomes across the health care journey through implementation of a 
``Universal Foundation'' of impactful measures across all CMS quality 
and value-based programs.\482\ Adoption of the Universal Foundation 
483 484 will focus clinician attention on specific quality 
measures,

[[Page 79321]]

reduce burden, help identify disparities in care, prioritize 
development of interoperable, digital quality measures, allow for 
cross-comparisons across programs, and help identify measurement gaps.
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    \481\ The National Quality Strategy: A Person-Centered Approach 
to Improving Quality . . . , https://www.cms.gov/blog/cms-national-quality-strategy-person-centered-approach-improving-quality.
    \482\ CMS National Quality Strategy. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/CMS-Quality-Strategy.
    \483\ Aligning Quality Measures across CMS. https://www.cms.gov/aligning-quality-measures-across-cms-universal-foundationhttps://www.cms.gov/aligning-quality-measures-across-cms-universal-foundation.
    \484\ CMS National Quality Strategy. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/CMS-Quality-Strategy.CMS National Quality Strategy. 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/CMS-Quality-Strategy.
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    We identified adult and pediatric measures for the Universal 
Foundation to be used across CMS programs and populations, including 
the Quality Payment Program, to the extent they are applicable. The 
Quality Payment Program measure inventory already includes quality 
measures in the adult core set from the Universal Foundation. In 
addition, we are finalizing our proposal in the CY 2024 PFS proposed 
rule (88 FR 52558 through 52559 and 88 FR 53193 through 53197) to 
consolidate the previously finalized Promoting Wellness and Optimizing 
Chronic Disease Management MVPs into a single consolidated primary care 
MVP that aligns with the adult Universal Core set of quality measures 
at section IV.A.4.b. and Appendix 3: MVP Inventory, Table B.11 of this 
final rule. We also finalizing our policy, proposed in the CY 2024 PFS 
proposed rule (88 FR 52426 through 52428) to expand the APM Performance 
Pathway (APP) reported by clinicians in the Medicare Shared Savings 
Program (Shared Savings Program) to include Medicare Clinical Quality 
Measure (Medicare CQM) collection types, at section III.G.2.c. of this 
final rule.
(2) Advancing Health Equity
    We also articulated a detailed strategy to advance health equity 
and accountability in order to design, implement, and operationalize 
policies to support health for all people served by our programs, 
eliminate avoidable differences in health outcomes experienced by 
people who are disadvantaged or underserved, and provide the care and 
support that our beneficiaries need to thrive.\485\ Specifically, the 
CMS Office of Minority Health released the CMS Framework for Health 
Equity, \486\ which updates the CMS Equity Plan with an enhanced and 
more comprehensive 10-year approach to further embed health equity 
across CMS programs including Medicare, Medicaid, Children's Health 
Insurance Program, and the Health Insurance Marketplaces. The CMS 
Office of Minority Health also released ``Paving the Way to Equity: A 
Progress Report'' \487\ in 2021, which describes the CMS Equity Plan 
for Medicare and progress from 2015 to 2021.
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    \485\ CMS National Quality Strategy. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/CMS-Quality-Strategy.
    \486\ CMS Equity Plan for Improving Quality in Medicare. https://www.cms.gov/About-CMS/Agency-Information/OMH/OMH_Dwnld-CMS_EquityPlanforMedicare_090615.pdf.
    \487\ CMS, Paving the Way to Equity: A Progress Report (2015-
2021) https://www.cms.gov/sites/default/files/2021-01/Paving%20the%20Way%20to%20Equity%20CMS%20OMH%20Progress%20Report.pdf.

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    In accordance with our health equity strategy, both MVPs and APMs 
share a goal of incenting improved equity as well as advancing value 
(87 FR 70035). For example, beginning in Performance Year 2023 the 
Shared Savings Program will implement an upside-only Health Equity 
Adjustment (HEA) to an ACO's MIPS Quality performance category score to 
reward ACOs that provide excellent care for underserved populations (87 
FR 69838 through 69857, also see HEA proposal at 88 FR 52429 through 
52430). We are finalizing the technical clarifications to our 
previously finalized HEA policy at section III.G.2.d. of this final 
rule.
(3) Accelerating Interoperability
    The CMS National Quality Strategy also calls for supporting the 
transition to a digital and data driven health care system. The CMS 
National Quality Strategy proposed to achieve this through the 
development of requirements for sharing, receipt, and use of digital 
data, including digital quality measures.\488\ We believe that, as 
clinicians strive to make improvements in patient care, clinicians 
should demonstrate increasingly more advanced and innovative uses of 
health information technology. In the CY 2024 PFS proposed rule (88 FR 
52433 through 52437), we proposed to require individual clinicians, or 
the ACO as an APM Entity, participating in the Shared Savings Program 
ACO to report the measures in the MIPS Promoting Interoperability 
performance category beginning with the CY 2024 performance year. We 
refer readers to section III.G.2.h.(2) of this final rule, where we 
finalize these proposals with modification, delaying the implementation 
of the MIPS Promoting Interoperability performance category reporting 
requirements for the Shared Savings Program until the CY 2025 
performance year. Additionally, in the CY 2024 PFS proposed rule (88 FR 
52625 through 52628), we proposed to modify the CEHRT use criterion for 
Advanced APMs to provide flexibility for APMs to adopt CEHRT use 
requirements that are clinically relevant to models and their 
participants, emphasizing the importance of interoperability and health 
information technology. We refer readers to section IV.A.4.n.(3) of 
this final rule where we finalize with modification the CEHRT use 
criterion for Advanced APMs. We believe these policies, in addition to 
ongoing efforts to build CMS infrastructure and develop technical 
solutions, are an important step towards evolving our health 
information technology ecosystem.
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    \488\ CMS National Quality Strategy. https://www.cms.gov/
medicare/quality-initiatives-patient-assessment-instruments/value-
based-programs/cms-quality-strategy.
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b. Quality Payment Program Vision and Goals
(1) Emphasizing the Importance of Value-Based Care
    The Quality Payment Program was designed and implemented to improve 
health outcomes, promote smarter spending, minimize burden of 
participation, and provide fairness and transparency in operations (81 
FR 77010). In the Advanced APM track of the Quality Payment Program, 
APM entities and eligible clinicians take responsibility for improving 
the quality of care, care coordination and health outcomes for a group 
of beneficiaries through participation in Advanced APMs.\489\ Advanced 
APMs can ensure that beneficiaries get the right care at the right time 
by reducing fragmentation between clinicians, which can reduce 
unnecessary duplication of services and preventable medical 
errors.\490\ Advanced APMs also support our goal that all Traditional 
Medicare beneficiaries be in a care relationship with clinicians 
accountable for quality and total cost of care by 2030, as outlined by 
the CMS Innovation Center strategy refresh.\491\
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    \489\ Medicare Value-Based Care Strategy: Alignment, Growth and 
Equity. The Medicare Value-Based Care Strategy: Alignment, Growth, 
And Equity. Health Affairs, Jacobs, Fowler, Fleisher, and Seshamani. 
https://www.healthaffairs.org/content/forefront/medicare-value-based-care-strategy-alignment-growth-and-equity.
    \490\ CMS Announces Increase in 2023 in Accountable Care 
Organizations and Beneficiaries Benefiting from Coordinated Care in 
Accountable Care Relationship. https://www.cms.gov/newsroom/press-releases/cms-announces-increase-2023-organizations-and-beneficiaries-benefiting-coordinated-care-accountable.
    \491\ Innovation Center Strategy Refresh. https://innovation.cms.gov/strategic-direction-whitepaper.
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    Our ongoing alignment of the Shared Savings Program and the Quality 
Payment Program supports new as well as long term participation in ACOs 
for clinicians choosing to participate in accountable care 
relationships. In the CY 2021 PFS final rule, we finalized the 
Alternative Payment Model (APM) Performance Pathway (APP) under

[[Page 79322]]

MIPS, in part, to reduce reporting burden, and create new scoring 
opportunities for MIPS eligible clinicians participating in MIPS APMs 
(85 FR 84720).
(2) MVP Reporting in the Quality Payment Program
    We believe the Quality Payment Program should continuously support 
the measurement and improvement of specialty and primary care practice. 
To this end, we are implementing MVPs to allow for clinicians to report 
on measures that are directly relevant to their clinical practice. 
Rather than selecting individual measures and activities from a large 
inventory to report under each of the siloed MIPS performance 
categories under traditional MIPS, eligible clinicians who select an 
MVP (for example, the Coordinating Stroke Care to Promote Prevention 
and Cultivate Positive Outcomes MVP) can select from a smaller, 
cohesive set of measures and activities focused on the clinician's 
performance in rendering care for their specialty or clinical 
condition.
    We also developed the MVP framework with the intention of 
supporting clinicians in their journey of continuous performance 
improvement and reducing barriers to APM participation as clinicians 
and practices prepare to take on, and successfully manage financial 
risk (84 FR 62946 through 62949).
c. Promoting Continuous Improvement in MIPS
    For MIPS, we developed policies and methodologies to assess 
clinicians' performance, and to support performance improvement across 
four performance categories (quality, cost, improvement activities, and 
Promoting Interoperability) in accordance with section 1848(q)(1)(A)(i) 
and (ii) of the Act. We believe we should evaluate our policies, 
requirements, and standards for MIPS periodically to determine if we 
need to raise the bar in order to foster the availability of 
opportunities for continuous performance improvement. We are 
considering how we can implement future policies to support continuous 
improvement for clinicians who consistently perform well in MIPS. One 
challenge we face is that, after a clinician has achieved high 
performance scores on the same measures and activities year over year, 
there may be little or no room for the clinician to improve their 
performance. Another challenge is that some MIPS eligible clinicians 
choose measures and activities for which they are already performing 
well, rather than measures and activities where they would be required 
to implement changes in their workflow, clinical care, or practices in 
order to achieve a positive payment adjustment. This selection 
practice, to repeatedly choose the same measures and activities for 
which the clinician is confident they will perform well, can mean that 
the clinician has less incentive to transform the way that care is 
delivered and continuously improve quality of the care they provide. 
For these reasons, we are considering modifying our policies in the 
future to encourage clinicians who have consistently been high 
performers in MIPS to continuously improve various areas of their 
clinical practice, including implementing more rigorous standards under 
MIPS and supporting participation in an APM.
    We were interested in feedback on approaches to modifying our 
policies, requirements, and standards under MIPS, while remaining 
cognizant of the burden any changes may place on MIPS eligible 
clinicians. Section 1848(q)(1)(A) and (5)(A) of the Act requires the 
Secretary to develop a methodology for assessing the total performance 
of each MIPS eligible clinician according to performance standards for 
applicable measures and activities in each performance category 
applicable to the MIPS eligible clinician for a performance period. We 
were particularly interested in how we can balance the impact of any 
policy changes on MIPS eligible clinicians who have become accustomed 
to our current program requirements with the benefit of potential 
modifications that foster clinicians' continuous improvement. For 
example, we could increase reporting requirements in traditional MIPS 
and MVPs, or we could require that specific measures be reported, 
instead of allowing choice of measures, once MVPs are mandatory to 
encourage improvement for clinicians with continuously perform well 
under MIPS.
d. Request for Feedback
    We solicited comments on how we can modify our policies under the 
Quality Payment Program to foster clinicians' continuous performance 
improvement and positively impact care outcomes for Medicare 
beneficiaries. Such modifications for MIPS may include requiring more 
rigorous performance standards, emphasizing year-to-year improvement in 
the performance categories, or requiring that MIPS eligible clinicians 
report on different measures or activities once they have demonstrated 
consistently high performance on certain measures and activities.
    In accordance with implementing regulations of the Paperwork 
Reduction Act of 1995 (PRA), specifically 5 CFR 1320.3(h)(4), this 
general solicitation request for information is exempt from the PRA.
    We requested public comment on specifically the following 
questions:
     What potential policies in the MIPS program would provide 
opportunities for clinicians to continuously improve care?
     Should we consider, in future rulemaking, changes in 
policies to assess performance to ensure ongoing opportunities for 
continuous performance improvement?
     Should we consider, for example, increasing the reporting 
requirements or requiring that specific measures are reported once MVPs 
are mandatory?
     Should we consider creating additional incentives to join 
APMs in order to foster continuous improvement, and if so, what should 
these incentives be?
     What changes to policies should CMS consider to assess 
continuous performance improvement and clinicians interested in 
transitioning from MIPS to APMs?
     We acknowledge the potential increase in burden associated 
with increasing measure reporting or performance standards. How should 
we balance consideration of reporting burden with creating continuous 
opportunities for performance improvement?
     While we are aware of potential benefits of establishing 
more rigorous policies, requirements, and performance standards, such 
as developing an approach for some clinicians to demonstrate 
improvement, we are also mindful that this will result in an increasing 
challenge for some clinicians to meet the performance threshold. Are 
there ways to mitigate any unintended consequences of implementing such 
policies, requirements, and performance standards?
    We thank submitters for their responses to this request for 
information. We may consider the information we received and use it to 
inform future rulemaking.
4. MVP Development, Maintenance, and Scoring
a. Development of New MIPS Value Pathways (MVPs)
    In the CY 2024 PFS proposed rule (88 FR 52558), we discuss the 
detailed MVP development process. Through our development processes for 
new MVPs (85 FR 84849 through 84856, 87 FR 70035 through 70037), we aim 
to

[[Page 79323]]

gradually develop new MVPs that are relevant and meaningful for all 
clinicians who participate in MIPs. We proposed the inclusion of five 
new MVPs (88 FR 52558) and (88 FR 53146 through 53166):
     Focusing on Women's Health;
     Prevention and Treatment of Infectious Disorders Including 
Hepatitis C and HIV;
     Quality Care in Mental Health and Substance Use Disorders;
     Quality Care for the Treatment of Ear, Nose, and Throat 
(ENT) Disorders; and
     Rehabilitative Support for Musculoskeletal Care.
    We referred readers to Appendix 3: MVP Inventory, of this final 
rule for discussion of each proposed new MVP, the public comments 
received, and our responses.
b. MVP Maintenance on Previously Finalized MVPs
    In the CY 2024 PFS proposed rule (88 FR 52558 through 52559) we 
discuss the MVP maintenance process and refer readers to the proposed 
rule for those details.
    In the CY 2024 PFS proposed final rule (88 FR 53167 through 88 FR 
53197), we proposed modifications to our 12 previously finalized MVPs 
for the addition and removal of measures and improvement activities 
based on the MVP development criteria (85 FR 84849 through 84854), 
feedback received through the MVP maintenance process, and based off 
the removals of certain improvement activities from the improvement 
activities inventory, as well as the addition of other relevant 
existing quality measures for MVP participants to select from. In 
addition, through the MVP maintenance process, we proposed to 
consolidate the previously finalized Promoting Wellness and Optimizing 
Chronic Disease Management MVPs into a single consolidated primary care 
MVP titled Value in Primary Care MVP, that aligns with the Adult 
Universal Core Set, as described in the journal article, ``Aligning 
Quality Measures across CMS- The Universal Foundation'' (https://www.nejm.org/doi/full/10.1056/NEJMp2215539).
    We refer readers to Appendix 3: MVP Inventory of this final rule 
for the proposed modifications of the established MVPs, the public 
comments received, and our responses.
c. Scoring MVP Performance
    In the CY 2022 PFS final rule, we finalized policies for MVP 
scoring that took effect beginning with the CY 2023 performance period/
2025 MIPS payment year. We refer readers to 86 FR 65419 through 65427 
for the details of those finalized policies. We previously finalized at 
Sec.  414.1365(d)(2) that, unless otherwise indicated in Sec.  
414.1365(d), the performance standards described at Sec.  
414.1380(a)(1)(i) through (iv) apply to the measures and activities 
included in the MVP (86 FR 65419 through 65421). We noted that in 
general, we intend to adopt scoring policies from traditional MIPS for 
MVP participants unless there is a compelling reason to adopt a 
different policy to further our goals for the MVP framework (86 FR 
65419).
    We refer readers to the CY 2024 PFS proposed rule for policies we 
proposed regarding MIPS scoring flexibilities in the quality 
performance category scoring (88 FR 52592 through 52593); for the 
change to scoring improvement in the cost performance category (88 FR 
52593 through 52596); for the improvement activity ``IA_MVP, Practice-
wide quality improvement in the MIPS Value Pathway Program (MVP)'' in 
the improvement activities performance category (88 FR 52577 through 
52578 and 88 FR 53133 through 53134); and for the policies for the 
Promoting Interoperability performance category (88 FR 52578 through 
52590), including modifications of the SAFER Guide Measure's 
requirements and the Query of Prescription Drug Monitoring Program 
(PDMP) measure's exclusion, a technical update to the e-Prescribing 
measure, an increase in the length of the performance period from 90 
continuous days to 180 continuous day, and continuation of our 
reweighting policy of the performance category for clinical social 
workers.
    In addition, we refer readers to the CY 2024 PFS proposed rule for 
policies we proposed regarding subgroups, including reweighting 
proposals, addition of subgroups to our Targeted Review policies, and a 
clarification regarding the scoring of facility-based clinicians at the 
subgroup level (88 FR 52559 through 52562).
    Finally, we refer readers to the CY 2024 PFS proposed rule for 
policies we proposed regarding Targeted Review process, including the 
addition of virtual groups to our Targeted Review policies (88 FR 52601 
through 52603).
    In this final rule, we are finalizing these policies as proposed. 
For a discussion of our finalized policies and the public comments 
received, please refer to section IV.A.4.g.(1)(c)(i) of this final rule 
for our discussion on MIPS scoring flexibilities in the quality 
performance category scoring; section IV.A.4.g.(1)(d)(i) in this final 
rule for our finalized updates to scoring improvement in the cost 
performance category; section IV.A.4.f.(3) and Appendix 2: Improvement 
Activities of this final rule for the finalized new improvement 
activity; section IV.A.4.f.(4) in this final rule for the finalized 
policies for the Promoting Interoperability performance category, 
section IV.A.4.d. of this final rule for finalized policies regarding 
subgroups, and section IV.A.4.d.(4). for finalized policies regarding 
Targeted Review process.
d. Subgroup Reporting
(1) Background
    In the CY 2022 PFS final rule, we finalized the option for 
clinicians to participate as subgroups for reporting MIPS value 
pathways (MVPs) beginning in the CY 2023 performance period/2025 MIPS 
payment year (86 FR 65392 through 65394). We referred readers to Title 
42 of CFR at Sec. Sec.  414.1318 and 414.1365, the CY 2022 PFS final 
rule (86 FR 65398 through 65405), and the CY 2023 PFS final rule (87 FR 
70038 through 70045) for additional details on previously finalized 
subgroup policies.
    In the CY 2024 PFS proposed rule, we proposed to: (1) update the 
subgroup policy for reweighting of MVP performance categories at Sec.  
414.1365(e)(2) (88 FR 52559 and 52560); (2) update the facility-based 
scoring and complex patient bonus for subgroups under final score 
calculation at Sec.  414.1365(e)(3) and (4) (88 FR 52560 and 52561); 
(3) update the targeted review policy for subgroups at Sec.  414.1385 
(88 FR 52561); and (4) codify in our regulations the subgroup policies 
finalized in previous years' rules (88 FR 52561 and 52562).
(2) Subgroup Reweighting
    In the CY 2022 PFS final rule (86 FR 65425 through 65426), we 
finalized at Sec.  414.1365(e)(2)(ii) that for an MVP Participant that 
is a subgroup, any reweighting applied to its affiliated group will 
also be applied to the subgroup. Additionally, we finalized that if 
reweighting is not applied to an affiliated group, then the subgroup 
may receive reweighting under the circumstances described at Sec. Sec.  
414.1365(e)(2)(ii)(A) and (B). In establishing this policy, we noted 
our concern about extreme and uncontrollable circumstances (EUC) that 
would impact only the subgroup (fire or natural disaster at a specific 
practice location) and does not affect the entire affiliated group. We 
also finalized that if a subgroup submits data for a performance 
category which was reweighted, the subgroup data

[[Page 79324]]

submission will void the reweighting applied to the performance 
category.
    Upon further consideration of the previously finalized policy, we 
identified technical constraints that affect our ability to implement 
the policy. Specifically, we are concerned that the time necessary to 
adjudicate reconsideration requests for both a subgroup and its 
affiliated group may deprive the subgroup of knowledge of its 
reweighting status during a significant portion of the relevant 
performance period and undermine its ability to plan data submission 
needs accordingly.
    There may be instances when a subgroup and its affiliated group 
have separate reasons to submit reweighting applications. Those 
separate applications may request the reweighting of different 
performance categories. Under Sec.  414.1380(c)(2), clinicians, groups, 
and APM Entities submit reweighting applications annually on a rolling 
basis throughout the performance period, or a date specified by CMS. 
However, the requirement in Sec.  414.1365(e)(2)(ii) that any 
reweighting applied to a subgroup's affiliated group is also applied to 
the subgroup means that when a subgroup and its affiliated group both 
submit reweighting applications, the subgroup will not know its 
reweighting status until CMS makes a determination regarding the 
group's reweighting application. Depending on when the group submitted 
its reweighting request, this may not happen until after the close of 
the performance period for which the reweighting application was made.
    We believe the uncertainty created for a subgroup by not knowing 
its reweighting status until later in the performance period would 
disrupt its ability to best plan for the measures and activities on 
which it will be scored. We recognize that there may be instances when 
only the subgroup is affected by an extreme and uncontrollable 
circumstance (natural disaster, fire, hurricane, etc.) and would want 
to request its own reweighting, independent of the affiliated group. 
However, we believe that the need for a subgroup to know of its data 
submission requirements outweighs the benefit of being able to request 
its own reweighting independent of the affiliated group.
    Separately, there are certain special status designations (non-
patient facing, small practice, etc.) that automatically qualify a 
group for reweighting of the Promoting Interoperability performance 
category. A subgroup can learn about its affiliated group's special 
status designation as described in the second paragraph under the 
definition of MIPS determination period at Sec.  414.1305. Given that 
subgroup eligibility and special status determinations are made at the 
group level, we believe that applying an affiliated group's reweighting 
to a subgroup and removing the ability of a subgroup to submit a 
separate reweighting application, would enable subgroups to receive 
their reweighting status and identify their data submission obligations 
in a timely manner. Therefore, we proposed to revise Sec.  
414.1365(e)(2)(ii) to limit the reweighting applied to a subgroup to 
that which is also applied to its affiliated group beginning with the 
CY 2024 performance period/2026 MIPS payment year.
    In order to operationalize the previously established policy, we 
intend to implement a manual process for reviewing subgroup reweighting 
applications for the CY 2023 performance period/2025 MIPS payment year. 
We considered also using the manual process for reviewing subgroup 
reweighting applications in future performance periods. However, we are 
concerned that manually reconciling the reweighting requests would 
delay the approval of the reweighting requests received from a 
subgroup. Additionally, we are concerned that it may create confusion 
for a subgroup to determine whether a performance category has been 
reweighted and its potential impact on subgroup data submission, 
specifically in instances when both the subgroup and its affiliated 
group submit a reweighting application for one or more of the MVP 
performance categories. For the above reasons, we would use the manual 
process only for the CY 2023 performance period/2025 MIPS payment year.
    We acknowledge that there may be instances when an extreme and 
uncontrollable circumstance impacts only a subgroup and not the entire 
affiliated group (for example, fire or natural disaster at the 
subgroup's practice location). Because subgroup reporting is not 
mandatory at this time, we believe that in these instances, when a 
registered subgroup is unable to participate in MVP reporting as a 
subgroup, the eligible clinicians in the registered subgroup would 
participate in MIPS via another available reporting option. These 
clinicians could either participate as individuals or as a group, if 
its affiliated group chooses to participate in traditional MIPS, or in 
MVP reporting. Additionally, we established the policy in Sec.  
414.1318(b)(1) to not assign a score for a registered subgroup that did 
not submit data for the applicable performance period (87 FR 70045). In 
the scenario that the registered subgroup did not submit data, we would 
assign the highest of the available final scores associated with the 
clinician's TIN/NPI for the eligible clinicians in the subgroup (86 FR 
65536 and 65537). We refer readers to the CY 2023 PFS proposed rule (87 
FR 46272 through 46275) for examples that illustrate how the final 
score is applied for a clinician who is part of a group TIN where only 
some of the clinicians under that TIN choose to participate in MIPS 
through subgroups. We will continue to monitor subgroup participation 
trends and will revisit this policy in the future, as needed.
    For the above reasons, we proposed (88 FR 52560) to revise Sec.  
414.1365(e)(2)(ii) to state that an MVP Participant that is a subgroup 
will receive the same reweighting that is applied to its affiliated 
group, but that for the CY 2023 performance period/2025 MIPS payment 
year, if reweighting is not applied to the affiliated group, the 
subgroup may receive reweighting in the circumstances independent of 
the affiliated group as described in Sec.  414.1365(e)(2)(ii)(A) and 
(B).
    We requested comments on this proposal. The following is a summary 
of the comments we received and our responses.
    Comment: A few commenters supported our proposal to remove the 
capability for a subgroup to submit its own reweighting application 
independent of the affiliated group.
    Response: We thank the commenters for their support.
    Comment: A few commenters did not support our proposal to remove 
the separate application reweighting request for subgroups. One 
commenter requested additional clarification on how the delayed 
reweighting review process would impact a subgroup when both the 
subgroup and the affiliated group requested reweighting. The commenter 
also shared their concerns that it is unclear how individual MIPS 
eligible clinicians in a subgroup affected by a natural disaster could 
submit MIPS data using other participation options. A commenter 
requested that CMS monitor the subgroup reweighting application trends 
and recommended that CMS consider alternate options that would permit 
both the subgroup and the affiliated group to submit reweighting 
applications. The commenter expressed concern that the proposed policy 
might negatively impact subgroups when subgroup reporting is mandatory.
    Response: We acknowledge the commenter's concerns with removing

[[Page 79325]]

the separate reweighting application requests for subgroups. We 
previously finalized at Sec.  414.1365(e)(2)(ii) that a subgroup will 
receive the same reweighting applied to the affiliated group (86 FR 
65425 through 65426). If both the affiliated group and a subgroup 
submit reweighting applications, CMS would need to wait until it has 
reviewed the affiliated group's reweighting application prior to making 
a determination on the subgroup's reweighting request. Doing so would 
delay informing the subgroup's of its reweighting status, allowing it 
to determine its data submission needs. Additionally, there could be 
instances when a group could submit their reweighting application 
towards the end or after the end of the MIPS performance period, 
preventing a subgroup from submitting data for a performance period. 
Therefore, we believe the benefit of a subgroup determining its data 
submission needs early in the performance period outweighs the benefit 
of submitting a separate reweighting application.
    In the scenario that a subgroup is affected by a natural disaster 
and the affiliated group is not, we note that the MIPS eligible 
clinicians in the subgroup will be included in the affiliated group's 
submission if the affiliated group submits data at the group level. If 
the affiliated group does not submit data, each MIPS eligible 
individual clinician could submit a reweighting application at the 
individual level. We will continue to monitor subgroup participation 
trends and revisit the policy in the future as we move towards 
mandatory subgroup reporting.
    After consideration of public comments, we are finalizing our 
proposal to revise Sec.  414.1365(e)(2)(ii) to provide that an MVP 
Participant that is a subgroup will receive the same reweighting that 
is applied to its affiliated group, but that for the CY 2023 
performance period/2025 MIPS payment year, if reweighting is not 
applied to the affiliated group, the subgroup may receive reweighting 
in the circumstances independent of the affiliated group as described 
in Sec.  414.1365(e)(2)(ii)(A) and (B).
(3) Subgroup Scoring Policies
(a) Facility-Based Score for Subgroups
    We established policies for facility-based measurement and scoring 
for MIPS eligible individual clinicians and groups at Sec.  
414.1380(e). Under these standards, we calculate a MIPS eligible 
clinician's final facility-based score using the clinician's 
performance in another value-based purchasing program (83 FR 59866 
through 59867). In the CY 2022 PFS final rule (86 FR 65425), we 
finalized at Sec.  414.1365(e)(3) that if an MVP Participant that is 
not an APM Entity and is eligible for facility-based scoring, a 
facility-based score will also be calculated in accordance with Sec.  
414.1380(e). We recognize that we inadvertently overlooked excluding 
MVP Participants that are subgroups from facility-based scoring. We 
noted that it was not our intent to calculate a facility-based score at 
the subgroup level.
    In the course of implementing MVPs, we have offered clinicians and 
groups the opportunity to elect to report via MVPs and via traditional 
MIPS. If a facility-based MIPS eligible clinician participates in MVP 
reporting as an individual or as part of a group, we will calculate a 
final score for the MIPS eligible clinician based on the MVP reporting. 
We would not use the facility-based scores to calculate the clinician's 
final scores under the MVP because we currently do not have an MVP 
specifically focused on facility-based measurement. We believe eligible 
clinicians would choose to participate in MVP reporting with the intent 
to report on measures applicable to the scope of care provided and 
therefore, it would be appropriate for facility-based clinicians 
participating in MVP reporting to receive a score based on the data 
submitted for the measures and activities in an MVP. If a facility-
based clinician chooses to participate in an MVP for a MIPS performance 
period, a facility-based score would be calculated as part of 
traditional MIPS. Clinicians will also receive a score for MVP 
reporting, that is not facility-based, and we will use the higher of 
the scores to determine the MIPS payment adjustment for the MIPS 
eligible clinicians. Subgroup reporting is limited to MVPs, and 
subgroup reporting is not available for clinicians reporting on 
measures in traditional MIPS. Therefore, we proposed (88 FR 52560) to 
modify the text at Sec.  414.1365(e)(3) to state that if an MVP 
Participant, that is not an APM Entity or a subgroup, is eligible for 
facility-based scoring a facility-based score will also be calculated 
in accordance with Sec.  414.1380(e).
    We requested comments on this proposal. The following is a summary 
of the comments we received and our responses.
    Comment: A few commenters supported our proposal to not calculate a 
facility-based score based for clinicians participating as a subgroup.
    Response: We thank the commenters for their support.
    Comment: A few commenters did not support our proposal to not 
calculate a facility-based score at the subgroup level and recommended 
CMS to calculate a facility-based score for subgroups participating in 
MVP reporting. The commenters shared their belief that using the higher 
of the facility-based or subgroup scores to determine the MIPS payment 
adjustment for facility-based clinicians participating in MVP reporting 
would align with the scoring policies for facility-based clinicians 
participating in traditional MIPS.
    Response: Under the previously established standards for facility-
based measurement and scoring for MIPS eligible individual clinicians 
and groups at Sec.  414.1380(e), we calculate a MIPS eligible 
clinician's final facility-based score using the clinician's 
performance in another value-based purchasing program (83 FR 59866 
through 59867). Facility-based clinicians and groups participating in 
traditional MIPS receive a facility-based score in the quality and cost 
performance categories derived from the applicable value-based 
purchasing score available for the facility-based clinician or group. 
Clinicians can choose to report on measures relevant to their scope of 
care by participating in subgroups and MVP reporting. It is most 
appropriate for CMS to assess the performance of a clinician 
participating in a subgroup and reporting an MVP using the measures and 
activities reported by the clinician's subgroup as it would allow CMS 
to provide feedback on the subgroup's performance based on the data 
submitted by the clinicians in the subgroup for the measures and 
activities in a MVP. We note that a facility-based clinician could 
still participate as a subgroup for reporting an MVP. However, we 
calculate the facility-based score for these clinicians based on their 
participation in traditional MIPS and not based on their participation 
as a subgroup in MVP reporting. It would defeat the purpose of MVPs to 
score a subgroup on a value-based purchasing program's measures that 
are not part of the MVP. Additionally, doing so would extend subgroup 
reporting of quality measures outside of MVPs to traditional MIPS, 
where it was never intended to be available. Our policy to not 
calculate a facility-based score at the subgroup level does not affect 
an individual facility-based clinician in a subgroup in that the 
clinician would also receive all the available scores from the 
affiliated group, including the traditional MIPS score derived from 
facility-based scoring. We will assign the highest of

[[Page 79326]]

the available final scores associated with clinician's TIN/NPI under 
the existing scoring hierarchy established in the CY 2022 PFS final 
rule (86 FR 65536 and 65537).
    Comment: A few commenters recommended that CMS assign the 
affiliated group's facility-based score for the clinicians 
participating as a subgroup as it would align with the subgroup scoring 
policies for cost measures. One commenter requested clarification on 
why CMS would calculate a facility-based score for a group 
participating in MVP reporting but not for a subgroup.
    Response: As noted in the proposed rule (88 FR 52560), if a 
facility-based clinician chooses to participate as a group in MVP and 
traditional MIPS reporting for a MIPS performance period, a facility-
based score would be calculated as part of traditional MIPS and not 
part of their MVP reporting. As described in response to the comment 
above, it would not be appropriate to calculate a facility-based score 
for a subgroup. Also as noted above, in addition to calculating a 
subgroup score based on the subgroup's MVP reporting for a facility-
based MIPS eligible clinician participating in a subgroup, we would 
also assign the MIPS eligible clinician their affiliated group's score 
if available, for its participation in traditional MIPS or MVP 
reporting as a group. We would use the higher of the group's 
traditional MIPS score or MVP score and the subgroup's MVP score to 
determine the MIPS payment adjustment for the MIPS eligible clinician 
in the subgroup.
    After consideration of public comments, we are finalizing our 
proposal at Sec.  414.1365(e)(3) to provide that a facility-based score 
will also be calculated in accordance with Sec.  414.1380(e) for an MVP 
Participant that is not an APM Entity or a subgroup and is otherwise 
eligible for facility-based scoring.
(b) Complex Patient Bonus for Subgroups
    In the CY 2018 Quality Payment Program final rule (82 FR 53776), we 
finalized at Sec.  414.1380(c)(3)(i) that we will add a complex patient 
bonus to the final score of certain MIPS eligible clinicians that 
submit data on at least one performance category during the applicable 
performance period. We finalized that this complex patient bonus would 
be calculated on the basis of the average Hierarchical Condition 
Category (HCC) risk score and the dual eligible ratio for beneficiaries 
seen by clinicians and groups. In the CY 2022 PFS final rule (86 FR 
65425), we finalized at Sec.  414.1365(e)(4) that a complex patient 
bonus will be added to the final score for an MVP Participant in 
accordance with Sec.  414.1380(c)(3). We also revised Sec.  
414.1380(c)(3) to permit subgroups to receive the complex patient bonus 
as, in the case of subgroups, we intended to apply the bonus based on 
the patient population of the subgroup.
    Since then, however, we have identified issues with using claims 
data associated with the clinicians in a subgroup that prevents us from 
calculating the complex patient bonus at the subgroup level. 
Specifically, we are unable to identify the beneficiaries seen by the 
clinicians in a subgroup, and therefore we cannot calculate the average 
HCC score and dual eligible ratio scores. At the time the relevant 
claims data is retrieved, the composition of the subgroup may not be 
known, making it impossible to calculate the required data elements for 
the complex patient bonus (for example, clinicians, beneficiaries that 
received care, etc.) at the subgroup level. Additionally, the group may 
have subgroups that do not collectively represent the entire group, 
restricting our ability to gather the beneficiary data necessary to 
calculate the complex patient bonus score at the subgroup level.
    We recognize that we would need to retroactively modify the 
previously established policy at Sec.  414.1365(e)(4) for the CY 2023 
performance period/2025 MIPS payment year to address the fact that we 
cannot calculate the complex patient bonus at the subgroup level. 
Section 1871(e)(1)(A)(ii) of the Act provides for retroactive 
application of a substantive change to an existing policy when the 
Secretary determines that failure to apply the policy change 
retroactively would be contrary to the public interest. We believe that 
the failure to apply the proposed change retroactively would be 
contrary to the public interest because the current rule provides for 
the calculation of the complex patient bonus score at the subgroup 
level when it would be impossible for CMS to do so. We proposed (88 FR 
52560 and 52561) to add Sec.  414.1365(e)(4)(i) to provide that for 
subgroups, beginning with the CY 2023 performance period/2025 MIPS 
payment year, the affiliated group's complex patient bonus will be 
added to the final score. Additionally, we proposed conforming changes 
in Sec.  414.1380(c)(3)(v) by removing the term ``subgroups'' so that 
beginning with the CY 2022 performance period/2024 MIPS payment year, 
the complex patient bonus is limited to MIPS eligible clinicians, 
groups, APM Entities, and virtual groups with a risk indicator at or 
above the risk indicator calculated median (88 FR 52560 and 52561). 
Similarly, we proposed conforming changes in Sec.  414.1380(c)(3)(vi) 
by removing the term ``subgroups'' so that beginning with the CY 2022 
performance period/2024 MIPS payment year, for MIPS eligible clinicians 
and groups, the complex patient bonus components are calculated as 
described under Sec.  414.1365(c)(3)(vi) (88 FR 52561).
    We requested comments on this proposal. The following is a summary 
of the comments we received and our responses.
    Comment: Many commenters supported our proposal to assign the 
affiliated group's complex patient bonus score to the subgroup as it 
would appropriately credit both the group and subgroup for the 
complexity in the care provided. One commenter recommended that CMS use 
the higher of the group or subgroup complex patient bonus scores, when 
CMS is able to calculate the complex patient bonus score at the 
subgroup level.
    Response: We thank the commenters for their support. We will 
consider the commenter's recommendation to assign the higher of the 
affiliated group or subgroup's complex patient bonus score when CMS can 
calculate the complex patient bonus score at the subgroup level.
    Comment: A few commenters did not support our proposal to apply the 
affiliated group's complex patient bonus score for a subgroup. The 
commenters shared their belief that CMS calculated the scores for 
administrative claims measures at the subgroup level and recommended 
that CMS could utilize the clinician information submitted during 
subgroup registration for attributing beneficiaries to calculate the 
complex patient bonus score at the subgroup level.
    Response: While we have established attribution methodologies for 
individual clinicians (NPI level) and group (TIN level), we are unable 
to identify beneficiaries at the subgroup level. Therefore, it would be 
impossible for us to calculate the average HCC and dual eligible ratio 
scores at the subgroup level. We may develop a methodology for 
identifying beneficiaries at the subgroup level after gaining further 
experience with subgroup reporting, at which time, we can consider 
changing our complex patient bonus approach for subgroup reporting 
through a proposal in future rulemaking.
    Regarding the commenter's concerns on beneficiary attribution and 
scoring of administrative claims measures at the

[[Page 79327]]

subgroup level, we discussed in the CY 2023 PFS final rule (87 FR 70043 
through 70045) the issues related to testing the reliability and 
validity of administrative claims measures at the subgroup level. We 
have established these thresholds only at the individual and group 
level. Therefore, we currently do not have the capability to score the 
administrative claims measures at the subgroup level and would need 
additional time for testing these measures and calculate the complex 
patient bonus score at the subgroup level.
    After consideration of public comments, we are finalizing our 
proposal to add Sec.  414.1365(e)(4)(i) such that, for subgroups, 
beginning with the CY 2023 performance period/2025 MIPS payment year, 
the affiliated group's complex patient bonus will be added to the final 
score. Additionally, we are finalizing the proposed conforming changes 
in Sec.  414.1380(c)(3)(v) by removing the term ``subgroups'' so that 
beginning with the CY 2022 performance period/2024 MIPS payment year, 
the complex patient bonus is limited to MIPS eligible clinicians, 
groups, APM Entities, and virtual groups with a risk indicator at or 
above the risk indicator calculated median. We are also finalizing the 
proposed conforming changes in Sec.  414.1380(c)(3)(vi) by removing the 
term ``subgroups'' so that beginning with the CY 2022 performance 
period/2024 MIPS payment year, for MIPS eligible clinicians and groups, 
the complex patient bonus components are calculated as described under 
Sec.  414.1365(c)(3)(vi).
(4) Targeted Review for Subgroups
    We previously established at Sec.  414.1385(a) that a MIPS eligible 
clinician or group may request a targeted review of the calculation of 
the MIPS payment adjustment factor under section 1848(q)(6)(A) of the 
Act and, as applicable, the calculation of the additional MIPS payment 
adjustment factor under section 1848(q)(6)(C) of the Act (collectively 
referred to as the MIPS payment adjustment factors) applicable to such 
MIPS eligible clinician or group for a year (81 FR 77353 through 77358 
and 77546). We also finalized the process to submit a targeted review 
application, codified at Sec.  414.1385(a) (81 FR 77353 through 77358 
and 77546). Similar to the previously established targeted review 
process for individual clinicians and groups, MIPS eligible clinicians 
who participate in MVP reporting and are scored as a subgroup may 
request a targeted review beginning with the CY 2023 performance 
period/2025 MIPS payment year. We recognize that we did not propose 
changes in the existing language for targeted review at Sec.  
414.1385(a) to reflect the availability of the targeted review process 
for subgroups.
    We proposed to modify Sec.  414.1385(a) to state that a MIPS 
eligible clinician, group, or subgroup may request a targeted review of 
the calculation of the MIPS payment adjustment factors applicable to 
such MIPS eligible clinician, group, or subgroup for a year (88 FR 
52561). We also proposed to modify Sec.  414.1385(a)(1) to state that a 
MIPS eligible clinician, group, or subgroup (including their designated 
support staff), or a third party intermediary as defined at Sec.  
414.1305, may submit a request for a targeted review (88 FR 52561). 
Additionally, we proposed to make conforming changes at Sec.  
414.1385(a)(3), (5), and (6) to remove the term ``MIPS eligible 
clinician or group'' and add in its place the term ``MIPS eligible 
clinician, group, or subgroup'' (88 FR 52561). With these proposals, a 
subgroup that would like to request a review of the calculation for the 
MIPS payment adjustment factor for MVP data submission in the CY 2023 
performance period/2025 MIPS payment year may also submit a targeted 
review application.
    In addition, we noted that we also proposed additional changes to 
the targeted review process overall as set forth in Sec.  414.1385(a) 
(88 FR 52601 through 52603). We refer readers to section IV.A.4.j. of 
this final rule for further discussion on these targeted review 
proposals.
    We requested comments on the above proposals related to targeted 
review for subgroups. The following is a summary of the comments we 
received and our responses.
    Comment: Several commenters supported our proposal allowing 
subgroups to submit a targeted review request. We received no other 
comments on this proposal.
    Response: We thank the commenters for their support.
    After consideration of public comments, we are finalizing our 
proposal to modify Sec.  414.1385(a) to state that a MIPS eligible 
clinician, subgroup, or group may request a targeted review of the 
calculation of the MIPS payment adjustment factors applicable to such 
MIPS eligible clinician, subgroup, or group for a year. We are also 
finalizing our proposal to modify Sec.  414.1385(a)(1) to state that a 
MIPS eligible clinician, subgroup, or group (including their designated 
support staff), or a third party intermediary as defined at Sec.  
414.1305, may submit a request for a targeted review. Additionally, we 
are finalizing our proposal with minor technical corrections to make 
conforming changes at Sec.  414.1385(a)(3), (5), and (6) to remove the 
term ``MIPS eligible clinician or group'' and add in its place the term 
``MIPS eligible clinician, subgroup, or group.'' As previously 
discussed, we refer readers to section IV.A.4.j. of this final rule for 
discussion of our other proposals related to targeted review and 
additional changes to Sec.  414.1385(a).
(5) Codification of Previously Finalized Subgroup Policies From 
Preamble
    We have identified that some subgroup policies were finalized in 
prior rulemaking but were not codified in the CFR. Additionally, we 
neglected to propose to include subgroups in our previously established 
definition of ``attestation'' in Sec.  414.1305. We have reviewed the 
existing language and identified policies that should be codified. We 
proposed to correct these errors (88 FR 52561 and 52562).
    Each of the changes to the policies described in this section must 
be effective beginning with the CY 2023 performance period/2025 MIPS 
payment year in order for MIPS Value Pathways to operate effectively. 
Section 1871(e)(1)(A)(ii) of the Act provides for retroactive 
application of a substantive change to an existing policy when the 
Secretary determines that failure to apply the policy change 
retroactively would be contrary to the public interest. Here, the 
failure to apply the changes retroactively would be contrary to the 
public interest because the discrepancies remedied by the below 
proposals may cause undue confusion for clinicians participating as 
subgroups and may also create unintended errors in program 
implementation.
(a) Definitions
(i) Attestation
    At Sec.  414.1305, we currently define attestation to mean a secure 
mechanism, specified by CMS, with respect to a particular performance 
period, whereby a MIPS eligible clinician or group may submit the 
required data for the Promoting Interoperability or the improvement 
activities performance categories of MIPS in a manner specified by CMS. 
Beginning in the CY 2023 performance period/2025 MIPS payment year, 
clinicians participating as subgroups would submit data for the 
Promoting Interoperability and improvement activities performance 
categories in an MVP as described at Sec.  414.1365(c). As described 
previously in this section, we proposed to adopt

[[Page 79328]]

this change retroactively pursuant to section 1871(e)(1)(A)(ii) of the 
Act. We believe that the failure to apply the proposed change 
retroactively would be contrary to the public interest because it would 
create ambiguity in the requirement for a subgroup to submit data 
through an attestation for the Promoting Interoperability and 
improvement activities performance categories as described in Sec.  
414.1365(c). Therefore, we proposed (88 FR 52562) to add the term 
``subgroup'' and revise the definition of attestation in Sec.  414.1305 
to state that attestation means a secure mechanism, specified by CMS, 
with respect to a particular performance period, whereby a MIPS 
eligible clinician, group, or subgroup may submit the required data for 
the Promoting Interoperability or the improvement activities 
performance categories of MIPS in a manner specified by CMS.
    We requested comments on this proposal. The following is a summary 
of the comments we received and our responses.
    Comment: One commenter supported our proposals to codify previously 
finalized policies for subgroups, including the addition of subgroups 
to ``attestation.''
    Response: We thank the commenter for their support.
    After consideration of public comments, we are finalizing the 
proposal to add the term ``subgroup'' and revise the definition of 
attestation in Sec.  414.1305 to state that attestation means a secure 
mechanism, specified by CMS, with respect to a particular performance 
period, whereby a MIPS eligible clinician, group, or subgroup may 
submit the required data for the Promoting Interoperability or the 
improvement activities performance categories of MIPS in a manner 
specified by CMS. This revision is effective beginning with the CY 2023 
performance period/2025 MIPS payment year.
(ii) Submitter Type
    At Sec.  414.1305, we defined a submitter type to mean the MIPS 
eligible clinician, group, Virtual Group, APM Entity, or third party 
intermediary acting on behalf of a MIPS eligible clinician, group, 
Virtual Group, or APM Entity, as applicable, that submits data on 
measures and activities under MIPS. In accordance with the subgroup 
reporting requirements at Sec.  414.1318(c), we inadvertently 
overlooked adding subgroups in the definition of submitter type at 
Sec.  414.1305. As described previously in this section, we proposed to 
adopt this change retroactively pursuant to section 1871(e)(1)(A)(ii) 
of the Act. We believe that the failure to apply the change 
retroactively would be contrary to the public interest because it would 
create ambiguity in the requirement for a subgroup to submit data as 
described at Sec.  414.1318(c). Therefore, we proposed (88 FR 52562) to 
add the term ``subgroup'' and revise the definition of submitter type 
at Sec.  414.1305 to state that a submitter type means the MIPS 
eligible clinician, group, Virtual Group, subgroup, APM Entity, or 
third party intermediary acting on behalf of a MIPS eligible clinician, 
group, Virtual Group, subgroup, or APM Entity, as applicable, that 
submits data on measures and activities under MIPS.
    We requested comments on this proposal. The following is a summary 
of the comments we received and our responses.
    Comment: One commenter supported our proposals to codify previously 
finalized policies for subgroups, including the addition of subgroups 
to ``submitter type.''
    Response: We thank the commenter for their support.
    After consideration of public comments, we are finalizing our 
proposal to add the term ``subgroup'' and revise the definition of 
submitter type at Sec.  414.1305 to state that a submitter type means 
the MIPS eligible clinician, group, Virtual Group, subgroup, APM 
Entity, or third party intermediary acting on behalf of a MIPS eligible 
clinician, group, Virtual Group, subgroup, or APM Entity, as 
applicable, that submits data on measures and activities under MIPS. 
This revision is effective beginning with the CY 2023 performance 
period/2025 MIPS payment year.
(b) Data Submission Criteria for the Improvement Activities Performance 
Category
    We refer readers to Sec.  414.1360 for data submission criteria for 
the improvement activities performance category. In the CY 2022 PFS 
final rule (86 FR 65462), we finalized revisions to the data submission 
criteria at Sec.  414.1360(a)(2) to allow subgroups to perform and 
attest to their improvement activities separately and to apply the 50 
percent threshold within their subgroup. We inadvertently overlooked 
codifying subgroups in the regulation text at Sec.  414.1360(a). The 
existing regulation text at Sec.  414.1360(a) refers to data submission 
criteria in the improvement activities performance category for only 
MIPS eligible clinicians and groups. As described previously, we 
proposed to adopt this change retroactively pursuant to section 
1871(e)(1)(A)(ii) of the Act. We believe that the failure to apply the 
change retroactively would be contrary to the public interest because 
it would create ambiguity in the data submission requirements 
established in Sec.  414.1360(a)(2) regarding the reporting of 
improvement activities by subgroups. Therefore, we proposed (88 FR 
52562) to revise Sec.  414.1360(a) to state that for purposes of the 
transition year of MIPS and future years, MIPS eligible clinicians, 
groups, or subgroups must submit data on MIPS improvement activities in 
one of the following manners described at Sec.  414.1360(a)(1) through 
(a)(1)(i).
    We requested comments on this proposal. The following is a summary 
of the comments we received and our responses.
    Comment: One commenter supported our proposals to codify previously 
finalized policies for subgroups
    Response: We thank the commenter for their support.
    After consideration of public comments, we are finalizing our 
proposal to revise Sec.  414.1360(a) to state that for purposes of the 
transition year of MIPS and future years, MIPS eligible clinicians, 
groups, or subgroups must submit data on MIPS improvement activities in 
one of the following manners described at Sec.  414.1360(a)(1) and 
(a)(1)(i). This revision is effective beginning with the CY 2023 
performance period/2025 MIPS payment year.
e. APM Performance Pathway
(1) Overview
    In the CY 2021 PFS final rule (85 FR 84859 through 84866), we 
finalized the APM Performance Pathway (APP) at Sec.  414.1367 beginning 
in performance year 2021, which was designed to provide a predictable 
and consistent MIPS reporting option to reduce reporting burden and 
encourage continued APM participation. We also established that ACOs 
will be required to report quality data for purposes of the Shared 
Savings Program via the APP (85 FR 84722).
    Under policies finalized under the CY 2023 PFS (87 FR 69858), to 
meet the quality performance standard under the Shared Savings Program 
through the 2024 performance year, we stated that ACOs must report the 
ten CMS Web Interface measures or the three eCQMs/MIPS CQMS and the 
CAHPS for MIPS survey. Beginning in the 2025 performance year and 
subsequent performance years, ACOs must report the three eCQMS/MIPS 
CQMs and the CAHPS for MIPS survey (87 FR 69858 through 69859).

[[Page 79329]]

(2) Provisions for the Medicare Clinical Quality Measure for 
Accountable Care Organizations Participating in the Medicare Shared 
Savings Program
    As discussed in the proposed rule (88 FR 52420-3), we proposed to 
establish the Medicare Clinical Quality Measure for Accountable Care 
Organizations Participating in the Medicare Shared Savings Program 
(Medicare CQM) collection type in the APP measure set. The Medicare CQM 
collection type will be available to only ACOs participating in the 
Shared Savings Program. ACOs in the Shared Savings Program will have 
the option to report the Medicare CQM under the APP on only 
``beneficiaries eligible for Medicare CQMs as defined at Sec.  
425.20'', instead of their all payer/all patient population, beginning 
with the 2024 performance year (88 FR 52420). The Medicare CQM also 
will serve as another collection type in addition to the existing eCQM/
MIPS CQM option, which is an all payer/all patient collection type 
under the APP.
    In the CY 2023 PFS final rule, we stated that we will monitor the 
impact of policies such as the sunsetting of the CMS Web Interface in 
the 2024 performance year and the requirement to report all payer/all 
patient eCQMs/MIPS CQMs beginning in the 2025 performance year (87 FR 
69833). We also stated that we may revisit these and related issues in 
future rulemaking based on lessons learned as we gain more experience 
with ACOs reporting eCQMs/MIPS CQMs (87 FR 69833). In the proposed 
rule, we reiterated that we are committed to supporting ACOs in the 
transition to all payer/all patient eCQMs/MIPS CQMs and in the 
transition to digital quality measurement reporting (88 FR 52420-3). We 
encouraged readers to review additional background on our proposal to 
include the Medicare CQM collection type in the APP measure set (88 FR 
52420-3). Similarly, we now refer readers to section III.G.2.b.(2) of 
this final rule for additional context on finalizing this proposal.
    The following is a summary of the comments we received on this 
proposal as outlined in this section and our responses. Related 
comments and responses may be found in section III.G.2.b.(2) of this 
final rule.
    Comment: We received one comment supporting the proposal to 
establish the Medicare CQM collection type in the APP measure set as 
described in this section.
    Response: We thank the commenter for their support.
    Comment: Some commenters expressed confusion about our reference in 
the proposed rule to ``attributed Medicare fee-for-service 
beneficiaries who meet the definition of a `beneficiary eligible for 
Medicare CQM(s)''' (88 FR 52562). In particular, commenters were 
concerned that our use of the word ``attributed'' may indicate a 
different beneficiary population for the Medicare CQM collection type 
than the population referenced elsewhere in the proposed rule (88 FR 
52420).
    Response: We agree that our use of the word ``attributed'' may have 
been confusing. We now clarify that our proposal to establish the 
Medicare CQM collection type in the APP measure set is intended to 
reference the same beneficiary population as that discussed in the 
Shared Savings Program section of the proposed rule (88 FR 52420), 
specifically beneficiaries eligible for Medicare CQMs as defined at 
Sec.  425.20. For more discussion on this matter, please refer to 
section III.G.2.b.(2) of this final rule.
    After consideration of public comments, we are finalizing as 
proposed to include the Medicare CQM collection type in the APP measure 
set beginning with the 2024 performance year.
f. MIPS Performance Category Measures and Activities
(1) Quality Performance Category
(a) Background
    Section 1848(q)(1)(A)(i) and (ii) of the Act requires the Secretary 
to develop a methodology for assessing the total performance of each 
MIPS eligible clinician according to certain specified performance 
standards and, using such methodology, to provide for a final score for 
each MIPS eligible clinician. Section 1848(q)(2)(A)(i) of the Act 
provides that the Secretary must use the quality performance category 
in determining each MIPS eligible clinician's final score, and section 
1848(q)(2)(B)(i) of the Act describes the measures that must be 
specified under the quality performance category.
    We referred readers to Sec. Sec.  414.1330 through 414.1340 and the 
CY 2017 and CY 2018 Quality Payment Program final rules (81 FR 77097 
through 77162 and 82 FR 53626 through 53641, respectively), and the CY 
2019, CY 2020, CY 2021, CY 2022, and CY 2023 PFS final rules (83 FR 
59754 through 59765, 84 FR 63949 through 62959, 85 FR 84866 through 
84877, 86 FR 65431 through 65445, and 87 FR respectively) for a 
description of previously established policies and statutory basis for 
policies regarding the quality performance category.
    In the CY 2024 PFS proposed rule (88 FR 52562 through 52568), we 
proposed to:
     Amend the definition of the term ``collection type'' to 
include the Medicare Clinical Quality Measures for Accountable Care 
Organizations Participating in the Medicare Shared Savings Program 
(Medicare CQMs).
     Amend (through technical modifications) the data 
submission criteria for MIPS quality measures and establish the data 
submission criteria for Medicare CQMs.
     Require the administration of the Consumer Assessment of 
Healthcare Providers and Systems (CAHPS) for MIPS Survey in the Spanish 
language translation.
     Maintain the data completeness criteria threshold of at 
least 75 percent for the CY 2026 performance period/2028 MIPS payment 
year, and increase the data completeness criteria threshold to at least 
80 percent for the CY 2027 performance period/2029 MIPS payment year.
     Establish data completeness criteria for Medicare CQMs.
     Modify the MIPS quality measure set as described in 
Appendix 1 of the CY 2024 PFS proposed rule, including the addition of 
new measures, updates to specialty sets, removal of existing measures, 
and substantive changes to existing measures.
(b) Definition of Collection Type
    With the proposed establishment of a new collection type, the 
Medicare Clinical Quality Measures for Accountable Care Organizations 
(ACOs) Participating in the Medicare Shared Savings Program (Medicare 
CQMs) specific to the APM Performance Pathway (APP) as described in the 
CY 2024 PFS proposed rule (88 FR 52420 through 52423), we proposed to 
amend the definition of the term ``collection type'' to include 
Medicare CQMs to account for the new collection type available only to 
Medicare Shared Savings Program ACOs meeting the reporting requirements 
of the APP. Specifically, starting with the CY 2024 performance period, 
we proposed to amend the definition of the term ``collection type'' in 
Sec.  414.1305 to mean a set of quality measures with comparable 
specifications and data completeness criteria, as applicable, 
including, but not limited to: Electronic clinical quality measures 
(eCQMs); MIPS clinical quality measures (MIPS CQMs); Qualified Clinical 
Data Registry (QCDR) measures; Medicare Part B claims measures; CMS Web 
Interface measures (except as provided in paragraph (1) of this 
definition, for the

[[Page 79330]]

CY 2017 through CY 2022 performance periods/2019 through 2024 MIPS 
payment years); the CAHPS for MIPS survey measure; administrative 
claims measures; and Medicare Clinical Quality Measures for Accountable 
Care Organizations Participating in the Medicare Shared Savings Program 
(Medicare CQMs). The Medicare CQMs collection type would serve as a 
transition collection type under the APP and be available as determined 
by CMS.
    We solicited public comment on the proposal to amend the definition 
of the term collection type to include the Medicare CQMs as an 
available collection type in MIPS. The following is a summary of the 
public comments received.
    Comment: Many commenters supported the proposal to amend the 
definition of the term collection type to include Medicare CQMs as an 
available collection type in MIPS. The commenters expressed support for 
the establishment of the new collection type as an available option to 
serve as a transitional means for Medicare Shared Savings Program ACOs 
to prepare for the reporting of eCQMs and MIPS CQMs under the APP.
    Response: We appreciate the support from commenters.
    Comment: A few commenters requested for the Medicare CQMs 
collection type to not be limited to Medicare Shared Savings Program 
ACOs meeting the reporting requirements under the APP, but expand the 
availability to MIPS eligible clinicians, groups, virtual groups, 
subgroups, and other APM Entities participating in MIPS.
    Response: Due to the complex technical challenges that Medicare 
Shared Savings Program ACOs encounter as they prepare for the reporting 
of eCQMs and/or MIPS CQMs, we established the new Medicare CQMs 
collection type to serve as a transition collection type under the APP. 
While the reporting of QCDR measures, eCQMs, MIPS CQMs, and Medicare 
Part B claims measures under MIPS is not new, the reporting of eCQMs 
and/or MIPS CQMs under the APP for Medicare Shared Savings Program ACOs 
is new and in order to facilitate the transition to the reporting of 
eCQMs and/or MIPS CQMs, the availability of the Medicare CQMs as a 
collection type to Medicare Shared Savings Program ACOs provides a 
means to assist with the transition of reporting eCQMs and/or MIPS 
CQMs, particularly as the complex technical challenges specific to 
Medicare Shared Savings Program ACOs are mitigated and addressed. We do 
not intend to expand the availability of the Medicare CQMs collection 
type, serving as a transition collection type, to MIPS eligible 
clinicians, groups, virtual groups, subgroups, and other APM Entities 
participating in MIPS.
    Comment: A few commenters suggested that the Medicare CQMs 
collection type be afforded the 7-point scoring floor for the first 
year of implementation and the 5-point scoring floor applied for the 
second year of implementation as a means for incentivizing Medicare 
Shared Savings Program ACOs to adopt the Medicare CQM collection type.
    Response: We note that the scoring policy providing measure 
achievement points of a 7-point scoring floor and a 5-point scoring 
floor pertains to the submission of new MIPS quality measures during 
their first 2 years in MIPS. Specifically, under the scoring policy for 
new MIPS quality measures in Sec.  414.1380(b)(1)(i)(C), the measure 
achievement points available for the submission of a new MIPS quality 
measure (having a benchmark, and meeting case minimum and data 
completeness requirements) in its first year of MIPS are between 7 and 
10 measure achievement points and the submission of a new MIPS quality 
measure (having a benchmark, and meeting case minimum and data 
completeness requirements) in its second year of MIPS are between 5 and 
10 measure achievement points. The scoring policy for new MIPS quality 
measures is not applicable to the establishment of a new collection 
type or the application of a newly available collection type to an 
existing MIPS quality measure. In the CY 2022 PFS final rule, we noted 
that such policy will not apply to measures that have existed as a MIPS 
quality measure but are being introduced for a new collection type (86 
FR 65500). For example, if a MIPS quality measure is currently 
available as a MIPS CQM and it becomes newly available as an eCQM or 
Medicare CQM, the application of the newly available collection type to 
an existing MIPS quality measure would not be considered a new measure 
under such scoring policy.
    After consideration of public comments, we are finalizing, as 
proposed, the proposal to amend the definition of the term collection 
type in Sec.  414.1305 to include Medicare CQMs as an available 
collection type in MIPS.
    To operationalize the implementation of the Medicare CQMs 
collection type, specifically the capability to distinguish between the 
submission of data for a Medicare CQM and a MIPS CQM to CMS, we created 
an identifier that reflects the Quality number associated with a 
quality measure (that is, Q001, Q134, and Q236) followed by the letters 
``SSP.'' For the reporting of Medicare CQMs, the identifiers are as 
follows: 001SSP, 134SSP, and 236SSP. We note that the Medicare CQM 
identifiers must be included in the submission files. We refer readers 
to section III.G.2.b.of this final rule for a summary of public 
comments received regarding the implementation and operationalization 
of the Medicare CQMs collection type under the APP.
(c) Quality Data Submission Criteria
(i) Data Submission Criteria for Quality Measures
    In the CY 2024 PFS proposed rule, we proposed technical amendments 
to data submission criteria for MIPS quality measures and proposed to 
establish data submission criteria for Medicare CQMs. The participants 
in MIPS have expanded from MIPS eligible clinicians and groups to 
virtual groups starting with the CY 2018 performance period (82 FR 
53593 through 53617), APM Entities starting with the CY 2021 
performance period (85 FR 84860), and subgroups starting with the CY 
2023 performance period (86 FR 65392 through 65394). In order to 
account for the expansion of participants in MIPS and the applicability 
of data submission criteria for MIPS quality measures, we proposed 
technical amendments. We proposed technical amendments to recognize 
that a virtual group, subgroup, and APM Entity are able to meet the 
data submission requirements pertaining to the quality performance 
category at Sec.  414.1325(a)(1), (c), and (d). Also, we proposed 
technical amendments to recognize that a virtual group and an APM 
Entity are able to meet the data submission requirements established at 
Sec.  414.1335(a)(1)(i) and (ii) for the data submission criteria 
pertaining to Medicare Part B claims measures, MIPS CQMs, eCQMs, and 
QCDR measures. Additionally, in Sec.  414.1335(a)(1)(ii), we proposed 
to modify references of MIPS eligible clinicians and groups, to refer 
to such clinicians and groups in the singular to ensure that Sec.  
414.1335 uniformly references the various types of MIPS participants in 
the singular. We made a grammatical correction to Sec.  
414.1335(a)(1)(i) to ensure subject-verb agreement. We noted that the 
technical amendments in Sec.  414.1335(a)(1)(i) and (ii) are not 
applicable to subgroups because MIPS subgroup participation is part of 
the MVP framework, which has separate data submission criteria 
specified in Sec.  414.1365.

[[Page 79331]]

    We proposed technical amendments to the data submission criteria 
for the CAHPS for MIPS Survey measure, which will identify the CAHPS 
for MIPS Survey as a measure in Sec.  414.1335(a)(3). Currently, Sec.  
414.1335(a)(3) does not reference the CAHPS for MIPS Survey as a 
measure, which is erroneous. Also, we proposed a revision to Sec.  
414.1335(a)(3) to recognize that a virtual group, subgroup, and APM 
Entity are able to administer the CAHPS for MIPS Survey in Sec.  
414.1335(a)(3)(i).
    Additionally, we proposed amendments to the data submission 
criteria for quality performance category at Sec.  414.1325(a)(1)(i) 
and (ii) in order to clarify that the data submission of MIPS quality 
measures specific to eCQMs must be submitted utilizing certified 
electronic health record technology (CEHRT). Section 1848(q)(5)(B)(ii) 
of the Act provides that under the methodology for assessing the total 
performance of each MIPS eligible clinician, the Secretary shall: (1) 
Encourage MIPS eligible clinicians to report on applicable measures 
under the quality performance category through the use of CEHRT and 
QCDRs; and (2) For a performance period for a year, for which a MIPS 
eligible clinician reports applicable measures under the quality 
performance category through the use of CEHRT, treat the MIPS eligible 
clinician as satisfying the CQMs reporting requirement under section 
1848(o)(2)(A)(iii) of the Act for such year. To encourage the use of 
CEHRT for quality improvement and reporting on measures under the 
quality performance category, we established a scoring incentive for 
MIPS eligible clinicians who use their CEHRT systems to capture and 
report quality information, specifically the end-to-end electronic 
reporting bonus points (81 FR 77294 through 77297). We sunset the end-
to-end electronic reporting bonus points starting with the CY 2022 
performance period (CY 2021 performance period/2023 MIPS payment year 
was the last performance period in which the end-to-end electronic 
reporting bonus points were available (85 FR 84907 through 84908)).
    With the framework for transforming MIPS through MVPs, we noted in 
the CY 2021 PFS final rule that we will find ways to incorporate 
digital measures without needing to incentivize end-to-end electronic 
reporting with bonus points (85 FR 84907 through 84908). In the CY 2018 
Quality Payment Program final rule (82 FR 53636), we encouraged 
interested parties to consider electronically specifying their quality 
measures as eCQMs, to encourage MIPS eligible clinicians, groups, and 
virtual groups to move towards the utilization of electronic reporting. 
As noted in the CY 2019 PFS final rule (83 FR 59851), bonus points were 
created as transition policies which were not meant to continue through 
the duration of the program. Since the inception of MIPS, our intention 
has been to encourage the utilization of CEHRT, which encompasses the 
requirement of CEHRT pertaining to eCQM data submission.
    With the sunset of the end-to-end electronic reporting bonus 
points, there is ambiguity regarding the requirement of utilizing CEHRT 
for the data submission of eCQMs. While the sunsetting of the end-to-
end electronic reporting bonus points was merely to eliminate such 
bonus points, our intention was to continue the requirement of 
utilizing CEHRT for eCQM data submission. However, with the sunset of 
the end-to-end electronic reporting bonus points, there is an 
inadvertent absence in policy that would continue the requirement of 
utilizing CEHRT for eCQM data submission. As a result of such 
inadvertent absence of policy establishing the overarching CEHRT 
requirements for eCQM data submission for purposes of the quality 
performance category (aside from the CEHRT requirements under the end-
to-end electronic reporting bonus point criteria), we are rectifying 
the issue by establishing the requirement to utilize CEHRT for the data 
submission of eCQMs. We proposed to establish the quality performance 
category data submission criteria for eCQMs that requires the 
utilization of CEHRT in Sec.  414.1335(a)(1). Specifically, in Sec.  
414.1335(a)(1)(i)(A) and (ii)(A), we proposed that the data submission 
criteria for eCQMs requires the utilization of CEHRT, as defined in 
Sec.  414.1305. Furthermore, we proposed to amend the definition of 
CEHRT in Sec.  414.1305(2)(ii) by broadening the applicability of the 
health IT certification criteria identified in 42 CFR 170.315 that are 
necessary to report objectives and measures specified under MIPS (would 
no longer be limited to the Promoting Interoperability performance 
category). As a result of this proposal, the health IT certification 
criteria identified in Sec.  414.1305(2)(ii) would be applicable, where 
necessary, for any MIPS performance category, including the criteria 
that support eCQMs identified in Sec.  414.1305(2)(ii)(B).
    We noted that the proposal pertaining to the data submission 
criteria for eCQMs requiring the utilization of CEHRT will not require 
third party intermediaries that report eCQMs on behalf of a MIPS 
eligible clinician, group, virtual group, subgroup, or APM Entity to 
obtain certification. Currently, third party intermediaries may 
facilitate reporting on behalf of a MIPS eligible clinician, group, 
virtual group, subgroup, or APM Entity for an eCQM while not having 
been certified to the certification criteria at 45 CFR 170.315(c)(1) 
through (3). However, if a MIPS eligible clinician, group, virtual 
group, subgroup, or APM Entity is relying on a third party intermediary 
for elements of the required certification capabilities for the MIPS 
eligible clinician, group, virtual group, subgroup, or APM Entity to 
meet the CEHRT definition applicable for their participation, then the 
third party intermediary will need to provide the MIPS eligible 
clinician, group, virtual group, subgroup, or APM Entity with a 
certified Health IT Module for the needed capability or capabilities.
    We noted that the definition of CEHRT in Sec.  414.1305 references 
several certification criteria in the ONC Health IT Certification 
Program for clinical quality measurement, including: ``Clinical quality 
measures (CQMs)--record and export'' (45 CFR 170.315(c)(1)), as part of 
the 2015 Base Electronic Health Record (EHR) definition in 45 CFR 
170.102; ``Clinical quality measures (CQMs)--import and calculate'' (45 
CFR 170.315(c)(2)); ``Clinical quality measures (CQMs)--report'' (45 
CFR 170.315(c)(3)); and, optionally, ``Clinical quality measures 
(CQMs)--filter'' (45 CFR 170.315(c)(4)). Under the proposal, at a 
minimum, a MIPS eligible clinician, group, virtual group, subgroup, or 
APM Entity would need to utilize technology certified to the criteria 
at 45 CFR 170.315(c)(1) through (3) to report on eCQMs. We reiterate 
that certified Health IT Modules meeting these criteria are not 
required to be provided by the same health IT developer; a MIPS 
eligible clinician, group, virtual group, subgroup, or APM Entity may 
use Health IT Modules to meet the certification requirements provided 
by more than one developer. For example, a MIPS eligible clinician, 
group, virtual group, subgroup, or APM Entity could use certified 
health IT meeting the criteria in 45 CFR 170.315(c)(1) and (c)(2) 
provided as part of their EHR system while a third party intermediary 
that supports reporting on behalf of a MIPS eligible clinician, group, 
virtual group, subgroup, or APM Entity could supply a Health IT Module 
that meets the criterion in 45 CFR 170.315(c)(3) to generate a measure 
report and thus, enable a MIPS eligible clinician, group, virtual 
group, subgroup, or APM Entity

[[Page 79332]]

to meet the requirement to use CEHRT for eCQMs.
    Lastly, we proposed to establish data submission criteria for the 
Medicare CQM collection type (as proposed under the APP in the CY 2024 
PFS proposed rule (88 FR 52420 through 52423)) in Sec.  414.1335(a)(4). 
Specifically, in Sec.  414.1335(a)(4)(i), we proposed that the data 
submission criteria pertaining to Medicare CQMs will be met by, a MIPS 
eligible clinician, group, and APM Entity reporting on the Medicare 
CQMs (reporting quality data on beneficiaries eligible for Medicare 
CQMs as defined at Sec.  425.20) within the APP measure set and 
administering the CAHPS for MIPS Survey as required under the APP.
    We solicited public comment on the proposals regarding the 
technical amendments that pertain to the data submission criteria for 
MIPS quality measures and the establishment of data submission criteria 
for Medicare CQMs. The following is a summary of the public comments 
received.
    Comment: One commenter supported all proposed technical amendments.
    Response: We appreciate the support from the commenter.
    Comment: Several commenters supported the technical amendment 
pertaining to the data submission criteria for eCQMs requiring the 
utilization of CEHRT, which provided clarification regarding the 
requirement of using CEHRT for the data submission of eCQMs. A few 
commenters supported that a MIPS eligible clinician, group, virtual 
group, subgroup, or APM Entity would need to utilize technology 
certified to the criteria at 45 CFR 170.315(c)(1) through (3) to report 
on eCQMs. The commenters indicated that while some third party 
intermediaries may not fully meet CEHRT criteria, it is essential that 
they adhere to the same standards as others when reporting eCQMs; such 
consistency would ensure uniform and reliable data submission across 
all third party intermediaries.
    Response: We appreciate the support from commenters and agree with 
commenters regarding third party intermediaries adhering to the same 
standards to ensure the uniform and reliable submission of data.
    Comment: One commenter encouraged CMS to further incentivize eCQM 
submissions by adding enough eCQMs to each MVP, which would allow for 
eCQMs alone to meet the reporting requirements under the quality 
performance category.
    Response: It should be noted that we implement applicable eCQMs in 
MVPs when they are available. As more eCQMs are implemented in MIPS, we 
will assess and determine which eCQMs would be available for reporting 
in an MVP.
    Comment: A few commenters indicated that EHR vendors with CEHRT do 
not automatically include the capability to easily report the most 
recent version of an eCQM for MIPS with minimal manual effort. Also, 
the commenters indicated that CEHRT requirements do not standardize the 
capture and reporting of individual eCQM data elements across vendor 
systems, which would require the tailoring of data extracts and uploads 
across systems and multiple sights (including Taxpayer Identification 
Numbers (TINs) participating in the Medicare Shared Savings Program as 
part of an ACO). Additionally, a few commenters indicated that CEHRT 
standards have not advanced enough to support quality measurement 
derived from multiple sources.
    Response: We appreciate the feedback from commenters. We note that 
certification criteria referenced in the CEHRT definition for clinical 
quality measurement incorporate QRDA standards, which enable 
standardization of quality data for reporting and exchange. Also, we 
recognize that MIPS eligible clinicians, groups, virtual groups, 
subgroups, and APM Entities, including Medicare Shared Savings Program 
ACOs, may use additional capabilities beyond those included in the 
certification criteria in 45 CFR 170.315(c)(1) through (3) to support 
aggregation of data for eCQMs across systems. We reiterate that the 
definition of CEHRT references the ``clinical quality measurement--
filter'' certification criterion at 45 CFR 170.315(c)(4) as an optional 
criterion. Such criterion requires health IT to be able to filter eCQM 
results at both patient and aggregate levels. Moreover, a Health IT 
Module must be able to filter by a single data element (for example, 
provider type) or a combination of any of certain data elements.\492\
---------------------------------------------------------------------------

    \492\ For more information regarding the ``clinical quality 
measurement-filter'' criterion, we refer readers to the ONC 
Certification Companion Guide available at https://www.healthit.gov/test-method/clinical-quality-measures-cqms-filter.
---------------------------------------------------------------------------

    Comment: One commenter did not support the proposal to require the 
utilization of CEHRT for the data submission of eCQMs because such 
requirement would increase costs and complexity for third party 
intermediaries.
    Response: We recognize that the proposal requiring the utilization 
of CEHRT for the data submission of eCQMs may require the investment of 
resources for third party intermediaries to support the submission of 
eCQMs. However, we previously noted that under the proposal, at a 
minimum, a MIPS eligible clinician, group, virtual group, subgroup, or 
APM Entity would need to utilize technology certified to the criteria 
at 45 CFR 170.315(c)(1) through (3) to report on eCQMs. We reiterated 
that certified Health IT Modules meeting these criteria are not 
required to be provided by the same health IT developer; a MIPS 
eligible clinician, group, virtual group, subgroup, or APM Entity may 
use Health IT Modules to meet the certification requirements provided 
by more than one developer. For example, a MIPS eligible clinician, 
group, virtual group, subgroup, or APM Entity could use certified 
health IT meeting the criteria in 45 CFR 170.315(c)(1) and (c)(2) 
provided as part of their EHR system while a third party intermediary 
that supports reporting on behalf of a MIPS eligible clinician, group, 
virtual group, subgroup, or APM Entity could supply a Health IT Module 
that meets the criterion in 45 CFR 170.315(c)(3) to generate a measure 
report and thus, enable a MIPS eligible clinician, group, virtual 
group, subgroup, or APM Entity to meet the requirement to use CEHRT for 
eCQMs.
    After consideration of public comments, we are finalizing, as 
proposed, the technical amendments that pertain to the data submission 
criteria for MIPS quality measures and the establishment of data 
submission criteria for Medicare CQMs.
(ii) Data Submission Criteria for the CAHPS for MIPS Survey Measure
    The CAHPS for MIPS Survey measures patients' experience of care 
within a group, virtual group, subgroup, and APM Entity, including 
Shared Savings Program ACOs. The survey measures 10 dimensions of 
patient experience of care, known as summary survey measures, for which 
patients may be the best, if not only source of information. The CAHPS 
for MIPS Survey is optional for all groups, virtual groups, subgroups, 
and APM Entities of 2 or more eligible clinicians reporting via 
traditional MIPS or MIPS Value Pathways (MVPs) and is required for 
Shared Savings Program ACOs reporting under the APP.
(A) Require the Administration of the CAHPS for MIPS Survey in the 
Spanish Translation
    We have created official translations of the CAHPS for MIPS Survey 
in 7 languages, including Spanish, Cantonese, Korean, Mandarin, 
Portuguese, Russian, and Vietnamese, in addition to the required 
administration

[[Page 79333]]

of English survey. However, use of these translations is generally 
voluntary, with the exception of the requirement to administer the 
Spanish language translation of the CAHPS for MIPS Survey for patients 
residing in Puerto Rico. Organizations (groups, virtual groups, 
subgroups, and APM Entities) that elect CAHPS for MIPS Survey must 
contract with a CMS-approved survey vendor to administer the CAHPS for 
MIPS Survey and must request survey translations for the vendor to 
administer the CAHPS for MIPS Survey in an optional language. 
Generally, the use of the survey translations are an additional survey 
administration cost to the organizations.
    Our analysis of historic CAHPS data indicated that the use of the 
survey translations has not been widespread and there is unmet need for 
access to surveys in the 7 available translations. The analysis of 
survey translation use by groups and Shared Savings Program ACOs 
fielding the CY 2021 performance period CAHPS for MIPS Survey indicated 
that 141 out of 559 organizations have 10 percent or more respondents 
reporting they speak a language other than English at home and out of 
these 141 organizations, 114 organizations have all of their survey 
responses in English. Analyzing data from the U.S. Census Bureau, 
specifically from the 2021 American Community Survey, we found that 
Spanish is spoken by 61 percent of those who speak a language other 
than English at home.\493\
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    \493\ U.S. Census Bureau, 2021 American Community Survey, S1603: 
Characteristics of People by Language Spoken at Home, 2021 American 
Community Survey 5-Year Estimate Subject Tables. Available at 
https://data.census.gov/table?q=S1603&tid=ACSST5Y2021.S1603.
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    To address unmet need, we proposed to require the administration of 
the CAHPS for MIPS Survey in the Spanish language translation; more 
specifically, we proposed to require organizations to contract with a 
CMS-approved survey vendor that, in addition to administering the 
survey in English, would administer the Spanish language translation to 
Spanish-preferring patients using the procedures detailed in the CAHPS 
for MIPS Quality Assurance Guidelines. Also, we recommended that 
organizations administer the survey in the other available translations 
(Cantonese, Korean, Mandarin, Portuguese, Russian, and Vietnamese) 
based on the language preferences of their patients. The proposal and 
recommendation would make the survey more accessible to survey 
respondents who can only respond in Spanish or another available 
translation, better ensure that we are assessing the experience of 
patients who have limited English proficiency, and is part of our 
efforts to advance health equity. We refer readers to the CY 2024 PFS 
proposed rule (88 FR 52565) for further information regarding the 
proposal requiring the administration of the Spanish language 
translation of the survey.
    We solicited public comment on the proposal to require the 
administration of CAHPS for MIPS Survey in the Spanish language 
translation, in particular from organizations that administer the CAHPS 
for MIPS Survey to understand if they consider contracting with vendors 
to administer the survey in one or more of the available survey 
translations based on the language preferences of patients. We were 
also interested in learning about the factors that more or less likely 
affect the administration of survey translations where there is need 
for one or more of the available translations.
    Simultaneously, we also proposed the same proposal regarding the 
requirement to administer the Spanish language translation of the 
survey for the Medicare Shared Savings Program Accountable Care 
Organizations (Shared Savings Program ACOs) reporting the CAHPS for 
MIPS Survey measure under the APP as described in section III.G.2.g. of 
this final rule.
    We received public comments regarding the proposal to require the 
administration of the CAHPS for MIPS Survey in the Spanish language 
translation. The following is a summary of the public comments 
received.
    Comment: Most commenters supported CMS's efforts to improve health 
equity and language accessibility by requiring administration of the 
Spanish language translation of the survey. Many commenters suggested 
that requiring Spanish language survey administration could improve 
survey participation and response rates. A few commenters noted that 
survey results will better reflect the true perspectives of patients 
when surveys are provided in their preferred language. Some commenters 
also expressed support of CMS's recommendation to offer other language 
translations of the survey, while other commenters encouraged CMS to 
consider requiring use of additional translations in future rulemaking.
    Response: We appreciate the commenters' support. We agree with 
commenters that requiring Spanish language survey administration will 
assist our efforts to advance health equity by assessing the experience 
of patients whose preferred language is Spanish and may result in 
increased survey participation and response rates. We are also 
appreciative of the support for our recommendation that organizations 
use the other available survey translations based on the needs of their 
patient populations and the suggestion to require additional language 
translations. We will consider this suggestion for future rulemaking; 
however, we intend to investigate the extent of additional burden, such 
as cost, to providing the survey translations before expanding the 
requirement to include translations other than Spanish.
    Comment: One commenter supported the proposal but expressed concern 
about the additional cost burden to organizations fielding the survey; 
this commenter suggested shifting the increased costs to the survey 
vendors. Another commenter noted that they believed the additional 
costs associated with the Spanish language administration were 
outweighed by the benefits.
    Response: We recognize the commenter's concern about the potential 
for additional cost burden of the Spanish language requirement to 
organizations fielding the CAHPS for MIPS survey. We do not have the 
legal authority to control vendor costs associated with the 
administration of the survey or to shift any increase in cost to the 
survey vendors as suggested. Further, we agree with the comment that 
any additional costs incurred by the Spanish language requirement is 
outweighed by the potential benefits such as promoting better response 
rates by enabling more patients to participate in the survey and 
ensuring that language does not hinder quality or experience of care. 
As mentioned earlier in this section, we intend to investigate the 
extent of additional costs to providing the survey translations before 
expanding the requirement to include translations other than Spanish.
    Comment: One commenter mentioned the challenges with capturing the 
correct language from the patient during patient registration and 
requested more time to administer additional languages after the 
addition of Spanish during CY 2024. Another commenter expressed support 
for the intent of requiring use of a validated and reliable translated 
CAHPS for MIPS survey, but also expressed concern with physician burden 
to meet the requirement.
    Response: We appreciate the commenters' concerns about physician 
burden to meet the requirement as well as the challenges with capturing 
the correct language preferences of patients

[[Page 79334]]

during patient registration and the additional time needed to assess 
the need for the other available translations. First, assessing Spanish 
language preference will not result in additional burden to 
organizations or physicians administering the CAHPS for MIPS Survey as 
this will be determined by the vendor during survey administration with 
the survey respondents. We also want to clarify that since we are not 
requiring the administration of the other available translations, 
organizations will continue to have the flexibility on how best to 
determine the language preferences of their patients within their 
practices and the need for the administration of the other available 
survey translations.
    After consideration of public comments, we are finalizing, as 
proposed, to require the administration of the CAHPS for MIPS Survey in 
the Spanish language translation.
(d) Data Completeness Criteria
(i) Data Completeness Criteria for Quality Measures, Excluding the 
Medicare CQMs
    As described in the CY 2017 Quality Payment Program proposed rule 
(81 FR 28188 and 28189), to ensure that data submitted on quality 
measures are complete enough to accurately assess each MIPS eligible 
clinician's quality performance, we established a data completeness 
requirement. Section 1848(q)(5)(H) of the Act provides that analysis of 
the quality performance category may include quality measure data from 
other payers, specifically, data submitted by MIPS eligible clinicians 
with respect to items and services furnished to individuals who are not 
individuals entitled to benefits under Part A or enrolled under Part B 
of Medicare. In the CY 2017 and CY 2018 Quality Payment Program final 
rules and the CY 2020 PFS final rule, we also noted that we would 
increase the data completeness criteria threshold over time (81 FR 
77121, 82 FR 53632, and 84 FR 62951). For the CY 2017 performance 
period/2019 MIPS payment year (first year of the implementation of 
MIPS), CMS established the data completeness criteria threshold to 
reflect a threshold of at least 50 percent (81 FR 77125). We increased 
the data completeness criteria threshold from at least 50 percent to at 
least 60 percent for the CY 2018 performance period/2020 MIPS payment 
year (81 FR 77125 and 82 FR 53633) and maintained a threshold of at 
least 60 percent for the CY 2019 performance period/2021 MIPS payment 
year (82 FR 53633 and 53634). For the CY 2020 performance period/2022 
MIPS payment year, we increased the data completeness criteria 
threshold from at least 60 percent to at least 70 percent (84 FR 
62952). We maintained data completeness criteria threshold of at least 
70 percent for the CY 2021, CY 2022, and CY 2023 performance periods/
2023, 2024, and 2025 MIPS payment years (86 FR 65435 through 65438). 
For the CY 2024 and CY 2025 performance periods/2026 and 2027 MIPS 
payment years, we increased the data completeness criteria threshold 
from at least 70 percent to at least 75 percent (87 FR 70049 through 
70052). We continue to believe that it is important to incrementally 
increase the data completeness criteria threshold as MIPS eligible 
clinicians, groups, virtual groups, subgroups, and APM Entities gain 
experience with MIPS.
    The incorporation of higher data completeness criteria thresholds 
in future years ensures a more accurate assessment of a MIPS eligible 
clinician's performance on quality measures and prevents selection bias 
to the extent possible (81 FR 77120, 82 FR 53632, 83 FR 59758, 86 FR 
65436, and 87 FR 70049). We have encouraged all MIPS eligible 
clinicians to perform the quality actions associated with the quality 
measures on their patients (82 FR 53632, 86 FR 65436, and 87 FR 70049). 
The data submitted for each measure is expected to be representative of 
the individual MIPS eligible clinician, group, or virtual group's 
overall performance for that measure. A data completeness criteria 
threshold of less than 100 percent is intended to reduce burden and 
accommodate operational issues that may arise during data collection 
during the initial years of the program (82 FR 53632, 86 FR 65436, and 
87 FR 70049).
    We previously noted concerns raised by interested parties regarding 
the unintended consequences of accelerating the data completeness 
thresholds too quickly, which may jeopardize a MIPS eligible 
clinicians' ability to participate and perform well under MIPS (81 FR 
77121, 82 FR 53632, 84 FR 62951, and 87 FR 70049). We want to ensure 
that an appropriate, yet achievable, data completeness criteria 
threshold is applied to all eligible clinicians participating in MIPS. 
Based on our analysis of data completeness rates from data submission 
for the CY 2017 performance period,\494\ it is feasible for eligible 
clinicians and groups to achieve a higher data completeness criteria 
threshold without jeopardizing their ability to successfully 
participate and perform in MIPS.
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    \494\ As described in the CY 2020 PFS final rule (84 FR 62951), 
the average data completeness rates were as follows: for individual 
eligible clinicians, it was 76.14; for groups, it was 85.27; and for 
small practices, it was 74.76.
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    As MIPS eligible clinicians, groups, and virtual groups have gained 
experience participating in MIPS, particularly meeting the data 
completeness criteria threshold over the last 7 years (from CY 2017 
performance period to CY 2023 performance period), such experience has 
prepared MIPS eligible clinicians, groups, virtual groups, subgroups, 
and APM Entity to meet incremental increases in the data completeness 
criteria threshold. We have maintained a data completeness criteria 
threshold of at least 70 percent for four years from the CY 2020 
performance period to the CY 2023 performance period and as a result, 
individual MIPS eligible clinicians, groups, virtual groups, subgroups, 
and APM Entities had 4 years of a maintained data completeness criteria 
threshold of at least 70 percent before transitioning to an increased 
data completeness criteria threshold of at least 75 percent for a 2-
year timeframe (CY 2024 and CY 2025 performance periods) with more than 
12 months to prepare for an increased data completeness criteria 
threshold of at least 75 percent before such threshold becomes 
effective for the CY 2024 and CY 2025 performance periods/2026 and 2027 
MIPS payment years.
    As we assessed the timeframe for increasing the data completeness 
criteria threshold, we determined that maintaining the data 
completeness criteria threshold of at least 75 percent for a total of 3 
years would provide sufficient time for MIPS eligible clinicians, 
groups, virtual groups, subgroups, and APM Entities to transition to 
another increase in the data completeness criteria threshold. For the 
CY 2026 performance period/2028 MIPS payment year, we proposed to 
maintain the data completeness criteria threshold of at least 75 
percent. This would provide MIPS eligible clinicians, groups, virtual 
groups, subgroups, and APM Entities with sufficient time to prepare for 
an incrementally increase in the data completeness criteria threshold 
starting with the CY 2027 performance period/2029 MIPS payment year. 
Therefore, MIPS eligible clinicians, groups, virtual groups, subgroups, 
and APM Entities could continue transitioning to an incrementally 
increased data completeness criteria threshold of at least 75 percent 
to at least 80 percent. In establishing data completeness criteria 
thresholds in advance of an applicable performance period, it is 
advantageous to delineate

[[Page 79335]]

the expectations for MIPS eligible clinicians, groups, virtual groups, 
subgroups, and APM Entities, so they can adequately prepare for a 
transition to higher data completeness criteria threshold, particularly 
the increase in data completeness criteria threshold to at least 80 
percent. Thus, we proposed to increase the data completeness criteria 
threshold from 75 percent to 80 percent for the CY 2027 performance 
period/2029 MIPS payment year.
    The use of EHRs and eCQMs can reduce burden associated with meeting 
higher data completeness standards as the collection of eCQM data 
within the EHR can allow eligible clinicians to report on 100 percent 
of the eligible population with data in the EHR for a measure. We 
continued to encourage individual MIPS eligible clinicians, groups, 
virtual groups, subgroups, and APM Entities, including small and rural 
practices, to explore EHR adoption and the reporting of eCQMs to reduce 
burden and technical challenges to ensure data accuracy as we seek to 
increase the data completeness criteria threshold. Individual MIPS 
eligible clinicians, groups, virtual groups, subgroups, and APM 
Entities that continue to utilize other means of data collection for 
MIPS CQMs, including the collection of MIPS CQM data reported by 
registries and/or QCDRs, would need to have the logic code of their 
EHRs to be updated to account for the increased data completeness 
criteria threshold. Increasing the data completeness criteria threshold 
would not pose a substantial burden to MIPS eligible clinicians, 
groups, virtual groups, subgroups, and APM Entities, unless they are 
manually extracting and reporting quality data. However, increasing the 
data completeness criteria threshold provides for the more accurate 
assessment of performance.
    For the aforementioned reasons, it is important to incrementally 
increase the data completeness criteria threshold. In the CY 2024 PFS 
proposed rule, we proposed to maintain the data completeness threshold 
for an additional year before incrementally increasing the data 
completeness criteria threshold. Specifically, in Sec.  414.1340(a), we 
proposed the following data completeness criteria thresholds pertaining 
to QCDR measures, MIPS CQMs, and eCQMs:
     At paragraph (a)(4), for the CY 2026 performance period/
2028 MIPS payment year, a MIPS eligible clinician, group, virtual 
group, subgroup, and APM Entity submitting quality measures data on 
QCDR measures, MIPS CQMs, or eCQMs must submit data on at least 75 
percent of the MIPS eligible clinician, group, virtual group, subgroup, 
or APM Entity's patients that meet the measure's Denominator criteria, 
regardless of payer.
     At paragraph (a)(5), for the CY 2027 performance period/
2029 MIPS payment year, a MIPS eligible clinician, group, virtual 
group, subgroup, and APM Entity submitting quality measures data on 
QCDR measures, MIPS CQMs, or eCQMs must submit data on at least 80 
percent of the MIPS eligible clinician, group, virtual group, subgroup, 
or APM Entity's patients that meet the measure's denominator criteria, 
regardless of payer.
    Similarly, in Sec.  414.1340(b), respectively, we proposed the 
following data completeness criteria thresholds pertaining to Medicare 
Part B claims measures:
     At paragraph (b)(4), for the CY 2026 performance period/
2028 MIPS payment year, a MIPS eligible clinician, group, virtual 
group, subgroup, and APM Entity submitting quality measures data on 
Medicare Part B claims measures must submit data on at least 75 percent 
of the MIPS eligible clinician, group, virtual group, subgroup, or APM 
Entity's patients seen during the corresponding performance period to 
which the measure applies.
     At paragraph (b)(5), for the CY 2027 performance period/
2029 MIPS payment year, a MIPS eligible clinician, group, virtual 
group, subgroup, and APM Entity submitting quality measures data on 
Medicare Part B claims measures must submit data on at least 80 percent 
of the MIPS eligible clinician, group, virtual group, subgroup, or APM 
Entity's patients seen during the corresponding performance period to 
which the measure applies.
    Also, for the data completeness criteria pertaining to the quality 
performance category, we proposed technical amendments to recognize 
that a virtual group, subgroup, and APM Entity must meet the data 
completeness criteria requirements established at Sec.  414.1340(a), 
(b), and formerly paragraph (d), new paragraph (e) due to the proposal 
to establish the data completeness criteria for the new collection 
type, Medicare CQM, in Sec.  414.1340(d) as described in the CY 2024 
PFS proposed rule (88 FR 52567).
    We solicited public comment on these proposals. The following is a 
summary of the public comments received.
    Comment: A few commenters expressed their appreciation for the 
gradual and incremental increase in the data completeness criteria 
threshold, which would allow for a more accurate assessment of 
performance.
    Response: We appreciate the support from commenters.
    Comment: Some commenters supported the data completeness criteria 
threshold of at least 75 percent for the CY 2026 performance period/
2028 MIPS payment year, which would extend the data completeness 
threshold of at least 75 percent for another performance period.
    Response: We appreciate the support from commenters.
    Comment: Some commenters requested for the previously established 
data completeness criteria threshold of at least 75 percent for the CY 
2024 and CY 2025 performance periods/2026 and 2028 MIPS payment years 
to be lowered to at 70 percent. A few commenters indicated that there 
are technical and interoperability challenges (that is, data collection 
variability across multiple EHRs, systems, and sights (including 
multiple TINs participating in the Medicare Shared Savings Program as 
part of an ACO); lack of agreed upon semantic and syntactic standards; 
data privacy concerns; and patient misidentification), which make it 
difficult to meet the data completeness criteria threshold. A few 
commenters indicated that a data completeness criteria threshold of 
more than 70 percent would make it difficult for small and rural 
practices with fewer resources and staff to meet the data completeness 
criteria threshold.
    Response: As previously noted, we believe that MIPS eligible 
clinicians, groups, and virtual groups have gained experience 
participating in MIPS, particularly meeting the increased data 
completeness criteria thresholds over the last 7 years (from CY 2017 
performance period to CY 2023 performance period), and such experience 
has prepared MIPS eligible clinicians, groups, virtual groups, 
subgroups, and APM Entity to meet incremental increases in the data 
completeness criteria threshold. The data completeness criteria 
threshold of at least 70 percent was maintained for 4 years from the CY 
2020 performance period to the CY 2023 performance period and as a 
result, individual MIPS eligible clinicians, groups, virtual groups, 
subgroups, and APM Entities had 4 years of a maintained data 
completeness criteria threshold of at least 70 percent before 
transitioning to an increased data completeness criteria threshold of 
at least 75 percent.
    We have implemented a slow, gradual, and incremental increase in 
the data completeness criteria threshold in order to provide sufficient 
time for the preparation of an increase. We continued to encourage 
individual MIPS

[[Page 79336]]

eligible clinicians, groups, virtual groups, subgroups, and APM 
Entities, including small and rural practices, to explore EHR adoption 
and the reporting of eCQMs to reduce burden and technical challenges to 
ensure data accuracy as we seek to increase the data completeness 
criteria threshold.
    Also, we recognize that there are technical challenges such as data 
collection variability across multiple EHRs, systems, and sights, 
particularly as such the technical challenges pertaining to Medicare 
Shared Savings Program ACOs with multiple TINs under an ACO. In order 
to assist with the mitigation of the technical challenges encountered 
by Medicare Shared Savings Program ACOs reporting eCQM and/or eCQM, we 
are finalizing, as proposed, the proposal that establishes the Medicare 
CQMs collection type; the Medicare CQMs will serve as a transition 
collection type under the APP and be available as determined by CMS. 
For the Medicare CQMs collection type, Medicare Shared Savings Program 
ACOs report quality data on a subset of Medicare beneficiaries 
(beneficiaries eligible for Medicare CQMs as defined at Sec.  425.20) 
instead of the reporting of quality data on all-payers as required for 
eCQMs and MIPS CQMs. We refer readers to section III.G.2.b.of this 
final rule for the discussion regarding the implementation and 
operationalization of the Medicare CQMs collection type under the APP.
    We are maintaining the previously finalized policy of increasing 
the data completeness criteria threshold of at least 75 percent for the 
CY 2024 and CY 2025 performance periods/2026 and 2027 MIPS payment 
years and extending such data completeness criteria threshold of at 
least 75 percent for the CY 2026 performance period/2028 MIPS payment 
year.
    Comment: No commenters supported the increase of the data 
completeness criteria threshold to at least 80 percent for the CY 2027 
performance period/2029 MIPS payment year. Many commenters indicated 
that increasing the data completeness criteria threshold to at least 80 
percent would increase burden, and in particular, disproportionately 
increase burden for smaller and rural practices due to limited 
resources and staff. Some commenters expressed concerns that an 
increase in the data completeness criteria threshold to at least 80 
percent would exacerbate the technical and interoperability challenges 
pertaining to data aggregation across multiple EHRs, systems (utilizing 
different registries, and EHR developers and vendors), and sites 
(including multiple TINs participating in the Medicare Shared Savings 
Program as an ACO), which would make it more difficult to meet the data 
completeness criteria threshold. A few commenters indicated that some 
practices are still recovering from the COVID-19 Public Health 
Emergency and as a result, increasing the data completeness criteria 
threshold would increase burden. One commenter recommended that CMS 
allow for the implementation of the data completeness criteria 
threshold of at least 75 percent to occur prior to increasing the data 
completeness criteria threshold to at least 80 percent, which would 
enable for the evaluation of the policy.
    Response: While we believe it is important to increase the data 
completeness criteria threshold in order to assess a MIPS eligible 
clinician's performance more accurately on quality measures and prevent 
selection bias to the extent possible performance, we recognize the 
concerns raised by the commenters and believe it is inappropriate to 
finalize the policy as proposed. In this final rule, we are not 
establishing the data completeness criteria threshold for the CY 2027 
performance period/2029 MIPS payment year.
    Comment: One commenter requested for CMS to stabilize the data 
completeness criteria threshold, which would allow clinicians 
participating in MIPS to focus on improvement and successfully 
transition to reporting digital quality measures and meeting reporting 
requirements under MVPs.
    Response: Advance notice of the gradual and incremental increase in 
the data completeness criteria threshold provides a sufficiently stable 
data completeness policy for MIPS eligible clinicians, groups, virtual 
groups, subgroups, and APM Entities to focus on improvement. The pace 
at which the data completeness standard has increased provides ample 
time to prepare for an increase while also transitioning to the 
reporting of digital quality measures and participation in an MVP. The 
data completeness criteria threshold of at least 70 percent was 
maintained for 4 years from the CY 2020 performance period/2022 MIPS 
payment year to the CY 2023 performance period/2025 MIPS payment year. 
The data completeness criteria threshold is increasing to at least 75 
percent and will be maintained at that level for 3 years from the CY 
2024 performance period/2026 MIPS payment year to the CY 2026 
performance period/2028 MIPS payment year. The data completeness 
criteria threshold is predictable and stable during a segment of time.
    Comment: One commenter requested for CMS to consider the 
establishment of different data completeness criteria thresholds for 
certain measures such as patient-reported outcome measures. As an 
example, the commenter indicated that it would be difficult to meet a 
data completeness criteria threshold of at least 50 percent for a 
patient-reported outcome measure.
    Response: We note that the CAHPS for MIPS Survey, which is a 
patient-reported outcome measure, has different data completeness 
criteria requirements from QCDR measures, eCQMs, MIPS CQMs, and 
Medicare Part B claims measures. For the CAHPS for MIPS survey measure, 
groups, virtual groups, subgroups, and APM Entities report data on a 
sample of Medicare Part B patients provided by CMS. We recognize that 
patient-reported outcome measures would require differing data 
completeness criteria threshold requirements from QCDR measures, eCQMs, 
MIPS CQMs, and Medicare Part B claims measures.
    Comment: Some commenters requested for CMS to establish a different 
data completeness criteria threshold for Medicare Shared Savings 
Program ACOs reporting eCQMs, MIPS CQMs, and Medicare CQMs. Other 
commenters expressed concerns regarding the data completeness criteria 
requirement for Medicare CQMs as having a much higher expectation for 
data completeness than the CMS Web Interface and as a result, may not 
ease the transition to the collection of all-payer data for the 
reporting of eCQMs and MIPS CQMs.
    Response: To provide consistency regarding the data completeness 
criteria threshold across collection types and prevent confusion 
regarding the expectations concerning the data completeness criteria 
threshold, we believe it is imperative to establish the same data 
completeness criteria threshold requirements for QCDR measures, eCQMs, 
MIPS CQMs, Medicare Part B claims measures, and Medicare CQMs.
    We recognize that there are technical challenges for Medicare 
Shared Savings Program ACOs as they prepare to report eCQMs and MIPS 
CQMs under the APP. As a result of the aforementioned technical 
challenges, we are finalizing, as proposed, to establish the Medicare 
CQMs collection type; the Medicare CQMs will serve as a transition 
collection type under the APP and be available as determined by CMS. 
For the Medicare CQMs collection type, Medicare Shared Savings Program 
ACOs

[[Page 79337]]

report quality data on a subset of Medicare beneficiaries 
(beneficiaries eligible for Medicare CQMs as defined at Sec.  425.20) 
instead of the reporting of quality data on all-payers as required for 
eCQMs and MIPS CQMs. We refer readers to section III.G.2.b.of this 
final rule for the discussion regarding the implementation and 
operationalization of the Medicare CQMs collection type under the APP.
    After consideration of public comments, we are finalizing, as 
proposed, the proposals in Sec.  414.1340(a), (b), (d), and (e) as 
follows:
     At paragraph (a)(4), for the CY 2026 performance period/
2028 MIPS payment year, a MIPS eligible clinician, group, virtual 
group, subgroup, and APM Entity submitting quality measures data on 
QCDR measures, MIPS CQMs, or eCQMs must submit data on at least 75 
percent of the MIPS eligible clinician, group, virtual group, subgroup, 
or APM Entity's patients that meet the measure's denominator criteria, 
regardless of payer.
     At paragraph (b)(4), for the CY 2026 performance period/
2028 MIPS payment year, a MIPS eligible clinician, group, virtual 
group, subgroup, and APM Entity submitting quality measures data on 
Medicare Part B claims measures must submit data on at least 75 percent 
of the MIPS eligible clinician, group, virtual group, subgroup, or APM 
Entity's patients seen during the corresponding performance period to 
which the measure applies.
     At paragraph (d)(1), for the CY 2024, CY 2025, and CY 2026 
performance periods/2026, 2027, and 2028 MIPS payment years, APM 
Entities, specifically Medicare Shared Savings Program Accountable Care 
Organizations meeting reporting requirements under the APP, submitting 
quality measure data on Medicare CQMs must submit data on at least 75 
percent of the applicable beneficiaries eligible for the Medicare CQM, 
as defined at Sec.  425.20, who meet the measure's denominator 
criteria.
     Technical amendments at Sec. Sec.  414.1340(a), (b), and 
formerly paragraph (d), new paragraph (e) due to the establishment of 
the data completeness criteria for the new collection type, Medicare 
CQM, in Sec.  414.1340(d).
    However, we are not finalizing the proposals at Sec.  
414.1340(a)(5), (b)(5), and (d)(2) to increase the data completeness 
criteria threshold to at least 80 percent for the CY 2027 performance 
period/2029 MIPS payment year.
(ii) Data Completeness Criteria for the Medicare CQMs
    As we proposed to establish a new collection type, the Medicare 
CQMs specific to the APM Performance Pathway (APP) as described in the 
CY 2024 PFS proposed rule (88 FR 52420 through 52423), we also proposed 
to establish the data completeness criteria thresholds for the Medicare 
CQMs. Specifically, in Sec.  414.1340(d), respectively, we proposed the 
following data completeness criteria thresholds pertaining to Medicare 
CQMs:
     At paragraph (d)(1), for the CY 2024, CY 2025, and CY 2026 
performance periods/2026, 2027, and 2028 MIPS payment years, an APM 
Entity, specifically a Shared Savings Program ACO that meets the 
reporting requirements under the APP, submitting quality measure data 
on Medicare CQMs must submit data on at least 75 percent of the APM 
Entity's applicable beneficiaries eligible for the Medicare CQM, as 
proposed to be defined at Sec.  425.20, who meet the measure's 
denominator criteria.
     At paragraph (d)(2), for the CY 2027 performance period/
2029 MIPS payment year, an APM Entity, specifically a Shared Savings 
Program ACO that meets the reporting requirements under the APP, 
submitting quality measure data on Medicare CQMs must submit data on at 
least 80 percent of the APM Entity's applicable beneficiaries eligible 
for the Medicare CQM, as proposed to be defined at Sec.  425.20, who 
meet the measure's denominator criteria.
    We proposed to establish the aforementioned data completeness 
criteria thresholds for the Medicare CQMs collection type in advance of 
the applicable performance periods. We recognize that it is 
advantageous to delineate the expectations for ACOs as they prepare to 
meet the quality reporting requirements for the Medicare CQMs 
collection type under the APP. We will assess the availability of the 
Medicare CQMs as a collection type under the APP during the initial 
years of implementation and determine the timeframe to sunset the 
Medicare CQM as a collection type in future rulemaking.
    As previously noted, we are finalizing, as proposed, the following 
proposal the following data completeness criteria thresholds pertaining 
to Medicare CQMs:
     At paragraph (d)(1), for the CY 2024, CY 2025, and CY 2026 
performance periods/2026, 2027, and 2028 MIPS payment years, APM 
Entities, specifically Medicare Shared Savings Program Accountable Care 
Organizations meeting reporting requirements under the APP, submitting 
quality measure data on Medicare CQMs must submit data on at least 75 
percent of the applicable beneficiaries eligible for the Medicare CQM, 
as defined at Sec.  425.20, who meet the measure's denominator 
criteria.
    However, we are not finalizing the proposal at Sec.  414.1340(d)(2) 
to increase the data completeness criteria threshold to at least 80 
percent for the CY 2027 performance period/2029 MIPS payment year.
(e) Selection of MIPS Quality Measures
    Section 1848(q)(2)(D)(i) of the Act requires the Secretary, through 
notice and comment rulemaking, to establish an annual final list of 
quality measures from which MIPS eligible clinicians may choose for the 
purpose of assessment under MIPS. Section 1848(q)(2)(D)(i)(II) of the 
Act requires that the Secretary annually update the list by removing 
measures from the list, as appropriate; adding to the list, as 
appropriate, new measures; and determining whether measures that have 
undergone substantive changes should be included on the updated list.
    Previously finalized MIPS quality measures can be found in the CY 
2023 PFS final rule (87 FR 70250 through 70633), CY 2022 PFS final rule 
(86 FR 65687 through 65968); CY 2021 PFS final rule (85 FR 85045 
through 85377); CY 2020 PFS final rule (84 FR 63205 through 63513); CY 
2019 PFS final rule (83 FR 60097 through 60285); CY 2018 Quality 
Payment Program final rule (82 FR 53966 through 54174); and CY 2017 
Quality Payment Program final rule (81 FR 77558 through 77816). We 
proposed changes to the MIPS quality measure set, as outlined in 
Appendix 1 of the CY 2024 PFS proposed rule, include the following: the 
addition of new measures; updates to specialty sets; removal of 
existing measures, and substantive changes to existing measures. For 
the CY 2024 performance period, we proposed a measure set of 200 MIPS 
quality measures in the inventory.
    The new MIPS quality measures that we proposed to include in MIPS 
for the CY 2024 performance period and future years can be found in 
Table Group A of Appendix 1 of the CY 2024 PFS proposed rule. For the 
CY 2024 performance period, we proposed 14 new MIPS quality measures, 
which includes one composite measure; and 7 high priority measures, of 
which 4 are also patient-reported outcome measures.
    In addition to the establishment of new individual MIPS quality 
measures,

[[Page 79338]]

we developed and maintained specialty measure sets to assist MIPS 
eligible clinicians with selecting quality measures that are most 
relevant to their scope of practice. We proposed modifications to 
existing specialty sets and new specialty sets as described in Table 
Group B of Appendix 1 of the CY 2024 PFS proposed rule. Specialty sets 
may include new measures, previously finalized measures with 
modifications, previously finalized measures with no modifications, the 
removal of certain previously finalized quality measures, or the 
addition of existing MIPS quality measures. Specialty and subspecialty 
sets are not inclusive of every specialty or subspecialty.
    On January 3, 2023, we announced that we would be accepting 
recommendations for potential new specialty measure sets or revisions 
to existing specialty measure sets for year 8 of MIPS under the Quality 
Payment Program.\495\ These recommendations were based on the MIPS 
quality measures finalized in the CY 2022 PFS final rule and the 2022 
Measures Under Consideration List; the recommendations include the 
addition or removal of current MIPS quality measures from existing 
specialty sets, or the creation of new specialty sets. All specialty 
set recommendations submitted for consideration were assessed and 
vetted, and as a result, the recommendations that we agree with were 
proposed in the CY 2024 PFS proposed rule.
---------------------------------------------------------------------------

    \495\ Message to the Quality Payment Program listserv on January 
3, 2023, entitled: ``The Centers for Medicare & Medicaid Services 
(CMS) is Soliciting Stakeholder Recommendations for Potential 
Consideration of New Specialty Measure Sets and/or Revisions to the 
Existing Specialty Measure Sets for the 2024 Performance Year of the 
Merit-based Incentive Payment System (MIPS).''
---------------------------------------------------------------------------

    In addition to establishing new individual MIPS quality measures 
and modifying existing specialty sets and new specialty sets as 
outlined in Tables Group A and Group B of Appendix 1 of the CY 2024 PFS 
proposed rule, we referred readers to Table Group C of Appendix 1 of 
the CY 2024 PFS proposed rule for a list of quality measures and 
rationales for measure removal. We have previously specified certain 
criteria that will be used when we are considering the removal of a 
measure (81 FR 77136 and 77137; 83 FR 59763 through 59765; 84 FR 62957 
through 62959). For the CY 2024 performance period, we proposed to 
remove 12 MIPS quality measures and partially remove 3 MIPS quality 
measures that are proposed for removal from traditional MIPS and 
proposed for retention for use in MVPs. We referred readers to Table 
Group DD of Appendix 1 of the CY 2024 PFS proposed rule for further 
information regarding the proposals to retain such measures for 
retention for use in relevant MVPs. Of the 12 MIPS quality measures 
proposed for removal, the following pertains to such measures: 2 MIPS 
quality measures are duplicative to a proposed new MIPS quality 
measure; 3 quality measures are duplicative of current measures; 5 MIPS 
quality measures that are under the topped-out lifecycle; one measure 
is extremely topped out; and one MIPS quality measure is constructed in 
a manner that makes it difficult to attribute the quality action to the 
clinician, which creates burden. We have continuously communicated to 
interested parties our desire to reduce the number of process measures 
within the MIPS quality measure set (see, for example, 83 FR 59763 
through 59765). The proposal to remove the quality measures described 
in Table Group C of the CY 2024 PFS proposed rule would lead to a more 
parsimonious inventory of meaningful, robust measures in the program, 
and that our approach to removing measures should occur through an 
iterative process that includes an annual review of the quality 
measures to determine whether they meet our removal criteria.
    Also, we proposed substantive changes to several MIPS quality 
measures, which can be found in Table Group D of Appendix 1 of the CY 
2024 PFS proposed rule. We have previously established criteria that 
would apply when we are considering making substantive changes to a 
quality measure (81 FR 77137, and 86 FR 65441 through 65442). We 
proposed substantive changes to 59 MIPS quality measures, which 
includes 3 MIPS quality measures proposed to be retained for 
utilization under MVPs (we referred readers to Table Group DD of 
Appendix 1 of the CY 2024 PFS proposed rule for such measures that are 
proposed for retention for use in relevant MVPs). On an annual basis, 
we review the established MIPS quality measure inventory to consider 
updates to the measures. Possible updates to measures may be minor or 
substantive.
    Lastly, we proposed substantive changes to the CMS Web Interface 
measures that are available as a collection type and submission type 
for the Medicare Shared Savings Program ACOs meeting reporting 
requirements under the APP. The substantive changes to the CMS Web 
Interface measures can be found in Table Group E of Appendix 1 of the 
CY 2024 PFS proposed rule.
    We solicited public comment on the proposals to modify the quality 
performance category measure set, a measure set of 200 MIPS quality 
measures in the inventory for the CY 2024 performance period, which 
includes the following:
     Implementation of 14 new MIPS quality measures: one 
composite measure; and 7 high priority measures, of which 4 are also 
patient-reported outcome measures;
     Removal of 12 MIPS quality measures: 2 quality MIPS 
measure are duplicative to a proposed new quality measure; 3 MIPS 
quality measures are duplicative to current quality measures; 5 MIPS 
quality measures are under the topped-out lifecycle; one MIPS quality 
measure is extremely topped out; and one MIPS quality measure is 
constructed in a manner that makes it difficult to attribute the 
quality action to the clinician, which creates burden;
     Partial removal of 3 MIPS quality measures: 3 MIPS quality 
measures removed from traditional MIPS and retained for use in MVPs; 
and
     Substantive changes to 59 MIPS quality measures.
    We refer readers to Table Groups A through E of Appendix 1 of this 
final rule for a summary of public comments received regarding the 
proposed modifications to the MIPS quality measure set for the CY 2024 
performance period and the discussion regarding final decisions.
    After consideration of public comments, and for the reasons stated 
in the aforementioned Table Groups A through E of Appendix 1 of this 
final rule and the CY 2024 PFS proposed rule (88 FR 52766 through 
53132), we are finalizing, with modification, a measure set of 198 MIPS 
quality measures in the inventory for the CY 2024 performance period, 
which includes the following:
     Implementation of 11 new MIPS quality measures: 1 
composite measure; and 6 high priority measures, of which 4 are also 
patient-reported outcome measures;
     Removal of 11 MIPS quality measures: 1 quality MIPS 
measure is duplicative to a new quality measure; 3 MIPS quality 
measures are duplicative to current quality measures; 5 MIPS quality 
measures are under the topped-out lifecycle; 1 MIPS quality measure is 
extremely topped out; and 1 MIPS quality measure is constructed in a 
manner that makes it difficult to attribute the quality action to the 
clinician, which creates burden;
     Partial removal of 3 MIPS quality measures: 3 MIPS quality 
measures removed from traditional MIPS and retained for use in MVPs; 
and
     Substantive changes to 59 MIPS quality measures.

[[Page 79339]]

(2) Cost Performance Category
    Section 1848(q)(2)(A) of the Act includes resource use as a 
performance category under MIPS. We refer to this performance category 
as the cost performance category. As required by sections 1848(q)(2) 
and (5) of the Act, the four performance categories of MIPS are used in 
determining the MIPS final score for each MIPS eligible clinician. In 
general, MIPS eligible clinicians will be evaluated under all four of 
the MIPS performance categories, including the cost performance 
category.
    In the CY 2024 PFS proposed rule (88 FR 52568 through 52576), we 
proposed to add five new episode-based measures to the cost performance 
category using a 20-episode case minimum and to remove the Simple 
Pneumonia with Hospitalization episode-based measure from the cost 
performance category beginning with the CY 2024 performance period/2026 
MIPS payment year. In addition, we proposed to add the five new 
episode-based measures and remove the Simple Pneumonia with 
Hospitalization episode-based measure from the operational list of care 
episode and patient condition groups and codes.
    For a description of the statutory basis for and existing policies 
pertaining to the cost performance category, we referred readers to 
Sec.  414.1350 and the CY 2017 Quality Payment Program final rule (81 
FR 77162 through 77177), CY 2018 Quality Payment Program final rule (82 
FR 53641 through 53648), CY 2019 PFS final rule (83 FR 59765 through 
59776), CY 2020 PFS final rule (84 FR 62959 through 62979), CY 2021 PFS 
final rule (85 FR 84877 through 84881), CY 2022 PFS final rule (86 FR 
65445 through 65461), and CY 2023 PFS final rule (87 FR 70055 through 
70057).
(a) Addition of Episode-Based Measures
(i) Background
    Under Sec.  414.1350(a), we specify cost measures for a performance 
period to assess the performance of MIPS eligible clinicians on the 
cost performance category. There are currently 25 cost measures in the 
cost performance category for the CY 2023 performance period/2025 MIPS 
payment year, comprising of 23 episode-based measures covering a range 
of conditions and procedures and two population-based measures. We 
worked with the measure development contractor to identify the proposed 
five new episode-based measures for development through empirical 
analyses and public comment. These measures cover clinical topics and 
MIPS eligible clinicians currently with limited or no applicable cost 
measures. As such, these measures will help fill gaps in the cost 
performance category's measure set. In addition, these measures will 
support the transition from traditional MIPS to MIPS Value Pathways 
(MVPs) by allowing new MVPs to be created and enhancing existing MVPs. 
Further, the addition of these measures will address interested 
parties' feedback about the need for more clinically refined episode-
based measures in the cost performance category. They will also 
increase the cost coverage of care episode and patient conditions 
groups, moving closer towards the statutory goal of covering 50 percent 
of expenditures under Medicare Parts A and B, as specified under 
section 1848(r)(2)(i)(I) of the Act.
    All five of the new measures have been developed with extensive 
engagement from interested parties, including clinicians, persons with 
lived experience, and the public. For more information regarding 
episode-based measures and the measure development process, we refer 
readers to the overview in the CY 2024 PFS proposed rule (88 FR 52569 
through 52571). In sections IV.A.4.f.(2)(a) and IV.A.4.f.(2)(b) of this 
final rule, we provide detail about the new measures that we proposed 
to include in the cost performance category beginning with the CY 2024 
performance period/2026 MIPS payment year.
(ii) New Episode-Based Measures Beginning With the CY 2024 Performance 
Period/2026 MIPS Payment Year
    In this section of this final rule, we discuss the five new 
episode-based measures, which we proposed to add to the cost 
performance category beginning with the CY 2024 performance period/2026 
MIPS payment year. As we discuss in this section, after consideration 
of public comments, we are finalizing our proposal to add the five new 
episode-based measures to the cost performance category beginning with 
the CY 2024 performance period/2026 MIPS payment year.
    In conjunction with our measure development contractor, we 
developed these measures with consideration of the common standards 
that are described in the CY 2022 PFS final rule (86 FR 65455 through 
65459) to ensure consistency across episode-based measures being 
developed. Specifically, the CY 2022 PFS final rule requires that any 
episode-based measure for the cost performance category include the 
following: (1) episode definition based on trigger codes that determine 
the patient cohort; (2) attribution; (3) service assignment; (4) 
exclusions; and (5) risk adjustment. The five new episode-based 
measures we proposed meet all requirements described in CY 2022 PFS 
final rule, including these features. We provide more information on 
the specific requirements for each of the episode-based measures later 
in this section of the final rule.
    Generally, for all episode-based measures, we exclude episodes 
where costs cannot be fairly compared to the costs for the whole cohort 
in the episode-based measure. These exclusions, like other features of 
each episode-based measure, are developed with extensive clinician and 
interested parties' engagement. We have specified exclusions for all 
five proposed episode-based measures. We discuss certain exclusions for 
the Psychoses and Related Conditions and the Emergency Medicine measure 
in further detail in this section of this final rule.
    We also apply a risk adjustment model to all episode-based measures 
in the cost performance category. The model includes standard risk 
adjustors that are applied to all episode-based measures (for example, 
CMS Hierarchical Condition Category [HCC] variables, comorbidities, age 
brackets, disability status, ESRD status), and measure-specific risk 
adjustors (for example, patient transfers from another setting for the 
Emergency Medicine measure). We assess the risk adjustment model at the 
level of each stratification to ensure that only like patients are 
compared to each other. The risk adjustment model we use in development 
of the cost performance category's episode-based measures is described 
in detail in CY 2019 PFS final rule (83 FR 59767 through 59773). As 
mentioned previously in this section, all five proposed episode-based 
measures have been risk adjusted in accordance with this model.
    More information on the episode-based measure development 
requirements, which were outlined so that external interested parties 
could develop measures in the future, are available in the Blueprint 
for the CMS Measures Management System (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/MMS-Blueprint) 
and the Meaningful Measures Framework (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page).
    The episode-based measures that we proposed for the CY 2024 
performance period/2026 MIPS payment year and future performance 
periods are listed in the Table 51.

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[GRAPHIC] [TIFF OMITTED] TR16NO23.073

    The three chronic condition episode-based measures assess 
outpatient treatment and ongoing management of the following chronic 
conditions: depression, heart failure, and low back pain. The measure 
construction for these three proposed measures follows the approach 
described in the CY 2022 PFS final rule (86 FR 65445 through 65461), 
which also includes detailed discussion of the attribution methodology 
and examples of how episodes are attributed.
    The attribution methodology that identifies a clinician-patient 
care relationship is slightly different at the clinician group and 
individual MIPS eligible clinician levels, to reflect that care 
provided at the clinician group and individual MIPS eligible clinician 
levels, respectively. At a high level, these proposed chronic condition 
episode-based measures attribute episodes to the clinician group that 
renders services that constitute a trigger event, which is identified 
by the occurrence of two claims billed in close proximity by the same 
clinician group. Both claims must have a diagnosis code indicating the 
same chronic condition related to the specific episode-based measure. 
For example, for the Heart Failure measure, both claims of the trigger 
event must have a diagnosis indicating heart failure. The services that 
trigger an event for these chronic condition episode-based measures are 
identified first by Evaluation and Management (E/M) codes for 
outpatient services, and then by a second claim with either another E/M 
code for outpatient services or a condition-related Current Procedural 
Terminology (CPT)/Healthcare Common Procedure Coding System (HCPCS) 
code (CPT/HCPCS) related to the treatment or management of the chronic 
condition. The trigger event opens a year-long attribution window from 
the date of the initial E/M outpatient service, during which the same 
clinician group could reasonably be considered responsible for managing 
the patient's chronic condition. If we see evidence that the 
relationship is ongoing, represented by another E/M or condition-
related procedure code that we refer to as the reaffirming claim, then 
this window can be extended.
    For individual MIPS Eligible clinicians, we would attribute 
episodes to each individual MIPS eligible clinician within an 
attributed clinician group that renders at least 30 percent of trigger 
or reaffirming codes on Part B Physician/Supplier claim lines during 
the episode, such as office visits or diagnostic services. We also 
apply conditions to ensure the MIPS eligible clinicians to whom the 
episode is attributed are reasonably responsible for the management of 
the patient's chronic condition. Specifically, the MIPS eligible 
clinician must have provided condition-related care to this patient 
prior to or on the episode start date.
    Additionally, we use the provider-level prescription billing 
patterns to ensure that we are capturing the MIPS eligible clinicians 
directly involved in providing ongoing chronic care management, rather 
than clinicians who might have only refilled a patient's prescription 
once, as a courtesy to the patient. Specifically, for some measures 
(that is, Diabetes, Asthma/COPD episode-based measure that were 
finalized for use in the MIPS cost performance category for the CY 2022 
PFS final rule [86 FR 64996], and Heart Failure episode-based measure 
that is being finalized in this rule), the MIPS eligible clinician must 
also have prescribed at least two prescriptions claimed under Medicare 
Part D and/or Medicare Part B related to the management of the 
condition for two different patients during the measurement period, 
plus a one-year lookback period. These conditions, which we use to 
attribute a cost measure to MIPS eligible clinicians, also apply to the 
attribution methodology at the clinician group level. Specifically, the 
clinician group will always meet the first condition by construction 
(that is, there will always be an individual MIPS eligible clinician 
under the clinician group that has provided care to the patient prior 
to or on the episode start date). However, the clinician group must 
have at least one potentially attributable MIPS eligible clinician 
under it who meets the second condition.
    The Psychoses and Related Conditions measure is an acute inpatient 
medical condition episode-based measure, which focuses on patients 
hospitalized for schizophrenia, delusional disorders, brief psychotic 
disorder, schizoaffective disorder, manic episode with psychotic 
symptoms, bipolar disorder with psychotic symptoms, major depressive 
disorder with psychotic symptoms, or unspecific psychosis. This acute 
inpatient medical condition was developed in accordance with the 
previously established framework for episode-based measures, which we 
described in detail in the CY 2019 PFS final rule (83 FR 59769 through 
59771). We selected the Psychoses and Related Conditions measure for 
development because empirical analyses have identified psychoses-
related hospitalizations are one of the most common inpatient stays, so 
it has a strong potential to be impactful on Medicare spending. This 
measure would also contribute to filling the current identified gap in 
the cost performance category's measurement of mental health care, as 
currently there are no episode-based or other cost measures assessing 
this clinical area.
    The Psychoses and Related Conditions measure has been refined since 
the RFI in CY 2020 PFS proposed rule (84 FR 40760 through 40761) 
considering expert and other interested parties' input and to further 
address the Measures Application Partnership (MAP) Coordinating 
Committee's previously expressed concerns in the 2018-2019 measure 
development cycle about the ability of inpatient clinicians to affect 
post-discharge care. In response to this input and these concerns, we 
implemented three refinements to this measure. First, we reduced the 
length of the episode window from 90 to 45 days. This shortened episode 
window helps to ensure that MIPS eligible clinicians

[[Page 79341]]

can reasonably be held accountable for post-discharge care, while still 
capturing readmissions and ED visits shortly after the trigger event, 
which persons with lived experience had noted as being important 
outcomes to identify and measure because these outcomes could be 
avoided with better discharge planning and follow-up care. Second, we 
refined this measure's specifications to account for specific scenarios 
where MIPS eligible clinicians have limited ability to influence a 
patient's care. Specifically, this measure now excludes episodes with 
involuntary holds at admission and episodes that are transfers to State 
hospitals. Third, we refined this measure's specifications to risk 
adjust for facility type to account for differences in payment policies 
between Inpatient Prospective Payment System (IPPS) and Inpatient 
Psychiatric Facility (IPF) hospitals. While we continue to believe that 
the original measure had accounted for concerns about the ability of 
inpatient clinicians to influence costs after discharge as described in 
the CY 2020 PFS proposed rule (84 FR 40760 through 40761), we also 
believe that these changes further refine the measure to meaningfully 
assess costs related to the role of clinicians caring for patients 
during mental health hospitalizations.
    The Emergency Medicine measure assesses the cost of care clinically 
related to the treatment of a patient during an ED visit. The intent of 
this measure is to comprehensively assess all types of care in an ED, 
so the construction of the measure reflects the goal of capturing this 
broad scope of care. As such, this measure is characterized as a ``care 
setting'' episode type.
    A CPT/HCPCS code indicating that a clinician has furnished care in 
the ED setting triggers the Emergency Medicine measure. The clinician 
billing the trigger code is attributed the episode. A clinician group 
is attributed by aggregating all episodes attributed to clinicians that 
bill to the clinician group. The trigger code also opens a 14-day 
episode window, during which the attributed clinician is responsible 
for costs.
    The Emergency Medicine measure stratifies episodes based on the 
type of care the patient received during their ED visit and by 
disposition status. First, episodes are divided into 28 mutually 
exclusive groups called ED visit types that characterize the focus of 
care a patient received during their visit. These represent more 
granular, exhaustive patient populations defined by clinical criteria 
including the three-digit diagnosis codes available on a patient's ED 
visit claims, as well as a Medicare Severity Diagnosis Related Group 
(MS-DRG) of a subsequent inpatient stay if present. Given the goal of 
the Emergency Medicine measure to capture the broader universe of care 
provided in the emergency setting, dividing this measure's episodes 
into ED visit types is a technique to ensure clinical comparability. 
Examples of a few of the most frequent ED visit types associated with 
this Emergency Medicine measure are respiratory, gastrointestinal or 
liver, and kidney and urinary conditions. The 28 ED visit types are 
further stratified by whether (1) the ED visit resulted in subsequent 
observation care or inpatient admission or (2) the patient was 
discharged without subsequent observation care or inpatient admission. 
For example, ED visits for a stroke that end in discharge are only 
compared with other ED visits for a stroke that also end in discharge.
    The Emergency Medicine measure includes all Medicare Parts A and B 
services during the 14-day episode window, except for certain services 
determined not to be clinically relevant to the ED visit type. This 
reflects the intent of the measure and the broad clinician role in the 
ED setting. The ED visit type associated with the specific episode 
determines whether a service is clinically unrelated and therefore 
excluded from the episode. For example, if a patient visits the ED for 
ear, nose and throat (ENT) and eye disorders, any subsequent services 
for psychoses or behavioral and developmental disorders are excluded. 
However, if a patient visits the ED to receive care for an altered 
mental state, these subsequent services for psychoses or behavioral and 
developmental disorders are not excluded.
    The Emergency Medicine measure risk adjusts costs just like all 
other episode-based measures. This measure uses the standard risk 
adjustment model described previously in this section. Also, as 
discussed, we assessed the risk adjustment model at the level of each 
stratification. This means that for the Emergency Medicine measure, the 
risk adjustment is applied to each combination of ED visit type and 
disposition status. For example, the risk adjustment model would assess 
separately a kidney and urinary episode that resulted in an inpatient 
stay, a kidney and urinary episode that resulted in a discharge, a 
fracture episode that resulted in an inpatient stay, and a fracture 
episode that resulted in a discharge.
    Similar to other episode-based measures in use in the cost 
performance category and the episode-based measures being finalized in 
this rule, we exclude episodes in cases where costs cannot be fairly 
compared to the costs for the whole cohort in the Emergency Medicine 
measure. For example, episodes are excluded for patients transferred to 
another ED facility from the triggering ED facility.
    The specifications for all five proposed episode-based measures, 
which we are finalizing in this rule, are available at https://www.cms.gov/medicare/quality/value-based-programs/quality-payment-program/quality-payment-program-cost-measure-information. The 
specifications documents for each measure consist of a methods document 
that describes the steps for constructing the measure and a measure 
codes list file that contains the medical codes used in that 
methodology. First, the methods document provides detailed methodology 
describing each step to construct the measure, including: identifying 
patients receiving care, defining an episode-based measure, attributing 
episodes to MIPS eligible clinicians and clinician groups, assigning 
costs, defining exclusions, risk adjusting, and calculating measure 
score. Second, the measure codes list file contains the codes used in 
the measure specifications, including the episode triggers, 
attribution, stratification, assigned items and services, exclusions, 
and risk adjustors.
    More information about the five episode-based measures is available 
in the measure justification forms, which provide a comprehensive 
characterization of the measures, their justification, and testing 
results of these measures' specifications. These documents are 
available through the QPP Cost Measure Information page at https://www.cms.gov/medicare/quality/value-based-programs/quality-payment-program/quality-payment-program-cost-measure-information.
    We solicited public comment on our proposal to add these five 
episode-based measures, which are listed in Table 51. We received 
public comments on the proposal. The following is a summary of the 
comments we received and our responses.
    Comment: Some commenters supported the adoption of new episode-
based measures. Commenters stated that cost measures are critical to 
understanding the value of care, that they should be centered on 
specific conditions or periods of care, and that they should reflect 
the group practice model of care where multiple practitioners utilize a 
team-based approach to treating patients. One commenter supported the 
development

[[Page 79342]]

of more cost measures that measure chronic conditions in primary care 
settings.
    Response: We appreciate the commenters' support of the new episode-
based measures and we agree with their comments. We will continue to 
assess potential areas for development of cost measures related to 
chronic conditions in the future.
    Comment: Commenters supported the inclusion of Emergency Medicine 
and Low Back Pain measures, as they capture specialties that have not 
had an applicable cost measure yet. For example, one commenter stated 
that physical therapists have limited options to participate in either 
track of the Quality Payment Program due to few physical therapy-
inclusive measures and to have applicable measures available in MIPS is 
the first step to improving participation by physical therapists and 
providing financial incentives to them. One commenter expressed that 
Low Back Pain was also a first step in increasing occupational therapy 
engagement within MIPS. Another commenter stated that maintaining 
multiple cost measures applicable to emergency medicine physicians will 
result in a more robust and adequate assessment of emergency medicine 
services in future years.
    Response: We thank the commenters for their support. We agree that 
the Emergency Medicine and Low Back Pain measures present an 
opportunity to provide cost measures to MIPS eligible clinicians who 
have previously not had an applicable measure.
    Comment: A few commenters expressed support for the Depression and 
Psychoses and Related Conditions episode-based measures, as their 
inclusion indicates that CMS values the care provided for behavioral 
health.
    Response: We thank the commenters for their support. We agree that 
the inclusion of the Depression and Psychoses and Related Conditions 
episode-based measures aligns with CMS's prioritization of behavioral 
health and our Behavioral Health Strategy (https://www.cms.gov/cms-behavioral-health-strategy).
    Comment: A few commenters supported the measure development process 
and engagement with specialty organizations. One commenter appreciated 
CMS' efforts to engage specialty organizations when developing 
appropriate attribution for anesthesiologists in cost measures. This 
commenter stated that its specialty organization's members have 
participated in several cost measure development panels and hope to 
continue these collaborative efforts with CMS to work toward a cost 
measure that fairly and consistently provides attribution to 
anesthesiologists.
    Response: We will continue to work with specialty societies in 
future years to develop episode-based measures for clinicians who 
currently do not have an applicable measure in MIPS.
    Comment: Some commenters urged CMS to ensure that measures 
appropriately adjust for clinical and social risk factors to avoid 
inadvertently creating disincentives for providing care.
    Response: We strive to ensure that episode-based measures adjust 
for clinical risk factors. During measure development, clinician 
experts discuss and advise on specific risk factors. As discussed 
previously in this section, the risk adjustment model includes standard 
risk adjustors as well as risk adjustors for factors specific to the 
condition or procedure, as identified by clinician feedback and empiric 
analyses. The standard risk adjustors include the following: 
comorbidities captured by 86 Hierarchical Condition Category (HCC) 
codes, which map with thousands of ICD-10-CM diagnosis codes; the 
number of HCC codes, which reflects the number of conditions risk 
adjusted for a patient; interaction variables, which account for 
instances where comorbidities are impacted by another variable (for 
example, the interaction between HCC 47 for immunity disorders and 
cancer); patient age category; patient disability status; patient end-
stage renal disease status; the number of clinician specialties and 
types of clinician specialties from which the patient has received 
care; and recent use of institutional long-term care.
    During measure development, we also consider adjusting for social 
risk factors. Many measures risk adjust for dual eligibility for 
Medicare and Medicaid as a proxy for social risk factors when testing 
suggests that it is appropriate. This includes three of the five 
proposed episode-based measures we are finalizing: Depression, 
Emergency Medicine, and Heart Failure. Additionally, the episode-based 
measure construction helps to safeguard against clinicians withholding 
necessary healthcare services because stinting on necessary care will 
lead to worse outcomes and higher cost scores by including the costs of 
complications and acute exacerbations.
    Comment: Some commenters suggested that CMS provide timely and 
actionable feedback on the five proposed measures. Some commenters 
recommended that CMS does not incorporate additional episode-based 
measures, suggesting that CMS wait to incorporate the measures into the 
MIPS cost performance category scoring while clinicians become familiar 
with the proposed episode-based measures or while clinicians become 
familiar with understanding their performance on episode-based measures 
already implemented for previous performance periods.
    Response: We are continuing to work towards providing meaningful 
and timely information on cost measures generally and we recognize the 
importance of providing this information for measures implemented in 
MIPS. We believe that clinicians have many opportunities to become 
familiar with the episode-based measures and their specifications in 
advance of any potential implementation. Opportunities include joining 
measure development meetings as listen-only participants and reviewing 
publicly posted meeting summaries, participating in national field 
testing, reviewing the publicly available information and discussions 
on the measures during pre-rulemaking (for example, MAP discussions), 
as well as reviewing the information outlined in the proposed rule. 
Generally, the cost performance category constitutes 30 percent of MIPS 
eligible clinicians' final score as required by section 
1848(q)(5)(E)(i)(II)(aa) of the Act and finalized under Sec. Sec.  
414.1380(c)(1)(ii) and 414.1350(d)(5). Unless an exception applies to 
an individual MIPS eligible clinician, group, virtual group, or 
subgroup under Sec.  414.1380(b)(2) or Sec.  414.1380(c)(2), we 
calculate and report all the cost measures for which we have determined 
a benchmark for MIPS eligible clinicians, groups, virtual groups, and 
subgroups who are attributed and met the case minimum for those 
measures implemented for use in the MIPS cost performance category.
    Comment: Some commenters expressed concerns about the methodology 
for assessing MIPS eligible clinicians' performance on episode-based 
measures. One commenter stated that the measure developer's multi-step 
approach to attributing measure performance, and the use of algorithms 
for identifying costs relevant to an episode, add unnecessary 
complexity. Another commenter recommended that the attribution 
methodology for cost measures be changed so that the same costs are not 
attributed to multiple physicians. One commenter requested that CMS 
consider measures for chronic conditions that do not have an inpatient 
trigger so that costs for chronic conditions can be included even if an 
inpatient stay does not occur. One commenter expressed concerns that 
the

[[Page 79343]]

measures could unfairly affect urologists.
    Response: We disagree with the commenters' feedback about our 
methodology for assessing MIPS eligible clinicians' performance on 
episode-based measures. The attribution methodology for the episode-
based measures was developed with extensive stakeholder feedback, as 
required by section 1848(r) of the Act. The measure developer gathered 
clinician and person and family feedback through a Technical Expert 
Panel (TEP), Clinical Subcommittees, Clinician Expert Workgroups, and 
public comment periods. Our attribution methodology identifies a 
clinician-patient care relationship and is unique to the type of care 
that is being assessed by the measure. The measure developer thoroughly 
tested this approach, and the analyses suggest that it works to 
accurately capture clinicians who have influence over the care of 
patients with a specific condition or procedure. Additionally, 
considering input from Clinician Expert Workgroups, we determine the 
triggering methodology for chronic condition episode-based measures 
based on what is appropriate for the type of condition. We will 
consider whether the current attribution methodology continues to be an 
appropriate approach for future measures. Finally, we clarify that a 
chronic condition measure does not rely on an inpatient trigger to 
initiate a clinician-patient relationship. A clinician must bill two 
services specific to the care of the condition. One must be a clinician 
visit (for example, diagnostic visit, office or other outpatient visit, 
or annual wellness visit), and the other can be either another visit or 
a service for the treatment of the condition (for example, lung imaging 
test for Asthma/COPD). Specifically, the trigger claim is for a 
``primary care'' E/M visit with a relevant chronic condition diagnosis, 
and the confirming claim is for either another ``primary care'' E/M 
visit with a relevant chronic condition diagnosis or a condition-
related CPT/HCPCS code with a relevant chronic condition diagnosis.
    Additionally, we do not see evidence that urologists are negatively 
impacted by the current set of episode-based measures we are finalizing 
for use.
    Comment: A few commenters expressed concerns with the development 
and implementation process for cost measures used in the cost 
performance category. One commenter recommended that CMS not prioritize 
developing cost measures that cover a large number of clinicians or 
portion of Medicare Parts A/B spending based on a statutory goal. 
Commenters recommended that CMS should focus on developing cost 
measures that align with quality measures (for example, outcome 
measures) and that CMS address areas of improvement for the clinical 
population participating in MIPS. Another commenter recommended that 
cost measures go beyond assessing whether there is waste in the system, 
and that CMS develop cost measures that seek to promote clinically 
appropriate utilization of health care services, including for those 
clinicians who serve a significant portion of the frail and elderly 
population. One commenter urged CMS to pursue consensus-based entity 
(CBE) endorsement of all cost measures.
    Response: When selecting measures for development, we base our 
decision on a variety of considerations. While one consideration is the 
potential scope of Medicare Parts A/B spending that is captured by the 
measures, as statutorily mandated by section 1848(r)(2)(D)(i) of the 
Act, we also consider potential for improvement and performance gaps to 
ensure that the measure will be a meaningful assessment of clinician 
performance. We also consider potential scope of Medicare beneficiaries 
that are captured by the measures. The goal of episode-based measures 
is not to categorically reduce resource use, but to encourage efficient 
and meaningful resource use. Considering areas where there is potential 
for improvement in clinicians' efficient use of resources (for example, 
overuse of diagnostic testing) can help to encourage appropriate use of 
health care services. During measure development, Clinician Expert 
Workgroups consider ways to align cost and quality goals, such as 
aligning with existing quality measures (for example, selecting an 
aligned episode window length or aligning overall measure scope). 
Additionally, the cost measures are risk adjusted for patient age and 
certain measures include risk adjustment variables that indicate 
patients' frailty to ensure that the measures do not disincentivize 
care for these populations. Finally, we plan to pursue CBE endorsement 
for the five new cost measures that we are finalizing in this rule in 
the future.
    Comment: Commenters raised concerns about the Heart Failure 
measure, stating that the complexity and heterogeneity of the patient 
population could lead to unintended consequences that impact care. 
Commenters made several recommendations to address this heterogeneity, 
such as adjusting certain trigger codes (for example, telehealth codes) 
and limiting the heart failure diagnosis to a more specific subset of 
ICD-10 codes to avoid capturing patients with other conditions. One 
commenter mentioned exclusion of patients with underlying health issues 
and that assessing heart failure with preserved ejection fraction 
(HFpEF) patient outcomes can be difficult because of a lack of 
information available on claims. A commenter also recommended the use 
of modeling as a proxy to distinguish between different ejection 
fraction (EF) classes for heart failure patients. Commenters expressed 
concerns about attribution of a heart failure episode to a single 
clinician as opposed to a clinician group, due to the breadth of care 
settings and the inclusion of multiple TINs within the same setting or 
care team. A commenter also expressed concerns that any clinicians that 
are part of a patient's care team (that is, cardiologists, primary care 
clinicians, clinician assistants, advanced practice nurses, and other 
specialties) could be attributed the full costs of the measure equally. 
Commenters added that based on field test reports, they anticipate that 
highly specialized subspecialties, specifically electrophysiologists, 
are attributed. They stated that while these specialists manage certain 
aspects of the patient's care, they are often not the primary clinician 
responsible for overall management. They encouraged CMS and Acumen to 
consider unintended consequences of specialists and subspecialists 
being identified as high-cost providers.
    Additionally, commenters emphasized the importance of alignment of 
cost measures with appropriate quality measures. The commenters 
cautioned against any unintended consequences of the measure, most 
notably if the measure could potentially inhibit guideline-directed 
care or encourage clinicians to switch to less effective care to lower 
costs.
    Response: While the Heart Failure measure assigns services 
identified as related to cardiac conditions, the initial trigger for an 
episode has to indicate explicitly that the patient has Heart Failure. 
The Clinician Expert Workgroup for the Heart Failure measure supported 
the inclusion of several ICD-10 diagnosis codes, rather than limiting 
to just ICD-10 CM codes for Heart Failure under the I50 classification. 
The measure developer and the Clinician Expert Workgroup also carefully 
evaluated the CPT/HCPCS trigger codes. The Heart Failure trigger 
methodology intends to identify care relationships but does not limit 
those care relationships to a new diagnosis of

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heart failure. Additionally, codes indicating services delivered via 
telehealth, such as telephone assessment and management, are used 
across all chronic condition episode-based measures, like this Heart 
Failure measure, as triggering, confirming, and reaffirming codes. The 
goal of the triggering and attribution methodology for the Heart 
Failure measure was to be inclusive of all clinically relevant settings 
where care for heart failure may be provided.
    In developing the Heart Failure measure, we addressed the 
heterogeneity and complexity of the heart failure patient population. 
The Clinician Expert Workgroup discussed whether to risk-adjust or sub-
group patients with diastolic heart failure. However, empirical data 
demonstrated that it would be challenging to categorize patients into 
these sub-populations, and that there would be no difference in risk-
adjusted episode cost for these sub-populations. The measure developer 
did exclude high-output heart failure and other conditions with rarer, 
more complex prognoses. The Heart Failure measure is also risk-adjusted 
for End-Stage Renal Disease (ESRD), patient eligibility for both 
Medicare and Medicaid, right heart failure (RHF) clinical syndrome, 
cardiomyopathy, coronary artery disease (CAD), idiopathic heart 
failure, rheumatic and other valve disease, all-cause recent inpatient 
admission, substance abuse/cardiomyopathy, and obstructive sleep apnea. 
Testing showed that the Heart Failure measure is valid and reliable and 
the differences, if any, among the other types of heart failure 
mentioned are unlikely to be impact the measure score.
    We had several reasons to not use modeling as a proxy to 
distinguish between different EF classes. The measure developer did 
consider qualified registries and/or electronic health record (EHR) 
data. However, there are concerns with using qualified registries and 
EHR data in administrative claims-based measures, including sufficient 
availability of data across the applicable patient and clinician 
cohorts captured by the measure. Given the lack of detailed information 
on EF in claims data, and an extensive conversation on shared treatment 
options and poor prognosis for both systolic and diastolic heart 
failure, the Clinician Expert Workgroup ultimately recommended pursuing 
a heart failure definition that was less reliant on EF information.
    In regards to the commenter's concern about measure attribution of 
primary care clinicians or care team members in addition to cardiology 
specialists, the purpose of the Heart Failure measure is to assess the 
ongoing care provided to patients with heart failure and these 
clinicians contribute to that care. We believe that it is appropriate 
to attribute primary care clinicians or specialists if they provide 
relevant chronic condition care management to encourage care 
coordination. Persons and family with lived experiences provided input 
that a range of clinician types comprised their care team. In 
particular, they reported that cardiologists, primary care clinicians, 
device nurses, cardiac rehabilitation specialists, nutritionists, 
mental health clinicians, at-home physical therapists, pulmonologists, 
and electrophysiologists were part of their care team. Given the wide 
range of clinicians providing care to these patients, they also noted 
the importance of medication reconciliation for coordination across 
their care team. As a result, a clinician can be attributed if we see 
evidence of a relationship between a patient and clinician where they 
are providing care related to the management or treatment of heart 
failure. . Additionally, cost measures are not intended to assign 
partial costs to certain types of clinician. If a clinician is 
attributed the cost measure, then they are assigned the costs of any 
services that they provide as outlined in the Heart Failure codes list 
available at https://www.cms.gov/medicare/quality/value-based-programs/quality-payment-program/quality-payment-program-cost-measure-information. The Clinician Expert Workgroup has identified these 
services as services that the attributed clinician could have influence 
on their provision, frequency, or intensity. They are intentionally 
included in the measure to gather a full picture of the care that a 
clinician provides a patient with the Heart Failure condition.
    However, the Heart Failure measure is risk-adjusted for the 
specialty group providing care to account for higher costs of care 
provided by certain clinician types like electrophysiologists. This was 
designed to mitigate the cost differences in expected cost based on 
attributed specialty. We aim not to penalize clinicians who provide 
high quality care that is higher cost.
    We aim to prioritize the alignment of cost measures with quality 
measures in MIPS. We consider cost and quality alignment throughout the 
measure development process and we include cost measures in MIPS in 
conjunction with quality measures to assess value of care.
    In developing cost measures, we strive to ensure that the measure 
does not inhibit guideline-directed care. Testing has not indicated 
that there are any concerns about unintended consequences, particularly 
those raised by the commenter, and we will continue to monitor the 
measure for any instances.
    Comment: A few commenters expressed concerns about the Low Back 
Pain episode-based measure. They recommended removing neurosurgeons and 
orthopedic surgeons from the list of eligible specialties for 
attribution to the measure to evaluate non-operative, chronic care. One 
commenter recommended that CMS develop a different episode-based 
measure for low back pain for care provided by orthopedic surgeons 
specifically. The commenters also urged CMS to incorporate clinical 
quality data from qualified registries into the measure.
    Response: We disagree with commenters' recommendation to remove 
neurosurgeons and orthopedic surgeons from potential attribution for 
the Low Back Pain measure. The intent of the Low Back Pain measure is 
to assess the treatment and management of Low Back Pain and the 
triggering logic was designed to capture the range of clinicians that 
have a role in treating and managing this condition. The Clinician 
Expert Workgroup thoroughly considered the role of the surgeon in the 
Low Back Pain measure after reviewing the public's feedback on this 
topic gathered during field testing. The Workgroup discussed this 
feedback in conjunction with testing from the measure developer to 
explore the relationship between low back pain care management and 
spinal surgery. They ultimately recommended that the role of the 
surgeon was appropriate to include in the measure, and also recommended 
that the measure take additional steps to minimize the risk of 
identifying relationships that are only pre-operative or consultative. 
The measure developer and CMS agreed that it is clinically appropriate 
to include surgeons in the measure. To help address these concerns, if 
a spinal surgery occurs 90 days before a trigger code through 60 days 
after a trigger code, the relationship between the clinician group and 
patient will not be initiated. More information regarding these 
discussions are available in the Low Back Pain Post Field Test Meeting 
Summary available on the QPP Cost Measures Information page at https://www.cms.gov/files/zip/summary-wave-4-post-field-test-refinement-webinar-pftr-workgroup-meetings.zip.
    Additionally, the Low Back Pain measure further safeguards against 
these concerns by stratifying episodes into subgroups to ensure that 
the measure

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fairly compares clinicians with a similar patient case-mix. For the Low 
Back Pain measure, we include subgroup surgical episodes with and 
without history of low back pain and non-surgical episodes with and 
without history of low back pain. The measure is also risk-adjusted for 
history of spine surgery. The intention of these measure specifications 
is to make sure that clinically similar patients and episodes of care 
are being compared to each other.
    Finally, we do not include data from qualified clinical data 
registries in this measure, but we will continue to monitor whether the 
measure includes the appropriate data elements for inclusion in the 
future.
    Comment: Some commenters expressed concerns about the Depression 
episode-based measure. Commenters stated concerns that a low percentage 
of clinical psychologists would be attributed to the cost measure, 
continuing to leave them out of the scope of MIPS cost measures and 
potentially indicating that the current measure methodology does not 
align with how clinical psychologists work within healthcare. 
Commenters also raised concerns that interruptions to treatment due to 
physical hospitalizations or circumstances related to social 
determinants of health are not taken into consideration and would 
result in attributing costs related to circumstances outside the 
control of a provider to their care. Finally, they expressed concern 
that the Depression measure does not account for the large variation in 
costs for different forms of treatment for depression (for example, 
electroconvulsive therapy (ECT) and Transcranial Magnetic Stimulation 
(TMS), medications, psychotherapy), and the potentially unintended 
consequences of attributing very high-cost interventions like ECT to 
psychologists who are predominantly delivering significantly less 
costly treatments such as psychotherapy. The commenters stated that 
these concerns could be applicable to the Psychoses and Related 
Conditions measure as well.
    Another commenter requested clarification about whether perinatal 
and postpartum depression is included in the Depression episode-based 
measure and if the measure would be attributed to obstetricians or 
gynecologists as a result.
    Response: We disagree with the concerns the commenters have raised. 
While it may be the case that few clinical psychologists may meet the 
case minimum as an individual clinician participant, most clinicians 
participate in MIPS via clinician groups. Therefore, the participation 
rate of clinical psychologists is likely higher because they 
participate by contributing to the total number of episodes of their 
clinician groups. This is supported by empiric analysis conducted by 
the measure developer on the specialties attributed the Depression 
measure.
    The attribution methodology for the Depression measure was 
developed with input from a TEP, a Clinician Expert Workgroup, and 
patients, families, and caregivers. Individuals with lived experience 
with receiving care for depression identified the most frequently 
attributed specialties as having been part of their respective care 
teams. Additionally, the measure includes a risk adjustor for dual 
status eligibility for Medicare and Medicaid. The process for 
determining whether it is appropriate to adjust for dual status 
involves rigorous statistical testing for each measure, and testing 
indicated that it is appropriate for the Depression measure. We risk 
adjust for dual status because it is both available and reliable in 
claims data at the individual beneficiary level. We will continue to 
monitor the potential for using Z codes for social determinants of 
health variables in the future. The measure includes other risk 
adjustors to account for the different types of care that a patient 
received. These include risk adjustors for two or more hospitalizations 
related to depression in the prior year, TMS within the last year, ECT 
within the last year, and prior observation stays that may indicate 
treatment-resistant depression (TRD).
    We also clarify that it is possible that an obstetrician or 
gynecologist is attributed the Depression episode-based measure if they 
render the relevant trigger and confirming claims for an episode and 
meet the attribution methodology checks. The trigger methodology 
includes codes for premenstrual depression and adjustment disorder with 
depression, but it does not include codes for post-partum depression. 
Additionally, it is unlikely that obstetricians or gynecologists would 
be frequently attributed this measure due to the typical age of the 
Medicare population that is assessed by this measure. For more 
information about these codes, please see the measure specifications 
available on the QPP Cost Measures Information page at https://www.cms.gov/medicare/quality/value-based-programs/quality-payment-program/quality-payment-program-cost-measure-information.
    Comment: Some commenters expressed concerns about the Psychoses and 
Related Conditions measure, and certain commenters did not support the 
implementation of the Psychoses and Related Conditions measure. One 
commenter stated that the use of this measure in MIPS could have a 
negative impact on the provision of mental health services to the most 
vulnerable patients, and may create a disincentive for psychiatrists to 
participate in Medicare. A couple commenters stated that it is 
inappropriate to hold inpatient psychiatrists responsible for 
outpatient care for persons with psychotic disorders because patients 
do not have adequate support when leaving the hospital and the 
inpatient psychiatrist rarely serves as the provider for follow-up 
outpatient care. One commenter expressed concerns about the geographic 
variation in the availability of care. Finally, one commenter stated 
that measure selection should not be based on potential savings to 
Medicare without an understanding of whether savings can be derived by 
reducing avoidable services while maintaining or improving the quality 
of care.
    Response: We disagree that the Psychoses and Related Conditions 
measure will have a negative impact on the provision of mental health 
services. Many psychiatrists participating in MIPS are already being 
assessed on inpatient care through the Medicare Spending Per 
Beneficiary (MSPB) Clinician measure, and the Psychoses and Related 
Conditions measure would allow MIPS eligible clinicians to have their 
costs of care evaluated on a more specific scope of care. The measure's 
construction also guards against clinicians withholding necessary 
healthcare services by including the costs of adverse events, so 
attempts to lower costs by stinting on care increases the risk of 
costly events like Emergency Department visits, hospitalizations, or 
other complications. Testing conducted on this measure does support the 
commenter's concerns about unintended consequences in providing care. 
The predicative ratios suggest that the measure calculates risk 
appropriately across different levels of patient complexity. Testing 
also shows that geographic location and a patient's dual eligibility 
status for Medicare and Medicaid has little impact, supporting that the 
measure would not exacerbate access to care challenges. However, we 
will continue to monitor the measure closely for any unintended 
consequences.
    Additionally, we believe that it is appropriate to include 
outpatient care in the Psychoses and Related Conditions measure. The 
measure aligns with the post-discharge care included in other episode-
based measures focused on

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inpatient care, MIPS claim-based readmission measures, and facility-
level quality metrics like those used in the Hospital Inpatient Quality 
Reporting Program and Inpatient Psychiatric Facility (IPF) Quality 
Reporting Program. We have also taken steps to ensure that the MIPS 
eligible clinician has influence over the services they are attributed, 
as we considered this feedback extensively when revising the measure, 
as previously discussed in this section and in the proposed rule. We 
exclude from calculation of this measure specific scenarios where 
clinicians have less ability to influence care, such as involuntary 
holds and State hospital transfers, we use a 45-day episode window 
(shortened from 90 days), and the measure risk adjusts for facility 
type to account for differences in payment policies between hospitals 
paid under Inpatient Prospective Payment System (IPPS) and IPFs. 
Additionally, fragmented care, such as a lack of support for patient 
discharged from an inpatient setting, points to the need for this 
measure as it encourages care coordination. Person and family input 
consistently highlighted the need for better care coordination, 
discharge planning, and collaboration across clinicians on diagnosing 
and treating patients. Some also noted that better care coordination 
and discharge planning could avoid readmissions. As a result, we 
believe that the person and family engagement (PFE) perspective 
suggests including these services could be impactful in reducing more 
costly adverse outcomes.
    While an important consideration in developing the Psychoses and 
Related Conditions measure was that psychoses is one of the most common 
inpatient stays, we also considered opportunities to improve care (for 
example, discharge planning, medication management, care coordination) 
identified through literature and feedback from interested parties. We 
believe that improving care and reducing resource use (for example, 
readmissions) will ultimately help improve capacity of the healthcare 
system, and improve access overall. MIPS includes cost measures 
alongside quality measures so that MIPS eligible clinicians can be 
assessed on the value of their care. The goal of assessing value is 
furthered through MVPs, which connect measures and activities across 
MIPS. The inclusion of this measure helps to support the transition to 
MVPs and reflects feedback from clinicians that they prefer the use 
episode-based measures.
    After consideration of public comments, we are finalizing our 
proposal as proposed to add the five new episode-based measures to the 
cost performance category beginning with the CY 2024 performance 
period/2026 MIPS payment year.
(b) Reliability and Case Minimum
    In this section of the final rule, we discuss the case minima to 
use for the five proposed episode-based measures and provide 
clarification on the interpretation of our regulation at Sec.  
414.1350(c) regarding the case minima for episode-based measures. As we 
discuss in this section of the final rule, after consideration of 
public comments, we are finalizing our proposals to adopt a case 
minimum of 20 episodes for each of the five proposed new episode-based 
measures, as well as codify the 20-episode case minimum for care 
setting episode-based measures under Sec.  414.1350(c)(7) and revisions 
to Sec.  414.1350(c)(4) through (6), as proposed.
    Reliability is a metric that evaluates the extent that variation in 
a measure comes from clinician performance (``signal'') rather than 
random variation (``noise''). Higher reliability suggests that a 
measure is effectively capturing meaningful differences between 
clinicians' performance. However, we continued to caution against using 
reliability as the sole metric to evaluate a measure because of the 
tradeoffs between accuracy and reliability, and the role of service 
assignment in reducing noise. These and other considerations are 
detailed in the CY 2022 PFS final rule (86 FR 65453 through 65455). We 
also noted that increasing case minima necessarily reduces the number 
of clinicians who meet the case minimum for a given measure. Because 
these are clinically refined measures, we aim to have as many MIPS 
eligible clinicians as possible to be able to have their costs 
evaluated by them. Therefore, we considered that a mean reliability of 
0.4 represents moderate reliability because it accounts for these 
considerations and is a sufficient threshold to ensure that the measure 
is performing as intended when assessed in conjunction with other 
testing.
    We previously established at Sec.  414.1350(c)(5) a case minimum of 
20 episodes for acute inpatient medical condition episode-based 
measures in the CY 2019 PFS final rule (83 FR 59773 through 59774). We 
also established at Sec.  414.1350(c)(6) a case minimum of 20 episodes 
for chronic condition episode-based measures in the CY 2022 final rule 
(86 FR 65453 through 65455). We have not adopted any care setting 
episode-based measures in the cost performance category, and therefore 
we have not established any case minima for this type of episode-based 
measures. In the CY 2024 PFS proposed rule (88 FR 52573 through 52574), 
we considered a case minimum of 20 for each of the five proposed 
episode-based measures and then examined the reliability of the 
measures against this case minimum.
    We examined the reliability of the five proposed episode-based 
measures, and Table 52 presents the percentage of tax identification 
numbers (TINs) and TIN/National Provider Identifiers (NPIs) that meet 
the 0.4 reliability threshold and the mean reliability for TINs and 
TIN/NPIs at our case minimum of 20 for each of the episode-based 
measures. At a 20-episode case minimum, the mean reliability for the 
Depression, Heart Failure, Low Back Pain, and Psychoses and Related 
Conditions measures exceeds 0.4 for both groups and individual 
clinicians, and the majority of groups and individual clinicians meet 
the 0.4 reliability threshold. Similarly, at a 20-episode case minimum, 
the mean reliability for the Emergency Medicine measure exceeds 0.4 for 
both groups and individual clinicians, and all groups and individual 
clinicians meet the 0.4 reliability threshold.

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[GRAPHIC] [TIFF OMITTED] TR16NO23.074

    We believe that calculating these five proposed episode-based 
measures with these case minimums will accurately and reliably assess 
the performance of clinicians and clinician group practices. Therefore, 
we proposed to adopt a case minimum of 20 episodes for each of the five 
proposed new episode-based measures. Given that we have not previously 
established any case minimums for the care setting episode-based 
measures, we also proposed to codify the 20-episode case minimum for 
care setting episode-based measures under Sec.  414.1350(c)(7).
    Additionally, as we reviewed our existing regulatory language under 
Sec.  414.1350(c), we recognized the need to clarify the intended 
interpretation of the language because we acknowledged that the current 
framing is open to reasonable interpretation. Specifically, we clarify 
that the regulatory language at Sec.  414.1350(c)(4) through (6) 
establishes the case minima for episode-based measures of each episode 
type (that is, procedural, acute inpatient medical condition, and 
chronic condition, respectively) such that the case minimum specified 
therein applies to all episode-based measures of that episode type, 
regardless of when the measure is adopted for inclusion in the cost 
performance category, unless otherwise specified for individual 
measure(s). For example, under Sec.  414.1350(c)(6), the chronic 
condition episode-based measures that were specified beginning with the 
CY 2022 performance period/2024 MIPS payment year when this regulatory 
provision was codified (that is, the Diabetes and the Asthma/COPD 
measure) and any chronic condition episode-based measure specified 
after the CY 2022 performance period/2024 MIPS payment year will have a 
case minimum of 20 episodes, unless we specify otherwise for an 
individual measure.
    In the CY 2024 PFS proposed rule (88 FR 52573 through 52574), we 
proposed to update the regulatory language under Sec.  414.1350(c)(4) 
through (6) to more clearly reflect this clarified interpretation. In 
addition, we proposed that this interpretation will also apply to Sec.  
414.1350(c)(7) for care setting episode-based measures, as discussed in 
this section of this final rule.
    We believe that it is appropriate to use the case minimum based on 
the measure type for current and future measures in MIPS, as each 
measure episode type uses a consistent framework across measures so the 
case minimum should be also consistent, where possible. Additionally, 
consistent case minimum simplifies the level of information a MIPS 
eligible clinician or clinician group must monitor for the episode-
based measures as the number of measures used in the cost performance 
category continues to grow. We noted that for any future measure under 
consideration to be implemented in the cost performance category, case 
minima would still be evaluated against reliability testing, and could 
be different from the standard case minimum established for the 
respective measure type under Sec.  414.1350(c), as needed.
    We invited comment on our proposals in section IV.A.4.f.(2)(b) of 
the proposed rule, including our proposal to adopt the case minima for 
the five episode-based measures proposed for the cost performance 
category and our interpretation of the existing regulatory language on 
the case minima for episode-based measures.
    We received public comments on the proposal. The following is a 
summary of the comments we received and our responses.
    Comment: Some commenters expressed their belief that episode-based 
measures in use in MIPS should have a high reliability and that CMS 
should increase all case minima to ensure a measure can meet or exceed 
this threshold at both the individual NPI and TIN level. One commenter 
stated that minimum reliability should be at least 0.7 and another 
stated it should be at least 0.8. A commenter also requested that CMS 
release more detailed reliability results, noting concerns that less 
than 100 percent of groups and individuals meet CMS's reliability 
threshold of 0.4 for certain measures.
    Response: We refer stakeholders to the CY 2022 PFS final rule (86 
FR 65453 through 65455), where we discussed the 0.4 reliability 
threshold in detail. As noted in section IV.A.4.f.(2)(b), we will 
continue to monitor the scientific evidence on reliability to consider 
whether the 0.4 threshold should be increased. In finding a balance 
between reliability and cost measures that have the potential to be 
impactful, we also consider stakeholder feedback about the need for 
clinicians to be assessed under episode-based measures. Since these 
measures are designed to be specific to a particular type of care, many 
clinicians would be attributed fewer of these episodes than of episodes 
for global or population-based cost measures. We do not have concerns 
about the reliability of these five proposed episode-based measures 
because their mean reliability is between 0.6 and 0.9, which well above 
the 0.4 threshold and falls within moderate to high reliability. Using 
a moderate reliability threshold ensures the reliability of the 
measures while also guarding against the unintended consequences of 
excluding clinicians from episode-based measures. More information 
about the measures' reliability testing, such as the percentage above a 
0.7 reliability at the TIN and TIN-NPI reporting level, is included in 
the Measure Justification Forms that are available on the QPP Cost 
Measures Information page at

[[Page 79348]]

https://www.cms.gov/files/zip/macra-wave-4-measure-justification-forms.zip.
    After consideration of public comments, we are finalizing our 
proposal to adopt a case minimum of 20 episodes for each of the five 
proposed new episode-based measures, codify the 20-episode case minimum 
for care setting episode-based measures under Sec.  414.1350(c)(7), and 
amend Sec.  414.1350(c)(4) through (6) to clarify our policy, as 
proposed.
    (c) Removal of Simple Pneumonia With Hospitalization Measure From 
the MIPS Cost Performance Category Beginning With the CY 2024 
Performance Period/2026 MIPS Payment Year
    In this section of the final rule, we proposed to remove the Simple 
Pneumonia with Hospitalization episode-based measure from the cost 
performance category beginning with the CY 2024 performance period/2026 
MIPS payment year. As we discuss in this section, after consideration 
of public comments, we are finalizing our proposal to remove the Simple 
Pneumonia with Hospitalization episode-based measure from the cost 
performance category as proposed.
    The Simple Pneumonia with Hospitalization episode-based measure was 
implemented for use in the MIPS cost performance category starting with 
CY 2019 performance period/2021 MIPS payment year (83 FR 59767 through 
59773). Due to the impact of the COVID-19 pandemic, in accordance with 
Sec.  414.1380(c)(2)(i)(A)(2), we assigned a weight of zero percent to 
the cost performance category for the CY 2020 performance period/2022 
MIPS payment year and CY 2021 performance period/2023 MIPS payment 
year, and redistributed the prescribed weight to another performance 
category or categories, as established at Sec.  414.1380(c)(2)(ii)(D) 
and (E), respectively. For the CY 2022 performance period/2024 MIPS 
payment year, the measure was excluded from scoring in accordance with 
Sec.  414.1380(b)(2)(v)(A) due to International Classification of 
Diseases, Tenth Revision (ICD-10) coding updates related to COVID-19 
that impacted the underlying population originally intended to be 
captured by this measure. More information is available in the CY 2024 
PFS proposed rule (88 FR 52574 through 52575).
    Empirical testing demonstrated that these coding changes have 
resulted in a marked decrease in the number of Simple Pneumonia with 
Hospitalization episodes. The measure does not use MS-DRGs 177-179 in 
its trigger logic and, therefore, the measure is unable to capture many 
pneumonia episodes, per the original measure intent. This significant 
decrease in the number of pneumonia episodes captured by this measure 
has resulted in many MIPS eligible clinicians no longer meeting the 20-
episode case minimum for attribution of the measure.
    Given that these underlying coding issues affect the measure's 
ability to capture the intended population and that their uneven impact 
on MIPS eligible clinicians is expected to continue, we proposed to 
remove the Simple Pneumonia with Hospitalization measure from the cost 
performance category beginning with CY 2024 performance period/2026 
MIPS payment year. We do not believe that it is appropriate to continue 
to use the measure as currently specified without any changes to 
address the coding changes that formed our basis to suppress this 
measure in the CY 2022 performance period/2024 MIPS payment year. More 
information is available in the CY 2024 PFS proposed rule (88 FR 52574 
through 52575).
    We invited comments on this proposal.
    Comment: Some commenters expressed support for the removal of the 
Simple Pneumonia with Hospitalization episode-based measure.
    Response: We appreciate the commenters' support of the removal of 
the Simple Pneumonia with Hospitalization episode-based measure and we 
agree with their comments.
    After considering the public comments, we are finalizing our 
proposal to remove the Simple Pneumonia with Hospitalization episode-
based measure from the cost performance category beginning with the CY 
2024 performance period/2026 MIPS payment year, as proposed.
(d) Revisions to the Operational List of Care Episode and Patient 
Condition Groups and Codes
    We proposed revisions to the operational list of care episode and 
patient condition groups and codes to reflect our proposals to add new 
episode-based measures and remove the Simple Pneumonia with 
Hospitalization measure beginning with the CY 2024 performance period/
2026 MIPS payment year. As we discuss in this section, after 
consideration of public comments, we are finalizing our proposal as 
proposed.
    In accordance with section 1848(r)(2)(H) of the Act, we proposed to 
revise the operational list beginning with the CY 2024 performance 
period/2026 MIPS payment year to include five new care episode and 
patient condition groups, based on input from clinician specialty 
societies and other interested parties, as outlined in section 
IV.A.4.f.(2)(a)(ii) of the proposed rule. We proposed including 
Emergency Medicine and Psychoses and Related Conditions as care episode 
groups and Heart Failure, Low Back Pain, and Depression as patient 
condition groups. These care episode and patient condition groups serve 
as the basis for the five new episode-based measures that we proposed 
in section IV.A.4.f.(2)(a)(iii) of the proposed rule for the cost 
performance category. The codes that define these five-care episode and 
patient condition groups align with the trigger codes of the proposed 
episode-based measures in section IV.A.4.f.(2)(a)(iii) of the proposed 
rule. As described in section IV.A.4.f.(2)(a)(ii), these specifications 
are developed with extensive input from interested parties. As 
discussed in section IV.A.4.f.(2)(a) of the final rule, we will add 
these five episode-based measures to the cost performance category.
    Additionally, we proposed to revise the operational list to remove 
the Simple Pneumonia with Hospitalization care episode group. As 
discussed in section IV.A.4.f.(2)(c) of the final rule, we will remove 
this episode-based measure from the cost performance category, so the 
codes that define this care episode group will no longer need to remain 
in the operational list.
    More information on the statutory requirements for care episode and 
patient condition groups and proposed changes to the operational list 
is available in the CY 2024 PFS proposed rule (88 FR 52575 through 
52576). Our revisions to the operational list are available on our QPP 
Cost Measure Information page at https://www.cms.gov/medicare/quality/value-based-programs/quality-payment-program/quality-payment-program-cost-measure-information.
    We invited comments on this proposal. We did not receive public 
comments on this provision, and we are finalizing it as proposed.
(e) Summary of Previously Established and Finalized Measures for the 
Cost Performance Category Beginning With the CY 2024 Performance 
Period/2026 MIPS Payment Year
    The previously established and finalized measures for the cost 
performance category for the CY 2024 performance period/2026 MIPS 
payment year and future periods are summarized in Table 53.
BILLING CODE 4120-01-P

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[GRAPHIC] [TIFF OMITTED] TR16NO23.075


[[Page 79350]]


BILLING CODE 4120-01-C
(3) Improvement Activities Performance Category
(a) Background
    For previous discussions on the general background of the 
improvement activities performance category, we refer readers to the CY 
2017 Quality Payment Program final rule (81 FR 77177 and 77178), the CY 
2018 Quality Payment Program final rule (82 FR 53648 through 53661), 
the CY 2019 PFS final rule (83 FR 59776 and 59777), the CY 2020 PFS 
final rule (84 FR 62980 through 62990), CY 2021 PFS final rule (85 FR 
84881 through 84886), the CY 2022 PFS final rule (86 FR 65462 through 
65466), and the CY 2023 PFS final rule (87 FR 70057 through 70061). We 
also refer readers to 42 CFR 414.1305 for the definitions of 
improvement activities and attestation, Sec.  414.1320 for standards 
establishing the performance period, Sec.  414.1325 for the data 
submission requirements, Sec.  414.1355 for standards related to the 
improvement activity performance category generally, Sec.  414.1360 for 
data submission criteria for the improvement activity performance 
category, and Sec.  414.1380(b)(3) for improvement activities 
performance category scoring.
    While we did not propose any changes to the traditional MIPS 
improvement activities policies for the CY 2024 performance period/2026 
MIPS payment year, we proposed changes to the improvement activities 
inventory for the CY 2024 performance period/2026 MIPS payment year and 
future years as follows: adding five new improvement activities; 
modifying one existing improvement activity; and removing three 
previously adopted improvement activities.
(b) Improvement Activities Inventory
(i) Annual Call for Activities Background
    We refer readers to the CY 2024 PFS proposed rule (88 FR 52576 
through 52577) for details about the annual Call for Improvement 
Activities.
(ii) Changes to the Improvement Activities Inventory
    We refer readers to the CY 2024 PFS proposed rule (88 FR 52577 
through 52578) for details about changes to the improvement activities 
Inventory.
    We also refer readers to the Quality Payment Program website under 
Explore Measures and Activities at https://qpp.cms.gov/mips/explore-measures?tab=improvementActivities&py=2022#measures for a complete list 
of the current improvement activities.
    We proposed to add five new improvement activities, modify an 
existing improvement activity, and remove three previously adopted 
improvement activities for the CY 2024 performance period/2026 MIPS 
payment year and future years. We refer readers to Appendix 2 of the CY 
2024 PFS proposed rule (88 FR 53132) for more details.
    Two of the five proposed new improvement activities are in the 
Population Management subcategory. One new activity, IA_PM_XX, titled 
``Improving Practice Capacity for Human Immunodeficiency Virus (HIV) 
Prevention Services'' will allow MIPS eligible clinicians to receive 
credit for establishing policies and procedures to improve practice 
capacity to increase HIV prevention screening and linkage to 
appropriate prevention resources through taking action with the goals 
of increasing capacity to expand HIV prevention screening, improving 
HIV prevention education and awareness, and reducing disparities in 
pre-exposure prophylaxis (PrEP) uptake. Another activity, IA_PM_XX, 
titled ``Use of Computable Guidelines and Clinical Decision Support to 
Improve Adherence for Cervical Cancer Screening and Management 
Guidelines'' will allow MIPS eligible clinicians to receive credit for 
incorporating cervical cancer clinical decision support (CDS) within 
the electronic health record (EHR) system. This activity leverages the 
convenience and efficiency of more sophisticated decision support 
tooling to assist clinicians in applying complex data-driven guidelines 
to provide optimal care and better engagement with their patient 
population, including historically underserved populations. This 
activity proposal was submitted by the CDC.
    Two of the five proposed new activities are in the Behavioral and 
Mental Health (BMH) subcategory, reflecting this important Federal 
priority. IA_BMH_XX, titled ``Behavioral/Mental Health and Substance 
Use Screening & Referral for Pregnant and Postpartum Women'' will allow 
MIPS eligible clinicians to receive credit for screening for perinatal 
mood and anxiety disorders (PMADs) and substance use disorder (SUD) in 
pregnant and postpartum women, as well as screening and referring to 
treatment and/or referring to appropriate social services in patient 
care plans. The second new activity proposed in the BMH subcategory, 
IA_BMH_XX, titled ``Behavioral/Mental Health and Substance Use 
Screening & Referral for Older Adults'' will allow MIPS eligible 
clinicians to receive credit for the completion of age-appropriate 
screening for mental health and substance use in older adults, as well 
as screening and referring to treatment and/or referring to appropriate 
social services in patient care plans.
    Of the five proposed new improvement activities, four activities 
directly align with Priority 5 of CMS' Framework for Health Equity, 
Increase All Forms of Accessibility to Health Care Services and 
Coverage. Efforts undertaken that align with Priority 5 aim to create a 
fair and just opportunity for all people to attain their optimal health 
regardless of race, ethnicity, disability, sexual orientation, gender 
identity, socioeconomic status, geography, preferred language, and/or 
other factors that affect access to care and health outcomes. These 
four new improvement activities are the following: IA_PM_XX, titled 
``Improving Practice Capacity for Human Immunodeficiency Virus (HIV) 
Prevention Services''; IA_PM_XX, titled ``Use of Computable Guidelines 
and Clinical Decision Support to Improve Adherence for Cervical Cancer 
Screening and Management Guidelines''; IA_BMH_XX, titled ``Behavioral/
Mental Health and Substance Use Screening & Referral for Pregnant and 
Postpartum Women''; IA_BMH_XX, titled ``Behavioral/Mental Health and 
Substance Use Screening & Referral for Older Adults.''
    The fifth new improvement activity is focused on MVP: IA_MVP, 
titled ``Practice-wide quality improvement in the MIPS Value Pathways 
Program (MVP).'' With the advent of MVPs, MIPS eligible clinicians can 
report measures that are more relevant to their specialized practice, 
including through subgroup reporting. The IA_MVP activity will require 
a clinician to complete a formal model for quality improvement action 
that is linked to a minimum of three of the measures within the 
specific MVP. We believe this activity will expand and formalize 
quality improvement (QI) activities across practices, ultimately 
leading to improvements in quality of care and fostering a culture of 
participation among staff. In addition, this activity will incentivize 
voluntary MVP adoption. It is important to note that, a clinician who 
reports an MVP can attest to the MVP improvement activity. However, a 
clinician in traditional MIPS is ineligible to report the MVP 
improvement activity. Also, registration for an MVP is not sufficient 
for reporting the MVP improvement activity. Reporting the chosen MVP 
and attesting to having completed the necessary elements of the MVP

[[Page 79351]]

improvement activity are both required. We referred readers to the 
proposed rule (88 FR 52557) for more information on MVPs.
    We proposed to modify one existing activity's description, titled 
``Use decision support and standardized treatment protocols to manage 
workflow in the team to meet patient needs,'' and its validation 
criteria to explicitly promote the use of clinical decision support 
(CDS), particularly open-source, freely available, interoperable CDS. 
Additionally, we proposed to remove three previously finalized 
improvement activities to ensure that the improvement activities 
Inventory best reflects current clinical practice.
    We refer readers to Appendix 2 of the CY 2024 PFS proposed rule (88 
FR 53132) for details on the proposed revisions to the improvement 
activities inventory, comments received and our responses.
(iii) Improvement Activity Reporting Policies
    We did not propose changes to the improvement activity group 
reporting policies. We refer readers to the CY 24 PFS proposed rule (88 
FR 52578) for details related to improvement activities reporting 
policies.
(4) Promoting Interoperability Performance Category
(a) Background
    Section 1848(q)(2)(A) of the Act includes the meaningful use of 
certified electronic health record (EHR) technology (CEHRT) as a 
performance category under MIPS. We refer to this performance category 
as the Promoting Interoperability performance category (and in past 
rulemaking, we referred to it as the advancing care information 
performance category).
    For our previously established policies regarding the Promoting 
Interoperability performance category, we refer readers to our 
regulation at Sec.  414.1375, the CY 2017 Quality Payment Program final 
rule (81 FR 77199 through 77245), CY 2018 Quality Payment Program final 
rule (82 FR 53663 through 53688), CY 2019 PFS final rule (83 FR 59785 
through 59820), CY 2020 PFS final rule (84 FR 62991 through 63006), CY 
2021 PFS final rule (85 FR 84886 through 84895), CY 2022 PFS final rule 
(86 FR 65466 through 65490), and the CY 2023 PFS final rule (87 FR 
70060 through 70087).
(b) Promoting Interoperability Performance Category Performance Period
    In the CY 2021 PFS final rule (85 FR 84886), we established that 
for the CY 2024 MIPS payment year and each subsequent MIPS payment 
year, the performance period for the Promoting Interoperability 
performance category is a minimum of any continuous 90-day period 
within the calendar year that occurs 2 years prior to the applicable 
MIPS payment year, up to and including the full calendar year. We 
codified the policy at Sec.  414.1320(g)(1) of our regulations, and 
subsequently re-designated that section as Sec.  414.1320(h)(1) in the 
CY 2022 PFS final rule (86 FR 65671).
    In the CY 2024 proposed rule (88 FR 52578 through 52579), we 
proposed that, beginning with the CY 2026 MIPS payment year, the 
performance period for the Promoting Interoperability performance 
category would be a minimum of any continuous 180-day period within the 
calendar year, up to and including the full calendar year (for CY 2024, 
January 1, 2024, through December 31, 2024). As discussed in V.B.11.a 
in this final rule, this policy would minimally increase the 
information collection burden on data submitters. We also proposed to 
revise the regulation text at Sec.  414.1320 to reflect this change. As 
discussed herein, after consideration of public comments, we are 
finalizing our proposal to require a continuous 180-day performance 
period for the Promoting Interoperability performance category 
beginning with the CY 2024 performance period/2026 MIPS payment year, 
and to revise the regulation text at Sec.  414.1320 to reflect this 
change as proposed.
    We believe that having additional data available from a longer 
performance period is beneficial to further improve the Promoting 
Interoperability performance category, and an integral step towards 
promoting health information exchange. Reporting on additional data 
during a longer performance period will provide MIPS eligible 
clinicians the opportunity to continuously monitor their performance, 
identify gaps in their reporting, and identify areas that may require 
their investigation and corrective action. We believe that requiring 
MIPS eligible clinicians to report additional data during a longer 
performance period will encourage MIPS eligible clinicians to produce 
more comprehensive and reliable data demonstrating that they are 
meaningful users of CEHRT.
    Our long-term goal for the Promoting Interoperability performance 
category is to ensure the meaningful use of CEHRT and information 
exchange throughout the year, for all data, all clinicians, and all 
patients. Currently, when MIPS eligible clinicians select a 90-day 
performance period, this data is often not representative of their 
overall use of CEHRT throughout the entire calendar year. Instead, it 
reflects their best performing 90-days during the calendar year. For 
MIPS eligible clinicians to have a more accurate understanding of their 
overall performance, we want to move towards reporting on a full years' 
performance, which can be achieved by incrementally increasing the 
number of days in the performance period.
    We continue to focus on patient safety, and the Promoting 
Interoperability performance category continues to focus on the safety 
and safe use of patient data by demonstrating the meaningful use of 
CEHRT. If a MIPS eligible clinician were to only focus on their best 
90-day performance period, they may not focus on improving their 
overall performance by meaningfully using CEHRT throughout the year, 
and ultimately, observe, correct, and mitigate any potential patient 
safety concerns that may arise due to gaps in interoperability 
throughout the calendar year. If a MIPS eligible clinician does not 
meaningfully use CEHRT throughout the entire calendar year, there is a 
possibility for gaps in the transfer of key patient data necessary for 
supporting a diagnosis, continued treatment, or overall care planning.
    Therefore, in the CY 2024 PFS proposed rule, we proposed to modify 
Sec.  414.1320(h) for the Promoting Interoperability performance 
category performance period to remove the reference to subsequent years 
after the CY 2024 MIPS payment year, and instead specify that the 
policy applies only through the CY 2025 MIPS payment year. We further 
proposed to add a new paragraph at Sec.  414.1320(i)(1) to reflect a 
performance period of a minimum of a continuous 180-day period within 
the calendar year that occurs 2 years prior to the applicable MIPS 
payment year, up to and including the full calendar year for the 
Promoting Interoperability performance category, beginning with the CY 
2026 MIPS payment year (88 FR 52578 through 52579).
    We invited public comments on these proposals.
    The following is a summary of the comments we received and our 
responses.
    Comment: Several commenters did not support our proposal to 
lengthen the performance period to a minimum of 180 days. One commenter 
stated that they did not believe the proposal was an effective or 
appropriate policy lever that would move the needle on health 
information exchange.

[[Page 79352]]

    Response: We respectfully disagree. As required by section 
1848(o)(2)(A) of the Act, one of our goals for the MIPS Promoting 
Interoperability performance category is for MIPS eligible clinicians 
to demonstrate their meaningful use of CEHRT, and that they maintain 
the interoperability of their CEHRT by ensuring it is connected in a 
manner that provides for the electronic exchange of health information 
to improve the quality of health care. We believe it is important for 
MIPS eligible clinicians to demonstrate their meaningful use of CEHRT 
continuously throughout the year, rather than only during a self-
selected best performance period. We believe our proposal, to require a 
longer period during which MIPS eligible clinicians must meet the 
requirements of the Promoting Interoperability performance category 
including ensuring their CEHRT is interoperable, will move health 
information exchange forward.
    Comment: Some commenters supported our proposal to extend the 
length of the minimum performance period to 180 days. One commenter 
requested that CMS consider offering an ``exception'' or additional 
flexibilities for MIPS eligible clinicians that may be switching their 
EHR vendor during their selected performance period, because EHR 
implementation often extends well beyond a 180-day timeframe. These 
commenters further recommended that CMS offer MIPS eligible clinicians 
the flexibility to report on two separate, but still continuous, 90-day 
periods within the performance year.
    Response: We appreciate the feedback provided in support of our 
proposal and asking for additional flexibilities. We do understand that 
MIPS eligible clinicians have planned and unplanned system downtime for 
their CEHRT, which may include scheduled software updates, or even a 
change in vendor. We do not specify which 180-day performance period a 
MIPS eligible clinician must select within a calendar year, only that 
the 180 days are a single, continuous period. Additionally, we 
understand that updates or changes to CEHRT may occur during any 180-
day period, regardless of the performance period chosen. We suggest 
that MIPS eligible clinicians work with their chosen vendor to minimize 
downtime during the 180-day performance period selected. We also note 
that, while downtime may occur during the performance period, this 
should not directly impact scoring for the Promoting Interoperability 
performance category, so long as the minimum reporting requirements for 
the objectives and measures are met during the performance period as 
well. As discussed in the Stage 1 final rule (75 FR 44329) and the 
Stage 3 final rule (80 FR 62779 through 62780), we understand that 
planned and unplanned downtime will occur; so long as the minimum 
threshold for each measure is met using CEHRT, specifically numerator/
denominator measures, this is acceptable.
    As a reminder, for any MIPS eligible clinician that faces a 
significant hardship, we recommend that the MIPS eligible clinician 
files a hardship exception application to potentially avoid penalty for 
reasons outside of their control. Even though there may be specific 
requirements or limitations associated with a basis to request and 
receive an exception under Sec.  414.1380(c)(2)(i)(C), we encourage 
MIPS eligible clinicians to apply for this exception as needed. For 
additional information on hardship exceptions, please see https://qpp.cms.gov/mips/exception-applications?py=2023#promotingInteroperabilityHardshipException-2023.
    Comment: Several commenters did not support our proposal to extend 
the length of the minimum performance period from 90 to 180 days and 
expressed concern over the increase in relation to administrative 
burden. One commenter stated that the capacity of EHR vendors is 
finite, and with multiple clinician types simultaneously drawing from 
the same pool of vendors, this increases the burden of work for these 
vendors, and reduces the amount of time the vendor can spend with each 
client. Compliance among clinicians and health care staff was also a 
concern, with one commenter expressing that training at the beginning 
of the year means that practices will not be able to adjust any 
technical or other problems that occur during the 180-day period, as 
there is little room for error. One commenter stated that additional 
support staff will need to be hired to capture information that is not 
directly collected by EHRs.
    Response: We believe that MIPS eligible clinicians utilizing CEHRT 
are using it throughout the entire calendar year. Therefore, we 
respectfully disagree that our proposal to extend the performance 
period from 90 to 180 days would create significant burden. We believe 
the extension will have few implications in implementing, updating, and 
testing CEHRT to maintain compliance throughout the performance period. 
We suggest MIPS eligible clinicians consider early planning with health 
IT vendors on the timing of system updates and downtimes to allow for 
maximum flexibility in choosing the 180-day performance period. We do 
understand that when technical issues arise, MIPS eligible clinicians 
will work with their vendor to remediate these issues. Unforeseen 
circumstances happen, and it is possible that they may happen at any 
time, regardless of the 180-days chosen. As discussed previously, so 
long as the minimum threshold for each measure is met using CEHRT, 
specifically numerator/denominator measures, this is acceptable.
    Another reminder that for any MIPS eligible clinician that faces a 
significant hardship, we recommend that the MIPS eligible clinician 
file a hardship exception application to potentially avoid penalty for 
reasons outside of their control. Even though there may be specific 
requirements or limitations associated with a basis to request and 
receive an exception under Sec.  414.1380(c)(2)(i)(C),we encourage MIPS 
eligible clinicians to apply for this exception as needed. For 
additional information on hardship exceptions, please see https://qpp.cms.gov/mips/exception-applications?py=2023num;promotingInteroperabilityHardshipException-
2023.
    We understand the burdens MIPS eligible clinicians face with 
maintaining adequate staffing; however, we disagree with the 
commenter's concerns regarding the need to hire additional staff solely 
to collect information to report on objectives and measures during a 
longer 180-day performance period. Regardless of the length of the 
performance period, we anticipate minimal additional administrative 
burden. Several of the objectives and measures for the Promoting 
Interoperability performance category require MIPS eligible clinicians 
to use the CEHRT itself to collect and submit the required data. For 
those objective and measures that require collection and reporting of 
information regarding the use of CEHRT (such as attestations) that do 
not rely on data collected by the CEHRT itself (such as the Security 
Risk Analysis measure or the SAFER Guides measure), we do not believe 
collection and reporting will be affected by the increased performance 
period. The completion and reporting of these objectives and measures 
is the same whether the performance period is 90 days or 180 days.
    Comment: Two commenters who opposed our proposal stated that the 
challenges created from the COVID-19 public health emergency (PHE) will 
present complications in meeting reporting requirements during the 
proposed 180-day performance period.

[[Page 79353]]

One commenter expressed that different types of clinical practices face 
different and unique challenges following the PHE. The commenters 
stated that choosing any continuous 90-day performance period currently 
allows individual MIPS eligible clinicians to best fit their needs 
while focusing on patient care in an unpredictable environment. Another 
commenter stated that the PHE has created financial, workforce, and 
operational challenges that have implications for the resources needed 
to meet new Promoting Interoperability performance category 
requirements.
    Response: We believe that the COVID-19 PHE has created 
opportunities for us to identify areas where MIPS eligible clinicians 
can put their focus into performance improvement, specifically within 
the performance period. Considering the COVID-19 PHE, we tried to keep 
our modifications to the Promoting Interoperability performance 
category in CY 2024 to a minimum, only proposing substantive changes to 
the SAFER Guide measure and the lengthening of the performance period. 
While we empathize with MIPS eligible clinicians that the COVID-19 PHE 
has brought a unique set of challenges that many continue to face, we 
also recognize that the COVID-19 PHE heightened the need to strengthen 
the interoperability of health IT, and to ensure meaningful use of 
CEHRT throughout the year. During the COVID-19 PHE, telehealth became 
more widely available, makeshift clinics were created to care for 
patients, and clinical partnerships allowed for more clinical coverage. 
The ability and inability to send and receive health information during 
the COVID-19 PHE showed all clinicians the importance of having fully 
functional and interoperable systems to best care for their patients 
and ensure records integral to the patient's care were sent and 
received.
    After consideration of public comments, we are finalizing our 
proposal to require a continuous 180-day performance period for the 
Promoting Interoperability performance category beginning with the CY 
2024 performance period/2026 MIPS payment year and are revising the 
regulation text at Sec.  414.1320 to reflect this change, as proposed.
(c) Certified Electronic Health Record Technology Requirements
    Section 1848(q)(2)(B)(iv) of the Act requires that, for the 
Promoting Interoperability performance category, the MIPS eligible 
clinician must meet the requirements established for the specified 
performance period under section 1848(o)(2) of the Act for determining 
whether the MIPS eligible clinician is a meaningful electronic health 
record (EHR) user. Under section 1848(o)(2)(A) of the Act, a MIPS 
eligible clinician must be using CEHRT for a specified performance 
period in order to be treated as a meaningful EHR user. Section 
1848(o)(4) of the Act defines CEHRT as a qualified electronic health 
record (as defined in section 3000(13) of the Public Health Service 
Act, or PHSA) that is certified by the Office of the National 
Coordinator for Health Information Technology (ONC) pursuant to section 
3001(c)(5) of the PHSA in accordance with the certification standards 
that ONC adopted under section 3004 of the PHSA.
    Accordingly, the MIPS Promoting Interoperability performance 
category regulation at Sec.  414.1375(b)(1) requires a MIPS eligible 
clinician to use CEHRT as defined at Sec.  414.1305 for the performance 
period. Since the CY 2019 performance period/2021 MIPS payment year, 
this has consisted of EHR technology (which could include multiple 
technologies) certified under ONC's Health IT Certification Program 
that meets the 2015 Edition Base EHR definition (as defined at 45 CFR 
170.102) and has been certified to certain other 2015 Edition health IT 
certification criteria as specified in the definition of CEHRT at Sec.  
414.1305.
    As discussed in the CY 2024 PFS proposed rule (88 FR 52546 through 
52548), in the Health Data, Technology, and Interoperability: 
Certification Program Updates, Algorithm Transparency, and Information 
Sharing proposed rule (88 FR 23758), which appeared in the April 18, 
2023 Federal Register, ONC proposed to discontinue the year-themed 
``editions,'' which ONC first adopted in 2012, to distinguish between 
sets of health IT certification criteria finalized in different rules. 
ONC proposed to instead maintain a single set of ``ONC Certification 
Criteria for Health IT,'' which will be updated in an incremental 
fashion in closer alignment to standards development cycles and regular 
health information technology (IT) development timelines (88 FR 23750). 
As further outlined in section III.R. of this final rule, we finalized 
our proposal to modify the definition of CEHRT for purposes of the 
Quality Payment Program at Sec.  414.1305 to incorporate any changes 
made by ONC to its definition of Base EHR and its certification 
criteria for health IT.
(d) Promoting Interoperability Performance Category Measures for MIPS 
Eligible Clinicians
i. Changes to the Query of Prescription Drug Monitoring Program Measure 
Under the Electronic Prescribing Objective
    We previously adopted the Query of Prescription Drug Monitoring 
Program (PDMP) measure under the Electronic Prescribing (e-Prescribing) 
objective for the Promoting Interoperability performance category. For 
background on this measure, we refer readers to the CY 2019 PFS final 
rule (83 FR 59800 through 59803) and the CY 2020 PFS final rule (84 FR 
62992 through 62994). In the CY 2021 PFS final rule (85 FR 84887 
through 84888) and the CY 2022 PFS final rule (86 FR 65466 through 
65467), we finalized that the Query of PDMP measure would remain 
optional and eligible for 10 bonus points for the CY 2021 and CY 2022 
performance periods/2023 and 2024 MIPS payment year.
    In the CY 2023 PFS final rule, we finalized our proposal to require 
the Query of PDMP measure beginning with the CY 2023 performance 
period/2025 MIPS payment year, and that the measure will be worth 10 
points (87 FR 70061 through 70067). In addition, along with other key 
specifications described in the CY 2023 PFS final rule, we removed the 
phrase ``except where prohibited in accordance with applicable law'' 
from the measure description, and established two exclusions beginning 
with the CY 2023 performance period/2025 MIPS payment year: (1) Any 
MIPS eligible clinician who is unable to electronically prescribe 
Schedule II opioids and Schedule III and IV drugs in accordance with 
applicable law during the performance period; and (2) Any MIPS eligible 
clinician who writes fewer than 100 permissible prescriptions during 
the performance period (87 FR 70061 through 70067). Finally, in the CY 
2023 PFS final rule, we finalized a third exclusion for the Query of 
PDMP measure, but this exclusion was only available for the CY 2023 
performance period/2025 MIPS payment year. (87 FR 70067)
    The second exclusion is the same exclusion that we adopted for e-
Prescribing measure in the CY 2018 PFS final rule (82 FR 53679). It has 
come to our attention that the second exclusion is problematic because 
it does not address situations where the MIPS eligible clinician does 
not electronically prescribe Schedule II opioids or Schedule III and IV 
drugs, in accordance with applicable law during the

[[Page 79354]]

performance period, but does write more than 100 permissible 
prescriptions during the performance period. Therefore, we proposed to 
modify the second exclusion criterion to state that any MIPS eligible 
clinician who does not electronically prescribe any Schedule II opioids 
or Schedule III or IV drugs during the performance period can claim the 
second exclusion. (88 FR 52579)
    We invited public comments on this proposal. The following is a 
summary of the comments we received and our responses.
    Comment: Many commenters expressed support for the proposal to 
modify the second exclusion for the Query of PDMP measure. They stated 
that the modification is consistent with the intent of this measure and 
provides necessary clarity surrounding reporting requirements.
    Response: We believe the modification better reflects our intent. 
It addresses situations where the MIPS eligible clinician does not 
electronically prescribe Schedule II opioids or Schedule III and IV 
drugs, in accordance with applicable law during the performance period.
    After consideration of public comments, we are finalizing our 
proposal to modify the second exclusion for the Query of PDMP measure 
as proposed so that it reads as follows: ``Any MIPS eligible clinician 
who does not electronically prescribe any Schedule II opioids or 
Schedule III or IV drugs during the performance period'' beginning with 
the CY 2024 performance period/2026 MIPS payment year, as proposed.
ii. Technical Update to the Electronic Prescribing Measure
    The ONC 21st Century Cures Act final rule (85 FR 25660 through 
25661) retired the ``drug-formulary and preferred drug list checks'' 
certification criterion at 45 CFR 170.315(a)(10), which was associated 
with measures under the Electronic Prescribing objective for the 
Medicare Promoting Interoperability Program and the MIPS Promoting 
Interoperability performance category (80 FR 62882 and 83 FR 59817). 
ONC retired this criterion after January 1, 2022, as provided in 45 CFR 
170.550(m)(1) (85 FR 26661).
    In the CY 2021 PFS final rule, we finalized that the ``drug-
formulary and preferred drug list checks'' criterion will no longer be 
associated with measures under the Electronic Prescribing objective and 
will no longer be required to meet the CEHRT definition for the 
Medicare Promoting Interoperability Program and the MIPS Promoting 
Interoperability performance category, beginning with CY 2021 EHR 
reporting and performance periods (85 FR 84815 through 84825).
    In the CY 2023 PFS final rule, we inadvertently omitted a revision 
to TABLE 92: Objectives and Measures for the Medicare Promoting 
Interoperability Performance Category for the CY 2023 performance 
period/2025 MIPS payment year to reflect this change (87 FR 70075). In 
an effort to more clearly capture the previously established policy 
finalized in the CY 2021 PFS final rule with respect to the e-
Prescribing measure, we proposed in the CY 2024 PFS proposed rule to 
revise the measure description as shown in Table 54 to read ``At least 
one permissible prescription written by the MIPS eligible clinician is 
transmitted electronically using CEHRT'' and the numerator will be 
updated to read ``Number of prescriptions in the denominator generated 
and transmitted electronically using CEHRT'' to reflect the removal of 
the health IT certification criterion ``drug-formulary and preferred 
drug list checks.'' (88 FR 52579 through 52580)
    We invited public comments on this proposal. The following is a 
summary of the comment we received and our response.
    Comment: One commenter expressed support for our proposal to make 
technical corrections to the e-Prescribing measure.
    Response: We thank the commenter for their support.
    After consideration of the public comment we received, we are 
finalizing our proposal to revise the e-Prescribing measure description 
as shown in Table 54 to read ``At least one permissible prescription 
written by the MIPS eligible clinician is transmitted electronically 
using CEHRT,'' and the numerator will be updated to read to indicate 
``Number of prescriptions in the denominator generated and transmitted 
electronically using CEHRT'' to reflect the removal of the health IT 
certification criterion ``drug-formulary and preferred drug list 
checks.''
iii. Changes to the Safety Assurance Factors for EHR Resilience Guides 
(SAFER Guides) Measure
A. Background
    In the CY 2022 PFS final rule (86 FR 65475 through 65477), we 
adopted the Safety Assurance Factors for EHR Resilience Guides (SAFER 
Guides) measure under the Protect Patient Health Information Objective 
in the Promoting Interoperability performance category beginning with 
the CY 2022 performance period/2024 MIPS payment year. ONC developed 
several SAFER Guides, including the High Priority Practices SAFER 
Guide, to help organizations at all levels conduct self-assessments 
which optimize the safety and use of EHRs. Under the SAFER Guides 
measure, MIPS eligible clinicians are currently required to attest to 
whether they have conducted an annual self-assessment using the High 
Priority Practices SAFER Guide (available at https://www.healthit.gov/topic/safety/safer-guides), at any point during the calendar year in 
which the performance period occurs, with one ``yes/no'' attestation 
statement. Beginning with the CY 2022 performance period/2024 MIPS 
payment year, we required MIPS eligible clinicians to complete this 
attestation for this measure, though MIPS eligible clinicians were not 
scored based on their answer to the attestation, or whether they fully 
implemented all components of the self-assessment. An attestation of 
``yes'' or ``no'' is currently acceptable, and a MIPS eligible 
clinician can attest ``no'' without penalty. For additional 
information, please refer to our discussion of the SAFER Guides measure 
in the CY 2022 PFS final rule (86 FR 65475 through 65477).
B. Modification of the SAFER Guides Measure
    The SAFER Guides measure is intended to encourage MIPS eligible 
clinicians to use the High Priority Practices SAFER Guide, annually, to 
assess their progress and status on important facets of patient safety, 
including CEHRT implementation and effectiveness, identifying 
vulnerabilities, and developing a ``culture of safety'' within their 
organization. For instance, the High Priority Practices SAFER Guide 
asks users to review and ensure that entries of allergies, problem 
lists, and diagnostic test results utilize standardized coding elements 
in their CEHRT (such as uniformly and consistently coding results as 
``normal'' or ``high''). By ensuring their CEHRT consistently documents 
and codes health information, MIPS eligible clinicians confirm their 
CEHRT supports clear communication of a patient's health status, 
mitigating the risk of oversight, gaps, or potential safety risks 
introduced by the CEHRT, in the interoperable exchange of health 
information. By continuing to implement the High Priority Practices 
SAFER Guide's recommended practices, MIPS eligible clinicians may be 
better positioned to operate CEHRT

[[Page 79355]]

responsibly in care delivery, and to make improvements to the safe use 
of CEHRT as necessary over time.
    Given our interest in promoting the safety and the safe use of 
CEHRT, in the CY 2024 PFS proposed rule (88 FR 52580 through 52581), we 
proposed to amend the SAFER Guides measure to require MIPS eligible 
clinicians to conduct this self-assessment annually, and attest a 
``yes'' response, accounting for completion of the self-assessment for 
the High Priority Practices SAFER Guide. The self-assessment should be 
completed as a team among clinicians, staff members, and their vendors 
together, allowing MIPS eligible clinicians to see a snapshot of the 
status of the CEHRT used by their organization in terms of safety, and 
to identify areas needing improvement. Therefore, we proposed to modify 
the SAFER Guides measure beginning with the CY 2024 performance period/
2026 MIPS payment year such that only a ``yes'' response on the 
attestation will constitute completion of this measure, and a ``no'' 
response will result in a score of zero for the whole Promoting 
Interoperability performance category, indicating that the MIPS 
eligible clinician failed the requirements of the Promoting 
Interoperability performance category and is not a meaningful user of 
CEHRT. To reflect this proposed amendment to the SAFER Guides measure, 
we also proposed to modify our reporting requirements at Sec.  
414.1375(b)(2)(ii)(C) to include ``For the 2024 MIPS payment year 
through the 2025 MIPS payment year'', and to add Sec.  414.1375 
(b)(2)(ii)(D), to say ``Beginning with the 2026 MIPS payment year, 
submit an affirmative attestation regarding the MIPS eligible 
clinician's completion of the annual self-assessment under the SAFER 
Guides measure during the year in which the performance period 
occurs.''
    We believe this modification is feasible for MIPS eligible 
clinicians to implement, as they have had two years to grow familiar 
with the use of the SAFER Guides under this measure by attesting either 
``yes'' or ``no'' to conducting the self-assessment. We also noted the 
availability of resources to assist MIPS eligible clinicians with 
completing the self-assessment as required by the SAFER Guides measure. 
One example of such a resource is the SAFER Guides authors' paper 
titled ``Guidelines for US Hospitals and Clinicians on Assessment of 
Electronic Health Record Safety Using SAFER Guides,'' available without 
charge to download or use at https://jamanetwork.com/journals/jama/fullarticle/2788984 (88 FR 52580).
    Therefore, we proposed to modify our requirements for the SAFER 
Guides measure beginning with the CY 2024 performance period and 
subsequent years, to require MIPS eligible clinicians to conduct, and 
therefore attest ``yes,'' an annual self-assessment of their CEHRT 
using the High Priority Practices SAFER Guide (available at https://www.healthit.gov/topic/safety/safer-guides), at any point during the 
calendar year in which the performance period occurs. We further 
proposed that, although the SAFER Guides measure would continue to be 
required with no associated points, an attestation of ``no'' would 
result in the MIPS eligible clinician not meeting the measure's 
requirements and therefore they would not be a meaningful user of 
CEHRT, which would result in a score of zero for the Promoting 
Interoperability performance category. We also proposed to modify our 
reporting requirements at Sec.  414.1375(b)(2)(ii)(C), and to add Sec.  
414.1375(b)(2)(ii)(D). Specifically, at Sec.  414.1375(b)(2)(ii)(C), we 
proposed to end our current requirements for the SAFER Guides measure 
with the 2025 MIPS payment year. Then, at Sec.  414.1375(b)(2)(ii)(D), 
we proposed to require, beginning with the 2026 MIPS payment year, that 
a MIPS eligible clinician submit an affirmative attestation regarding 
the MIPS eligible clinician's completion of the annual self-assessment 
under the SAFER Guides measure during the year in which the performance 
period occurs. As discussed herein, after consideration of public 
comments, we are finalizing our proposal to modify the SAFER Guides 
measure and amend our regulation at Sec.  414.1375(b)(2)(ii), as 
proposed.
    As a reminder, under the SAFER Guides measure, we do not currently 
require, and did not propose to require MIPS eligible clinicians to 
attest to whether they have implemented any best practices ``fully in 
all areas'' as described in the High Priority SAFER Guide, nor will a 
MIPS eligible clinician be scored on how many of the practices they 
have fully implemented. We refer readers to Table 54 in this final rule 
for a description of the measure, and to the CY 2022 PFS final rule for 
additional background information (86 FR 65475 through 65477).
    Upon review of our current regulation governing reporting of the 
current SAFER Guides measure at Sec.  414.1375(b)(2)(ii)(C), we 
identified areas where our regulation is unclear regarding the 
requirements for reporting the SAFER Guides measure. Therefore, we also 
proposed to amend the regulatory text at Sec.  414.1375(b)(2)(ii)(C) to 
specify clearly that a MIPS eligible clinician must submit an 
attestation, with either a ``yes'' or ``no'' response, with respect to 
whether the MIPS eligible clinician completed the annual self-
assessment under the SAFER Guides measure during the year in which the 
performance period occurs. As previously discussed, the regulatory 
provision will only be applicable for the 2024 MIPS payment year 
through the 2025 MIPS payment year. (88 FR 52580 through 52581)
    We invited public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Some commenters expressed their overall support for the 
proposal. One commenter stated that in requiring a ``yes'' attestation 
of the SAFER Guides measure, we are promoting safe patient care.
    Response: We agree that requiring an annual self-assessment of the 
High Priority Practices SAFER Guide is an important component of 
promoting safe patient care.
    Comment: Several commenters supported the overall goals and utility 
of the High Priority Practices SAFER Guide measure, stating that 
protecting patient health information remains a top priority for 
clinicians, vendors, patients, and policy makers alike. However, 
commenters asked that CMS delay implementation of this proposed 
requirement from the CY 2024 performance period/2026 MIPS payment year 
to a later date. One commenter suggested that we consider delaying this 
requirement until the CY 2025 performance period/2027 MIPS payment 
year, allowing for MIPS eligible clinicians to continue to submit a 
``yes'' or ``no'' response without penalty for the CY 2024 performance 
period/2026 MIPS payment year. Another commenter suggested that CMS 
wait another three years before requiring a ``yes'' attestation for 
this measure, implementing this modification to the SAFER Guides 
measure beginning with the CY 2027 performance period/2029 MIPS payment 
year. This commenter stated that such delay would allow ONC additional 
time to review the guides' content to ensure it remains current. A 
couple commenters asked that we delay requiring a ``yes'' attestation 
on the SAFER Guides measure until CMS has publicly reported the number 
of MIPS eligible clinicians who responded ``yes'' and ``no,'' allowing 
for the public to gauge overall performance.
    Response: We note that MIPS eligible clinicians will have had 2 
years to complete the self-assessments without penalty (the CY 2022 and 
CY 2023

[[Page 79356]]

performance periods) before requiring a ``yes'' attestation beginning 
with the CY 2024 performance period/2026 MIPS payment year as we 
proposed. Therefore, while we understand that commenters have asked for 
additional time, we believe that the 2 years of preparation that we 
provided is adequate. We also understand that commenters have requested 
that CMS and ONC work together on reviewing the SAFER Guides, and that 
ONC update the content as appropriate. CMS will continue to share the 
feedback we receive with ONC, so they may update the content as deemed 
appropriate. In addition, as the SAFER Guides measure was required with 
both ``yes'' and ``no'' attestation fulfilling the requirement, we do 
not believe that publicly reporting this data reflects performance or 
ability, as much as it reflects which MIPS eligible clinician chose to 
complete the self-assessment or not. As a reminder, for all MIPS 
performance categories, we will continue to publicly post data on MIPS 
eligible clinicians' performance on measures and activities as the data 
becomes available.
    Comment: Several commenters supported utilizing the High Priority 
Practices SAFER Guide in clinical practice but suggested that CMS and 
ONC seek stakeholder feedback regarding updates to consider including 
in the SAFER Guides. These commenters expressed concern that the SAFER 
Guides have not had a comprehensive review since their release, several 
references are outdated, and current practices are not reflected, such 
as the use of telehealth which grew and changed substantially during 
and after the COVID-19 PHE. Additionally, commenters asked that CMS 
communicate suggestions for ONC to consider for the SAFER Guides, such 
as data privacy protections, social determinants of health, and 
present-day safety practices.
    Response: As mentioned, ONC continues to review of the SAFER 
Guides' content, and questions included in the self-assessment. At this 
time, we believe that the baseline self-assessment questions are 
relevant to MIPS eligible clinicians, but we will share commenters' 
suggestions on including telehealth, patient privacy, and social 
determinants of health with ONC for future consideration. As a 
reminder, we encourage MIPS eligible clinicians to utilize the annual 
MIPS Promoting Interoperability performance category call for measures 
to submit feedback for future policy consideration before we release 
our next proposed rule.
    Comment: Several commenters supported requiring MIPS eligible 
clinicians to complete an annual self-assessment using the High 
Priority Practices SAFER Guide, but they asked that CMS and ONC make 
publicly available the additional resources and materials mentioned in 
rulemaking (86 FR 65476). Commenters asked for educational materials, 
examples of how to complete the guides, and sources of information 
available to aid in the self-assessment.
    Response: We thank commenters for their support and suggestions. We 
are sharing one resource that is now publicly available for MIPS 
eligible clinicians as one additional tool to assist with completing 
their self-assessments. The ``Guidelines for US Hospitals and 
Clinicians on Assessment of Electronic Health Record Safety Using SAFER 
Guides,'' is now publicly available without charge to download or use 
at https://jamanetwork.com/journals/jama/fullarticle/2788984. We may 
also take into consideration making additional resources available to 
the public.
    Comment: Some commenters did not support the proposed modification 
to the SAFER Guides measure, stating that requiring MIPS eligible 
clinicians to attest to having completed the self-assessment places 
additional administrative burden on already taxed clinicians. 
Commenters also raised concern that administrative tasks are taking 
away from clinical time, while many are still recovering from staffing 
shortages after the COVID-19 PHE.
    Response: While we fully appreciate that MIPS eligible clinicians 
are still working through the complexities that arose during the COVID-
19 PHE, we also recognize that the COVID-19 PHE has had a direct effect 
on health IT, patient data, and system infrastructures. We disagree 
that the administrative burden associated with this proposed 
modification to this measure outweighs the protection of health IT, as 
well as the safety and safe use of CEHRT. As mentioned previously, 
while we understand the initial self-assessment may require the most 
effort, subsequent self-assessments should largely remain the same, 
unless there have been changes in vendors, or significant system 
upgrades (see section V.B.11.a. of this final rule and 86 FR 65476). 
Also, to reiterate, we are only requiring the completion and 
attestation of the self-assessment. We do not require that all items in 
the questionnaire are implemented fully, nor that the worksheets be 
completed in full. We also remind commenters that we understand not all 
recommended practices are applicable to every organization. In these 
instances, it is acceptable to check ``not implemented'' for that 
practice (86 FR 65475). Our minimum requirements to satisfy the SAFER 
Guides measure are to complete the self-assessment for self-awareness, 
and to attest to having completed the checklist. Lastly, we encourage 
MIPS eligible clinicians to complete the self-assessment in a team 
approach, utilizing administrative staff, clinicians, and their 
vendors, to lessen clinician burden.
    Comment: Several commenters supported the High Priority SAFER Guide 
self-assessment, but they did not agree that we should take an ``all or 
nothing'' approach to determining whether a MIPS eligible clinician 
passes or fails the SAFER Guides measure. Commenters suggested a 
performance-based scoring approach instead to create incentives for 
MIPS eligible clinicians to continuously make improvements.
    Response: We understand that an ``all or nothing'' approach is not 
a typical performance-based approach and appreciate the feedback. While 
we do have performance-based objectives and measures in the Promoting 
Interoperability performance category, we also have several unscored 
requirements as well. It is difficult to score the SAFER Guides 
measure, as it is constructed to only require an attestation of 
completion (did you complete the self-assessment, ``yes'' or ``no''). 
Without scoring based on the level of implementation of each of the 
practices, an all or nothing approach is more appropriate.
    After consideration of public comments, we are finalizing our 
proposal to modify our requirements for the SAFER Guides measure 
beginning with the CY 2024 performance period/2026 MIPS payment year, 
to require MIPS eligible clinicians to conduct, and therefore, attest 
``yes,'' to having completed an annual self-assessment of their CEHRT 
using the High Priority Practices SAFER Guide. We are finalizing our 
proposal to codify this modification at Sec.  414.1375(b)(2)(ii)(D). 
Additionally, we are finalizing our proposal to amend the regulatory 
text at Sec.  414.1375(b)(2)(ii)(C) to clearly specify that a MIPS 
eligible clinician must submit an attestation, with either an 
affirmative or negative response, with respect to whether the MIPS 
eligible clinician completed the annual self-assessment under the SAFER 
Guides measure during the year in which the performance period occurs; 
this regulatory provision will only be applicable for the 2024 MIPS 
payment year through the 2025 MIPS payment year.

[[Page 79357]]

(e) Requirements for the Promoting Interoperability Performance 
Category for the CY 2024 Performance Period/2026 MIPS Payment Year
i. Objectives and Measures for the CY 2024 Performance Period/2026 MIPS 
Payment Year
    For ease of reference, Table 54 lists the objectives and measures 
for the Promoting Interoperability performance category required for 
the CY 2024 performance period/2026 MIPS payment year as revised to 
reflect the policies we are finalizing in this final rule.
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ii. Scoring Methodology for the CY 2024 Performance Period/2026 MIPS 
Payment Year
    Table 55 reflects the scoring methodology for the Promoting 
Interoperability performance category for the CY 2024 performance 
period/2026 MIPS payment year.
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[[Page 79363]]


iii. Exclusion Redistribution
    Many required measures have exclusions associated with them as 
shown in Table 54. If a MIPS eligible clinician believes that an 
exclusion for a particular measure applies to them, they may claim it 
when they submit their data. The maximum points available in Table 55 
do not include the points that will be redistributed if a MIPS eligible 
clinician claims an exclusion. For ease of reference, Table 56 shows 
how points will be redistributed among the objectives and measures for 
the CY 2024 performance period/2026 MIPS payment year in the event a 
MIPS eligible clinician claims an exclusion for a given measure.
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iv. 2015 Edition Health IT Certification Criteria
    For ease of reference, Table 57 lists the objectives and measures 
for the Promoting Interoperability performance category for the CY 2024 
performance period/2026 MIPS payment year and the associated ONC health 
IT certification criteria set forth at 45 CFR 170.315, as is currently 
applicable. We refer readers to section III.R. of this final rule for 
our discussion of and amendments to the definition of CEHRT at Sec.  
414.1305.

[[Page 79364]]

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(f) Clinical Social Workers
    In the CY 2022 PFS final rule (86 FR 65387 through 65389), we added 
clinical social workers to the definition of a MIPS eligible clinician 
under Sec.  414.1305, beginning with the CY 2022 performance period/
2024 MIPS payment year. Prior to the CY 2022 performance period, this 
clinician type was not eligible to participate in the Medicare 
Promoting Interoperability

[[Page 79365]]

Program to earn incentive payments for the meaningful use of CEHRT, or 
to receive reduced Medicare payments for failing to meaningfully use 
CEHRT. Clinical social workers were also not eligible for Medicaid EHR 
incentive payments.
    In the CY 2022 PFS final rule (86 FR 65489), we stated that 
clinical social workers therefore may lack experience with the adoption 
or use of CEHRT, and that we believed there may not be sufficient 
Promoting Interoperability performance category measures that are 
applicable and available to them. In the CY 2022 PFS final rule (86 FR 
65489) and the CY 2023 PFS final rule (87 FR 70087), we established 
that we will apply to clinical social workers the same reweighting 
policy for the Promoting Interoperability performance category that we 
adopted previously for nurse practitioners, physician assistants, 
clinical nurse specialists, certified registered nurse anesthetists, 
and other types of MIPS eligible clinicians who are non-physician 
practitioners for the CY 2022 performance period/2024 MIPS payment year 
and the CY 2023 performance period/2025 MIPS payment year. 
Specifically, because we believed there may not be sufficient Promoting 
Interoperability performance category measures available and applicable 
to clinical social workers, pursuant to section 1848(q)(5)(F) of the 
Act, we assigned a weight of zero to the Promoting Interoperability 
performance category for clinical social workers. However, if a 
clinical social worker submits any data for any of the measures 
specified for the Promoting Interoperability performance category, then 
this category will not be reweighted to zero, and we will score the 
clinical social worker on this category as part of their final 
composite performance score in accordance with Sec.  414.1380(c)(1). 
This reweighting policy for clinical social workers is codified at 
Sec.  414.1380(c)(2)(i)(A)(4)(iii).
    Because CY 2022 was the first year that clinical social workers 
were included in our definition of MIPS eligible clinicians, we do not 
yet have any performance period data that we could use to evaluate 
whether the Promoting Interoperability performance category measures 
are applicable to this type of MIPS eligible clinician. In the CY 2023 
PFS final rule (87 FR 70087), when we reweighted the Promoting 
Interoperability performance category for clinical social workers for 
the CY 2023 performance period/2025 MIPS payment year, we noted we 
would evaluate whether this reweighting policy should be continued for 
future years when we have performance period data available. Given that 
we do not have data from the CY 2022 performance period available to 
analyze, we proposed (88 FR 52590) to continue the existing policy of 
reweighting the Promoting Interoperability performance category for 
clinical social workers for the CY 2024 performance period/2026 MIPS 
payment year, and to make the corresponding revisions to the regulatory 
text at Sec.  414.1380(c)(2)(i)(A)(4)(iii).
    We invited public comments on this proposal, but did not receive 
public comments on this provision, and we are finalizing as proposed.
(5) APM Improvement Activities Performance Category Score
(a) Background
    Section 1848(q)(5)(C) of the Act establishes scoring rules for the 
MIPS improvement activities performance category. Section 
1848(q)(5)(C)(ii) of the Act specifically provides that a MIPS eligible 
clinician who is in an Alternative Payment Model (APM), as defined in 
section 1833(z)(3)(C) of the Act, with respect to a performance period 
shall earn a minimum score of one half of the highest potential score 
for the improvement activities performance category. In accordance with 
section 1848(q)(5)(C)(ii) of the Act, we codified at Sec.  
414.1380(b)(3)(i) that individual MIPS eligible clinicians 
participating in APMs (as defined in section 1833(z)(3)(C) of the Act) 
for a performance period will earn at least 50 percent for the 
improvement activities performance category (81 FR 30132). Further, we 
also stated that MIPS eligible clinicians participating in an APM for a 
performance period may receive an improvement activity score higher 
than 50 percent (81 FR 30132). Subsequently, in the CY 2021 PFS final 
rule, we finalized the APM Performance Pathway (APP) under MIPS (85 FR 
84859 through 84866).
    The APP is an optional MIPS reporting and scoring pathway available 
to MIPS eligible clinicians and groups who are also participants in 
MIPS APMs. The APP is designed to reduce reporting burden and encourage 
participation in APMs (85 FR 50285). Performance in the APP is weighted 
across 3 areas--quality, improvement activities, and Promoting 
Interoperability (Sec.  414.1380(d)). Like traditional MIPS, the APP 
allows APM participants to receive credit for improvement activities. 
With respect to the APP, eligible clinicians, groups, and APM Entities 
currently receive full credit for the improvement activities 
performance category with no additional data submission requirements 
because we have identified all MIPS APMs as having met the improvement 
activity threshold score requirement to receive a score of 100 percent 
for that performance category (85 FR 84865, 85031).
(b) Proposal
    We stated in the CY 2024 PFS proposed rule that it had come to our 
attention that in the preamble to the MIPS Performance Category Scoring 
in the APM Performance Pathway of the CY 2021 PFS final rule (85 FR 
84865) the terminology ``automatically'' was used in reference to the 
baseline score provided by section 1848(q)(5)(C)(ii) of the Act (85 FR 
84865). This has led to an interpretation by some that the baseline 
score represents ``credit'' that is ``automatically applied'' in all 
circumstances.\496\ This is not how we intended this provision to 
function, and we wish to clarify that our rules do not automatically 
grant such ``credit''.\497\ Further, we are concerned that absent 
revisions, application of our current regulation, which initiates MIPS 
composite scoring when at least two performance categories are reported 
in traditional MIPS, may produce unintended or unexpected scoring 
outcomes for MIPS eligible clinicians and groups.
---------------------------------------------------------------------------

    \496\ For example, in the ``2022 Data Submission FAQs,'' 
available at https://qpp.cms.gov/resources/resource-library, we 
stated that MIPS eligible clinicians participating in APMs are 
eligible to receive ``automatic credit'' in the improvement 
activities performance category.
    \497\ Similarly, in the CY 2021 PFS final rule, we finalized a 
proposal to modify Sec.  414.1380(b)(3)(ii) to make clear that the 
baseline score provided by section 1848(q)(5)(C)(i) of the Act for 
the improvement activities performance category is not automatically 
granted for clinicians participating in patient-centered medical 
homes and comparable specialty practices (83 FR 59868).
---------------------------------------------------------------------------

    To prevent such scoring scenarios, we proposed to amend Sec.  
414.1380 by revising paragraph (b)(3)(i) to require that, in order to 
receive the baseline score of 50 percent for the improvement activities 
performance category, a MIPS eligible clinician or group with APM 
participation must have submitted data for two performance categories 
or attest to having completed an improvement activity. We also proposed 
to amend Sec.  414.1380 by adding paragraph (c)(2)(iv) to provide that 
we will not apply a baseline score of 50 percent for the improvement 
activities performance category if we have also approved a request for 
performance category reweighting or hardship exception affecting the 
improvement activities performance category, including MIPS EUC 
Exception applications under

[[Page 79366]]

Sec.  414.1380(c)(2)(i)(A)(6) or (C)(2), and automatic EUC events per 
Sec.  414.1380(c)(2)(i)(A)(8) or (C)(3).
    These proposals relate to reporting and scoring in traditional 
MIPS. We believe that these proposals are necessary in part because 
Sec.  414.1380(c)(2)(i)(A)(6) requires us to score any data submitted 
by a MIPS eligible clinician with an approved application-based 
hardship exception or who was identified as a clinician in a CMS-
designated area affected by an EUC event as identified by CMS under 
Sec. Sec.  414.1380(c)(2)(i)(A)(6), (A)(8), (C)(2), and (C)(3), 
regardless of whether that submission was for the purpose of MIPS final 
scoring. Based upon our current policies, a submission of data for the 
quality or Promoting Interoperability performance categories makes the 
improvement activities performance category eligible for scoring. For 
MIPS eligible clinicians participating in APMs, this means the 
improvement activities performance category score would be 50 percent, 
potentially resulting in a lower composite score than may otherwise be 
possible, unless additional improvement activities are attested to. We 
believe that result is contrary to the purpose of hardship exceptions, 
such as the MIPS EUC Exception application provided by Sec.  
414.1380(c)(2)(i)(A)(6), which are designed to reweight the improvement 
activities performance category to zero percent.
    We also believe this proposal will further our vision that ``the 
bedrock of the Quality Payment Program is high-quality, patient-
centered care followed by useful feedback, in a continuous cycle of 
improvement'' (81 FR 77010). Generally speaking, through MIPS, we 
collect feedback based upon data and measures submitted for the 
quality, Promoting Interoperability, improvement activities, and cost 
performance categories. We need scores from at least two of those four 
performance categories for us to calculate a clinician's final score. 
There is no data submission requirement for the cost performance 
category--we use the Medicare claims data submitted by that clinician 
to calculate their cost-measure performance. Similarly, a MIPS eligible 
clinician is not required to submit detailed data for the improvement 
activities performance category; instead, a MIPS eligible clinician 
simply attests to having completed an activity or activities to report 
the performance category. Therefore, we believe that it is most 
appropriate for a MIPS eligible clinician to submit measurable data on 
the quality and Promoting Interoperability performance categories for 
the purpose of final scoring in order to be credited with the baseline 
score for the improvement activities performance category.\498\
---------------------------------------------------------------------------

    \498\ There is no data submission requirement for the quality 
and cost performance categories for a MIPS eligible clinician 
assessed under the facility-based measurement scoring methodology 
described in Sec.  414.1380(e). Therefore, we would require that 
such clinicians report data on the Promoting Interoperability 
performance category (or attest to having completed an improvement 
activity) to prompt the baseline score for the improvement 
activities performance category.
---------------------------------------------------------------------------

    We believe these proposals are timely in light of the proposal at 
section III.F.h.2. of the CY 2024 PFS proposed rule to require that 
Medicare Shared Savings Program (SSP) Accountable Care Organization 
(ACO) clinicians report the Promoting Interoperability performance 
category at the TIN level, as opposed to the APM Entity (that is, the, 
ACO) or individual level. Reporting the quality performance category 
through the APP is already required for MIPS eligible clinicians 
participating in a Medicare SSP ACO. If our existing policies are not 
amended, an SSP ACO clinician's submission of data to the Promoting 
Interoperability category will prompt the baseline score in the 
improvement activities performance category in every circumstance 
regardless of whether the clinician's group requested or otherwise 
qualified for reweighting of the performance categories, leaving these 
Medicare ACO clinicians reporting improvement activities outside the 
APP at risk of unintended or unexpected MIPS scoring outcomes. This 
proposal will allow us to conform to the general scoring expectation 
that, in the event the participant's request to reweight three or four 
performance categories to zero percent due to a hardship, per 
Sec. Sec.  414.1380(c)(2)(i)(A)(6), (A)(8), (C)(2), and (C)(3), the 
participant will receive a final score equal to the performance 
threshold, resulting in a neutral payment adjustment, even if data are 
incidentally submitted for other performance categories.
    In summary, we proposed to amend Sec.  414.1380 by revising 
paragraph (b)(3)(i) and adding paragraph (c)(2)(iv) to limit the 
application of baseline scores provided under section 1848(q)(5)(C)(ii) 
of the Act for the purpose of MIPS final scoring. We sought comment on 
these proposals.
    The following is a summary of the comments we received on these 
proposals and our responses.
    Comment: We received one comment in support of our proposed 
changes.
    Response: We thank the commenter for their support.
    Comment: A commenter expressed concern that our proposal will 
increase reporting burden for MIPS eligible clinicians in APMs 
reporting through the APP. The commenter stated that the objective of 
the proposal could easily be accomplished without additional reporting 
by scoring MIPS eligible clinicians reporting through the APP that have 
requested a hardship exemption when such clinicians report a MIPS 
performance category score other than the improvement activities 
performance category and the final score is higher than performance 
threshold that would otherwise be achieved through the hardship 
exception. This commenter further indicated that they believe that our 
proposal is a departure from current CMS guidance.
    Response: We appreciate the commenter's concern about 
administrative burden as we are mindful of the burden placed on 
clinicians and groups who are APM participants and report MIPS 
performance categories. We recognize that we could have been more clear 
about our intent and what is required of MIPS eligible clinicians to 
meet MIPS reporting requirements outside the APP. Here, additional 
information from the MIPS eligible clinician or group is necessary to 
ensure that a MIPS eligible clinician or group does, in fact, intend to 
trigger the scoring consequences that will result from their reporting.
    As we discussed in the proposed rule (88 FR 52590 and 52591), the 
submission of quality or Promoting Interoperability data would trigger 
a minimum improvement activities performance category score of 50 
percent for all APM participants, resulting in the calculation of a 
MIPS final score, even in situations where the improvement activities 
performance category otherwise would have been reweighted to zero. This 
is not a common scenario; nonetheless, it is significant for those MIPS 
eligible clinicians and groups that it affects as it can be the 
difference between a clinician or group receiving a neutral payment 
adjustment and a negative payment adjustment due to existing CMS 
scoring rules. When a MIPS eligible clinician is scored on two MIPS 
performance categories, CMS will calculate a final score for the MIPS 
eligible clinician (Sec.  414.1380(c)), subjecting the clinician to a 
MIPS payment adjustment (Sec.  414.1405(a) and (b)). For this reason, 
any marginal increase in the reporting burden is justified by the 
protection it offers MIPS eligible clinicians from inadvertently 
receiving an unexpected MIPS final score and payment adjustment.

[[Page 79367]]

    We appreciate the commenter's suggested alternative policy as it 
highlights some of the confusion that our past statements may have 
caused. Not all APM participants are scored under the APP, which is an 
optional reporting pathway for eligible clinicians and groups who are 
participants in MIPS APMs.
    Our proposal was intended to resolve an issue that affects APM 
participants who are not scored under the APP. Section 1848(q)(5)(C) of 
the Act provides that a MIPS eligible clinician participating in an 
APM, with respect to a performance period, shall earn a minimum score 
of one half of the highest potential score for the improvement 
activities performance category. Separate and distinct from this 
statutory credit, CMS scoring rules provide for a MIPS eligible 
clinician who elects to be scored under the APP to be assigned an 
improvement activities performance category score ``based on the 
activities required by the MIPS APM'' (42 CFR 414.1367(c)(3)).\499\ A 
MIPS eligible clinician who does not elect to be scored under the APP 
will not automatically receive full credit for the improvement 
activities performance category but would instead receive the minimum 
statutory credit of 50 percent unless the clinician attests to 
additional improvement activities. While affirmatively electing to be 
scored under the APP demonstrates a MIPS eligible clinician's clear 
intention to trigger scoring in the improvement activities performance 
category, passive eligibility for the 50 percent statutory credit 
outside the APP provides no similar indication of intent.
---------------------------------------------------------------------------

    \499\ As noted under the proposed rule (88 FR 52590), to date, 
CMS has determined each MIPS APM to require the performance of 
improvement activities worth 100 percent of the improvement activity 
performance score (85 FR 84865, 85031).
---------------------------------------------------------------------------

    For this reason, we proposed to limit the circumstances in which we 
would provide the statutory credit to a MIPS eligible clinician 
participating in a APM to circumstances in which the clinician's 
actions clearly indicate an intention to receive a MIPS final score: 
when the clinician has attested to one or more additional improvement 
activities or when the clinician has submitted data for the quality and 
Promoting Interoperability performance categories. To make this intent 
easier to understand, we are revising Sec.  414.1380(b)(3)(i) to state 
that a MIPS eligible clinician participating in an APM receives an 
improvement activities performance category score of at least 50 
percent if the MIPS eligible clinician reports a completed improvement 
activity or submits data for the quality and Promoting Interoperability 
performance categories. This revision more clearly reflects the policy 
we described in the CY 2024 PFS proposed rule (88 FR 52590).
    We acknowledge that our proposal could be viewed as different from 
our past guidance. Indeed, the purpose of the proposal is to correct 
confusion caused by our past statements while clarifying our intent 
with respect to those statements. We note that in the proposed rule we 
acknowledged that we may have caused confusion through past guidance 
and cited prior rulemaking where we better indicated how our actual 
intent has evolved based on our experience operating the program (88 FR 
52590 and 52591).
    After consideration of the comments, we are finalizing this 
proposal with modification.
g. MIPS Final Score Methodology
(1) Performance Category Scores
(a) Background
    Sections 1848(q)(1)(A)(i) and (ii) and (5)(A) of the Act provide, 
in relevant part, that the Secretary shall develop a methodology for 
assessing the total performance of each MIPS eligible clinician 
according to certain specified performance standards with respect to 
applicable measures and activities specified for the four performance 
categories for a performance period and use such methodology to provide 
for a composite performance score for each such clinician for each 
performance period.
    For the CY 2024 performance period/2026 MIPS payment year, we 
intend to continue to build on the scoring methodology we have 
finalized for prior years. This scoring methodology allows for 
accountability and alignment across the performance categories and 
minimizes burden on MIPS eligible clinicians. In the CY 2024 proposed 
rule, we proposed to update our scoring policies consistent with this 
framework. Specifically, we proposed to--
     Provide a technical update to Sec.  414.1380(a)(1)(i) and 
(b)(1)(v)(A),
     Amend our criteria for assessing ICD-10 coding impacts 
under our scoring flexibilities policy; and
     Update our policies regarding Improvement scoring for the 
cost performance category.
    We did not propose changes to scoring policies for the Promoting 
Interoperability or improvement activities performance categories.
(b) Technical updates
    In the CY 2022 PFS final rule, we finalized proposals to remove 
measure bonus points for reporting additional high priority measures 
and using end to end electronic reporting beginning in the CY 2022 
performance period/2024 MIPS payment year (86 FR 65504 through 65507). 
We updated corresponding regulation at Sec.  
414.1380(b)(1)(v)(B)(1)(iii) regarding the end- to- end measure bonus 
points, but not Sec.  414.1380(a)(1)(i) regarding performance standards 
or Sec.  414.1380(b)(1)(v)(A) regarding the high priority bonus points. 
Accordingly, we proposed to revise Sec.  414.1380(a)(1)(i) to provide 
that, measure bonus points for submitting high priority measures and 
using end-to-end reporting are available for performance periods and 
payment years prior to the CY 2023 performance period/2025 MIPS payment 
year. We also proposed to revise Sec.  414.1380(b)(1)(v)(A) to state 
that, beginning with the CY 2022 performance period/2024 MIPS payment 
year, MIPS eligible clinicians will no longer receive these measure 
bonus points for submitting high priority measures.
    We referred readers to our regulation at Sec.  414.1380 for our 
current policies on scoring. We requested comments on these technical 
update proposals.
    We did not receive public comments on the technical update 
proposals. We are finalizing this proposal as proposed.
(c) Scoring the Quality Performance Category for the Following 
Collection Types: Medicare Part B Claims Measures, eCQMs, MIPS CQMs, 
QCDR Measures, the CAHPS for MIPS Survey Measure and Administrative 
Claims Measures
    We referred readers to Sec.  414.1380(b)(1) for our current 
policies regarding quality measure benchmarks, calculating total 
measure achievement and measure bonus points, calculating the quality 
performance category score, including achievement and improvement 
points, and the small practice bonus (81 FR 77276 through 77308, 82 FR 
53716 through 53748, 83 FR 59841 through 59855, 84 FR 63011 through 
63018, 85 FR 84898 through 84913, 86 FR65490 through 65509, and 87 FR 
70088 through 70091). In the CY 2023 PFS final rule, we finalized 
policies to score administrative claims measures in the quality 
performance category using benchmarks calculate from data submitted 
during the associated performance period and clarified the topped-out 
measure lifecycle (87 FR 70088 through 70091).

[[Page 79368]]

(i) Scoring Flexibility for Changes That Impact Quality Measures During 
the Performance Period
    We referred readers to CY 2018, CY 2019, Quality Payment Program 
final rules and the CY 2021, and CY 2022 PFS final rules (82 FR 53714 
through 53716, 83 FR 59845 through 59847, 85 FR 84898 through 84901, 
and 86 FR 65491 and 65492 respectively) and Sec.  
414.1380(b)(1)(vii)(A) for our previously established scoring 
flexibilities policy.
    We refer readers to the CY 2024 PFS proposed rule (88 FR 52592) for 
a detailed description of the development of the scoring flexibilities 
policy.
    In the CY 2024 PFS proposed rule, we proposed two modifications to 
the criteria by which we assess the impacts of ICD-10 coding changes 
(88 FR 52592). Firstly, we proposed to eliminate the 10 percent ICD-10 
coding change factor established in the CY 2018 Quality Payment Program 
rule (82 FR 53714). The quality and cost performance categories rely on 
measures that use detailed specifications that include ICD-10 code 
sets. We annually issue new ICD-10 coding updates, which are effective 
from October 1 through September 30. As part of this update, codes are 
added and removed from the ICD-10 code sets. When we adopted this 
standard in the CY 2018 Quality Payment Program final rule (82 FR 
53714), we were concerned that ICD-10 coding changes in the final 
quarter of the performance period may render a measure no longer 
comparable to its historical benchmark. However, we have found that a 
10 percent change to ICD-10 codes does not necessarily reflect a 
meaningful impact to clinicians' ability to report and be fairly scored 
on a quality measure. In the CY 2018 Quality Payment Program proposed 
rule, we discussed an approach where we would consider any change in 
ICD-10 coding to impact performance on a measure and thus only rely on 
the first 9 months of the 12-month performance period for such 
measures; however, we stated that such an approach was too broad 
(overly inclusive of changes) and would truncate measurement for too 
many measures where performance may not be significantly affected (82 
FR 30098). We maintain this perspective but have concluded that a 10 
percent change in codes is similarly over inclusive as it leads to the 
suppression of measures that can still be scored using all 12 months of 
the performance period. In place of the 10 percent threshold, we 
proposed to assess the overall impact on a measure resulting from 
changes to ICD-10 codes. Rather than consider a flat 10 percent change 
as a factor for when ICD-10 coding changes affect a measure, we will 
instead assess how the coding changes affect the measure numerator, 
denominator, exclusions, and exceptions in ways that could lead to 
misleading or harmful results. We will assess whether resultant changes 
to the numerator, denominator, exceptions, exclusions, or other measure 
elements change the scope or intent of the measure.
    Changes in measure scope or intent will be considered significant 
changes that affect the applicability of the historical benchmark. ICD-
10 codes include information related to clinical diagnoses and eligible 
patient population. For example, ICD-10 codes in the denominator 
correspond to the total eligible patient population considered for a 
measure. If as a result of a clinical guideline change a code is 
changed from an exclusion to a code to be considered in the total 
patient population indicated in the denominator for a measure, this 
will meaningfully change the scope of the measure and could lead to 
misleading results in measurement. Additionally, instances in which 
coding changes change the designation of whether performance was met or 
not (numerator) could similarly lead to misleading results. These 
changes would be considered significant and therefore trigger our 
scoring flexibilities policy.
    Second, we proposed to assess the impacts of coding changes and our 
associated course of action (suppression, truncation, or standard 12-
month reporting) by measure collection type. Our scoring policy states 
that we calculate benchmarks by collection type (Sec.  
414.1380(b)(1)(ii). As benchmarks are assessed by collection type, we 
must consider by collection type whether the changes or errors will 
result in patient harm or misleading results. We refer readers to the 
2024 PFS proposed (88 FR 52592) rule for relevant discussion.
    Each collection type has different technical limitations. For 
example, measure specifications for the MIPS CQMs and Medicare Part B 
claims collection types can be updated in the performance period 
immediately following the publication each October of changes to ICD-10 
codes. If an ICD-10 coding change occurs in October of 2024, CMS can 
immediately update the specifications for the measure's MIPS CQMs and 
Medicare Part B claims collection types for the next performance 
period, and the ICD-10 changes would not result in any misleading 
results for the measure for those collection types.
    This differs from eCQM measure specifications, which are posted in 
the May the year before the measure specifications take effect and are 
valid for the 12-month reporting period. For the CY 2024 performance 
period/2026 MIPS payment year, eCQM measures specifications will be 
posted in May of 2023 and are valid for the applicable 12-month 
performance period in CY 2024. In the example given above, the 
measure's eCQM collection type would not be updated again until May 
2025 for the CY 2026 performance period/2028 MIPS payment year, and 
clinicians would be left reporting pursuant to outdated specifications 
for the final quarter of the CY 2024 performance period. This could 
result in misleading results for the measure's eCQM collection type. As 
a result, it would be appropriate for CMS to assess the impact of 
changes to measures and implement the appropriate scoring flexibility 
by collection type. Lastly, we proposed that measure specifications for 
eCQMs include the capability to be truncated to a 9-month performance 
period. Current measure specifications for eCQMs provide exclusively 
for a 12-month reporting period. If a measure is significantly impacted 
by ICD-10 coding changes, it therefore cannot be reported for a 
truncated performance period of 9-month. In order to implement the 
scoring flexibilities policy as intended and protect our ability to 
score measures where 9 consecutive months of data is available, we 
proposed to begin requiring measure specifications to include logic for 
a 9-month performance period in addition to the currently existing 12-
month performance period.
    These updates will help us to better provide scoring flexibilities 
to clinicians by being sensitive to the particular impacts to and 
capabilities of the particular quality measures collection types. We 
sought comment on our proposal to update the criteria by which be apply 
scoring flexibilities in response to ICD-10 coding changes.
    We received public comments on the proposal. The following is a 
summary of the comments we received and our responses.
    Comment: Several commenters supported the proposal for CMS to 
eliminate the criterion of a 10 percent change in the ICD-10 coding 
specifications and instead assess the significance of changes. One 
commenter encouraged CMS to work with interested parties in each 
instance to assess the appropriateness of measuring on 9 months of data 
for quality

[[Page 79369]]

measures with a 12-month performance period. Another commenter stated 
that suppressing a measure at the end of the year could undermine the 
work of the care team to achieve high performance and that if the 
measure intent remains the same and the coding impact is minimal, 
providers should be able to continue to report the measure. One 
commenter stated that evaluating measure changes on a case-by-case 
basis could prevent suppression of measures with favorable performance 
scores. One commenter agreed with assessing the impact of ICD-10 coding 
changes separately for each collection type.
    Response: We agree with interested parties that assessing the 
measures for appropriateness could help to ensure quality measurement, 
working to recognize and support the hard work clinicians are doing to 
improve clinical quality. Eliminating the 10 percent change in ICD-10 
coding specifications and consideration by collection type and on a 
case-by-case basis, will help us to better support quality measurement 
and clinicians in this way.
    Comment: One commenter opposed elimination of the 10 percent ICD-10 
coding change factor, stating that although coding education on annual 
changes is important, education does not overcome the impact of the 
transition to updated ICD-10 codes. Another commenter expressed 
concerns about the burden imposed on practices by coding changes and 
suppression/truncation of measures during the performance year. The 
commenter stated that because benchmark and logic changes are released 
late in the year, their EHR vendor does not implement updates until 
well into the new year, resulting in workflow changes and 
administrative burden.
    Response: Eliminating the 10 percent threshold, will allow us to 
better find alternatives to suppression or truncation to support 
clinicians and their workflows. We will continue to consider 
alternatives that will preserve scoring and support clinicians, to the 
extent feasible.
    Comment: A few commenters opposed the proposal to require eCQM 
measure stewards to develop specifications to support a truncated 9-
month reporting period. One commenter stated that EHR developers should 
not be required to support two sets of specifications for each measure 
when CMS or the measure developer makes changes during the reporting 
period. One commenter stated that it may not be feasible to develop 
specifications for a 9-month reporting period for measures that depend 
on actions from more than one patient encounter. A few commenters 
raised concerns about the burden associated with requiring both 9-month 
and 12-month specifications for eCQMs, stating that this would increase 
burden for EHR developers and undermine their ability to support eCQMs. 
A few commenters offered alternatives to requiring measure stewards to 
develop specifications for a 9-month reporting period. One commenter 
suggested that CMS could change the date of ICD-10 to the end of the 
calendar year to align with the quality measure performance period. 
Another commenter recommended that eCQMs be specified for only a 9-
month reporting period running from January to September.
    Response: We thank commenters for expressing their concerns 
regarding the proposed requirement for eCQM measures to account for the 
reporting of a 9-month performance period. While supporting a truncated 
9-month reporting period would help our mission to preserve quality 
measurement and scoring in MIPS, we recognize the concerns described by 
commenters in implementing these changes. We will possibly consider the 
implementation of alternative options through future rulemaking.
    After consideration of public comments, we are finalizing this 
proposal with modifications. We are finalizing our proposal to the 
implementation of the scoring flexibilities policy at Sec.  
414.1380(b)(1)(vii)(A) to eliminate the 10 percent ICD-10 coding change 
factor established in the CY 2018 Quality Payment Program rule (82 FR 
53714) and to assess the impacts of coding changes and our associated 
course of action (suppression, truncation, or standard 12-month 
reporting) by measure collection type. We are not finalizing our 
proposal to require eCQM measure specifications to include logic for a 
truncated 9-month performance period.
(d) Cost Performance Category Score
(i) Improvement Scoring Methodology
(A) Background
    We refer readers to the CY 2024 PFS proposed rule (88 FR 52593) for 
details on the history of the cost improvement scoring methodology.
    Briefly, in the CY 2018 Quality Payment Program final rule (82 FR 
53748 through 53752), we established policies related to measuring 
improvement for the cost performance category at the measure level. We 
codified these policies at 42 CFR 414.1380(b)(2)(iii) and (iv) (82 FR 
53748 through 53752, 53957). After the publication of the CY 2018 
Quality Payment Program final rule, the Bipartisan Budget Act of 2018 
(BBA 18) (Pub. L. 115-123, February 9, 2018) was enacted. Section 
51003(a)(1)(B) of the BBA 18 added a new clause at section 
1848(q)(5)(D)(iii) of the Act which provided that the cost performance 
category score shall not take in to account the improvement of the MIPS 
eligible clinician for CY 2018 performance period/2020 MIPS payment 
year through the CY 2021 performance period/2023 MIPS payment year. On 
this basis, we set the maximum cost improvement score for the CY 2018 
performance period/2020 MIPS payment year through the CY 2021 
performance period/2023 MIPS payment year at zero percentage points, in 
the CY 2019 PFS final rule (83 FR 35956, 36080 through 36082), which we 
codified at Sec.  414.1380(a)(1)(ii) and (b)(2)(iv)(E). Further, due to 
the COVID-19 Public Health Emergency (PHE) ((85 FR 19277 through 19278; 
See ``Extension to Data Submission Deadline'' on Quality Payment 
Program website at https://qpp.cms.gov/) and under our authority at 
Sec.  414.1380(c)(2)(i)(A)(8), we reweighted the cost performance 
category's score to zero percent of the final score for the CY 2020 
performance period/2022 MIPS payment year through the CY 2021 
performance period/2023 MIPS payment year. In the CY 2024 PFS proposed 
rule (88 FR 52593), we this reweighting began with stated the CY 2019 
performance period/2022 MIPS payment year, but we want to clarify that 
we were referring to the CY 2020 performance period/2022 MIPS payment 
year.
    On these bases, to date, we have not applied a cost improvement 
score to MIPS eligible clinicians' final scores in accordance with the 
policies we established in the CY 2018 Quality Payment Program final 
rule and our regulations at Sec.  414.1380(b)(2)(iii) and (iv).
(B) Description of Previously Finalized Cost Improvement Scoring 
Methodology
    We refer readers to the CY 2024 PFS proposed rule (88 FR 52593 and 
52594) for details on previously finalized cost improvement scoring 
methodology that we established in the CY 2018 Quality Payment Program 
final rule (82 FR 53748 through 53752). In summary, we established the 
following policies:
     Determine the cost improvement score at the individual 
measure level (82 FR 53749 through 53750);
     Calculate the cost improvement score, generally by 
comparing the number of cost measures with

[[Page 79370]]

significant improvement in performance and the number of cost measures 
with significant declines in performance for a MIPS eligible clinician 
or group between two consecutive performance periods (82 FR 53750 
through 53752);
     Determine whether there was significant improvement or 
decline in performance for individual cost measures between the two 
performance periods by applying a common standard statistical test to 
measure significance, the t-test, as used in the Shared Savings Program 
(82 FR 53750 through 53752); and
     Establish that the cost improvement score cannot be lower 
than zero percentage points (82 FR 53750 through 53752).
(C) Mathematical Feasibility Issue for Cost Improvement Scoring 
Methodology
    In reviewing our cost improvement scoring methodology, we 
discovered that calculating cost improvement scoring based on comparing 
only cost measures with a statistically significant change, determined 
by using a t-test, is not congruent with the underlying data. We refer 
readers to the CY 2024 PFS proposed rule (88 FR 52594) for details on 
the mathematical feasibility issues of calculating cost improvement 
scoring with a statistical significance requirement. Generally, we 
failed to identify that the currently established cost improvement 
scoring method is not mathematically feasible, because we have not 
implemented cost improvement scoring since we finalized this 
methodology in the CY 2018 Quality Payment Program final rule as 
discussed previously. We identified the mathematical infeasibility of 
the current cost improvement methodology in the process of implementing 
cost improvement scoring for the CY 2023 performance period/2025 MIPS 
payment year. To address this mathematical feasibility issue, we 
proposed to remove the statistical significance requirement for the 
cost improvement scoring methodology (88 FR 52594 and 52595).
(D) Operational Feasibility Issues for Cost Improvement Scoring 
Methodology
    In addition, in the process of implementing cost improvement 
scoring for the CY 2023 performance period/2025 MIPS payment year, we 
identified three issues with our current policy at Sec.  
414.1380(b)(2)(iv)(A) because we determine each MIPS eligible 
clinician's cost improvement score at the individual cost measure 
level, and not the category level, for the cost performance category. 
We refer readers to the CY 2024 PFS proposed rule (88 FR 52594 and 
52595) for detailed descriptions of these issues. In summary, these 
issues are:.
     Measure level improvement scoring implementation issue: As 
of CY 2023 performance/2025 MIPS payment year, there are 25 cost 
measures, two of which are population based measures and the remaining 
23 are episode-based measures. We expect to add additional episode-
based measures to the cost performance category as MIPS matures. The 
growing number of cost measures bring into question if using the 
current methodology for cost improvement scoring introduces 
complexities to its implementation, which in turn brings into question 
operational feasibility. Maintaining measure level improvement scoring, 
for a performance category that will continue to see growth in the 
number of measures, would be resource intensive, complex to implement, 
and error prone (88 FR 52594).
     Performance category improvement scoring consistency: As 
set forth at Sec.  414.1380(b)(1)(vi)(C), we calculate each MIPS 
eligible clinician's improvement score for the quality performance 
category in MIPS at the performance category level. Upon further 
evaluation, we found that using two different methods of improvement 
scoring for the quality and cost performance categories would increase 
the implementation cost and operational complexity described above--as 
well as confuse MIPS eligible clinicians and call into question why we 
use two different methodologies. As such, we concluded that using 
category level assessment for cost improvement scoring would establish 
consistency across MIPS and allow effective communication with MIPS 
eligible clinicians, while reducing implementation cost and operational 
complexity (88 FR 52594).
     Fairness of improvement scoring: The episode-based cost 
measures are specific to certain clinical conditions and/or care 
settings. Some MIPS eligible clinicians might not have the sufficient 
volume threshold for any or all the episode-based cost measures for two 
consecutive performance periods, which would make year over year 
improvement scoring at the measure level less viable. Measure level 
improvement scoring might negatively impact these clinicians' overall 
cost performance category score because of the inclusion of measures 
outside of their scope of practice. A category level assessment 
provides an equitable cost improvement scoring for MIPS eligible 
clinicians with different scopes of practice because it would only 
reflect measures that are applicable to them (88 FR 52594 and 52595).
    To address these three issues, we proposed to revise our policy so 
that we will determine the cost improvement score at the category 
level, instead of the cost measure level, for the cost performance 
category.
(E) Modifications for Cost Improvement Scoring Methodology Beginning 
with the CY 2023 Performance Period/2025 MIPS Payment Year
    In the CY 2024 PFS proposed rule (88 FR 52595 and 52596), we 
proposed two modifications to our current cost improvement scoring 
methodology beginning with the CY 2023 performance period/2025 MIPS 
payment year because of the mathematical and operational feasibility 
issues we discovered.
    First, we proposed to determine each MIPS eligible clinician's cost 
improvement score at the category level, instead of the current measure 
level, beginning with the CY 2023 performance period/2025 MIPS payment 
year. We proposed this modification based on the operational 
feasibility considerations previously discussed. We also proposed that, 
if this proposal is finalized, Sec.  414.1380(b)(2)(iv)(A) and (C) will 
be amended to reflect that the cost improvement score will be 
determined at the category level for the cost performance category. In 
addition, we proposed that, if this proposal is finalized, Sec.  
414.1380(b)(2)(iv)(B) will be amended to reflect that we will determine 
whether sufficient data are available to measure improvement to 
calculate the cost improvement score based on whether a MIPS eligible 
clinician or group participates in MIPS using the same identifier in 2 
consecutive performance periods and is scored on the cost performance 
category for 2 consecutive performance periods.
    Second, we proposed to modify the cost improvement scoring 
methodology to remove the requirement that we compare measures with a 
``statistically significant change (improvement or decline) in 
performance'' as determined based on application of a t-test beginning 
with the CY 2023 performance period/2025 MIPS payment year. As 
previously discussed, determining cost improvement scoring based on 
statistical significance, using a t-test, is not congruent with our 
underlying data and is mathematically infeasible.
    As such, we proposed to remove the statistical significance 
requirement and update the calculation on how we quantify cost 
improvement scoring

[[Page 79371]]

accordingly. Specifically, at Sec.  414.1380(b)(2)(iv)(C), we proposed 
to determine the cost improvement score at the category level by 
subtracting the cost performance category score from the previous 
performance period (for example, CY 2022 performance period/2024 MIPS 
payment year) from the cost performance category score from the current 
performance period (for example, CY 2023 performance period/2025 MIPS 
payment year), and then by dividing the difference by the cost 
performance category score from the previous performance period (for 
example, CY 2022 performance period/2024 MIPS payment year), and by 
dividing by 100.
    In our current and established policy set forth at Sec.  
414.1380(b)(2)(iii), the overall cost performance category score for 
the current year with the improvement assessment is based on the 
following calculation: Cost Performance Category Score = Current Year 
Performance Score + Improvement Score. We did not propose any changes 
to this established policy.
    We proposed that these two modifications to our cost improvement 
scoring policy would be effective beginning with the CY 2023 
performance period/2025 MIPS payment year. As discussed in the CY 2024 
PFS proposed rule (88 FR 52593), section 1848(q)(5)(D)(i) of the Act 
requires that we account for a MIPS eligible clinician's improvement in 
the cost performance category if we have sufficient data available to 
measure improvement. Because we have not implemented cost improvement 
scoring to date, we did not have sufficient data available to measure 
year-over-year improvement scoring for the cost performance category 
until the CY 2023 performance period/2025 MIPS payment year. However, 
we do have such sufficient data available beginning with the CY 2023 
performance period/2025 MIPS payment year. Further, section 
1848(q)(5)(D)(iii) of the Act, requiring that we delay our 
implementation of cost improvement scoring through the CY 2021 
performance period/2023 MIPS payment year, no longer applies. 
Therefore, we proposed to implement cost improvement scoring, with 
these two proposed modifications, beginning with the CY 2023 
performance period/2025 MIPS payment year.
    On this basis, we proposed to amend Sec.  414.1380(b)(2)(iv)(E) to 
state that the maximum cost improvement score for the 2020, 2021, 2022, 
2023, and 2024 MIPS payment years is zero percentage points and that 
the maximum cost improvement score beginning with the CY 2025 MIPS 
payment year is 1 percentage point. In addition, we proposed to amend 
Sec.  414.1380(a)(1)(ii) to state that improvement scoring is available 
in the cost performance category starting with the 2025 MIPS payment 
year, instead of the 2024 MIPS payment year. The remainder of the 
language currently at Sec.  414.1380(a)(1)(ii) will remain the same.
    We solicited public comment on these proposals.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Several commenters supported the proposed changes to 
modify the cost improvement scoring methodology stating they appreciate 
CMS's thoughtful approach in continuing to refine the methodology.
    Response: We thank and appreciate the commenters for their support 
of our proposed modifications to the cost improvement scoring 
methodology.
    Comment: A few commenters suggested for CMS to use a phase-in 
approach for increasing the maximum cost improvement percentage point 
to allow for better year-to year comparisons in the cost performance 
category scores, given the COVID-19 PHE and lack of cost data from the 
last few years.
    Response: As discussed previously, section 1848(q)(5)(D)(i) of the 
Act requires that we account for a MIPS eligible clinician's 
improvement in the cost performance category if we have sufficient data 
available to measure improvement. We did not implement cost improvement 
scoring to date because we did not have 2 consecutive years of cost 
performance category data to measure year-over-year improvement 
scoring. We do have such data beginning with CY 2023 performance 
period/2025 MIPS payment year. On this basis, we proposed to implement 
cost improvement scoring beginning with the CY 2023 performance period/
2025 MIPS payment year. Further, we are taking a phased-in approach by 
also proposing that the maximum cost improvement score beginning with 
the 2025 MIPS payment year is only 1 percentage point. We may consider 
amending the maximum percentage point amount for the cost improvement 
score as the program matures.
    Comment: A few commenters stated that there is a need for CMS to 
prioritize clinician education, to help providers understand how the 
cost improvement score impacts their overall MIPS performance. For 
example, the commenters asked for clarification regarding how cost 
improvement score is a bonus for the cost performance category score 
rather than of a separate benchmark.
    Response: We agree with commenters regarding the need to prioritize 
clinician education on how the cost improvement score impacts their 
cost performance category and their overall MIPS performance. To this 
end, we are looking into possible educational resources for cost 
improvement scoring, in the future.
    Comment: A commenter shared their concerns regarding our for 
proposal to increase the maximum cost improvement score to 1 percentage 
point beginning with CY 2023 performance period/2025 MIPS payment year, 
which is an increase from 0 percentage points for previous years. The 
commenter stated they are concerned that this modification is being 
proposed mid-performance cycle. They stated that practices work to 
implement updates to their data collection and refinement activities 
for a given performance year based on proposals made and finalized in 
previous MIPS rulemaking cycles. Further, the commenter stated that, if 
this proposal is implemented mid-cycle, they will likely not be able to 
modify their collection and refinement practices with enough time to 
mitigate this change in cost performance category scoring. As such, 
they recommended delaying this proposed update to the cost performance 
category scoring to give clinicians the ability to prepare for the 
changes.
    Response: We believe a few clarifications are needed. First, 
clinicians do not report cost performance category measures to CMS. 
Instead, we use administrative claims data, which clinicians already 
submit for billing purposes, to calculate scores on the cost 
performance category's measures and we take into consideration all 
applicable cost measures for each given performance year. Second, our 
current policy at Sec.  414.1380(a)(1)(ii), established prior to the CY 
2024 PFS proposed rule, states that, starting with the 2024 MIPS 
payment year, improvement scoring is available in the cost performance 
category. As discussed previously, we are statutorily required to take 
into account the improvement of a MIPS eligible clinician in the cost 
performance category and potentially provide a bonus to the cost 
performance category score through this mechanism. MIPS eligible 
clinicians are generally incentivized under MIPS to always improve 
their performance.
    The change in the cost improvement scoring methodology being 
finalized in

[[Page 79372]]

this rule for the CY 2023 performance period/2025 MIPS payment year 
should not necessarily change MIPS eligible clinicians' behavior since 
they should have been aware of the potential benefit of improving their 
performance on the cost performance category's measures.
    Since we calculate performance on cost measures based on 
administrative claims data submitted for billing purposes in the 
regular course of business, MIPS eligible clinicians do not need to 
make any data collection changes in order to be scored for the cost 
performance category and are scored on all applicable cost measures for 
a given performance period. Second, cost improvement scoring is a bonus 
that can be applied to the cost performance category score. The 
proposed 1 percentage point is the maximum cost improvement score 
available that we will apply to the cost performance category.
    Comment: A commenter shared concerns with the CMS proposal to 
determine the cost improvement score at the category level instead of 
the measure level. They shared an example where a clinician was scored 
on one measure and performed well. However, they were unexpectedly 
attributed a measure outside of their specialty and scored poorly, 
bringing their cost performance category score down significantly.
    Response: We thank and appreciate the commentor for bringing to our 
attention issues with clinicians being attributed measures outside of 
their specialty and thus impacting their overall cost performance 
category score.
    We understand that inclusion of out-of-scope cost measures would 
cause concerns for evaluating improvement at the category level. We 
score MIPS eligible clinicians on cost measures that are applicable to 
the care they provided during the performance period for the cost 
performance category. We continually review our attribution methodology 
for the cost performance category to make sure we attribute cost 
measures appropriately to MIPS eligible clinicians. We note that each 
cost measure has a minimum case volume threshold (Sec.  414.1350(c)) 
that the MIPS eligible clinician must exceed for CMS to assess 
performance and calculate a score on that measure (Sec.  
414.1380(b)(2)(ii), (iv)); therefore, a MIPS eligible clinician would 
need to provide a service that triggered that cost measure more than a 
few times before CMS would attribute that cost measure to them. 
Further, we note that, if a MIPS eligible clinician has a concern that 
CMS has attributed a cost measure to them incorrectly, they may request 
targeted review under Sec.  414.1385.
    In the CY 2024 PFS proposed rule (88 FR 52594 and 52595), we 
described in detail the three reasons that informed our decision to 
change cost improvement scoring from measure to category level. These 
reasons are summarized previously in this section of the final rule. 
For instance, we explained that some MIPS eligible clinicians might not 
have the sufficient volume threshold for any or all the episode-based 
measures for two consecutive performance periods. This would make year 
over year improvement scoring at the measure level less viable. As 
such, we explained that measure level improvement scoring might 
negatively impact these clinicians' overall cost performance category 
scoring because of the inclusion of episode-based measures outside of 
their scope of practice (88 FR 52594 and 52595).
    Comment: A few commenters suggested CMS further modify the cost 
improvement methodology as it continues to be confusing for clinicians. 
One commenter suggested a more straightforward approach would be to 
multiply the change between current and previous year performance 
scores by the maximum cost improvement score (for example, 1 percentage 
point as proposed). Another commenter noted that there may be 
unintended errors in the newly proposed formula for the cost 
improvement score, specifically in the final step of the calculation 
(dividing the calculated score by 100).
    Response: Upon reviewing the final step of the cost improvement 
score calculation, (that is, dividing by 100), we agree that there was 
an unintended error in our proposal and the suggested approach to 
multiply the change between current and previous year performance 
scores by the maximum cost improvement score (for example, 1 percentage 
point as proposed) addresses this error.
    After consideration of public comments, we are finalizing our 
policies for the cost improvement scoring methodology with some 
modifications.
    First, we are finalizing that we will determine each MIPS eligible 
clinician's cost improvement score at the category level, instead of 
the current measure level, beginning with the CY 2023 performance 
period/2025 MIPS payment year. As such, we are finalizing as proposed 
amendments to Sec.  414.1380(b)(2)(iv)(A) and (C) to reflect that the 
cost improvement score will be determined at the category level for the 
cost performance category. In addition, we are finalizing as proposed 
amendments to Sec.  414.1380(b)(2)(iv)(B) to reflect that we will 
determine whether sufficient data are available to measure improvement 
to calculate the cost improvement score based on whether a MIPS 
eligible clinician or group participates in MIPS using the same 
identifier in 2 consecutive performance periods and is scored on the 
cost performance category for 2 consecutive performance periods.
    Second, we are finalizing our proposal to modify the cost 
improvement scoring methodology to remove the requirement that we 
compare measures with a ``statistically significant change (improvement 
or decline) in performance'' as determined based on application of a t-
test beginning with the CY 2023 performance period/2025 MIPS payment 
year. Accordingly, we are finalizing our proposal to remove the 
statistical significance requirement and update the calculation on how 
we quantify cost improvement scoring.
    However, based on feedback from commenters, we are finalizing our 
proposal with modification to amend our formula for calculating the 
cost improvement score at the category level. Specifically, at Sec.  
414.1380(b)(2)(iv)(C), we are finalizing that we will determine the 
cost improvement score at the category level by subtracting the cost 
performance category score from the previous performance period from 
the cost performance category score from the current performance 
period, then by dividing the difference by the cost performance 
category score from the previous performance period, and by multiplying 
the result with the maximum available cost improvement score (for 
example, 1 percentage point beginning in CY 2023 performance year/2025 
MIPS payment year). With this approach, the finalized cost improvement 
scoring methodology is consistent with improvement scoring for the 
quality performance category and previously finalized cost improvement 
scoring calculation at Sec.  414.1380(b)(2)(iv)(C) (82 FR 53748 through 
53752), where the final step was also to multiply the resulting 
fraction with the maximum available cost improvement score.
    We are also finalizing our proposal to amend Sec.  
414.1380(b)(2)(iv)(E) to state that the maximum cost improvement score 
for the 2020, 2021, 2022, 2023, and 2024 MIPS payment years is zero 
percentage points and that the maximum cost improvement score beginning 
with the CY 2025 MIPS payment year is 1 percentage point. In addition, 
we are finalizing our proposal to amend Sec.  414.1380(a)(1)(ii) to 
state

[[Page 79373]]

that improvement scoring is available in the cost performance category 
starting with the 2025 MIPS payment year, instead of the 2024 MIPS 
payment year. The remainder of the language currently at Sec.  
414.1380(a)(1)(ii) will remain the same.
f. MIPS Payment Adjustments
(1) Background
    Section 1848(q)(6)(A) of the Act requires that we specify a MIPS 
payment adjustment factor for each MIPS eligible clinician for a year. 
This MIPS payment adjustment factor is a percentage determined by 
comparing the MIPS eligible clinician's final score for the given year 
to the performance threshold we established for that same year in 
accordance with section 1848(q)(6)(D) of the Act. The MIPS payment 
adjustment factors specified for a year must result in differential 
payments such that MIPS eligible clinicians with final scores above the 
performance threshold receive a positive MIPS payment adjustment 
factor, those with final scores at the performance threshold receive a 
neutral MIPS payment adjustment factor, and those with final scores 
below the performance threshold receive a negative MIPS payment 
adjustment factor.
    For previously established policies regarding our determination and 
application of MIPS payment adjustment factors to each MIPS eligible 
clinician, we refer readers to the CY 2017 Quality Payment Program 
final rule (81 FR 77329 through 77343), CY 2018 Quality Payment Program 
final rule (82 FR 53785 through 53799), CY 2019 PFS final rule (83 FR 
59878 through 59894), CY 2020 PFS final rule (84 FR 63031 through 
63045), CY 2021 PFS final rule (85 FR 84917 through 84926), CY 2022 PFS 
final rule (86 FR 65527 through 65537), and CY 2023 PFS final rule (87 
FR 70096 through 70102).
    In the CY 2023 PFS final rule (87 FR 70096 through 70102), we 
established the performance threshold for the CY 2023 performance 
period/2025 MIPS payment year by calculating the mean of the final 
scores for all MIPS eligible clinicians using CY 2017 performance 
period/2019 MIPS payment year data. In addition, we included 
information about our timing for providing MIPS performance feedback to 
MIPS eligible clinicians for the CY performance period in accordance 
with section 1848(q)(12) of the Act.
(2) Establishing the Performance Threshold
(a) Statutory Background and Authority
    As discussed above, in order to determine a MIPS payment adjustment 
factor for each MIPS eligible clinician for a year, we must compare the 
MIPS eligible clinician's final score for the given year to the 
performance threshold we established for that same year in accordance 
with Section 1848(q)(6)(D) of the Act. Section 1848(q)(6)(D)(i) of the 
Act requires that we compute the performance threshold such that it is 
the mean or median (as selected by the Secretary) of the final scores 
for all MIPS eligible clinicians with respect to a ``prior period'' 
specified by the Secretary. Section 1848(q)(6)(D)(i) of the Act also 
provides that the Secretary may reassess the selection of the mean or 
median every 3 years.
    Sections 1848(q)(6)(D)(ii) through (iv) of the Act provided special 
rules, applicable only for certain initial years of MIPS, for our 
computation and application of the performance threshold for our 
determination of MIPS payment adjustment factors. These special rules 
are no longer applicable for establishing the performance threshold for 
the CY 2024 performance period/2026 MIPS payment year. We refer readers 
to the CY 2024 PFS proposed rule (88 FR 52596) for further information 
on these previously applicable requirements as they explain our prior 
computations of the performance threshold.
    In the CY 2022 PFS final rule (86 FR 65527 through 65532), we 
selected the mean as the methodology for determining the performance 
threshold for the CY 2022 through 2024 performance periods/2024 through 
2026 MIPS payment years. We also established in our regulation at Sec.  
414.1405(g) that, for the CY 2022 through 2024 performance periods/2024 
through 2026 MIPS payment years, the performance threshold would be the 
mean of the final scores for all MIPS eligible clinicians from a prior 
period.
    For the CY 2022 through CY 2023 performance periods/2024 through 
2025 MIPS payment years, we selected a single performance period when 
selecting a prior period to compute the mean of the final scores and 
establish the performance threshold. However, as discussed under 
paragraph (b) of this section, we proposed to modify and refine our 
policy for selecting a ``prior period'' to establish the performance 
threshold under paragraph (b) of this section.
    For further information on our current performance threshold 
policies, we refer readers to the CY 2017 Quality Payment Program final 
rule (81 FR 77333 through 77338), CY 2018 Quality Payment Program final 
rule (82 FR 53787 through 53792), CY 2019 PFS final rule (83 FR 59879 
through 59883), CY 2020 PFS final rule (84 FR 63031 through 63037), CY 
2021 PFS final rule (85 FR 84919 through 84923), CY 2022 PFS final rule 
(86 FR 65527 through 65532), and CY 2023 PFS final rule (87 FR 70096 
through 70100).
    We codified the performance thresholds for each of the first 7 
years of MIPS at Sec.  414.1405(b)(4) through (9). These performance 
thresholds are shown in Table 58.
[GRAPHIC] [TIFF OMITTED] TR16NO23.086


[[Page 79374]]


(b) Modification to Our Policy for Establishing the Performance 
Threshold
    In previous years, we selected a single performance period when 
selecting a prior period. In the proposed rule, we reassessed our 
previous interpretation of ``prior period'' as described at section 
1848(q)(6)(D)(i) of the Act. We refer readers to the CY 2024 PFS 
proposed rule for more detailed information on how we interpreted 
``prior period'' within the statutory language (88 FR 52597). Because 
section 1848(q)(6)(D)(i) of the Act does not specifically refer to ``a 
performance period'' or ``year'' to establish the performance 
threshold, we noted that the term ``prior period'' could refer to a 
time span other than a single year or performance period as long as 
that ``prior period'' is specified by the Secretary.
    Given our interpretation that ``prior period'' does not require CMS 
to select a single performance year as the period, we proposed to add 
Sec.  414.1405(g)(2) to specify that, beginning with the CY 2024 
performance period/2026 MIPS payment year, a ``prior period'' for 
purposes of establishing a performance threshold as identified in Sec.  
414.1405(b) is a time span of 3 performance periods. Subsequently, we 
also proposed to redesignate language at Sec.  414.1405(g) which states 
that, for each of the 2024, 2025, and 2026 MIPS payment years, the 
performance threshold is the mean of the final scores for all MIPS 
eligible clinicians from a prior period as specified under paragraph 
(b) of this section, as Sec.  414.1405(g)(1) (88 FR 52597 and 52598).
    Using three performance periods as the prior period would prevent 
the performance threshold from being dependent on a single potentially 
anomalous performance period, or on two performance periods, whose mean 
or median final score may be an outlier compared to other performance 
periods. The mean or median of final scores over 36 months is less 
likely to be impacted by unusual fluctuations in performance specific 
to a shorter time frame, is more likely to reflect clinician 
performance, and therefore, more appropriate to set the performance 
threshold. Additionally, as more data become available, we will 
consider whether a longer time span than three performance periods may 
be appropriate to mitigate outliers and better reflect clinician 
performance trends.
    We requested comments on our proposal to use three performance 
periods as the ``prior period'' we use to establish the performance 
threshold and codify the policy at Sec.  414.1405(g)(2).
    We received public comments on the proposal. The following is a 
summary of the comments we received and our responses.
    Comment: Several commenters supported the proposal that, for 
purposes of establishing a performance threshold, a ``prior period'' 
would be 3 performance periods beginning with the CY 2024 performance 
period/2026 MIPS payment year. Some commenters stated that this 
proposal has promise to improve stability in MIPS in future years.
    Response: We thank the commenters for their support.
    Comment: A number of commenters suggested that we treat the CY 2024 
performance period/2026 MIPS payment year as a ``recovery'' period 
given the public health emergency (PHE) for COVID-19. On this basis, 
commenters suggested we delay implementation of the proposal to define 
``prior period'' as 3 years. Several commenters suggested not using a 
3-year prior period until we are able to use more recent data that is 
not impacted by the PHE for COVID-19.
    Response: We agree that MIPS eligible clinicians, health systems, 
and physician groups may still be recovering from the PHE for COVID-19, 
which expired on May 11, 2023,\500\ and this recovery may continue into 
CY 2024. After consideration of this feedback, we are not finalizing 
our proposal in defining a ``prior period'' as a time span of 3 
performance periods for purposes of establishing a performance 
threshold. While we continue to believe that using 3 years of data 
better accounts for outliers as opposed to using a single year, we 
agree with commenters that it is in our best interest to delay 
finalizing this proposal until we have more recent data that is not 
impacted by the PHE for COVID-19. We will continue to examine the issue 
and will propose any changes in future rulemaking. In response to 
public comment, we also note that we do not intend to rely on data from 
the CY 2020 through 2021 performance periods/CY 2022 through CY 2023 
MIPS payment years due to the PHE for COVID-19, as discussed in section 
IV.A.4.h.(2)(c)of this final rule.
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    Comment: A few commenters did not support our proposal to define 
``prior period'' for purposes of establishing a performance threshold 
as a time span of 3 performance periods. More specifically, a few 
commenters noted their belief that we misinterpreted the statute's 
language when it references ``prior period'' and do not believe that 
the statute allows us to combine performance data from multiple years 
to establish the performance threshold. Rather, the commenters stated 
that we should continue to use a single performance period for the 
purposes of establishing the performance threshold.
    Response: We disagree that we misinterpreted the statute's language 
when it references ``prior period.'' As previously stated, the use of 
``prior period'' in section 1848(q)(6)(D)(i) of the Act differs from 
other provisions in the statute which specifically refer to ``a year'' 
or ``performance period.'' Certain statutory provisions governing MIPS 
clearly distinguish the terms ``performance period'' and ``year'' from 
``prior period'' used in section 1848(q)(6)(D)(i) of the Act. If the 
``prior period'' we use to determine the mean or median of all MIPS 
eligible clinicians' final scores to establish the performance 
threshold under section 1848(q)(6)(D)(i) of the Act was intended to be 
limited to a single year or performance period, we believe the statute 
would have been more specific and used ``performance period'' or 
``year'' rather than using the unique term ``prior period.'' However, 
as discussed herein, after consideration of the feedback we received, 
we will continue to use a single performance period for the purposes of 
establishing the performance threshold for the CY 2024 performance 
period/CY 2026 MIPS payment year. We note that we will continue to 
examine the issue and will propose any changes in future rulemaking.
    After consideration of public comments, we are not finalizing our 
proposal to add to Sec.  414.1405(g)(2) such that it will specify that, 
beginning with the CY 2024 performance period, we will define a ``prior 
period'' for purposes of establishing a performance threshold as 
identified in Sec.  414.1405(b) as a time span of 3 performance 
periods. We are also not finalizing our proposal to redesignate 
language at Sec.  414.1405(g) which states that, for each of the 2024, 
2025, and 2026 MIPS payment years, the performance threshold is the 
mean of the final scores for all MIPS eligible clinicians from a prior 
period as specified under paragraph (b) of this section, as Sec.  
414.1405(g)(1).
(c) Performance Threshold for the CY 2024 Performance Period/2026 MIPS 
Payment Year
    While we chose to use the mean in our methodology for determining 
the performance threshold for the CY 2022 through 2024 performance 
periods/2024

[[Page 79375]]

through 2026 MIPS payment years, we did not specify which prior 
period's mean final score we would use for the CY 2024 performance 
period/2026 MIPS payment year's performance threshold. From our review 
of the data available at the time, we identified the mean final scores 
for each of the CY 2017 through 2021 performance periods/2019 through 
2023 MIPS payment years individually, as well as the mean of the final 
scores for CY 2017 through CY 2019 performance periods/2019 through 
2021 MIPS payment years combined, as shown in Table 59. We included 
means of final scores for MIPS eligible clinicians spanning over three 
performance periods within Table 59 in addition to a single year 
performance period. These six values represent the mean final scores 
for all MIPS eligible clinicians from prior periods that are available 
for consideration for the CY 2024 performance period/2026 MIPS payment 
year performance threshold.
    We did not consider the means of the final scores for certain prior 
periods for the purpose of establishing the performance threshold 
because of issues with the underlying data. First, we did not consider 
the CY 2020 through 2021 performance periods/2022 through 2023 MIPS 
payment years because we extensively applied our extreme and 
uncontrollable circumstances policies described under Sec.  
414.1380(c)(2)(i) to MIPS eligible clinicians nationwide due to the 
COVID-19 PHE, which we believe resulted in skewing the final scores 
from those years such that they are not an appropriate indicator for 
future clinician performance. We announced on April 6, 2020, the 
application of extreme and uncontrollable circumstances policies 
described under Sec.  414.1380(c)(2)(i) to MIPS eligible clinicians 
nationwide due to the COVID-19 PHE for the CY 2019 performance period/
2021 MIPS payment year (85 FR 19277 through 19278). However, given the 
timing of the COVID-19 PHE and this announcement, the data from that CY 
2019 performance period was likely minimally impacted because many MIPS 
eligible clinicians had already submitted the data. Second, the final 
scores for the CY 2022 performance period/2024 MIPS payment year were 
not finalized in time for the proposed rule and, therefore, the mean 
final score for the CY 2022 performance period/2024 MIPS payment year 
was not included for consideration as a potential performance threshold 
value for the CY 2024 performance period/2026 MIPS payment year.
[GRAPHIC] [TIFF OMITTED] TR16NO23.087

    As shown in Table 59, the mean final scores available for 
consideration for the CY 2024 performance period/2026 MIPS payment year 
performance threshold cover a range of values from 74.65 points to 
89.47 points (rounded to 75 points and 89 points, respectively). We 
proposed to use the CY 2017 through CY 2019 performance periods/2019 
through 2021 MIPS payment years (mean of 82 points, rounded down from 
82.06 points) as the prior period for the purpose of establishing the 
performance threshold for the CY 2024 performance period/2026 MIPS 
payment year for several reasons. We refer readers to the CY 2024 PFS 
proposed rule for our discussion of this proposal (88 FR 52598 through 
52599).
    For the last 2 performance periods/MIPS payment years, we 
established at Sec.  414.1405(b)(9) the performance threshold as 75 
points based on the CY 2017 performance period/2019 MIPS payment year. 
We did not increase the performance threshold between the CY 2023 
performance period/2025 MIPS payment year and the prior year (CY 2022 
performance period/2024 MIPS payment year) due to reasons noted in the 
CY 2023 PFS final rule (87 FR 70096 through 70100) and discussed in the 
CY 2024 PFS proposed rule (88 FR 52599). Generally, these reasons were 
related to expiration of transition policies and the COVID-19 PHE.
    We proposed, pursuant to the methodology we established previously 
at Sec.  414.1405(g), that the performance threshold for the CY 2024 
performance period/2026 MIPS payment year would be the mean of the 
final scores for all MIPS eligible clinicians for the CY 2017 through 
2019 performance periods/2019 through 2021 MIPS payment years, which is 
82 points (rounded from 82.06 points). We proposed corresponding 
changes to Sec.  414.1405(b)(9) to reflect this proposal (88 FR 52599).
    Alternatively, in an effort to use more recent data, we considered 
using the single CY 2019 performance period/2021 MIPS payment year, 
with a mean of 86 (rounded from 85.63) to establish the performance 
threshold for the CY 2024 performance period/2027 MIPS payment year. 
However, in an effort to use more robust data from a longer period of 
time, we proposed using the CY 2017 through 2019 performance period/
2019 through 2021 MIPS payment year as the prior period, with its mean 
of 82 points, to set the performance threshold for the CY 2024 
performance period/2026 MIPS payment year. We also believe the 
performance threshold of 82 instead of 86 would be more appropriate for 
clinician practices that are still recovering from the impacts of the 
COVID-19 PHE.
    In the Regulatory Impact Analysis (RIA) in section VI.E.22.d.(4) of 
the final rule, we estimate that approximately 22 percent of MIPS 
eligible clinicians would receive a negative payment adjustment for the 
CY 2024 performance period/2026 MIPS payment year if the performance 
threshold is established at 75 points. Under the original proposal of 
establishing the performance threshold at 82 points, we estimated that 
approximately 46 percent of MIPS eligible clinicians would receive a 
negative payment adjustment for the CY 2024 performance period/2026 
MIPS payment year (88 FR 52599). We refer readers to the alternatives 
considered under the RIA where we present the impact of using data from 
alternative years to determine the performance threshold for the CY 
2024 performance period/2026 MIPS payment year.

[[Page 79376]]

    We requested comments on this proposal, as well as whether we 
should use means of final scores from alternative years to set the 
performance threshold for the CY 2024 performance period/2026 MIPS 
payment year, which we considered and discussed in the RIA in section 
VII.F.4 of the proposed rule. We received public comments on the 
proposal. The following is a summary of the comments we received and 
our responses.
    Comment: A few commenters supported our proposal to use the CY 2017 
through CY 2019 performance periods/2019 through 2021 MIPS payment 
years (mean of 82 points), as the prior period for the purpose of 
establishing the performance threshold for the CY 2024 performance 
period/2016 MIPS payment year.
    Response: We thank the commenters for their support.
    Comment: Many commenters urged us to not finalize the proposal to 
use the CY 2017 through the CY 2019 performance periods/2019 through 
2021 MIPS payment years (mean of 82 points), as the prior period for 
the purpose of establishing the performance threshold for the CY 2024 
performance period/2026 MIPS payment year. Specifically, some 
commenters stated that many health systems and physician practices 
continue to face financial and resource constraints and clinicians are 
continuing to recover from the PHE for COVID-19.
    Commenters further opposed using data from the CY 2017 through 2019 
performance periods/2019 through 2021 MIPS payment years as the prior 
period for the CY 2024 performance period/2026 MIPS payment year due to 
concern that those years, and their data and final scores, reflect 
prior transition policies. A few commenters voiced concerns that, 
because there are now new cost measures within the program in addition 
to the cost performance category weight increasing, MIPS eligible 
clinicians need more time getting acclimated with those measures. Many 
commenters suggested we continue to keep the performance threshold at 
75 points and treat the CY 2024 performance period/CY 2026 MIPS payment 
year as a transition year given that we applied our automatic extreme 
and uncontrollable circumstances (EUC) policy for the COVID-19 PHE for 
the CY 2019 through 2021 performance periods/CY 2021 through 2023 MIPS 
payment years.
    Response: We aim to balance concerns regarding the impact of the 
PHE for COVID-19 on MIPS eligible clinicians with policies that 
motivate clinicians to participate in MIPS and strive for continuous 
improvement on the measures and activities. When we proposed 
establishing the performance threshold at 82 points for the CY 2024 
performance period/2026 MIPS payment year, we considered what was 
appropriate for clinician practices that are still recovering from the 
impacts of the COVID-19 PHE (88 FR 52599). However, after consideration 
of public comments, we believe that establishing the performance 
threshold at 75 points, using data from the CY 2017 performance period/
2019 MIPS payment year, for the CY 2024 performance period/2026 MIPS 
payment year better achieves this goal. This means that the performance 
threshold will remain at the same level as was established for CY 2022 
through CY 2023 performance periods/2024 through 2025 MIPS payment 
years.
    We recognize that clinician recovery from the PHE coincides with 
several changes to the Quality Payment Program, including the removal 
of transition policies such as quality bonus points, which had been 
established for scoring the quality performance category for the CY 
2018 through 2020 performance periods/2020 through 2022 MIPS payment 
years (86 FR 65491 through 65507). We also acknowledge that for the CY 
2019 through 2021 performance periods/2021 through 2023 MIPS payment 
years, we applied certain extreme and uncontrollable circumstances 
policies described under Sec.  414.1380(c)(2)(i) to MIPS eligible 
clinicians nationwide due to the COVID-19 PHE, which resulted in some 
clinicians not gaining experience with reporting on MIPS measures and 
activities due to the reweighting of some performance categories. The 
application of the automatic extreme and uncontrollable policies also 
resulted in many clinicians not submitting data for certain performance 
categories in order to receive reweighting of some performance 
categories leading to potentially inflated scores that would not be 
representative of our current scoring policies. (87 FR 70097). Given 
the expiration of those transition policies, as well as the possibility 
that the performance categories will be reweighted for fewer MIPS 
eligible clinicians for the CY 2023 performance period/2025 MIPS 
payment year, we expect the mean final score for CY 2023 performance 
period/2025 MIPS payment year to be lower than the mean final scores 
from the CY 2018 through 2020 performance periods/2020 through 2022 
MIPS payment years.
    We note that, on a similar basis, we established the performance 
threshold at 75 points for the CY 2023 performance period/2025 MIPS 
payment year, without any change from the prior performance period (87 
FR 70096 through 70100). Maintaining the performance threshold at 75 
points, without any change, for the CY 2024 performance period/2026 
MIPS payment year is consistent with our prior policy and addresses 
concerns raised by commenters, as previously discussed.
    After receiving overwhelming public comment in favor of continuing 
the existing performance threshold of 75 points, we believe the 
rationale we used in selecting the performance threshold for the CY 
2023 performance period/2025 MIPS payment year should be further 
applied to the CY 2024 performance period/2026 MIPS payment year. We 
believe this approach addresses commenters' concerns about the COVID-19 
PHE, the impact of removing transition policies and bonuses, and 
changes to the cost performance category weight and measure inventory. 
This approach also allows for at least one complete year of performance 
(the CY 2024 performance period) after the COVID-19 PHE expired on May 
11, 2023, from which we may later gather data regarding final scores to 
inform future performance thresholds. Further, this policy aligns with 
the policy we are finalizing in section IV.A.4.h.(2)(b) of this final 
rule, where we are not finalizing the proposal that a ``prior period'' 
is a time span of 3 performance periods.
    We continue to believe that once MIPS eligible clinicians have been 
given at least one complete year of performance after expiration of the 
COVID-19 PHE, as clinicians gain more experience with MIPS, and as more 
recent data are available, we should incorporate more recent data in 
determining the performance threshold. Accordingly, we will continue to 
consider updating the performance threshold with more recent data in 
future years.
    Comment: A few commenters opposed using the CY 2017 through 2019 
performance periods/CY 2019 through 2021 MIPS payment years but agreed 
that CMS should not use data from the CY 2020 through 2021 performance 
periods/2022 through 2023 MIPS payment years. One commenter suggested 
that we use data from CY 2022 through CY 2024 performance periods/CY 
2024 through CY 2026 MIPS payment years for the purposes of 
establishing the performance threshold in future years.
    Response: We agree with commenters that we should not use data from 
the CY 2020 through 2021 performance

[[Page 79377]]

periods/2022 through 2023 MIPS payment years, as discussed previously, 
and note our continued intention to not use these data. We also note 
that as more recent data becomes available (for example, CY 2024 
performance period/CY 2026 MIPS payment year) we will continue to 
consider updating the performance threshold with more recent data in 
future years.
    Comment: A few commenters expressed concerns that setting the 
performance threshold at 82 will inadvertently harm small and rural 
practices, creating further challenges for them to successfully 
participate within the MIPS program.
    Response: We have several policies within MIPS that continue to 
support small and rural practices, including scoring and reweighting 
policies, and opportunities to apply for hardships. However, as 
previously discussed, we are finalizing a policy to establish the 
performance threshold for the CY 2024 performance period/2026 MIPS 
payment year at 75 points. As we consider the performance threshold and 
its related policies in future years, we will continue to consider the 
impact on small and rural practices.
    Comment: A few commenters expressed concerns that there were not 
enough quality measures within MIPS for certain specialties (for 
example, psychologists and non-patient facing clinicians) to 
successfully achieve the performance threshold of 82 points. One 
commenter suggested we delay increasing the performance threshold until 
we adopt new quality measures for additional specialties within MIPS. 
Additionally, a few commenters stated their concerns that certain 
specialties only have topped out measures to report. For example, the 
quality measures available for physical therapists are process-based 
measures capped at seven points which make it difficult for them to 
meet the increased performance threshold even if they perform very well 
on those measures.
    Response: We understand that some MIPS eligible clinicians may not 
have six measures to select in the quality performance category which 
are relevant to their practice or may be topped out measures. To 
address this, we established an eligible measure applicability policy 
within the quality performance category, to reduce the denominator of 
required measures for the collection type used by a clinician if the 
clinician has fewer than six applicable measures to report in that 
collection type. This allows clinicians to be scored on the quality 
measures that are relevant to their scope of practice. For more 
information on the eligible measure applicability policy please see the 
CY 2017 and CY 2018 Quality Payment Program final rules (81 FR 77290 
through 77291, 82 FR 53730 through 53732). To address the commenters' 
concerns on the specialty measures available, we solicit commenter 
recommendations for new specialty measure sets and revisions to 
existing specialty measure sets on an annual basis. We encourage 
interested parties to provide recommendations during the specialty 
measure set solicitation process (for more information please see the 
QPP resource library at http://www.qpp.cms.gov). We also encourage 
clinicians that do lack sufficient quality measures relevant to their 
scope of practice to work with their specialty societies to provide 
recommendations during the specialty measure set solicitation process 
and to consider reporting a relevant MVP when one becomes available. As 
previously discussed, we also note that, in response to commenters' 
concerns with the impact of PHE for COVID-19 still continuing, we are 
establishing the performance threshold at 75 points for the CY 2024 
performance period/2026 MIPS payment year, which may be more achievable 
for specialists with limited measures relevant to their practice.
    Comment: A few commenters suggested that we break down the data 
analysis by specialty and establish multiple performance thresholds for 
certain clinician types (for example, specialties or MIPS eligible 
clinicians within their first or second year, etc.).
    Response: Section 1848(q)(6)(D)(i) of the Act requires that we 
compute the performance threshold, with respect to which ``the 
composite score of MIPS eligible professionals shall be compared for 
purposes of determining [MIPS] adjustment factors,'' such that it is 
the mean or median (as selected by the Secretary) of the final scores 
for all MIPS eligible clinicians with respect to a ``prior period'' 
specified by the Secretary. We would like to emphasize that section 
1848(q)(6)(D)(i) of the Act requires us to compute ``a performance 
threshold,'' meaning one performance threshold. Similarly, section 
1848(q)(6)(A)(i) of the Act requires that we then compare each MIPS 
eligible clinician's final score to ``the performance threshold 
established'' under section 1848(q)(6)(D)(i) of the Act for such year, 
requiring comparison of final scores against a singular threshold. We 
are unable to establish multiple performance thresholds as requested.
    Comment: One commenter stated that clinicians with limited 
resources tend to score lower within MIPS and therefore have their 
payments reduced leading to having fewer resources to continue treating 
patients. Rather, the commenter stated their belief that MIPS is more 
about rewarding the ``well-resourced'' groups with significant bonuses 
at the expense of other groups that may not have the opportunity to 
score well.
    Response: We strive to ensure that performing well within MIPS is 
an achievable goal across all MIPS eligible clinician types, and we 
have established various policies in place to allow that as possible. 
Further, we remind the commenter who is concerned about the magnitude 
or distribution of the positive payments adjustments that MIPS is a 
budget neutral by statute. Generally stated, it is designed to balance 
the positive payment adjustments of clinicians that achieve final 
scores above the performance threshold against the negative payment 
adjustments of clinicians that achieve final scores below the 
performance threshold. Therefore, a larger proportion of clinicians 
receiving a negative payment adjustment generally would result in 
larger positive payment adjustments for those above the performance 
threshold. Additionally, as discussed herein, after consideration of 
commenters' feedback, we are finalizing the performance threshold at 75 
points, which we believe is an achievable performance threshold across 
all MIPS eligible clinicians. We encourage the commenter to look at our 
estimates of how our finalized policies will affect the payment 
adjustments in our regulatory impact analysis in section VI.E.22.d.(4). 
of this final rule.
    Comment: A few commenters stated concerns about the proposed 
performance threshold due to the absence of an inflationary update and 
continued cuts to the conversion factor within the PFS.
    Response: We note that, to determine a MIPS payment adjustment 
factor for each MIPS eligible clinician for a payment year, we must 
compare the MIPS eligible clinician's final score for the given 
performance period/payment year to the performance threshold we 
established for that same year in accordance with section 1848(q)(6)(D) 
of the Act. Section 1848(q)(6)(D)(i) of the Act requires that we 
compute the performance threshold such that it is the mean or median 
(as selected by the Secretary) of the final scores for all MIPS 
eligible clinicians with respect to a ``prior period'' specified by the 
Secretary. We are unable to consider issues such as the inflation rate 
or the conversion factor that is discussed in the broader PFS rule. 
Rather, as is statutorily required, we continue to consider performance 
thresholds that are the mean or median of the final

[[Page 79378]]

scores from a ``prior period'' specified by the Secretary for all MIPS 
eligible clinicians.
    As previously discussed, after consideration of public comments, we 
are not finalizing our proposal to use the CY 2017 through CY 2019 
performance periods/2019 through 2021 MIPS payment years (mean of 82 
points, rounded from 82.06 points) as the prior period for the purpose 
of establishing the performance threshold for the CY 2024 performance 
period/2026 MIPS payment year. We are no longer required by section 
1848(q)(6)(D)(iv) of the Act \501\ to methodically increase the 
performance threshold each year to ``ensure a gradual and incremental 
transition'' to the expected performance threshold. Instead, we are 
establishing that the performance threshold for the CY 2024 performance 
period/2026 MIPS payment year is 75 points, using the mean of the final 
scores for all MIPS eligible clinicians using CY 2017 performance 
period/2019 MIPS payment year data. We are codifying this performance 
threshold of 75 points for the 2026 MIPS payment year, based on the 
2019 MIPS payment year, at Sec.  414.1405(b)(9)(iii).
---------------------------------------------------------------------------

    \501\ Section 1848(q)(6)(D)(iv) of the Act is a special rule 
applicable to establishing the performance threshold for the third, 
fourth, and fifth years of MIPS. As we are entering the eighth year 
of MIPS, the requirements of section 1848(q)(6)(D)(iv) of the Act no 
longer apply.
---------------------------------------------------------------------------

    We note that since we anticipate clinicians' scores to increase as 
they gain more experience in MIPS, the performance threshold may 
increase in future years based on the selected mean or median. We also 
strive to foster continuous improvement within MIPS.
(3) Example of Adjustment Factors
    Figure 1 provides an illustrative example of how various final 
scores will be converted to a MIPS payment adjustment factor using the 
statutory formula and based on our proposed policies for the CY 2024 
performance period/2026 MIPS payment year. In Figure 1, the performance 
threshold is set at 75 points, as we finalized in section 
IV.A.4.h.(2)(c) of this final rule.
    For purposes of determining the maximum and minimum range of 
potential MIPS payment adjustment factors, section 1848(q)(6)(B) of the 
Act defines the applicable percentage as 9 percent for the CY 2024 
performance period/2026 MIPS payment year. The MIPS payment adjustment 
factor is determined on a linear sliding scale from zero to 100, with 
zero being the lowest possible score which receives the negative 
applicable percentage and resulting in the lowest payment adjustment, 
and 100 being the highest possible score which receives the highest 
positive applicable percentage and resulting in the highest payment 
adjustment.
    However, there are two modifications to this linear sliding scale. 
First, as specified in section 1848(q)(6)(A)(iv)(II) of the Act, there 
is an exception for a final score between zero and one-fourth of the 
performance threshold (zero and 18.75 points based on the performance 
threshold of 75 points for the CY 2024 performance period/2026 MIPS 
payment year). All MIPS eligible clinicians with a final score in this 
range will receive a negative MIPS payment adjustment factor equal to 9 
percent (the applicable percentage). Second, the linear sliding scale 
for the positive MIPS payment adjustment factor is adjusted by the 
scaling factor, which cannot be higher than 3.0, as required by section 
1848(q)(6)(F)(i) of the Act.
    If the scaling factor is greater than zero and less than or equal 
to 1.0, then the MIPS payment adjustment factor for a final score of 
100 will be less than or equal to 9 percent (the applicable 
percentage). If the scaling factor is above 1.0 but is less than or 
equal to 3.0, then the MIPS payment adjustment factor for a final score 
of 100 will be greater than 9 percent. Only those MIPS eligible 
clinicians with a final score equal to 75 points (the performance 
threshold for the CY 2024 performance period/2026 MIPS payment year) 
will receive a neutral MIPS payment adjustment.
    Beginning with the CY 2023 performance period/2025 MIPS payment 
year, the additional MIPS payment adjustment for exceptional 
performance described in section 1848(q)(6)(C) of the Act is no longer 
available. For this reason, Figure 1 does not illustrate an additional 
adjustment factor for MIPS eligible clinicians with final scores at or 
above the additional performance threshold described in section 
1848(q)(6)(D)(ii) of the Act.

[[Page 79379]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.088

    Table 60 illustrates the changes in payment adjustment based on the 
final policies from the CY 2023 PFS final rule (87 FR 70096 through 
70103) for the CY 2023 performance period/2025 MIPS payment year and 
the finalized policies for the CY 2024 performance period/2026 MIPS 
payment year, as well as the applicable percent required by section 
1848(q)(6)(B) of the Act.
[GRAPHIC] [TIFF OMITTED] TR16NO23.089


[[Page 79380]]


g. Review and Correction of MIPS Final Score
(1) Feedback and Information To Improve Performance
    Under section 1848(q)(12)(A)(i) of the Act, we are required to 
provide MIPS eligible clinicians with timely (such as quarterly) 
confidential feedback on their performance under the quality and cost 
performance categories beginning July 1, 2017, and we have discretion 
to provide such feedback regarding the improvement activities and 
Promoting Interoperability performance categories. In the CY 2018 
Quality Payment Program final rule (82 FR 53799 through 53801), we 
finalized that on an annual basis, beginning July 1, 2018, performance 
feedback will be provided to MIPS eligible clinicians and groups for 
the quality and cost performance categories, and if technically 
feasible, for the improvement activities and advancing care information 
(now called the Promoting Interoperability) performance categories.
    We made performance feedback available for the CY 2019 performance 
period/2021 MIPS payment year on August 5, 2020; for the CY 2020 
performance period/2022 MIPS payment year on August 2 and September 27, 
2021; and for the CY 2021 performance period/2023 MIPS payment year on 
August 22, 2022. Feedback for the CY 2022 performance period/2024 MIPS 
payment year was made available on August 10, 2023. We direct readers 
to qpp.cms.gov for more information.
K. Targeted Review
a. Background
    Section 1848(q)(13)(A) of the Act requires that the Secretary 
establish a process under which a MIPS eligible clinician may seek an 
informal review of the calculation of the MIPS adjustment factor (or 
factors) applicable to the MIPS eligible clinician. In the CY 2017 
Quality Payment Program final rule (81 FR 77353 through 77358), we 
finalized a targeted review process and related requirements under MIPS 
wherein a MIPS eligible clinician or group may request a review of the 
calculation of the MIPS payment adjustment factor and, as applicable, 
the calculation of the additional MIPS payment adjustment factor 
applicable to such MIPS eligible clinician or group for a year. 
Currently, MIPS eligible clinicians, groups, and Alternative Payment 
Model (APM) entities may request and receive targeted review of our 
calculation of their MIPS payment adjustment factor(s) under our 
established process and related requirements. In the CY 2017 Quality 
Payment Program final rule (81 FR 77546), we codified the MIPS targeted 
review process and related requirements at Sec.  414.1385(a).
    In the CY 2020 PFS final rule (84 FR 63045 through 63049), we 
revised the MIPS targeted review process and related requirements to 
address persons eligible to request targeted review, timeline for 
submission of targeted review requests, denial of targeted review 
requests, our requests for additional information, notification of 
targeted review decisions, and scoring recalculations. We codified 
these revisions to the targeted review process and related requirements 
at Sec.  414.1385(a) (84 FR 63197 through 63198).
    Currently, as specified at Sec.  414.1385(a)(2), we provide that 
all requests for targeted review must be submitted within a 60-day 
period, beginning on the day that we make available the MIPS payment 
adjustment factors for the MIPS payment year applicable to each MIPS 
eligible clinician. In addition, Sec.  414.1385(a)(2) provides that we 
may extend the targeted review request submission period. However, this 
current submission period for MIPS targeted review presents significant 
challenges to CMS as we seek to implement application of a 
differentially higher PFS conversion factor for eligible clinicians who 
are Qualifying APM Participants (QPs) for a year beginning with the CY 
2024 QP Performance period/2026 payment year, as required by section 
1848(d)(1)(A) of the Act.
    Specifically, to ensure application of the alternative conversion 
factor for eligible clinicians who are QPs, we must submit the final 
list of QPs to our Medicare Administrative Contractors no later than 
October 1st of the preceding year. However, under our current targeted 
review timeline for MIPS, this information would not be available until 
the first week of December. This is because the targeted review request 
submission period begins upon notification of the MIPS payment 
adjustment factors, which takes place sometime in August, and ends 60 
days later, sometime in November. While QPs are excluded from MIPS 
reporting and any MIPS payment adjustment, we have received and 
addressed several requests for targeted review based on a clinician 
disputing whether they should be designated as a QP or a MIPS eligible 
clinician for purposes of payment under the Quality Payment Program. 
Based on our experience, we have found that more often than not a MIPS 
eligible clinician was initially identified as a QP but did not in fact 
participate in an Advanced APM and, conversely, a MIPS eligible 
clinician who believes they had achieved QP status was not identified 
as such. The targeted review process allows for clinicians to bring 
these issues to our attention. Accordingly, the targeted review process 
is essential to compiling an accurate list of QPs, which is necessary 
for purposes of determining who receives the application of the higher 
PFS conversion factor (also known as ``qualifying APM conversion 
factor'') of 0.75 percent (versus non-QPs, who receive 0.25 percent).
    Section 1848(q)(13)(A) of the Act does not specify a timeframe for 
targeted review, broadly requiring that we ``establish a process'' for 
informal review of our calculation of the MIPS adjustment factor. 
Section 1848(q)(13)(A) of the Act only requires that the targeted 
review process permit a MIPS eligible clinician to seek ``informal 
review of the calculation of the MIPS adjustment factor (or factors)'' 
applicable to the MIPS eligible clinician for a MIPS payment year. We 
believe this broad authority for establishing this targeted review 
process, and lack of specificity as to any timeframe required for such 
process, permits CMS to determine a reasonable time period for 
submission of a request for targeted review so long as a MIPS eligible 
clinician can submit a request after we have informed them of our 
calculation of their MIPS adjustment factor(s).
    Therefore, we proposed to permit submission of a request for 
targeted review beginning on the day we make available the MIPS final 
score and ending 30 days after publication of the MIPS payment 
adjustment factors for the MIPS payment year (88 FR 52601 through 
52603). This proposal will allow for a total of approximately 60 days 
for the targeted review submission period (approximately 30 days before 
publication of the MIPS payment adjustments factors and 30 days 
thereafter). We believe this proposal provides us with the necessary 
time to adjudicate the targeted reviews and finalize the QP status list 
by October 1st. If finalized, we proposed to codify this modification 
to this policy at Sec.  414.1385(a)(2).
    In Figure 2, we illustrate our proposed change to the timeline of 
the targeted review. The text above the timeline reflects the current 
process for targeted review while the text below the timeline reflects 
the proposed process in Figure 2.

[[Page 79381]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.090

    To further shorten the timeline of the targeted review process for 
the reasons outlined above, we also proposed to amend Sec.  
414.1385(a)(5) (88 FR 52601 through 52603). Specifically, we proposed 
to require that, if CMS requests additional information under the 
targeted review process, that the additional information must be 
provided to and received by CMS within 15 days of receipt of such 
request. This proposal will modify the current timeline to respond to 
CMS' request set forth at Sec.  414.1385(a)(5), which is within 30 days 
of receipt.
    In the CY 2017 Quality Payment Program final rule (81 FR 77353 
through 77358), we implemented a virtual groups participation option 
under MIPS. Since virtual groups are eligible to submit data to the 
MIPS program, we proposed to add virtual groups as being eligible to 
submit a request for targeted review (88 FR 52603). Finally, as 
discussed in section IV.A.4.d of the proposed rule, we also proposed to 
add subgroups as being eligible to submit a request for targeted 
review. We proposed to codify these additions at Sec.  414.1385(a).
    We invited public comment on these proposals.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Commenters supported the proposal to allow virtual groups 
and subgroups to request a targeted review.
    Response: We thank commenters for supporting our proposal to allow 
virtual groups and subgroups to request a targeted review.
    Comment: Commenters opposed the shortened time for practices to 
review their payment adjustment information prior to the closing of the 
targeted review submission period. Most commenters urged CMS to 
preserve the 60-day targeted review period that allows for a minimum of 
60-days after payment adjustments are released, noting that clinicians 
need sufficient time to fully evaluate their final MIPS scores and see 
how their adjustments may play out before requesting targeted review. 
Some commenters also opposed reducing the timeframe for clinicians to 
respond to CMS requests for additional information from 30 to 15 days, 
noting their concern that this does not allow enough response time for 
providers to review and gather the required information.
    Response: We thank commenters for their feedback and understand the 
burdens MIPS eligible clinicians may face given the adjustments to the 
targeted review submission timeframe. In evaluating our options for 
implementing these operationally necessary adjustments to the targeted 
review submission timeframe, we considered the complexity of 
implementation, clinician burden, and ability to communicate this 
change clearly and effectively. While the proposed targeted review 
submission timeframe shortens the time in which a MIPS eligible 
clinician may request targeted review of a payment adjustment after 
receipt of their payment adjustment factors, it does not substantively 
shorten the total time for MIPS eligible clinicians to request targeted 
review, which will remain at 60 days. At this point in time, the 
targeted review process is sufficiently mature in that MIPS eligible 
clinicians are familiar with scoring, performance feedback, and the 
targeted review process to account for the proposed adjustments to the 
targeted review submission timeline.
    We understand that MIPS eligible clinicians prefer to have their 
payment adjustment factors at the start of the targeted review 
submission timeframe. However, under our proposal, MIPS eligible 
clinicians may begin to request targeted reviews related to various 
elements essential to our final calculation of the MIPS payment

[[Page 79382]]

adjustment factors, such as their status as MIPS eligible clinicians 
versus QPs or Partial QPs, their scores on performance categories and 
their final scores, prior to the release of payment adjustment factors. 
We believe that starting the targeted review submission period with 
release of MIPS final scores provides sufficient notice of key 
information for the MIPS eligible clinician to evaluate whether they 
would like to request targeted review. As provided in section 
1848(q)(6) of the Act and Sec.  414.1405, the MIPS eligible clinician's 
final score, as compared to the established performance threshold for 
that MIPS payment year, generally indicates whether the MIPS eligible 
clinician will receive a positive, neutral, or negative payment 
adjustment.
    Finally, to ease the burden associated with the adjustments to the 
submission timeline, CMS will ensure adequate, timely and clear 
communications with eligible clinicians and stakeholders.
    Comment: One commenter asked CMS to clarify when CMS intends to 
release the MIPS final score and performance feedback reports.
    Response: We expect to release MIPS final scores in early June, 
which, under our proposal, will correlate with the start of the 
targeted review submission timeframe. Currently, performance feedback 
reports will be released, along with the issuance of the MIPS payment 
adjustment factors, approximately 30 days after the release of the MIPS 
final scores. While we appreciate that MIPS eligible clinicians may 
benefit from reviewing their performance feedback reports before 
deciding whether to request targeted review, we believe 30 days should 
be sufficient time for such review before the targeted review 
submission period ends. We will continue to explore options to provide 
performance feedback reports as early in the process as is 
operationally feasible to do so.
    Comment: One commenter noted their support for the proposed 
adjustment to the targeted review submission timeline so long as CMS 
can ensure clearer cost measure specifications and cost measure 
performance feedback reports, preferably at the time that MIPS final 
scores are released. The commenter noted that this information is 
essential to understanding the context of their final score. The 
commenter also requested that CMS consider extending the targeted 
review submission timeframe for eligible clinicians impacted by 
multiple promoting interoperability (PI) submissions to allow them to 
receive the PI category score from the highest scored collection type 
as required under CMS-finalized policy and to allow those who submitted 
a performance year 2022 targeted review due to this issue and were 
denied appropriate PI scoring to resubmit the targeted review.
    Response: There are operational and budgetary constraints that 
limit our ability to issue these performance feedback reports earlier. 
However, we continue to explore options for providing more frequent and 
useful cost measure feedback data that MIPS eligible clinicians can use 
to analyze practice patterns that could lead to improved performance 
and would allow eligible clinicians to react during the performance 
period. As previously discussed in this section of the final rule, due 
to operational constraints, we cannot re-open or extend the targeted 
review submission timeline as requested. As stated in the regulation at 
Sec.  414.1385(a)(7), ``Decisions based on the targeted review are 
final, and there is no further review or appeal. CMS will notify the 
individual or entity that submitted the request for a targeted review 
of the final decision.''
    After consideration of public comments, we are finalizing our 
proposal with minor technical corrections to modify Sec.  414.1385(a) 
to allow virtual groups and subgroups to request a targeted review. We 
refer readers to section IV.A.4.d of this final rule regarding our 
discussion of allowing subgroups to request targeted review.
    We are also finalizing our proposal to adjust the targeted review 
submission timeframe to permit submission of a request for targeted 
review beginning on the day we make available the MIPS final score and 
ending 30 days after publication of the MIPS payment adjustment factors 
for the MIPS payment year and to require that, if CMS requests 
additional information under the targeted review process, that the 
additional information must be provided to and received by CMS within 
15 days of receipt of such request. We are revising the regulation text 
with minor technical corrections at Sec.  414.1385(a)(2) and (5) to 
reflect this change.
k. Third Party Intermediaries General Requirements
(1) Codification of Previously Finalized Policy From Preamble
    A third party intermediary is an entity that CMS has approved under 
Sec.  414.1400 to submit data on behalf of a MIPS eligible clinician, 
group, virtual group, subgroup, or APM Entity for one or more of the 
Quality, Improvement Activities, and Promoting Interoperability 
performance categories (Sec.  414.1305). Many of the policies that 
apply to third party intermediaries were finalized through prior 
rulemaking, but not codified in the CFR. Among other things, this has 
made it challenging for third party intermediaries to track certain 
program requirements and has caused confusion for MIPS participants and 
third party intermediaries.
    We have reviewed the previously finalized language and identified 
policies that we believe should be codified for these reasons. We 
describe these proposals and provide background throughout this 
section.
(2) General Requirements
(a) Background
    We refer readers to Sec. Sec.  414.1305 and 414.1400, the CY 2017 
Quality Payment Program final rule (81 FR 77362 through 77390), the CY 
2018 Quality Payment Program final rule (82 FR 53806 through 53819), 
the CY 2019 PFS final rule (83 FR 59894 through 59910), the CY 2020 PFS 
final rule (84 FR 63049 through 63080), the May 8th COVID-19 IFC (85 FR 
27594 and 27595), the CY 2021 PFS final rule (85 FR 84926 through 
84947), the CY 2022 PFS final rule (86 FR 65538 through 65550), and the 
CY 2023 PFS final rule (87 70102 FR through 70109) for our previously 
established policies regarding third party intermediaries. Where we 
proposed to codify existing final policy, we incorporated the rationale 
described in these prior rules by reference.
    In the proposed rule, in addition to codifying previously finalized 
policies and making technical updates for clarity, we proposed to: (1) 
Add requirements for third party intermediaries to obtain 
documentation; (2) Specify the use of a simplified self-nomination 
process for existing qualified clinical data registries (QCDRs) and 
qualified registries; (3) Add requirements for QCDRs and qualified 
registries to provide measure numbers and identifiers for performance 
categories; (4) Add a requirement for QCDRs and qualified registries to 
attest that information on the qualified posting is correct; (5) Modify 
requirements for QCDRs and qualified registries to support MVP 
reporting; (6) Specify requirements for a transition plan for QCDRs and 
qualified registries; (7) Specify requirements for data validation 
audits; (8) Add additional criteria for rejecting QCDR measures; (9) 
Add a requirement for QCDR measure specifications to be displayed 
throughout the performance period and data submission period; (10) 
Eliminate the Health IT vendor category; (11) Add

[[Page 79383]]

failure to maintain updated contact information as criteria for 
remedial action; (12) Revise corrective action plan requirements; (13) 
Specify CMS's authority to terminate third party intermediaries that 
are on remedial action for 2 consecutive years; (14) Specify the 
process for publicly posting remedial action; and (15) Specify the 
criteria for audits (88 FR 52603 through 52610).
(b) Requirement To Obtain Documentation
    In the CY 2017 Quality Payment Program final rule (81 FR 77367 
through 77369 and 77384 and 77385), we established requirements that 
QCDRs and qualified registries obtain signed documentation from 
clinicians and groups regarding their authority to handle and submit 
data on the clinician and group's behalf. We established that QCDRs and 
qualified registries must enter into appropriate Business Associate 
Agreements with MIPS eligible clinicians. QCDRs and qualified 
registries must obtain signed documentation that each holder of a 
national provider identifier (NPI) has authorized the third party 
intermediary to submit ``quality measure results, improvement 
activities measure and activity results, advancing care information 
objective results and numerator and denominator data or patient-
specific data on Medicare and non-Medicare beneficiaries to CMS for the 
purpose of MIPS participation.'' The documentation should be annually 
obtained at the time the clinician or group enters into an agreement 
with the QCDR or qualified registry for the submission of MIPS data to 
the QCDR or qualified registry. A group, subgroup, Virtual Group, or 
APM Entity may have their authorized representative give permission to 
the third party intermediary to submit their data. Additionally, in the 
CY 2018 Quality Payment Program final rule (82 FR 53812), we clarified 
that Business Associate Agreements must comply with the HIPAA Privacy 
and Security Rules. Records of the authorization must be maintained for 
6 years after the performance period ends (81 FR 77370). We proposed to 
codify these requirements at Sec.  414.1400(b)(3)(xii) and (xiii) (88 
FR 52603).
    We invited comments on this proposal.
    We received public comments on the proposal. The following is a 
summary of the comments we received and our responses.
    Comment: One commenter expressed concern that a requirement for 
individual signatories for virtual group reporting creates unnecessary 
administrative burden and suggested that CMS should instead allow for 
documentation of submission authority for virtual groups to occur at 
either the TIN or clinician level.
    Response: If data is reported at a group level, the practice admin 
can sign for the group. A direct signature from an individual clinician 
is only required if the individual clinician's data is reported to CMS 
as an individual.
    After consideration of public comments, we are finalizing as 
proposed our proposal at Sec.  414.1400(b)(3)(xii) and (xiii) to codify 
that QCDRs and qualified registries must enter into appropriate 
Business Associate Agreements with MIPS eligible clinicians and that 
they must maintain records of their authorization to submit data to CMS 
for the purpose of MIPS participation for each NPI whom they submit 
data to CMS for. The records must be annually obtained, be signed by an 
eligible clinician or by an authorized representative of the reporting 
group, and records of the authorization must be maintained for 6 years 
after the performance period ends.
(c) Requirement To Report in Form and Manner Specified
(i) Criteria for Data Submission
    At Sec.  414.1400(a)(2)(C), we required that all data submitted by 
a third party intermediary must be submitted in the form and manner 
specified by CMS. We specified that these requirements include the 
obligation for a third party intermediary to: (1) report the number of 
eligible instances (reporting denominator); (2) report the number of 
instances a quality service is performed (performance numerator); (3) 
report the number of performance exclusions, meaning the quality action 
was not performed for a valid reason as defined by the measure 
specification; (4) comply with a CMS-specified secure method for data 
submission, such as submitting the QCDR's data in an XML file; (5) be 
able to calculate and submit measure-level reporting rates or the data 
elements needed to calculate the reporting and performance rates by 
taxpayer identification number (TIN)/NPI and/or TIN; (6) be able to 
calculate and submit a performance rate (that is the percentage of a 
defined population who receive a particular process of care or achieves 
a particular outcome based on a calculation of the measures' numerator 
and denominator specifications) for each measure on which the TIN/NPI 
or TIN reports; (7) provide the performance period start date the QCDR 
will cover; (8) provide the performance period end date the QCDR will 
cover; (9) report the number of reported instances, performance not 
met, meaning the quality actions was not performed for no valid reason 
as defined by the measure specification; and (10) submit quality, 
advancing care information, or improvement activities data and results 
to us in the applicable MIPS performance categories for which the QCDR 
is providing data (81 FR 77367 through 77369 and 77384 through 77385). 
These criteria for data submission are technical requirements of 
functioning QCDRs and qualified registries.
(ii) Reporting on All Patients, Including Non-Medicare Patients
    In the CY 2017 Quality Payment Program final rule (81 FR 77367 
through 77369 and 77384 through 77385), we established that QCDRs and 
qualified registries are required to submit data on all patients, not 
just Medicare patients. In section IV.A.4.f.(1)(b) of the proposed 
rule, we proposed a revision to the definition of the term collection 
type to allow Shared Saving Program ACOs meeting the reporting 
requirements under the APP to report on a subset of patients that is 
partially defined by having the payer of Medicare (88 FR 52563). We 
proposed to codify our previously established requirement that data 
submitted by third party intermediaries must include data on all of the 
MIPS eligible clinician's patients regardless of payer, with the 
addition of the phrase ``unless otherwise specified by the collection 
type'' at Sec.  414.1400(a)(3)(ii)(A) (88 FR 52604). We invited 
comments on this proposal.
    We did not receive public comments on this provision. We are 
finalizing this proposal as proposed.
(3) Requirements for QCDRs and Qualified Registries
(a) Background
    As described at Sec.  414.1305, a QCDR is an entity that 
demonstrates clinical expertise in medicine and quality measurement 
development experience and collects medical or clinical data on behalf 
of a MIPS eligible clinician for the purpose of patient and disease 
tracking to foster improvement in the quality of care provided to 
patients. Section 1848(q)(5)(B)(ii) of the Act provides that the 
Secretary shall encourage MIPS eligible professionals to report on 
applicable measures through the use of certified EHR technology (CEHRT) 
and qualified clinical data registries.
    We referred readers to Sec.  414.1400(b)(4), the CY 2017 Quality

[[Page 79384]]

Payment Program final rule (81 FR 77374 and 77375), the CY 2018 Quality 
Payment Program final rule (82 FR 53813 and 53814), the CY 2019 PFS 
final rule (83 FR 59900 through 59906), the CY 2020 PFS final rule (84 
FR 63058 through 63074), the May 8th COVID-19 IFC (85 FR 27594 and 
27595), the CY 2021 PFS final rule (85 FR 84937 through 84944), the CY 
2022 PFS final rule (86 FR 65540 through 65550) and the CY 2023 PFS 
final rule (87 FR 70103 through 70106) for previously finalized 
standards and criteria for QCDRs and QCDR measure requirements.
    As described at Sec.  414.1305, a qualified registry is a medical 
registry, a maintenance of certification program operated by a 
specialty body of the American Board of Medical Specialties or other 
data intermediary that, with respect to a particular performance 
period, has self-nominated and successfully completed a vetting process 
(as specified by CMS) to demonstrate its compliance with the MIPS 
qualification requirements specified by CMS for that performance 
period. The registry must have the requisite legal authority to submit 
MIPS data (as specified by CMS) on behalf of a MIPS eligible clinician 
or group to CMS.
    We referred readers to Sec.  414.1400(b), the CY 2017 Quality 
Payment Program final rule (81 FR 77382 and 77386), the CY 2018 Quality 
Payment Program final rule (82 FR 53815 and 53818), the CY 2019 PFS 
final rule (83 FR 59906), the CY 2020 PFS final rule (84 FR 63074 
through 63077), the CY 2021 PFS final rule (85 FR 84944 through 84947), 
and the CY 2022 PFS final rule (86 FR 65539 through 65548) for 
previously finalized standards and criteria for qualified registries.
(b) Self-Nomination and Program Requirements
(i) Subgroup Reporting
    In the CY 2022 Quality Payment Program final rule (86 FR 65544), we 
established the requirement that third party intermediaries must 
support subgroup reporting beginning with the CY 2023 performance 
period/2025 MIPS payment year. This requirement that third party 
intermediaries support subgroup reporting was finalized because it 
would allow for clinicians to meaningfully report MIPS Value Pathways 
(MVPs) given that subgroups will be implemented concurrently with MVPs. 
We proposed to add new language to codify this policy. We proposed to 
revise Sec.  414.1400(b)(1)(iii) that beginning with the CY 2023 
performance period/2025 MIPS payment year, QCDRs and qualified 
registries must support subgroup reporting (88 FR 52604).
    We invited comments on this proposal.
    We received public comments on the proposal. The following is a 
summary of the comments we received and our responses.
    Comment: One commenter suggested that third party intermediaries 
should only be required to support subgroups if they are reporting on 
MVPs since subgroups can only report through MVPs.
    Response: We have announced our intention to eventually make MVP 
reporting mandatory (although an official start date has not been 
proposed yet), and therefore, believe that subgroup reporting will be 
an integral part of reporting in the future.
    After consideration of public comments, we are finalizing our 
proposal as proposed at Sec.  414.1400(b)(1)(iii) to codify that 
beginning with the CY 2023 performance period/2025 MIPS payment year, 
QCDRs and qualified registries must support subgroup reporting.
(ii) Simplified Self-Nomination Process for Existing QCDRs and 
Qualified Registries in MIPS, That Are in Good Standing
    In the CY 2018 Quality Payment Program final rule (82 FR 53811 
through 53812 and 53817 through 53818), we established that beginning 
with the CY 2019 performance period/2021 MIPS payment year, QCDRs and 
qualified registries in good standing (that is, QCDRs and qualified 
registries that are not on probation or disqualified) (81 FR 77386 
through 77389) that ``wish to self-nominate using the simplified 
process can attest, in whole or in part, that their previously approved 
form is still accurate and applicable'' (see also Sec.  
414.1400(b)(2)). When this is the case, third party intermediaries may 
use the simplified process. The goal of the simplified self-nomination 
form is to reduce the self-nomination burden for third party 
intermediaries in good standing by allowing them to self-nominate with 
a mostly pre-populated self-nomination form. The policy allows third 
party intermediaries to attest that sections of their application have 
no changes even if there are minimal changes or substantive changes in 
other parts of their application. An example of a minimal change is 
adding or removing MIPS quality measures. An example of a substantive 
change is the submission of new QCDR measures for consideration. For 
sections of an application that do require changes, the requirements 
are the same as those for the normal self-nomination process (82 FR 
53808).
    In the course of implementing this policy, we have learned that the 
text of Sec.  414.1400(b)(2) has confused some third party 
intermediaries such that they have attested that their previously 
approved self-nomination form is still accurate and have not submitted 
self-nomination forms because they thought they did not need to do so 
if they had no changes. We proposed to revise Sec.  414.1400(b)(2) to 
reflect that QCDRs and qualified registries are still required to 
submit their self-nomination form even if they utilize the simplified 
self-nomination process (88 FR 52604 through 52605). Even if a third 
party intermediary has no change to make to its form from the previous 
year, there may be new sections to fill out and they need to respond to 
attestations within the course of the application. We proposed to 
revise the last sentence of Sec.  414.1400(b)(2) from ``For the CY 2019 
performance period/2021 MIPS payment year and future years, existing 
QCDRs and qualified registries that are in good standing may attest 
that certain aspects of their previous year's approved self-nomination 
have not changed and will be used for the applicable performance 
period'' to state, ``For the CY 2019 performance period/2021 MIPS 
payment year and future years, an existing QCDR or qualified registry 
that is in good standing may use the simplified self-nomination process 
during the self-nomination period, from July 1 and September 1 of the 
CY preceding the applicable performance period.'' This will ensure that 
third party intermediaries that have previously participated in MIPS 
and are in good standing can use the process to reduce the burden of 
self-nomination.
    We invited comments on this proposal.
    We did not receive public comments on this provision. We are 
finalizing this proposal as proposed.
(iii) Measure Numbers and Identifiers and Titles for the Improvement 
Activity Performance Category, the Promoting Interoperability 
Performance Category, and MVPs
    In the CY 2017 Quality Payment Program final rule (81 FR 77367 
through 77369 and 77384 through 77385), we established that QCDRs and 
qualified registries must provide the measure numbers for the MIPS 
quality measures on which the QCDR and qualified registry is reporting. 
We proposed to codify this previously finalized provision at Sec.  
414.1400(b)(3)(ix). For completion and consistency, we also

[[Page 79385]]

need to receive identifiers for improvement activities, Promoting 
Interoperability, and titles for MVPs. This information is used to 
track which quality measures, improvement activities, Promoting 
Interoperability performance category measures and MVPs QCDRs and 
qualified registries support in a performance period. This information 
is available on the qualified postings that are published on the QPP 
Resource Library. We proposed that Sec.  414.1400(b)(3)(ix) will 
additionally require QCDRs and qualified registries to submit to CMS 
the identifiers for the improvement activity performance category, the 
Promoting Interoperability performance category measures, and titles 
for MVPs (88 FR 52605).
    We invited comments on this proposal.
    We did not receive public comments on this provision. We are 
finalizing this proposal as proposed.
(iv) Quality Measures
    In the CY 2017 Quality Payment Program final rule (81 FR 77367 
through 77369 and 77384 through 77385), we established that one 
criterion for data submission for QCDRs and qualified registries is 
that they must be able to submit results to CMS for at least six 
individual quality measures with at least one outcome measure during 
self-nomination. If an outcome measure is not available, a QCDR or 
qualified registry must be able to submit to CMS results for at least 
one other high priority measure. We proposed to codify this previously 
finalized provision at Sec.  414.1400(b)(3)(x) (88 FR 52605).
    We invited comments on this proposal.
    We did not receive public comments on this provision. We are 
finalizing this proposal as proposed.
(v) Qualified Posting Attestation
    In the CY 2017 Quality Payment Program final rule (81 FR 77367 
through 77369 and 77384 through 77385), we established that QCDRs and 
qualified registries must sign a document that verifies their ``name, 
contact information, cost for MIPS eligible clinicians or groups to use 
the qualified registry, services provided, and the specialty-specific 
measure sets the qualified registry intends to report.'' As technology 
has progressed, we no longer need third party intermediaries to sign a 
document and instead require an attestation. We became aware that this 
requirement is not consistent with our established policy in describing 
the manner in which the QCDR or qualified registry documents this 
information. In order to align with current processes, we proposed to 
add Sec.  414.1400(b)(3)(xiv), which would require that QCDRs and 
qualified registries attest that the information listed on the 
qualified posting is accurate. The qualified posting contains 
information to help clinicians, groups, subgroups, virtual groups, APM 
Entities determine the services, cost, reporting options, measures/
activities, etc. that a CMS-approved intermediary supports. We publish 
it every performance period and update it, as needed. While we have 
used the term qualified posting since the inception of the Quality 
Payment Program, we have not previously defined this term, and 
therefore, we proposed to define qualified posting as the document made 
available by CMS that lists QCDRs or qualified registries available for 
use by MIPS eligible clinicians, groups, subgroups, virtual groups, and 
APM Entities at Sec.  414.1305.
    We invited comments on these proposals.
    We did not receive public comments on this provision. We are 
finalizing this proposal as proposed.
(vi) Data Access Capabilities
    In the CY 2017 Quality Payment Program final rule (81 FR 77367 
through 77369 and 77384 through 77385), we established that QCDRs and 
qualified registries must comply with any request by CMS to review data 
submitted by a third party intermediary for purposes of MIPS. We 
proposed to codify this previously finalized provision at Sec.  
414.1400(b)(3)(xv) (88 FR 52605).
    We invited comments on this proposal.
    We did not receive public comments on this provision. We are 
finalizing this proposal as proposed.
(vii) Attestation of Data Access Capabilities
    As was previously described, the CY 2017 Quality Payment Program 
rule finalized the requirement for third party intermediaries to comply 
with any request by CMS to review data submitted by a third party 
intermediary for purposes of MIPS reporting requirements (81 FR 77367 
through 77369 and 77384 through 77385). However, it did not require 
third party intermediaries to attest to their capabilities. Attestation 
during the self-nomination period emphasizes the importance of this 
capability for third party intermediaries even if the capability is not 
ultimately utilized later. We proposed to add Sec.  
414.1400(b)(3)(xvi)(A) to require that a QCDR or a qualified registry 
attest that it has required each MIPS eligible clinician on whose 
behalf it reports to provide the QCDR or qualified registry with all 
documentation necessary to verify the accuracy of the data on quality 
measures that the eligible clinician submitted to the QCDR or qualified 
registry (88 FR 52605). We also proposed to add Sec.  
414.1400(b)(3)(xvi)(B) to require that a QCDR or a qualified registry 
must attest that it has required each MIPS eligible clinician to permit 
the QCDR or qualified registry to provide the information described in 
Sec.  414.1400(b)(3)(xvi)(A) to CMS upon request to ensure that data 
can be accessed by the third party intermediary for auditing purposes. 
We have received correspondence from some third party intermediaries, 
stating that they do not have access to the data and depend on 
clinicians to do the audit (88 FR 52605).
    We received public comments on the proposal. The following is a 
summary of the comments we received and our responses.
    Comment: One commenter urged CMS to consider the financial and 
administrative burden of requiring a QCDR or a qualified registry to 
attest that is has required each MIPS eligible clinician to permit the 
QCDR or qualitied registry to provide the information requested to CMS, 
and to provide resources QCDRs would need to implement the requirement.
    Response: Existing policy already requires third party 
intermediaries comply with CMS requests to review data (81 FR 77367 
through 77369 and 77384 through 77385). Attesting to the ability to 
require clinicians to provide documentation necessary to verify the 
accuracy of data submitted and to be able to submit that documentation 
to CMS should not be viewed as broadening the scope of this requirement 
as it would be a logical component of an audit. Therefore, we consider 
this to be a baseline requirement and not overly burdensome. CMS's 
ability to access the underlying documentation to verify the accuracy 
of the data submitted by clinicians is critical to ensuring that all 
data submitted is true, accurate, and complete.
    Comment: One commenter suggested that the language be modified to 
require third party intermediaries to attest that they have access to 
the data to clarify that intermediaries are not expected to maintain 
all data necessary for an audit at all times.
    Response: This requirement does not detail how intermediaries 
maintain the data but rather that the third party intermediary provide 
the documentation when CMS requests it.
    After consideration of public comments, we are finalizing our

[[Page 79386]]

proposal as proposed at Sec.  414.1400(b)(3)(xvi) that a QCDR or a 
qualified registry must attest that it has required each MIPS eligible 
clinician on whose behalf it reports to provide all documentation 
necessary to verify the accuracy of the data the eligible clinician 
submitted to the QCDR or qualified registry. Additionally, a QCDR or 
qualified registry must also attest that it has required each MIPS 
eligible clinician to permit the QCDR or qualified registry to provide 
the information described in paragraph 414.1400(b)(3)(xviii)(A) to CMS 
upon request.
(viii) Third Party Intermediary Support of MVPs
    In the CY 2022 PFS final rule (86 FR 65543), we finalized a new 
requirement at Sec.  414.1400(b)(1)(ii) that, beginning with the CY 
2023 performance period/2025 MIPS payment year, QCDRs and qualified 
registries must support MVPs that are applicable to the MVP 
participants on whose behalf they submit MIPS data. QCDRs and qualified 
registries may also support the APP. This proposal was finalized 
because MVPs are beginning to be implemented in the CY 2023 performance 
period/2025 MIPS payment year, and third party intermediaries have the 
necessary experience reporting data to support MVP reporting.
    To further clarify this finalized policy, we responded to a comment 
in the CY 2022 PFS final rule (86 FR 65543) by explaining that third 
party intermediaries who support MVPs are required to ``support all 
measures and activities available in the MVP across the quality, 
improvement activities, and Promoting Interoperability performance 
categories. The exceptions to this requirement are the cost measures 
and population health measures . . . [and] QCDR measures, which are 
only reportable through a QCDR. In instances where QCDR measures are 
included in an MVP, a qualified registry or health IT vendor will be 
expected to support all other quality measures included within the 
MVP.'' Some interested parties have expressed concern regarding this 
requirement as many MVPs include measures that may be reported by 
clinicians across multiple specialties, some of whom might be outside 
their intended customer base. We are concerned that continuing this 
strict requirement for MVP support could undermine adoption during the 
time in which MVP submission is an option under MIPS. Given that many 
third party intermediaries may not support measures for clinicians in 
all specialty areas that might report a MVP, we proposed to add a 
sentence at the end of Sec.  414.1400(b)(1)(ii) that a QCDR or a 
qualified registry is required to support MVPs pertinent to the 
specialties they support (88 FR 52605 through 52606). The addition 
states that a QCDRs or a qualified registry must support all measures 
and improvement activities available in the MVP with two exceptions. 
The first exception to this requirement at Sec.  414.1400(b)(1)(ii)(A) 
is that if an MVP includes several specialties, then a QCDR or a 
qualified registry is only expected to support the measures that are 
pertinent to the specialty of their clinicians. For example, if an 
orthopedic care MVP includes both surgery and physical therapy 
measures, and the third party intermediary caters specifically to 
physical therapists, they are not required to support the surgical 
measures. The second exception at Sec.  414.1400(b)(1)(ii)(B) is that 
QCDR measures are only required to be reported by the QCDR measure 
owner. In instances where a QCDR does not own the QCDR measures in the 
MVP, the QCDR may only support the QCDR measures if they have the 
appropriate permissions.
    We received public comments on these proposals. The following is a 
summary of the comments our responses.
    Comment: Several commenters supported the proposed exception that 
if an MVP includes several specialties, then a QCDR or a qualified 
registry is only expected to support the measures that are pertinent to 
the specialty of their clinicians. One commenter appreciated the 
agency's recognition that there may be operational barriers to 
reporting all measures within an MVP that span multiple specialties 
indicating that a QCDR or qualified registry may not have access to all 
the necessary data, urging the agency to provide sufficient flexibility 
to registries when determining the precise scope of a specialty. A few 
commenters supported the proposed exception that QCDR measures are only 
required to be reported by the QCDR measure owner and in instances 
where a QCDR does not own the QCDR measures in the MVP, the QCDR may 
only support those QCDR measures with the appropriate permissions.
    Response: We thank the commenters for their support.
    Comment: One commenter warned that incorporating QCDR measures into 
MVPs and restricting their availability puts some practices at a 
disadvantage if they cannot afford to pay the fees associated with the 
QCDR registration.
    Response: A QCDR measure incorporated into an MVP is not required 
to be reported on by an MVP participant or supported by QCDRs who are 
not the owners of the QCDR measures in the MVP. To the extent possible 
with the existing MIPS quality measure inventory, we aim to construct 
MVPs that include MIPS quality measures which are broadly available for 
as many clinicians as possible.
    Comment: One commenter urged CMS to consider adding an exception 
for the requirement that QCDRs or qualified registries support all 
measures and activities within an MVP in situations in which the care 
setting associated with the measure or activity does not apply to the 
participants of the QCDR or qualified registry. One commenter requested 
CMS clarify that third party intermediaries are only expected to 
support the categories that are pertinent to the specialty of their 
clinicians (such as not supporting Promoting Interoperability in 
traditional MIPS if the clinicians are exempt).
    Response: We are uncertain of an organized method to incorporate 
care setting location into the assessment of whether a QCDR or 
qualified registry is able to support all measures and activities 
within an MVP outside of measure specifications that are already 
included. In regards to the requirements to report the Promoting 
Interoperability performance category in situations in which the 
specialty supported is not subject to that performance category, we 
note that Sec.  414.1400(b)(1)(i)(C) does allow for approval of a self-
nomination of a QCDR or qualified registry that does not support the 
Promoting Interoperability performance category if the third party 
intermediary's MIPS eligible clinicians, groups, virtual groups, or 
subgroups fall under the reweighting policies at Sec.  
414.1380(c)(2)(i)(A)(4)(i) through (iii), or (c)(2)(i)(C)(1) through 
(7), or (c)(2)(i)(C)(9)
    Comment: One commenter requested broadening of the exclusion for 
situations that may be beyond the control of the qualified registry 
that would limit their ability to collect a measure, such as the timing 
of the receipt of pharmacy claims in measures that may incorporate this 
data.
    Response: The intent of the policy is to recognize that the MVP 
area of focus may not align in its entirety with the focus of a third 
party intermediary which we understand often focus ozn a clinician 
specialty. We will continue to evaluate the environment to ensure 
clinicians have access to third party intermediaries while balancing 
the need to ensure that most clinicians are able

[[Page 79387]]

to report as many measures on MVPs as possible.
    After consideration of public comments, we are finalizing at Sec.  
414.1400(b)(1)(ii) our proposal to clarify that that a QCDR or a 
qualified registry must support all measures and activities included in 
the MVP except if an MVP is intended for reporting by multiple 
specialties, a QCDR or a qualified registry are required to report 
those measures pertinent to the specialty of its MIPS eligible 
clinician or if an MVP includes a QCDR measure, it is not required to 
be reported by a QCDR other than the measure owner.
(ix) Readiness To Accept Data
    In the CY 2019 PFS final rule (83 FR 59761), we established that a 
QCDR or a qualified registry must be up and running by January 1st of 
the performance period so that they can accept and retain clinician 
data starting on January 1st. We proposed to codify at Sec.  
414.1400(b)(3)(xvii) the requirement that a QCDR or a qualified 
registry must be able to accept and retain data by January 1 of the 
applicable performance period (88 FR 52606).
    We invited comments on this proposal.
    We did not receive public comments on this provision. We are 
finalizing this proposal as proposed.
(x) Duration of Services Provided
    In the CY 2020 PFS final rule (84 FR 63053), we finalized a new 
requirement at Sec.  414.1400(a)(2)(i)(E) that the organization must 
provide services throughout the entire performance period and 
applicable data submission period. In section IV.A.4.k.(3)(b)(xi) of 
the proposed rule, we outlined the requirements for a transition plan 
for cases in which organizations are not able to provide services 
throughout the entire year. While we recognize and allow for cases in 
which organizations may find themselves unable to provide services 
throughout the course of an entire year, we would require that they 
indicate their intent to do so as part of program requirements. We 
proposed to modify this requirement to state the organization must 
certify it intends to provide services throughout the entire 
performance period and applicable data submission period (88 FR 52606). 
We proposed to make this change at Sec.  414.1400(a)(2)(i)(C) as a 
result of our proposal to divide requirements for self-nomination from 
programmatic requirements as outlined in section IV.A.4.k.(7) of the 
proposed rule.
    We invited comments on these proposals.
    We did not receive public comments on this provision. We are 
finalizing this proposal as proposed.
(xi) Transition Plan Requirements
    In the CY 2020 PFS final rule (84 FR 63052 through 63053), we 
finalized a new requirement at Sec.  414.1400(a)(2)(i)(F) that prior to 
discontinuing services to any MIPS eligible clinician, group, virtual 
group, subgroup, or APM Entity during a performance period, the third 
party intermediary must support the transition of such MIPS eligible 
clinician, group, virtual group, subgroup, or APM Entity to an 
alternate third party intermediary, submitter type, or, for any measure 
on which data has been collected, collection type according to a CMS 
approved a transition plan. As part of an overall effort to divide 
self-nomination requirements from program requirements as discussed in 
section IV.A.4.k.(7) of the proposed rule, at Sec.  414.1400, we 
proposed to redesignate and revise paragraph (a)(2)(i)(F) to paragraph 
(a)(3)(iv) that, prior to discontinuing services to any MIPS eligible 
clinician, group, virtual group, subgroup, or APM entity during a 
performance period, the third party intermediary must support the 
transition of such MIPS eligible clinician, group, virtual group, 
subgroup, or APM Entity to an alternate third party intermediary, 
submitter type, or, for any measure on which data has been collected, 
collection type according to a CMS approved transition plan by a date 
specified by CMS. The transition plan must address the following 
issues, unless different or additional information is specified by CMS. 
We proposed to specify the contents required in the transition plan in 
paragraphs (a)(3)(iv)(A) through (E) (88 FR 52606). We proposed to add 
Sec.  414.1400(a)(3)(iv)(A) to require that the transition plan state 
the issues that contributed to the withdrawal mid-performance period or 
discontinuation of services mid-performance period. We also proposed to 
add Sec.  414.1400(a)(3)(iv)(B), which will require that the transition 
plan state the number of clinicians, groups, virtual groups, subgroups 
or APM entities inclusive of MIPS eligible, opt-in and voluntary 
participants that will need to find another way to report and as 
applicable, and identify any QCDRs that were granted licenses to QCDR 
measures which will no longer be available for reporting due to the 
transition. We further proposed to add paragraph (a)(3)(iv)(C) to state 
the steps the third party intermediary will take to ensure that the 
clinicians, groups, virtual groups, subgroups, or APM Entities 
identified in Sec.  414.1400(a)(3)(iv)(B)(1) are notified of the 
transition in a timely manner and successfully transitioned to an 
alternate third party intermediary, submitter type, or, for any measure 
or activity on which data has been collected, collection type, as 
applicable. At paragraph (a)(3)(iv)(D), we proposed to require that the 
transition plan include a detailed timeline of when the third party 
intermediary will take the steps identified in paragraph (a)(3)(iv)(C), 
including notification of affected clinicians, groups, virtual groups, 
subgroups, or APM Entities, the start of the transition, and the 
completion of the transition. Finally, we proposed to add at paragraph 
(a)(3)(iv)(E) that the third party intermediary must communicate to CMS 
that the transition was completed by the date included in the detailed 
timeline. The proposals would enable CMS to have documentation of the 
steps, actions, tasks, and timeline for completion of the transition of 
clients.
    We invited comments on these proposals.
    We received public comments on these proposals. The following is a 
summary of the comments our responses.
    Comment: One commenter supported the proposal for a transition plan 
for QCDRs and qualified registries withdrawing from the program 
indicating this would help share the responsibility of clinician 
support, increase the speed and cooperation for data transfer, and 
ensure that all pertinent agreements and compliances are in place.
    Response: We thank the commenters for their support.
    Comment: One commenter requested that CMS specify how much time is 
permissible for a completed transition plan indicating that a minimum 
of 90-business days would allow a QCDR to complete the requirements, 
with a longer timeline approved by CMS depending on the size of the 
QCDR.
    Response: The transition plan should be developed with the intent 
to cause as little disruption as possible to the clinicians 
participating with their third party intermediary. While we required a 
timeline within the transition plan, we did not include a specific 
timeframe for a completed transition plan.
    Comment: One commenter recommended that CMS enable other QCDRs in 
the program be notified immediately upon CMS receiving the resignation 
notice, as well as the reasoning as this would allow participating 
QCDRs to anticipate and

[[Page 79388]]

accept those clinicians, especially if it is past their last day to 
accept new clients via the qualified posting deadline.
    Response: We do update the qualified posting each month if a QCDR 
or Qualified Registry is terminated from the program or placed on 
remedial action. Third party intermediaries are encouraged to 
periodically review the updated qualified postings for this 
information.
    After consideration of public comments, we are finalizing our 
proposal as proposed.
(c) Submission Requirements
(i) Risk-Adjusted Measures
    In the CY 2017 Quality Payment Program final rule (81 FR 77384 
through 77385), we established that qualified registries ``submitting 
MIPS quality measures that are risk-adjusted . . . must submit the 
risk-adjusted measure results to CMS when submitting the data for these 
measures'' (88 FR 52606). We proposed to codify this previously 
finalized provision at Sec.  414.1400(b)(3)(xi).
    We did not receive public comments on this provision, and 
therefore, we are finalizing it as proposed.
(ii) Data Validation Audit Requirements
    Section 414.1400(b)(3)(v) outlines the requirements for third party 
intermediary's annual data validation audits. As specified at paragraph 
(b)(3)(v)(E), the QCDR or qualified registry must conduct each data 
validation audit using a sampling methodology that meets the following 
requirements: (1) Uses a sample size of at least 3 percent of the TIN/
NPIs for which the QCDR or qualified registry will submit data to CMS, 
except that if a 3 percent sample size would result in fewer than 10 
TIN/NPIs, the QCDR or qualified registry must use a sample size of at 
least 10 TIN/NPIs, and if a 3 percent sample size would result in more 
than 50 TIN/NPIs, the QCDR or qualified registry may use a sample size 
of 50 TIN/NPIs. (2) Uses a sample that includes at least 25 percent of 
the patients of each TIN/NPI in the sample, except that the sample for 
each TIN/NPI must include a minimum of 5 patients and does not need to 
include more than 50 patients. We finalized this policy (81 FR 77366 
through 77367) to reflect the number of reporting entities, which may 
be individuals, as represented by TIN/NPIs, but are often compositions 
of TIN/NPIs as represented by groups, subgroups, or APM entities. Since 
these compositions represent a single unit of measurement, we believe 
that they should be considered as a single unit.
    We have received questions about the required sampling methodology 
from interested parties who are confused by the references to TIN/NPI 
in the context of sample size and how they map to individual MIPS 
eligible clinicians, groups, virtual groups, subgroups or APM Entities. 
To reduce confusion among third party intermediaries regarding the data 
validation audit sample, we proposed to revise Sec.  
414.1400(b)(3)(v)(E)(1) and (2) to replace references to TIN/NPI with 
``a combination of individual MIPS eligible clinicians, groups, virtual 
groups, subgroups and APM Entities'' (88 FR 52607). The new text would 
state: (1) Uses a sample size of at least 3 percent of a combination of 
individual clinicians, groups, virtual groups, subgroups and APM 
entities for which the QCDR or qualified registry will submit data to 
CMS, except that if the sample size may be no fewer than a combination 
of 10 individual clinicians, groups, virtual groups, subgroups and APM 
entities, and no more than a combination of 50 individual clinicians, 
groups, virtual groups, subgroups and APM entities, the QCDR or 
qualified registry may use a sample size of a combination of 50 
individual clinicians, groups, virtual groups, subgroups and APM 
entities; and (2) Uses a sample that includes at least 25 percent of 
the patients of each individual clinician, group, virtual group, 
subgroup or APM entity in the sample, except that the sample for each 
individual clinician, group, virtual group, subgroup or APM entity must 
include a minimum of 5 patients and need not include more than 50 
patients.
    We invited comments on this proposal.
    We received public comments on the proposal. The following is a 
summary of the comments and our responses.
    Comment: One commenter supported the revision of wording to replace 
references to TIN/NPI but noted concern that the proposed wording of 
``a combination of individual MIPS eligible clinicians, groups, virtual 
groups, subgroups and APM Entities'' will make the regulation difficult 
to read and is confusing. The commenter suggested using the term 
``submitter type'' defined in Sec.  414.1305 instead. In addition, the 
commenter suggested removing the word ``may'' from the statement 
indicating sample size reading ``the QCDR or qualified registry may use 
a sample size of . . . 50'' stating the use of the word ``may'' means 
the QCDR or Qualified Registry may submit 50 but also more than 50.
    Response: We appreciate the commenter's suggestion; however, we 
fear that acting on this suggestion would only cause more confusion. 
The term ``submitter type'' is not limited to MIPS eligible clinicians, 
groups, virtual groups, subgroups, and APM entities. The term also 
includes third party intermediaries, which are not intended to be 
covered by this requirement. We note that the use of the term ``may'' 
is correctly interpreted by the commenter as we do not mandate a 
maximum sample size. We will monitor service center feedback to ensure 
that this policy is well understood by representatives from third party 
intermediaries, but do not believe we should change this terminology at 
this time.
    After consideration of public comments, we are finalizing our 
proposal at Sec.  414.1400(b)(3)(v)(E)(1) and (2) to modify the 
description of sample size as proposed.
(4) Requirements Specific to QCDRs
(a) Background
    As described at Sec.  414.1305, a QCDR is an entity that 
demonstrates clinical expertise in medicine and quality measurement 
development experience and collects medical or clinical data on behalf 
of a MIPS eligible clinician for the purpose of patient and disease 
tracking to foster improvement in the quality of care provided to 
patients. Section 1848(q)(5)(ii)(B) of the Act provides that the 
Secretary shall encourage MIPS eligible professionals to report on 
applicable measures through the use of CEHRT and qualified clinical 
data registries.
    We referred readers to Sec.  414.1400(b)(4), the CY 2017 Quality 
Payment Program final rule (81 FR 77374 and 77375), the CY 2018 Quality 
Payment Program final rule (82 FR 53813 and 53814), the CY 2019 PFS 
final rule (83 FR 59900 through 59906), the CY 2020 PFS final rule (84 
FR 63058 through 63074), the May 8th COVID-19 IFC (85 FR 27594 and 
27595), the CY 2021 PFS final rule (85 FR 84937 through 84944), the CY 
2022 PFS final rule (86 FR 65540 through 65550) and the CY 2023 PFS 
final rule (87 FR 70103 through 70106) for previously finalized 
standards and criteria for QCDRs and QCDR measure requirements.
(b) QCDR Measure Self-Nomination Requirements
(i) New QCDR Measures May Not Be Submitted After Self-Nomination
    In the CY 2017 Quality Payment Program final rule (81 FR 77375 
through 77377), we established that QCDRs could submit measures that 
are not on the annual list of MIPS quality measures

[[Page 79389]]

as part of the self-nomination process for an entity to become a QCDR. 
In the CY 2018 Quality Payment Program final rule (82 FR 53808), we 
established a process by which existing QCDRs that are in good standing 
could attest that certain aspects of their previous year's approved 
self-nomination have not changed. We intended for the self-nomination 
document to be comprehensive in terms of which QCDR measures would be 
submitted for consideration. However, we have received requests to add 
measures following the completion of the QCDR self-nomination process 
for the performance year. Our review process requires consideration of 
a complete self-nomination with all measures, so we proposed to add 
that the measure was submitted after self-nomination to our list of 
reasons for rejecting a QCDR measure at Sec.  414.1400(b)(4)(iv)(O) (88 
FR 52607).
    We received public comments on the proposal. The following is a 
summary of the comments we received and our responses.
    Comment: One commenter opposed the proposal and stated their belief 
that it would discourage the development of new measures and 
potentially slow participation of QCDRs.
    Response: It does not logically follow that establishing a deadline 
for the submission of measures as part of the self-nomination process 
would hamper the development or use of QCDRs in MIPS. As a practical 
matter, there is a point at which we can no longer accept the 
submission of measures in order for us to review a QCDR's complete 
application. QCDRs have generally met these requirements in the past, 
and adoption of this proposal would merely clarify for a QCDR what it 
must include at the time of its self-nomination.
    Comment: A few commenters requested that CMS clarify whether all 
measures submitted after September 1 will be rejected for the reporting 
period or if only newly developed measures would be rejected. One 
commenter expressed concern that this may lead to the rejection of 
measures previously approved for use.
    Response: A QCDR or Qualified Registry can add a MIPS quality 
measures after the September self-nomination deadline. CMS allows third 
party intermediaries to support additional MIPS quality measures until 
early May of the performance period and this date is communicated to 
third party intermediaries during monthly support calls for the given 
performance period. However, neither a new QCDR measure nor a 
previously approved QCDR measure that was not included in the third 
party intermediary's self-nomination can be accepted after the close of 
the self-nomination period on September 1st. Each QCDR measure that is 
self-nominated is evaluated and approved by CMS for its appropriateness 
and use in the MIPS program.
    After consideration of public comments, we are finalizing our 
proposal to add that the measure was submitted after self-nomination 
closes to our list of reasons for rejecting a QCDR measure at Sec.  
414.1400(b)(4)(iv)(O) as proposed.
(ii) Limitations on Number of QCDR Measures Submitted for Self-
Nomination
    In the CY 2017 Quality Payment Program final rule, we established 
at Sec.  414.1400(b)(4)(i) that QCDRs must submit certain 
specifications for QCDR measures that would be considered for approval 
by CMS (81 FR 77374 through 77378). These measures would then be 
considered for approval or rejection under the requirements of Sec.  
414.1400(b)(4)(iii) and (iv). CMS reviews these measures carefully and 
each additional measure takes considerable time and effort to review. 
We have had experiences in which a single QCDR has submitted a large 
number of QCDR measures for consideration. While we are mindful that 
there may be a number of valid measure concepts, we are generally 
trying to focus measurement within the Quality Payment Program. In an 
effort to optimize resource allocation and encourage QCDRs to focus 
their submitted measures on those that have the highest value, we 
proposed to add at Sec.  414.1400(b)(4)(iv)(P) that a QCDR measure may 
be rejected if the QCDR submits more than 30 quality measures not in 
the annual list of MIPS quality measures for CMS consideration (88 FR 
52607). We considered a lower limit given that clinicians in 
traditional MIPS are only required to report on 6 quality measures and 
clinicians reporting via MVPs may report even fewer. However, we 
recognize that some QCDRs serve more diverse clinical populations and 
could conceivably wish to submit this many as part of self-nominations. 
We noted that we would continue to evaluate individual measures on 
their merits as specified in our requirements at Sec.  
414.1400(b)(4)(iii) and (iv).
    We received public comments on the proposal. The following is a 
summary of the comments we received and our responses.
    Comment: One commenter supported our proposal that a QCDR measure 
may be rejected if the QCDR submits more than 30 quality measures not 
in the annual list of MIPS quality measures for CMS consideration and 
suggested that it would reduce the likelihood of irrelevant measures 
being reported by a QCDR.
    Response: We thank the commenter for their support.
    Comment: A few commenters opposed our proposal and suggested that 
establishing this limit would not allow a QCDR to best report for all 
the subspecialty clinicians which report through that QCDR.
    Response: We understand that some QCDRs serve diverse clinical 
populations and may wish to offer a large number of measure reporting 
opportunities to their clinicians. However, we also note that we are 
engaging in efforts such as the development of MVPs that would focus 
measures on those that are most relevant. We note that QCDRs have no 
limitation on the number of measures they report that are on the annual 
list of MIPS quality measures. Even a QCDR supporting diverse 
populations should have sufficient measures with this limit.
    After consideration of public comments, we are finalizing our 
proposal at Sec.  414.1400(b)(4)(iv)(P) that a QCDR measure may be 
rejected if the QCDR submits more than 30 quality measures not in the 
annual list of MIPS quality measures for CMS consideration as proposed.
(iii) Requirements for Previous Data on QCDR Measures
    In the CY 2017 Quality Payment Program final rule (81 FR 77368), we 
established a requirement that for non-MIPS measures the QCDR must 
provide us, if available, data from years prior to the start of the 
performance period. We proposed to codify this previously finalized 
provision at Sec.  414.1400(b)(4)(i)(C) (88 FR 52607 through 52608).
    We did not receive public comments on this provision, and 
therefore, we are finalizing it as proposed.
(iv) Requirement for QCDR Measure Specifications To Remain Published 
Through the Performance Period and Data Submission Period
    In the CY 2017 Quality Payment Program final rule (81 FR 77375 
through 77376), we established at Sec.  414.1400(b)(4)(i)(B) that no 
later than 15 calendar days following CMS posting of all approved 
specifications for a QCDR measure, the QDCR must publicly post the CMS-
approved measure specifications for the QCDR measure (including the 
CMS-assigned QCDR measure ID) and provide CMS

[[Page 79390]]

with a link to where this information is posted. While we established 
when this posting was required, we did not establish a standard for the 
duration of this posting. We have become aware of situations in which 
QCDR measure owners have removed this documentation during the course 
of the performance period or before the closure of the submission 
period. We proposed to revise Sec.  414.1400(b)(4)(i)(B) to add a 
provision that the approved QCDR measure specifications must remain 
published through the performance period and data submission period (88 
FR 52608). Although it was not previously specified, it was our 
intention that this information be made available for the entirety of 
the time that the measure could be considered and reported by 
clinicians or groups as part of the Quality Payment Program. Measure 
specifications must be available throughout the duration of measure use 
for interested parties to understand the target population of the 
measure, how the measure is built and calculated, and to identify 
existing measure gaps. Clinicians may elect to begin collecting data at 
various times in the year and even if data collection has started, may 
need to consult specifications throughout the performance period to 
confirm that data collection is in concordance with the specifications. 
We stated that we believe this addition will prevent QCDRs from 
removing specifications following the initial required posting and 
increase transparency for participants. We also proposed to make a 
technical update to the language removing the reference to providing 
the NQF number due to changes in the contractor that CMS uses for 
measure endorsement (88 FR 52608).
    We received public comments on the proposal. The following is a 
summary of the comments our responses.
    Comment: One commenter opposed this proposal and suggested that it 
would discourage the development of new measures and potentially slow 
participation of QCDRs in MIPS.
    Response: We note that this requirement merely specifies the length 
required before removal of a posted document. We believe that the 
specifications for a measure used in a public program should be 
publicly available while being used in that program. It is not clear 
how this proposal would discourage development of new measures or 
participation of QCDRs in the MIPS program.
    After consideration of public comments, we are finalizing our 
proposal at Sec.  414.1400(b)(4)(i)(B) that the approved QCDR measure 
specifications must remain published through the performance period and 
data submission period as proposed.
(5) Health IT Vendors
(a) Background
    In the CY 2017 Quality Payment Program final rule (81 FR 77377 
through 77382), we established the category of health IT vendor in the 
Quality Payment Program, along with requirements for data submission. 
In the CY 2019 PFS final rule, we codified the definition of a health 
IT vendor as an entity that supports the health IT requirements on 
behalf of a MIPS eligible clinician (including obtaining data from a 
MIPS eligible clinician's CEHRT) (83 FR 59907). In the CY 2022 PFS 
final rule (86 FR 65541), we finalized a reorganization of the 
regulatory text governing the third party intermediary section to 
improve clarity and readability. In that revised text, we established 
general requirements at Sec.  414.1400(a), additional requirements for 
QCDRs and qualified registries at Sec.  414.1400(b), and additional 
requirements for health IT vendors at Sec.  414.1400(c).
(b) Proposal To Remove Health IT Vendor Category
    In the CY 2021 PFS final rule, we established additional program 
safeguards regarding data validation audit and targeted audit 
requirements that would apply specifically to QCDRs and qualified 
registries. We noted (85 FR 84928 and 84929) that while we did not 
propose these additional requirements for health IT vendors, we had 
become aware of situations in which health IT vendors have submitted 
data that are inaccurate and unusable and that could result in improper 
payments or otherwise undercut the integrity of the MIPS program. In 
our review of comments in response to our solicitation on the future 
application of such requirements on health IT vendors, we observed that 
several commenters supported requirements for health IT vendors to 
perform data validation to align requirements with QCDRs and qualified 
registries and improve data integrity. We also observed that several 
commenters opposed additional data validation requirements for health 
IT vendors due to the associated cost, and that such a requirement 
would be duplicative of requirements of health IT vendors under the ONC 
regulatory framework.
    Since the publication of the CY 2021 PFS final rule, we continue to 
have experiences with third party intermediaries submitting data that 
is inaccurate and unusable. We believe this necessitates a 
reconsideration of the lack of data validation requirements for health 
IT vendors in contrast to those requirements for QCDRs and qualified 
registries.
    In the CY 2019 PFS final rule (83 FR 59747 through 59749), we 
established the definition of collection type, submitter type, and 
submission type. These definitions are intended to more precisely 
describe how data is collected and submitted for the Quality Payment 
Program. For the quality, Promoting Interoperability, and improvement 
activity performance categories, an approved third party intermediary 
may submit directly to the submissions application programming 
interface (API), or upload files via qpp.cms.gov. Historically, third 
party intermediaries are able to receive tokens by virtue of successful 
self-nomination as a QCDR or qualified registry or, for those 
technologies that use CEHRT, through a request to CMS.
    In examining the different requirements for QCDRs and qualified 
registries and health IT vendors, we noted that the primary difference 
is the requirement for self-nomination at Sec.  414.1400(b)(2) and 
requirements primarily related to data validation audits at Sec.  
414.1400(b)(3). We considered whether we should add a self-nomination 
requirement for health IT vendors or require data validation audits for 
health IT vendors or both. However, we noted that we believe that 
adding a self-nomination requirement or data validation audit 
requirements would essentially eliminate the difference between a 
health IT vendor and a qualified registry. We noted our observation 
that many vendors serve in capacities as qualified registries, QCDRs or 
health IT vendors with similar technology. Rather than establish 
identical or nearly identical requirements for different categories of 
vendors, we instead proposed to eliminate the health IT vendor category 
beginning with the CY 2025 performance period and by revising Sec.  
414.1400(a)(1)(iii) (88 FR 52608). Absent a self-nomination process for 
Health IT vendors, we do not believe we can establish a meaningful 
enforcement mechanism to ensure that the vendors are meeting the 
requirements as we have laid out.
    We noted that our proposal to remove Health IT vendors from the 
definition of third party intermediary would not preclude the vendors 
from assisting MIPS eligible clinicians with reporting under the 
program. Instead, the vendors may still provide their technology for

[[Page 79391]]

clinicians to directly report under MIPS. We noted our belief that 
eliminating the category of Health IT vendor as a distinct type of 
third party intermediary will create a clearer distinction between 
those vendors that are submitting data to us for the purposes of MIPS 
and must meet the requirements of a qualified registry or QCDR and 
those vendors that work with clinicians through the sale and support of 
health IT that permits the clinician or group to submit the data.
    We received public comments on the proposal. The following is a 
summary of the comments and our responses:
    Comment: Several commenters supported our proposal to remove the 
Health IT vendor category, suggesting that this policy would improve 
clarity and set a consistent standard among third party intermediaries. 
A few commenters who supported the proposal to remove the Health IT 
vendor category suggested that CMS establish data validation standards 
for direct reporting of data for the purposes of MIPS in order to 
further improve consistency among submission types.
    Response: We appreciate the support from the commenters for our 
proposal to remove Health IT vendors from the definition of a third 
party intermediary and agree it will improve clarity and establish a 
consistent standard. In response to concerns about data quality for 
those clinicians and groups that may directly submit data, we note that 
direct submitters are subject to the same requirements for data quality 
as data submitted through a third party intermediary and may be subject 
to audit.
    Comment: A few commenters opposed our proposal to eliminate the 
health IT vendor category of third party intermediaries and suggested 
that this could limit the opportunity for clinicians to report MIPS 
data using their EHRs. One commenter recommended that CMS align data 
submission requirements with the Digital Quality Measure Roadmap and 
continue to build on existing eCQMs. One of the commenters suggested 
that CMS instead adopt corrective action plan requirements for health 
IT vendors that submit inaccurate data and adopt more stringent data 
validation strategies.
    Response: Our proposal was made based on our observation that many 
EHRs can self-nominate to serve as registries or QCDRs under our 
existing requirements and that many others can also facilitate direct 
reporting of MIPS data by clinicians and groups. This proposal will not 
limit opportunities for clinicians to submit data and most clinicians 
and groups can continue to use the vendors they currently use to 
facilitate reporting. This change will improve clarity and ensure that 
there is clear understanding of what has been reviewed in the approval 
of a third party intermediary. As noted in the 2024 PFS proposed rule 
(88 FR 52608), a lack of self-nomination process has made it difficult 
to fully understand the nature of the health IT vendors and therefore 
made it difficult to properly identify and develop corrective action 
plans for those with data issues. We continue to emphasize the 
importance of digital measures in MIPS and throughout CMS quality 
programs.
    Comment: A few commenters requested further clarification on how 
the organizations previously identified as health IT vendors could 
support MIPS-eligible clinicians. One commenter asked if those 
organizations could provide QRDA files for the improvement activity and 
Promoting Interoperability performance categories.
    Response: The organizations previously identified as health IT 
vendors may complete self-nomination as registries or QCDRs and submit 
data, which would include measures and activities in the improvement 
activity and Promoting Interoperability performance categories which 
may be reported using QRDA. They may also facilitate the direct 
reporting of data by clinicians and groups which is reported via QRDA.
    Comment: One commenter opposed this proposal and suggested that it 
would have a disproportionate effect on hospitals that treat 
disadvantaged patients.
    Response: We offer a number of different options for clinicians who 
practice in environments in which they may be treating disadvantaged 
patients and are uncertain how such a policy would affect them 
disproportionately.
    Comment: One commenter opposed our proposal because they stated 
that it may be difficult for some vendors to support the self-reporting 
by clinicians and groups and also difficult for these vendors to meet 
the requirements of a qualified registry or QCDR. One commenter 
suggested that technological solutions that are available such as OAuth 
are limited because they are assigned to individuals.
    Response: Those organizations that served as health IT vendors that 
are unable to support self-reporting by clinicians and groups may be 
able to self-nominate to serve as a qualified registry or QCDR. We note 
that many organizations have successfully completed these requirements 
so we do not believe that they prevent a significant barrier.
    Comment: One commenter requested that CMS require that health IT 
vendors that are serving as third party intermediaries be required to 
support a transition to another third party intermediary due to the 
elimination of the health IT vendor category.
    Response: We will continue to offer as many resources as possible 
to help clinicians identify third party intermediaries that could 
facilitate data reporting for MIPS, as well as educate clinicians on 
opportunities to report data directly. In addition, it is important to 
note that this change will occur beginning with the CY 2025 performance 
period--thereby, providing clinicians and third party intermediaries 
additional time to prepare for the transition.
    After consideration of the public comments, we are finalizing our 
proposal at Sec.  414.1400(a)(1)(iii) to eliminate the health IT vendor 
category beginning with the CY 2025 performance period.
(6) Remedial Action and Termination of Third Party Intermediaries
(a) Background
    We referred readers to Sec.  414.1400(e), the CY 2017 Quality 
Payment Program final rule (81 FR 77386 through 77389), the CY 2019 PFS 
final rule (83 FR 59908 through 59910), the CY 2020 PFS final rule (84 
FR 63077 through 63080), the CY 2021 PFS final rule (85 FR 84947), the 
CY 2022 PFS final rule (86 FR 65542 and 65550) and the CY 2023 PFS 
final rule (87 FR 70106 through 70109) for previously finalized 
policies for remedial action and termination of third party 
intermediaries.
(b) Additional Basis for Remedial Action
(i) Failure To Maintain Correct Contact Information
    In the CY 2017 Quality Payment Program final rule, we established 
the process for self-nomination for QCDRs (81 FR 77364 through 77367) 
and qualified registries (81 FR 77383 through 77384). We also 
established the process for corrective action plans in the CY 2017 
Quality Payment Program final rule (81 FR 77389). In our work with 
QCDRs and qualified registries, we experienced times when the QCDR or 
qualified registry did not respond to certain requests in a timely 
manner, thereby delaying program operations. In some cases, we had 
further correspondence with the QCDR or qualified registry and those 
organizations suggested that the contact information (generally an 
email address) submitted as part of the self-nomination

[[Page 79392]]

was not correct, so the request was never received. While we understand 
that personnel can change over time in an organization, such a change 
does not relieve the QCDR or qualified registry of its obligations 
under these rules. Therefore, we proposed an additional provision at 
Sec.  414.1400(e)(2)(iv) to allow us to immediately or with advance 
notice terminate a third party intermediary that has not maintained 
current contact information for correspondence (88 FR 52609).
    We received public comments on the proposal. The following is a 
summary of the comments we received and our responses.
    Comment: A few commenters opposed our proposal to add failure to 
maintain correct contact information to the list of reasons for 
corrective action plan and suggested that this proposal was too 
inflexible. One commenter suggested that the requirement for three 
separate contacts already provide an undue burden for smaller 
registries and that maintaining current information would add to that 
burden.
    Response: We note that this policy does not require us to terminate 
a third party intermediary in all circumstances in which a third party 
intermediary fails to maintain current contact information; instead, it 
gives us the discretion to do so. Being able to contact a 
representative of a QCDR or Qualified Registry is a basic operational 
requirement.
    After consideration of the public comments, we are finalizing our 
proposal at Sec.  414.1400(e)(2)(iv) to allow us to immediately or with 
advance notice terminate a third party intermediary that has not 
maintained current contact information for correspondence.
(ii) Consecutive Years on Remedial Action
    In the CY 2017 Quality Payment Program final rule, we established a 
process for placing third party intermediaries on probation for not 
meeting requirements (81 FR 77387). Specifically, if a third party 
intermediary did not meet requirements for qualification, they could be 
placed on probation for the current performance period and/or the 
following performance period. We also established that after two years 
on probation, a third party intermediary would be disqualified for the 
subsequent performance year (81 FR 77387 through 77389). In the CY 2019 
PFS final rule, policies relating to probation and disqualification 
were renamed and reorganized under remedial action and termination of 
third party intermediaries (83 FR 59908 through 59910). Additionally, 
we finalized reasons for terminating third party intermediaries 
including being placed on remedial action, not submitting a corrective 
action plan, and not promptly correcting data errors (83 FR 59908 
through 59910). At that time, we did not propose any actions related to 
third party intermediaries on remedial action for multiple years, as 
had been established under our initial probation policy.
    We noted that we continue to experience issues with third party 
intermediaries that require corrective action plans over multiple 
years. We believe that third party intermediaries that consistently 
require corrective action plans, whether for the same or unrelated 
issues, do not further the goals of the Quality Payment Program, which 
are to improve quality of care while limiting administrative burden. We 
believe allowing third party intermediaries that have consistently 
demonstrated failure to comply with CMS requirements such that they 
required corrective action plans undermine clinicians' and groups' 
efforts to improve quality and could result in increased administrative 
burden for those clinicians and groups. For this reason, we proposed to 
add at Sec.  414.1400(e)(2)(v) that CMS may terminate third party 
intermediaries that are on remedial action for 2 consecutive years (88 
FR 52609). We noted our belief that this proposal would minimize risk 
within the Quality Payment Program by terminating third party 
intermediaries that are consistently deemed as non-compliant.
    We received public comments on the proposal. The following is a 
summary of the comments we received and our responses:
    Comment: One commenter opposed our proposal that CMS may terminate 
third party intermediaries that are on remedial action for 2 
consecutive years. The commenter suggested that CMS has had difficulty 
in determining if certain elements of the corrective action plan have 
been completed and further suggested that continuous years of 
corrective action could be a result of this lack of awareness.
    Response: As part of our corrective action plans, we track and 
maintain status of progress on a monthly basis. Our policy to require 
third party intermediaries under a corrective action plan to 
communicate the final resolution of that plan, finalized in section 
IV.A.4.k.(6)(c) of this rule, will further facilitate awareness on our 
part of the resolution of a corrective action plan.
    After consideration of public comments, we are finalizing our 
proposal at Sec.  414.1400(e)(2)(v) that CMS may terminate third party 
intermediaries that are on remedial action for 2 consecutive years.
(c) Revised Corrective Action Plan Requirements
    As described in Sec.  414.1400(e)(1)(i), among the remedial actions 
that CMS may take against a non-compliant third party intermediary is a 
corrective action plan (CAP). Under paragraphs (e)(1)(i)(A) through 
(D), unless different or additional information is specified by CMS, 
the CAP must address the following issues: (A) the issues that 
contributed to the non-compliance; (B) the impact to individual 
clinicians, groups, virtual groups, subgroups, or APM Entities, 
regardless of whether they are participating in the program because 
they are MIPS eligible, voluntarily participating, or opting in to 
participating in the MIPS program; (C) the corrective actions to be 
implemented by the third party intermediary to ensure that the non-
compliance has been resolved and will not recur in the future; and (D) 
a detailed timeline for achieving compliance with the applicable 
requirements. In the CY 2023 PFS final rule, we finalized a policy at 
Sec.  414.1400(e)(1)(i)(E) to require third party intermediaries to 
provide a communication plan for communicating the impact to the 
parties identified within the corrective action plan (87 FR 70107).
    Based on our experience with corrective action plans from third 
party intermediaries through the years, we have identified a gap in our 
ability to determine if certain elements of the corrective action plan 
have been completed in the time and manner specified within the action 
plan. Therefore, we proposed to add at Sec.  414.1400(e)(1)(i)(F) an 
additional requirement for a third party intermediary under a 
corrective action plan to communicate the final resolution to CMS once 
the resolution is complete, and to provide an update, if any, to the 
monitoring plan provided under Sec.  414.1400(e)(1)(i)(C) (88 FR 
52609). We noted our belief that this additional step will ensure that 
third party intermediaries complete the required actions within the 
corrective action plan.
    We did not receive public comments on this provision. We are 
finalizing this proposal as proposed.

[[Page 79393]]

(d) Public Posting of Deficiencies
    In the CY 2017 Quality Payment Program final rule (81 FR 77386 
through 77388), we established a remedial action that, in the event 
that a QCDR or qualified registry had data inaccuracies that affected 
more than 3 percent but less than 5 percent of the total number of MIPS 
eligible clinicians, we would have this information identified on the 
CMS public posting. We modified this requirement in the CY 2019 PFS 
final rule (83 FR 59909) that the data error rate would be publicly 
disclosed until the data error rate falls below 3 percent.
    We proposed to modify this requirement. While we previously 
determined that a single, objective measure (that is, a 3 percent error 
rate) would support our goals of public notice, we noted our belief 
that the precise metric is not a meaningful indicator. Specifically, 
some errors may be minor in nature yet affect a large number of 
clinicians for whom the QCDR or qualified registry has reported data. 
Other errors, however, may be materially significant but may not affect 
3 percent of the MIPS eligible clinicians due to the unique nature of 
the data point at issue.
    We believe that there is significant value in informing the public 
and potential customers which QCDRs and qualified registries are under 
remedial action or are terminated. Therefore, we proposed to add a new 
provision at Sec.  414.1400(e)(1)(ii)(B) that CMS may, beginning with 
the CY 2025 performance period/2027 MIPS payment year, publicly 
disclose on the CMS website that CMS took remedial action against or 
terminated the third party intermediary. We noted that this public 
disclosure would be limited to the presence of the corrective action 
plan and would not include any proprietary information from the QCDR or 
qualified registry (88 FR 52610). We also proposed to modify Sec.  
414.1400(e)(1)(ii) by redesignating it as Sec.  414.1400(e)(1)(ii)(A) 
and ending this policy after the CY 2025 performance period/2027 MIPS 
payment year (88 FR 52610). We proposed to remove this policy because 
we believe it would be superseded by the proposal included in Sec.  
414.1400(e)(1)(ii)(B).
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses:
    Comment: A few commenters opposed our proposal to publicly post the 
existence of a corrective action plan for third party intermediaries, 
suggesting that this would make it more difficult for these third party 
intermediaries to participate in MIPS. One commenter suggested that the 
information only be released if the third party intermediary is unable 
or unwilling to address the issue.
    Response: A third party intermediary is given the opportunity to 
address deficiencies in a corrective action plan. We again note that 
the nature of the corrective action plan would not be identified. We 
believe that those considering the use of these third party 
intermediaries should be aware if there is a current deficiency when 
considering options for reporting MIPS data.
    After consideration of public comments, we are finalizing our 
policies to add a new provision at Sec.  414.1400(e)(1)(ii)(B) that CMS 
may, beginning with the CY 2025 performance period/2027 MIPS payment 
year, CMS will publicly disclose on the CMS website that we took 
remedial action against or terminated the third party intermediary. We 
also finalize our proposal to modify Sec.  414.1400(e)(1)(ii) by 
redesignating it as paragraph (e)(1)(ii)(A) and end this policy after 
the CY 2025 performance period/2027 MIPS payment year.
(e) Considering Past Performance in Approving Third Party 
Intermediaries
    In the CY 2017 Quality Payment Program final rule, we established 
that third party intermediaries would be placed on probation status if 
they had not met criteria for qualification following self-nomination 
(81 FR 77386 through 77389). Under the terms of the probation policy, a 
corrective action plan could be required to address any deficiencies or 
prevent them from recurring. In addition, a third party intermediary 
that was on probation status for 2 years would be disqualified for the 
subsequent performance period. In the CY 2019 PFS final rule (83 FR 
59909), we consolidated the corrective actions that we would take in 
the event of a deficiency or error on the part of a third party 
intermediary. This included the elimination of a policy of probation 
for third party intermediaries and the establishment of a policy of 
remedial action for third party intermediaries. We did not change the 
factors made to determine a remedial action or probation.
    We have continued to experience issues related to data errors from 
third party intermediaries and these errors often extend over multiple 
years. We are concerned that some third party intermediaries fail to 
address deficiencies with regularity, and are required to perform 
remedial actions as defined in corrective action plans over the course 
of many years. This suggests that these organizations are not able to 
properly adhere to the criteria for qualification for third party 
intermediaries. While we have established criteria for approval of 
third party intermediary at Sec.  414.1400(a)(2)(ii)(A) which state 
that our determination to approve a third party intermediary may take 
into account whether the entity failed to comply with the requirements 
for a previous MIPS payment year, we wish to clarify that the 
consideration of past compliance can also include remedial actions. 
While we already have the ability to consider whether the entity failed 
to comply with certain requirements, we do not believe that the 
existing requirements are explicit enough for third party 
intermediaries to understand that a history of remedial actions, even 
if addressed such that the third party intermediary was not terminated 
could result in CMS not approving future approval.
    We did not receive public comments on this provision. We are 
finalizing this proposal as proposed.
(f) Terms of Audits
    In the CY 2017 Quality Payment Program final rule (81 FR 77389 
through 77390), we finalized that third party intermediaries submitting 
MIPS data must comply with auditing procedures as a condition to 
participate in MIPS. In the proposed rule, we did not establish the 
reasons we have for auditing a particular third party intermediary. We 
noted that we perform both random and targeted compliance audits based 
on a number of reasons and we wish to document those reasons for 
transparency to the public. Therefore, we proposed at Sec.  414.1400(f) 
that third party intermediaries may be randomly selected for compliance 
evaluation or may be selected at the suggestion of CMS if there is an 
area of concern regarding the third party intermediary (88 FR 52610). 
For example, areas of concern could include but are not limited to: 
high data errors, support call absences, delinquent deliverables, 
remedial action status, clinician concerns regarding the third party 
intermediary, a continuing pattern of Quality Payment Program Service 
Center inquiries or support call questions, and/or CMS concerns 
regarding the third party intermediary. We also proposed to redesignate 
the existing section Sec.  414.1400(f) (which includes paragraphs 
(f)(1), (2), and (3)) as paragraph (a)(3)(v) with minor changes in the 
text for clarity (88 FR 52610). We noted that this section refers to 
program requirements, which we

[[Page 79394]]

believe is a more appropriate characterization of these requirements.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: A few commenters opposed the specific element of our 
proposal which referenced a continuing pattern of Quality Payment 
Program service center inquires or support call questions. The 
commenters suggested this could discourage third party intermediaries 
from engaging with the support center.
    Response: We clarify that a third party intermediary would not be 
identified for an audit on the basis of communication between the 
service center and the third party intermediary. However, a pattern of 
particular third party intermediary users contacting the Quality 
Payment Program for issues could indicate that the third party 
intermediary was having trouble meeting our program requirements, which 
would be a basis for taking corrective action.
    After consideration of public comments, we are finalizing our 
proposal at Sec.  414.1400(f) that third party intermediaries may be 
randomly selected for compliance evaluation or may be selected at the 
suggestion of CMS if there is an area of concern regarding the third 
party intermediary. We are also finalizing our policy to redesignate 
the existing section Sec.  414.1400(f) (which includes paragraphs 
(f)(1), (2), and (3)) as paragraph (a)(3)(v) with minor changes in the 
text for clarity.
(7) Technical Changes
    In the course of reviewing the regulation for third party 
intermediaries, we identified areas in which certain language was used 
that is not as consistent or clear as it could be. We proposed to make 
the following changes to Sec.  414.1400 to improve clarity as denoted 
below (88 FR 52610):
     At paragraph (a)(2), to clarify that an organization may 
only become a third party intermediary for the purposes of MIPS by 
meeting the approval criteria by replacing the term ``third party 
intermediary'' with ``organization''.
     Redesignate paragraph (a)(3) to delineate third party 
intermediary approval criteria from requirements for third party 
intermediaries as they participate in the Quality Payment Program. We 
proposed the following redesignations:
     Sec.  414.1400(a)(3) redesignated as Sec.  
414.1400(a)(3)(i);
     Sec.  414.1400(a)(2)(i)(C) redesignated as Sec.  
414.1400(a)(3)(ii);
     Sec.  414.1400(a)(2)(i)(D) redesignated as Sec.  
414.1400(a)(3)(iii);
     Sec.  414.1400(a)(2)(i)(F) redesignated as Sec.  
414.1400(a)(3)(iv); and
     Sec.  414.1400 (a)(2)(iii) redesignated as Sec.  
414.1400(a)(3)(vi).
    These reorganized sections also include minor changes to the text. 
Please note that we outlined new proposals related to these 
requirements in section IV.A.4.k.(3) of the proposed rule. There is 
also a conforming change to reference this section at Sec.  
414.1400(e)(1).
     At Sec.  414.1400(e)(3) to remove the word ``total'' from 
the phrase ``total clinicians'' as this word was included in error.
     At Sec.  414.1400(e)(4) to improve clarity and remove a 
paragraph.
    We invited comments on these proposals.
    We did not receive public comments on this provision. We are 
finalizing these technical changes as proposed.
l. Public Reporting on Compare Tool
    Section 10331(a)(1) of the Affordable Care Act provides for the 
development of a Physician Compare internet website (``Physician 
Compare'') with information on physicians and other eligible 
professionals enrolled in Medicare who participate in the Physician 
Quality Reporting Initiative (PQRI). Section 1848(q)(9) of the Act, as 
added by section 101(c) of MACRA, aligned Physician Compare with the 
newly established Merit-Based Incentive Payment System (MIPS) by 
requiring the public reporting of MIPS performance information for MIPS 
eligible professionals through Physician Compare.
    For previous discussions of public reporting of physician and 
clinician performance and information, we refer readers to the CY 2016 
Physician Fee Schedule (PFS) final rule (80 FR 71116 through 71123), 
the CY 2017 Quality Payment Program final rule (81 FR 77390 through 
77399), the CY 2018 Quality Payment Program final rule (82 FR 53819 
through 53832), the CY 2019 PFS final rule (83 FR 59910 through 59915), 
the CY 2020 PFS final rule (84 FR 63080 through 63083), the CY 2022 PFS 
final rule (86 FR 65550 through 65554), the CY 2023 PFS final rule (87 
FR 70109 through 70113) and the Care Compare: Doctors and Clinicians 
Initiative web page at https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/care-compare-dac-initiative. 
We also note, that as finalized at Sec.  414.1305 ``Physician Compare'' 
is defined as the Physician Compare internet website of CMS (or a 
successor website). As discussed in prior rulemaking, the current 
website is the Compare Tools hosted by the U.S. Department of Health 
and Human Services (HHS), referred to as the ``Compare tool'' 
throughout prior rulemaking and this proposed rule (86 FR 39466). 
(https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/care-compare-dac-initiative.) As finalized at Sec.  
414.1305, ``Physician Compare'' is defined as the Physician Compare 
internet website of CMS (or a successor website). As discussed in prior 
rulemaking, we note the current website is the Compare Tools hosted by 
the U.S. Department of Health and Human Services (HHS), referred to as 
the ``Compare tool'' throughout prior rulemaking and this proposed rule 
(86 FR 39466).
(1) Telehealth Indicator
    In the CY 2023 PFS final rule, we finalized the addition of an 
indicator to the profile pages of clinicians who furnish telehealth 
services (87 FR 70109 through 70111) to established processes and 
coding policies to identify such clinicians (id.). As discussed in the 
CY 2024 proposed rule (88 FR 52611), under our current policy, we would 
already be using the most current CPT codes for each telehealth 
indicator update; however, we would need to use annual rulemaking to 
update the POS and claims modifier codes used for telehealth indicator 
public reporting purposes. Adding coding flexibility for other codes, 
such as POS and claims modifiers, would both help avoid future 
regulatory burden and allow for more real-time accuracy of the 
telehealth information provided on Care Compare.
    For these reasons, we proposed to update our policy for identifying 
clinicians furnishing telehealth services, such that we remain current 
with CMS coding changes, without proposing and finalizing such coding 
changes via rulemaking. Specifically, instead of only using POS code 
02, 10, or modifier 95 to identify telehealth services furnished for 
the telehealth indicator, we will use the most recent codes at the time 
the data are refreshed that identify a clinician as furnishing services 
via telehealth. We proposed that at the time of such a data refresh we 
will publish the details of which codes are used for the telehealth 
indicator through education and outreach, such as via a fact sheet, 
listserv, and information posted on the Care Compare: Doctors and 
Clinicians Initiative page, available at https://www.cms.gov/medicare/
quality-initiatives-patient-assessment-instruments/care-compare-dac-

[[Page 79395]]

initiative. We refer readers to the CY 2024 PFS proposed rule (88 FR 
52611) for details on the Telehealth Indicator proposal.
    The following is a summary of the comments on this proposal we 
received and our responses.
    Comment: Commenters supported the use of the most recent codes at 
the time the data are refreshed that identify a clinician as furnishing 
services via telehealth. The commenters noted the importance of 
providing an accurate indicator of telehealth services on clinician 
profile pages. One commenter noted that providing meaningful 
information on care delivery options available could help to further 
access to care and health equity goals.
    Response: We appreciate the commenters' support for updating the 
telehealth indicator process for identifying and updating telehealth 
service information on clinician profile pages. We agree that it is 
important to ensure accuracy in knowing whether a clinician offers 
services via telehealth to be useful to patients and caregivers, 
particularly for those who have access to care barriers.
    Comment: One commenter recommended having a clinician review and 
correction process that would allow clinicians to update and correct 
the telehealth indicator and other information listed on their profiles 
if needed.
    Response: Since claims are the data source for identifying 
telehealth services rendered by a clinician, we encourage clinicians to 
first look into any billing errors. However, as with any other 
questions or concerns regarding the information on clinician and group 
profile pages on the Compare tool, interested parties may contact the 
Quality Payment Program at 1-866-288-8292 or by email at 
[email protected]. Those who are hard of hearing can dial 711 to be 
connected to a Telecommunications Relay Service (TRS) Communications 
Assistant. We also encourage clinicians to ensure their information is 
current in the Provider Enrollment, Chain, and Ownership System (PECOS) 
and to visit the Doctors and Clinicians initiative page for more 
information https://www.cms.gov/Medicare/Quality-Initiatives-Patient-
Assessment-Instruments/Care-Compare-DAC-Initiative.
    After consideration of public comments, we are finalizing our 
proposal to use the most recent codes at the time the data are 
refreshed that identify a clinician as furnishing services via 
telehealth, as proposed.
(2) Publicly Reporting Utilization Data on Profile Pages
    Section 104(a) of MACRA provides that, beginning with 2015, the 
Secretary shall make publicly available on an annual basis, in an 
easily understandable format, information with respect to physicians 
and, as appropriate, other eligible professionals, on items and 
services furnished to Medicare beneficiaries. Section 104(e) of the 
MACRA also requires that we integrate this data into the Compare tool. 
We finalized a policy to report the most recent available utilization 
data in downloadable format beginning in late 2017 (80 FR 71130). This 
information continues to be available today in the Medicare Provider 
Data Catalog (PDC) available at https://data.cms.gov/provider-data/topics/doctors-clinicians. Separately, we have reported on the Compare 
tool clinician training information as well as a clinician's primary 
and secondary specialties.
    In the CY 2023 PFS final rule (87 FR 70111 through 70113), and as 
discussed in the CY 2024 proposed rule (88 FR 52611 through 52612), we 
established a policy for publicly reporting procedure information on 
clinician profile pages to provide patients more information in their 
clinician searches in an understandable format, beginning no earlier 
than CY 2023.
    We also established that priority procedures selected for 
utilization data public reporting will meet one or more of the 
following criteria:
     Have evidence of a positive relationship between volume 
and quality in the published peer reviewed clinical research;
     Are affiliated with existing MIPS measures indicating 
importance to CMS;
     Represent care that a patient might shop for a clinician 
to provide; and/or
     Are an HHS priority.
    We finalized that this data would be based on a 12-month lookback 
period, with data refreshes updated bi-monthly, as technically 
feasible, and we would not initially prioritize complex, rare 
procedures. We noted that the utilization data shown on profile pages 
would only reflect Medicare Fee-for-Service (FFS) claims data and would 
not include procedures performed for patients who have other types of 
insurance. To meaningfully categorize procedures, we finalized the 
policy of using the Restructured Berenson-Eggers Type of Service 
(BETOS) Codes Classification System to collapse Healthcare Common 
Procedure Coding System (HCPCS) data into procedural categories, and 
when no Restructured BETOS categories are available, procedure code 
sources used in MIPS, such as the procedure categories already defined 
for MIPS cost or quality measures.
    Consumer testing showed that publicly reporting utilization data on 
patient-facing clinician profile pages and using plain language, is 
helpful for patients and caregivers to make informed healthcare 
decisions, since it allows them to find clinicians who have performed 
specific types of procedures. Consumer testing results showed that 
patients and caregivers understand this language, would not select a 
health care provider based on this information alone, and find the 
information helpful but would like the procedure volume to also reflect 
patients with other insurance if possible. Our data analyses have 
confirmed the availability of Medicare Advantage (MA) data increasing 
the representativeness of the procedure (that is, utilization) data, as 
discussed later in this section.
(a) Updating the Provider Data Catalog (PDC) Utilization Data Policy
    As discussed in the CY 2024 PFS proposed rule (88 FR 52611 through 
52612), we historically have published a PDC file that is a subset of 
the most commonly performed procedures in the PUF. With the upcoming 
release of the initial procedural utilization data, we will publish a 
second utilization file in the PDC that will reflect the procedure 
category information on clinician profile pages. That is, consistent 
with what will be publicly reported on profile pages, the second PDC 
file will aggregate like procedures and include an indication of low 
volume counts, in accordance with the CMS small cell size policy, in 
which counts below 11 cannot be publicly reported, to protect patient 
privacy.
    It would be of greater use for the PDC to only have one utilization 
downloadable file that reflects the same subset of data, in the same 
format, as what will be publicly reported on clinician profile pages. 
Doing so aligns the criteria for selecting utilization data in the PDC 
to reflect the same criteria for selection on clinician profile pages 
and will assist researchers in analyses of utilization data on 
clinician profile pages.
    Therefore, we proposed revising the policy to publicly report a 
subset of the Medicare PUF on the PDC to instead provide a single 
downloadable dataset including the procedure utilization data that 
would appear on clinician profile pages. We proposed to remove the PUF 
subset file from the PDC and only keep the utilization data file that 
reflects the information on clinician profile pages in the PDC. We 
refer readers to the CY

[[Page 79396]]

2024 PFS proposed rule (88 FR 52612 through 52613) for details on the 
PDC Utilization Data File proposal.
    We solicited comment on all aspects of this proposal, including any 
concerns about technical feasibility; our approach to aligning the 
criteria for selecting utilization data in the PDC to reflect the same 
criteria for selection on clinician profile pages; ways in which we 
inform researchers on the location of the full CMS PUF for continued 
use; and any other considerations.
    The following is a summary of the comments on this proposal we 
received and our responses.
    Comment: One commenter supported providing a single downloadable 
dataset including the procedure utilization data that would appear on 
clinician profile pages, noting the importance of access to the data 
for research purposes.
    Response: We appreciate the commenter's support and agree that 
maintaining a single downloadable dataset that reflects the same 
procedure utilization data that will appear on clinician profile pages 
will be useful to researchers and clinicians interested in this 
information.
    After consideration of public comments, we are finalizing the PDC 
Utilization Data File Policy as proposed. We will remove the PUF subset 
file from the PDC and only keep the utilization data file that reflects 
the information on clinician profile pages in the PDC.
(b) Procedure Grouping Policy for Publicly Reporting Utilization Data
    As mentioned earlier in this section, in the CY 2023 PFS final 
rule, we finalized using Restructured BETOS and procedure code sources 
used in MIPS when no Restructured BETOS categories are available, such 
as the procedure categories already defined for MIPS measures to 
meaningfully categorize procedures for public reporting (87 FR 70111). 
However, since finalizing this policy, we identified some commonly 
sought procedures, such as hysterectomy, that do not have a procedure 
category specified in the Restructured BETOS categorization system or a 
relevant code set in any MIPS quality or cost measures.
    In the CY 2024 PFS proposed rule (88 FR 52613), we proposed to 
define meaningful categories using subject matter expert (for example 
clinician) input in instances where a procedure category is unavailable 
under the Restructured BETOS or MIPS measures, if a code category 
exists but is not suitable for public reporting, or in instances where 
a procedure category does not exist, to create new, clinically 
meaningful, and well-understood procedure categories as needed. Added 
flexibility in grouping HCPCS codes to create procedure categories 
meaningful to patients and caregivers will allow users of the Compare 
tool to better assess a clinician's volume and scope of experience with 
a particular procedure and inform healthcare decision making.
    To implement this, we proposed to modify the existing policy such 
that, in addition to the two previously finalized sources (Restructured 
BETOS categorization system and code sources used in MIPS), we may use 
alternate sources to create clinically meaningful and appropriate 
procedural categories, particularly when no relevant grouping exists. 
If we develop new procedure categories for publicly reporting 
utilization data on clinician profile pages, we proposed to engage 
subject matter experts and interested parties through periodic requests 
for feedback using methods outside of rulemaking, such as listserv 
emails, listening sessions, and focus groups to solicit feedback on 
bespoke procedure categories planned for future releases of utilization 
data, as appropriate and technically feasible. We refer readers to the 
CY 2024 PFS proposed rule (88 FR 52613) for details on methods to 
solicit feedback on new procedure categories planned for future 
utilization data releases, as appropriate and technically feasible.
    The following is a summary of the comments on the proposal we 
received and our responses.
    Comment: Two commenters supported the proposal to modify existing 
procedural categorization policy to use alternate sources to create 
clinically meaningful and appropriate procedural categories.
    Response: We appreciate the commenters' support and agree that the 
ability to create clinically meaningful and appropriate procedural 
categories, particularly when no relevant grouping exists will allow 
users of the Compare tool to better assess a clinician's volume and 
scope of experience with a particular procedure and inform healthcare 
decision making.
    Comment: One commenter expressed concerns that BETOS is outdated, 
has broad categories and, as a result, may lead to errors that mislead 
patients. The commenter additionally stated there is no standard or 
systematic way to group procedures by Common Procedural Terminology 
(CPT) or HCPCS codes beyond the BETOS system and expressed concern that 
Restructured BETOS does not contain all procedure codes.
    Response: In response to the concern that BETOS is outdated, we 
clarify that we do not use original BETOS. We use Restructured BETOS, 
which is updated on an annual basis, the most recent of which are from 
2022. We discuss the differences between the two categorization systems 
in the CY 2023 PFS final rule (87 FR 70111 through 70113). We also 
recognized limitations with Restructured BETOS, which was why in the CY 
2023 PFS final rule we also finalized that we would utilize procedure 
code sources used in MIPS, such as the procedure categories already 
defined for MIPS cost or quality measures, for procedures in which no 
Restructured BETOS categories are available. However, we have since 
identified the need for additional flexibility in defining procedure 
categories, as proposed in the CY 2024 PFS proposed rule (88 FR 52613).
    Comment: One commenter noted that specialty societies could provide 
helpful feedback to aid CMS in making accurate determinations in the 
creation of new, clinically meaningful, and well-understood procedure 
categories.
    Response: We appreciate the support specialty societies and other 
subject matter experts may provide in the development of additional 
procedure categories in future years.
    Comment: One commenter cautioned against expanding the list of 
publicly reported procedures to include services such as reproductive 
health care and gender-affirming care citing safety concerns for 
physicians who furnish such services.
    Response: We appreciate the commenter raising this concern and will 
take it into consideration as we expand procedure categories in the 
future.
    After consideration of public comments, we are finalizing the 
Procedure Grouping Policy for Publicly Reporting Utilization Data as 
proposed. Specifically, in addition to Restructured BETOS and code 
sources used in MIPS, we may use alternate sources to create clinically 
meaningful and appropriate procedural categories, particularly when no 
relevant grouping exists. We will engage subject matter experts and 
interested parties through periodic requests for feedback using methods 
outside of rulemaking, including but not limited to listserv emails, 
listening sessions, or focus groups to solicit feedback on bespoke 
procedure categories planned for future releases of utilization data, 
as appropriate and technically feasible.
(c) Incorporating Medicare Advantage (MA) data into Public Reporting
    As discussed in the CY 2024 proposed rule (88 FR 52613 through 
52614), between the time of the CY 2023 PFS

[[Page 79397]]

proposed and final rules, our Medicare FFS claims data analyses showed 
that for the initial 13 priority procedures identified, approximately 
50 percent of clinician-procedure combinations fall into the low volume 
category, which meant that, based on Medicare physician and ancillary 
service (carrier) claims in the past 12 months, we could only publish 
an indicator that a clinician has experience with the procedure rather 
than specific counts. Under the small cell size policy, we prohibit the 
use of specific procedure or patient counts in cases where the count is 
below ten. The high number of clinicians with a low volume indicator is 
partly due to not including data for patients with other coverage, such 
as MA plans or other payers, for whom a given clinician has also 
performed such procedures. As such, we are currently limited in our 
ability to contextualize low volume clinician experience with 
procedures in a way that is useful and easily understandable for 
patients and caregivers who may be looking for a clinician with 
experience performing a specific procedure.
    As we identify more priority procedures for public reporting, more 
procedures may be subject to the small cell size policy using Medicare 
FFS data alone, which would prevent us from publicly reporting health 
care provider experience with such procedures for patients and 
caregivers to use in their healthcare decisions. Based on public 
comments and consumer testing, including other payer data would help 
prevent this issue. Consumer testing findings have also shown that 
patients and caregivers would like procedure information to reflect all 
procedures performed, since it better represents clinicians' 
experience.
    While we agreed with comments received on the CY 2023 PFS proposed 
rule, we were unable to finalize the possibility of using other payer 
data as appropriate and technically feasible at that time. However, we 
have subsequently determined through analysis of MA encounter data 
submitted to CMS that it is technically feasible to integrate MA 
encounter data into procedure category counts and that adding such data 
adds to the representation of some clinicians' scope of care.
    Therefore, we proposed to publicly report aggregated counts of 
procedures performed by providers based on MA encounter data in 
addition to Medicare FFS utilization data, given that we have 
determined it is appropriate and technically feasible. Section 104(a) 
and (b) of MACRA provides for the public reporting of items and 
services furnished to Medicare beneficiaries under title XVIII of the 
Act, including, at a minimum, information on the most frequent services 
or groupings of services furnished by physicians or other eligible 
professionals under part B of title XVIII of the Act. This provision 
authorizes the publication of information on the items and services 
furnished to ``Medicare beneficiaries under Medicare by physicians and 
certain other professionals.'' Notably, the statute authorizes the 
disclosure of information on all items and services furnished to 
Medicare beneficiaries under the Medicare Act; that is, the statute 
does not limit the disclosure to a particular subset of Medicare 
services. Indeed, section 104(c)(1) of MACRA provides that the 
information made available must include ``at a minimum'' certain 
information on Part B services. This does not limit the disclosure 
authorized by section 104(a) of MACRA to information on Part B items 
and services; instead, it specifies the minimum information that CMS 
must disclose, leaving additional disclosures under section 104(a) of 
MACRA to CMS' discretion. MA plans cover Part A and Part B benefits 
(excluding hospice services, acquisition costs for kidneys used for 
transplants, and, for a limited period, certain services under new 
National Coverage Determinations and changes in legislation) for 
Medicare beneficiaries that elect to enroll in an MA plan; this 
coverage is also under Title XVIII of the Act. Section 104(a) of MACRA 
thus authorizes the disclosure of certain information about items and 
services provided as benefits under an MA plan and furnished by a 
physician or other eligible professional.
    Separately, section 10331(b)(4) of the Affordable Care Act provides 
for the Secretary to, in developing and implementing his plan to make 
information as determined appropriate by the Secretary available on 
Physician Compare, include data that reflects the care provided to all 
patients seen by physicians, under both the Medicare program and, to 
the extent practicable, other payers, to the extent such information 
would provide a more accurate portrayal of physician performance. Thus, 
the inclusion of MA encounter data is consistent with the relevant 
statutory provisions regarding the disclosures on the Care Compare 
website.
    Per section 1853(a)(3)(B) of the Act, CMS has required MA 
organizations to submit the data necessary to characterize the context 
and purposes of each item and service provided to a Medicare 
beneficiary enrolled in an MA plan to use for risk adjusting payments 
by CMS to MA plans. Per the MA regulation at Sec.  422.310(f)(1)(vii), 
CMS may use this risk adjustment data, which includes MA encounter 
data, for activities to support administration of the Medicare program 
and for purposes authorized by other applicable law. The MA regulation 
at Sec.  422.310(f)(2) allows CMS to release encounter data for any of 
the purposes specified in Sec.  422.310(f)(1) in accordance with 
applicable Federal laws and CMS data sharing procedures, subject to 
protections of beneficiary confidentiality and commercially sensitive 
data. Finally, Sec.  422.310(f)(3) imposes restrictions on when the 
data is available for release. We proposed to rely on Sec.  422.310(f), 
as well as section 104 of the MACRA and section 10331 of the Affordable 
Care Act, for using and releasing the MA encounter data as part of the 
Care Compare website. To accomplish this, we also proposed to amend 
Sec.  422.310(f)(3) to permit the release of the MA encounter data on 
the timeframe(s) used for disclosure and release of the data on the 
Care Compare website. We stated in the proposed rule that this proposal 
would ensure that there is no confusion about our ability to use and 
release the MA encounter data for the Care Compare website and 
downloadable files and permit release of MA encounter data when 
necessary and appropriate to support activities or authorized uses 
under paragraph (f)(1)(vii) of this section.
    Using and analyzing MA encounter data as part of the aggregated 
information disclosed through the Care Compare website will more 
completely fulfill the public reporting required by section 104 of the 
MACRA and section 10331 of the ACA and using the MA encounter data in 
implementing these statutory provisions supports administration of the 
Medicare program. In addition, it is also consistent with administering 
the Medicare program overall to provide appropriate and helpful 
information to beneficiaries in selecting a provider. Thus, the use and 
disclosure of the MA encounter data here are within the scope of Sec.  
422.310(f)(1)(vii) without any amendment to Sec.  422.310(f)(1)(vii).
    The aggregated utilization data we proposed to include in the 
Compare tool meets the additional requirements to protect beneficiary 
and commercially sensitive information at Sec.  422.310(f)(2) because 
only identifying information about healthcare providers and types of 
procedures performed within a specific time period were proposed to be 
disclosed on the website and available for release in the PDC 
downloadable files. The disclosure and release of these

[[Page 79398]]

portions of the MA encounter data are consistent with CMS data sharing 
procedures, which are applied to the Medicare FFS data already 
displayed and available for download on the Care Compare website. 
However, when releasing the MA encounter data under Sec.  
422.310(f)(2), the timing limitations at Sec.  422.310(f)(3) prohibit 
releasing the encounter data before the applicable payment year's 
reconciliation has been completed except for in specified 
circumstances, none of which apply here. Because we proposed to use 
information from the MA encounter data, in combination with FFS claims 
data, over a 12-month rolling period, but risk adjustment 
reconciliation occurs no sooner than 13 months after the end of the 
year that services were provided, the timing of the release of the MA 
encounter data is not within the scope of the timing requirements in 
Sec.  422.310(f)(3).
    MA organizations submit encounter data continuously, but do not 
have the same timeliness requirements for submission that FFS providers 
have for submitting claims. In the August 22, 2014 final rule entitled, 
``Medicare Program; Hospital Inpatient Prospective Payment Systems for 
Acute Care Hospitals and the Long-Term Care Hospital Prospective 
Payment System and Fiscal Year 2015 Rates; Quality Reporting 
Requirements for Specific Providers; Reasonable Compensation 
Equivalents for Physician Services in Excluded Hospitals and Certain 
Teaching Hospitals; Provider Administrative Appeals and Judicial 
Review; Enforcement Provisions for Organ Transplant Centers; and 
Electronic Health Record (EHR) Incentive Program'' (79 FR 49854), CMS 
adopted Sec.  422.310(f)(3) to address concerns that the need to update 
or correct MA encounter data prior to the final submission deadline 
could mean that the MA encounter data was not sufficiently complete or 
fully reliable for public release. However, since that time, which was 
during the first few years of submission of MA encounter data to CMS, 
submissions of MA encounter data have improved. In particular, the 
provider identifying information and procedure codes required for the 
Compare tool are well reported. Furthermore, including utilization and 
limited provider-identifying data from MA encounters prior to the data 
being reconciled by the MA organization would substantially improve the 
Compare tool and, thereby, the administration of the Medicare program 
overall by providing patients and caregivers with more useful and 
easily understandable information about procedures performed by 
providers in their search for a clinician. Therefore, we proposed to 
amend Sec.  422.310(f)(3) to include an additional exception at 
paragraph (f)(3)(iv) that permits CMS to release aggregated risk 
adjustment data before the reconciliation for the applicable payment 
year has been completed if CMS determines that releasing aggregated 
data is necessary and appropriate for the purposes specified in Sec.  
422.310(f)(1)(vii).
    Based on our analyses, the inclusion of data about utilization in 
the MA program will reduce the low volume procedure counts subject to 
the small cell size policy, in which precise counts less than ten 
procedures or patients cannot be publicly reported. This will allow us 
to more accurately report the types of services that Medicare 
clinicians provide. Based on the public comments in our prior 
rulemakings about the Care Compare website and consumer feedback, 
aggregating utilization data from the Medicare FFS and MA program will 
also enhance patient use of the information. Although the initial 
release of publicly reported utilization data on the Compare tool is 
limited to clinicians' Medicare FFS claims, publicly reporting 
utilization data that includes Medicare FFS and MA would also be more 
consistent with MIPS quality information submitted via health IT 
vendors or registries that include other payer data. Lastly, adding MA 
data to the counts in the existing Medicare FFS utilization data file 
will mitigate interested party concerns that information available 
through the Compare tool does not fully reflect the physician's/
clinician's scope of practice. Including MA data with the FFS data will 
provide more information about a physician's/clinician's experience and 
scope of practice. We refer readers to the CY 2024 PFS proposed rule 
(88 FR 52613 through 52615) for details on incorporating MA data to FFS 
procedure counts.
    The following is a summary of the comments on these proposals we 
received and our responses.
    Comment: Three commenters supported the proposal to incorporate 
Medicare Advantage data to FFS procedure counts without any concerns. 
The commenters stated it is important to include MA data so that 
beneficiaries receive accurate information regarding what procedures 
are conducted by a specific clinician. One commenter noted this 
proposal directly addressed their concerns expressed in the CY 2023 PFS 
proposed rule public comment period that publicly reporting utilization 
data did not reflect the clinician's full scope of experience. Two 
commenters also encouraged CMS to continue exploring expanding the data 
to include Medicaid, Veterans Affairs, and private payers to provide a 
fuller representation of clinicians' experience. One commenter provided 
similar suggestions but also stated that utilization data that only 
reflects Medicare FFS and MA would not be meaningful to beneficiaries.
    Response: We agree that publicly reporting additional sources, such 
as Medicare Advantage data, provides more accurate information on 
procedures performed by a clinician. We appreciate the suggestion to 
look into adding other types of payer data. We also note that our 
consumer testing has found patients and caregivers would find 
utilization data based only on Medicare FFS and MA data to be helpful, 
even if it does not cover clinicians' full scope of practice.
    Comment: Several commenters expressed concerns related to patient 
understanding of the information. Two commenters were concerned 
patients could incorrectly equate higher volume of procedures to higher 
quality of care and better outcomes, particularly in the absence of 
quality information on profile pages. Another commenter expressed 
concern regarding the number of clinicians with low-volume counts as 
still too high and that, as a result, procedure volume could be 
misleading to patients.
    Response: Prior to the CY 2023 PFS proposed rule public comment 
period and the CY 2023 PFS final rule (87 FR 70109 through 70113), we 
conducted comprehensive user testing with patients and caregivers to 
see if they accurately understand the information. Plain language text 
included explanations that: the data do not reflect all procedures the 
clinicians perform; the information shown only reflects procedures 
performed on patients with Medicare (Original Medicare and Medicare 
Advantage); and that the utilization data on their own are not the only 
indicator of quality. Findings show that patients and caregivers: 
understood that higher volumes may not be a consistent indicator of 
quality; would not select a provider based on utilization data 
information alone; and found the information helpful but would like the 
procedure volume to also reflect patients with other insurance if 
possible. We also found that low volume counts are well understood, 
perceived as an indicator that the clinician has experience performing 
the procedure, and that patients would not rely on utilization data 
alone to inform clinician selection.

[[Page 79399]]

    Comment: Two commenters noted that ``incident to'' billing may 
limit procedure attribution for certain clinicians, such as nurse 
practitioners (NPs) and physician assistants (PAs).
    Response: We agree that if a clinician, such as a NP or PA, bills 
Medicare incident to a physician, then we would attribute a procedure 
billed in this way to the physician listed on the claim. However, we 
believe such attribution is appropriate, since the billing physician 
supervised and is accountable for the procedure billed. Additionally, 
we note that the attribution concern is a non-issue for clinicians who 
only bill Medicare incident to a supervising physician since these 
clinicians would not have a Compare tool profile page through which we 
could display utilization data specific to that clinician. Furthermore, 
due to an operational update since the time of the previous final rule, 
utilization data will not currently be publicly reported on NP and PA 
profile pages.
    Comment: One commenter expressed concerns that the encounter data 
are incomplete and that options for validating the data are limited. 
Given these concerns, the commenter requested CMS to publish the 
methodology used to calculate counts of procedures from the encounter 
data; which encounter data files were used to identify procedures (for 
example, physician, outpatient, inpatient, etc.); how procedures were 
attributed to individual clinicians (including whether any edits or 
data-cleaning procedures were applied to the NPI field); and what 
deduplication procedures were applied to the data. Two other commenters 
expressed concerns with potential data inaccuracies. One commenter 
noted difficulty in maintaining accurate counts on a routine basis, and 
another noted inaccurate encounter data might skew portrayals of 
clinician performance. One additional commenter provided a suggestion 
to release Part C utilization encounter data in a manner similar to how 
Part B data is released to allow for greater evaluation of how 
utilization differs between Part B and Part C.
    Response: Regarding concerns that the encounter data are incomplete 
or inaccurate and options for validating the data are limited, MA plans 
are required to submit encounter data records for all items and 
services provided to their enrollees. CMS regularly undertakes analyses 
to understand what data MA organizations may have challenges 
submitting. CMS also provides guidance and technical assistance to MA 
organizations to help resolve these challenges. We continually monitor 
the accuracy and completeness of the encounter data and take steps to 
remedy identified issues as appropriate. In using the MA encounter data 
for this purpose, we identify the procedures using physician/supplier 
Medicare Part C non-institutional encounters on certain services and 
procedures and will group them using Restructured BETOS categories or 
utilize procedure code sources used in MIPS, such as the procedure 
categories already defined for MIPS cost or quality measures, for 
procedures in which no Restructured BETOS categories are available in 
the same way in which we finalized in the CY 2023 final rule for 
Medicare Part B non-institutional claims (87 FR 46331). We note that, 
similar to Part B non-institutional claims, Part C physician/supplier 
non-institutional encounters use clinician NPIs, so there is no further 
attribution process. We may also use alternate sources to create 
clinically meaningful and appropriate procedural categories, 
particularly when no relevant grouping exists, which we are finalizing 
as proposed in section IV.A.4.l.(2)(b) of this final rule. According to 
Sec.  422.310(d)(5), MA organizations must submit a NPI in a billing 
provider field on each MA encounter data record, per CMS guidance. 
Procedures are then attributed to individual clinicians using their 
individual NPI, specifically the rendering clinician and procedure code 
are listed on the same line. Regarding edits or data-cleaning applied 
to the NPI field, we are limiting what procedure data is publicly 
reported on clinician profile pages based on Medicare's definition of a 
physician. Procedure data for other types of clinicians would be 
reported in the PDC only. Lastly, deduplication procedures are applied 
at the clinician, patient, date of service, and procedure category 
level.
    Comment: Two commenters expressed concerns regarding the proposal 
to publicly report aggregated claims data of both Medicare Advantage 
and FFS. One commenter noted the MA encounter data may not be complete, 
having found in their analysis that some MA enrollees had inpatient, 
home health, and dialysis services not reported in the MA encounter 
data, and that it may be more appropriate to publish the data 
separately when there are sufficient sample sizes for each. Another 
commenter stated that it is not appropriate to report the aggregated 
data before reconciliation given that CMS has stated in other contexts 
that pre-reconciled encounter data is not always complete and accurate 
and referenced section 104 of MACRA as not being supportive of using 
unreconciled encounter data for this purpose.
    Response: We disagree that section 104 of MACRA pertains only to 
items or services provided under Medicare part B. We refer the 
commenter to the CY 2024 PFS proposed rule (88 FR 52613 through 52615), 
where we discussed in detail the legal basis for using Medicare 
Advantage encounter data, including our interpretation of the scope of 
section 104 of MACRA.
    Regarding the suggestion to report FFS and MA data separately, the 
proposal to include encounter data in the procedure count is intended 
to reduce the number of instances when data could not be reported due 
to small cell sizes. That is, to describe the types of Medicare covered 
services that a provider has performed as accurately as possible. 
Presenting separate counts of the services for a clinician would not 
aide this goal as, when separated, each count may be too small to be 
reported. We do not believe consumers would make a meaningful 
distinction between the two sources, nor is it clear why they should do 
so. For this reason, reporting counts separately may cause unnecessary 
confusion.
    We have determined that reporting the aggregated data before 
reconciliation is appropriate for the following reasons. First, since 
the adoption of Sec.  422.310(f)(3) to address concerns that the need 
to update or correct MA encounter data prior to the final submission 
deadline could mean that the MA encounter data was not sufficiently 
complete or fully reliable for public release, MA organizations' data 
submission processes have matured and are well-established. MA 
encounter data submissions have improved compared to the early years of 
encounter data collection, such that data are submitted more timely and 
comprehensively. In addition, CMS maintains several checks and edits in 
the encounter data system to minimize duplicate, incomplete or 
inappropriate data stored in the encounter data system. Moreover, 
because using the data submitted before reconciliation might result in 
the under counting of procedures (for example, if encounter data 
records are updated to include more procedures as the data becomes more 
complete), including procedures from encounter data records is not 
likely to misinform consumers.
    We proposed to amend Sec.  422.310(f)(3) to include an additional 
exception at paragraph (f)(3)(iv) that permits CMS to release 
aggregated risk adjustment data before reconciliation for the 
applicable payment year has been completed if CMS determines that 
releasing

[[Page 79400]]

aggregated data is necessary and appropriate for the purposes specified 
in Sec.  422.310(f)(1)(vii). When releasing aggregated encounter data 
for Medicare program administration before risk adjustment 
reconciliation, CMS will evaluate the potential for the release to 
misinform or otherwise result in undesirable consequences. CMS will not 
release aggregated encounter data before risk adjustment reconciliation 
unless we have determined releasing the data is necessary and 
appropriate.
    For the Compare tool, including utilization and limited provider-
identifying data from the MA encounter data prior to risk adjustment 
reconciliation is necessary in that the Compare tool's utility is 
substantially improved by including the data, and as noted before, is 
appropriate because there is limited risk that consumers will be 
misinformed if the MA encounter data are included. Rather, including 
the encounter data will provide patients and caregivers with more 
useful and easily understandable information about procedures performed 
by providers in their search for a clinician.
    After consideration of public comments and for the reasons outlined 
in the proposed rule and our responses to comments, we are finalizing 
both the proposal to incorporate Medicare Advantage data to FFS 
procedure volume counts and the proposal to amend Sec.  422.310(f)(3) 
to add a new paragraph (iv) authorizing CMS to release aggregated risk 
adjustment data before the reconciliation for the applicable payment 
year has been completed if CMS determines that releasing aggregated 
data is necessary and appropriate for activities to support 
administration of the Medicare program, as proposed.
(d) Request for Information: Publicly Reporting Cost Measures
    In the CY 2024 PFS proposed rule (88 FR 52615 through 52617), we 
included a Request for Information (RFI) to evaluate ways to publicly 
report MIPS eligible clinicians' performance on measures under the MIPS 
cost performance category (cost measures). Specifically, we sought 
public comment on ways to publicly report performance on cost measures 
on clinician and group profile pages and signaled our intent to propose 
in future rulemaking to publicly report cost measures in CY 2026 
beginning with data from the CY 2024 performance period/2026 MIPS 
payment year. We believe public reporting of these data would assist 
patients and caregivers in making healthcare decisions.
    Additionally, in the proposed rule, we noted that we have not 
publicly reported any cost measure information from the MIPS cost 
performance category since the inception of MIPS. (88 FR 52615). As one 
of the reasons for this current status, we stated ``[W]e have not had 
cost measures available for public reporting because of the COVID-19 
Public Health Emergency (PHE), during which we reweighted the cost 
performance category to zero percent for MIPS eligible clinicians' 
final scores in the CY 2019 performance period/2021 MIPS payment year, 
as discussed at https://qpp.cms.gov/resources/covid19?py=2019.'' (88 FR 
52615). As stated in section IV.A.4.g.(1) of this final rule, we 
clarify that the reweighting of the cost performance category to zero 
percent began in CY 2020 and not 2019.
    We thank commenters for their feedback on this RFI, which may be 
considered in future rulemaking.
m. Overview of QP Determinations and the APM Incentive
(1) Overview
    The Quality Payment Program provides incentives for eligible 
clinicians to engage in value-based, patient-centered care under 
Medicare Part B via MIPS and Advanced APMs. The structure of the 
Quality Payment Program enables us to advance accountability and 
encourage improvements in care. The Secretary has also adopted the 
closely related goal that all people with Original Medicare will be in 
an accountable care relationship by 2030, so that their needs are 
holistically assessed and their care is coordinated within a broader 
total cost of care system. Our vision for increased participation among 
clinicians in Advanced APMs is driven by the belief that integrating 
individuals' clinical needs across a spectrum of providers and settings 
will improve patient care and population health.
    As we continue to make improvements to the Quality Payment Program, 
we seek to develop, propose, and implement policies that encourage 
broad and meaningful clinician participation, including by specialists, 
in Advanced APMs. For example, in this section, we had proposed to 
calculate QP determinations at the individual level for each unique NPI 
associated with an eligible clinician participating in an Advanced APM. 
As discussed further in the proposal, we believe that this change would 
provide a more accurate measure of the actual engagement of individual 
clinicians participating in Advanced APMs. Accuracy is important for 
administration of the Quality Payment Program incentives and could help 
us better identify and understand the motivating factors and indicators 
of clinician readiness for greater adoption of Advanced APMs.
    In the CY 2017 Quality Payment Program final rule (81 FR 77439 
through 77445), we finalized our policy at Sec.  414.1425(b) for 
Qualifying APM Participant (QP) determinations. For the purposes of 
making QP determinations, an eligible clinician must be present on the 
Participation List of an APM Entity in an Advanced APM on one of the 
``snapshot dates'' (March 31, June 30, or August 31) for the QP 
Performance Period. An eligible clinician included on a Participation 
List on any such snapshot date is included in the APM Entity group even 
if that eligible clinician is not included on that Participation List 
at one of the prior- or later-listed dates. We perform QP 
determinations for eligible clinicians in an APM Entity group three 
times during the QP Performance Period using claims data for services 
furnished from January 1 through each of the respective QP 
determination snapshot dates. An eligible clinician can be determined 
to be a QP only if the eligible clinician appears on the Participation 
List on a snapshot date that we use to determine the APM Entity group 
and to make QP determinations at the APM Entity group level based on 
participation in the Advanced APM. For eligible clinicians who appear 
on a Participation List for more than one APM Entity, but who do not to 
achieve QP status based on any APM Entity-level determinations, we make 
QP determinations at the individual level as described in Sec.  
414.1425(c)(4). Likewise, for eligible clinicians on an Affiliated 
Practitioner list for an Advanced APM, we make QP determinations at the 
individual-level three times during the QP Performance Period using 
claims data for services furnished from January 1 through each of the 
respective QP determination snapshot dates as described in Sec.  
414.1425(b)(2).
(2) Individual QP Determination
    Under the current policy at Sec.  414.1425(b), QP determinations 
for most eligible clinicians participating in Advanced APMs are made at 
the APM Entity-level. In the CY 2017 Quality Payment Program proposed 
rule (81 FR 28319), we contemplated that ``as with any group 
assessment, there will be some situations in which individual Threshold 
Scores would differ from group Threshold Scores if assessed separately. 
This could lead to some

[[Page 79401]]

eligible clinicians becoming QPs when they would not have met the QP 
Threshold individually (a `free-rider' scenario) or, conversely, some 
eligible clinicians not becoming QPs within an Advanced APM Entity when 
they might have qualified individually (a dilution scenario).'' At that 
time, we believed that the benefits of performing QP determinations at 
the APM Entity-level for groups outweighed these potential scenario 
concerns. However, as we previously indicated in a Request for 
Information in the CY 2023 PFS proposed rule (87 FR 46337 through 
46339), we started to believe that the effects of these types of 
scenarios, including effects that we had not intended or foreseen in 
the 2017 rule, were outweighing the benefits of performing QP 
determinations at the APM Entity-level.
    First, it has been brought to our attention that our policy to 
conduct most QP determinations at the APM Entity-level may have 
inadvertently discouraged some APM Entities from including certain 
types of eligible clinicians, particularly in multi-specialty APM 
Entities such as ACOs, leading those clinicians to be excluded from 
participation in Advanced APMs. Because the APM Entity Threshold Scores 
(using the payment amount and patient count methods) that are used to 
make APM Entity-level QP determinations are based on an aggregate 
calculation across all eligible clinicians participating in the APM 
Entity group, eligible clinicians in the APM Entity group who furnish 
proportionally fewer services that lead to attribution of patients or 
payment amounts to the APM Entity are likely to lower the APM Entity's 
Threshold Score. Many Advanced APMs attribute patients to APM Entity 
groups based in part on the provision of primary care services, but not 
all eligible clinicians furnish primary care services. For example, 
primary care physicians may furnish proportionally more evaluation and 
management (E/M) (office visit) services, which, as we explain more in 
the next section, are frequently the basis for attribution of patients 
and payment amounts to the numerator of the APM Entity's Threshold 
Score, whereas specialist physicians may furnish proportionally more 
diagnostic tests and surgical procedures, which are not usually part of 
the attribution basis to the APM Entity.
    We have received reports from Advanced APM participants and 
specialty societies that some APM Entities have taken steps to exclude 
from their APM Entity groups (and consequently from their Participation 
Lists) eligible clinicians who furnish proportionally fewer services 
that lead to the attribution of patients or payment amounts for 
purposes of calculating Threshold Scores for APM Entity-level QP 
determinations. For reasons stated above, this action typically would 
lead to the exclusion of certain specialists from the APM Entity.
    However, there are also benefits to the APM entity of including 
specialists and other eligible clinicians who furnish relatively fewer 
services that lead to attribution. For example, in both the Medicare 
Shared Savings Program and in models tested by the Innovation Center 
that meet the criteria to be Advanced APMs, CMS seeks to promote 
patient-centered care that is integrated across the continuum of care. 
The inclusion of specialists in APM Entities is helpful for achieving 
this goal. A comprehensive network that includes a range of specialists 
is central to the success of an ACO in the Medicare Shared Savings 
Program for its intended purpose in patient-centered care that 
coordinates items and services for Medicare FFS beneficiaries, a key 
aim of value-based care and practice transformation.\502\ The 
methodology used in beneficiary assignment for the Shared Savings 
Program is deliberately constructed such that assignment is largely 
based on primary care, rather than specialty care, which results in 
specialists contributing proportionately less in terms of payment 
amounts and patient counts to the numerator of the ACO's Threshold 
Score calculation used for APM Entity-level QP determination. Moreover, 
it was not our intent to create a policy whereby eligible clinicians 
who see most or all their Medicare patients through an Advanced APM to 
remain unable to achieve QP status because the APM Entity with which 
they participate in the Advanced APM includes eligible clinicians who 
furnish very few services through the Advanced APM. It has always been 
one of the goals of the APM track of the Quality Payment Program for 
the availability of QP status to incentivize eligible clinicians to 
join Advanced APMs. But under our current policy to make most QP 
determinations at the APM Entity-level, there is the potential that 
eligible clinicians who individually fully engage with an Advanced APM 
may still be unable to earn QP status because it is calculated at the 
entity-level. We carefully considered our policy to make most QP 
determinations at the APM Entity-level, and believed it was the best 
approach at the time. However, we did not intend for the policy to 
create potentially conflicting incentives for APM Entities between the 
goal for their eligible clinicians to achieve QP status under the 
Quality Payment Program, and their full participation in an Advanced 
APM with a group of eligible clinicians that can deliver a full 
spectrum of care.
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    \502\ https://www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/sharedsavingsprogram/about.
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    In the CY 2017 Quality Payment Program proposed rule (81 FR 28319), 
we stated that ``the statute consistently refers to an eligible 
clinician throughout section 1833(z) of the Act and clearly identifies 
that the QP determinations are to be made for an eligible clinician,'' 
then noted that ``in section 1833(z)(3)(B) of the Act, the definition 
of an eligible clinician includes a group of such professionals.'' 
While the statutory scheme provides for the flexibility to establish 
policies that apply for groups of eligible clinicians, it does not 
require that approach. When we proposed the policy to calculate 
Threshold Scores at the APM Entity-level, we based this policy in part 
on ``a premise that positive change occurs when entire organizations 
commit to participating in an Advanced APM and focusing on its cost and 
quality goals as a whole.'' While we continue to believe in this 
premise, we also recognize that, if APM Entities are removing or 
otherwise excluding eligible clinicians who may technically contribute 
less to the APM Entity-level Threshold Score, such actions may impede 
other worthy goals of the Advanced APM (such as increased care 
coordination among all providers caring for a patient), in which case 
that larger positive change we were seeking to foster is not being 
achieved.
    Conversely, we are concerned that, under our current policy to make 
most QP determinations at the APM Entity-level, in situations where an 
APM Entity does achieve QP status, some eligible clinicians who furnish 
relatively fewer services through that APM Entity may receive a QP 
designation despite limited Advanced APM participation because their QP 
status was achieved as a result of the care furnished by other eligible 
clinicians in the APM Entity while their APM Incentive Payment is 
calculated based on all of the covered professional services that the 
individual eligible clinician furnishes during the base year, including 
services that were not furnished through an Advanced APM. Our policy to 
make most QP determinations at the APM Entity-level allows these 
anomalies because we calculate the Threshold Scores using the aggregate 
of payment amounts or patient counts for attributed patients based on 
Medicare Part B covered professional services furnished by all the 
eligible

[[Page 79402]]

clinicians in the APM Entity, whether an individual eligible clinician 
furnished a few or many such services. When an eligible clinician 
receives QP status for a year, the individual QP will receive an APM 
Incentive Payment for covered professional services across all their 
TINs in the base year. This can enable an eligible clinician with 
minimal Advanced APM participation to receive an APM Incentive Payment, 
which we do not believe aligns with the intent of the Quality Payment 
Program.
    As a result, we proposed to amend Sec.  414.1425(b) so that, 
beginning with the QP Performance Period for CY 2024, we would make all 
QP determinations at the individual-level. We note that we already make 
some QP determinations at the individual level. Under Sec. Sec.  
414.1425(b)(2) and 414.1425(c)(4) we currently calculate Threshold 
Scores at the individual level when the Advanced APM includes eligible 
clinicians only on an Affiliated Practitioner List, and further, under 
Sec.  414.1425(c)(4) we also make QP determinations individually when 
the eligible clinician participates in multiple Advanced APMs and does 
not achieve QP status at the APM Entity-level. The proposal would not 
have changed our policy for these determinations but would have changed 
the way we make QP determinations for all other eligible clinicians. 
Under the proposal, we would have calculated Threshold Scores for QP 
determinations at the individual-level for each unique NPI associated 
with an eligible clinician participating in an Advanced APM. We would 
have calculated a Threshold Score for each NPI based on all covered 
professional services furnished across all Tax Identification Numbers 
(TINs) to which the eligible clinician has reassigned their billing 
rights. This individual Threshold Score would have provided a more 
specific measurement of each eligible clinician's participation in an 
Advanced APM. This proposed methodology would have ensured that those 
eligible clinicians who individually meet a QP threshold would receive 
QP status and its commensurate financial incentives and other benefits. 
At the same time, it would have removed the incentive for APM Entities 
to exclude certain types of eligible clinicians from their 
Participation Lists, because the success or failure of the APM Entity's 
eligible clinicians to reach QP status no longer would be collective. 
Because each eligible clinician on the APM Entity's Participation List 
would have been evaluated individually at the NPI level, eligible 
clinicians with lower proportions of payments and payments through the 
Advanced APM Entity would not have affected the QP status of other 
eligible clinicians on the APM Entity's Participation List.
    We solicited comment on this proposal to amend Sec.  414.1425(b) so 
that, beginning with the QP Performance Period for CY 2024, we would 
make all QP determinations at the individual-level.
    We received public comments on the proposal. The following is a 
summary of the comments we received and our responses.
    Comment: Two commenters supported our approach to move to QP 
determinations at the individual-level. One of these commenters stated 
that certain APM entities may be excluding specialists in order to meet 
the QP threshold. This commenter supports efforts that promote accurate 
attribution and increased inclusion of specialists in APMs.
    Response: We appreciate these comments.
    Comment: Many commenters suggested we keep the APM Entity-level 
determinations for QP status. These commenters stated that the proposed 
change would make it very difficult for individual specialists to 
qualify for QP status. They also stated it would negatively impact 
specialists' participation in ACOs and APMs.
    Response: We appreciate this comment and are taking these concerns 
seriously. As we detail in the previous section, while APM Entity-level 
determinations have been used in some circumstances since the beginning 
of the Quality Payment Program, we have identified conflicting 
incentives for APM Entities between the goal for their eligible 
clinicians to achieve QP status under the Quality Payment Program, and 
the goal to build participation in an Advanced APM with a group of 
eligible clinicians that can deliver a full spectrum of care. We also 
believe that when QP determinations are made at the APM Entity level, 
some eligible clinicians who furnish relatively fewer of their services 
through that APM Entity would receive a QP status that is not 
reflective of their individual participation in the APM. The intent of 
our proposal was to mitigate these conflicting issues, which we 
recognize are difficult.
    Comment: Many commenters either opposed or expressed concern with 
our proposed change to make QP determinations at the individual-level. 
These commenters stated they believed that even after making the 
change, our proposal would still serve as a disincentive for 
specialists to participate in Advanced APMs because it would still be 
difficult for them to achieve QP status. Several commenters stated the 
change would make it challenging or nearly impossible for specialists 
to achieve QP status. Some of these commenters also stated that making 
the change at the same time that QP thresholds are scheduled to 
increase could result in the opposite effect despite this change in 
policy, and make it still even more difficult for eligible clinicians 
to achieve QP status because they would be depending on their own 
participation activities. A few commenters expressed concern for the 
impact on certain other health professionals whose services are in 
part, or largely, billed incident to the services of a physician or 
practitioner with whom they work.
    Response: We share the commenters' goal of making the participation 
of all health professionals in APMs as straightforward as possible, 
including specialists. Our proposal was intended to eliminate the 
incentive for APM Entities to reduce the number of certain specialists 
or exclude them simply for financial considerations as sometimes occurs 
under our current policy of making QP determinations at the APM Entity-
level. In this scenario, specialists themselves often lack control over 
whether they have the option to participate in the APM Entity. While we 
understand that specialists face certain challenges in achieving QP 
status, and therefore, may choose not to engage with Advanced APMs, we 
believe it is important to avoid having their participation precluded 
or terminated by the APM Entity. In addition, the proposed change to 
make QP determinations at the individual level was intended to prevent 
the assignment of QP status to eligible clinicians who have furnished 
relatively few of their services through the Advanced APM.
    We appreciate the commenters' point that the increase in the QP 
threshold, required by statute, will make it more challenging for 
certain eligible clinicians to achieve QP status, and we share the goal 
of allowing more specialists the opportunity to participate in Advanced 
APMs.
    Comment: Several commenters stated that the proposal to make QP 
determinations at the individual level does not support transition to 
value-based arrangements and will negatively impact specialists in 
particular. A few commenters suggested that the proposal will 
negatively affect team-based care or care coordination needed for 
patient-centered care because the incentive will no longer encourage 
collaboration. A few commenters stated that the proposal is not 
consistent with providing accountable care. Several commenters

[[Page 79403]]

expressed concern that APM Entities, particularly ACOs, could become 
responsible for both coordinating MIPS measure submissions and 
administering an Advanced APM, which would be unduly burdensome. 
Several commenters also stated the proposed changes would increase the 
administrative burden on individual physicians, both specialists and 
primary care.
    Response: We believe the current policy of making QP determinations 
at the APM Entity level creates conflicting incentives for APM Entities 
between their eligible clinicians' interest in achieving QP status, and 
their participation in an Advanced APM that includes providers that 
deliver an appropriate spectrum of services. We continue to be 
concerned that the current policy may have inadvertently created 
incentives for APM Entities to make decisions about which eligible 
clinicians to include in their organization based on the clinicians' 
likely contribution to achieving QP status rather than providing a 
comprehensive continuum of patient-centered care. We share the 
commenters' goal of designing payment incentives that support the 
delivery of the appropriate spectrum of services, allowing APM Entities 
to focus on what is best according to their Advanced APM's goals and 
their own organizational goals relating to the provision of patient-
centered care.
    Comment: Many commenters suggested that rather than moving to QP 
determinations at the individual level, CMS should make QP 
determinations at both the APM Entity level and the individual level, 
and then select the most favorable result for each clinician.
    Response: We do not believe this approach would adequately address 
our concerns related to specialist participation in Advanced APMs. 
While such an approach might avoid decreases in nominal specialist 
participation, it would do so without encouraging more intensive 
Advanced APM participation by individual eligible clinicians, 
perpetuating the issue of QP status for eligible clinicians with 
minimal participation in an Advanced APM.
    Comment: A few commenters suggested that not enough analysis has 
been conducted to estimate the impact of the proposal on clinicians 
participating in Advanced APMs and their QP status. These commenters 
suggested that more modeling and data analysis is needed to look at the 
impact it will have particularly on specialists before any policy 
change is implemented. Some of these commenters also suggested that the 
impact of the proposal on different types of specialties should be 
conducted. One commenter stated that our impact analysis did not 
breakdown the effect on different types of specialties.
    Response: We have conducted an analysis to estimate the impact of 
this policy on QP status, and presented the results in the proposed 
rule that was available for commenters' review (88 FR 52718). In short, 
we anticipated that implementing our proposal would have led to a 
decrease in the total number of eligible clinicians achieving QP status 
but would reflect improved attribution of APM participation. We will 
consider conducting additional analysis in the future.
    Comment: One commenter stated that certain specialists are 
restricted in the number of ACOs they are allowed to participate in, 
while others do not face such restrictions. That commenter suggested 
that CMS change the requirements and allow all types of specialists to 
participate in as many ACOs as they choose, which would help them to 
achieve QP status. That commenter also suggested that we work more 
closely with the Physician Technical Advisory Committee to design more 
models for specialist.
    Response: The Quality Payment Program does not restrict the number 
or type of Advanced APMs in which specialists may participate. 
Different Advanced APMs are available to different provider types and 
patient populations, and provider options are available.
    Although we continue to believe that our proposal to make all QP 
determinations at the individual level has strong merit, and that it 
would be broadly beneficial for APM Entities and eligible clinicians 
participating in Advanced APMs, after consideration of public comments, 
we are not finalizing our proposal for the CY 2024 QP performance 
period. Meaningful participation in Advanced APMs by a broad range of 
providers remains a goal that we share with many of the commenters, and 
we are committed to implement policies in the future that address undue 
QP determinations. However, we recognize the concerns raised by 
commenters, especially with respect to specialist participation in 
Advanced APMs, and that the changes in incentives and the interactions 
between them, combined with the anticipated statutory increases in QP 
thresholds, would create significant uncertainty among specialist 
communities. Given the comments we received expressing concerns about 
the potential impact of the new policies, we have concluded that it 
would be appropriate to conduct further consultation and analysis to 
evaluate the expected impact of these policies on eligible clinicians, 
especially specialists, participating in Advanced APMs. We plan to 
share our findings with interested parties when information becomes 
available so that the impact of the policies is better understood 
throughout the provider community. We will also consider the results of 
this analysis before potentially revisiting these proposed policy 
changes in future rulemaking. Our current policy of making QP 
determinations at the APM-Entity will remain in place for 2024.
(3) Payment Amount and Patient Count Methods
    In the CY 2017 Quality Payment Program final rule (81 FR 77450 
through 77457) we finalized the payment amount method and patient count 
method for calculation of Threshold Scores used for QP determinations 
under the Medicare option and codified these methods at Sec.  
414.1435(a) and (b), respectively. The payment amount method is based 
on payments for Medicare Part B covered professional services, 
including certain supplemental service payments, while the patient 
count method is based on numbers of patients. Both methods use the 
ratio of ``attributed beneficiaries'' to ``attribution-eligible 
beneficiaries, as defined at Sec.  415.1305.\503\
---------------------------------------------------------------------------

    \503\ For technical information on the QP calculation 
methodology, see the ``QP Methodology Fact Sheet'' that we publish 
annually, which can be found as part of the ``2023 Learning 
Resources for QP Status and APM Incentive Payment'' materials on the 
Quality Payment Program Resource Library at https://qpp-cm-prod-content.s3.amazonaws.com/uploads/1509/2023%20Learning%20Resources%20for%20QP%20Status%20and%20APM%20Incentive%20Payment.zip.
---------------------------------------------------------------------------

    Attributed beneficiaries are those who are attributed to the APM 
Entity under the terms of the Advanced APM as indicated on the most 
recent available list of attributed beneficiaries at the time of a QP 
determination. Attribution-eligible beneficiaries generally are those 
who, during the QP Performance Period, meet six criteria specified in 
the definition of that term at Sec.  414.1305 and described in section 
IV.A.4.m.(3) of the proposed rule.
    When making QP determinations at the APM Entity-level or individual 
eligible clinician level, we begin by calculating Threshold Scores 
using the payment amount and patient count methods. These Threshold 
Scores are percentages based on the ratio of the payment amounts or 
patient counts for attributed beneficiaries to the payment amounts or 
patient counts for

[[Page 79404]]

attribution-eligible beneficiaries during the QP performance period. If 
the Threshold Score (using either the payment amount or patient count 
method) for the eligible clinician or APM Entity, as applicable, meets 
or exceeds the relevant QP threshold described at Sec.  414.1430(a), 
the relevant eligible clinician or clinicians (either the individual 
eligible clinician or all those on the APM Entity's Participation List) 
achieve QP status for such year.
[GRAPHIC] [TIFF OMITTED] TR16NO23.091

    The regulation at Sec.  414.1435(b)(3) provides that a beneficiary 
may be counted only once in the numerator and denominator for a single 
APM Entity group, and at Sec.  414.1435(b)(4), that a beneficiary may 
be counted multiple times in the numerator and denominator for multiple 
different APM Entity groups. In the CY 2021 PFS final rule (85 FR 84951 
through 84952), we amended Sec.  414.1435(c)(1)(i) to specify that 
beneficiaries who have been prospectively attributed to an APM Entity 
for a QP Performance Period will be excluded from the attribution-
eligible beneficiary count for any other APM Entity that is 
participating in an APM where that beneficiary would be ineligible to 
be added to the APM Entity's attributed beneficiary list. This means 
that beneficiaries who have been attributed to one APM Entity and are 
thus barred under the terms of an Advanced APM from attribution to 
another APM Entity are removed from the denominator of both the payment 
amount method and patient count method in QP Threshold Score 
calculations for the APM Entity to which they cannot be attributed (in 
other words, we do not penalize an APM Entity in the QP Threshold Score 
calculation by including a beneficiary in its denominator when the 
terms of an Advanced APM do not permit such beneficiary to be 
attributed to such APM Entity).
    (a) Attributed beneficiary:
    An attributed beneficiary is a beneficiary attributed to the APM 
Entity under the terms of the Advanced APM as indicated on the most 
recent available list of attributed beneficiaries at the time of a QP 
determination. There may be beneficiaries on the most recent available 
list who do not meet the criteria to be attribution-eligible 
beneficiaries because the QP performance period does not coincide with 
the Advanced APM's performance period or attribution period, or for 
other reasons. There may be cases where a beneficiary's status changes, 
for example by enrolling in a Medicare Advantage Plan. We exclude these 
beneficiaries from our Threshold Score calculations because they do not 
meet criteria to be attribution-eligible beneficiaries. Although APMs 
may have reconciliation processes in place to address changes in 
beneficiary status at various intervals, those processes do not 
necessarily coincide with the timeframe of QP determinations. 
Therefore, when calculating Threshold Scores for QP determinations, we 
exclude from the list of attributed beneficiaries any beneficiaries who 
do not meet the criteria to be attribution-eligible beneficiaries at 
that point in time.
    (b) Attribution-eligible beneficiary:
    An attribution-eligible beneficiary is a beneficiary who:
     Is not enrolled in Medicare Advantage or a Medicare cost 
plan;
     Does not have Medicare as a secondary payer;
     Is enrolled in both Medicare Parts A and B;
     Is at least 18 years of age;
     Is a United States resident; and
     Has a minimum of one claim for E/M services furnished by 
an eligible clinician who is in the APM Entity for any period during 
the QP Performance Period or, for an Advanced APM that does not base 
attribution on E/M services and for which attributed beneficiaries are 
not a subset of the attribution-eligible beneficiary population based 
on the requirement to have at least one claim for E/M services 
furnished by an eligible clinician who is in the APM Entity for any 
period during the QP Performance Period, the attribution basis 
determined by CMS based upon the methodology the Advanced APM uses for 
attribution, which may include a combination of E/M and/or other 
services.
    Our stated intent when we finalized the definition of attribution-
eligible beneficiary (81 FR 77451 through 77452) was to have a 
definition that would, for purposes of QP determinations, allow us to 
be consistent across Advanced APMs in how we consider the population of 
beneficiaries served by an APM Entity. The criteria we used to define 
attribution-eligible beneficiary were aligned with the attribution 
methodologies and rules for our contemporaneous Advanced APMs. The 
first five criteria are conditions that are required for a beneficiary 
to be attributed to any Advanced APM. The sixth criterion identifies 
beneficiaries who have received certain services from an eligible 
clinician who is associated with an APM Entity for any period during 
the QP Performance Period. For Most Advanced APMs, we chose to refer to 
E/M services because many Advanced APMs use E/M services to attribute 
beneficiaries to their participant APM Entities. Over time, we have 
updated the list of services that are considered to be E/M services for 
purposes of identifying attribution-eligible beneficiaries and have 
published this list as part of the ``2023 Learning Resources for QP 
Status and APM Incentive Payment'' materials on the Quality Payment 
Program Resource Library at https://qpp-cm-prod-content.s3.amazonaws.com/uploads/1509/2023%20Learning%20Resources%20for%20QP%20Status%20and%20APM%20Incentive%20Payment.zip.
    We also included an exception in this sixth criterion to allow an 
alternative approach for Advanced APMs that do not base attribution 
exclusively on E/M services, and thus for which attributed 
beneficiaries are not a subset of the attribution-eligible beneficiary 
population based on the requirement to have at least one claim for and 
E/M

[[Page 79405]]

service. To date, we have implemented this alternative approach for 
four Advanced APMs:
     Bundled Payments for Care Improvement Advanced Model.
     Comprehensive Care for Joint Replacement Payment Model 
(CEHRT Track).
     Comprehensive ESRD Care Model (LDO arrangement and Non LDO 
Two Sided Risk Arrangement).
     Maryland Total Cost of Care Model (Care Redesign Program).
    We have published links to the methodologies we use to identify 
attribution-eligible beneficiaries for these Advanced APMs in the 
``2023 Learning Resources for QP Status and APM Incentive Payment'' 
materials on the Quality Payment Program Resource Library at https://qpp-cm-prod-content.s3.amazonaws.com/uploads/1509/2023%20Learning%20Resources%20for%20QP%20Status%20and%20APM%20Incentive%20Payment.zip.
    We adopted the general rule with flexibility to apply alternative 
methods for this criterion to ensure that, for the Advanced APMs for 
which attribution is based on services other than E/M services, the 
attributed beneficiary population is truly a subset of such Advanced 
APMs' attribution-eligible beneficiary populations and, ultimately, so 
that our way of identifying beneficiaries for purposes of Threshold 
Score calculations for QP determinations is appropriate for such 
Advanced APMs. That said, our thinking at the time that we developed 
these approaches was shaped by the form and nature of the Advanced APMs 
that existed at that time. A key lesson we have learned over time as we 
have implemented the APM track of the Quality Payment Program is that, 
by affording sufficient flexibility within the program, we can both 
foster innovation in Advanced APMs and simplify our execution of the 
program. By having a more narrowly-defined default approach to 
beneficiary attribution (relying on E/M services), we frequently needed 
to exercise flexibility to determine an appropriate attribution 
methodology for Advanced APMs that fell into the exception, which meant 
that we identified several individually-tailored ways of performing the 
attribution methodology for each specific Advanced APM. As such, we 
have come to believe that application of our current regulations may 
result in increased complexity over time if, as we anticipate, Advanced 
APMs continue to evolve and use novel approaches to value-based care 
that may emphasize a broad range of covered professional services.
    Further, as we noted in our discussion of the proposal to calculate 
QP status at the individual NPI level, primary care practitioners 
generally furnish a higher proportion of E/M services than do 
specialists with the same beneficiary, and as for the Threshold Score 
calculations described previously, the emphasis on E/M services in our 
beneficiary attribution policy may have inadvertently encouraged APM 
Entities to exclude specialists from their Participation Lists. Under 
our current policy, if one or more eligible clinicians on the APM 
Entity's Participation List furnish covered professional services to a 
beneficiary but none of those services are among the E/M services we 
use for attribution, that beneficiary would not be attribution-
eligible, and therefore, would not be included in our QP determination 
calculation, even though the beneficiary is actually receiving covered 
professional services from an eligible clinician on the APM Entity's 
Participation List.
    We proposed to change the definition of ``attribution-eligible 
beneficiary'' at Sec.  414.1305 so that a single definition using 
covered professional services will be applied regardless of the 
Advanced APMs in which the eligible clinician participates. We believe 
that this complemented our proposal to make QP determinations at the 
individual eligible clinician level. We are also concerned that 
retention of the current policy where E/M services are the default 
basis for attribution, and where special processes are required for 
Advanced APMs that use a different attribution basis, could result in a 
complex set of unique attribution approaches for Advanced APMs.
    To create a uniform basis for beneficiary attribution across all 
Advanced APMs, we proposed to modify the sixth criterion of the 
definition of ``attribution-eligible beneficiary'' at Sec.  414.1305 to 
include any beneficiary who has received a covered professional service 
furnished by the eligible clinician (NPI) for whom we are making the QP 
determination. By no longer specifying E/M services as the default 
attribution basis in the sixth criterion, we also eliminate the need 
for flexibility to use a different attribution basis that ties 
attribution-eligibility to a specific Advanced APM's attribution 
methodology. This would have simplified and streamlined the attribution 
methodology by making attribution based on covered professional 
services across all Advanced APMs
    The proposal to base attribution eligibility on the receipt of a 
covered professional service also would have addressed the issue 
discussed earlier in this section whereby, under our current policy, 
beneficiary attribution for purposes of QP determinations is contingent 
upon the beneficiary receiving an E/M service, and as a result, 
beneficiaries who are actually being provided covered professional 
services by eligible clinicians on an APM Entity's Participation List 
are not attribution-eligible if none of the services provided are E/M 
services. Under our proposal, because we would consider all covered 
professional services for attribution, and not solely E/M services, we 
would have been able to include as attributed beneficiaries those who 
are receiving only other (non-E/M) covered professional services 
through the Advanced APM. We believe this proposal will result in a QP 
calculation that, by including beneficiaries receiving any covered 
professional service, more accurately reflects eligible clinicians' 
actual participation in Advanced APMs.
    We note that the proposal will not change the dates of service used 
for purposes of QP determinations. As such, QP determinations at any 
given snapshot date (March 31, June 30, and August 31, respectively) 
will be made by including all covered professional services furnished 
during the QP Performance Period for January 1 through the applicable 
snapshot date.
    We believe that this change will more appropriately recognize the 
Advanced APM participation of the eligible clinicians for whom these 
determinations are being made, particularly when considered in 
conjunction with the proposal to make QP determinations at the 
individual eligible clinician level. We further believe that this 
proposal will simplify and streamline QP determinations and address the 
challenges to Advanced APM participation reportedly faced by 
specialists who are less likely than primary care practitioners to 
provide E/M services.
    We solicited comment on this proposal to modify the sixth criterion 
in the definition of ``attribution-eligible beneficiary'' at Sec.  
414.1305 to include a beneficiary who has a minimum of one claim for a 
covered professional service furnished by an eligible clinician who is 
on the Participation List for the APM Entity at any determination date 
during the QP Performance Period.
    We received public comments on the proposal. The following is a 
summary of the comments we received and our responses.

[[Page 79406]]

    Comment: Two commenters expressed support for our proposal to 
change the definition of ``attribution-eligible beneficiary''. One of 
these commenters suggested we implement this change as a better 
alternative to our proposal to change QP determinations at the 
individual level.
    Response: We appreciate the comments. We believe our proposal to 
change the definition of ``attribution-eligible beneficiary'' would 
complement QP determination at the individual level in terms of the 
policy objectives we are pursuing and would work best if it is 
implemented at the same time.
    Comment: Two commenters noted that our proposal to change the 
definition of ``attribution-eligible beneficiary'' to base attribution 
on covered professional services would be applied regardless of the 
Advanced APMs in which the eligible clinician participates. These 
commenters expressed concern with making the change, particularly as we 
proposed to change QP determinations to the individual-level.
    Response: We continue to believe the proposed change in the 
definition of ``attribution-eligible beneficiary'' would complement the 
change to make all QP determinations at the individual level. The 
change would expand the scope of services that could lead to 
attribution to include services that are more often furnished by 
specialists, which would lead to relatively higher Threshold Scores for 
specialist eligible clinicians. We also believe that the definition 
change would create a uniform, predictable, understandable basis for 
beneficiary attribution across all Advanced APMs. Further, it would 
simplify and streamline the attribution methodology by making 
attribution based on covered professional services across all Advanced 
APMs.
    As with our proposal to make QP determinations at the individual 
level, we continue to believe that our proposal to modify the 
definition of ``attribution-eligible beneficiary'' has strong merit, 
but after consideration of public comments, we will not implement 
either of these proposals for the CY 2024 QP performance period. 
Modifying the definition of ``attribution-eligible beneficiary'' is 
closely tied to the proposal to make QP determinations at the 
individual level and we do not believe it would be productive to 
implement one without the other. Our current definition of 
``attribution-eligible beneficiary'' will remain in place for 2024.
(4) QP thresholds and Partial QP thresholds
    Section 1833(z)(2) of the Act specifies the thresholds for the 
level of participation in Advanced APMs required for an eligible 
clinician to become a QP for a year. The Medicare Option, based on Part 
B payments for covered professional services or counts of patients 
furnished covered professional services under Part B, has been 
applicable since payment year 2019 (performance year 2017). The All-
Payer Combination Option, through which QP status is calculated using 
the Medicare Option, as well as an eligible clinician's participation 
in Other Payer Advanced APMs, has been applicable since payment year 
2021 (performance year 2019). In the CY 2017 Quality Payment Program 
final rule (81 FR 77433 through 77439), we finalized our policy for QP 
and Partial QP Thresholds for the Medicare Option as codified at Sec.  
414.1430(a) and for the All-Payer Combination Option at Sec.  
414.1430(b).
    Section 4111(a)(2) of the Consolidated Appropriations Act, 2023 
(CAA, 2023) (Pub. L. 117-328, December 29, 2022) amended section 
1833(z)(2) of the Act by extending for payment years 2024 and 2025 
(performance years 2022 and 2023) the applicable payment amount and 
patient count thresholds for an eligible clinician to achieve QP 
status. Specifically, section 4111(a)(2) of the CAA, 2023, amended 
section 1833(z)(2) of the Act to continue the QP payment amount 
thresholds that applied in payment year 2024 (performance year 2022) to 
payment year 2025 (performance year 2023). Additionally, section 
4111(a)(2) of the CAA, 2023, amended section 1833(z)(2) of the Act to 
require that, for payment year 2025, the Secretary use the same 
percentage criteria for the QP patient count threshold that applied in 
payment year 2022. As such, the Medicare Option QP thresholds for 
payment year 2025 will remain at 50 percent for the payment amount 
method and 35 percent for the patient count method. Section 4111(b) of 
the CAA, 2023, also amended section 1848(q)(1)(C)(iii) of the Act to 
extend through payment year 2025 the Partial QP thresholds that were 
established since payment year 2021 under the Medicare Option. 
Therefore, the Partial QP thresholds for payment year 2025 (performance 
year 2023) will remain at 40 percent for the payment amount method and 
25 percent for the patient count method.
    Under the All-Payer Combination Option, the QP thresholds for 
payment year 2025 (performance year 2023) will be 50 percent for the 
payment amount method and 35 percent for the patient count method. The 
Partial QP thresholds for payment year 2025 will be 40 percent for the 
payment amount method and 25 percent for the patient count method. To 
become a QP through the All-Payer Combination Option, eligible 
clinicians must first meet certain minimum threshold percentages under 
the Medicare Option. For payment year 2025 (performance year 2023), the 
minimum Medicare Option threshold an eligible clinician must meet for 
the All-Payer Combination Option to become a QP is 25 percent for the 
payment amount method or 20 percent for the patient count method. For 
Partial QP status, the minimum Medicare Option threshold an eligible 
clinician must meet for the All-Payer Combination Option is 20 percent 
for the payment amount method or 10 percent for the patient count 
method.
    To conform our regulation with the amendments made by the CAA, 
2023, we proposed to amend Sec.  414.1430 by revising paragraphs (a) 
and (b) to reflect the statutory QP and Partial QP threshold 
percentages for both the payment amount and patient count under the 
Medicare Option and the All-Payer Option with respect to payment year 
2025 (performance year 2023) in accordance with the CAA, 2023 
amendments.
    The proposed revisions to Sec.  414.1430(a) and (b) for the 
Medicare Option and All-Payer Combination Option QP and Partial QP 
thresholds are as follows:
     Paragraph (a)(1)(iv) to state that for 2025 the amount is 
50 percent, and paragraph (a)(1)(v) to state that for 2026 and later, 
the amount is 75 percent.
     Paragraph (a)(2)(iv) to state that for 2025 the amount is 
40 percent, and paragraph (a)(2)(v) to state that for 2026 and later, 
the amount is 50 percent.
     Paragraph (a)(3)(iv) to state that for 2025 the amount is 
35 percent, and paragraph (a)(3)(v) to state that for 2026 and later, 
the amount is 50 percent.
     Paragraph (a)(4)(iv) to state that for 2025 the amount is 
25 percent, and paragraph (a)(4)(v) to state that for 2026 and later, 
the amount is 35 percent.
     Paragraph (b)(1)(i)(A) to state that for 2021 through 2025 
the amount is 50 percent, and paragraph (b)(1)(i)(B) to state that for 
2026 and later, the amount is 75 percent.
     Paragraph (b)(2)(i)(A) to state that for 2021 through 2025 
the amount is 40 percent and paragraph (b)(2)(i)(B) to state that for 
2026 and later, the amount is 50 percent.
     Paragraph (b)(3)(i)(A) to state that for 2021 through 2025 
the amount is 35 percent, and paragraph (b)(3)(i)(B) to

[[Page 79407]]

state that for 2026 and later, the amount is 50 percent.
     Paragraph (b)(4)(i)(A) to state that for 2021 through 2025 
the amount is 25 percent, and paragraph (b)(4)(i)(B) to state that for 
2026 and later, the amount is 35 percent.
    We did not receive public comments on this provision, and 
therefore, we are finalizing as proposed.
[GRAPHIC] [TIFF OMITTED] TR16NO23.092

(5) APM Incentive Payment
    Prior to amendments made by the CAA, 2023, section 1833(z)(1) of 
the Act provided for APM Incentive Payments for eligible clinicians who 
are QPs with respect to a year in each payment year from 2019 through 
2024. Specifically, for each of the specified payment years, in 
addition to the amount of payment that would otherwise be made for 
covered professional services furnished by an eligible clinician who is 
a QP for such year, there is an additional lump sum APM Incentive 
Payment equal to 5 percent of the eligible clinician's estimated 
aggregate payment amounts for such covered professional services for 
the preceding year (which we defined as the ``base year''). Covered 
professional services is defined at Sec.  414.1305, with reference to 
the statutory definition at section 1848(k)(3) of the Act, as services 
for which payment is made under, or based on, the PFS and which are 
furnished by an eligible clinician (physician; practitioner as defined 
in section 1842(b)(18)(C) of the Act; PT, OT, or speech-language 
pathologist; or qualified audiologist as defined under section 
1861(ll)(4)(B) of the Act).
    In the CY 2017 Quality Payment Program final rule (81 FR 77445), we 
established a policy that, beginning with the 2017 QP Performance 
Period, the QP Performance Period would be the calendar year that is 2 
calendar years before the payment year for the APM Incentive Payment. 
Thus, we established that the first QP Performance Period would begin 
on January 1, 2017, the first ``base year'' (established at 81 FR 77481 
and 77482) for which we would use claims for professional services to 
calculate the 5 percent APM Incentive Payment amount would be in 2018, 
and the first payment year for the APM Incentive Payment would be in 
2019 as required by the statute. Under our previously finalized 
policies, the QP Performance Period, base year, and payment year 
continue in this fashion on a rolling basis through payment year 2024, 
which was the final year for which the statute authorized an APM 
Incentive Payment. In the CY 2023 PFS final rule (87 FR 70114 through 
70116), we explained that, beginning in payment year 2025, which 
correlates with performance year 2023, the statute

[[Page 79408]]

did not provide for any type of payment incentive for eligible 
clinicians who become QPs.
    Section 4111(a) of the CAA, 2023 amended section 1833(z)(1) of the 
Act to provide that eligible clinicians who are QPs with respect to 
payment year 2025 (performance year 2023) will receive an APM Incentive 
Payment equal to 3.5 percent of their estimated aggregate payment 
amounts for Medicare Part B covered professional services in the 
preceding year. In effect, this statutory change extends the APM 
Incentive Payment for one additional year, at a new percentage of 3.5 
percent rather than 5 percent.
    Accordingly, we proposed to incorporate the change made by the CAA, 
2023, by amending the regulation text at Sec.  414.1450 to add the 
payment year 2025 APM Incentive Payment amount of 3.5 percent of 
covered professional services payments. We proposed to amend paragraph 
(b)(1) to state that the amount of the APM Incentive Payment for 
payment years 2019 through 2024 is equal to 5 percent and, for payment 
year 2025, 3.5 percent, of the estimated aggregate payments for covered 
professional services furnished during the calendar year immediately 
preceding the payment year.
    We also noted that the CAA, 2023, did not extend the APM Incentive 
Payment beyond payment year 2025. Beginning for the 2026 payment year, 
which relates to the 2024 QP Performance Period, section 1848(d)(1)(A) 
of the Act specifies that there shall be two separate PFS conversion 
factors, one for items and services furnished by a QP (the qualifying 
APM conversion factor), and the other for other items and services (the 
nonqualifying APM conversion factor). Each conversion factor will be 
equal to the conversion factor for the previous year multiplied by the 
applicable update for the year specified in section 1848(d)(20) of the 
Act. The update specified for the qualifying APM conversion factor will 
be 0.75 percent, while the update for all others will be 0.25 percent.
    We did not receive public comments on this provision, and 
therefore, we are finalizing as proposed.
(6) Targeted Review of QP Determinations
    In the CY 2021 PFS final rule (85 FR 84952), we finalized a policy 
to provide an opportunity for eligible clinicians to bring to our 
attention potential clerical errors we may have made that could have 
resulted in the omission of an eligible clinician from a Participation 
List used for purposes of QP determinations, and for us to review and 
make corrections if warranted. We also finalized that, after the 
conclusion of the time period for targeted review, there would be no 
further review of our QP determination with respect to an eligible 
clinician for the QP Performance Period. We noted that, consistent with 
section 1833(z)(4) of the Act, and as provided under Sec.  414.1455(a) 
of our regulations, there is no right to administrative or judicial 
review under sections 1869 or 1878 of the Act, or otherwise, of the 
determination that an eligible clinician is a QP or Partial QP under 
Sec.  414.1425, or of the determination of the amount of the APM 
Incentive Payment under Sec.  414.1450.
    In the CY 2021 PFS final rule (85 FR 84953), we finalized our 
proposal to align the timing and procedures for this targeted review 
process with the MIPS targeted review process as codified at Sec.  
414.1385. We noted this alignment would reduce the likelihood of 
confusion and burden on eligible clinicians and APM Entities.
    In light of the transition in incentives for eligible clinicians 
who are QPs for a year, as provided in statute, from an APM Incentive 
Payment to the differentially higher PFS conversion factor beginning 
with the 2024 QP performance period and 2026 payment year, we proposed 
at section IV.A.4.j. of the proposed rule to adjust the Targeted Review 
period in order to meet operational timelines to ensure that we can 
meet statutory requirements for the application of the differential 
conversion factors, and the resulting differential PFS payment rates, 
to eligible clinicians who are, and are not, QPs for the year. As 
discussed in section IV.A.4.j. of the proposed rule, we believe that 
adjusting the Targeted Review period will enable us to meet our 
statutory obligation to apply the differentially higher QP conversion 
factor beginning on January 1 of each payment year beginning with CY 
2026. We encourage readers to review section IV.A.4.j. of the proposed 
rule.
n. Advanced APMs
(1) General Overview
    In this section, we address policies regarding several aspects of 
the Advanced APM criterion for CEHRT use at Sec.  414.1415(a). We 
proposed to amend the definition of CEHRT at Sec.  414.1305 that 
applies to Advanced APM participants, and to modify the Advanced APM 
CEHRT use criterion at Sec.  414.1415(a) to recognize the CEHRT that is 
relevant to the clinical practice of participants in the Advanced APM.
    We believe the Quality Payment Program must be responsive to, and 
supportive of, innovation in technology and in a provider organization. 
It is our goal to encourage not only provider ownership of health 
information technology (health IT), but full adoption and integration 
of the most advanced health IT into clinical practice. We developed 
these proposals to modify the CEHRT that is required for Advanced APMs 
with this goal in mind, and we will continue to monitor advancements 
and opportunities in the health IT space to better prepare and align 
our program and APMs with the most cutting-edge technologies and 
innovative provider arrangements, for the benefit of APM Entities and 
eligible clinicians, and the Medicare beneficiaries we serve.
(2) Background
(a) Advanced APM CEHRT Use Criterion
    Under section 1833(z)(3)(D)(i)(I) of the Act, Advanced APMs are 
those APMs that (among other things) require participants to use CEHRT. 
We codified this CEHRT use criterion for Advanced APMs at Sec.  
414.1415(a)(1). As such, the CEHRT use criterion under Sec.  
414.1415(a)(1) states that, to be an Advanced APM, the APM must require 
at least a certain percentage of eligible clinicians in each 
participating APM Entity group, or, for APMs in which hospitals are the 
APM Entities, each hospital, to use CEHRT to document and communicate 
clinical care to their patients or health care providers. In the CY 
2017 Quality Payment Program final rule, we specified at Sec.  
414.1415(a)(1)(i) that an Advanced APM is one that requires at least 50 
percent of eligible clinicians in each APM Entity group to use CEHRT to 
document and communicate clinical care to their patients or health 
providers (81 FR 77410). In the CY 2019 PFS final rule (83 FR 59918), 
we amended Sec.  414.1415(a)(1) to increase the required percentage 
from 50 percent to 75 percent.
(b) Definition of CEHRT
    Section 1848(o)(4) of the Act defines CEHRT as a qualified 
electronic health record (as defined in section 3000(13) of the Public 
Health Service Act, or PHSA) that is certified by the Office of the 
National Coordinator for Health Information Technology (ONC) pursuant 
to section 3001(c)(5) of the PHSA in accordance with the certification 
standards that ONC adopted under section 3004 of the PHSA.
    In implementing the definition of CEHRT at Sec.  414.1305 for the 
MIPS track of the Quality Payment Program, we adopted the definition of 
CEHRT used

[[Page 79409]]

for the Medicare EHR Incentive Program (also known as ``Meaningful 
Use'') at Sec.  495.4 (81 FR 77211 through 77213). In the CY 2017 
Quality Payment Program final rule, we explained that we intended ``to 
maintain continuity for MIPS eligible clinicians and health IT vendors 
who may already have CEHRT or who have begun planning for a transition 
to technology certified to the 2015 Edition based on the definition of 
CEHRT finalized for the EHR Incentive Programs in the 2015 EHR 
Incentive Programs final rule'' and ``to maintain consistency with the 
EHR Incentive Programs CEHRT definition at 42 CFR 495.4'' (81 FR 
77212).
    For the Advanced APM track of the Quality Payment Program, we in 
turn adopted the definition of CEHRT for MIPS under Sec.  414.1305 (81 
FR 77409 through 77410). We explained that applying the same definition 
of CEHRT for purposes of both the MIPS and Advanced APM tracks of the 
Quality Payment Program would reduce administrative costs and confusion 
among eligible clinicians and maintain consistency across programs, 
permitting eligible clinicians to use shared CEHRT systems to 
participate in either MIPS or Advanced APMs (81 FR 77409 through 
77410).
    Consequently, the MIPS and Advanced APM tracks of the Quality 
Payment Program share the same definition of CEHRT at Sec.  414.1305. 
Since the CY 2019 performance period, this has generally meant EHR 
technology (which could include multiple technologies) certified under 
the ONC Health IT Certification Program that meets the 2015 Edition 
Base EHR definition (as defined at 45 CFR 170.102) and that has been 
certified to certain other 2015 Edition health IT certification 
criteria as specified in the definition of CEHRT at Sec.  414.1305. The 
currently applicable definition of CEHRT at Sec.  414.1305 specifically 
requires that the EHR technology has been certified to the following 
2015 Edition health IT certification criteria: (1) family health 
history at 45 CFR 170.315(a)(12); (2) patient health information 
capture at 45 CFR 170.315(e)(3); and (3) as necessary to report on 
applicable objectives and measures specified for the MIPS Promoting 
Interoperability performance category, including applicable measure 
calculation certification criteria at 45 CFR 170.315(g)(1) or (2) and 
clinical quality measure certification criteria that support the 
calculation and reporting of clinical quality measures at 45 CFR 
170.315(c)(2) and (c)(3)(i) and (ii) (and optionally (c)(4)) and can be 
electronically accepted by CMS.
    Because our definition of CEHRT at Sec.  414.1305 ultimately 
derives from the definition of CEHRT used for the Meaningful Use 
Program, our Advanced APMs have required their participants to use 
CEHRT that is capable of meeting all requirements of a qualified EHR. 
As such, Advanced APMs generally require participants to use CEHRT that 
meets requirements for the 2015 Edition Base EHR (as defined at 45 CFR 
170.102); all requirements of Meaningful Use set forth in section 
1848(o)(2) of the Act; and all requirements for reporting on applicable 
objectives and measures specified for the MIPS Promoting 
Interoperability performance category. When we adopted the same 
definition of CEHRT at Sec.  414.1305 for purposes of MIPS and Advanced 
APMs in the CY 2017 Quality Payment Program final rule, we acknowledged 
that such a policy may include some requirements not directly 
applicable to the APM Entities' practice. Specifically, we stated at 
that time that ``we understand this proposed CEHRT definition may 
include some EHR functionality used by MIPS eligible clinicians which 
may be less relevant for an APM participant and likewise APM 
participants may use additional functions that are not required for 
MIPS participation'' (81 FR 77409). At the time, we reasoned that 
``using the same CEHRT definition for both MIPS and Advanced APMs would 
allow eligible clinicians to continue to use shared EHR systems and 
give eligible clinicians flexibility of participation as a MIPS 
eligible clinician or an eligible clinician in an Advanced APM without 
needing to change or upgrade EHR systems'' (81 FR 77409).
    Although we acknowledged that this CEHRT definition may impose more 
rigorous requirements on APM participants than necessary, we 
nonetheless maintained that ``we generally want APMs to retain the 
flexibility to require activities performed using CEHRT that may vary 
from those prescribed under the advancing care information performance 
category in MIPS'' (81 FR 77412).\504\ We also recognized that aligning 
the CEHRT definition for Advanced APMs with MIPS ``would go beyond what 
the statute requires'' (81 FR 77412). When we adopted the CEHRT 
definition for MIPS and Advanced APMs, one commenter suggested that our 
proposed CEHRT criterion for Advanced APMs was narrow, and that ``a 
strong, broad health IT infrastructure should be a key element used to 
identify Advanced APMs rather than the narrow proposed CEHRT criteria'' 
(81 FR 77410). We agreed that ``Advanced APMs need a strong health IT 
infrastructure as a foundation for communicating and delivering 
comprehensive and coordinated care to their patients,'' but at that 
time we wanted to prioritize continuity between the two tracks of the 
Quality Payment Program to maximize flexibility for eligible 
clinicians. However, we indicated that we would be prepared to update 
this definition as needed in the future.
---------------------------------------------------------------------------

    \504\ Section 1848(q)(2)(A)(iv) and (B)(iv) of the Act requires 
that the Secretary assess MIPS eligible clinicians' performance with 
respect to the ``meaningful use of certified EHR technology'' in 
accordance with the requirements set forth at section 1848(o)(2) of 
the Act as one of the four performance categories for MIPS. In the 
CY 2017 Quality Payment Program final rule, we named this required 
MIPS performance category the ``advancing care information 
performance category.'' (81 FR 77010). We have since renamed this 
MIPS performance category, requiring the meaningful use of CEHRT, as 
the ``Promoting Interoperability performance category.'' (85 FR 
84820 through 84821).
---------------------------------------------------------------------------

(3) Proposal To Update CEHRT Definition and CEHRT Use Criterion for 
Advanced APMs
    After several years of experience with the uniform definition of 
CEHRT for purposes of MIPS and Advanced APMs and based on input we have 
received from interested parties, we now believe that the standard for 
CEHRT use for Advanced APMs may have been unnecessarily burdensome, 
imposing unwarranted barriers to organization of and participation in 
Advanced APMs, and not clinically relevant for many prospective and 
current participants in Advanced APMs. As previously discussed, our 
policy at Sec.  414.1415(a)(1)(i) currently requires that at least 75 
percent of eligible clinicians in each participating APM Entity group, 
and for APMs in which hospitals are APM Entities, each hospital, to use 
CEHRT, as defined in Sec.  414.1305, to document and communicate 
clinical care to their patients or health care providers. By referring 
in the Advanced APM CEHRT use criterion to CEHRT, as defined in Sec.  
414.1305, Advanced APMs have required participants to adopt and 
implement health IT that is capable of meeting all requirements of a 
qualified EHR, which means CEHRT that meets all requirements for 2015 
Edition Base EHR (as defined at 45 CFR 170.102); all requirements of 
Meaningful Use set forth in section 1848(o)(2) of the Act; and all 
requirements for reporting on applicable objectives and measures 
specified for the MIPS Promoting Interoperability performance category. 
We have heard from many interested parties that our CEHRT use 
requirements for Advanced APMs are

[[Page 79410]]

falling short of some of our intended goals. Specifically, we have 
heard from many interested parties that our current requirements for 
use of CEHRT have led Advanced APMs to apply an inflexible standard 
that does not allow them to take into account whether certain CEHRT 
modules are relevant for, and applicable to, the specific clinical 
practice areas of their intended or actual participants. By placing a 
broad set of requirements for use of CEHRT, particularly regarding the 
criteria the health IT must be certified as meeting to satisfy our 
definition of CEHRT at Sec.  414.1305, interested parties report that 
we are needlessly burdening some potential and actual participants in 
Advanced APMs because they must adopt health IT modules that are not 
always clinically relevant across provider types that would participate 
in an Advanced APM. Specifically, interested parties noted that the 
CEHRT definition used for our Advanced APM criterion means that the APM 
must require participants to use health IT certified as meeting 
criteria necessary to report on objectives and measures of the MIPS 
Promoting Interoperability performance category, even when such health 
IT is not clinically relevant for or applicable to APM participants' 
practice, is needlessly burdensome and a barrier to innovation and 
participation in APMs. To support their position, interested parties 
noted as an example that application of our current Advanced APM CEHRT 
use criterion and associated CEHRT definition has required specialists 
in the Kidney Care Choices (KCC) Model or providers in the ACO 
Realizing Equity, Access, and Community Health (REACH) Model to 
purchase certified Health IT Modules beyond those required as part of 
the 2015 Edition Base EHR definition at 45 CFR 170.102 that are not 
immediately necessary or applicable to their clinical practice.
    We have learned that Advanced APMs have not had the flexibility to 
require certified health IT that is tailored to their specific 
participants' practice areas. Likewise, we could envision a scenario 
where, to comply with the Advanced APM CEHRT use criterion under our 
current policy, an APM or APM Entity would exclude from participation 
specialists or other eligible clinician types, such as pathologists, 
for whom compliance with our current CEHRT requirements beyond the Base 
EHR definition would be burdensome and beyond the scope of their 
typical practice, even though participation of such eligible clinicians 
would be relevant and beneficial to the goals of the APM.
    For Advanced APMs, we believe that it is important both to apply a 
rigorous standard for use of CEHRT and to allow sufficient flexibility 
to Advanced APMs to specify CEHRT modules that are clinically relevant 
for their participants. We believe that our current CEHRT use 
requirements meet the former goal (application of a rigorous standard), 
but not the latter (allowing sufficient flexibility).
    Further, our current CEHRT use criterion specifies that 75 percent 
of participants in the APM must use CEHRT as defined in Sec.  414.1305 
and allows for 25 percent of participants to not have or use CEHRT. 
This policy establishes a minimum percentage of Advanced APM 
participants that must use CEHRT, but without consideration of which 
eligible clinicians in each participating APM Entity (or hospital) must 
use CEHRT, or whether it is clinically appropriate for any of those 
eligible clinicians to not use CEHRT. As such, this policy could allow 
eligible clinicians who could and should be using CEHRT to forego CEHRT 
use solely because enough of their colleagues are using CEHRT to meet 
the requirement of the Advanced APM. Additionally, we have heard from 
interested parties that, for most Advanced APM participants, CEHRT use 
among eligible clinicians is close to 100 percent. Given this 
information and the fact that the 75 percent CEHRT use standard has 
been in effect for almost five years, we believe it is appropriate to 
re-evaluate our approach to the application of the CEHRT use 
requirement to Advanced APMs and their participants. We want to 
maintain the rigor of our CEHRT use criterion for Advanced APMs while 
providing Advanced APMs flexibility to require CEHRT use that is 
applicable for the practice areas of their participants and their 
eligible clinicians. Further, we believe any exceptions to CEHRT use 
that are permitted under the Advanced APM should be based on clinical 
appropriateness, rather than on generalized application of percentages.
    First, we proposed to amend the definition of CEHRT at Sec.  
414.1305 by adding a new paragraph (3) to specify that, for purposes of 
the Advanced APM CEHRT use criterion under Sec.  414.1415(a)(1), 
beginning with CY 2024, CEHRT means EHR technology certified under the 
ONC Health IT Certification Program that meets: (1) the 2015 Edition 
Base EHR definition, or any subsequent Base EHR definition (as defined 
in at 45 CFR 170.102); and (2) any such ONC health IT certification 
criteria adopted or updated in 45 CFR 170.315 that are determined 
applicable for the APM, for the year, considering factors such as 
clinical practice areas involved, promotion of interoperability, 
relevance to reporting on applicable quality measures, clinical care 
delivery objectives of the APM, or any other factor relevant to 
documenting and communicating clinical care to patients or their health 
care providers in the APM.
    We believe our proposal to revise the definition of CEHRT for 
Advanced APMs at Sec.  414.1305 would provide flexibility to each APM 
to determine what CEHRT functionalities are relevant to the model and 
its participant APM Entities and eligible clinicians. We believe that 
providing Advanced APMs with the greater flexibility permitted by the 
statute with respect to requiring CEHRT use will foster innovation in 
model design and diversity in APM participation. Specifically, we 
believe our amendment to the CEHRT definition at Sec.  414.1305 will 
facilitate innovation in APM design, and enable a broad range of 
participants and their eligible clinicians to meet Advanced APM CEHRT 
use requirements by adopting health IT that satisfies the 2015 Edition 
Base EHR definition, or subsequent Base EHR definition, at 45 CFR 
170.102 and is certified as meeting other ONC health IT certification 
criteria adopted, or updated in 45 CFR 170.315, as is clinically 
relevant to their practice, without unnecessarily obtaining other 
health IT, such as the health IT necessary to report on applicable 
objectives and measures specified for the MIPS Promoting 
Interoperability performance category.
    We note that participation in an Advanced APM does not 
automatically exclude eligible clinicians from MIPS. Eligible 
clinicians in an Advanced APM who do not achieve Qualifying APM 
Participant (QP) status or Partial QP status, or who are not otherwise 
excluded or exempt from MIPS (for example, on the basis of low Medicare 
volume, new Medicare enrollment, or eligible clinician type), remain 
subject to the MIPS reporting requirements and payment adjustment. 
Accordingly, under our proposal, eligible clinicians in Advanced APMs 
will still need to be prepared to report to MIPS, including using CEHRT 
as necessary to report on applicable objectives and measures specified 
for the MIPS Promoting Interoperability performance category, in the 
event that they do not achieve QP or Partial QP status or are not 
excluded or exempt from MIPS on another basis.
    In section IV.A.4.f.(4) of the proposed rule, we also proposed 
other

[[Page 79411]]

modifications to the CEHRT definition at Sec.  414.1305 to be more 
flexible in reflecting any changes ONC may make to its Base EHR 
definition, certification criteria, and other standards for health IT 
at 45 CFR part 170. Our proposed amendment to the CEHRT definition 
under paragraph (3) at Sec.  414.1305 for Advanced APMs is consistent 
with our other amendments to the CEHRT definition, which we are 
finalizing as set forth in section IV.A.4.f.(4) of this final rule.
    Second, we proposed to amend our current Advanced APM CEHRT use 
criterion at Sec.  414.1415(a)(1). Specifically, we proposed to amend 
the regulation to end the current 75 percent CEHRT use requirement at 
Sec.  414.1415(a)(1)(i) with the CY 2023 QP performance period. Then we 
proposed to add a new paragraph at Sec.  414.1415(a)(1)(iii) to specify 
that, to be an Advanced APM, the APM must require all eligible 
clinicians in each participating APM Entity, or for APMs in which 
hospitals are the participants, each hospital, to use CEHRT that meets 
our proposed new paragraph (3) of the CEHRT definition at Sec.  
414.1305. In essence, we proposed to no longer specify a minimum number 
of eligible clinicians that an Advanced APM must require to use CEHRT, 
and instead, simply specify that the Advanced APM must require all 
participating eligible clinicians to use CEHRT that meets our proposed 
modified, and more flexible, definition. We also proposed to revise 
Sec.  414.1415 by making non-substantive technical edits to paragraphs 
(a)(1)(i) and (ii) to improve clarity.
    This policy, which we proposed and are finalizing with modification 
as discussed herein, is consistent with section 1833(z)(3)(D)(i)(I) of 
the Act, which generally requires that Advanced APMs require their 
participants to use CEHRT as defined in section 1848(o)(4) of the Act. 
We believe this amendment to the Advanced APM CEHRT use criterion will 
further enhance innovation in Advanced APM development and diversity in 
participation, allowing for novel APM Entity compositions, because 
Advanced APM participants will no longer have to concern themselves 
with the percentage of eligible clinicians that meet our current CEHRT 
requirements. We further believe that, under our more flexible CEHRT 
definition and Advanced APM CEHRT use criterion, Advanced APMs could 
create their own CEHRT use requirements, potentially beyond what we 
currently require, tailored to the various types of clinicians and 
practice areas the Advanced APM intends to include in its model. We 
believe our proposal will permit Advanced APMs to recruit and retain 
participants that represent a variety of practice types, and to require 
different types of EHR technologies certified under the ONC Health IT 
Certification Program as meeting the 2015 Edition Base EHR definition, 
or subsequent Base EHR definition, at 45 CFR 170.102 and additional ONC 
health IT certification criteria adopted and updated in 45 CFR 170.315 
as specifically applicable to different types of clinical practice.
    We sought comment on this proposal.
    The following is a summary of the comments we received and our 
responses.
    Comment: Most commenters expressed support for the proposal to 
amend the definition of CEHRT at Sec.  414.1305, noting their 
appreciation for the greater flexibility it would afford, as well as 
for making permanent references to ONC regulations such that CMS 
rulemaking will not be necessary to incorporate future updates to ONC 
health IT certification criteria within the definition of CEHRT.
    Response: We thank commenters for their support.
    Comment: One commenter expressed concern about changing the CEHRT 
definition to be ``edition-less,'' citing concerns with respect to 
smaller practices being able to meet deadlines for updating EHRs. This 
commenter noted they believe additional flexibility is warranted to 
give time to these practices to keep up with CEHRT requirements as they 
change. Another commenter expressed concern about the timing of our 
proposal to modify our CEHRT definition with respect to ONC's proposed 
rule that proposes to modify definitions and certification requirements 
in ONC's regulations that our CEHRT definition references and 
recommended that we wait until ONC's rule is finalized before modifying 
our definition.
    Response: We appreciate a desire to meet the needs of smaller 
practices. We note that section 1833(z)(3)(D)(i)(I) of the Act 
specifies that Advanced APMs are those that require participants to use 
CEHRT, and that the definition of CEHRT references health IT 
certification criteria established by ONC, which in turn is implemented 
under regulations promulgated by ONC. The CEHRT definition used for 
purposes of the Advanced APM criterion must inherently, and at a 
minimum, require technology to meet certification criteria established 
by ONC. As such, we believe our regulatory definition of CEHRT must be 
flexible to reflect any changes ONC proposes and finalizes regarding 
its own definition of Base EHR and its certification criteria to ensure 
our Advanced APM standard aligns with ONC's regulations as required by 
our statute. We believe that waiting to revise our CEHRT definition, 
based on whether ONC finalizes its proposals (88 FR 23757 through 
23762), would increase regulatory burden and complexity. Rather, this 
final policy would incorporate the timelines ONC adopts through notice 
and comment rulemaking for health IT developers to update and provide 
certified technology to their customers. While our proposals have been 
informed by the ``edition-less'' approach and related proposals 
described by ONC (88 FR 23757 through 23762), we believe that our final 
policies will simplify participation and reduce confusion for CMS 
program participants whether or not ONC finalizes its proposals. 
However, we do recognize that smaller practices may face additional 
burden to keep up with changes, and we will continue to examine the 
ability of small practices to meet CEHRT requirements in Advanced APMs, 
including through the examining the potential use of flexibilities 
described in greater detail below.
    Comment: One commenter supported our proposal to replace the 75 
percent CEHRT use threshold with a requirement that Advanced APMs 
require the use of CEHRT.
    Response: We thank the commenter for their support.
    Comment: Most commenters opposed our proposal to remove the current 
75 percent CEHRT use requirement at Sec.  414.1415(a)(1)(i) and 
requested that we retain this aspect of the current regulations, noting 
that the threshold provides flexibility, and citing concerns that 
requiring Advanced APMs to require all eligible clinicians to have 
CEHRT is unforgiving. One commenter cited that a single clinician could 
fail to use CEHRT for reasons such as ``travel, sickness, or injury,'' 
and expressed concern that this could make the entire Advanced APM fail 
to meet our proposed standard. One commenter encouraged us to instead 
look at data other Federal Agencies collect on the levels of CEHRT 
adoption, such as ONC's ``Insights Condition'' data from its most 
recent proposed rule. One commenter indicated that we should be 
encouraging clinicians not currently using CEHRT to join APMs. One 
commenter specifically expressed concern relating to the ability of 
smaller practices to participate in Advanced APMs.
    Response: We understand commenters' concerns that requiring all 
eligible clinicians to use CEHRT is an

[[Page 79412]]

exacting standard on its face. We believe that the flexibilities 
introduced in our proposed amendment to the definition of CEHRT at 
Sec.  414.1305 would allow Advanced APMs to establish requirements for 
CEHRT use that are reasonable expectations for Advanced APM 
participants. As discussed in the proposed rule, our original 
definition of CEHRT was one that we recognized would not necessarily be 
relevant to all practice areas. Under the new definition, Advanced APMs 
can consider clinical practice when establishing their CEHRT use 
requirements, and thereby establish a standard that would be reasonable 
to expect participating APM Entities and eligible clinicians in 
relevant clinical practice areas to be capable of meeting.
    As we discussed in the proposed rule, the use of a CEHRT use 
threshold without consideration of which eligible clinicians in each 
participating APM Entity (or hospital) must use CEHRT, or whether it is 
clinically appropriate for any of those eligible clinicians to not use 
CEHRT, would potentially allow for eligible clinicians who could and 
should be using CEHRT to forego CEHRT use solely because enough of 
their colleagues are using CEHRT to meet the requirement of the 
Advanced APM. We note that section 1833(z)(3)(D)(i)(I) of the Act does 
not specify the use of any threshold for purposes of the Advanced APM 
CEHRT use criterion, whereas the statute does specify the use of, and 
sometimes also level for, thresholds for other provisions (such as the 
level of Advanced APM participation necessary to achieve QP status). 
After several years of experience applying the threshold-based CEHRT 
use criterion, we do not believe it is serving as a sufficiently 
meaningful approach for measuring eligible clinicians' adoption of 
clinically appropriate CEHRT.
    In describing the proposal, we stated that we expect Advanced APMs 
to require all eligible clinicians to use CEHRT (88 FR 52627). 
Specifically, our proposal was that Advanced APMs would have to require 
participants to use CEHRT that meets the (current or subsequent) Base 
EHR definition at 45 CFR 170.102 and could require CEHRT to meet 
additional certification criteria under 45 CFR 170.315 as clinically 
appropriate. As further outlined below in this response, we believe 
that it is reasonable to expect all Advanced APM participants to have 
technology that is capable of meeting at least the Base EHR definition. 
However, we do not expect that this would occur entirely without 
exceptions across all possible circumstances. As we stated in the 
proposed rule, we believe that any exceptions permitted under the 
Advanced APM should be based on clinical appropriateness, rather than 
the provision of a generalized application of percentages to CEHRT use 
(88 FR 52626).
    We also note that we apply the Advanced APM criteria and identify 
Advanced APMs before the beginning of each QP performance period based 
on the structure of the APM and, in the case of CEHRT use, what health 
IT technology the APM requires of its participant APM entities and 
eligible clinicians. We would not anticipate removing Advanced APM 
status from an APM under circumstances such as a single eligible 
clinician failing to use CEHRT; and we recognize that Advanced APMs may 
provide for, and have reasons to apply, exceptions from time to time. 
In the example of travel, illness, or injury, that one commenter cited, 
an Advanced APM may have in place and choose to apply an exception 
based on significant hardship or an Extreme and Uncontrollable 
Circumstance (EUC) policy, and we would work with that Advanced APM 
with respect to the application of such an exception to the Advanced 
APM criteria, including CEHRT use. For example, in the spring of 2020, 
we recognized that, as part of CMS's COVID-19 response to reduce burden 
or ease financial strain, Advanced APMs might apply exceptions to their 
requirements to the extent permitted by the terms of each Advanced APM, 
and did not consider removing Advanced APM status on the basis of any 
such decisions that may have affected one or more of the Advanced APM 
criteria. If a circumstance were to arise in which we were to determine 
that a particular Advanced APM or its participants were not in 
compliance with one of the Advanced APM criteria, including the CEHRT 
use criterion, we first would seek to identify steps for the Advanced 
APM and/or its participants to remediate the identified problem such 
that Advanced APM status could be maintained. In the event that we 
determine that the removal of Advanced APM status would be necessary, 
such a removal would apply to future performance years and would 
involve a process for notice to its participants and the public that 
the APM no longer would be an Advanced APM for the upcoming performance 
period.
    Additionally, as one commenter noted, CEHRT may be a barrier for 
smaller practices to participate in Advanced APMs. We acknowledge that 
this may be the case, and will consider whether greater flexibility in 
our CEHRT use criterion is warranted, for example, if a particular APM 
were designed to include smaller practices and identified a reason why 
time- or situation-limited exceptions to the CEHRT use criterion for 
those small practices may be appropriate as a matter of the APM's 
design. In general, we believe that taking specific circumstances into 
account in the context of APM design is a better approach for CEHRT use 
requirements in contrast to applying a blanket threshold, which leaves 
room for eligible clinicians in Advanced APMs to not engage 
meaningfully in CEHRT use for no real reason. To the extent that we 
identify in the future that further rulemaking may be warranted or 
necessary to establish specific criteria for exceptions, we would 
update our rules accordingly through notice-and-comment rulemaking. At 
this time, we believe that the Advanced APM should lead the way in 
identifying the potential appropriateness of any exceptions, and we 
would consider those exceptions when determining or reviewing Advanced 
APM status.
    We expect that Advanced APMs readily can require that their 
participants use CEHRT that meets at least the 2015 Edition Base EHR 
definition, or subsequent Base EHR definition at 45 CFR 170.102, 
because these participants would use CEHRT that meets at least this 
Base EHR definition under several Medicare programs. First, as we noted 
in the CY 2024 PFS proposed rule, the current Advanced APM CEHRT use 
criterion is that the APM must require 75 percent of eligible 
clinicians participating in the APM to use CEHRT that meets both the 
Base EHR definition at 45 CFR 170.102 and the ONC health IT 
certification criteria at 45 CFR 170.315 to satisfy Meaningful Use 
requirements and MIPS Promoting Interoperability performance category 
requirements (88 FR 52626). Second, MIPS eligible clinicians, who may 
also participate in an Advanced APM, use CEHRT (Sec.  414.1375(b)(1)) 
as defined at Sec.  414.1305, meeting both the Base EHR definition at 
45 CFR 170.102 and specific certification criteria at 45 CFR 170.315 
for reporting applicable measures and activities, for purposes of the 
MIPS Promoting Interoperability performance category. Although these 
requirements vary with respect to what additional ONC health IT 
certification criteria at 45 CFR 170.315 the CEHRT must meet, both the 
Advanced APM CEHRT use criterion and MIPS expect eligible clinicians to 
use CEHRT that at least meets the Base EHR definition at 45 CFR 
170.102. As discussed herein, we are finalizing our proposal to revise

[[Page 79413]]

the definition of CEHRT that Advanced APMs must require to mean CEHRT 
that meets the Base EHR definition at 45 CFR 170.102 and any additional 
ONC health IT certification criteria set forth in 45 CFR 170.315 that 
the Advanced APM determines applicable, considering certain factors. 
Given this revision, we believe that Advanced APM participants who are 
using CEHRT already under the more strenuous requirements should be 
able to ensure their CEHRT continues to meet the Base EHR definition at 
170.102.
    The only gap we expect in CEHRT use are Advanced APM participants 
who have not been required to use CEHRT to date either under MIPS, such 
as due to application of exceptions or reweighting policies, or the 
Advanced APM CEHRT use criterion at Sec.  414.1415(a)(1)(i). However, 
as we noted in the CY 2024 PFS proposed rule, we have heard from 
interested parties that CEHRT use among eligible clinicians in Advanced 
APMs is close to 100 percent (88 FR 52626). Therefore, we believe that 
given the opportunity for a transition year as described further below 
in this section, and our ability under the revised definition to 
consider a potential exception that a particular Advanced APM believes 
is clinically appropriate, as a general matter we can reasonably expect 
that by 2025, all eligible clinicians participating in Advanced APMs 
should have CEHRT that meets at least the Base EHR definition.
    We believe that adopting a flexible definition of CEHRT, as 
proposed, would permit Advanced APMs to select more specific CEHRT 
requirements (for instance, specifying which certification criteria 
under 45 CFR 170.315 should be incorporated into CEHRT requirements 
beyond the applicable Base EHR definition) that their participating 
eligible clinicians must meet and use to document and communicate their 
clinical care to patients and other health care providers. CMS 
collaborates with ONC regarding certification criteria for health IT 
referenced in the CEHRT definition, including relevant capabilities for 
Advanced APMs, and we agree that the examination of available data from 
ONC (and other Federal partners) is relevant in decision-making; that 
is, we believe that these types of data are most useful when considered 
at the individual Advanced APM level, as the purpose of a specific 
Advanced APM and the practice areas of its participants will be 
relevant drivers of the specific ONC health IT certification criteria 
required by that Advanced APM, and is likely to be different between 
Advanced APMs.
    Comment: One commenter expressed support for increasing the current 
75 percent threshold to 100 percent ``over the next few performance 
years,'' but expressed concern that removing the 75 percent threshold 
by QP performance period 2024 does not give participants sufficient 
time to work with or remove eligible clinicians that do not currently 
use CEHRT. This commenter notes that CMS's deadline to remove 
participating TINs from the Shared Savings Program (CMS's largest 
Advanced APM) was September 5, 2023, which was before the proposed rule 
would be finalized and therefore prior to participant ACOs knowing what 
policies would be in place for QP performance period 2024. Similarly, 
another commenter requested that we consider finalizing the proposal 
for QP performance period 2025 rather than 2024 because, while its 
organization's CEHRT use is close to 100 percent, it is not quite 
there, and the additional year would provide a sufficient glide path to 
full compliance either through adoption of CEHRT by the remaining few 
that do not have it or removal of those participants from the 
organization. One commenter did not express outright support or 
opposition to the proposal to end the 75 percent CEHRT use threshold, 
but recommended that we incorporate a transition period and delay 
ending the 75 percent threshold until a later QP performance period.
    Response: After further reflection, we agree that a transition 
period would be appropriate, and agree with the commenters that 
indicated that some participants had to make decisions about 2024 
participation without certainty about what rules would be in place for 
that QP performance period or having much time to work with members 
that may be using technology that does not currently meet the CEHRT 
definition. Our information pertaining to CEHRT use by Advanced APM 
participants indicates readiness to meet the new standard, but we 
recognize that a transition period would be helpful to address 
potential circumstances on which we may not have information, such as 
the CEHRT readiness of practices that may have been considering joining 
Advanced APMs in the near future, and give current and future potential 
participants the ability to make participation decisions for a 
particular QP performance period with full knowledge of the policies 
that will be in place for that year. We note that, because the 
definition of CEHRT that we are finalizing in this rule will allow for 
Advanced APMs to tailor their CEHRT requirements to clinical practice, 
it is possible that technology that eligible clinicians currently have 
that did not meet the existing CEHRT definition will meet the new 
definition. We encourage Advanced APMs to evaluate the CEHRT their 
eligible clinicians use with that new definition in mind (for example 
by determining if at least the Base EHR definition at 45 CFR 170.102 is 
met). We believe that providing an additional year should afford 
sufficient time for such an evaluation and we encourage participants to 
further use the time to work with their participant membership who do 
not have technology meeting the CEHRT definition to adopt it, as 
opposed to simply removing those clinicians from participation. We also 
believe that a transition year will allow us time to address concerns 
about the proposed new standard that were expressed in the previous 
comment. Accordingly, we will delay removal of the 75 percent threshold 
for CEHRT use until the CY 2025 QP performance period. We encourage 
Advanced APM participants to work with their Advanced APMs to 
understand what requirements apply to them.
    After consideration of public comments, we are finalizing our 
proposal to amend the definition of CEHRT at Sec.  414.1305 by adding a 
new paragraph (3) to specify that, for purposes of the Advanced APM 
criterion under Sec.  414.1415, beginning with CY 2024, CEHRT means EHR 
technology certified under the ONC Health IT Certification Program that 
meets: (1) the 2015 Edition Base EHR definition, or any subsequent Base 
EHR definition (as defined in at 45 CFR 170.102); and (2) any such ONC 
health IT certification criteria adopted or updated in 45 CFR 170.315 
that are determined applicable for the APM, for the year, considering 
factors such as clinical practice areas, promotion of interoperability, 
relevance to reporting on applicable quality measures, clinical care 
delivery objectives of the APM, or any other factor relevant to 
documenting and communicating clinical care to patients or their health 
care providers in the APM. We are also finalizing our proposal with 
modification to add a new paragraph at Sec.  414.1415(a)(1)(iii) to 
specify that beginning with the CY 2025 QP performance period, to be an 
Advanced APM, the APM must require all eligible clinicians in each 
participating APM Entity, or for APMs in which hospitals are the 
participants, each hospital, to use CEHRT that meets our proposed new 
paragraph (3) of the CEHRT definition at Sec.  414.1305. Finally, we 
are finalizing, with modification, our

[[Page 79414]]

proposal to amend Sec.  414.1415(a)(1)(i) to end the current 75 percent 
CEHRT use requirement with the CY 2024 QP performance period, instead 
of the CY 2023 QP performance period.
(4) All Payer Advanced APMs
    In the CY 2017 Quality Payment Program final rule (81 FR 77459), we 
proposed policies, effective beginning for performance year 2021, that 
would allow eligible clinicians to earn QP status through participation 
in a combination of Medicare Advanced APMs and other payment 
arrangements designed and implemented by other payers (Other Payer 
Advanced APMs). The statute includes a CEHRT use criterion for Other 
Payer Advanced APMs as it does for Medicare Advanced APMs, and we 
finalized the same CEHRT use criterion for Other Payer Advanced APMs as 
for Medicare Advanced APMs (81 FR 77463). Likewise, in this rule, we 
proposed to amend the Other Payer Advanced APM criteria at Sec.  
414.1420(b) to conform with the changes we proposed for Medicare 
Advanced APMs, and to be reflected in amendments to Sec.  
414.1415(a)(1)(i), to remove the 75 percent minimum CEHRT use 
requirement for Advanced APMs, and replace it with a more flexible 
CEHRT use requirement based on our revised definition of CEHRT for 
purposes of Advanced APM determinations. We also proposed to revise 
Sec.  414.1420(b) by making additional non-substantive technical edits 
to improve clarity.
    The changes we proposed for Medicare Advanced APMs are designed to 
require use of technologically sufficient EHRs consistent with the ONC 
Base EHR definition at 45 CFR 170.102, while affording Advanced APMs 
the ability to tailor additional CEHRT use requirements to those 
features or capabilities that are clinically relevant to the APM and 
its participants. We believe that this same flexibility should be 
afforded in the context of Other Payer Advanced APMs. The All-Payer 
Combination Option through which we consider the participation of 
eligible clinicians in Other Payer Advanced APMs offers an additional 
pathway to achieve QP status for eligible clinicians participating in 
both Medicare Advanced APMs and Other Payer Advanced APMs. Under the 
All-Payer Combination Option, we consider the combined participation of 
eligible clinicians in Medicare and Other Payer Advanced APMs. Similar 
to the statutory CEHRT use requirement for Advanced APMs under section 
1833(z)(3)(D)(i)(I) of the Act, section 1833(z)(2)(iii)(II)(bb) of the 
Act specifies that Other Payer Advanced APMs are those under which 
CEHRT is used. Since the All-Payer Combination Option for QP 
determinations involves the same eligible clinician as the Medicare 
Option and, considers their participation in both Medicare Advanced 
APMs and Other Payer Advanced APMs, we believe we should continue to 
apply the same CEHRT use standard for both Medicare and Other Payer 
Advanced APMs. Further, we believe the same need exists for flexibility 
in the CEHRT that is required to be used in Other Payer Advanced APMs. 
This will allow Other Payer Advanced APMs to structure their CEHRT use 
requirements to be clinically relevant to the APM and participating 
eligible clinicians and avoid the need for participants to obtain 
clinically unnecessary technology simply for purposes of meeting what 
we now believe to be an overly restrictive CEHRT use criterion.
    We sought comment on this proposal.
    We did not receive public comments on this provision. However, one 
key goal of ours in implementation of Medicare Advanced APM and Other 
Payer Advanced APM policies is to align them wherever appropriate, and 
with that alignment in mind, because we are delaying the removal of the 
75 percent threshold for Medicare Advanced APMs, and we also are 
finalizing the Other Payer Advanced APM proposal with a one-year delay. 
As such, we are finalizing that the conforming changes we proposed in 
Sec.  414.1420(b) to remove the 75 percent CEHRT use threshold and 
instead require the use of CEHRT will be finalized with an effective 
date of QP Performance Period 2025. We note that because the definition 
for CEHRT at 414.1305 will be finalized as proposed, the more flexible 
definition will be in place for Other Payer Advanced APMs, as well as 
for Medicare Advanced APMs.

V. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et 
seq.), we are required to publish a 60-day notice in the Federal 
Register and solicit public comment before a ``collection of 
information'' requirement is submitted to the Office of Management and 
Budget (OMB) for review and approval. For the purposes of the PRA and 
this section of the preamble, collection of information is defined 
under 5 CFR 1320.3(c) of the PRA's implementing regulations.
    To fairly evaluate whether an information collection should be 
approved by OMB, PRA section 3506(c)(2)(A) requires that we solicit 
comment on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our burden estimates.
     The quality, utility, and clarity of the information to be 
collected.
     Our effort to minimize the information collection burden 
on the affected public, including the use of automated collection 
techniques.
    We solicited public comment on each of these issues for the 
following sections of this document that contain information collection 
requirements.
    Comments received are summarized under each relevant section.

A. Wage Estimates

    Private Sector: To derive average costs, we used data from the U.S. 
Bureau of Labor Statistics' (BLS) May 2022 National Occupational 
Employment and Wage Estimates for all salary estimates (https://www.bls.gov/oes/2022/oes_nat.htm). In this regard, Table 62 presents 
BLS' mean hourly wage, our estimated cost of fringe benefits and other 
indirect costs (calculated at 100 percent of salary), and our adjusted 
hourly wage. There are many sources of variance in the average cost 
estimates, both because fringe benefits and other indirect costs vary 
significantly from employer to employer, and because methods of 
estimating these costs vary widely from study to study. Therefore, we 
believe that doubling the hourly wage to estimate total cost is a 
reasonably accurate estimation method.

[[Page 79415]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.093

    For our purposes, BLS' May 2022 National Occupational Employment 
and Wage Estimates does not provide an occupation that we could use for 
``Physician'' wage data. To estimate a Physician's costs, we are using 
an average conglomerate wage of $274.44/hr as demonstrated below in 
Table 63.
[GRAPHIC] [TIFF OMITTED] TR16NO23.094

    Beneficiaries: We believe that the cost for beneficiaries 
undertaking administrative and other tasks on their own time is a post-
tax wage of $21.98/hr.
    The Valuing Time in U.S. Department of Health and Human Services 
Regulatory Impact Analyses: Conceptual

[[Page 79416]]

Framework and Best Practices \505\ identifies the approach for valuing 
time when individuals undertake activities on their own time. To derive 
the costs for beneficiaries, a measurement of the usual weekly earnings 
of wage and salary workers of $1,059 \506\ for 2022, divided by 40 
hours to calculate an hourly pre-tax wage rate of $26.48/hr. This rate 
is adjusted downwards by an estimate of the effective tax rate for 
median income households of about 17 percent or $4.50/hr ($26.48/hr x 
0.17), resulting in the post-tax hourly wage rate of $21.98/hr ($26.48/
hr-$4.50/hr). Unlike our State and private sector wage adjustments, we 
are not adjusting beneficiary wages for fringe benefits and other 
indirect costs since the individuals' activities, if any, would occur 
outside the scope of their employment.
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B. Information Collection Requirements (ICRs)

1. ICRs Requiring Manufacturers of Certain Single-Dose Container or 
Single-Use Package Drugs To Provide Refunds With Respect To Discarded 
Amounts (Sec.  414.940)
    The following changes will be submitted to OMB for approval under 
control number 0938-1435 (CMS-10835).
    As discussed in section III.A. of this final rule, as a part of 
implementing section 1847A(h) of the Act, as added by section 90004 of 
the Infrastructure Act, the Secretary is authorized to recognize, 
through notice and comment rulemaking, drugs with unique circumstances 
that justify an increase of the applicable percentage greater than 10 
percent. In section III.A.3.d of this final rule, we finalized 
modifications to Sec.  414.940 to establish an application process for 
drug manufacturers to request an increased applicable percentage for an 
individual drug product based on its unique circumstances.
    To request we consider increasing the applicable percentage for a 
particular refundable drug, a manufacturer must submit the following: 
(1) a written request that a drug be considered for an increased 
applicable percentage based on its unique circumstances; (2) FDA-
approved labeling for the drug, or, if the drug is not yet approved, 
documentation of the FDA acceptance or filing of the NDA or BLA 
submission; (3) justification for the consideration of an increased 
applicable percentage based on such unique circumstances; and (4) 
justification for the requested increase in the applicable percentage. 
Such justification can include documents, such as (but not limited to) 
a minimum vial fill volume study or a dose preparation study. We are 
also finalizing that for manufacturers that do not have FDA approval 
for their product by February 1, the product must be FDA-approved label 
by August 1 and the manufacturer must notify and submit the approved 
labeling to CMS no later than September 1 for their application to be 
complete and eligible for consideration for an increased applicable 
percentage based on unique circumstances.
    As discussed in section VI.E.4. of this final rule, our estimates 
show a projected 27 billing and payment codes meeting the definition of 
refundable single-dose container or single-use package drug with more 
discarded units than their respective applicable percentage, (that is, 
10 percent for those not increased through rulemaking, as specified in 
section 1847A(h)(3) of the Act, or 26, 45, or 90 percent, as finalized 
in section III.A. for certain drugs). Therefore, we anticipate a 
similar number of drugs could owe a refund under section 90004 of the 
Infrastructure Act. Since 22 of those billing codes have an estimated 
annual refund obligation of over $50,000, we expect that, initially 
(that is, the first year the application process is available), the 
manufacturers of those 22 drugs to submit an application for 
consideration of an increased applicable percentage based on unique 
circumstances.
    Once a manufacturer has applied for a drug and a decision has been 
made regarding whether an increased applicable percentage is 
appropriate, the manufacturer will not need to apply again. We clarify 
in section III.A. of this final rule, that unique circumstances and 
increased applicable percentage for an individual drug, once finalized 
through rulemaking, are permanent, unless modified through subsequent 
rulemaking. Therefore, subsequent years we will expect a smaller number 
of applications. When evaluating the approval dates of these 22 drugs, 
we find that there is a range of 0 to 4 drugs per year approved that 
will be expected to owe a refund of more than $50,000 per year. From 
2010 through 2020, the mean number of such approvals is 1.45 per year. 
Rounding that figure up, we estimate that we will typically receive 2 
applications per year subsequent to the initial application year.
    We estimate that the burden per respondent/applicant of drafting 
and submitting the unique circumstance application to be 5 hours. As we 
anticipate no more than 22 applications in the initial year that 
applications are available, we estimate a one-time first year burden of 
110 hours (22 applications x 5 hr) at a cost of $4,591 ($41.74/hr x 110 
hr). For subsequent years, we estimate an annual burden of 10 hours (2 
applications x 5 hr per respondent/applicant) at a cost of $418 
($41.74/hr x 10 hr).
2. ICRs Regarding the Clinical Laboratory Fee Schedule: Data Reporting 
by Laboratories
    As described in section III.D. of this final rule, under the 
Clinical Laboratory Fee Schedule, ``reporting entities'' must report to 
CMS during a ``data reporting period'' ``applicable information'' 
collected during a ``data collection period'' for their component 
``applicable laboratories,'' and we revised the regulations at Sec.  
414.504(a)(1) to account for a delay in reporting until January 1, 2024 
through March 31, 2024. As stated in section 1834A(h)(2) of the Act, 
chapter 35 of title 44 U.S.C., which includes such provisions as the 
PRA does not apply to information collected under section 1834A of the 
Act. Consequently, we are not setting out any requirements or burden 
for public review and OMB approval as prescribed under the PRA. Please 
refer to section VI.E.7. of this final rule for a discussion of the 
impacts associated with the changes described in section III.D. of this 
final rule.
3. ICRs Regarding the Medicare Shared Savings Program
    Section 1899(e) of the Act provides that chapter 35 of title 44 of 
the U.S.C., which includes such provisions as the PRA, shall not apply 
to the Shared Savings Program. Accordingly, we are not setting out 
Shared Savings Program burden estimates under this section of the 
preamble. Please refer to section VI.E.10. of this final rule for a 
discussion of the impacts associated with the changes to the Shared 
Savings Program as described in section III.G. of this final rule.
4. ICRs Regarding the Updates to the Medicare Diabetes Prevention 
Program
    In section III.L. of this final rule, we finalized the proposed 
policy to extend specific Medicare Diabetes Prevention Program (MDPP) 
flexibilities allowed during the PHE for the COVID-19 1135 waiver event 
by 4 years. In addition, we finalized the policies necessary to update 
the MDPP payment structure to pay for beneficiary attendance on a fee-
for-service basis while retaining the

[[Page 79417]]

diabetes risk reduction performance payments. Finally, we are 
finalizing the provision to remove the requirement for MDPP interim 
preliminary recognition and replace it with CDC preliminary recognition 
as well as remove most references to, and requirements of, the Ongoing 
Maintenance Sessions given that eligibility for these services will end 
on December 31, 2023. We expect the policies will increase the number 
of eligible organizations willing to enroll as MDPP suppliers. We also 
anticipate that the extended PHE flexibilities will make MDPP more 
marketable to both suppliers and beneficiaries due to the continued 
flexibility in how the MDPP set of services are delivered live, either 
in-person or virtually (or a combination of the two). We anticipate the 
payment structure changes will motivate suppliers to retain 
participants due to more frequent payments. Section 1115A(d)(3) of the 
Act exempts Innovation Center model tests and expansions, which include 
the MDPP expanded model, from the provisions of the PRA. Accordingly, 
this collection of information section does not set out any burden for 
the provisions.
5. Appropriate Use Criteria for Advanced Diagnostic Imaging
    As discussed in section III.J. of this final rule, we are 
finalizing our proposal to pause efforts to implement the Appropriate 
Use Criteria (AUC) for Advanced Diagnostic Imaging Services program for 
reevaluation and to rescind and reserve for future use the current AUC 
program regulations at Sec.  414.94. The program was established in the 
Protecting Access to Medicare Act of 2014 (PAMA) and we have used 
rulemaking over the ensuing years to stand up the program in phases 
while aiming for a clinically useful and least provider-burdensome 
approach. At this time, we have exhausted all reasonable options for 
fully operationalizing the AUC program consistent with the statutory 
provisions as prescribed in section 1834(q)(B) of the Act directing CMS 
to require real-time claims-based reporting to collect information on 
AUC consultation and imaging patterns for advanced diagnostic imaging 
services to ultimately inform outlier identification and prior 
authorization. As a result, we have determined in section III.J. of 
this final rule to pause implementation of the AUC program for 
reevaluation and rescind the current AUC program regulations from Sec.  
414.94.
    The following collection of information requests are affected by 
this rule's final decision to rescind the AUC program regulations from 
Sec.  414.94: CMS-10570 (OMB 0938-1288), CMS-10624 (OMB 0938-1315), and 
CMS-10654 (OMB 0938-1345). Given that the AUC program regulations, 
which include these information collection requirements, will be 
rescinded, all three collections are no longer needed.
    CMS-10570 (OMB 0938-1288) relates to the application and 
qualification process for provider-led entities (PLEs). Since we are 
finalizing the proposal and will rescind the AUC regulations at Sec.  
414.94, we are discontinuing this collection of information. Table 64 
scores the impact of discontinuing the requirements and burden that are 
currently active and approved by OMB under the aforementioned control 
number, showing an expected 10 re-applications per year. We note 
however, that because we received less than 10 applicants in each year 
2017-2022, there have been and will continue to be fewer than 10 re-
applicants each year. In fact, the number of PLEs has overall decreased 
as qualified PLEs exit the program, choosing not to re-apply. In 2022 
we expected all seven PLEs approved in 2017 to reapply; however, only 
two submitted re-applications and were re-qualified. For 2023, we froze 
the re-application process, continuing the approval of the three PLEs 
that had initially qualified in 2018. If we were not pausing the AUC 
program and rescinding the current regulations at Sec.  414.94, then we 
would expect one re-application in 2024 and no re-applications in 2025.
    At the time of the last approval in 2021, we expected the burden 
for PLEs re-applying for qualification to be half the burden of the 
initial application process. In the explanation below, we continue to 
use the previously approved number of responses, respondents and time, 
while updating the labor cost to reflect May 2022 BLS wages. As 
previously estimated, the PLEs would be able to make modifications to 
their original application which should result in a burden of 10 hours 
at $80.08/hr for a business operations specialist (occupation code 13-
100) to compile, prepare and submit the required information, 2.5 hours 
at $123.06/hr for a medical and health services manager (occupation 
code 11-911) to review and approve the submission, and 2.5 hours at 
$242.3/hr for a physician (occupation code 29-1210) to review and 
approve the submission materials. Annually, we estimate 15 hours per 
submission at a cost of $1,714.2 per organization. In aggregate, we 
estimate 150 hours (15 hr x 10 submissions) at $17,142 ($1,714 x 10 
submissions).
[GRAPHIC] [TIFF OMITTED] TR16NO23.095

    CMS-10624 (OMB 0938-1315) relates to the application and 
qualification process for Clinical Decision Support Mechanisms (CDSMs). 
This collection of information is no longer active. CMS-10624 was first 
approved on March 6, 2017, and was associated with the CY 2017 
Physician Fee Schedule final rule (November 15, 2016; 81 FR 80170). 
CMS-10624 last expired on March 31, 2020. In June 2020, CMS filed a 
request to discontinue CMS-10624 (OMB 0938-1315).
    CMS-10654 (OMB 0938-1345) relates to the consultation of AUC 
through a qualified CDSM by an ordering professional or clinical staff 
acting under the direction of the ordering professional. While this 
collection of information is no longer active, the impact of 
discontinuing the requirements and burden is addressed in this final 
rule RIA (see section VII.

[[Page 79418]]

Regulatory Impact Analysis of this final rule).
6. ICRs for Medicare Provider and Supplier Enrollment
    None of this rule's Medicare and Medicaid provider enrollment 
provisions include any new, revised, or removed information collection 
requirements or burden. Regarding the finalization of our policy to 
reduce the timeframe for reporting practice location changes from 90 
days to 30 days, this change will not alter the requirement for 
disclosing the change via the applicable Form CMS-855 or Form CMS-
20134. It will only revise the timeframe in which the change must be 
reported. Hence, there will be no change in the ICR burden.
7. ICRs Regarding the Medicare Ground Ambulance Data Collection System 
(GADCS) (Sec.  414.626)
    Section 1834(l)(17) of the Act requires that the Secretary develop 
a ground ambulance data collection system that collects cost, revenue, 
utilization, and other information determined appropriate by the 
Secretary with respect to providers of services and suppliers of ground 
ambulance services (ground ambulance organizations). Section 
1834(l)(17)(I) of the Act states that the PRA does not apply to the 
collection of information required under section 1834(l)(17) of the 
Act. Accordingly, we did not set out any burden estimates under this 
section of the rule.
    We did not receive any public comments on our claim that the 
provision is exempt from the PRA and are finalizing that claim as 
proposed.
8. ICRs Related to the Changes in the RHC/FQHC CfCs and Hospice CoPs
a. Permitting MFT and MHCs to Furnish Services in RHC/FQHCs
    The following changes will be submitted to OMB for approval under 
control number 0938-0344 (CMS-R-38).
    In section III.C. of this final rule, we implement section 4121 of 
the CAA by conforming changes at Sec.  491.8(a)(3) and (6) that would 
add MFT and MHCs to the list of staff who may be the owner or an 
employee of the clinic or center or may furnish services under contract 
to the clinic or center as well as included as staff available to 
furnish patient care services at all times the clinic or center 
operates. If an RHC or FQHC provides services furnished by an MFT or 
MHC, they will be required to update their patient care policy, as set 
out in section Sec.  491.9(b)(2) of the CfCs.
    The existing requirement at Sec.  491.9(b)(2), Patient care 
policies, requires that policies are developed with the advice of a 
group of professional personnel that includes one or more physicians 
and one or more physician assistants or nurse practitioners, with at 
least one member who is not a member of the clinic or center staff. The 
patient care policies must describe the services the clinic or center 
furnishes directly, through agreement or arrangement, guidelines for 
medical management of health problems, and rules for the storage, 
handling, and administration of drugs and biologicals.
    As we proposed to include MFTs and MHCs as professionals who can 
provide services in an RHC and FQHC, there will be a burden associated 
with the existing requirement at Sec.  491.9(b)(3)(i). This requirement 
states that policies include ``A description of the services they 
provide directly or through agreement or arrangement.'' Therefore, if 
an RHC or FQHC provides services furnished by an MFT or MHC they must 
update their policies to include a description of the services 
provided.
    We note that the time and effort required to conduct this activity 
will vary depending on if a clinic or center chooses to provide 
services furnished by an MFT or MHC. We also believe that some RHCs and 
FQHCs may already provide services furnished by an MFT or MHC. State 
Medicaid programs can cover ambulatory care services (including mental 
health and substance use disorder services) under a number of different 
mandatory Medicaid benefits such as outpatient hospital services, 
physician services, RHC and FQHC services, as well as optional benefits 
such as rehabilitative services, and services of other licensed 
practitioners.
    The National Association of Community Health Center's 2017 policy 
assessment suggests that 21 State Medicaid programs cover services 
provided by MFTs, and 25 State Medicaid programs cover services 
provided by licensed professional counselors.\507\ Due to approximately 
half of the State's Medicaid programs already covering services 
furnished by an MFT or MHC and the assumption that some centers and 
clinics will not provide these services, we believe only 50 percent of 
RHCs and 50 percent of FQHCs will incur this burden. The total RHCs and 
FQHCs who will have to meet this 1-time burden is 2,643 clinics and 
5,643 centers, or 8,286 combined.508 509
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    Each clinic or center is required by the existing requirement at 
Sec.  491.9(b)(2) to have at least one physician/administrator at 
$274.44/hr and one advanced practice provider (nurse practitioner or 
physician assistant) at $120.17/hr ($119.88 + $120.46/2) reviewing and 
updating the policies. We estimate that it takes existing RHCs and 
FQHCs 4 hours every 2 years for clinical staff to review and make 
changes to all patient care policies. Based on this, we estimate that 
adding MFT and MHC services (as necessary) to the patient care policies 
would take approximately 15 minutes (0.25 hr) for each clinical 
professional. In aggregate, we estimate an annual burden of 4,143 hours 
(0.50 hr x 8,268 RHC and FQHCs) at a cost of $817,631.92 [(2,072 hr x 
$274.44/hr) + (2,072/hr x $120.17/hr)].
    We did not receive public comments on this provision; and 
therefore, we are finalizing as proposed.
b. ICRs Related to Permitting MFTs and MHCs To Serve as Members of the 
Interdisciplinary Group (IDG) in Hospices (Sec.  418.56 and Sec.  
418.114)
    In section III.O. of this final rule, we will implement subtitle C, 
section 4121 of the CAA 2023 by conforming changes at Sec.  
418.56(a)(1)(iii) that will permit MFTs or MHCs, in addition to social 
workers, to serve as members of the IDG. The conforming change will 
require hospices to include one SW, MFT or MHC to serve as a member of 
the IDG. Hospices will have the flexibility to determine which 
discipline(s) are appropriate to serve on the IDG. We believe that with 
the introduction of MFT and MHC into the hospice CoPs, it is important 
to include these new disciplines into the personnel qualifications at 
Sec.  418.114.
    In this rule we also proposed to add both MFT and MHC to the 
provider requirements under 42 CFR subpart B (Medical and Other Health 
Services) at Sec. Sec.  410.53 and 410.54. Therefore, to avoid 
duplication and confusion between the CoP and the provider requirements 
under the Medical and Other Health Services provision, we proposed to 
add both MFT and MHC to the requirements at Sec.  418.114(b)(9) and 
(10) and referencing the new requirement at Sec. Sec.  410.53 and 
410.54, respectively.

[[Page 79419]]

    In accordance with the implementing regulations of the PRA at 5 CFR 
1320.3(b)(2), we believe that both the existing requirements and the 
revisions to the requirements at Sec. Sec.  418.56(a)(iii) and 
418.114(b)(9) and (10) are exempt from the PRA. We believe permitting 
hospices the ability to select one of these disciplines (SW, MFT or 
MHC) to serve as a member of the IDG and the addition of both MFT and 
MHC to the personnel requirements with reference to the new requirement 
at Sec. Sec.  410.53 and 410.54 respectively, is reasonable and 
customary business practice. We state such in the information 
collection request that is currently approved under OMB control number: 
0938-1067 ((CMS-10277). Therefore, we did not propose to seek OMB's 
approval for any information collection or recordkeeping activities 
that may be conducted in connection with the revisions to Sec. Sec.  
418.56(a)(1)(iii) and 418.114(b)(9) and (10), but we requested public 
comment on our determination that the time and effort necessary to 
comply with these evaluation requirements is usual and customary and 
this time and effort would be incurred by hospice staff even absent 
this regulatory requirement.
    The following is a summary of the comments we received and our 
responses.
    Comment: A commenter questioned if the hospice would need to 
document how a decision was made to assign the MFT, MHC, or SW to the 
patients IDG. They also stated that this may cause additional 
administrative burden if hospices are required to prove how they chose 
the MFT, MHC or SW to serve on the patients IDG.
    Response: We appreciate the clarification question on how the IDG 
is to show the decision on which provider (MFT, MHC, or SW) to serve as 
a member of the patients IDG. We have removed the proposed requirement 
``depending on the needs and preferences of the patient'', Therefore, 
the hospice will not be required to show the decision on which provider 
(MFT, MHC, or SW) would serve as a member of the patients IDG. It is 
important for the hospice to assess and determine, along with the input 
from the patient and family, which care and services best align with 
the needs of the patient. Therefore, we expect that the hospice would 
include the patient's needs as part of the patient assessment and care 
planning process. This information would be included in the patients' 
medical record and discussed at the IDG team meeting just as other 
important care aspects are discussed and documented by the IDG, 
including any changes to care delivery. We believe the IDG 
documentation is reasonable and customary business practice, therefore 
no additional burden on the provider.
    After consideration of public comments on this provision, we are 
finalizing Sec.  418.56 with one modification of the proposed language. 
We are deleting ``depending on the needs and preferences of the 
patient.'' The inclusion of an MFT and MHC as members of the hospice 
IDG helps to accommodate the patient's needs. We believe that this 
action strengthens our response to the need for increased access to 
behavioral and mental health services.
9. RFI: Histopathology, Cytology, and Clinical Cytogenetics Regulations 
Under the Clinical Laboratory Improvement Amendments (CLIA) of 1988
    Please note that this is an RFI only. In accordance with the 
implementing regulations of the Paperwork Reduction Act of 1995 (PRA), 
specifically 5 CFR 1320.3(h)(4), this general solicitation is exempt 
from the PRA. Facts or opinions submitted in response to general 
solicitations of comments from the public, published in the Federal 
Register or other publications, regardless of the form or format 
thereof, provided that no person is required to supply specific 
information pertaining to the commenter, other than that necessary for 
self-identification, as a condition of the agency's full consideration, 
are not generally considered information collections and therefore not 
subject to the PRA.
    This RFI is issued solely for information and planning purposes; it 
does not constitute a Request for Proposal, applications, proposal 
abstracts, or quotations. This RFI does not commit the U.S. Government 
to contract for any supplies or services or make a grant award. 
Further, we did not seek proposals through this RFI and will not accept 
unsolicited proposals. Responders are advised that the U.S. Government 
will not pay for any information or administrative costs incurred in 
response to this RFI; all costs associated with responding to this RFI 
will be solely at the interested party's expense. We noted that not 
responding to this RFI does not preclude participation in any future 
procurement, if conducted. It is the responsibility of the potential 
responders to monitor this RFI announcement for additional information 
pertaining to this request. In addition, we noted that we will not 
respond to questions about the policy issues raised in this RFI.
    We will actively consider all input as we develop future regulatory 
proposals or future subregulatory policy guidance. We may or may not 
choose to contact individual responders. Such communications would be 
for the sole purpose of clarifying statements in the responders' 
written responses. Contractor support personnel may be used to review 
responses to this RFI. Responses to this notice are not offers and 
cannot be accepted by the U.S. Government to form a binding contract or 
issue a grant. Information obtained as a result of this RFI may be used 
by the Government for program planning on a non-attribution basis. 
Respondents should not include any information that might be considered 
proprietary or confidential. This RFI should not be construed as a 
commitment or authorization to incur cost for which reimbursement will 
be required or sought. All submissions become U.S. Government property 
and will not be returned.
10. Basic Health Program (BHP) Provisions
a. Information Collection Requirements (ICRs)
    We did not receive any public comments on the collection of 
information requirements for the BHP provisions; and therefore, we are 
finalizing as proposed. The following finalized provisions will be 
submitted to OMB for approval under OMB control number 0938-1218 (CMS-
10510).
(1) ICRs Regarding the BHP Blueprint (Sec.  600.125)
    We finalized at Sec.  600.125(a)(1) through (3) that Blueprint 
revisions must be submitted to reflect: (1) changes in Federal laws, 
regulations, policy interpretations or court decisions that affect 
provisions in the certified Blueprint; (2) significant changes that 
alter core program operations or the BHP benefit package; or (3) 
changes to enrollment, disenrollment, and verification policies 
described in the certified Blueprint. We noted that only Sec.  
600.125(a)(1) is a new requirement. The requirements under Sec.  
600.125(a)(2) and (3) are existing. We finalized at Sec.  600.125(b) 
that a State may submit revisions to its certified Blueprint at any 
time within the same quarter of the proposed effective date of revised 
Blueprint. We finalized at Sec.  600.125(c) that HHS must review the 
revised Blueprint within 90 calendar days or provide the State written 
notice of disapproval or additional information it needs to make a 
final determination.
    We estimated that, on average, a State operating a BHP will submit 
one revised Blueprint in response to Sec.  600.125(a)(1)

[[Page 79420]]

annually. Because only two States are currently certified to operate a 
BHP, we provided the burden estimate for two States. We estimated that 
the provision under Sec.  600.125(a)(1) will increase State burden. We 
estimated that the provisions under Sec.  600.125(b) and (c) will have 
no impact on State burden. We estimated that, on average, it will take 
a State 4 additional hours at $80.08/hr for a Business Operations 
Specialist and 2 additional hours at $118.14/hr for a General Manager 
to meet the new Blueprint requirements under Sec.  600.125(a)(1). In 
aggregate, we estimated an increased burden of 12 hours (2 States x 6 
hr/State) at a cost of $1,113 [2 States x ((4 hr x $80.08/hr) + (2 hr x 
$118.14/hr))]. We noted that this cost will be incurred 100 percent by 
the State, as Federal BHP funds cannot be used for program 
administration.
(2) ICRs Regarding the Operation of a BHP (Sec. Sec.  600.145(a), 
600.145(f)(2), and 600.330(f))
    We finalized at Sec.  600.145(a) that a State must implement its 
BHP in accordance with: (1) the approved and full certified State BHP 
Blueprint; or (2) the approved suspension application (see ICR section 
3 below).
    We finalized at Sec.  600.145(f)(2) that the State operating a BHP 
must perform eligibility and health services appeals as specified in 
Sec.  600.335.
    The ongoing burden associated with the requirements under Sec.  
600.145 is the time and effort it would take each participating State 
to perform the recordkeeping and reporting portions of the core 
operating functions of a BHP including eligibility determinations and 
appeals as well as enrollment and disenrollment, health plan 
contracting, oversight and financial integrity, consumer assistance, 
and if necessary program termination or suspension.
    Because only two States are currently certified to operate a BHP, 
we provided the burden estimate for two States. We estimated that it 
would take a business operations specialist 4 additional hours at 
$80.08/hr to meet these new recordkeeping and reporting requirements 
for health services appeals. In aggregate, we estimated an increased 
burden of 8 hours (2 States x 4 hr/response) at a cost of $641 (2 
States x 4 hr x $80.08/hr). We noted that this cost will be incurred 
100 percent by the State, as Federal BHP funds cannot be used for 
program administration.
    We finalized at Sec.  600.330(f), BHP eligibility notices must be 
written in plain language and be provided in a manner which ensures 
individuals with disabilities are provided with effective communication 
and takes steps to provide meaningful access to eligible individuals 
with limited English proficiency. These notices must be developed and 
processed in a coordinated fashion with other insurance affordability 
programs which have the same accessibility standards at 45 CFR 
155.230(b). As such, we estimated no additional burden for the BHP for 
the noticing requirement.
(3) ICRs Regarding Suspension of a BHP (Sec. Sec.  600.140(b) and 
600.170(a)(2))
    We finalized at Sec.  600.140(b)(1) if a State decides to suspend 
its BHP or requests a suspension extension, a State must submit to the 
Secretary a suspension application or suspension extension application. 
We finalized at Sec.  600.140(b)(3) that a State must submit written 
notices to all BHP enrollees and participating standard health plan 
offers at least 90 days prior to the effective date of the suspension. 
We finalized at Sec.  600.140(b)(4) that the State must submit to HHS 
within 12 months of the suspension effective date the data required by 
Sec.  600.610 needed to complete the financial reconciliation process 
with HHS. We finalized at Sec.  600.140(b)(5) that the State must 
submit the annual report required by Sec.  600.170(a)(2). We finalized 
at Sec.  600.140(b)(6) that the State must annually remit to HHS any 
interest that has accrued on the balance of the BHP trust fund during 
the suspension period. We finalized at Sec.  600.140(b)(7) that the 
State must submit a transition plan to HHS that describes how the State 
will reinstate its BHP or terminate the program.
    Two States are currently certified to operate a BHP; therefore, we 
provided the burden estimate for two States.
    We estimated that, on average, it will take a Business Operations 
Specialist 30 hours at $80.08/hr and a General Manager 4 hours at 
$118.14/hr to submit a suspension application to the Secretary. In 
aggregate, we estimated a one-time burden of 68 hours (2 States x 34 
hr/response) at a cost of $5,780 [2 States x ((30 hr x $80.08/hr) + (4 
hr x $118.14/hr))]. We estimated that, on average, it will take a 
Business Operations Specialist 30 hours at $80.08/hr and a General 
Manager 4 hours at $118.14/hr to submit a suspension extension 
application to the Secretary. In aggregate, we estimated a one-time 
burden of 68 hours (2 States x 34 hr/response) at a cost of $5,780 [2 
States x ((30 hr x $80.08/hr) + (4 hr x $118.14/hr))].
    We estimated that, on average, it will take a Business Operations 
Specialist 32 hours at $80.08/hr to prepare and submit notification to 
all participating standard health plans and enrollees. In aggregate, we 
estimated a one-time burden of 64 hours (2 States x 32 hr/response) at 
a cost of $5,125 [2 States x (32 hr x $80.08/hr)].
    We estimated that it would take a Business Operations Specialist 25 
hours at $80.08/hr and a General Manager 4 hours at $118.14/hr to 
compile and submit data required for quarterly financial 
reconciliation. In aggregate, we estimated an annual burden of 232 
hours (2 States x 29 hr/response x 4 responses/yr) at a cost of $19,796 
[2 States x 4 responses/yr ((25 hr x $80.08/hr) + (4 hr x $118.14/hr)).
    We estimated that, on average, it will take a Financial Specialist 
8 hours at $88.74/hr to remit annually the interest accrued on the 
balance of the BHP trust fund while in suspension. In aggregate, we 
estimated an annual burden of 16 hours (2 States x 8 hr/response) at a 
cost of $1,420 [2 States x (8 hr x $88.74/hr)].
    We estimated that it will take a Business Operations Specialist 20 
hours at $80.08/hr and a General Manager 4 hours at $118.14/hr to 
submit a transition plan to reinstate its BHP or terminate the program. 
In aggregate, we estimated a one-time burden of 48 hours (2 States x 24 
hr/response) at a cost of $4,148 [2 States x ((20 hr x $80.08/hr) + (4 
hr x $118.14/hr))].
    We estimated that, on average, it will take a Business Operations 
Specialist 40 hours at $80.08/hr and 4 hours at $118.14/hr for a 
General Manager to complete and submit the State's annual report, for a 
total annual burden of 88 hours at a cost of $7,352 [2 States x ((40 hr 
x $80.08/hr) + (4 hr x $118.14/hr))]. We noted that these costs will be 
incurred 100 percent by the State, as Federal BHP funds cannot be used 
for program administration.
b. Burden Summary
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11. The Quality Payment Program (QPP) (42 CFR Part 414 and Section IV. 
of This Final Rule)
    The following QPP-specific ICRs reflect changes to our currently 
approved burden due to policy changes in this CY 2024 final rule as 
well as adjustments to the policies that have been previously finalized 
in the CY 2017 and CY 2018 Quality Payment Program final rules (81 FR 
77008 and 82 FR 53568, respectively), CY 2019, CY 2020, CY 2021, CY 
2022, and CY 2023 PFS final rules (83 FR 59452, 84 FR 62568, 85 FR 
84472, 86 FR 64996, and 87 FR 70131, respectively) due to revised 
assumptions based on updated data available at the time of the 
publication of this final rule.
a. Background

(1) ICRs Associated With Merit-Based Incentive Payment System (MIPS) 
and Advanced Alternative Payment Models (APMs)

    In the following sections, we discuss a series of ICRs associated 
with the Quality Payment Program, including for MIPS and Advanced APMs. 
The following sections describe the changes in the estimated burden for 
the information collections relevant to the policies discussed in the 
CY 2024 PFS final rule and the revisions to our currently approved 
information requests for MIPS and Advanced APM ICRs. The estimated 
burden will be submitted to OMB under control number 0938-1314 (CMS-
10621). The estimated burden for the CAHPS for MIPS Survey discussed in 
sections V.B.11.c.(5), V.B.11.e.(8), and V.B.11.e.(9) of this rule was 
submitted under OMB control number 0938-1222 (CMS-10450). We noted that 
we have received approvals for the collection of information associated 
the virtual group election process under OMB control number 0938-1343 
(CMS-10652).
(2) Summary of Changes for the Quality Payment Program: MIPS
    We have included the change in the estimated burden for the CY 2024 
performance period/2026 MIPS payment year due to the policies and 
information collections in this final rule. The policies in this final 
rule impact the burden estimates for the CY 2024 performance period/
2026 MIPS payment year.
    The following five MIPS ICRs show changes in burden due to the 
policies in

[[Page 79422]]

this final rule: (1) Quality performance category data submission by 
Medicare Part B claims collection type; (2) Quality performance 
category data submission by qualified clinical data registry (QCDR) and 
MIPS CQM collection type; (3) Quality performance category data 
submission by eCQM collection type; (4) MIPS Value Pathways (MVP) 
quality performance category submission, and (5) MVP registration. In 
aggregate, we estimate the policies will result in a net decrease in 
burden of 4,147 hours and $477,101 for the CY 2024 performance period/
2026 MIPS payment year. The remaining changes to our currently approved 
burden estimates are adjustments due to the revised burden assumptions 
based on the updated data available at the time of publication of this 
final rule. As discussed in section VI.E.23.a.(2) of this final rule, 
we based our estimates on submission data from the CY 2022 performance 
period/2024 MIPS payment year.
    In the CY 2024 PFS proposed rule (88 FR 52636), we proposed to add 
two new ICRs, ``QCDR full self-nomination process'' and ``qualified 
registry full self-nomination process'' to distinctly capture the 
burden for the number of QCDRs and qualified registries submitting 
applications for the simplified and full self-nomination process. We 
noted that the addition of these ICRs is not due to finalizing the 
policies discussed in section IV.A.4.k. of this final rule. It is a 
change in our approach in representing the estimated burden for the 
third-party intermediary self-nomination process due to availability of 
updated data. We discuss the details of these changes in sections 
V.B.11.c.(2) and V.B.11.c.(3) of this final rule.
    We proposed to remove one ICR, ``nomination of Promoting 
Interoperability measures,'' in the CY 2024 PFS proposed rule (88 FR 
52636). We note that the removal of the ICR is not due to finalizing 
the policies discussed in section IV.A.4.f.(4) of this final rule. It 
is due to a consistent decline in the number of submissions received 
for the ICR.
    We did not propose any changes or adjustments to the following ICRs 
(88 FR 52636): Registration for virtual groups; OAuth credentialing and 
token request process; Quality Payment Program identity management 
application process; subgroups registration; nomination of MVPs; and 
opt-out of performance data display on Compare Tools for voluntary 
participants. We note that we have received updated data for this final 
rule and adjusted the estimated burden as applicable. See section 
V.B.11. of this final rule for a summary of the ICRs, the overall 
burden estimates, and a summary of the assumption and data changes 
affecting each ICR.
    The accuracy of our estimates of the total burden for data 
submission under the quality, Promoting Interoperability, and 
improvement activities performance categories may be impacted by two 
primary factors. First, we are unable to predict with absolute 
certainty who will be a Qualifying APM Participant (QP) for the CY 2024 
performance period/2026 MIPS payment year. New eligible clinician 
participants in Advanced APMs who become QPs will be excluded from MIPS 
reporting requirements and payment adjustments, and as such, are 
unlikely to report under MIPS; while some current Advanced APM 
participants may end participation such that the APM Entity's eligible 
clinicians may not be QPs for a year based on Sec.  414.1425(c)(5), and 
thus be required to report under MIPS. Second, it is difficult to 
predict whether Partial QPs, who can elect to report to MIPS, will 
choose to participate in the CY 2024 performance period/2026 MIPS 
payment year compared to the CY 2022 performance period/2024 MIPS 
payment year. Therefore, the actual number of Advanced APM participants 
and how they elect to submit data may be different than our estimates. 
However, we believe our estimates are the most appropriate given the 
available data. Additionally, we will continue to update our estimates 
annually as data becomes available.
(3) Summary of Quality Payment Program Changes: Advanced APMs
    For these ICRs (identified above under, ``ICRs Associated with MIPS 
and Advanced APMs''), we did not implement any changes to currently 
approved burden estimates for the CY 2024 performance period/2026 MIPS 
payment year. Therefore, we did not propose any changes to the Partial 
QP elections; Other Payer Advanced APM identification: Payer Initiated 
and Eligible Clinician Initiated Processes; and submission of Data for 
QP determinations under the All-Payer Combination Option (88 FR 52636).
(4) Framework for Understanding the Burden of MIPS Data Submission
    Because of the wide range of information collection requirements 
under MIPS, Table 67 presents a framework for understanding how the 
organizations permitted or required to submit data on behalf of 
clinicians vary across the types of data, and whether the clinician is 
a MIPS eligible clinician or other eligible clinician voluntarily 
submitting data, MIPS APM participant, or an Advanced APM participant. 
In Table 67, MIPS eligible clinicians and other clinicians voluntarily 
submitting data to MIPS may submit data as individuals, groups, or 
virtual groups for the quality, Promoting Interoperability, and 
improvement activities performance categories. Note that virtual groups 
are subject to the same data submission requirements as groups, and 
therefore, we will refer only to groups for the remainder of this 
section, unless otherwise noted. Beginning with the CY 2023 performance 
period/2025 MIPS payment year, clinicians could also participate as 
subgroups for reporting measures and activities in an MVP. We note that 
the subgroup reporting option is not available for clinicians 
participating in traditional MIPS. We finalized in the CY 2022 PFS 
final rule that a subgroup reporting measures and activities in an MVP 
will submit its affiliated group's data for the Promoting 
Interoperability performance category and in the scenario that a 
subgroup does not submit its affiliated group's data, the subgroup will 
receive a zero score for the Promoting Interoperability performance 
category (86 FR 65413 through 65414).
    Because MIPS eligible clinicians are not required to submit any 
additional information for assessment under the cost performance 
category, the administrative claims data used to calculate the scores 
for the cost performance category is not represented in Table 67.
    For MIPS eligible clinicians participating in MIPS APMs, the 
organizations submitting data on behalf of MIPS eligible clinicians 
will vary between performance categories and, in some instances, 
between MIPS APMs. We previously finalized in the CY 2021 PFS final 
rule that the APM Performance Pathway is available for both Accountable 
Care Organization (ACO) participants and non-ACO participants to submit 
quality data (85 FR 84859 through 84866). Due to data limitations and 
our inability to determine who will use the APM Performance Pathway 
versus the traditional MIPS submission mechanism for the CY 2024 
performance period/2026 MIPS payment year, we assume ACO APM Entities 
will submit data through the APM Performance Pathway, using the CMS Web 
Interface option, and non-ACO APM Entities will participate through 
traditional MIPS, thereby submitting as an individual or group rather 
than as an entity. We also want to note that as finalized in the CY 
2022 PFS final rule (86 FR 65259

[[Page 79423]]

through 65263), the CMS Web Interface collection type is available 
through the CY 2024 performance period/2026 MIPS payment year only for 
clinicians participating in the Shared Savings Program. Per section 
1899(e) of the Act, submissions received from eligible clinicians in 
ACOs are not included in burden estimates for this final rule because 
quality data submissions to fulfill requirements of the Shared Savings 
Program are not subject to the PRA.
    For the Promoting Interoperability performance category, group TINs 
may submit data on behalf of eligible clinicians in MIPS APMs, or 
eligible clinicians in MIPS APMs may submit data individually. 
Additionally, we finalized the introduction of a voluntary reporting 
option for APM Entities to report the Promoting Interoperability 
performance category at the APM Entity level beginning with the CY 2023 
performance period/2025 MIPS payment year (87 FR 70087 and 70088). For 
the improvement activities performance category, we will assume no 
reporting burden for MIPS APM participants. In the CY 2017 Quality 
Payment Program final rule, we established that, for MIPS APMs, we 
compare the requirements of the specific MIPS APM with the list of 
activities in the improvement activities inventory and score those 
activities in the same manner that they are otherwise scored for MIPS 
eligible clinicians (81 FR 77185). Although the policy allows for the 
submission of additional improvement activities if a MIPS APM Entity 
receives less than the maximum improvement activities performance 
category score, to date all MIPS APM Entities have qualified for the 
maximum improvement activities score. Therefore, we assume that no 
additional submission will be needed.
    Eligible clinicians who attain Partial QP status may incur 
additional burden if they elect to participate in MIPS, which is 
discussed in more detail in the CY 2018 Quality Payment Program final 
rule (82 FR 53841 through 53844).
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BILLING CODE 4120-01-C
    The policies finalized in the CY 2017 and CY 2018 Quality Payment 
Program final rules (81 FR 77008 and 82 FR 53568), the CY 2019, CY 
2020, CY 2021, CY 2022, and CY 2023 PFS final rules (83 FR 59452, 84 FR 
62568, 85 FR 84472, 86 FR 64996, and 87 FR 70131), and continued in 
this final rule create some additional data collection requirements not 
listed in Table 67. These additional data collections, some of which 
are currently approved by OMB under the control numbers 0938-1314 
(Quality Payment Program, CMS-

[[Page 79425]]

10621) and 0938-1222 (CAHPS for MIPS, CMS-10450), are as follows:
    Additional ICRs related to MIPS third-party intermediaries (see 
sections V.B.11. c. and V.B.11.d. of this final rule):
     Self-nomination of new and returning QCDRs (81 FR 77507 
through 77508, 82 FR 53906 through 53908, and 83 FR 59998 through 
60000) (OMB 0938-1314).
     Self-nomination of new and returning qualified registries 
(81 FR 77507 through 77508, 82 FR 53906 through 53908, and 83 FR 59997 
through 59998) (OMB 0938-1314)
     Third party intermediary plan audits
     Approval process for new and returning CAHPS for MIPS 
survey vendors (82 FR 53908) (OMB 0938-1222).
     Open Authorization Credentialing and Token Request Process 
(OMB 0938-1314) (85 FR 84969 through 84970).
    Additional ICRs related to the data submission and the quality 
performance category (see section V.B.11.e. of this final rule):
     CAHPS for MIPS survey completion by beneficiaries (81 FR 
77509, 82 FR 53916 through 53917, and 83 FR 60008 through 60009) (OMB 
0938-1222).
     Quality Payment Program Identity Management Application 
Process (82 FR 53914 and 83 FR 60003 through 60004) (OMB 0938-1314).
    Additional ICRs related to the Promoting Interoperability 
performance category (see section V.B.11.g. of this final rule):
     Reweighting Applications for Promoting Interoperability 
and other performance categories (82 FR 53918 and 83 FR 60011 through 
60012) (OMB 0938-1314).
    Additional ICRs related to call for new MIPS measures and 
activities (see sections V.B.11.j, V.B.11.f, V.B.11.k., and V.B.11.h. 
of this final rule):
     Nomination of improvement activities (82 FR 53922 and 83 
FR 60017 through 60018) (OMB 0938-1314).
     Call for MIPS quality measures (83 FR 60010 through 60011) 
(OMB 0938-1314).
     Nomination of MVPs (85 FR 84990 through 84991) (OMB 0938-
1314).
     Nomination of Promoting Interoperability measures (83 FR 
60014 through 60015) (OMB 0938-1314).
    Additional ICRs related to MIPS (see section V.B.11.o. of this 
final rule):
     Opt out of performance data display on Compare Tools for 
voluntary reporters under MIPS (82 FR 53924 through 53925 and 83 FR 
60022) (OMB 0938-1314).
    Additional ICRs related to APMs (see sections V.B.11.m. and 
V.B.11.n. of this final rule):
     Partial QP Election (81 FR 77512 through 77513, 82 FR 
53922 through 53923, and 83 FR 60018 through 60019) (OMB 0938-1314).
     Other Payer Advanced APM determinations: Payer Initiated 
Process (82 FR 53923 through 53924 and 83 FR 60019 through 60020) (OMB 
0938-1314).
     Other Payer Advanced APM determinations: Eligible 
Clinician Initiated Process (82 FR 53924 and 83 FR 60020) (OMB 0938-
1314).
     Submission of Data for All-Payer QP Determinations (83 FR 
60021) (OMB 0938-1314).
b. ICRs Regarding the Virtual Group Election (Sec.  414.1315)
    We did not propose any new or revised collection of information 
requirements or burden related to the virtual group election for the CY 
2024 performance period/2026 MIPS payment year. The virtual group 
election requirements and burden are currently approved by OMB under 
control number 0938-1343 (CMS-10652). Consequently, we are not making 
any changes under that control number.
c. ICRs Regarding Third Party Intermediaries (Sec.  414.1400)
    The following changes will be submitted to OMB for review under 
control number 0938-1314 (CMS-10621). As discussed above in section 
V.B.11.a.(2) of this final rule, we proposed to add two new ICRs, 
``QCDR simplified self-nomination process'' and ``qualified registry 
self-nomination process'', to represent the estimated burden for the 
third party intermediaries submitting applications for the simplified 
self-nomination process. We discuss the details of these changes in the 
below sections.
    As discussed in section IV.A.4.k. of this final rule, we are 
finalizing our proposals to: (1) add requirements for third party 
intermediaries to obtain documentation of their authority to submit on 
behalf of a MIPS eligible clinician, group, virtual group, subgroup, or 
an APM Entity; (2) specify the use of a simplified self-nomination 
process for existing QCDRs and qualified registries; (3) add 
requirements for QCDRs and qualified registries to provide measure 
numbers and identifiers for performance categories; (4) add a 
requirement for QCDRs and qualified registries to attest that 
information contained in the qualified posting about them is correct; 
(5) modify requirements for QCDRs and qualified registries to support 
MVP reporting to increase flexibility for measures supported; (6) 
specify requirements for a transition plan for QCDRs and qualified 
registries withdrawing from the program; (7) specify requirements for 
data validation audits; (8) add additional criteria for rejecting QCDR 
measures; (9) add a requirement for QCDR measure specifications to be 
displayed throughout the performance period and data submission period; 
(9) eliminate the Health IT vendor category; (10) add failure to 
maintain updated contact information as criteria for remedial action; 
(11) revise corrective action plan requirements; (12) allow CMS to 
terminate third-party intermediaries that are on remedial action for 2 
consecutive years; (13) specify the process for publicly posting 
remedial action; and (14) specify the criteria for audits. In the CY 
2024 PFS proposed rule (88 FR 52639), we noted that the policy to 
eliminate the health IT vendor category beginning with the CY 2025 
performance period/2027 MIPS payment year will not have any impact on 
the estimated burden for third party self-nomination process in the CY 
2024 performance period/2026 MIPS payment year. We discussed that the 
removal of health IT vendor category beginning with the CY 2025 
performance period/2027 MIPS payment year could encourage some existing 
health IT vendors to complete the requirements under the qualified 
registry self-nomination process. However, we did not propose any 
adjustments in the number of qualified registries that will submit 
applications for the qualified registry self-nomination process during 
the CY 2024 performance period/2026 MIPS payment year because we 
believe that many third party intermediaries serve as both health IT 
vendors and qualified registries for the purposes of submitting data 
for MIPS eligible clinicians.
    We assume that the changes to codify previously finalized preamble 
language related to third party intermediaries in the regulatory text 
will result in modifying the regulatory text to reflect previously 
finalized policies for third party intermediaries or provide additional 
clarification of the previously finalized policies. We do not expect to 
receive additional information from QCDRs and qualified registries 
during the self-nomination process due to finalizing the above policies 
and therefore, we are not making any adjustments to the currently 
approved burden estimates for third party intermediaries. We refer 
readers to

[[Page 79426]]

section IV.A.4.k. of this rule for additional details on the finalized 
policies for third party intermediaries. Additionally, we refer readers 
to section VI.E.23.e.(2)(a) of this rule where we discuss the details 
in our impact analysis for these policies.
(1) Background
    Under MIPS, the quality, Promoting Interoperability, and 
improvement activities performance category data may be submitted via 
relevant third-party intermediaries, such as qualified registries, 
QCDRs, and health IT vendors. Data on the CAHPS for MIPS survey, which 
counts as either one quality performance category measure, or towards 
an improvement activity, can be submitted via CMS-approved survey 
vendors. Entities seeking approval to submit data on behalf of 
clinicians as a qualified registry, QCDR, or survey vendor must 
complete a self-nomination process annually.\510\ The processes for 
self-nomination of entities seeking approval as qualified registries 
and QCDRs are similar with the exception that QCDRs have the option to 
nominate QCDR measures for approval for the reporting of quality 
performance category data. Therefore, differences between QCDRs and 
qualified registry self-nomination are associated with the preparation 
of QCDR measures for approval.
---------------------------------------------------------------------------

    \510\ As stated in the CY 2019 PFS final rule (83 FR 59998), 
health IT vendors are not included in the burden estimates for MIPS.
---------------------------------------------------------------------------

(2) QCDR Self-Nomination Applications
    As described below in this section, we proposed to separate the 
burden for the number of QCDR self-nomination applications submitted 
for the simplified and full self-nomination process for the CY 2024 
performance period/2026 MIPS payment year (88 FR 52639 through 52642). 
In the CY 2023 PFS final rule (87 FR 70137 through 70139), we used the 
same estimate for the number of respondents that submitted applications 
for the simplified and full self-nomination process because we did not 
have separate estimates at the time. Additionally, we only used the 
burden for the full QCDR self-nomination process in our final burden 
summary estimates. Due to the availability of updated data and the 
distinct number of estimated respondents for the simplified and full 
self-nomination process, we proposed to add a new ICR to capture the 
burden for the simplified QCDR self-nomination process. We note that 
the change in estimated burden is not due to finalizing the policies 
discussed in section IV.A.4.k. of this rule. To accurately represent 
the estimated burden incurred by the QCDRs for the simplified and full 
self-nomination process, we discuss the burden under separate ICRs.
    As discussed later in this section, we are updating our estimates 
for the simplified and full QCDR self-nomination process based on the 
number of applications received during the CY 2023 self-nomination 
period for the CY 2024 performance period/2026 MIPS payment year. 
Specifically, we are updating our estimates for: (1) the number of 
QCDRs that will submit applications under the simplified and full self-
nomination process; (2) the number of measures (existing or borrowed 
and new measures) submitted by a QCDR; (3) the average time required 
for a QCDR to submit the measure information; and (4) the time required 
for the simplified and full QCDR self-nomination process.
    We refer readers to the CY 2017 and CY 2018 Quality Payment Program 
final rules (81 FR 77507 through 77508, and 82 FR 53906 through 53908, 
respectively), and the CY 2019, CY 2020, CY 2021, CY 2022, and CY 2023 
PFS final rules (83 FR 59998 through 60000, 84 FR 63116 through 63121, 
85 FR 84964 through 84969, 86 FR 65569 through 65573, and 87 FR 70138 
through 70139, respectively) for our previously finalized requirements 
and estimated burden for self-nomination of QCDRs and nomination of 
QCDR measures.
(a) Simplified Self-Nomination Process and Other Requirements
    Based on updated data for the number of applications received 
during the CY 2023 QCDR self-nomination period for the CY 2024 
performance period/2026 MIPS payment year, we estimate that 44 existing 
QCDRs will submit applications under the simplified self-nomination 
process. We continue to estimate that each QCDR will submit 12 
measures, on average, however, based on the number of QCDR measure 
submissions received during the CY 2023 QCDR self-nomination period, we 
are adjusting our estimates for the number of new and existing or 
borrowed measures discussed in the CY 2023 PFS final rule (87 FR 
70138). We note that we are not revising or adjusting our estimated per 
response time for a QCDR to submit a new measure (2 hr/response) and an 
existing or borrowed measure (0.5 hr/response). For the QCDRs that 
submit measures for consideration during the self-nomination process, 
we estimate that we will receive approximately 2 new measures and 10 
existing or borrowed measures on average per QCDR. Due to this change, 
we are also adjusting the estimated weighted average time required for 
each QCDR to submit a measure from 0.63 hours to 0.75 hours [((2 new 
measure x 2 hr) + (10 existing or borrowed measures x 0.5 hr))/total # 
of measures (12)]. We note that we are not making any changes to the 
currently approved time of 0.5 hours required for existing QCDRs that 
do not submit measures under the simplified self-nomination process. 
For existing QCDRs that submit measures as part of their self- 
nomination process, due to the estimated decrease in the number of 
existing or borrowed QCDR measures and an increase in the number of new 
QCDR measures submitted with the self-nomination application discussed 
previously in this section, we estimate that it will take 9.5 hours 
[0.5 hr for the simplified self- nomination process + (12 measures x 
0.75 hr/measure for QCDR measure submission)] for a QCDR to submit an 
application under the simplified self-nomination process. We note that 
this will result in an overall increase of 1.4 hours from the estimated 
time the currently approved time of 8.1 hours required for the 
simplified QCDR self-nomination process (87 FR 70139).
    Based on the above assumptions, we provide an estimate of the total 
annual burden associated with a QCDR self-nominating to be considered 
``qualified'' to submit data on behalf of MIPS eligible clinicians.
    As shown in Table 68, we assume that the staff involved in the 
simplified QCDR self-nomination process will continue to be computer 
systems analysts or their equivalent who have an average adjusted labor 
rate of $103.40/hr. We estimate the burden per response will be $982.30 
(9.5 hr x $103.40/hr). In aggregate, for the CY 2024 performance 
period/2026 MIPS payment year, we estimate that the annual burden for 
the simplified QCDR self-nomination process will be 418 hours (44 
responses x 9.5 hr) at a cost of $43,221 (44 applications x $982.30/
application).

[[Page 79427]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.099

    In Table 69, the addition of this new ICR for the CY 2024 
performance period/2026 MIPS payment year will result in an increase of 
418 hours at a cost of $43,221 for the simplified QCDR self-nomination 
process. We note that the increase in burden is due to separating the 
estimated burden for the simplified QCDR self-nomination process.
[GRAPHIC] [TIFF OMITTED] TR16NO23.100

    We did not receive any comments on our proposed requirements and 
burden estimates for the simplified QCDR self-nomination process. We 
note that we adjusted the burden estimates from the CY 2024 PFS 
proposed rule (88 FR 52639 through 52641) due to the availability of 
updated data.
(b) Full QCDR Self-Nomination Process and Other Requirements
    Based on the number of applications that we received during the CY 
2023 self-nomination period for the CY 2024 performance period/2026 
MIPS payment year, we estimate that 12 new QCDRs would submit 
applications under the full self-nomination process. This is a decrease 
of 51 respondents from the currently approved estimate of 63 for the 
QCDR self-nomination process (87 FR 70139). We continue to estimate 
that each QCDR will submit 12 measures, on average, however, based on 
the number of QCDR measure submissions received during the CY 2023 QCDR 
self-nomination period, we are adjusting our estimates for the number 
of new and existing or borrowed measures discussed in the CY 2023 PFS 
final rule (87 FR 70138). We note that we are not revising or adjusting 
our estimated per response time for a QCDR to submit a new measure (2 
hr/response) and an existing or borrowed measure (0.5 hr/response). For 
the QCDRs that submit measures for consideration during the self-
nomination process, we estimate that we will receive approximately 2 
new measures and 10 existing or borrowed measures on average per QCDR. 
Due to this change, we are also adjusting the estimated weighted 
average time required for each QCDR to submit a measure from 0.63 hours 
to 0.75 hours [((2 new measure x 2 hr) + (10 existing or borrowed 
measures x 0.5 hr))/total # of measures (12)]. We note that we are not 
making any changes to the currently approved time of 0.5 hours required 
for the QCDRs that do not submit measures under the simplified self-
nomination process. For new QCDRs that submit measures as part of their 
self- nomination process, due to the estimated decrease in the number 
of existing or borrowed QCDR measures and an increase in the number of 
new QCDR measures submitted with the self-nomination application 
discussed above, we estimate that it will take 11.5 hours [2.5 hr for 
the full self- nomination process + (12 measures x 0.75 hr/measure for 
QCDR measure submission)] for a QCDR to submit an application under the 
full self-nomination process. We note that this will result in an 
overall increase of 1.4 hours from the estimated time the currently 
approved time of 10.1 hours required for the full QCDR self-nomination 
process (87 FR 70139).
    Based on the above assumptions, we provide an estimate of the total 
annual burden associated with a QCDR self-nominating to be considered 
``qualified'' to submit data on behalf of MIPS eligible clinicians.
    In Table 70, we assume that the staff involved in the full QCDR 
self-nomination process will continue to be computer systems analysts 
or their equivalent who have an average adjusted labor rate of $103.40/
hr. We estimate the burden per response would be $1,189.10 (11.5 hr x 
$103.40/hr). In aggregate, for the CY 2024 performance period/2026 MIPS 
payment year, we estimate that the annual burden for the full QCDR 
self-nomination process will be 138 hours (12 applications x 11.5 hr)

[[Page 79428]]

at a cost of $14,269 (12 applications x $1,189.10/application).
[GRAPHIC] [TIFF OMITTED] TR16NO23.101

    In Table 71, we use the currently approved burden as the baseline 
for calculating the net change in burden for the full QCDR self-
nomination process. We note that we discussed the estimated burden for 
the full QCDR self-nomination process under ``maximum burden'' in Table 
108 in the CY 2023 PFS final rule (87 FR 70139). For the CY 2024 
performance period/2026 MIPS payment year, the change in the 
representation of burden for this ICR described above in this section 
results in a decrease of 498 hours and $51,524 for the full self-
nomination process. We also note that the decrease in burden accounts 
for the change due to separating the estimated burden based on the 
simplified and full self-nomination process.
[GRAPHIC] [TIFF OMITTED] TR16NO23.102

    We did not receive any comments on our proposed requirements and 
burden estimates for the full QCDR self-nomination process. We note 
that we adjusted the burden estimates from the CY 2024 PFS proposed 
rule (88 FR 52641 through 52642) due to the availability of updated 
data.
(c) QCDR Measure Requirements
    In the CY 2017 Quality Payment Program final rule (81 FR 77375 
through 77377), we established that QCDRs could submit measures that 
are not on the annual list of MIPS quality measures as part of the 
self-nomination process for an entity to become a QCDR.
    As discussed in section IV.A.4.k.(4)(b)(i) of this final rule, we 
are finalizing our proposal to add that the measure being submitted 
after self-nomination to our list of reasons for rejecting a QCDR 
measure at Sec.  414.1400(b)(4)(iv)(O). We will not revise or adjust 
our burden estimates because the policy only clarifies requirements for 
rejecting a QCDR measure and will not substantively change the 
estimated average weighted time required for a QCDR to submit 
information for a QCDR measure at the time of self-nomination.
    As discussed in section IV.A.4.k.(4)(b)(ii) of this final rule, we 
are finalizing our proposal at Sec.  414.1400(b)(4)(iv)(P) that a QCDR 
measure may be rejected if the QCDR submits more than 30 quality 
measures not in the annual list of MIPS quality measures for CMS 
consideration. We will not revise or adjust our burden estimates as 
result of this change because limiting the number of measures submitted 
during the QCDR self-nomination process will not substantively change 
the estimated average weighted time required for a QCDR to submit 
information for a QCDR measure at the time of self-nomination.
    As discussed in section IV.A.4.k.(4)(b)(iv) of this final rule, we 
are finalizing our proposal to revise Sec.  414.1400(b)(4)(i)(B) to add 
a provision that the approved QCDR measure specifications must remain 
published through the performance period and data submission period. We 
will not revise or adjust our burden estimates as result of this change 
because establishing a standard for the duration of posting the 
approved QCDR measure specifications would not substantively change the 
estimated average weighted time required for a QCDR to submit 
information for a QCDR measure at the time of self-nomination.
(3) Qualified Registry Self-Nomination Process and Other Requirements
    We refer readers to Sec.  414.1400(b)(2) which states that entities 
seeking to

[[Page 79429]]

qualify as a qualified registry for the applicable performance period 
must complete a self-nomination process to be considered for approval.
    As described in the CY 2024 PFS proposed rule, we proposed to 
separate the burden for the number of qualified registry self-
nomination applications submitted for the simplified and full self-
nomination process for the CY 2024 performance period/2026 MIPS payment 
year (88 FR 52642 through 52644). In the CY 2023 PFS final rule (87 FR 
70139 through 70140), we used the same estimate for the number of 
respondents that submitted applications for the simplified and full 
self-nomination process because we did not have separate estimates at 
the time. Additionally, we only used the burden for the full qualified 
registry self-nomination process in our final burden summary estimates. 
Due to the availability of updated data and the distinct number of 
estimated respondents for the simplified and full self-nomination 
process, we proposed to add a new ICR to capture the burden for the 
qualified registry self-nomination process. We note that the change is 
not due to finalizing the policies discussed in section IV.A.4.k. of 
this final rule. With the addition of a new ICR, we believe that we 
will be able to accurately represent the estimated burden incurred by 
the qualified registries for both the simplified and full self-
nomination process.
(a) Simplified Qualified Registry Self-Nomination Process
    Based on the number of applications received during the CY 2023 
self-nomination period for the CY 2024 performance period/2026 MIPS 
payment year, we estimate that 84 qualified registries will submit 
applications under the simplified self-nomination process. We note that 
we are not making any changes to the currently approved time of 0.5 
hours required for the simplified qualified registry self-nomination 
process (87 FR 70140).
    Based on the above assumptions, we provided an estimate of the 
total annual burden associated with a qualified registry self-
nominating to be considered ``qualified'' to submit data on behalf of 
MIPS eligible clinicians.
    In Table 72, we assume that the staff involved in the simplified 
qualified registry self-nomination process will continue to be computer 
systems analysts or their equivalent, who have an average adjusted 
labor rate of $103.40/hr. We estimate the burden per response will be 
$51.70 (0.5hr x $103.40/hr) for the simplified self-nomination process. 
In aggregate, for the CY 2024 performance period/2026 MIPS payment 
year, we estimate that the annual burden for the simplified qualified 
registry self-nomination process will be 42 hours (84 applications x 
0.5 hr) at a cost of $4,343 (84 applications x $51.70//application).
[GRAPHIC] [TIFF OMITTED] TR16NO23.103

    In Table 73, the addition of this ICR for the CY 2024 performance 
period/2026 MIPS payment year will result in a change of +42 hours at a 
cost of $4,343 for the simplified qualified registry self-nomination 
process. We note that the increase in burden is due to separating the 
estimated burden for the simplified and full qualified registry self-
nomination process.
[GRAPHIC] [TIFF OMITTED] TR16NO23.104

    We did not receive any comments on our proposed requirements and 
burden estimates for the simplified qualified registry self-nomination 
process. We note that we adjusted the burden estimates from the CY 2024 
PFS proposed rule (88 FR 52642 through 52643) due to the availability 
of updated data.

[[Page 79430]]

(b) Full Qualified Registry Self-Nomination Process
    Based on the number of applications we received during the CY 2023 
self-nomination period for the CY 2024 performance period/2026 MIPS 
payment year, we estimate that 27 qualified registries will submit 
applications under the full self-nomination process. This is a decrease 
of 105 from the currently approved estimate of 132 for the qualified 
registry self-nomination process (87 FR 70140). We note we are not 
making any changes to our currently approved per response time estimate 
of 2 hours for the full qualified registry self-nomination process (87 
FR 70139 through 70140).
    Based on the assumptions discussed in this section, we provide an 
estimate of the total annual burden associated with a qualified 
registry self-nominating to be considered ``qualified'' to submit data 
on MIPS eligible clinicians.
    In Table 74, we assume the staff involved in the qualified registry 
self-nomination process will continue to be computer systems analysts 
or their equivalent, who have an average labor rate of $103.40/hr. We 
estimate the burden per response will be $206.80 (2 x 103.40/hr) for 
the full self-nomination process. In aggregate, for the CY 2024 
performance period/2026 MIPS payment year, we estimate that the annual 
burden for the full qualified registry self-nomination process will be 
54 hours (27 applications x 2 hr) at a cost of $5,584 (27 applications 
x $206.80/application).
[GRAPHIC] [TIFF OMITTED] TR16NO23.105

    In Table 75, we use the currently approved burden as the baseline 
for calculating the net change in burden for the simplified qualified 
registry self-nomination process. We note that we discussed the 
estimated burden for the full qualified registry self-nomination 
process under ``maximum burden'' in Table 110 in the CY 2023 PFS final 
rule (87 FR 70140). For the CY 2024 performance period/2026 MIPS 
payment year, the change in the representation of burden for this ICR 
described above results in a decrease of 210 hours and a decrease of 
$21,714 for the full qualified registry self-nomination process. We 
note the decrease in burden accounts for the changes due to separating 
the estimated burden based on the simplified and full qualified 
registry self-nomination process.
[GRAPHIC] [TIFF OMITTED] TR16NO23.106

    We did not receive any comments on our proposed requirements and 
burden estimates for the full qualified registry self-nomination 
process. We note that we adjusted the burden estimates from the CY 2024 
PFS proposed rule (88 FR 52643 through 52644) due to the availability 
of updated data.
(4) Third Party Intermediary Plan Audits
    The following changes associated with developing the plans and 
audits by QCDRs and qualified registries will be submitted to OMB for 
review under control number 0938-1314 (CMS-10621).
(a) Targeted Audits
    In the CY 2022 PFS final rule (86 FR 65547 through 65548), we 
finalized that beginning with the CY 2021 performance period/CY 2023 
MIPS payment year, the QCDR or qualified registry must conduct targeted 
audits in accordance with requirements at Sec.  414.1400(b)(3)(vi). 
Consistent with our assumptions in the CY 2022 PFS and CY 2023 PFS 
final rules for the QCDRs (86 FR 65574 and 87 FR 70141 respectively) 
and qualified registries (86 FR 65571 and 87 FR 70141 respectively) 
that would submit the results of targeted audits, we estimate the time 
required for a QCDR or qualified registry to submit a targeted audit 
ranges between 5 and 10 hours for the simplified and full self-
nomination process, respectively. We assume the staff involved in 
submitting the targeted audits will continue to be computer systems 
analysts or their

[[Page 79431]]

equivalent, who have an average labor rate of $103.40/hr.
    Based on the number of data validation execution reports submitted 
for the CY 2022 performance period/2024 MIPS payment year, we estimate 
that 29 third party intermediaries will submit targeted audits for the 
CY 2024 performance period/2026 MIPS payment year (See Table 76). We 
estimate that the cost for a QCDR or a qualified registry to submit a 
targeted audit will range from $517 (5 hr x $103.40/hr) to $1,034 (10 
hr x $103.40/hr). In aggregate, we estimate an annual burden ranging 
from 145 hours (29 responses x 5 hr/audit) and $14,993 (29 targeted 
audits x $517/audit) to 290 hours (29 responses x 10 hr/audit) and 
$29,986 (29 targeted audits x $1,034/audit) (see Table 77 for the cost 
per audit).
(b) Participation Plans
    In the CY 2022 PFS final rule (86 FR 65546), we finalized 
requirements for approved QCDRs and qualified registries that did not 
submit performance data and therefore will need to submit a 
participation plan as part of their self-nomination process. We refer 
readers to Sec.  414.1400(e) for additional details on policies for 
remedial action and termination of third party intermediaries.
    In the CY 2023 PFS final rule, we estimated that it will take 3 
hours for a QCDR or qualified registry to submit a participation plan 
(87 FR 70141). We found that we overestimated the time required to 
submit a participation plan and therefore, are revising our estimate 
that it would take 2 hours for a QCDR or qualified registry to submit a 
participation plan. We assume the staff involved in submitting a 
participation plan will continue to be computer systems analysts or 
their equivalent, who have an average labor rate of $103.40/hr.
    As shown in Table 76, following additional review of the MIPS data 
submission reports, we estimate that 64 third party intermediaries will 
submit participation plans for the CY 2024 performance period/2026 MIPS 
payment year.
    In Table 77, we estimate that the cost for a QCDR or a qualified 
registry to submit a participation plan is $206.80 (2 hours x $103.40/
hr). In aggregate, we estimate the total impact associated with QCDRs 
and qualified registries to submit participation plans would be 128 
hours (64 participation plans x 2 hr/plan) at a cost of $13,235 (64 
participation plans x $206.80/plan) (see Table 77 for the cost per 
audit).
(c) Corrective Action Plans (CAPs)
    In the CY 2017 Quality Payment Program final rule, we established 
the process for corrective action plans (CAPs) (81 FR 77386 through 
77389). As discussed in section IV.A.4.k.(6)(b) of this final rule, we 
are finalizing our proposal an additional provision at Sec.  
414.1400(e)(2)(iv) to allow us to immediately or with advance notice 
terminate a third party intermediary that has not maintained current 
contact information for correspondence. Additionally, we are finalizing 
to add at Sec.  414.1400(e)(2)(v) that CMS may terminate third party 
intermediaries that are on remedial action for 2 consecutive years. We 
are not making any changes to our currently approved estimated burden 
due to these finalized policies because these changes provide 
additional rationale for remedial action policies and do not add any 
additional requirements for third party intermediaries.
    Based on the increased number of QCDR and qualified registries that 
required remedial actions for the CY 2022 performance period/2024 MIPS 
payment year, we anticipate the same trend would continue for the CY 
2024 performance period/2026 MIPS payment year. Therefore, we estimate 
24 third party intermediaries will submit CAPs for the CY 2024 
performance period/2026 MIPS payment year. This is an increase of 14 
respondents from the currently approved estimate of ten (87 FR 70142). 
We are not changing our currently approved estimate of 3 hours for a 
QCDR or qualified registry to submit a CAP. We also assume the staff 
involved in submitting the CAP will continue to be computer systems 
analysts or their equivalent, who have an average labor rate of 
$103.40/hr. As shown in Table 77, we estimate that the cost for a QCDR 
or a qualified registry to submit a CAP is $310.20 (3 hours x $103.40/
hr). In aggregate, we estimate the total impact associated with QCDRs 
and qualified registries to CAPs will be 72 hours (24 CAPs x 3 hr/plan) 
at a cost of $7,445 (24 CAPs x $310.20/plan).
(d) Transition Plans
    We established a policy at Sec.  414.1400(a)(2)(F) which states a 
condition of approval for the third party intermediary is to agree that 
prior to discontinuing services to any MIPS eligible individual 
clinician, group, virtual group, subgroup, or APM Entity during a 
performance period, the third party intermediary must support the 
transition of such MIPS eligible clinician, group, virtual group, 
subgroup, or APM Entity to an alternate third party intermediary, 
submitter type, or, for any measure on which data has been collected, 
collection type according to a CMS approved transition plan. In this 
final rule, we estimate that we will receive nine transition plans for 
the CY 2024 performance period/2026 MIPS payment year. This adjustment 
will result in a decrease of one from the currently approved estimate 
of 10 (87 FR 70142). We continue to estimate it will take approximately 
1 hour for a computer system analyst or their equivalent at a labor 
rate of $103.40/hr to develop a transition plan on behalf of each QCDR 
or qualified registry during the self-nomination period. However, we 
are unable to estimate the burden for implementing the actions in the 
transition plan because the level of effort may vary for each QCDR or 
qualified registry. In aggregate, we estimate the impact associated 
with qualified registries completing transition plans is 9 hours (9 
transition plans x 1 hr/plan) at a cost of $931 (9 transition plans x 
$103.40/hr). We refer readers to section VI.E.23.e.(2)(a) of this final 
rule where we discuss our impact analysis for the transition plans 
submitted by QCDRs and qualified registries.
    As discussed in section IV.A.4.k.(6)(c) of this final rule, we are 
finalizing our proposal to add an additional requirement at Sec.  
414.1400(e)(1)(i)(F) for the QCDR or qualified registry under a 
corrective action plan to communicate the final resolution to CMS once 
the resolution is complete and to provide an update, if any, to the 
monitoring plan provided under Sec.  414.1400(e)(1)(i)(C). We believe 
the revision will ensure third party intermediaries complete the 
requirements within the communication plan and will not add any 
additional requirements for a third-party intermediary to submit a CAP.
    As discussed in section IV.A.4.k.(6)(d) of this rule, we are 
finalizing our proposal to add a new provision at Sec.  
414.1400[euro](1)(ii)(B) that CMS may, beginning with the CY 2025 
performance period/2027 MIPS payment year, publicly disclose on the CMS 
website that CMS took remedial action against or terminated the third 
party intermediary. We are also finalizing to modify Sec.  
414.1400(e)(1)(ii) by redesignating it as Sec.  414.1400(a)(2)(ii)(A) 
and ending the policy after the CY 2025 MIPS reporting period/CY 2027 
MIPS payment year.
    As discussed in section IV.A.4.k.(6)(e) of this final rule, we are 
finalizing our proposal to clarify the previously established policy 
under Sec.  414.1400(a)(2)(ii)(A) to state that our consideration can 
include past

[[Page 79432]]

compliance including remedial actions. We are also finalizing at Sec.  
414.1400(f) that third party intermediaries may be randomly selected 
for compliance evaluation or may be selected at the suggestion of CMS 
if there is an area of concern regarding the third party intermediary. 
We are also finalizing to redesignate the existing section Sec.  
414.1400(f) (which includes paragraphs (f)(1), (2), and (3)) as 
paragraph (a)(3)(vii) with minor changes in the text for clarity.
    We do not expect to receive additional information from QCDRs and 
qualified registries during the self-nomination process due to 
finalizing the above policies and therefore, are not making any 
adjustments to the currently approved burden estimates for third party 
intermediary plan audits. Additionally, we refer readers to section 
VI.E.23.e.(2)(a) of this final rule where we outline the details in our 
impact analysis for these policies.
(e) Final Burden for Third Party Intermediary Plan Audits
    In aggregate, as shown in Table 76, we assume that 126 third party 
intermediaries will submit plan audits (29 targeted audits, 64 
participation plans, 24 CAPs, and 9 transition plans).
[GRAPHIC] [TIFF OMITTED] TR16NO23.107

    As shown in in Table 77, we assume that the staff involved in the 
submission of the plan audits during the third party intermediary self-
nomination process will continue to be computer systems analysts or 
their equivalent, who have an average labor rate of $103.40/hr. For the 
CY 2024 performance period/2026 MIPS payment year, in aggregate, the 
estimated annual burden for the submission of third party intermediary 
plan audits will range from 354 hours to 499 hours at a cost ranging 
from $36,604 (354 hr x $103.40/hr) and $51,597 (499 hr x $103.40/hr).
[GRAPHIC] [TIFF OMITTED] TR16NO23.108

    As shown in Table 78, for the CY 2024 performance period/2026 MIPS 
payment year, the change in the number of respondents for third party 
intermediary plan audits results in a change of -71 hours at a cost of 
-$7,341 under the simplified self-nomination process and -86 hours at a 
cost of -$8,892 under the full self-nomination process.
    We note for the purposes of calculating estimated change in burden

[[Page 79433]]

in Tables 109 through 111 of this rule, we use only estimated burden 
for the plan audits submitted under the full self-nomination process.
[GRAPHIC] [TIFF OMITTED] TR16NO23.109

    We did not receive any comments on our proposed requirements and 
burden estimates for the QCDRs and qualified registries submitting plan 
audits under the self-nomination process. We note that we adjusted the 
burden estimates from the CY 2024 PFS proposed rule (88 FR 52644 
through 52646) due to the availability of updated data.
(5) Survey Vendor Requirements
    The following changes associated with CAHPS survey vendors to 
submit data for eligible clinicians will be submitted to OMB for review 
under control number 0938-1222 (CMS-10450). We noted that the 
associated burden will be made available for public review and comment 
under the standard non-rule PRA process which includes the publication 
of 60- and 30-day Federal Register notices.
    We refer readers to Sec.  414.1400(d) for the requirements for CMS-
approved survey vendors that may submit data on the CAHPS for MIPS 
Survey.
    In the CY 2024 PFS proposed rule, we proposed to adjust the 
estimated number of currently approved vendors that will apply to 
participate as CAHPS for MIPS Survey vendors (88 FR 52646 through 
52647). We estimated that we will receive approximately 10 survey 
vendor applications for the CY 2024 performance period/2026 MIPS 
payment year. This adjustment will result in a decrease of 5 survey 
vendor applications from our currently approved estimate of 15 vendors 
in the CY 2018 QPP final rule (82 FR 53908). As shown in Table 79, for 
the CY 2024 performance period/2026 MIPS payment year, we continue to 
estimate that the per response time is 10 hours. This will result in an 
estimated annual burden of 100 hours (10 survey vendor applications x 
10 hr/application) at a cost of $10,340 (10 applications x $1,034/
application).
[GRAPHIC] [TIFF OMITTED] TR16NO23.110

    In Table 80, we illustrate the net change in estimated burden for 
survey vendor requirements using the currently approved burden in the 
CY 2018 Quality Payment Program final rule (82 FR 53908). In aggregate, 
using our currently approved per response time estimate, the decrease 
in the number of respondents participating as CAHPS for MIPS Survey 
vendors will result in a total annual adjustment of -50 hours (-5 
responses x 10 hr/application) at a cost of -$5,170 (-5 x (10 hr x 
$103.40/hr)) for the CY 2024 performance period/2026 MIPS payment year.

[[Page 79434]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.111

    We did not receive any comments on our proposed requirements and 
burden estimates for the estimated burden on the requirements for the 
CAHPS Survey vendors.
d. ICRs Regarding Open Authorization (OAuth) Credentialing and Token 
Request Process
    We did not propose any new or revised collection of information 
requirements or burden related to the OAuth credentialing and token 
request process for the CY 2024 performance period/2026 MIPS payment 
year. The requirements and burden for the OAuth credentialing and token 
request process are currently approved by OMB under control number 
0938-1314 (CMS-10621). Consequently, we are not making any changes to 
the burden for the OAuth credentialing and token request process under 
that control number.
e. ICRs Regarding Quality Data Submission (Sec. Sec.  414.1318, 
414.1325, 414.1335, and 414.1365)
(1) Background
    We refer readers to the CY 2017 and CY 2018 Quality Payment Program 
final rules (81 FR 77502 through 77503 and 82 FR 53908 through 53912, 
respectively), the CY 2019, CY 2020, CY 2021, CY 2022, and CY 2023 PFS 
final rules (83 FR 60000 through 60003, 84 FR 63121 through 63124, 85 
FR 84970 through 84974, 86 FR 65576 through 65588, and 87 FR 70145 
through 70154, respectively) for our previously finalized estimated 
burden associated with data submission for the quality performance 
category.
    Under our current policies, two groups of clinicians must submit 
data for the quality performance category under MIPS: those who submit 
data as MIPS eligible clinicians, and those who submit data voluntarily 
but are not subject to MIPS payment adjustments. Clinicians are 
ineligible for MIPS payment adjustments if they are newly enrolled to 
Medicare; are QPs; are partial QPs who elect to not participate in 
MIPS; are not one of the clinician types included in the definition for 
MIPS eligible clinician; or do not exceed the low-volume threshold as 
an individual or as a group.
(2) Changes and Adjustments to Quality Performance Category Respondents
    To determine which QPs should be excluded from MIPS, we used the 
Advanced APM payment and patient percentages from the APM Participant 
List for the final snapshot date for the 2021 QP Performance period. 
From this data, we calculated the QP determinations as described in the 
Qualifying APM Participant (QP) definition at Sec.  414.1305 for the CY 
2024 performance period/2026 MIPS payment year. Due to data 
limitations, we could not identify specific clinicians who have not yet 
enrolled in APMs, but who may become QPs in the future for the CY 2024 
performance period/2026 MIPS payment year (and therefore will no longer 
need to submit data to MIPS); hence, our model may underestimate or 
overestimate the number of respondents.
    In the CY 2024 PFS proposed rule (88 FR 52648), we noted that we 
continued to use submissions data from the CY 2021 performance period/
2023 MIPS payment year to estimate the number of respondents that will 
submit data for the CY 2024 performance period/2026 MIPS payment year. 
We note that in this final rule, we have received updated data and 
therefore, adjusted the estimated number of respondents that will 
submit data for the CY 2024 performance period/2026 MIPS payment year 
based on the submissions received for the CY 2022 performance period/
2024 MIPS payment year. We refer readers to sections V.B.11.e.(4), 
V.B.11.e.(5), V.B.11.e.(6), V.B.11.e.7.(a)(i) and V.B.11.e.(7)(a)(iii) 
of this final rule for additional details.
    We assume 100 percent of ACO APM Entities will submit quality data 
to CMS as required under their models. While we do not believe there is 
additional reporting for ACO APM entities, consistent with assumptions 
used in the CY 2021, CY 2022, and CY 2023 PFS final rules (85 FR 84972, 
86 FR 65567 and 87 FR 70145), we include all quality data voluntarily 
submitted by MIPS APM participants at the individual or TIN-level in 
our respondent estimates. As stated in section V.B.11.a.(4) of this 
final rule, we assume non-ACO APM Entities will participate through 
traditional MIPS and submit as an individual or group rather than as an 
entity. To estimate who will be a MIPS APM participant in the CY 2024 
performance period/2026 MIPS payment year, we used the Advanced APM 
payment and patient percentages from the APM Participant List for the 
final snapshot date for the 2021 QP performance period. We elected to 
use this data source because the overlap with the data submissions for 
the CY 2022 performance period/2024 MIPS payment year enabled the 
exclusion of Partial QPs that elected to not participate in MIPS and 
required fewer assumptions as to who is a QP or not. Based on this 
information, if we determine that a MIPS eligible clinician will not be 
scored as a MIPS APM, then their reporting assumption is based on their 
reporting as a group or individual for the CY 2022 performance period/
2024 MIPS payment year.
    Our burden estimates for the quality performance category do not 
include the burden for the quality data that APM Entities submit to 
fulfill the requirements of their APMs. The associated burden is 
excluded from this collection of information section but is discussed 
in the regulatory impact analysis section of this final rule because 
sections 1899(e) and

[[Page 79435]]

1115A(d)(3) of the Act (42 U.S.C. 1395jjj(e) and 1315a(d)(3), 
respectively) state that the Shared Savings Program and the testing, 
evaluation, and expansion of Innovation Center models tested under 
section 1115A of the Act (or section 3021 of the Affordable Care Act) 
are not subject to the PRA.\511\
---------------------------------------------------------------------------

    \511\ Our estimates do reflect the burden on MIPS APM 
participants of submitting Promoting Interoperability performance 
category data, which is outside the requirements of their APMs.
---------------------------------------------------------------------------

    For the CY 2024 performance period/2026 MIPS payment year, 
respondents will have the option to submit quality performance category 
data via Medicare Part B claims, direct, and log in and upload 
submission types. We estimated the burden for collecting data via 
collection type: Medicare Part B claims, QCDR and MIPS CQMs, and eCQMs. 
Additionally, we captured the burden for clinicians who choose to 
submit via these collection types for the quality performance category 
of MVPs. We believe that, while estimating burden by submission type 
may be better aligned with the way clinicians participate with the 
Quality Payment Program, it is more important to reduce confusion and 
enable greater transparency by maintaining consistency with previous 
rulemaking. In the CY 2019 PFS final rule, we finalized proposals to 
limit the Medicare Part B claims collection type to small practices 
beginning with the CY 2019 performance period/2021 MIPS payment year 
and to allow clinicians in small practices to report Medicare Part B 
claims as a group or as individuals (83 FR 59752).
    Because MIPS eligible clinicians may submit data for multiple 
collection types for a single performance category, the estimated 
numbers of individual clinicians and groups to collect via the various 
collection types are not mutually exclusive and reflect the occurrence 
of individual clinicians or groups that collected data via multiple 
collection types during the CY 2022 performance period/2024 MIPS 
payment year. We captured the burden of any eligible clinician that may 
have historically collected via multiple collection types, as we assume 
they will continue to collect via multiple collection types and that 
our MIPS scoring methodology will take the highest score where the same 
measure is submitted via multiple collection types.
    Table 81 uses methods similar to those described above to estimate 
the number of MIPS eligible clinicians that will submit data as 
individual clinicians via each collection type in the CY 2024 
performance period/2026 MIPS payment year. For the CY 2024 performance 
period/2026 MIPS payment year, we estimate that approximately 13,413 
clinicians will submit data as individuals using the Medicare Part B 
claims collection type; approximately 10,682 clinicians will submit 
data as individuals using MIPS CQM and QCDR collection type; and 
approximately 22,897 clinicians will submit data as individuals using 
eCQMs collection type. Based on performance data from the CY 2022 
performance period/2024 MIPS payment year, these are adjustments of -
1,323, -776, and 4,535 respondents from the currently approved 
estimates of 14,736, 11,458, and 18,362 for the Medicare Part B claims, 
MIPS CQM and QCDR, and eCQM collection types, respectively.
[GRAPHIC] [TIFF OMITTED] TR16NO23.112

    Consistent with the policy finalized in the CY 2018 Quality Payment 
Program final rule that for MIPS eligible clinicians who collect 
measures via Medicare Part B claims, MIPS CQM, eCQM, or QCDR collection 
types and submit more than the required number of measures (82 FR 53735 
through 54736), we will score the clinician on the required measures 
with the highest assigned measure achievement points and thus, the same 
clinician may be counted as a respondent for more than one collection 
type. Therefore, our columns in Table 81 are not mutually exclusive.
    Table 82 provides our estimates for the number of groups or virtual 
groups that will submit quality data on behalf of clinicians for each 
collection type in the CY 2024 performance periods/2026 MIPS payment 
year. We assume clinicians who submitted quality data as groups in the 
CY 2022 performance period/2024 MIPS payment year will continue to 
submit data for the quality performance category either as groups, or 
virtual groups for the same collection types for the 2024 performance 
period/2026 MIPS payment years. We used the same methodology described 
in the CY 2022 PFS final rule (86 FR 65577) on our assumptions related 
to the use of an alternate collection type for groups that submitted 
data via the CMS Web Interface collection type for the CY 2022

[[Page 79436]]

performance period/2024 MIPS payment year.
    As shown in Table 82, for the CY 2024 performance period/2026 MIPS 
payment year, we estimate that 5,950 groups and virtual groups will 
submit data for the MIPS CQM and QCDR collection type and 5,817 groups 
and virtual groups will submit for the eCQM collection type. These are 
adjustments of x508 and 290 respondents from the currently approved 
estimates of 6,458, and 5,527 for the groups and virtual groups that 
will submit data using MIPS CQM and QCDR, and eCQM collection types, 
respectively.
[GRAPHIC] [TIFF OMITTED] TR16NO23.113

    The burden associated with the submission of quality performance 
category data has some limitations. We believe it is difficult to 
quantify the burden accurately because clinicians and groups may have 
different processes for integrating quality data submission into their 
practices' workflows. Moreover, the time needed for a clinician to 
review quality measures and other information, select measures 
applicable to their patients and the services they furnish, and 
incorporate the use of quality measures into the practice workflows is 
expected to vary along with the number of measures that are potentially 
applicable to a given clinician's practice and by the collection type. 
For example, clinicians submitting data via the Medicare Part B claims 
collection type need to integrate the capture of quality data codes for 
each encounter whereas clinicians submitting via the eCQM collection 
types may have quality measures automated as part of their Electronic 
Health Record (EHR) implementation.
    We believe the burden associated with submitting quality measures 
data will vary depending on the collection type selected by the 
clinician, group, or third-party. As such, we separately estimate the 
burden for clinicians, groups, and third parties to submit quality 
measures data by the collection type used. For the purposes of our 
burden estimates for the Medicare Part B claims, MIPS CQM and QCDR, and 
eCQM collection types, we also assume that, on average, each clinician 
or group will submit 6 quality measures. Additionally, as finalized in 
the CY 2022 PFS final rule (86 FR 65394 through 65397), group TINs 
could also choose to participate as subgroups for MVP reporting 
beginning with the CY 2023 performance period/2025 MIPS payment year. 
We refer readers to the CY 2022 PFS final rule for additional details 
on MVP quality reporting requirements (86 FR 65411 through 65412).
    In terms of the quality measures available for clinicians and 
groups to report for the CY 2024 performance period/2026 MIPS payment 
year, we proposed a measure set of 200 quality measures (88 FR 52567 
through 52568). As shown in Table 83, we are finalizing 198 quality 
measures for the CY 2024 performance period/2026 MIPS payment year. The 
new MIPS quality measures for inclusion in MIPS for the CY 2024 
performance period/2026 MIPS payment year and future years are found in 
Table Group A of Appendix 1; MIPS quality measures with substantive 
changes can be found in Table Group D of Appendix 1; and MIPS quality 
measures proposed for removal can be found in Table Group C of Appendix 
1. These measures are stratified by collection type in Table 83, as 
well as counts of new, removed, and substantively changed measures. 
There are no changes to the remaining measures not included in Appendix 
1. We refer readers to Appendix 1: MIPS Quality Measures of this final 
rule for additional information.

[[Page 79437]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.114

    For the CY 2024 performance period/2026 MIPS payment year, we are 
finalizing 198 measures, which is the same as the currently approved 
estimate of 198 measures. Specifically, as discussed in section 
IV.A.4.f.(1)(e) of this rule, we are finalizing our proposal, with 
modification, to add 11 new MIPS quality measures. We are also 
finalizing our proposal, with modification, to remove 11 MIPS quality 
measures, and finalizing as proposed, to partially remove 3 MIPS 
quality measures (from traditional MIPS for use in MVPs) and make 
substantive updates to 59 MIPS quality measures. We do not anticipate 
our provision to remove these measures will increase or decrease the 
reporting burden on clinicians and groups as respondents generally are 
still required to submit quality data for 6 measures in traditional 
MIPS reporting or submit quality data for 4 measures in an MVP.
(3) Quality Payment Program Identity Management Application Process
    We did not propose any new or revised collection of information 
requirements or burden related to the identity management application 
process for the CY 2024 performance period/2026 MIPS payment year. The 
identity management application process requirements and burden are 
currently approved by OMB under control number 0938-1314 (CMS-10621). 
Consequently, we are not making any changes for the identity management 
application process under that control number.
(4) Quality Data Submission by Clinicians: Medicare Part B Claims-Based 
Collection Type
    The following changes will be submitted to OMB for review under 
control number 0938-1314 (CMS-10621).
    In this rule, we did not propose any new or revised collection of 
information requirements or burden related to the submission of 
Medicare Part B claims data for the quality performance category. Our 
updated estimate for MVP participation due to policy changes to the MVP 
inventory as discussed in section IV.A.4.a. of this rule, impacts the 
number of clinicians submitting quality data for MIPS using the 
Medicare Part B Claims-based collection type. We refer readers to Table 
87 of this section for the change in associated burden related to the 
submission of Medicare Part B claims data for the MVP quality 
performance category in the CY 2024 performance period/2026 MIPS 
payment year.
    We refer readers to the CY 2017 and CY 2018 Quality Payment Program 
final rules (81 FR 77501 through 77504 and 82 FR 53912, respectively), 
the CY 2019, CY 2020, CY 2021, CY 2022, and CY 2023 PFS final rules (83 
FR 60004 through 60005, 84 FR 63124 through 63126, 85 FR 84975 through 
84976, 86 FR 65582 through 65584, and 87 FR 70149 through 70151 
respectively) for our previously finalized requirements and burden for 
quality data submission via the Medicare Part B claims collection type.
    As noted in Table 81, we estimate that 13,413 individual clinicians 
will collect and submit quality data via the Medicare Part B claims 
collection type, a decrease of 1,323 from the currently approved 
estimate of 14,736 (87 FR 70150).
    In Table 84, consistent with our currently approved per response 
time figures and using the updated wage rates in Table 62 of this final 
rule, we continue to estimate the burden of quality data submission 
using Medicare Part B claims will range from 0.15 hours (9 minutes) at 
a cost of $15.51 (0.15 hr x $103.40) for a computer systems analyst to 
7.2 hours at a cost of $744.48 (7.2 hr x $103.40/hr). The burden also 
accounts for the effort needed to become familiar with MIPS quality 
measure specifications.
    Consistent with our currently approved per response time estimates 
and using the updated wage rates in Table 62 of this final rule, we 
believe that the start-up cost for a clinician's practice to review 
measure specifications is 7 hours, consisting of 3 hours for a medical 
and health services manager at $123.06/hr, 1 hour for a physician at 
$274.44/hr, 1 hour for an LPN at $53.72/hr, 1 hour for a computer 
systems analyst at $103.40/hr, and 1 hour for a billing and posting 
clerk at $43.08/hr.
    In Table 84, considering both data submission and start-up 
requirements for our adjusted number of clinicians, the estimated time 
(per clinician) ranges from a minimum of 7.15 hours (0.15 hr + 7 hr) to 
a maximum of 14.2 hours (7.2 hr + 7 hr). In aggregate, the total annual 
time for the CY 2024 performance period/2026 MIPS payment year ranges

[[Page 79438]]

from 95,903 hours (7.15 hr x 13,413 respondents) to 190,465 hours (14.2 
hr x 13,413 respondents). The total annual cost for the CY 2024 
performance period/2026 MIPS payment year ranges from a minimum of 
$11,526,193 (13,413 respondents x $859.33/response) to a maximum of 
$21,303,868 (13,413 respondents x $1588.30/response).
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TR16NO23.115

BILLING CODE 4120-01-C
    In Table 85, we used the currently approved burden as the baseline 
to calculate the net burden for the quality data submissions from 
clinicians using the Medicare Part B Claims-based collection type. In 
aggregate, using our currently approved per response time estimates, 
the decrease in number of responses from 14,736 to 13,413 (-1,323) 
results in a total maximum adjustment of -18,786 hours (-1,323 
responses x 14.2 hr/response) at a cost of -$2,101,321 (-1,323 
responses x $1,588.30/response). For purposes of calculating total 
burden associated with this final rule as shown in Tables 109 through 
111, only the maximum burden is used.

[[Page 79439]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.116

    We did not receive any comments on our proposed requirements and 
burden estimates for the quality performance category submission using 
the Medicare Part B Claims collection type. We note that we adjusted 
the burden estimates from the CY 2024 PFS proposed rule (88 FR 52651 
through 52653) due to the availability of updated data.
(5) Quality Data Submission by Individuals and Groups Using MIPS CQM 
and QCDR Collection Types
    The following changes will be submitted to OMB for review under 
control number 0938-1314 (CMS-10621).
    We refer readers to the CY 2017 and CY 2018 Quality Payment Program 
final rules (81 FR 77504 through 77505 and 82 FR 53912 through 53914, 
respectively), the CY 2019, CY 2020, CY 2021, CY 2022, and CY 2023 PFS 
final rules (83 FR 60005 through 60006, 84 FR 63127 through 63128, 85 
FR 84977 through 84979, 86 FR 65584 through 65586, and 87 FR 70151 
through 70153, respectively) for our previously finalized requirements 
and burden for quality data submission via the MIPS CQM and QCDR 
collection types. We refer readers to Table 92 for the estimated change 
in associated burden for quality data submission using MIPS CQM and 
QCDR collection types related to MVP and subgroup reporting in the CY 
2024 performance period/2026 MIPS payment year.
    As noted in Tables 78 and 79, based on data from the CY 2022 
performance period/2024 MIPS payment year, for the CY 2024 performance 
period/2026 MIPS payment year, we estimate that 16,632 clinicians 
(10,682 individuals and 5,950 groups and virtual groups) will submit 
quality data as individuals or groups using MIPS CQM or QCDR collection 
types. This is a decrease of 1,284 clinicians from the currently 
approved estimate of 17,916 clinicians provided in the CY 2023 PFS 
final rule (87 FR 70152). Given the number of measures required for 
clinicians and groups is the same, we expect the burden to be the same 
for each respondent collecting data via MIPS CQM or QCDR, whether the 
clinician is participating in MIPS as an individual or group.
    Under the MIPS CQM and QCDR collection types, the individual 
clinician or group may either submit the quality measures data directly 
to us, log in and upload a file, or utilize a third party intermediary 
to submit the data to us on the clinician's or group's behalf. We 
estimate that the burden associated with the QCDR collection type is 
similar to the burden associated with the MIPS CQM collection type; 
therefore, we discuss the burden for both together below. For MIPS CQM 
and QCDR collection types, we estimate an additional time for 
respondents (individual clinicians and groups) to become familiar with 
MIPS quality measure specifications and, in some cases, specialty 
measure sets and QCDR measures. Therefore, we believe the burden for an 
individual clinician or group to review measure specifications and 
submit quality data is a total of 9 hours at a cost of $1,039.54 per 
response. This consists of 3 hours at $103.40/hr for a computer systems 
analyst (or their equivalent) to submit quality data along with 2 hours 
at $123.06/hr for a medical and health services manager, 1 hour at 
$103.40/hr for a computer systems analyst, 1 hour at $53.72/hr for a 
LPN, 1 hour at $43.08/hr for a billing clerk, and 1 hour at $274.44/hr 
for a physician to review measure specifications. Additionally, 
clinicians and groups who do not submit data directly will need to 
authorize or instruct the qualified registry or QCDR to submit quality 
measures' results and numerator and denominator data on quality 
measures to us on their behalf. We estimate the time and effort 
associated with authorizing or instructing the quality registry or QCDR 
to submit this data will be approximately 5 minutes (0.083 hr) at 
$103.40/hr for a computer systems analyst at a cost of $8.15 (0.083 hr 
x $103.40/hr). Overall, we estimate 9.083 hr/response (3 hr + 2 hr + 1 
hr + 1 hr + 1 hr + 1 hr + 0.083 hr) at a cost of $1,039.54/response [(3 
hr x $103.40/hr) + (2 hr x $123.06/hr) + (1 hr x $274.44/hr) + (1 hr x 
$103.40/hr) + (1 hr x $53.72/hr) + (1 hr x $43.08/hr) + (0.083 hr x 
$103.40/hr)].
    In Table 86, for the CY 2024 performance period/2026 MIPS payment 
year, in aggregate, we estimate a burden of 151,068 hours [9.083 hr/
response x 16,632 responses] at a cost of $17,289,629 (16,632 responses 
x $1,039.54/response).
BILLING CODE 4120-01-P

[[Page 79440]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.117

BILLING CODE 4120-01-C
    In Table 87, we calculated the net change in estimated burden for 
quality performance category submissions using the MIPS CQM and QCDR 
collection type by using the currently approved burden in the CY 2023 
PFS final rule (87 FR 70151 through 70153). In aggregate, using the 
unchanged currently approved time per response estimate, the decrease 
of 1,284 respondents from 17,916 to 16,632 for the CY 2024 performance 
period/2026 MIPS payment year results in a decrease of 11,663 hours (-
1,284 responses x 9.083 hr/response) at a cost of -$1,334,770 (-1,284 
responses x $1,039.54/response).

[[Page 79441]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.118

    We did not receive any comments on our proposed requirements and 
burden estimates for the quality performance category submission using 
the MIPS CQM and QCDR collection type. We note that we adjusted the 
burden estimates from the CY 2024 PFS proposed rule (88 FR 52653 
through 52654) due to the availability of updated data.
(6) Quality Data Submission by Clinicians and Groups: eCQM Collection 
Type
    The following changes will be submitted to OMB for review under 
control number 0938-1314 (CMS-10621).
    We refer readers to the CY 2017 and CY 2018 Quality Payment Program 
final rules (81 FR 77505 through 77506 and 82 FR 53914 through 53915), 
CY 2019 PFS final rule (83 FR 60006 through 60007), CY 2020 PFS final 
rule (84 FR 63128 through 63130), CY 2021 PFS final rule (85 FR 84979 
through 84980), the CY 2022 PFS final rule (86 FR 65586 through 65588), 
and the CY 2023 PFS final rule (87 FR 70153 through 70154) for our 
previously finalized requirements and burden for quality data 
submission via the eCQM collection types. For the change in associated 
burden for quality data submission related to the provisions 
introducing MVP and subgroup reporting beginning in the CY 2024 
performance period/2026 MIPS payment year, we refer readers to Table 
92.
    Based on updated data from the CY 2022 performance period/2024 MIPS 
payment year data, we assume that 28,714 clinicians (22,897 individual 
clinicians and 5,817 groups and virtual groups) will submit quality 
data using the eCQM collection type for the CY 2024 performance period/
2026 MIPS payment year. This is an increase of 4,825 clinicians from 
the currently approved estimate of 23,889 clinicians provided in the CY 
2023 PFS final rule (87 FR 70153). We assume the burden to be the same 
for each respondent using the eCQM collection type, whether the 
clinician is participating in MIPS as an individual or group.
    Under the eCQM collection type, the individual clinician or group 
may either submit the quality measures data directly to us from their 
eCQM, log in and upload a file, or utilize a third-party intermediary 
to derive data from their certified EHR technology (CEHRT) and submit 
it to us on the clinician's or group's behalf.
    To prepare for the eCQM collection type, the clinician or group 
must review the quality measures on which we will be accepting MIPS 
data extracted from eCQMs, select the appropriate quality measures, 
extract the necessary clinical data from their CEHRT, and submit the 
necessary data to a QCDR/qualified registry or use a health IT vendor 
to submit the data on behalf of the clinician or group. We assume the 
burden for collecting quality measures data via eCQM is similar for 
clinicians and groups who submit their data directly to us from their 
CEHRT and clinicians and groups who use a health IT vendor to submit 
the data on their behalf. This includes extracting the necessary 
clinical data from their CEHRT and submitting the necessary data to a 
QCDR/qualified registry.
    We estimate that it will take no more than 2 hours at $103.40/hr 
for a computer systems analyst to submit the actual data file. The 
burden will also involve becoming familiar with MIPS quality measure 
specifications. In this regard, we estimate it will take 6 hours for a 
clinician or group to review measure specifications. Of that time, we 
estimate 2 hours at $123.06/hr for a medical and health services 
manager, 1 hour at $274.44/hr for a physician, 1 hour at $103.40/hr for 
a computer systems analyst, 1 hour at $53.72/hr for an LPN, and 1 hour 
at $43.08/hr for a billing clerk. Overall, we estimate a cost of 
$927.56/response [(2 hr x $103.40/hr) + (2 hr x $123.06/hr) + (1 hr x 
$274.44/hr) + (1 hr x $103.40/hr) + (1 hr x $53.72/hr) + (1 hr x 
$43.08/hr)].
    In Table 88, for the CY 2024 performance period/2026 MIPS payment 
year, in aggregate, we estimate a burden of 229,712 hours [8 hr x 
28,714 responses] at a cost of $26,633,958 (28,714 responses x $927.56/
response).
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BILLING CODE 4120-01-C
    In Table 89, we illustrate the net change in burden for submissions 
in the quality performance category using the eCQM collection type from 
the currently approved burden in the CY 2023 PFS final rule (87 FR 
70153 through 70154). In aggregate, using our currently approved time 
per response burden estimate, the increase of 4,825 respondents from 
23,889 to 28,714 for the CY 2024 performance period/2026 MIPS payment 
year results in an increase of 38,600 hours (4,825 responses x 8 hr/
response) at a cost of $4,475,477 (4,825 responses x $927.56/response).
[GRAPHIC] [TIFF OMITTED] TR16NO23.120

    We did not receive any comments on our proposed requirements and 
burden estimates for the quality performance category submission using 
the eCQM collection type. We note that we adjusted the burden estimates 
from the CY 2024 PFS proposed rule (88 FR 52655 through 52656) due to 
the availability of updated data.
(7) ICRs Regarding Burden for MVP Reporting
    The following changes will be submitted to OMB for review under

[[Page 79443]]

control number 0938-1314 (CMS-10621).
(a) Burden for MVP Reporting Requirements
    In the CY 2022 PFS final rule, we finalized an option for 
clinicians choosing to report MVPs to participate through subgroups 
beginning with the CY 2023 performance period/2025 MIPS payment year 
(86 FR 65392 through 65394). We refer readers to the CY 2022 and CY 
2023 PFS final rules for our previously finalized burden assumptions 
and requirements for submission data for the MVP performance category, 
and for the estimated number of clinicians participating as subgroups 
in the CY 2023 performance period/2025 MIPS payment year (86 FR 65590 
through 65592 and 87 FR 70155).
    As discussed in section IV.A.4.a of this final rule, we are 
finalizing our proposal to add five new MVPs to the MVP Inventory. 
Additionally, we are finalizing our proposal to consolidate the 
previously finalized Promoting Wellness and Optimizing Chronic Disease 
Management MVPs into a single consolidated primary care MVP titled 
Value in Primary Care MVP. Therefore, MVP participants will have a 
total of 16 MVPs available for the CY 2024 performance period/2026 MIPS 
payment year. Due to the availability of new MVPs, we expect an 
increase in the projected number of MVP participants. For each newly 
proposed MVP, we calculated the average quality measure submission rate 
across the measures available in each MVP for the CY 2021 performance 
period/2023 MIPS payment year. The total of these average quality 
measure submissions for each MVP was equivalent to about 2 percent of 
total quality measure submissions in the CY 2021 performance period/
2023 MIPS payment year. We assume there would not be any changes to MVP 
submissions due to the finalizing of our proposal discussed in section 
IV.A.4.b. of this final rule to consolidate the measures in the 
Promoting Wellness and Optimizing Chronic Disease Management MVPs into 
a Value in Primary Care MVP. That is, we assume clinicians who would 
have submitted the Optimizing Chronic Disease Management MVP, or the 
Promoting Wellness MVP would instead submit the Value in Primary Care 
MVP. Therefore, we estimate that 14 percent of the clinicians will 
participate in MVP reporting in the CY 2024 performance period/2026 
MIPS payment year. This is an increase of 2 percentage points from the 
currently approved estimate of 12 percent in the CY 2023 PFS final rule 
(87 FR 70155). We refer readers to Appendix 3: MVP Inventory of this 
final rule for additional details on the MVPs available for the CY 2024 
performance period/2026 MIPS payment year. We assume the changes to the 
existing MVPs and the addition of new MVPs will not impact the 
currently approved number of subgroups. We expect clinician 
participation in subgroups will be relatively low for the CY 2024 
performance period/2026 MIPS payment year due the voluntary subgroup 
reporting option and the additional burden involved for groups to 
organize clinicians into subgroups. Therefore, we did not make any 
adjustments to our previously finalized estimate in the CY 2023 PFS 
final rule (87 FR 70155) that 20 subgroups will participate in MVP 
reporting.
(i) Burden for MVP Registration: Individuals, Groups and APM Entities
    We refer readers to the CY 2023 PFS final rule (87 FR 70155 through 
70156) for our previously finalized burden relevant to MVP registration 
for clinicians participating as an individual and/or group for MVP 
reporting.
    As previously discussed, we estimate that approximately 14 percent 
of the clinicians that currently participate in MIPS will submit data 
for the measures and activities in an MVP. For the CY 2024 performance 
period/2026 MIPS payment year, we assume that the total number of 
individual clinicians, groups, subgroups and APM Entities that will 
complete the MVP registration process is 9,585. In Table 90, we 
estimate that it will take 2,396 hours (9,585 responses x 0.25 hr/
response) at a cost of $247,772 (9,585 registrations x $25.85/
registration) for individual clinicians, groups and APM Entities to 
register for MVP reporting in the CY 2024 performance period/2026 MIPS 
payment year.
[GRAPHIC] [TIFF OMITTED] TR16NO23.121

    In Table 91, we illustrate the net change in burden for MVP 
registration using the currently approved burden in the CY 2023 PFS 
final rule (87 FR 70155 through 70156). In aggregate, for the CY 2024 
performance period/2026 MIPS payment year, the adjustment in the number 
of respondents expected to register for MVP reporting from 7,731 to 
9,585 results in an increase of 1,854 responses. In aggregate, when 
combined with the currently approved per response time estimate, this 
will result in an increase of 463 hours (2,396 hours-1,933 hours) at a 
cost of $47,926 ($247,772-$199,846).

[[Page 79444]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.122

    We did not receive any comments on our proposed requirements and 
burden estimates for the MVP registrations. We note that we adjusted 
the burden estimates from the CY 2024 PFS proposed rule (88 FR 52657 
through 52658) due to the availability of updated data.
(ii) Burden for Subgroup Registration
    We did not propose any changes to our currently approved subgroup 
registration burden (86 FR 65590). We note that the subgroup policies 
discussed in section IV.A.4.d. of this final rule do not impact the 
currently approved burden for subgroup registration. We discuss in 
detail below, the policies and our reasons for not changing the 
currently approved burden for subgroup registration. The burden 
relevant to the subgroup registration requirement is currently approved 
by OMB under control number 0938-1314 (CMS-10621). Consequently, we are 
not making any changes pertaining to subgroup registration under that 
control number.
    As discussed in section IV.A.4.d.(2) of this final rule, we are 
finalizing our proposal to modify Sec.  414.1365(e)(2)(ii) to read 
that, an MVP Participant that is a subgroup will receive the same 
reweighting that is applied to its affiliated group, but that for the 
CY 2023 MIPS performance period/2025 MIPS payment year, if reweighting 
is not applied to the affiliated group, the subgroup may receive 
reweighting in the circumstances independent of the affiliated group as 
described in Sec.  414.1365(e)(2)(ii)(A) and (B). We believe that the 
modification to the subgroup reweighting policy will not impact the 
currently approved burden for subgroup registration because it will not 
change any requirements related to subgroup registration.
    As discussed in section IV.A.4.d.(3) of this final rule, we are 
also finalizing our proposal to modify the text at Sec.  414.1365(e)(3) 
to read that if an MVP Participant, that is not an APM Entity or a 
subgroup, is eligible for facility-based scoring, a facility-based 
score will also be calculated in accordance with Sec.  414.1380(e). 
Additionally, we are finalizing our proposal to add Sec.  
414.1365(e)(4)(i) to read that for subgroups, the affiliated group's 
complex patient bonus will be added to the final score. The revisions 
will not impact the currently approved burden for subgroup registration 
since these changes only modify the regulatory text relevant to 
subgroup scoring policies.
    As discussed in section IV.A.4.d.(4) of this final rule, we are 
finalizing our proposal to modify Sec.  414.1385(a)(1) to read that a 
MIPS eligible clinician, subgroup, or group (including their designated 
support staff), or a third-party intermediary as defined at Sec.  
414.1305, may submit a request for a targeted review. The change will 
not impact the currently approved burden for subgroup registration 
since the addition of subgroups to the targeted review language only 
modifies the regulatory text relevant to the targeted review process 
and does not change the subgroup registration requirements. We 
finalized in the CY 2017 Quality Payment Program final rule that a MIPS 
eligible clinician or group may request a targeted review of the 
calculation of the MIPS payment adjustment factor under section 
1848(q)(6)(A) of the Act and, as applicable, the calculation of the 
additional MIPS payment adjustment factor under section 1848(q)(6)(C) 
of the Act (collectively referred to as the MIPS payment adjustment 
factors) applicable to such MIPS eligible clinician or group for a year 
(81 FR 77546). We note that information collection requirements, such 
as targeted reviews, that are imposed after an administrative action 
are not subject to the PRA under 5 CFR 1320.4(a)(2). Therefore, we are 
not making any adjustments to the currently approved subgroup 
registration burden because of the proposal to add subgroups to the 
targeted review regulation text.
(iii) Burden for MVP Quality Performance Category Submission
    In the CY 2022 PFS final rule (86 FR 65411 through 65415), we 
previously finalized the reporting requirements for the MVP quality 
performance category at Sec.  414.1365(c)(1)(i). As discussed in 
section V.B.11.e. of this rule, we did not propose new requirements to 
submit data for the quality performance category of MVPs. Therefore, we 
are not making any changes to our currently approved per response time 
estimates for submitting the MVP quality performance category data.
    As described in section V.B.11.e.(7)(a) of this final rule, we 
estimate that 14 percent of the clinicians who participated in MIPS for 
the CY 2022 performance period/2024 MIPS payment year will submit data 
for the quality performance category of MVP in the CY 2024 performance 
period/2026 MIPS payment year. We also estimate there will be 20 
subgroup reporters in the CY 2024 performance period/2026 MIPS payment 
year. In Table 92, we estimate that 4,674 clinicians and 10 subgroups 
will submit data using eCQMs collection type at $614.45/response (see 
line q for eCQMs); 2,707 clinicians and 10 subgroups will submit data 
using MIPS CQM and QCDR collection type at $683.73/response (see line q 
for CQM and QCDRs); and 2,184 clinicians and 0 subgroups will submit 
data for the MVP quality performance category using the Medicare Part B 
claims collection type at $1,055.70/response (see line q for claims). 
For the CY 2024 performance period/2026 MIPS payment year, using our 
currently approved per response time estimates

[[Page 79445]]

for the clinicians and subgroups submitting data for the MVP quality 
performance category, we estimate a burden of 24,825 hours [5.3 hr x 
4,684 (4,674 +10) responses] at a cost of $2,878,084 (4,684 responses x 
$614.45/response) for the eCQM collection type, 16,220 hours [5.97 hr x 
2,717 (2,707 +10)] at a cost of $1,857,694 (2,717 responses x $683.73/
responses) for the MIPS CQM and QCDR collection type, and 20,617 hours 
(9.44 hr x 2,184 clinician responses) at a cost of $2,305,649 (2,184 
responses x $1,055.70/response) for the Medicare Part B claims 
collection type.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TR16NO23.123

BILLING CODE 4120-01-C
    Table 93 illustrates the changes in estimated burden for clinicians 
who will submit the MVP quality performance category utilizing the 
eCQM, MIPS CQM and QCDR, and claims collection types in the CY 2024 
performance period/2026 MIPS payment year. We note we used the 
currently approved burden in the CY 2023 PFS final rule (87 FR 70157 
through 70159) as the baseline to determine the net change in burden. 
In aggregate, when combined with our currently approved per response 
time estimate, the increase in 1,854 respondents who will submit data 
for the MVP quality performance category will result in an increase of 
7,505 hours and $870,048 for the eCQM collection type, an increase of 
1,576 hours and $180,499 for the CQM and QCDR collection type, and an 
increase of 1,643 hours and $183,687 for the claims collection type.

[[Page 79446]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.124

    We did not receive any comments on our proposed requirements and 
burden estimates for the MVP quality performance category submission. 
We note that we adjusted the burden estimates from the CY 2024 PFS 
proposed rule (88 FR 52658 through 52660) due to the availability of 
updated data.
(8) Beneficiary Responses to CAHPS for MIPS Survey
    The following changes associated with CAHPS survey vendors to 
submit data for eligible clinicians will be submitted to OMB for review 
under control number 0938-1222 (CMS-10450). We noted that the 
associated burden will be made available for public review and comment 
under the standard non-rule PRA process which includes the publication 
of 60- and 30-day Federal Register notices.
    We refer readers to the CY 2021 Quality Payment Program final rule 
(85 FR 84982 through 84983) for our previously finalized estimated 
burden associated with beneficiary responses to the CAHPS for MIPS 
Survey.
    As discussed in section IV.A.4.f.(1)(c)(ii)(A) of this final rule, 
we are finalizing our proposal to require Spanish language 
administration of the CAHPS for MIPS Survey. Specifically, we are 
finalizing our proposal to require organizations to contract with a 
CMS-approved survey vendor that, in addition to administering the 
survey in English, will administer the Spanish survey translation to 
Spanish-preferring patients using the procedures detailed in the CAHPS 
for MIPS Quality Assurance Guidelines. For requirements and burden, we 
estimate an average administration time of 13.1 minutes (or 0.2183 hr) 
at a pace of 4.5 items per minute for the English version of the 
survey. For the Spanish version, we estimate an average administration 
time of 15.7 minutes (assuming 20 percent more words in the Spanish 
translation). However, since less than 1 percent of surveys were 
administered in Spanish for the CY 2022 performance period/2024 MIPS 
payment year, we are not updating our burden estimates to include the 
time associated with the Spanish version at this time.
    In the CY 2024 PFS proposed rule (88 FR 52660), we proposed to 
adjust the currently approved estimated number of beneficiaries that 
will respond to the CAHPS for MIPS survey. For the CY 2024 performance 
period/2026 MIPS payment year, we estimated that 100 groups will elect 
to report on the CAHPS for MIPS survey. Based on the number of complete 
and partially complete surveys for groups participating in CAHPS for 
MIPS survey administration for the CY 2022 performance period/2024 MIPS 
payment year, we estimated that an average of 255 beneficiaries will 
respond per group for the CY 2024 performance period/2026 MIPS payment 
year. Therefore, we estimated that the CAHPS for MIPS survey will be 
administered to approximately 25,500 beneficiaries for the CY 2024 
performance period/2026 MIPS payment year. This adjustment will result 
in a decrease of 4,452 beneficiary respondents from our currently 
approved estimate of 29,952 beneficiary respondents in the CY 2021 PFS 
final rule (85 FR 84982). As shown in Table 94, for the CY 2024 
performance period/2026 MIPS payment year, we continue to estimate that 
the per response time to administer the survey is 0.2183 hours. This 
will result in an estimated annual burden of 5,567 hours at a cost of 
$165,750.
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[[Page 79447]]


    In Table 95, we illustrate the net change in estimated burden for 
beneficiary response requirements using the currently approved burden 
in the CY 2021 PFS final rule (85 FR 84982 through 84983). In 
aggregate, using our currently approved per response time estimate, the 
decrease in the number of respondents submitting responses for the 
CAHPS for MIPS survey results in a total annual adjustment of -972 
hours at a cost of -$28,938 for the CY 2024 performance period/2026 
MIPS payment year.
[GRAPHIC] [TIFF OMITTED] TR16NO23.126

    We did not receive any comments on our proposed requirements and 
burden estimates for the beneficiaries responding to the CAHPS for MIPS 
Survey.
(9) Group Registration for CAHPS for MIPS Survey
    The following changes will be submitted to OMB for review under 
control number 0938-1222 (CMS-10450). We noted that the associated 
burden will be made available for public review and comment under the 
standard non-rule PRA process which includes the publication of 60- and 
30-day Federal Register notices.
    We refer readers to CY 2019 PFS final rule (83 FR 60009 through 
60010) for the previously approved requirements and burden for group 
registration for the CAHPS for MIPS Survey.
    In the CY 2024 PFS proposed rule (88 FR 52661), we proposed to 
adjust the estimated number of groups registering for the CAHPS for 
MIPS Survey that were previously approved in the CY 2019 PFS final rule 
(83 FR 60009 through 60010) based on updated data from the CY 2022 
performance period/2024 MIPS payment year. We estimated that 266 groups 
will register for the CAHPS for MIPS Survey for the CY 2024 performance 
period/2026 MIPS payment year. This adjustment will result in a 
decrease of 16 group registrations from our currently approved estimate 
of 282 groups in the CY 2019 PFS final rule (83 FR 60010). In Table 96, 
for the CY 2024 performance period/2026 MIPS payment year, we continue 
to estimate that the per response time is 0.75 hours. This will result 
in an estimated annual burden of 200 hours (266 groups x 0.75 hr/
registration) at a cost of $20,628 (266 registrations x $77.55/
registration) for a computer systems analyst).
[GRAPHIC] [TIFF OMITTED] TR16NO23.127

    In Table 97, we illustrate the net change in estimated burden for 
groups registering for the CAHPS for MIPS Survey using the currently 
approved burden in the CY 2019 PFS final rule (83 FR 60009 through 
60010). In aggregate, using our currently approved per response time 
estimate, the decrease in the number of respondents registering for the 
CAHPS for MIPS Survey from 282 to 266 results in a total annual 
adjustment of -12 hours (-16 responses x 0.75 hr/nomination) at a cost 
of -$1,241 for the CY 2024 performance period/2026 MIPS payment year.

[[Page 79448]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.128

    We did not receive any comments on our proposed requirements and 
burden estimates for the groups registering for the CAHPS for MIPS 
Survey.
f. ICRs Regarding the Call for MIPS Quality Measures
    The following changes will be submitted to OMB for review under 
control number 0938-1314 (CMS-10621).
    In this rule, we did not propose any new or revised collection of 
information requirements or burden related to the call for MIPS quality 
measures. However, based on the actual number of quality measure 
submissions received for CMS consideration during the 2023 Annual Call 
for Quality Measures, we adjusted our burden estimates for the CY 2024 
performance period/2026 MIPS payment year.
    In the CY 2024 PFS proposed rule (88 FR 52662), we estimated that 
we will receive 31 quality measure submissions during the 2023 Annual 
Call for Quality Measures, an increase of 2 from the currently approved 
number of quality measure submissions for consideration (87 FR 70159 
through 70160). We did not propose any changes to the 5.5 hour (2.4 hr 
for practice administrator + 3.1 hr for clinician) per response time 
estimate for quality measure submissions.
    In Table 98, we estimate an annual burden of 171 hours (31 measure 
submissions x 5.5 hr/measure) at a cost of $35,529 (31 measure 
submissions x $1,146.11/submission for the CY 2024 performance period/
2026 MIPS payment year.
[GRAPHIC] [TIFF OMITTED] TR16NO23.129

    In Table 99, we illustrate the net change in estimated burden for 
the call for quality measures using the currently approved burden in 
the CY 2023 PFS final rule (87 FR 70159 through 70160). In aggregate, 
the estimated increase in the number of quality measure submissions 
will result in an adjustment of +11 hours (+2 measure submissions x 5.5 
hr/measure submission) at a cost of $2,292 (+2 measure submissions x 
$1,146.11/measure submission) for the CY 2024 performance period/2026 
MIPS payment year.

[[Page 79449]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.130

    We did not receive any comments on our proposed requirements and 
burden estimates for the call for quality measures.
g. ICRs Regarding Promoting Interoperability Data (Sec. Sec.  414.1375 
and 414.1380)
(1) Background
    For the CY 2024 performance period/2026 MIPS payment year, MIPS 
eligible clinicians, groups, subgroups, and APM Entities can submit 
Promoting Interoperability performance category data through direct log 
in and upload or log in and attest submission types. We note that the 
log in and attest submission type is only available for the Promoting 
Interoperability performance category and is not available for the 
quality performance category. With the exception of submitters who 
elect to use the log in and attest submission type for the Promoting 
Interoperability performance category, we anticipated that MIPS 
eligible individual clinicians, groups, subgroups, and APM Entities 
will use the same data submission type for both the quality and 
Promoting Interoperability performance categories and that the 
clinicians, practice managers, and computer systems analysts involved 
in supporting the quality data submission will also support the 
Promoting Interoperability data submission process. The following 
burden estimates show only incremental hours required above and beyond 
the time already accounted for in the quality data submission process. 
We note that this analysis assesses burden by performance category and 
submission type and emphasizes that MIPS is a consolidated program. We 
analyzed data submitted by MIPS eligible clinicians, groups, subgroups 
and APM Entities, and assesses clinician performance based on all the 
four MIPS performance categories, as applicable.
(2) Reweighting Applications for Promoting Interoperability and Other 
Performance Categories
    The following changes will be submitted to OMB for review under 
control number 0938-1314 (CMS-10621).
    We refer readers to the CY 2017 Quality Payment Program final rule 
(81 FR 77240 through 77243), CY 2018 Quality Payment Program final rule 
(82 FR 53918 through 53919), and the CY 2019, CY 2020, CY 2021, CY 
2022, and CY 2023 PFS final rules (83 FR 60011 through 60012, 84 FR 
63134 through 63135, 85 FR 84984 through 84985, 86 FR 65596 through 
65598, and 87 FR 70160 through 70162, respectively) for our previously 
finalized requirements for, and our analysis of the information 
collection and reporting burden associated with, reweighting 
applications for Promoting Interoperability and other performance 
categories.
    As established in the CY 2017 and CY 2018 Quality Payment Program 
final rules, MIPS eligible clinicians may submit an application 
requesting reweighting to zero percent for the Promoting 
Interoperability, quality, cost, and/or improvement activities 
performance categories under specific circumstances as set forth in 
Sec.  414.1380(c)(2), including, but not limited to, extreme and 
uncontrollable circumstances and significant hardship or other type of 
exception (81 FR 77240 through 77243, 82 FR 53680 through 53686, and 82 
FR 53783 through 53785). Table 100 summarizes our analysis of the 
estimated burden, including for MIPS eligible clinicians to apply for 
reweighting of the Promoting Interoperability performance category and 
other performance categories to zero percent due to a significant 
hardship or other exception as provided in Sec.  414.1380(c)(2)(i).
    Respondents (MIPS eligible individual clinicians, groups, or APM 
Entities) who apply for a reweighting of the quality, cost, and/or 
improvement activities performance categories have the option of 
applying for reweighting of the Promoting Interoperability performance 
category on the same online form. We assume respondents applying for a 
reweighting of the Promoting Interoperability performance category due 
to extreme and uncontrollable circumstances (for example, PHE for 
COVID-19, vendor issues, etc.) will also request a reweighting of at 
least one of the other performance categories simultaneously and not 
submit multiple reweighting applications.
    As discussed in section IV.A.4.f.(4)(f) of this final rule, we are 
finalizing our proposal to continue the existing policy of CMS 
automatically reweighting the Promoting Interoperability performance 
category for clinical social workers for the CY 2024 performance 
period/2026 MIPS payment year and making the corresponding revisions to 
the regulatory text at Sec.  414.1380(c)(2)(i)(A)(4)(iii). In our 
analysis of the information collection and reporting burden, we did not 
adjust our estimated number of respondents submitting reweighting 
applications due to this proposal because these changes only modify the 
regulatory text and do not change the existing reweighting policy for 
these clinician types participating in MIPS in the CY 2024 performance 
period/2026 MIPS payment year. To further clarify, these clinician 
types are automatically reweighted for the Promoting Interoperability 
performance category and do not need to submit a reweighting 
application, and therefore do not impact our information collection and 
reporting burden analysis.
    Based on the number of reweighting applications received at the 
time of the publication of this rule for the CY 2022 performance 
period/2024 MIPS payment year, we adjusted our burden

[[Page 79450]]

estimates relevant to this ICR. In this final rule, we estimate that we 
will receive a total of 29,227 applications to request reweighting for 
any or all the four MIPS performance categories for the CY 2024 
performance period/2026 MIPS payment year. Out of the 29,227, we 
estimate that 2,706 respondents will submit a request to reweight the 
Promoting Interoperability performance category to zero percent due to 
a significant hardship or other exception as provided in Sec.  
414.1380(c)(2)(i)(C). We estimate that the remaining 26,510 respondents 
will submit a request to reweight one or more of the quality, cost, 
Promoting Interoperability, or improvement activities performance 
categories due to an extreme or uncontrollable circumstance as provided 
in Sec.  414.1380(c)(2)(i). Additionally, we estimated 11 APM Entities 
will submit an extreme and uncontrollable circumstances exception 
application for the CY 2024 performance period/2026 MIPS payment year. 
This adjustment results in an increase of 23,788 respondents compared 
to our currently approved estimate of 5,439 respondents (87 FR 70161). 
This increase is based on the actual number of reweighting applications 
submitted for the CY 2022 performance period/2024 MIPS payment year. We 
note this estimate reflects the significant increase in the number of 
submitted applications due to extending the deadline, as a result of 
the ongoing PHE for COVID-19 at the time, for submitting the 
reweighting applications for the CY 2022 performance period/2024 MIPS 
payment year to March 3rd, 2023.
    Consistent with our assumptions in the CY 2023 PFS final rule (87 
FR 70160 through 70162), we continued to estimate it will take 0.25 
hours for a computer system analyst to complete and submit the 
reweighting application. In Table 100, we estimate an annual burden of 
7,307 hours (29,227 applications x 0.25 hr/application) at a cost of 
$755,518 (29,227 applications x $25.85/application).
[GRAPHIC] [TIFF OMITTED] TR16NO23.131

    In Table 101, we illustrate the net change in estimated burden for 
submission of reweighting applications for Promoting Interoperability 
and other performance categories using the currently approved burden in 
the CY 2023 PFS final rule (87 FR 70160 through 70162). The adjustment 
in the estimated number of respondents, from 5,439 to 29,227 
respondents, results in an increase of 23,788 respondents. In 
aggregate, using our currently approved per response time estimate, as 
shown in Table 101, the increase in 23,788 respondents results in an 
increase of 5,947 hours (+23,788 responses x 0.25 hr/response) and 
$614,920 (+5,947 hr x $103.40/hr) for the CY 2024 performance period/
2026 MIPS payment year.
[GRAPHIC] [TIFF OMITTED] TR16NO23.132

    We did not receive any comments on our proposed requirements and 
burden estimates for the submission of reweighting applications for 
Promoting Interoperability and other performance categories.

[[Page 79451]]

(3) Submitting Promoting Interoperability Data
    The following changes relevant to the submission of Promoting 
Interoperability data requirements and burden will be submitted for 
approval under OMB under control number 0938-1314 (CMS-10621). We note 
that we adjusted the burden estimates from the CY 2024 PFS proposed 
rule (88 FR 52664 through 52665) due to the availability of updated 
data from the CY 2022 performance period/2024 MIPS payment year.
    We refer readers to the CY 2017 and CY 2018 Quality Payment Program 
final rules (81 FR 77509 through 77511, and 82 FR 53919 through 53920, 
respectively), and the CY 2019, CY 2020, CY 2021, CY 2022, and CY 2023 
PFS final rules (83 FR 60013 through 60014, 84 FR 63135 through 63137, 
85 FR 84985 through 84987, 86 FR 65598 through 65600, and 87 FR 70162 
through 70164, respectively) for our previously finalized requirements 
and burden for submission of data for the Promoting Interoperability 
performance category.
    As discussed in section IV.A.4.f.(4)(b) of this final rule, we are 
finalizing our proposal to require a continuous 180-day performance 
period for the Promoting Interoperability performance category 
beginning with the CY 2024 performance period/2026 MIPS payment year 
and are revising the regulation text at Sec.  414.1320 to reflect this 
change. We assume MIPS eligible clinicians and groups that currently 
submit data for the Promoting Interoperability performance category 
will utilize the CEHRT for an entire calendar year performance period 
and therefore, the increase in the length of the performance period for 
the Promoting Interoperability performance category from 90 to 180 days 
will not create additional burden for MIPS eligible clinicians and 
groups that will submit data for the Promoting Interoperability 
performance category. We note that this is consistent with the 
discussion of burden for the above policy in the FY 2022 IPPS final 
rule (86 FR 45515).
    As discussed in section IV.A.4.f.(4)(d)(i) of this final rule, we 
are finalizing our proposed changes to the Query of Prescription Drug 
Monitoring Program Measure under the Electronic Prescribing Objective. 
Specifically, we are modifying the second exclusion for the Query of 
PDMP measure as proposed so that it reads as follows: Any MIPS eligible 
clinician who does not electronically prescribe any Schedule II opioids 
or Schedule III or IV drugs during the performance period. The changes 
will not affect the requirements for MIPS eligible clinicians and 
groups that submit data for the Promoting Interoperability performance 
category since the revision is meant to revise the previously finalized 
second exclusion in the CY 2018 Quality Payment Program final rule (82 
FR 53679). Therefore, we are not making any adjustments to our 
currently approved estimated burden for this ICR.
    As discussed in section IV.A.4.f.(4)(d)(ii) of this final rule, we 
are finalizing to revise the e-Prescribing measure description in Table 
51 to read ``At least one permissible prescription written by the MIPS 
eligible clinician is transmitted electronically using CEHRT'' and the 
numerator will be updated to read to indicate ``Number of prescriptions 
in the denominator generated and transmitted electronically using 
CEHRT'' to reflect the removal of the health IT certification criterion 
``drug-formulary and preferred drug list checks.'' These revisions will 
not affect the requirements for MIPS eligible clinicians and groups 
that submit data for the Promoting Interoperability performance 
category since these changes provide technical updates to the e-
prescribing measure. Therefore, we are not making any adjustments to 
our currently approved estimated burden for this ICR.
    As discussed in section IV.A.4.f.(4)(d)(iii) of this final rule, we 
are finalizing our proposal to modify our requirements for the SAFER 
Guides measure beginning with the CY 2024 performance period/2026 MIPS 
payment year and subsequent years, to require MIPS eligible clinicians 
conduct, and therefore attest ``yes'' to having completed an annual 
self-assessment of the CEHRT using the High Priority Practices SAFER 
Guide. Additionally, we are finalizing our proposal to amend the 
regulatory text at Sec.  414.1375(b)(2)(ii)(C) to clearly specify that 
a MIPS eligible clinician must submit an attestation, with either an 
affirmative or negative response, with respect to whether the MIPS 
eligible clinician completed the annual self-assessment under the SAFER 
Guides measure during the year in which the performance period occurs; 
this regulatory provision will only be applicable for the 2024 MIPS 
payment year through the 2025 MIPS payment year. We noted we have 
captured the estimated burden for reporting this measure in the CY 2022 
PFS final rule (86 FR 65599) and the revision will not affect the data 
collection and submission requirements for MIPS eligible clinicians and 
groups that submit data for the Promoting Interoperability performance 
category. Therefore, we are not making any adjustments to our currently 
approved estimated burden for this ICR.
    As shown in Table 102, based on updated data from the CY 2022 
performance period/2024 MIPS payment year, we are adjusting our 
currently approved estimated burden for the submission of data in 
Promoting Interoperability performance category (87 FR 70162 through 
70164). We estimate that a total number of 25,990 respondents, 
consisting of 19,292 individual MIPS eligible clinicians, 6,678 groups 
and virtual groups, and 20 subgroups will submit data for the Promoting 
Interoperability performance category in the CY 2024 performance 
period/2026 MIPS payment year. For MIPS eligible clinicians 
participating in an APM, we assume that each MIPS eligible clinician in 
an APM Entity reports data for the Promoting Interoperability 
performance category through either their group TIN or individual 
reporting. Sections 1899 and 1115A of the Act (42 U.S.C. 1395jjj and 42 
U.S.C. 1315a, respectively) state that the Shared Savings Program and 
the testing, evaluation, and expansion of Innovation Center models are 
not subject to the PRA. However, in the CY 2019 PFS final rule, we 
established that MIPS eligible clinicians who participate in the Shared 
Savings Program are no longer limited to reporting for the Promoting 
Interoperability performance category through their ACO participant TIN 
(83 FR 59822 through 59823). Burden estimates for this rule assume 
group TIN-level reporting as we believe this is the most reasonable 
assumption for the Shared Savings Program, which requires that ACOs 
include full TINs as ACO participants.

[[Page 79452]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.133

    As shown in Table 103, we are not making any changes to the 
currently approved estimated time of 2.70 hours per response. 
Therefore, we estimate that it will result in a total burden of 70,173 
hours (25,990 respondents x 2.70 incremental hours for a computer 
analyst's time above and beyond the physician, medical and health 
services manager, and computer system's analyst time required to submit 
quality data) and $7,989,083 (81,289 hrs x $98.28/hr)) to submit data 
for the Promoting Interoperability performance category in the CY 2024 
performance period/2026 MIPS payment year.
[GRAPHIC] [TIFF OMITTED] TR16NO23.134

    As shown in Table 104, we illustrate the change in burden for 
clinicians to submit data in the Promoting Interoperability performance 
category for the CY 2024 performance period/2026 MIPS payment year. In 
aggregate, we estimate that the decrease in the number of respondents 
from 30,107 to 25,990 will result in a decrease of 11,116 hours (-4,117 
respondents x 2.70 hrs/response) at a cost of -$1,149,384 (-4,117 
respondents x $279.18/response).

[[Page 79453]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.135

    We did not receive any comments on our proposed requirements and 
burden estimates for the data submission in the Promoting 
Interoperability performance category. We note that we adjusted the 
burden estimates from the CY 2024 PFS proposed rule (88 FR 52664 
through 52665) due to the availability of updated data from the CY 2022 
performance period/2024 MIPS payment year.
h. ICRs Regarding the Nomination of Promoting Interoperability Measures
    The following changes associated with the information collection 
related to the nomination of Promoting Interoperability measures will 
be submitted to OMB for review to remove the information collection 
relevant to the nomination of Promoting Interoperability measures under 
control number 0938-1314 (CMS 10621). This rule does create any new or 
revised collection of information requirements or burden related to the 
nomination of Promoting Interoperability performance category measures. 
Due to a consistent decline in the number of submissions received for 
the Promoting Interoperability performance category measures, we 
estimated to receive fewer than 10 responses for this ICR. Therefore, 
we proposed to remove the ICR for nomination of Promoting 
Interoperability performance category measures.
    As shown in Table 105, we estimated an annual burden of zero hours 
at a cost of $0 for the CY 2024 performance period/2026 MIPS payment 
year.
[GRAPHIC] [TIFF OMITTED] TR16NO23.136

    In Table 106, we illustrated the net change in estimated burden for 
nomination of Promoting Interoperability measures using the currently 
approved burden in the CY 2023 PFS final rule (87 FR 70163). The 
removal of the ICR for nomination of Promoting Interoperability 
measures results in a decrease of 5 hours (-10 responses x 0.5 hr/
response) and a decrease of $918 for the CY 2024 performance period/
2026 MIPS payment year.

[[Page 79454]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.137

    We did not receive any comments on our proposal to remove the ICR 
for the nomination of Promoting Interoperability measures.
i. ICRs Regarding Improvement Activities Submission (Sec. Sec.  
414.1305, 414.1355, 414.1360, and 414.1365)
    The following requirements and burden will be submitted for 
approval under OMB control number 0938-1222 (CMS-10450).
    As discussed in section IV.A.4.f.(3)(b)(ii) of this final rule, we 
are finalizing our proposed changes to the improvement activities 
inventory for the CY 2024 performance period/2026 MIPS payment year and 
future years as follows: adding five new improvement activities; 
modifying one existing improvement activity; and removing three 
previously adopted improvement activities. We do not believe the 
changes will impact our currently approved time for interested parties 
to submit information because MIPS eligible clinicians are still 
required to submit the same number of activities and the estimated per 
response time for each activity is uniform. Therefore, we are not 
adjusting our currently approved burden for improvement activities 
submission as a result of this proposal.
    As shown in Table 107, we are adjusting the currently approved 
burden estimates (87 FR 70164 through 70165) due to availability of 
updated data from the CY 2022 performance period/2024 MIPS payment 
year. We estimate that a total of 50,269 respondents consisting of 
37,939 individual clinicians, 12,330 groups and 20 subgroups will 
submit improvement activities during the CY 2024 performance period/
2026 MIPS payment year. This adjustment represents an increase of 6,153 
respondents from the currently approved estimate of 44,136 respondents 
in the CY 2023 PFS final rule (87 FR 70164 through 70165). As discussed 
in section V.B.11.e.(2) of this final rule, we did not include in our 
estimates clinicians who participate in an APM Entity and are 
determined to be QPs for the CY 2024 performance period/2026 MIPS 
payment year as we assume they will not be required to submit 
improvement activities data.
[GRAPHIC] [TIFF OMITTED] TR16NO23.138

    As shown in Table 108, we continue to estimate that the time 
required per response per individual or group is 5 minutes or 0.083 
hours for a computer system analyst at a labor rate of $103.40/hr to 
submit by logging in and manually attesting that certain activities 
were performed in the form and manner specified by CMS with a set of 
authenticated credentials. Therefore, we estimate an annual burden of 
4,174 hours (50,289 respondents x 0.083 hr/response) at a cost of 
$431,480 (50,289 respondents x $8.58/response)) for the CY 2024 
performance period/2026 MIPS payment year.

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    As shown in Table 109, using our unchanged currently approved per 
respondent burden estimate, the increase in the number of respondents 
results in an increase of 511 hours (+6,153 respondents x 0.083 hr/
respondent) at a cost of $52,793 (+6,153 respondents x $8.58/response) 
for the CY 2024 performance period/2026 MIPS payment year.
[GRAPHIC] [TIFF OMITTED] TR16NO23.140

    We did not receive any comments on our proposed requirements and 
burden estimates for the submission of improvement activities. We note 
that we updated the burden estimates from the CY 2024 PFS proposed rule 
(87 FR 52666) due to the availability of updated data.
j. ICRs Regarding the Nomination of Improvement Activities (Sec.  
414.1360)
    The changes associated with data submission will be submitted to 
OMB for review under control number 0938-1314 (CMS 10621).
    In the CY 2024 PFS proposed rule (88 FR 52666 through 52667), based 
on the actual number of respondents that submitted improvement activity 
nominations, we proposed to adjust the estimated number of improvement 
activity nominations that were previously approved in the CY 2022 PFS 
final rule (86 FR 65603 through 65605). We estimate that we will 
receive approximately 15 improvement activity nominations for the CY 
2024 performance period/2026 MIPS payment year. This adjustment will 
result in a decrease of 16 improvement activity nominations from our 
currently approved estimate of 31 nominations in the CY 2022 PFS final 
rule (86 FR 65605). In Table 110, for the CY 2024 performance period/
2026 MIPS payment year, we continue to estimate that the per response 
time is 4.4 hours. This will result in an estimated annual burden of 66 
hours (15 nominations x 4.4 hr/nomination) at a cost of $11,755 (15 x 
[(2.8 hr x $123.06/hr for a medical and health services manager) + (1.6 
hr x $274.44/hr for a physician)]).

[[Page 79456]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.141

    In Table 111, we illustrate the net change in estimated burden for 
nomination of improvement activities using the currently approved 
burden in the CY 2022 PFS final rule (86 FR 65605). In aggregate, using 
our currently approved per response time estimate, the proposed 
decrease in the number of respondents submitting improvement activity 
nominations results in a total annual adjustment of -70 hours (-16 
responses x 4.4 hr/nomination) at a cost of -$12,539 (-16 x [(2.8 hr x 
$123.06/hr) + (1.6 hr x $274.44/hr)]) for the CY 2024 performance 
period/2026 MIPS payment year.
[GRAPHIC] [TIFF OMITTED] TR16NO23.142

    We did not receive any comments on our proposed requirements and 
burden estimates for the nomination of improvement activities.
k. Nomination of MVPs
    We did not propose any new or revised collection of information 
requirements or burden related to the nomination of MVPs for the CY 
2024 performance period/2026 MIPS payment year. The requirements and 
burden for nomination of MVPs are currently approved by OMB under 
control number 0938-1314 (CMS-10621). Consequently, we are not making 
any changes to the nomination of MVPs under that control number.
l. ICRs Regarding the Cost Performance Category (Sec.  414.1350)
    The cost performance category relies on administrative claims data. 
The Medicare Parts A and B claims submission process (OMB control 
number 0938-1197; CMS-1500 and CMS-1490S) is used to collect data on 
cost measures from MIPS eligible clinicians. MIPS eligible clinicians 
are not required to provide any documentation by CD or hardcopy. 
Moreover, the policies in this rule do not result in the need to add or 
revise or delete any claims data fields. Consequently, we are not 
making any changes under that control number.
m. ICRs Regarding Partial QP Elections (Sec. Sec.  414.1310(b) and 
414.1430)
    We did not propose any new or revised collection of information 
requirements or burden related to the Partial QP Elections to 
participate in MIPS as a MIPS eligible clinician in the CY 2024 
performance period/2026 MIPS payment year. The requirements and burden 
for Partial QP Elections are currently approved by OMB under control 
number 0938-1314 (CMS-10621). Consequently, we are not making any 
changes to Partial QP Elections under that control number.
n. ICRs Regarding Other Payer Advanced APM Determinations: Payer-
Initiated Process (Sec.  414.1445) and Eligible Clinician-Initiated 
Process (Sec.  414.1445)
    We did not propose any new or revised collection of information 
requirements related to Other Payer Advanced APM determinations for the 
CY 2024 performance period/2026 MIPS payment year.
(1) Payer-Initiated Process (Sec.  414.1445)
    We did not propose any new or revised collection of information 
requirements related to the Payer-Initiated Process for the CY 2024 
performance period/2026 MIPS payment year. The requirements and

[[Page 79457]]

burden associated with this information collection are currently 
approved by OMB under control number 0938-1314 (CMS-10621). 
Consequently, we are not making any changes to the Payer-Initiated 
process under that control number.
(2) Eligible Clinician-Initiated Process (Sec.  414.1445)
    We did not propose any new or revised collection of information 
requirements or burden related to the Eligible Clinician-Initiated 
Process for the CY 2024 performance period/2026 MIPS payment year. The 
requirements and burden associated with this information collection are 
currently approved by OMB under control number 0938-1314 (CMS-10621). 
Consequently, we are not making any changes to the Eligible Clinician-
Initiated Process under that control number.
(3) Submission of Data for QP Determinations Under the All-Payer 
Combination Option (Sec.  414.1440)
    We did not propose any new or revised collection of information 
requirements or burden related to the Submission of Data for QP 
Determinations under the All-Payer Combination Option for the CY 2024 
performance period/2026 MIPS payment year. The requirements and burden 
for the All-Payer Combination option are currently approved by OMB 
under control number 0938-1314 (CMS-10621). Consequently, we are not 
making any changes under that control number.
o. ICRs Regarding Voluntary Participants Election To Opt-Out of 
Performance Data Display on Compare Tools (Sec.  414.1395)
    We did not propose any new or revised collection of information 
requirements or burden related to the election by voluntary 
participants to opt-out of public reporting on Compare Tools for the CY 
2024 performance period/2026 MIPS payment year. The requirements and 
burden associated with this information collection are currently 
approved by OMB under control number 0938-1314 (CMS-10621). 
Consequently, we are not making any changes to the election of 
voluntary participants to opt-out of performance data display on 
Compare Tools under that control number.
p. Summary of Annual Quality Payment Program Burden Estimates
    Table 112 summarizes this rule's total burden estimates for the 
Quality Payment Program for the CY 2024 performance period/2026 MIPS 
payment year.
    In the CY 2023 PFS final rule, the total estimated burden for the 
CY 2024 performance period/2026 MIPS payment year (see Table 112, row 
a) was 710,644 hours at a cost of $75,687,130 (87 FR 70169). Accounting 
for updated wage rates and the subset of all Quality Payment Program 
ICRs outlined in this rule compared to the CY 2023 PFS final rule, the 
total estimated annual burden of continuing policies and information 
set forth in the CY 2023 PFS final rule into the CY 2024 performance 
period/2026 MIPS payment year is 710,964 hours at a cost of $79,563,761 
(see Table 112, row b). These represent an increase of 320 hours and an 
increase of $3,876,631. To understand the burden implications of the 
policies in this rule, we provided an estimate of the total burden 
associated with continuing the policies and information collections set 
forth in the CY 2023 PFS final rule into the CY 2024 performance 
period/2026 MIPS payment year. The estimated burden of 728,359 hours at 
a cost of $81,799,657 (see Table 112, row c) reflects the availability 
of more accurate data to account for all potential respondents and 
submissions across all the performance categories and represents an 
increase of 17,395 hours and $2,235,896 (see Table 112, row d). Our 
total burden estimate for the CY 2024 performance period/2026 MIPS 
payment year is 724,212 hours and $81,332,556 (see Table 112, row e), 
which represents an increase of 13,248 hours and $1,758,795 from the CY 
2023 PFS final rule estimate with updated wage rates and ICRs (see 
Table 112, row f). The difference of -4,147 hours (13,248 hours-17,395 
hours) and -$477,101 ($1,758,795-$2,235,896) (see Table 112, row g) 
between this estimate and the total burden shown in Table 112 is the 
decrease in burden associated with impacts of the policies for the CY 
2024 performance period/2026 MIPS payment year.
BILLING CODE 4120-01-P

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[GRAPHIC] [TIFF OMITTED] TR16NO23.145

    Table 114 provides the reasons for changes in the estimated burden 
for information collections in the Quality Payment Program segment of 
this final rule. We have divided the reasons for our change in burden 
into those related to policies in the CY 2024 PFS rule and those 
related to adjustments in burden continued from the CY 2023 PFS final 
rule policies that reflect updated data and revised methods.

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C. Summary of Annual Burden Estimates for Changes

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BILLING CODE 4120-01-C

VI. Regulatory Impact Analysis

A. Statement of Need

    In this final rule, we are finalizing payment and policy changes 
under the Medicare PFS and required statutory changes under the 
Consolidated Appropriations Act, 2021 (CAA, 2021); sections 301, 302, 
303, 304, and 305 under the Consolidated Appropriations Act, 2022 (CAA, 
2022); sections 2003 and 2005 of the SUPPORT for Patients and 
Communities Act of 2018, sections 4113, 4114, and 4121 under the 
Consolidated Appropriations Act of 2023 (CAA, 2023), section 90004 of 
the Infrastructure Investment and Jobs Act, section 6 of the Sustaining 
Excellence in Medicaid Act of 2019, and sections 11101, 11402, 11403, 
11407 under the Inflation Reduction Act (IRA). Our policies in this 
rule specifically address: changes to the PFS; other changes to 
Medicare Part B payment policies to ensure that payment systems are 
updated to reflect changes in medical practice, the relative value of 
services, and changes in the statute; updates and refinements to 
Medicare Shared Savings Program (Shared Savings Program) requirements; 
updates to the Quality Payment Program; updates to the Medicare 
coverage of opioid use disorder services furnished by opioid treatment 
programs; updates to certain Medicare provider enrollment policies; 
updates to electronic prescribing for controlled substances for a 
covered Part D drug under a prescription drug plan or an MA-PD plan 
(section 2003 of the SUPPORT Act); changes to the regulations 
associated with the Ambulance Fee Schedule and the Medicare Ground 
Ambulance Data Collection System; and changes to release Medicare 
Advantage risk adjustment data early for use with Care Compare 
websites. The policies reflect CMS' stewardship of the Medicare program 
and overarching policy objectives for ensuring equitable beneficiary 
access to appropriate and quality medical care.
1. Statutory Provisions
a. Extension of Certain Medicare Telehealth Flexibilities, Under 
Section 1834(m) of the Act, as Amended by the CAA, 2023
    Section II.D.1.e. of this final rule implements section 4113, of 
the CAA, 2023, which extended through CY 2024 several temporary 
flexibilities for Medicare telehealth services adopted during the PHE 
for COVID-19. Specifically, section 4113 extended the temporary 
inapplicability of geographic and location restrictions, extended the 
temporary expansion of practitioner types who can be paid for Medicare 
telehealth services, delayed the in-person visit requirements for 
mental health services furnished via telehealth, and extended audio-
only flexibilities for certain telehealth services. This provision is 
necessary to fulfill the

[[Page 79463]]

statutory requirement to implement this extension through December 31, 
2024.
b. Drugs and Biological Products Paid Under Medicare Part B
    In section III.A.1. of this final rule, we discuss regulations text 
changes to implement provisions of the Inflation Reduction Act of 2022 
that affect payment amounts or patient out-of-pocket costs for certain 
drugs and biologicals payable under Part B. Two provisions affect 
payment amounts for biosimilar biological products. Section 11402 of 
the IRA amends the payment limit for new biosimilars furnished on or 
after July 1, 2024 during the initial period when ASP data is not 
available. Section 11403 makes changes to the payment limit for certain 
biosimilar products with an ASP that is not more than the ASP of the 
reference biological for a period of 5 years. Two other provisions make 
statutory changes to patient out-of-pocket costs for certain drugs 
payable under Medicare Part B. Section 11101 of the IRA requires that 
beneficiary coinsurance for a Part B rebatable drug is to be based on 
the inflation-adjusted payment amount if the Medicare payment amount 
for a calendar quarter exceeds the inflation-adjusted payment amount, 
beginning on April 1, 2023. Section 11407 makes statutory changes to 
waive the deductible for insulin that is furnished through a covered 
item of durable medical equipment (DME) and establishes a $35 cap on 
cost sharing for a month's supply of insulin furnished through a 
covered item of DME, both beginning July 1, 2023.
    In section III.A.3. of this final rule, we discuss policies to 
implement section 90004 of the Infrastructure Investment and Jobs Act 
(Pub. L. 117-9, November 15, 2021) (IIJA) which requires drug 
manufacturers to provide a refund to CMS for certain discarded amounts 
from a refundable single-dose container or single-use package drug. 
These provisions are necessary to fulfill the statutory requirement to 
implement this policy effective January 1, 2023 and reduce unnecessary 
Medicare spending for discarded drug.
c. Rural Health Clinics (RHCs) and Federally Qualified Health Centers 
(FQHCs)
    In section III.B.2. of this final rule, we implement sections 4113, 
4121, and 4124 of the CAA, 2023. Section 4113 of the CAA, 2023 amends 
section 1834(m)(8) of the Act to extend payment for telehealth services 
furnished by RHCs and FQHCs for the limited period beginning on the 
first day after the end of the PHE for COVID-19 and ending on December 
31, 2024. Section 4113 also delays the in-person requirements under 
Medicare for mental health visits furnished by RHCs and FQHCs via 
telecommunications technology until January 1, 2025.
    Section 4121 of the CAA, 2023 amends section 1861(aa)(1)(B) of the 
Act by adding marriage and family therapists (MFT) and mental health 
counselors (MHC) as eligible practitioners of RHCs and FQHCs beginning 
January 1, 2024. Section 4121 allows MFTs and MHCs to bill directly and 
be paid as an RHC and FQHC practitioner under the RHC AIR an FQHC PPS.
    Section 4124 of the CAA, 2023 establishes an Intensive Outpatient 
benefit in RHCs and FQHCs. Final policies related to implementation of 
IOP for RHCs and FQHCs are outlined in the CY 2024 OPPS final rule.
d. Clinical Laboratory Fee Schedule (CLFS)--Revisions Consistent With 
Recent Statutory Changes
    In section III.D. of this final rule, we discuss the conforming 
regulations text changes for CLFS data reporting requirements due to 
the enactment of section 4114 of the CAA, 2023. For clinical diagnostic 
laboratory tests (CDLTs) that are not advanced diagnostic laboratory 
tests (ADLTs), the CAA, 2023 delayed the next data reporting period by 
one year. Instead of taking place from January 1, 2023 through March 
31, 2023, data reporting will now take place from January 1, 2024 
through March 31, 2024, based on the original data collection period of 
January 1, 2019 through June 30, 2019. Data reporting for these tests 
then resumes on a 3-year cycle (2027, 2030, etc.). Additionally, the 
CAA, 2023 amended the statutory provisions for the phase-in of payment 
reductions resulting from private payor rate implementation to specify 
that the applicable percent in CY 2023 is 0 percent, meaning that the 
payment amount determined for a CDLT for CY 2023 shall not result in 
any reduction in payment as compared to the payment amount for that 
test for CY 2022. The CAA, 2023 further amended the statutory phase-in 
provisions to provide that for CYs 2024 through 2026, the payment 
amount for a CDLT may not be reduced by more than 15 percent as 
compared to the payment amount for that test established in the 
preceding year.
e. Pulmonary Rehabilitation (PR), Cardiac Rehabilitation (CR) and 
Intensive Cardiac Rehabilitation (ICR) Expansion of Supervising 
Practitioners
    In section III.E. of this final rule, we are finalizing the 
proposed revisions to Sec. Sec.  410.47 (PR) and 410.49 (CR/ICR) to add 
to the types of practitioners who may supervise PR, CR and ICR programs 
to also include a physician assistant (PA), nurse practitioner (NP) or 
clinical nurse specialist (CNS). These provisions are necessary to 
fulfill the statutory requirement to implement these changes made in 
section 51008 of the Bipartisan Budget Act of 2018 (Pub. L. 115-123, 
enacted February 9, 2018) (BBA of 2018) effective January 1, 2024.
f. Requirement for Electronic Prescribing for Controlled Substances for 
a Covered Part D Drug Under a Prescription Drug Plan or an MA-PD Plan 
(Section 2003 of the SUPPORT Act)
    In the CY 2024 PFS proposed rule (88 FR 52531 through 52536), we 
proposed changes to the electronic prescribing for controlled 
substances (EPCS) requirement specified in section 2003 of the SUPPORT 
Act (referred to as the CMS EPCS Program). The provisions finalized in 
section III.M. of this final rule specify the basis for the evaluation 
of compliance by describing how prescriptions are calculated, remove 
the same entity exception while conditioning the electronic prescribing 
requirement as subject to the exemption in Sec.  423.160(a)(3)(iii), 
identify non-compliance actions for subsequent measurement years, and 
update other CMS EPCS Program exceptions. Previously finalized policies 
did not include actions for non-compliance after the 2024 measurement 
year, and we needed to identify actions for non-compliance in 
subsequent measurement years.
g. Ambulance Fee Schedule and the Medicare Ground Ambulance Data 
Collection System
    Section 4103 of the CAA amended section 1834(l)(12)(A) and (l)(13) 
of the Act to extend the payment add-ons set forth in those subsections 
through December 31, 2024. The ambulance extender provisions are 
enacted through legislation that is self-implementing. In this final 
rule, we are finalizing our proposal only to revise the dates in Sec.  
414.610(c)(1)(ii) and (c)(5)(ii) to conform the regulations to these 
self-implementing statutory requirements.
    Section 1834(l)(17)(A) of the Act requires the Secretary to develop 
a data collection system (which may include

[[Page 79464]]

use of a cost survey) to collect cost, revenue, utilization, and other 
information determined appropriate by the Secretary for providers and 
suppliers of ground ambulance services. In this final rule, we are 
finalizing our proposed revisions to the Medicare Ground Ambulance Data 
Collection Instrument. The changes and clarifications aimed to reduce 
burden on respondents, improve data quality, or both.
h. Quality Payment Program
    This final rule is also necessary to make changes to the Quality 
Payment Program to move the program forward to focus more on 
measurement efforts, refine how clinicians will be able to participate 
in a more meaningful way through the Merit-based Incentive Payment 
System (MIPS) Value Pathways (MVPs), and highlight the value of 
participating in Advanced Alternative Payment Models (APMs). Authorized 
by MACRA, the Quality Payment Program is an incentive program that 
includes two participation tracks, MIPS and Advanced APMs. MIPS 
eligible clinicians are subject to a MIPS payment adjustment based on 
their performance in four performance categories: cost, quality, 
improvement activities, and Promoting Interoperability. Currently, 
reporting for traditional MIPS is seen as siloed across the performance 
categories. These policy proposals are intended to promote better 
quality reporting to improve patient health outcomes by coordinating 
reporting for MIPS across performance categories, and make changes to 
scoring that will provide a better picture of clinicians' performance.
2. Discretionary Provisions
a. Drugs and Biological Products Paid Under Medicare Part B
    Section III.A.3. of this final rule, as part of our continued 
implementation of section 90004 of the Infrastructure Investment and 
Jobs Act (Pub. L. 117-9, November 15, 2021) (IIJA), which amended 
section 1847A of the Act to require manufacturers to provide a refund 
to CMS for certain discarded amounts from a refundable single-dose 
container or single-use package drug, finalizes the dates we will issue 
the initial refund report and subsequent annual reports to 
manufacturers, the method of calculation of the refund amount when 
there are multiple manufacturers of a refundable drug, increased 
applicable percentages for certain drugs with unique circumstances, and 
a future application process by which manufacturers may apply for an 
increased applicable percentage for a drug.
b. RHCs and FQHCs
    In section III.B. of this final rule, we finalized the policy to 
adopt the definition ``immediate availability'' as including real-time 
audio and visual interactive telecommunications for the direct 
supervision of services and supplies furnished incident to a 
physician's service through December 31, 2024 for RHCs and FQHCs. We 
also finalized the policy change the required level of supervision for 
behavioral health services furnished ``incident to'' a physician or 
non-physician practitioner's services at RHCs and FQHCs to allow 
general supervision, rather than direct supervision, consistent with 
the policies finalized under the PFS for CY 2023.
    In section III.B.4. of this final rule, we finalized the policy to 
include Remote Patient Monitoring (RPM), Remote Therapeutic Monitoring 
(RTM), Community Health Integration (CHI), and Principal Illness 
Navigation (PIN) services in the general care management HCPCS code 
G0511 when these services are provided by RHCs and FQHCs. We also 
finalized the revision of the calculation for G0511 to include the 
weighted average of these services using the CY 2021 PFS non-facility 
utilization. These provisions are necessary in that we evaluate coding 
policies in this rule and their applicability to RHCs and FQHCs.
    Also, in section III.B.4. of this final rule, we clarified the 
supervision requirement for obtaining consent for CCM services and 
virtual communication services furnished in RHCs and FQHCs.
c. Modifications Related to Medicare Coverage for Opioid Use Disorder 
(OUD) Treatment Services Furnished by Opioid Treatment Programs (OTPs)
    As outlined in section III.F. of this final rule, we finalized the 
policy to allow periodic assessments to be furnished via audio-only 
communication when two-way audio-video communications technology is not 
available to the beneficiary through the end of CY 2024, to the extent 
that it is authorized by SAMHSA and DEA at the time the service is 
furnished and all other applicable requirements are met. We believe 
this modification is needed because extending these audio-only 
flexibilities for an additional year may minimize disruptions 
associated with the conclusion of the PHE, and evidence has shown that 
Medicare beneficiaries from historically underserved populations are 
more likely to be offered and use audio-only telemedicine services than 
audio-video services.\512\ Therefore, minimizing disruptions to care 
for audio-only periodic assessments may further promote health equity 
and minimize disparities in access to care.
---------------------------------------------------------------------------

    \512\ https://pubmed.ncbi.nlm.nih.gov/33471458/.
---------------------------------------------------------------------------

d. Medicare Shared Savings Program
    In section III.G. of this final rule, we are finalizing 
modifications to the Shared Savings Program to further advance 
Medicare's overall value-based care strategy of growth, alignment, and 
equity, and to respond to concerns raised by ACOs and other interested 
parties. The changes to the Shared Savings Program include the 
following: modifications to the quality performance standard and 
reporting requirements under the APP that would continue to move ACOs 
toward digital measurement of quality and to align with the Quality 
Payment Program; modifications to the step-wise beneficiary assignment 
methodology to add a new third step and related changes to how we 
identify the assignable beneficiary population; updates to the 
definition of primary care services used for purposes of beneficiary 
assignment to remain consistent with billing and coding guidelines; 
refinements to the financial benchmarking methodology for ACOs in 
agreement periods beginning on January 1, 2024, and in subsequent years 
to (1) cap the risk score growth in an ACO's regional service area when 
calculating regional trends used to update the historical benchmark at 
the time of financial reconciliation for symmetry with the cap on ACO 
risk score growth, (2) apply the same CMS-HCC risk adjustment 
methodology applicable to the calendar year corresponding to the 
performance year in calculating risk scores for Medicare FFS 
beneficiaries for each benchmark year, (3) further mitigate the impact 
of the negative regional adjustment on the benchmark to encourage 
participation by ACOs caring for medically complex, high cost 
beneficiaries, and (4) specify the circumstances in which CMS would 
recalculate the prior savings adjustment for changes in values used in 
benchmark calculations due to compliance action taken to address 
avoidance of at-risk beneficiaries, or as a result of the issuance of a 
revised initial determination of financial performance for a previous 
performance year following a reopening of ACO shared savings and shared 
losses calculations; refine newly established AIP policies; make 
updates to other programmatic areas including the

[[Page 79465]]

program's eligibility requirements; and make timely technical changes 
to the regulations for clarity and consistency.
e. Medicare Part B Payment for Preventive Vaccine Administration 
Services
    Section III.H. of this final rule outlines the implementation of 
policies that impact the payment amount for administration of 
preventive vaccines paid under the Part B vaccine benefit, specifically 
the in-home additional payment for Part B vaccine administration. 
Section III.H. of this final rule also codifies other amendments to the 
regulation text for Part B preventive vaccine administration. These 
provisions are necessary to provide stable payment for preventive 
vaccine administration and to allow predictability for providers and 
suppliers to rely on for building and sustaining robust vaccination 
programs.
f. Appropriate Use Criteria (AUC) for Advanced Diagnostic Imaging
    In section III.J. of this final rule, we are finalizing our 
proposal to pause efforts to implement the AUC program for reevaluation 
and to rescind and reserve for future use the current AUC program 
regulations at Sec.  414.94. These provisions are necessary because we 
have exhausted all reasonable options for fully operationalizing the 
AUC program consistent with the statutory provisions as prescribed in 
section 1834(q)(B) of the Act directing CMS to require real-time 
claims-based reporting to collect information on AUC consultation and 
imaging patterns for advanced diagnostic imaging services to ultimately 
inform outlier identification and prior authorization.
g. Medicare and Medicaid Provider Enrollment
    This final rule also includes several regulatory enhancements to 
our Medicare and Medicaid provider enrollment policies that we 
proposed. These provisions focus on, but are not limited to: (1) 
expanding the bases for denying or revoking a provider's or supplier's 
Medicare enrollment; (2) revising the effective dates of certain 
Medicare revocations; and (3) revising certain policies regarding 
Medicaid terminations. These changes are necessary to help ensure that 
payments are made only to qualified providers and suppliers and/or to 
increase the efficiency of the Medicare and Medicaid provider 
enrollment processes. We believe that fulfilling these objectives will 
assist in protecting the Trust Funds and Medicare beneficiaries.
h. Expand Diabetes Screening and Diabetes Definitions
    In section III.L. of this final rule, we are finalizing our 
proposal to (1) expand coverage of diabetes screening tests to include 
the Hemoglobin A1C test (HbA1c) test, (2) expand and simplify the 
frequency limitations for diabetes screening, and (3) simplify the 
regulatory definition of ``diabetes'' for diabetes screening, Medical 
Nutrition Therapy (MNT) and Diabetes Outpatient Self-Management 
Training Services (DSMT). Diabetes is a chronic disease that affects 
how the body turns food into energy and includes three main types: Type 
1, Type 2, and gestational diabetes. The Centers for Disease Control 
and Prevention (CDC) reports that approximately 37.3 million Americans 
are living with diabetes and an additional 96 million Americans are 
living with prediabetes.\513\ CDC reports that 326,000 persons age 65 
years and older are newly diagnosed with diabetes each year. CDC also 
estimates that among persons age 65 years and older, 21 percent have 
been diagnosed with diabetes while 5 percent have undiagnosed 
diabetes.\514\ Diabetes is the leading cause of kidney failure and new 
cases of blindness among adults, and the sixth leading cause of death 
among adults age 65 years and older in the US.\515\ Screening is 
performed on persons who may not exhibit symptoms to identify persons 
with either prediabetes or diabetes, who can then be referred for 
appropriate prevention or treatment, with the intention of improving 
health outcomes.
---------------------------------------------------------------------------

    \513\ CDC website on diabetes at https://www.cdc.gov/diabetes/basics/index.html.
    \514\ Centers for Disease Control and Prevention. National 
Diabetes Statistics Report, 2020. Accessed March 9, 2023. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf.
    \515\ Heron M. Deaths: Leading causes for 2019. National Vital 
Statistics Reports; vol 70 no 9. Hyattsville, MD: National Center 
for Health Statistics. 2021. DOI: https://dx.doi.org/10.15620/cdc:107021.
---------------------------------------------------------------------------

i. Basic Health Program Provisions
    Section 1331 of the ACA requires the Secretary to establish a BHP, 
and section 1331(c)(4) of the ACA specifically provides that a State 
shall coordinate the administration of, and provision of benefits under 
the BHP with other State programs. Additionally, section 1331(f) of the 
ACA requires the Secretary to review each State's BHP on an annual 
basis. These regulations build from previous BHP regulations to provide 
for options for BHP implementation and operations as well as oversight 
of the BHP program, beginning with program year 2024.
j. A Social Determinants of Health Risk Assessment in the Annual 
Wellness Visit
    As outlined in section III.S. of this final rule, we are finalizing 
our proposal to exercise our authority in section 1861(hhh)(2)(I) of 
the Act to add elements to the Annual Wellness Visit (AWV) by adding a 
new Social Determinants of Health (SDOH) Risk Assessment as an 
optional, additional element with an additional payment. We proposed 
that the SDOH Risk Assessment be separately payable with no beneficiary 
cost sharing when furnished as part of the same visit with the same 
date of service as the AWV. The AWV includes the establishment (or 
update) of the patient's medical and family history, application of a 
health risk assessment and the establishment (or update) of a 
personalized prevention plan. The AWV also provides an optional Advance 
Care Planning (ACP) service. The AWV is covered for eligible 
beneficiaries who are no longer within 12 months of the effective date 
of their first Medicare Part B coverage period and who have not 
received either an Initial Preventive Physical Examination (IPPE) or 
AWV within the past 12 months. The goals of AWV are health promotion, 
disease prevention and detection and include education, counseling, a 
health risk assessment, referrals for prevention services, and a review 
of opioid use. Additional information about the AWV can be found on the 
CMS website at (https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/preventive-services/medicare-wellness-visits.html).

B. Overall Impact

    We have examined the impacts of this rule as required by Executive 
Order 12866 on Regulatory Planning and Review (September 30, 1993), 
Executive Order 13563 on Improving Regulation and Regulatory Review 
(January 18, 2011), Executive Order 14094 entitled ``Modernizing 
Regulatory Review'' (April 6, 2023), the Regulatory Flexibility Act 
(RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the 
Social Security Act, section 202 of the Unfunded Mandates Reform Act of 
1995 (March 22, 1995; Pub. L. 104-4), and Executive Order 13132 on 
Federalism (August 4, 1999).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory

[[Page 79466]]

approaches that maximize net benefits (including potential economic, 
environmental, public health and safety effects, distributive impacts, 
and equity). The Executive Order 14094 entitled ``Modernizing 
Regulatory Review'' (hereinafter, the Modernizing E.O.) amends section 
3(f)(1) of Executive Order 12866 (Regulatory Planning and Review). The 
amended section 3(f) of Executive Order 12866 defines a ``significant 
regulatory action'' as an action that is likely to result in a rule: 
(1) having an annual effect on the economy of $200 million or more in 
any 1 year (adjusted every 3 years by the Administrator of OIRA for 
changes in gross domestic product), or adversely affect in a material 
way the economy, a sector of the economy, productivity, competition, 
jobs, the environment, public health or safety, or State, local, 
territorial, or tribal governments or communities; (2) creating a 
serious inconsistency or otherwise interfering with an action taken or 
planned by another agency; (3) materially altering the budgetary 
impacts of entitlement grants, user fees, or loan programs or the 
rights and obligations of recipients thereof; or (4) raise legal or 
policy issues for which centralized review would meaningfully further 
the President's priorities or the principles set forth in this 
Executive order, as specifically authorized in a timely manner by the 
Administrator of OIRA in each case.
    A regulatory impact analysis (RIA) must be prepared for major rules 
with significant regulatory action/s and/or with significant effects as 
per section 3(f)(1) ($200 million or more in any 1 year). Based on our 
estimates, OMB's Office of Information and Regulatory Affairs has 
determined this rulemaking is significant per section 3(f)(1)) as 
measured by the $200 million or more in any 1 year. Accordingly, we 
have prepared an RIA that, to the best of our ability, presents the 
costs and benefits of the rulemaking. The RFA requires agencies to 
analyze options for regulatory relief of small entities. For purposes 
of the RFA, small entities include small businesses, nonprofit 
organizations, and small governmental jurisdictions. Most hospitals, 
practitioners, and most other providers and suppliers are small 
entities, either by nonprofit status or by having annual revenues that 
qualify for small business status under the Small Business 
Administration standards. (For details, see the SBA's website at 
https://www.sba.gov/document/support-table-size-standards (refer to the 
620000 series)). Individuals and States are not included in the 
definition of a small entity.
    The RFA requires that we analyze regulatory options for small 
businesses and other entities. We prepare a regulatory flexibility 
analysis unless we certify that a rule would not have a significant 
economic impact on a substantial number of small entities. The analysis 
must include a justification concerning the reason action is being 
taken, the kinds and number of small entities the rule affects, and an 
explanation of any meaningful options that achieve the objectives with 
less significant adverse economic impact on the small entities.
    Approximately 95 percent of practitioners, other suppliers, and 
providers are considered to be small entities, based upon the SBA 
standards. There are over 1 million physicians, other practitioners, 
and medical suppliers that receive Medicare payment under the PFS. 
Because many of the affected entities are small entities, the analysis 
and discussion provided in this section, as well as elsewhere in this 
final rule is intended to comply with the RFA requirements regarding 
significant impact on a substantial number of small entities.
    In addition, section 1102(b) of the Act requires us to prepare an 
RIA if a rule may have a significant impact on the operations of a 
substantial number of small rural hospitals. This analysis must conform 
to the provisions of section 604 of the RFA. For purposes of section 
1102(b) of the Act, we define a small rural hospital as a hospital that 
is located outside of a Metropolitan Statistical Area for Medicare 
payment regulations and has fewer than 100 beds. Medicare does not pay 
rural hospitals for their services under the PFS; rather, Medicare 
payment is made under the PFS for physicians' services, which can be 
furnished by physicians and NPPs in a variety of settings, including 
rural hospitals. We did not prepare an analysis for section 1102(b) of 
the Act because we determined, and the Secretary certified, that this 
rule will not have a significant impact on the operations of a 
substantial number of small rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits on State, 
local, or tribal governments or on the private sector before issuing 
any rule whose mandates require spending in any 1 year of $100 million 
in 1995 dollars, updated annually for inflation. In 2023, that 
threshold is approximately $177 million. This rule will impose no 
mandates on State, local, or tribal governments or on the private 
sector.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it issues a proposed rule (and subsequent final 
rule) that imposes substantial direct requirement costs on State and 
local governments, preempts State law, or otherwise has federalism 
implications. Since this rule does not impose any costs on State or 
local governments, the requirements of Executive Order 13132 are not 
applicable.
    We prepared the following analysis, which, together with the 
information provided in the rest of this rule, meets all assessment 
requirements. The analysis explains the rationale for and purposes of 
this rule; details the costs and benefits of the rule; analyzes 
alternatives; and presents the measures we will use to minimize the 
burden on small entities. As indicated elsewhere in this rule, we 
discussed various changes to our regulations, payments, or payment 
policies to ensure that our payment systems reflect changes in medical 
practice and the relative value of services and to implement provisions 
of the statute. We provide information for each policy change in the 
relevant sections of this final rule. We are unaware of any relevant 
Federal rules that duplicate, overlap, or conflict with this rule. The 
relevant sections of this final rule describe significant alternatives 
we considered, if applicable.

C. Changes in Relative Value Unit (RVU) Impacts

1. Resource-Based Work, PE, and MP RVUs
    Section 1848(c)(2)(B)(ii)(II) of the Act requires that increases or 
decreases in RVUs may not cause the amount of Medicare Part B 
expenditures for the year to differ by more than $20 million from what 
expenditures would have been in the absence of these changes. If this 
threshold is exceeded, we make adjustments to preserve budget 
neutrality.
    Our estimates of changes in Medicare expenditures for PFS services 
compared payment rates for CY 2023 with payment rates for CY 2024 using 
CY 2022 Medicare utilization. The payment impacts described in this 
final rule reflect averages by specialty based on Medicare utilization. 
The payment impact for an individual practitioner could vary from the 
average and will depend on the mix of services they furnish. The 
average percentage change in total revenues will be less than the 
impact displayed here because

[[Page 79467]]

practitioners and other entities generally furnish services to both 
Medicare and non-Medicare patients. In addition, practitioners and 
other entities may receive substantial Medicare revenues for services 
under other Medicare payment systems. For instance, independent 
laboratories receive approximately 83 percent of their Medicare 
revenues from clinical diagnostic laboratory tests that are paid under 
the Clinical Laboratory Fee Schedule (CLFS).
    The PFS update adjustment factor for CY 2024, as specified in 
section 1848(d)(19) of the Act, is 0.00 percent before applying other 
adjustments. In addition, the CAA, 2023 provided a one-year 2.50 
percent increase in PFS payment amounts for services furnished in CY 
2023, and a one-year 1.25 percent increase in PFS payment amounts for 
services furnished during CY 2024, and required that the supplementary 
percentage increases shall not be taken into account in determining PFS 
payment rates for subsequent years.
    To calculate the CY 2024 PFS conversion factor (CF), we took the CY 
2023 conversion factor without the one-year 2.50 percent payment 
increase provided by the CAA, 2023 for CY 2023 and multiplied it by the 
budget neutrality adjustment required as described in the preceding 
paragraphs and the 1.25 percent PFS payment increase provided by the 
CAA, 2023 for CY 2024. We estimate the CY 2024 PFS CF to be 32.7442 
which reflects the -2.18 percent budget neutrality adjustment under 
section 1848(c)(2)(B)(ii)(II) of the Act, the 0.00 percent update 
adjustment factor specified under section 1848(d)(19) of the Act, and 
the 1.25 percent payment increase for services furnished in CY 2024, as 
provided in the CAA, 2023. We estimate the CY 2024 anesthesia CF to be 
20.4349, reflecting the same overall PFS adjustments with the addition 
of anesthesia-specific PE and MP adjustments.
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[GRAPHIC] [TIFF OMITTED] TR16NO23.150

    Table 118 shows the payment impact of the policies in this final 
rule on PFS services. To the extent that there are year-to-year changes 
in the volume and mix of services provided by practitioners, the actual 
impact on total Medicare revenues will be different from those shown in 
Table 118 (CY 2023 PFS Estimated Impact on Total Allowed Charges by 
Specialty). The following is an explanation of the information 
represented in Table 118.
     Column A (Specialty): Identifies the specialty for which 
data are shown.
     Column B (Allowed Charges): The aggregate estimated PFS 
allowed charges for the specialty based on CY 2022 utilization and CY 
2023 rates. That is, allowed charges are the PFS amounts for covered 
services and include coinsurance and deductibles (which are the 
financial responsibility of the beneficiary). These amounts have been 
summed across all services furnished by physicians, practitioners, and 
suppliers within a specialty to arrive at the total allowed charges for 
the specialty.
     Column C (Impact of Work RVU Changes): This column shows 
the estimated CY 2024 impact on total allowed charges of the changes in 
the work RVUs, including the impact of changes due to potentially 
misvalued codes.
     Column D (Impact of PE RVU Changes): This column shows the 
estimated CY 2024 impact on total allowed charges of the changes in the 
PE RVUs.
     Column E (Impact of MP RVU Changes): This column shows the 
estimated CY 2024 impact on total allowed charges of the changes in the 
MP RVUs.
     Column F (Combined Impact): This column shows the 
estimated CY 2024 combined impact on total allowed charges of all the 
changes in the previous columns. Column F may not equal the sum of 
columns C, D, and E due to rounding.
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[[Page 79469]]


[GRAPHIC] [TIFF OMITTED] TR16NO23.152

BILLING CODE 4120-01-C
    In recent years, we have received requests from interested parties 
for CMS to provide more granular information that separates the 
specialty-specific impacts by site of service. These interested parties 
have presented high-level information to CMS suggesting that Medicare 
payment policies are directly responsible for consolidating privately 
owned physician practices and freestanding supplier facilities into 
larger health systems. Their concerns highlight a need to update the 
information under the PFS to account for current trends in healthcare 
delivery, especially concerning independent versus facility-based 
practices. We published an RFI in the CY 2023 PFS proposed rule to 
gather feedback on this issue and refer readers to the discussion in 
last year's final rule (87 FR 69429 through 69438). As part of our 
holistic review of how best to update our data and offer interested 
parties additional information that addresses some of the concerns 
raised, we have recently improved our current suite of public use files 
(PUFs) by including a new file that shows estimated specialty payment 
impacts at a more granular level, specifically by showing ranges of 
impact for practitioners within a specialty. This file is available on 
the CMS website under downloads for the CY 2024 PFS proposed rule at 
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    We provided an additional impact table for this rulemaking cycle 
that includes a facility/non-facility breakout of payment changes. The 
following is an explanation of the information represented in Table 
119.
     Column A (Specialty): Identifies the specialty for which 
data are shown.
     Column B (Setting): Identifies the facility or nonfacility 
setting for which data are shown.
     Column C (Allowed Charges): The aggregate estimated PFS 
allowed charges for the specialty based on CY 2022 utilization and CY 
2023 rates. That is, allowed charges are the PFS amounts for covered 
services and include coinsurance and deductibles (which are the 
financial responsibility of the beneficiary). These amounts have been 
summed across all services furnished by physicians, practitioners, and 
suppliers within a specialty to arrive at the total allowed charges for 
the specialty.
     Column D (Combined Impact): This column shows the 
estimated CY 2024 combined impact on total allowed charges.
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BILLING CODE 4120-01-C
2. CY 2024 PFS Impact Discussion
a. Changes in RVUs
    The most widespread specialty-level impacts of the RVU changes are 
generally related to the changes to RVUs for specific services 
resulting from the misvalued code initiative, including RVUs for new 
and revised codes. The estimated impacts for some specialties, 
including family practice, endocrinology, nurse practitioner, physician 
assistant, clinical social worker, psychiatry, clinical psychologist, 
and general practice, reflect increases relative to other specialties. 
These increases can largely be attributed to our implementation of the 
separate payment for the O/O E/M visit inherent complexity add-on code, 
the Year 3 update to clinical labor pricing, and/or the proposed 
adjustment to certain behavioral health services. Approximately 90 
percent of the budget neutrality adjustment is attributable to the O/O 
E/M visit inherent complexity add-on code, with all other proposed 
valuation changes making up the other 10 percent. The services 
furnished by these specialties include relatively more E/M services, 
behavioral health care, or clinical labor for their practice expense 
costs. These increases are also due to increases in value for 
particular services after considering the recommendations from the 
American Medical Association's (AMA) Relative Value Scale Update 
Committee (RUC) and CMS review, and increased payments resulting from 
supply and equipment pricing updates.
    The estimated impacts for several specialties, including 
anesthesiology, interventional radiology, radiology, nuclear medicine, 
vascular and thoracic surgery, physical/occupational therapy, 
anesthesiology, and audiology, reflect decreases in payments relative 
to payment to other specialties, largely resulting from the 
redistributive effects of the implementation of separate payment for 
the O/O E/M visit inherent complexity add-on code, the Year 3 update to 
clinical labor pricing, and/or the proposed adjustment to certain 
behavioral health services. The services furnished by these specialties 
were negatively affected by the redistributive effects of increases in 
work RVUs for other codes, and/or rely primarily on supply/equipment 
items for their practice expense costs and, therefore, were affected 
negatively by the updated Year 3 clinical labor pricing under budget 
neutrality. These decreases are also due to the revaluation of 
individual procedures based on reviews, including consideration of AMA 
RUC review and recommendations, as well as decreases resulting from the 
continued phase-in implementation of the previously finalized supply 
and equipment pricing updates. The estimated impacts also reflect 
decreases due to the continued implementation of previously finalized 
code-level reductions that are being phased in over several years. For 
independent laboratories, it is important to note that these entities 
receive approximately 83 percent of their Medicare revenues from 
services that are paid under the CLFS.
    We often receive comments regarding the changes in RVUs displayed 
on the specialty impact table (Table 118), including comments received 
in response to the valuations. We remind interested parties that 
although the estimated impacts are displayed at the specialty level, 
typically, the changes are driven by the valuation of a relatively 
small number of new and/or potentially misvalued codes. The percentage 
changes in Table 118 are based upon aggregate estimated PFS allowed 
charges summed across all services furnished by physicians, 
practitioners, and suppliers within a

[[Page 79475]]

specialty to arrive at the total allowed charges for the specialty, and 
compared to the same summed total from the previous calendar year. 
Therefore, they are averages and may not necessarily represent what is 
happening to the particular services furnished by a single practitioner 
within any given specialty.
    As discussed above, we have reviewed our suite of public use files 
and have worked on new ways to offer interested parties additional 
information that addresses concerns about the lack of granularity in 
our impact tables. To illustrate how impacts can vary within 
specialties, we created a public use file that models the expected 
percentage change in total RVUs per practitioner. Using CY 2022 
utilization data, Total RVUs change between -1 percent and 1 percent 
for more than 15 percent of practitioners, representing approximately 
26 percent of the changes in Total RVUs for all practitioners, with 
variation by specialty. Specialties, such as gastroenterology, exhibit 
little variation in changes in total RVUs per practitioner. Table 118 
(CY 2024 PFS Estimated Impact on Total Allowed Charges by Specialty) 
indicates an overall change of 0 percent for this specialty, and the 
practitioner-level distribution shows that 89 percent of these 
practitioners will experience a change in Total RVUs between -2 percent 
and 2 percent. The specific service mix within a specialty may vary by 
practitioner, so individual practitioners may experience different 
changes in total RVUs. For example, Table 118 indicates a 1 percent 
increase in RVUs for the internal medicine specialty as a whole; 
however, 49 percent of internal medicine specialty practitioners--
representing over 41 percent of Total RVUs for the specialty--will 
experience a 1 percent or more decrease in Total RVUs. Meanwhile, 40 
percent of internal medicine specialty practitioners will experience 2 
percent or more increases in Total RVUs, and these practitioners 
account for 40 percent of Total RVUs for this specialty. We also note 
the code level RVU changes are available in the Addendum B public use 
file that we make available with each rule.
    The specialty impacts displayed in Table 118 reflect changes within 
the pool of total RVUs. The specialty impacts table, therefore, 
includes any changes in spending that result from finalized policies 
within BN (such as the updated proposals associated with the complexity 
add-on code G2211 in CY 2024 or the clinical labor pricing update that 
began in CY 2022) but does not include any changes in spending which 
result from finalized policies that are not subject to BN adjustment, 
and therefore, have a neutral impact across all specialties. The 2.50 
and 1.25 percent payment supplements for CY 2023 and CY 2024, 
respectively, are statutory changes that take place outside of BN, and 
therefore, are not captured in the specialty impacts displayed in Table 
118.
b. Impact
    Column F of Table 118 displays the estimated CY 2024 impact on 
total allowed charges, by specialty, of all the RVU changes. A table 
showing the estimated impact of all of the changes on total payments 
for selected high volume procedures is available under ``downloads'' on 
the CY 2024 PFS final rule website at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/. We selected these 
procedures for the sake of illustration from among the procedures most 
commonly furnished by a broad spectrum of specialties. The change in 
both facility rates and nonfacility rates are shown. For an explanation 
of facility and nonfacility PE, we referred readers to Addendum A on 
the CMS website at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/.
3. Health Equity
    Advancing health equity is the first pillar of CMS's 2022 Strategic 
Framework.\516\ As part of our efforts to gain insight into how the PFS 
policies could affect health equity, we considered adding elements to 
our impact analysis detailing how policies impact particular patient 
populations. Patient populations that have been disadvantaged or 
underserved by the healthcare system may include patients with the 
following characteristics, among others: members of racial and ethnic 
minorities; members of federally recognized Tribes, people with 
disabilities; members of the lesbian, gay, bisexual, transgender, and 
queer (LGBTQ+) community; individuals with limited English proficiency, 
members of rural communities, and persons otherwise adversely affected 
by persistent poverty or inequality.
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    \516\ Available at https://www.cms.gov/files/document/2022-cms-strategic-framework.pdf.
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    In the FY 2024 IPPS/LTCH PPS final rule (88 FR 59395 through 
59401), we included a table that details providers in terms of the 
beneficiaries they serve, as well as differences in estimated average 
payments per case and changes in estimated average payments per case 
relative to other providers. Because we do not have data for all 
characteristics that may identify disadvantaged or underserved patient 
populations, we use several proxies to capture these characteristics, 
including elements from claims data and Medicare enrollment data. The 
characteristics included in the table in the IPPS/LTCH PPS final rule, 
described in further detail below, include race/ethnicity, dual 
eligibility for Medicaid and Medicare, Medicare low-income subsidy 
(LIS) enrollment, a joint indicator for dual or LIS enrollment, 
presence of an ICD-10-CM Z code indicating a ``social determinant of 
health'' (SDOH), presence of a behavioral health diagnosis code, 
receiving end-stage renal disease (ESRD) Medicare coverage, qualifying 
for Medicare due to disability, living in a rural area, and living in 
an area with an area deprivation index (ADI) greater than or equal to 
85.
a. Race and Ethnicity
    The first health equity-relevant grouping is race/ethnicity. To 
assign the race/ethnicity variables, we utilized the Medicare Bayesian 
Improved Surname Geocoding (MBISG) data in conjunction with the claims 
data. The method used to develop the MBISG data involves estimating a 
set of six racial and ethnic probabilities (White, Black, Hispanic, 
American Indian or Alaska Native, Asian or Pacific Islander, and 
multiracial) from the surname and address of beneficiaries by using 
previous self-reported data from a national survey of Medicare 
beneficiaries, post-stratified to CMS enrollment files. The CMS Office 
of Minority Health uses the MBISG method in its reports analyzing 
Medicare Advantage plan performance on Healthcare Effectiveness Data 
and Information Set (HEDIS) measures, and is being considered by CMS 
for use in other CMS programs. In the 2024 IPPS/LTCH proposed rule (88 
FR 27261 through 27266), we estimated the percentage of discharges for 
each specified racial/ethnic category for each hospital by taking the 
sum of the probabilities for that category for that hospital and 
dividing by the hospital's total number of discharges.

[[Page 79476]]

b. Income
    The two main proxies for income available in the Medicare claims 
and enrollment data are dual eligibility for Medicare and Medicaid and 
Medicare LIS status. Dual-enrollment status is a powerful predictor of 
poor outcomes on some quality and resource use measures even after 
accounting for additional social and functional risk factors.\517\ 
Medicare LIS enrollment refers to a beneficiary's enrollment in the 
low-income subsidy program for the Part D prescription drug benefit. 
This program covers all or part of the Part D premium for qualifying 
Medicare beneficiaries and gives them access to reduced copays for Part 
D drugs. (We note that beginning on January 1, 2024, eligibility for 
the full low-income subsidy will be expanded to include individuals 
currently eligible for the partial low-income subsidy.) Because 
Medicaid eligibility rules and benefits vary by State/territory, 
Medicare LIS enrollment identifies beneficiaries who are likely to have 
low income but may not be eligible for Medicaid. Not all beneficiaries 
who qualify for the duals or LIS programs actually enroll. Due to 
differences in the dual eligibility and LIS qualification criteria and 
less than complete participation in these programs, sometimes 
beneficiaries were flagged as dual but not LIS or vice versa. Hence 
this analysis also used a ``dual or LIS'' flag as a third proxy for low 
income. The dual and LIS flags were constructed based on enrollment/
eligibility status in the CMS Chronic Conditions Data Warehouse (CCW) 
during the month of the hospital discharge.
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    \517\ https://aspe.hhs.gov/sites/default/files/migrated_legacy_files//195046/Social-Risk-in-Medicare%E2%80%99s-VBP-2nd-Report-Executive-Summary.pdf.
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c. Social Determinants of Health (SDOH)
    Social determinants of health (SDOH) are the conditions in the 
environments where people are born, live, learn, work, play, worship, 
and age that affect a wide range of health, functioning, and quality-
of-life outcomes and risks.\518\ These circumstances or determinants 
influence an individual's health status and can contribute to wide 
health disparities and inequities. ICD-10-CM contains Z-codes that 
describe a range of issues related--but not limited--to education and 
literacy, employment, housing, ability to obtain adequate amounts of 
food or safe drinking water, and occupational exposure to toxic agents, 
dust, or radiation. The presence of ICD-10-CM Z-codes in the range Z55-
Z65 identifies beneficiaries with these SDOH characteristics. The SDOH 
flag used for this analysis was turned on if one of these Z-codes was 
recorded on the claim for the physician service itself (that is, the 
beneficiary's prior claims were not examined for additional Z-codes). 
Analysis of Z-codes in Medicare claims data from 2019 suggests that Z-
codes are used inconsistently across provider types and population 
groups, and are generally underreported.\519\ Therefore, we believe Z-
codes may not reflect the actual rates of SDOH.
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    \518\ Available at: https://health.gov/healthypeople/priority-areas/social-determinants-health.
    \519\ Maksut JL, Hodge C, Van CD, Razmi, A, & Khau MT. 
Utilization of Z Codes for Social Determinants of Health among 
Medicare Fee-For-Service Beneficiaries, 2019. Office of Minority 
Health (OMH) Data Highlight No. 24. Centers for Medicare and 
Medicaid Services (CMS), Baltimore, MD, 2021. Available at https://www.cms.gov/files/document/z-codes-data-highlight.pdf.
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d. Behavioral Health
    Beneficiaries with behavioral health diagnoses often face co-
occurring physical illnesses but often experience difficulty accessing 
care.\520\ The combination of physical and behavioral health conditions 
can exacerbate both conditions and result in poorer outcomes than one 
condition alone.\521\ Additionally, the intersection of behavioral 
health and health inequities is a core aspect of CMS' Behavioral Health 
Strategy.\522\ We used the presence of one or more ICD-10-CM codes in 
the range of F01- F99 to identify beneficiaries with a behavioral 
health diagnosis.
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    \520\ Viron M, Zioto K, Schweitzer J, Levine G. Behavioral 
Health Homes: an opportunity to address healthcare inequities in 
people with serious mental illness. Asian J Psychiatr. 2014 
Aug;10:10-6. doi: 10.1016/j.ajp.2014.03.009.
    \521\ Cully, J.A., Breland, J.Y., Robertson, S. et al. 
Behavioral health coaching for rural veterans with diabetes and 
depression: a patient randomized effectiveness implementation trial. 
BMC Health Serv Res 14, 191 (2014). https://doi.org/10.1186/1472-6963-14-191.
    \522\ https://www.cms.gov/cms-behavioral-health-strategy.
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e. Disability
    Individuals under age 65 who are determined eligible for social 
security disability benefits may also be eligible for Medicare 
coverage.\523\ Individuals may qualify for social security disability 
benefits on the basis of a medically determinable physical or mental 
impairment(s) that has lasted or is expected to last for a continuous 
period of at least 12 months or is expected to result in death \524\. 
Disabled beneficiaries often have complex healthcare needs and 
difficulty accessing care. Compared to people without disabilities, 
people with disabilities generally have less access to health care, 
have more depression and anxiety, engage more often in risky health 
behaviors such as smoking, and are less physically active.\525\ 
Beneficiaries were classified as disabled for the purposes of this 
analysis if their original reason for qualifying for Medicare was 
disability; this information was obtained from Medicare's CCW 
enrollment data. We noted that this is likely an underestimation of 
disability, because it does not account for beneficiaries who became 
disabled after becoming entitled to Medicare.
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    \523\ Medicare eligibility on the basis of disability is 
discussed in 42 CFR 406.12.
    \524\ https://www.ssa.gov/disability/professionals/bluebook/general-info.htm.
    \525\ https://www.cdc.gov/ncbddd/humandevelopment/health-equity.html#ref.
---------------------------------------------------------------------------

f. End-Stage Renal Disease (ESRD)
    Beneficiaries with ESRD have high healthcare needs and high medical 
spending, and often experience comorbid conditions and poor mental 
health. Beneficiaries with ESRD also experience significant 
disparities, such as a limited life expectancy.\526\ Beneficiaries were 
classified as ESRD for the purposes of this analysis if they were 
receiving Medicare ESRD coverage during the month of the discharge; 
this information was obtained from the CCW enrollment data.
---------------------------------------------------------------------------

    \526\ Smart NA, Titus TT. Outcomes of early versus late 
nephrology referral in chronic kidney disease: a systematic review. 
Am J Med. 2011 Nov;124(11):1073-80.e2. doi: 10.1016/
j.amjmed.2011.04.026. PMID: 22017785.
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g. Geography
    Beneficiaries in some geographic areas--particularly rural areas or 
areas with concentrated poverty--often have difficulty accessing 
care.527 528 For this analysis, beneficiaries were 
classified on two dimensions: from a rural area and from an area with 
an area deprivation index (ADI) greater than or equal to 85.
---------------------------------------------------------------------------

    \527\ National Healthcare Quality and Disparities Report 
chartbook on rural health care. Rockville, MD: Agency for Healthcare 
Research and Quality; October 2017. AHRQ Pub. No. 17(18)-0001-2-EF 
available at https://www.ahrq.gov/sites/default/files/wysiwyg/research/findings/nhqrdr/chartbooks/qdr-ruralhealthchartbook-update.pdf.
    \528\ Muluk, S, Sabik, L, Chen, Q, Jacobs, B, Sun, Z, Drake, C. 
Disparities in geographic access to medical oncologists. Health Serv 
Res. 2022; 57(5): 1035-1044. doi:10.1111/1475-6773.13991.
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    Rural status is defined for this analysis using the primary Rural-
Urban Commuting Area (RUCA) codes 4-10 (including micropolitan, small 
town, and rural areas) corresponding to each beneficiary's zip code. 
RUCA codes are defined at the census tract level based on measures of 
population density, urbanization, and daily commuting. The ADI is 
obtained from a publicly

[[Page 79477]]

available dataset designed to capture socioeconomic disadvantage at the 
neighborhood level.\529\ It utilizes data on income, education, 
employment, housing quality, and 13 other factors from the American 
Community Survey (ACS) and combines them into a single raw score, which 
is then used to rank neighborhoods (defined at various levels), with 
higher scores reflecting greater deprivation. The version of the ADI 
used for this analysis is at the Census Block Group level and the ADI 
corresponds to the Census Block Group's percentile nationally. Living 
in an area with an ADI score of 85 or above, a validated measure of 
neighborhood disadvantage, is shown to be a predictor of 30-day 
readmission rates, lower rates of cancer survival, poor end of life 
care for patients with heart failure, and longer lengths of stay and 
fewer home discharges post-knee surgery even after accounting for 
individual social and economic risk 
factors.530 531 532 533 534 The MedPAR discharge data was 
linked to the ADI data available in the CCW. Beneficiaries with no 
recorded ADI were treated as being from an urban area and as having an 
ADI less than 85.
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    \529\ https://www.neighborhoodatlas.medicine.wisc.edu/.
    \530\ 7 U.S. Department of Health & Human Services, ``Executive 
Summary: Report to Congress: Social Risk Factors and Performance in 
Medicare's Value-Based Purchasing Program,'' Office of the Assistant 
Secretary for Planning and Evaluation, March 2020. Available at 
https://aspe.hhs.gov/sites/default/files/migrated_legacy_files//195046/Social-Risk-inMedicare%E2%80%99s-VBP-2nd-Report-Executive-Summary.pdf.
    \531\ Kind AJ, et al., ``Neighborhood socioeconomic disadvantage 
and 30-day rehospitalization: a retrospective cohort study.'' Annals 
of Internal Medicine. No. 161(11), pp 765-74, doi: 10.7326/M13-2946 
(December 2, 2014), available at https://www.acpjournals.org/doi/epdf/10.7326/M13-2946.
    \532\ Jencks SF, et al., ``Safety-Net Hospitals, Neighborhood 
Disadvantage, and Readmissions Under Maryland's All-Payer Program.'' 
Annals of Internal Medicine. No. 171, pp 91-98, doi:10.7326/M16-2671 
(July 16, 2019), available at https://www.acpjournals.org/doi/epdf/10.7326/M16-2671.
    \533\ Cheng E, et al., ``Neighborhood and Individual 
Socioeconomic Disadvantage and Survival Among Patients With 
Nonmetastatic Common Cancers.'' JAMA Network Open Oncology. No. 
4(12), pp 1-17, doi: 10.1001/jamanetworkopen.2021.39593 (December 
17, 2021), available at https://onlinelibrary.wiley.com/doi/epdf/10.1111/jrh.12597.
    \534\ Khlopas A, et al., ``Neighborhood Socioeconomic 
Disadvantages Associated With Prolonged Lengths of Stay, Nonhome 
Discharges, and 90-Day Readmissions After Total Knee Arthroplasty.'' 
The Journal of Arthroplasty. No. 37(6), pp S37-S43, doi: 10.1016/
j.arth.2022.01.032 (June 2022), available at https://www.sciencedirect.com/science/article/pii/ S0883540322000493.
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    In examining how we might expand our PFS impact analysis, we 
considered what framework might accurately provide insight into the 
relationship between PFS policies and health equity. Rather than 
examining changes in estimated average payments, we believe that 
illuminating the baseline is a necessary first step toward advancing 
our goal of measuring the impact of PFS policies on health equity. 
Table 121 displays the share of utilization for each of the health-
equity relevant characteristics listed above. First, we list the share 
of enrollees with each characteristic. Next, we list the share of 
utilization by beneficiaries (that is, enrollees with at least one 
claim for a physician service in CY 2022) with each characteristic by 
provider specialty. The information contained in Table 121 is provided 
solely to demonstrate beneficiary utilization of services by provider 
specialty impact across a number of health equity dimensions and does 
not form the basis or rationale for the finalized policies.
    In consideration of the differences between IPPS/LTCH and the PFS 
discussed below, we solicited comment from interested parties about how 
we might structure a PFS impact analysis that addresses these and other 
considerations to examine how changes in the PFS will impact 
beneficiaries of particular groups. We also solicited comment about how 
such a framework will allow us to consider developing policies that 
enhance health equity under our existing statutory authority. We 
welcomed suggestions about alternative measures of health equity in our 
impact analysis, in particular with regard to the ADI as a proxy for 
disparities related to geographic variation. Finally, we sought 
feedback about additional categories beyond those described previously 
that should be considered in our analysis, along with potential data 
sources.
    We received public comments on these proposals. The following is a 
summary of the comments we received and our responses.
    Comment: Commenters generally supported the inclusion of Table 121. 
One commenter suggested an alternative index of vulnerability in place 
of the ADI, citing concerns about the accuracy of the ADI. This 
commenter also requested clarification about how CMS may use the 
information in Table 121.
    Response: We appreciate commenters support for our inclusion of the 
data in Table 121. With respect to the comment regarding an alternative 
vulnerability index, we may consider this in future rulemaking.
    Comment: A commenter stated that the rule ``contemplates variable 
payments for factors such as race/ethnicity . . .'' and ``it's clear 
that CMS means to use the data to produce a payment based on billing or 
outcomes''.
    Response: We believe the commenter misunderstood the purpose of 
including Table 121. We did not contemplate variable payments for 
factors such as race/ethnicity. As stated in the proposed rule, ``the 
information contained in Table 107 is provided solely to demonstrate 
beneficiary utilization by provider specialty impact across several 
health equity dimensions. This does not form the basis or rationale for 
the proposed policies in the proposed rule.'' As stated in the proposed 
rule, the purpose of including this data was to seek comment on how we 
might structure a PFS impact analysis that addresses these 
considerations and how we might develop policies that enhance health 
equity under our existing statutory authority.
    Comment: A commenter requested clarification about the MBISG, 
specifically how it addresses mixed-race couples and individuals who 
are not appropriately placed in any racial category.
    Response: The purpose of our use of the MBISG method is to augment 
CMS administrative measures of race and ethnicity (that is, enrollment 
data) to more accurately assign individuals into racial and ethnic 
categories for purposes of displaying utilization data across 
specialty. While no imputation method is 100 percent accurate, it is an 
improvement over administrative data and we believe it is sufficient 
for the purpose for which it is being used--to gain a general 
understanding of beneficiary utilization across specialty.
    Nature of a service. In the table that details providers in terms 
of the beneficiaries they serve in the IPPS/LTCH PPS final rule, the 
unit of measurement we used was a hospital discharge. A discharge 
includes all resources involved in the hospital's caring for a 
beneficiary during the hospital stay. There is no parallel construct 
under the PFS. While the resources involved in furnishing a given 
discharge can and do vary under the IPPS, a discharge consists of a 
somewhat predictable set of resources that occur across a number of 
cost centers. On the other hand, a service unit under the PFS can range 
from very discrete services, such as a single pulse oximetry 
measurement (CPT code 94760) with total RVUs of 0.07 to complex 
services that include several visits during a global period, such as a 
liver transplant (CPT code 47135) with total RVUs of 160.44. As an 
illustration, based on the MS-DRGs reported in the claims data, the 
standard deviation of the mean IPPS relative weight is of

[[Page 79478]]

similar magnitude to the mean. In contrast, based on the PFS services 
reported in the claims data, the standard deviation of the mean PFS RVU 
service is vastly larger than the mean.
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    \535\ The IPPS relative weights are not fully comparable to PFS 
RVUs because IPPS payments may include outliers. Even considering 
outliers, however, the standard deviation on IPPS payments is only 
slightly higher relative to the mean($17,104+/-$21,825).
[GRAPHIC] [TIFF OMITTED] TR16NO23.158

    In addition, under the PFS, some services furnished during a single 
encounter are billed in multiple units. These services could range from 
allergy testing (CPT codes 95004 through 95078) to anesthesia services 
(CPT codes 00100 through 01860). The average total RVUs for services 
billed in multiple units are not comparable to services billed in a 
single unit per encounter.
    Number of practitioners serving a beneficiary and associated 
spending. Under the IPPS, most beneficiaries who had one or more IPPS 
claims during fiscal year 2022 were served by 1 or 2 providers, which 
accounts for most of the spending under the IPPS. The share of 
beneficiaries served by a given number of providers is consistent with 
the share of spending incurred for these discharges. Less than 10 
percent of beneficiaries were served by 5 or more providers. Under the 
PFS, during CY 2022, most beneficiaries with one or more PFS claims saw 
5 or more practitioners. In contrast to the pattern under the IPPS, PFS 
spending for beneficiaries who saw 10 or more practitioners accounted 
for a disproportionate share of total spending. Under the IPPS, 
examining providers in terms of beneficiary characteristics reflects 
the care of most beneficiaries with one or more discharges under the 
IPPS. Under the PFS, the same framework would be mostly describing the 
40 percent of beneficiaries with one or more PFS services who account 
for close to 80 percent of total spending.
    Utilization of services by beneficiary characteristic. As shown in 
Table 121, the specialty-level services utilized by beneficiaries with 
particular characteristics varies widely. Beneficiaries with the 
characteristics in Table 121 do not access services consistent with the 
share of enrollees with that characteristic. As a result, comparing 
across deciles, for example, of practitioners serving beneficiaries of 
one race, would often be comparing very different service mixes. How 
discrete a service is, the setting it is furnished in, and the 
associated inputs may result in services that have very different 
baseline allowed charges.
    A significant body of literature has examined the reasons for 
differential access to physician services by beneficiary 
characteristics. Some of the explanations of the differential 
utilization of services include:
     Patient preferences and willingness to undergo procedures, 
such as due to decreased belief in treatment efficacy and concerns 
about surgical risks.536 537 538 539
---------------------------------------------------------------------------

    \536\ Ibrahim SA, Siminoff LA, Burant CJ, et al. Differences in 
expectations of outcome mediate African American/white patient 
differences in ``willingness'' to consider joint replacement. 
Arthritis Rheum. 2002;46:2429-2435.
    \537\ Vina ER, Cloonan YK, Ibrahim SA, et al. Race, sex, and 
total knee replacement consideration: role of social support. 
Arthritis Care Res (Hoboken) 2013;65:1103-1111.
    \538\ Allen KD, Golightly YM, Callahan LF, et al. Race and sex 
differences in willingness to undergo total joint replacement: the 
Johnston County Osteoarthritis Project. Arthritis Care Res (Hoboken) 
2014;66:1193-1202.
    \539\ Hausmann LR, Mor M, Hanusa BH, et al. The effect of 
patient race on total joint replacement recommendations and 
utilization in the orthopedic setting. J Gen Intern Med. 
2010;25:982-988.
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     Geographic location: specialists and sub-specialists are 
sometimes clustered in urban areas due to higher demand for 
services.\540\
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    \540\ Cyr, M.E., Etchin, A.G., Guthrie, B.J. et al. Access to 
specialty healthcare in urban versus rural US populations: a 
systematic literature review. BMC Health Serv Res 19, 974 (2019). 
https://doi.org/10.1186/s12913-019-4815-5.
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     Differences in referral patterns \541\ from primary care 
physicians and following hospitalizations.
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    \541\ Landon BE, Onnela J, Meneades L, O'Malley AJ, Keating NL. 
Assessment of Racial Disparities in Primary Care Physician Specialty 
Referrals. JAMA Netw Open. 2021;4(1):e2029238. doi:10.1001/
jamanetworkopen.2020.29238.
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     Differences in providers who can speak the language of 
beneficiaries with Limited English Proficiency.\542\
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    \542\ Berdahl TA, Kirby JB. Patient-Provider Communication 
Disparities by Limited English Proficiency (LEP): Trends from the US 
Medical Expenditure Panel Survey, 2006-2015. J Gen Intern Med. 2019 
Aug;34(8):1434-1440. doi: 10.1007/s11606-018-4757-3. Epub 2018 Dec 
3. PMID: 30511285; PMCID: PMC6667581.
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    The information contained in Table 121 is provided solely to 
demonstrate beneficiary utilization by provider specialty impact across 
a number of health equity dimensions. This does not form the basis or 
rationale for the policies in this final rule.
BILLING CODE 4120-01-P

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    \543\ American Asian and Pacific Islander.
    \544\ American Indian and Alaskan Native.

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[[Page 79483]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.163


[[Page 79484]]


BILLING CODE 4120-01-C

D. Impact of Changes Related to Telehealth Services

    In this final rule, we finalized implementation of the provisions 
of the CAA, 2023 that amended section 1834(m) of the Act to extend the 
application of certain Medicare telehealth flexibilities through 
December 31, 2024, including allowing Medicare telehealth services to 
be furnished to patients located anywhere within the U.S.; continuing 
the expanded scope of telehealth practitioners to include occupational 
therapists, physical therapists, speech-language pathologists, and 
audiologists; extending payment for telehealth services furnished by 
FQHCs and RHCs; and delaying the requirement that there be an in-person 
visit with the physician or practitioner within 6 months before an 
initial mental health telehealth service.
    In this final rule, we finalized a refined process for considering 
requests received for adding services to the Medicare Telehealth 
Services List, which will include a decision on whether the services 
should be included on the list on a permanent or provisional basis. 
Because the underlying criteria for adding services to the Medicare 
Telehealth Services List are not changing, we do not expect this to 
impact the utilization of Medicare Telehealth services beginning in CY 
2024 but we will continue to monitor the utilization of these services. 
We are finalizing that, beginning in CY 2024, claims billed with POS 10 
(Telehealth Provided in Patient's Home) are paid at the non-facility 
PFS rate. Claims billed with POS 02 (Telehealth Provided Other than in 
Patient's Home) will continue to be paid at the PFS facility rate. As 
we are currently paying for the majority of services that will be 
billed with POS 10 at the PFS non-facility rate under the PHE-specific 
policy of basing payment on the place of service (and POS code) had the 
service been furnished in person, we believe that these services 
furnished via telehealth will largely continue to be paid as they are 
currently. Therefore, we believe the impact of this proposal will be 
roughly neutral even if utilization remains at current levels for these 
services. We anticipate that these provisions will result in continued 
utilization of Medicare telehealth services during CY 2024 at levels 
comparable to observed utilization of these services during the PHE for 
COVID-19.

E. Other Provisions of the Regulation

1. Impact of Provisions for Medicare Parts A and B Payment for Dental 
Services Inextricably Linked to Specific Covered Medical Services
    In section II.K.2. of this final rule, we are finalizing to allow 
Medicare Parts A and B payment for dental or oral examination performed 
as part of a comprehensive workup prior to, and medically necessary 
diagnostic and treatment services to eliminate an oral or dental 
infection prior to, or contemporaneously with chemotherapy, chimeric 
antigen receptor (CAR) T-cell therapy, and the administration of high-
dose bone-modifying agents (antiresorptive therapy) in the treatment of 
cancer. We are also finalizing to allow Medicare Parts A and B payment 
for dental or oral examination performed as part of a comprehensive 
workup prior to, medically necessary diagnostic and treatment services 
to eliminate an oral or dental infection prior to, or contemporaneously 
with, and medically necessary diagnostic and treatment services to 
address dental or oral complications after, treatment of head and neck 
cancer using radiation, chemotherapy, surgery, or any combination of 
these. However, we do not anticipate any significant increase in 
utilization or payment impact for additional dental services given the 
historically low utilization of these therapies. Although, we 
acknowledge that the observed utilization of these services might have 
been low because of the size of the population of patients whose 
treatment would include such dental services and also because the 
dental services have been viewed as subject to the payment preclusion 
under section 1862(a)(12).
    Based on an analysis of 2018-2022 incurred claims experience, we 
estimated that there are potentially 155,000 additional beneficiaries 
who might receive dental services for which Medicare payment could be 
made, relative to the current number of beneficiaries that received 
dental services. These are beneficiaries who would receive any of the 
treatments identified in our finalized policies for CY 2024 (that is, 
chemotherapy/CAR T-cell therapy/bone-modifying agent therapies used in 
the treatment of cancer and treatments for head and neck cancer) who 
would likely require dental services, and could utilize dental services 
for which services Medicare could pay in CY 2024. The estimated average 
cost for these additional dental services is about $525 per person on 
an allowed charge basis and roughly $420 per person on a Medicare 
payment basis. This assumption is based on an analysis of 2019 incurred 
claims, but we believe results using more recent data would not be 
likely to change, due to the limited claims involving these services. 
Based on this same analysis, the effective rate of coverage was less 
than 0.2 percent. We do acknowledge that the actual take-up rate of 
services could be higher due to the proposed additional examples of 
medical services to which dental services are inextricably linked, 
which may raise awareness that payment is available. Therefore, we 
prepared impact estimates under the utilization assumptions of 0.2 
percent and between 1-3 percent. We then applied these utilization 
ratios to estimate projected payments for dental exams and treatments 
in connection with cancer therapies. We found that the estimated yearly 
impact beginning in CY 2024 to be roughly $130,000 per year with a 0.2 
percent utilization assumption, and roughly $650,000 to 2 million per 
year for the utilization assumptions of 1-3 percent. Therefore, we do 
not anticipate a significant payment impact for these provisions. It is 
important to note that there is a certain amount of uncertainty in 
these take-up rate assumptions, but they are consistent with the 
current utilization of dental services, including the expansion 
provided for in the CY 2023 PFS final rule. Additionally, since the 
cost impact of this proposal is negligible, it is not necessary to 
adjust the budget neutrality factor for the conversation factor.
2. Impact of Proposal To Implement Separate Payment for the Office/
Outpatient (O/O) E/M Visit Inherent Complexity Add-On Code (HCPCS 
G2211)
    In recent years, the AMA's CPT Editorial Committee has largely 
restructured the E/M visit code sets to acknowledge changes in medical 
practice. The AMA RUC has reviewed and provided recommendations for the 
revised E/M visit code sets in the context of the generally recognized 
need to better recognize resources involved in furnishing different 
types of services within the broader PFS. While we adopted the RUC-
recommended values for the O/O E/M visit code family in the CY 2021 
final rule, recognizing that those values generally reflect the 
resources involved in furnishing those services, we did not believe 
those valuations appropriately reflected the resource costs involved in 
furnishing primary and other similarly longitudinal medical care for a 
serious or complex condition in office settings. To address this 
concern, effective beginning in CY 2021, we finalized an add-on code to

[[Page 79485]]

separately pay for visit complexity inherent to O/O E/M visits for 
primary care and other medical care services that are part of ongoing 
care related to a patient's single, serious, or complex condition in 
the office setting (the O/O E/M visit inherent complexity add-on). 
After we finalized the CY 2021 payment changes for O/O E/M visits, in 
the CAA of 2021, Congress imposed a statutory moratorium on Medicare 
payment for the O/O E/M visit inherent complexity add-on code until 
January 1, 2024.
    We proposed to implement payment for the O/O E/M visit inherent 
complexity add-on, HCPCS code G2211, with significant refinements to 
target improved payment for primary and other similar longitudinal care 
for serious or complex conditions. Specifically, we proposed that the 
O/O E/M visit complexity add-on code cannot be billed with visits 
reported using Modifier 25 which is used to indicate that the service 
is billed on the same day as a minor procedure or another E/M visit. 
(Previously, in the CY 2021 final rule, we stated we would not expect 
such billing; but as there was no explicit prohibition, these visits 
were included in the budget neutrality adjustment (85 FR 84572)). We 
also proposed to set PFS rates with a refined, more specific 
utilization assumption that better recognizes likely uptake of the 
code, differential use among specialties, and new and established 
patient visits, among other changes. These refined assumptions were 
developed, considering perspectives and information from interested 
parties. The resulting estimate reflects that the O/O E/M visit 
inherent complexity add-on code would likely be reported with 
approximately 38 percent of all O/O E/M visits for CY 2024. As 
discussed previously and shown below, we estimated the specific portion 
of the total budget neutrality adjustment attributable to the proposal 
to make payment for the O/O E/M inherent complexity add-on code to be 
approximately 2.00 percent compared to an attributable budget 
neutrality adjustment of 3.20 percent as calculated in CY 2021 
rulemaking.
3. Advancing Access to Behavioral Health
a. Impact of Proposed Payment for Marriage and Family Therapist (MFT) 
Services and Mental Health Counselor (MHC) Services
    As outlined in section II.J. of this final rule, section 4121 of 
CAA, 2023 added section 1861(s)(2)(II) to establish a new Medicare 
benefit category for MFT services and MHC services furnished and billed 
by MFTs and MHCs, respectively. MFT and MHC services are defined in 
section 1861(lll)(2) and 1861(lll)(4), respectively, as services for 
the diagnosis and treatment of mental illnesses (other than services 
furnished to an inpatient of a hospital). An MFT or MHC is defined as 
an individual who possesses a master's or doctor's degree, is licensed 
or certified by the State in which they furnish services, who has 
performed at least 2 years of clinical supervised experience, and meets 
other requirements as the Secretary determines appropriate. Section 
1833(a)(1)(FF) of the statute requires that MFT and MHC services be 
paid at 75 percent of the amount determined for payment of a clinical 
psychologist. MFT and MHC services are excluded from consolidated 
billing requirements under the skilled nursing facility prospective 
payment system. Services furnished by an MFT and MHC are covered when 
furnished in a rural health clinic and federally qualified health 
center. In addition, the hospice interdisciplinary team is required to 
include one social worker, MFT or MHC. Expenditures associated with 
payment for services furnished by MFTs and MHCs in CY 2024 will be 
incorporated into budget neutrality for PFS ratesetting in future 
years.
4. Drugs and Biological Products Paid Under Medicare Part B
    Section 90004 of the Infrastructure Investment and Jobs Act (Pub. 
L. 117-9, November 15, 2021) amended section 1847A of the Act to 
require manufacturers to provide a refund to CMS for certain discarded 
amounts from a refundable single-dose container or single-use package 
drug. The refund amount is either as noted in section 1847A(b)(1)(B) of 
the Act in the case of a single source drug or biological or as noted 
in section 1847A(b)(1)(C) of the Act in the case of a biosimilar 
biological product, multiplied by the amount of discarded drug that 
exceeds an applicable percentage, which is required to be at least 10 
percent, of total charges (subject to certain exclusions) for the drug 
in a given calendar quarter. In the CY 2023 final rule, we finalized 
several policies to implement the provision, including: reporting 
requirements for the JW and JZ modifiers; the date upon which we will 
begin to edit claims for appropriate use of the JW and JZ modifiers, 
October 1, 2023; the definition of ``refundable single-dose container 
or single-use package drug''; the manner in which refund amounts will 
be calculated; the annual basis we will send reports to manufacturers; 
the dispute resolution process; and enforcement provisions. In section 
III.A.3. of this final rule, we finalize the date of the initial report 
to manufacturers, the dates for subsequent reports, the method of 
calculation of the refund amount when there are multiple manufacturers 
of a refundable drug, increased applicable percentages for certain 
drugs with unique circumstances, and a future application process by 
which manufacturers may apply for an increased applicable percentage 
for a drug.
    As we discussed in the CY 2024 PFS proposed rule (88 FR 52699 
through 52704), we analyzed JW modifier data from 2021 as if the data 
represented dates of service on or after the effective date of section 
90004 of the Infrastructure Act (that is, January 1, 2023).\545\ 
Similar to our regulatory impact analysis in the CY 2023 PFS final rule 
(87 FR 70187 through 70188), we used the 2021 JW modifier data to 
estimate refund amounts as described in section 1847A(h)(3) of the Act. 
First, we subtracted the percent units discarded by 10 percent (the 
applicable percentage for most refundable drugs), except for five drugs 
for which we are finalizing higher applicable percentages in this final 
rule (for example, J9262, J0775, J0223, J3300, and J9269). Then, we 
multiplied that percentage by the CY 2021 total allowed amount to 
estimate the annual refund for a given billing and payment code. The 
quarterly refund was estimated by dividing the annual estimate by 4. We 
note that this analysis remains appropriate for this final rule because 
we are finalizing the increased applicable percentages for the two 
categorical unique circumstances and the associated five billing and 
payment codes as proposed. In addition, the JW modifier data from 2021 
is still the most recent data available for estimating how our final 
policies impact Medicare Part B expenditures.
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    \545\ https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug/medicare-part-b-discarded-drug-units.
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    Overall in the 2021 calendar year, Medicare paid nearly $1.56 
billion for discarded amounts of drugs from a single-dose container or 
single-use package paid under Part B. In that year, there were 51 
billing and payment codes with 10 percent or more discarded units based 
on JW modifier data. Of these, 11 did not meet the definition of 
refundable single-dose container or single-use package drug in section 
1847A(h)(8) of the Act because they are multiple source drug codes; 5 
were excluded from the definition of refundable single-dose container 
or single-use package drug (as specified in

[[Page 79486]]

section 1847A(h)(8)(B) of the Act) because they are identified as 
radiopharmaceuticals or imaging agents in FDA-approved labeling; and 3 
are products referred to as skin substitutes, which were removed 
because we anticipate making changes to coding and payment policies 
regarding those products in future rulemaking. After these exclusions, 
there were 31 billing and payment codes that met the definition of 
refundable single-dose container or single-use package drug and have 
discarded units above the relevant finalized applicable percentage. Of 
these, three have discarded units that would fall below increased 
applicable percentages finalized in this final rule.
    We estimated refund amounts as described in section 1847A(h)(3) of 
the Act were calculated based on this data by subtracting the percent 
units discarded by 10 percent (the applicable percentage), except for 
drugs with higher applicable percentages finalized in the CY 2023 final 
rule or as finalized in this final rule. Then, we multiplied the 
appropriate percentage by the CY 2021 total allowed amount to estimate 
the annual refund for a given billing and payment code. The quarterly 
refund was estimated by dividing the annual estimate by 4. Based on 
this data, there will be approximately $83.1 million in refunds due 
from manufacturers for the calendar year of 2021 ($20.8 million each 
calendar quarter). See Table 122.
BILLING CODE 4120-01-P

[[Page 79487]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.164

     
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    \546\ https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug/medicare-part-b-discarded-drug-units.

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[[Page 79488]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.165


[[Page 79489]]


[GRAPHIC] [TIFF OMITTED] TR16NO23.166

BILLING CODE 4120-01-C

[[Page 79490]]

    There are several limitations to this analysis that could 
substantially affect the total quarterly refund. Since new drugs are 
continually being approved, this estimate does not consider newer drugs 
that will meet the definition of refundable single-dose container or 
single-use package drug on or after the effective date of January 1, 
2023. Since section 1847A(h)(8)(B)(iii) of the Act excludes drugs 
approved by FDA on or after November 15, 2021 and for which payment has 
been made under Part B for fewer than 18 months from this definition, 
we expect an impact on refund amounts after the 18-month exclusion has 
ended if the drug otherwise meets the definition. We also noted that 
this estimate is based on CY 2021 data for discarded drug amounts, 
which, for reasons discussed in the CY 2023 PFS final rule (87 FR 
69716), we believe to be an underestimate due to the frequent omission 
of the JW modifier. Once we begin to edit claims for both the JW and JZ 
modifiers, reported discarded drug amounts will likely increase. Other 
substantial changes to this estimate may occur if a billing and payment 
code no longer meets this definition. For example, if a generic version 
of one of these drugs is marketed, the billing and payment code will 
become a multiple source drug code and will no longer meet the 
definition of refundable single-dose container or single-use package 
drug. Subsequently, the manufacturers will not be responsible for 
refunds under this provision. There may be changes in the percent 
discarded units for a given refundable single-dose container or single-
use package drug if the manufacturer introduces additional vial sizes 
or modifies the vial size to reduce the amount discarded. Lastly, since 
data from the CMS website only includes billing and payment codes on 
the ASP drug pricing file \547\ and implementation of section 90004 of 
the Infrastructure Act is not restricted to billing and payment codes 
included on the file, there may be other applicable data that was not 
assessed as part of this estimate.
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    \547\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-
Part-B-Drugs/McrPartBDrugAvgSalesPrice.
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    We received one public comment on this economic impact analysis. 
The following is a summary of the comment and our response.
    Comment: One commenter stated that our economic impact analysis on 
the discarded drug refund provision reflects incomplete and inaccurate 
data because use of the JW modifier was not uniformly enforced during 
the year from which the data was collected. The commenter requested 
that we take efforts to verify the accuracy of the analysis.
    Response: As noted previously in this final rule, we understand our 
analysis to have several limitations, including that we believe our 
refund estimates to understate actual discarded amounts for refundable 
drugs due to low compliance with the JW modifier requirement that went 
into effect on January 1, 2017. The discarded drug data that has been 
reported with the JW modifier data since 2013 is the best data 
available and is what we used for this analysis. We expect this data 
and our impact analyses to become more accurate after the 
implementation of claims edits for appropriate JW and JZ modifier use 
on October 2, 2023.
a. Impacts Related to the Issuance of the Initial Report
    In section III.A.3.b. of this final rule, we finalized the policy 
to issue the initial refund report to manufacturers, to include all 
calendar quarters for 2023, no later than December 31, 2024. 
Accordingly, as outlined in section III.B.3.c. of this final rule, we 
finalized the policy to require that the refund amounts specified in 
the initial refund report be paid no later than February 28, 2025, 
except in circumstances where a report is under dispute.
    Delaying the receipt of the rebate, that is in 2025 instead of 
2024, only represents a cost to the extent the SMI trust fund receives 
less interest revenue. Only a portion of SMI trust fund revenue ends up 
invested in the bond portfolio. Based on current SMI trust fund 
operation patterns a delay in rebate collection as described in the 
rule would represent a cost less than $2 million dollars in any given 
year and therefore would be negligible to SMI trust fund operations.
b. Impacts Related to the Application for Consideration
    As outlined in section V.B.1. of this final rule, the information 
collection requirements, we estimated the annual burden per applicant 
to be 5 hours. If we anticipate no more than 22 applications in the 
initial year applications are available, the total annual drafting and 
submitting burden would be 110 hours (22 applications per year x 5 hrs 
per applicant). We estimate an annual cost of this burden to be 
$4,591.40 ($41.74/hr x 110 hr). For subsequent years, we estimate a 
total annual burden related to drafting and submission of 10 hours (2 
applications x 5 hr per respondent/applicant) at an annual cost of $418 
(41.74/hr x 10 hr).
5. Rural Health Clinics (RHCs) and Federally Qualified Health Centers 
(FQHCs)
    In section III.B.4. of this final rule, we finalized the policy to 
include Remote Patient Monitoring (RPM) and Remote Therapeutic 
Monitoring (RTM) services, Community Health Integration (CHI) and 
Principal Illness Navigation (PIN) services, in the general care 
management HCPCS code G0511 when these services are provided by RHCs 
and FQHCs. Due to the growing number of services in the code, we 
revised the calculation for G0511 to include the weighted average of 
these services based on utilization under the PFS as this may provide a 
more complete and accurate payment amount.
    In terms of estimated impacts to the Medicare program, expanding 
use of General Care Management HCPCS code G0511 to include RPM, RTM, 
CHI, and PIN may result in an increase in spending. Prior updates to 
G0511 have resulted in negligible increases.
6. RHC and FQHC CfC Changes: Permitting MFTs and MHCs To Furnish 
Services
    Section 4121 of the CAA, 2023 amends section 1861(aa)(1)(B) of the 
Act by adding MFTs and MHCs as eligible practitioners of RHCs and FQHCs 
beginning January 1, 2024. We proposed regulation text changes to 
permit MFT and MHCs to provide services furnished at RHCs and FQHCs. 
These changes will include MFTs and MHCs as members of the staff who 
may be the owner or an employee of the clinic or center, or furnish 
services under contract to the clinic or center. Along with other 
permitted physicians and nonphysician practitioners, MFT and MHCs may 
be available to furnish patient care services at all times the clinic 
or center operates.
    At Sec.  491.9(b)(3) RHCs and FQHCs must have patient care policies 
that include: (1) a description of the services the clinic or center 
furnishes directly or through agreement or arrangement; (2) guidelines 
for medical management of health problems; and (3) rules for storage, 
handling, and administration of drugs and biologicals. Additionally, 
Sec.  491.9(b)(4) states that the RHC and FQHC patient policies must 
regularly be reviewed at least once every 2 years by a group of 
professional personnel that includes one or more physicians, one or 
more physician assistants (PAs) or nurse practitioners (NPs), and at 
least one person who is not a member of the clinic or center staff. If 
an RHC or FQHC provides services furnished by an MHC or MFT they must 
update their patient

[[Page 79491]]

care policies with a description of the services they will provide.
    The most recently published collection of information for RHCs and 
FQHCs (OMB control number 0938-0334), estimates that an annual review 
of the patient care policies may take approximately 2 hours. Therefore, 
we assume, it would take each medical professional (at least one 
physician and at least one PA or NP) 1 hour to review all policies and 
procedures, annually. Based on the prior analysis, we estimated it will 
take 30 minutes to add the description of MFT and MHC services. We also 
assume that only half of the RHCs and half of the FQHCs will have this 
burden applied to them, for a total burden estimate of $817,631.92. We 
noted that there would be variations in how many clinics or centers 
employ or contract with an MFT and MHC based on their ability to expand 
their services. We also recognized that some RHCs and FQHCs may already 
provide these services as some States provide reimbursement under the 
Medicaid program; however, we do not know the exact number of clinics 
or centers that already have these practitioners on staff and will not 
incur the burden.
    While this final rule does have a 1-time burden, there is evidence 
to suggest there are long-term financial savings in integrating mental 
health in medical care. Effectively integrating mental and medical care 
can save upwards of $52 billion annually due to the existing Medicare 
mental health coverage gap.\548\ Though this total encompasses all 
facility types, expanding access to MFT and MHC services in RHCs and 
FQHCs will have individual and societal cost savings. Older adults with 
mental health conditions have poorer health outcomes, higher 
hospitalization rates, and emergency room visits.\549\ While there is 
an increasing need for mental health services, one barrier to effective 
treatment is access to mental health services.\550\ Ensuring access to 
mental health care in rural communities is challenging as there are 
fewer mental health providers per capita in nonmetropolitan 
counties.\551\ This coincides with HRSA's second quarter of the fiscal 
year 2023 designated health professional shortage area (HPSA) quarterly 
summary, which breaks down the number of HPSAs by primary medical care, 
dental, and mental health HPSAs based on four categories (rural, non-
rural, partial rural, and unknown); and as population HPSAs, geographic 
HPSAs, or Facility HPSAs. The report does not provide accumulative 
HPSAs by the four categories.\552\ Approximately 65 percent of 
federally designated health professional shortage areas are located in 
rural areas, and about 30 percent are located in non-rural areas.\553\ 
The shortage of professionals in rural areas is severe, and the 
shortage of qualified professionals in combination with geographic 
limitations only exacerbates the mental health crisis in older 
adults.\554\ While there are disparities in the availability of the 
behavioral workforce between rural and nonrural areas, counselors are 
integral to providing care in rural areas.\555\
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    \548\ https://onlinelibrary.wiley.com/doi/full/10.1002/jcad.12409?casa_token=z412GCn3OuYAAAAA%3AHO3p-cHeiVrLww0dZjTkIcuCbwMxvYtRUo4aj8AwB-tq2w_ZJV11gGpWW-oxilDK3awU0xIc2XKMnKhtAQ#jcad12409-bib-0003.
    \549\ https://onlinelibrary.wiley.com/doi/full/10.1002/jcad.12409?casa_token=z412GCn3OuYAAAAA%3AHO3p-cHeiVrLww0dZjTkIcuCbwMxvYtRUo4aj8AwB-tq2w_ZJV11gGpWW-oxilDK3awU0xIc2XKMnKhtAQ#jcad12409-bib-0005.
    \550\ https://psycnet.apa.org/fulltext/2020-75725-002.html.
    \551\ https://psycnet.apa.org/record/2018-25164-007.
    \552\ https://data.hrsa.gov/topics/health-workforce/shortage-areas.
    \553\ https://data.hrsa.gov/Default/GenerateHPSAQuarterlyReport.
    \554\ https://psycnet.apa.org/fulltext/2020-75725-002.html.
    \555\ chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/
https://depts.washington.edu/fammed/rhrc/wp-content/uploads/sites/4/2016/09/RHRC_DB160_Larson.pdf.
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7. Clinical Laboratory Fee Schedule
    In section III.D. of this final rule, we outline statutory 
revisions to the data reporting period and phase-in of payment 
reductions under the CLFS. In accordance with section 4114 of the CAA, 
2023, we finalized certain conforming changes to the data reporting and 
payment requirements in our regulations at 42 CFR part 414, subpart G. 
Specifically, for CDLTs that are not ADLTs, we are updating certain 
definitions and revising Sec.  414.504(a)(1) to indicate that 
initially, data reporting begins January 1, 2017, and is required every 
3 years beginning January 2024. The CAA, 2023 delays the next data 
reporting period under the CLFS for CDLTs that are not ADLTs by 1 year, 
that is, it requires the next data reporting period for these tests to 
take place during the period of January 1, 2024 through March 31, 2024. 
Subsequently, the next private payor rate-based CLFS update for these 
tests will be effective January 1, 2025, instead of January 1, 2024. In 
addition, we are making conforming changes to our requirements for the 
phase-in of payment reductions to reflect the CAA, 2023 amendments. 
Specifically, we are revising Sec.  414.507(d) to indicate that for CY 
2023, payment may not be reduced by more than 0.0 percent as compared 
to the amount established for CY 2022, and for CYs 2024 through 2026, 
payment may not be reduced by more than 15 percent as compared to the 
amount established for the preceding year.
    We recognize that private payor rates for CDLTs paid on the CLFS 
and the volumes paid at each rate for each test, which are used to 
determine the weighted medians of private payor rates for the CLFS 
payment rates, have changed since the first data collection period 
(January 1, 2016 through June 30, 2016) and data reporting period 
(January 1, 2017 through March 31, 2017). In addition, as outlined in 
section III.D. of this final rule, in the CY 2019 PFS final rule (83 FR 
59671 through 59676), we amended the definition of applicable 
laboratory to include hospital outreach laboratories that bill Medicare 
Part B using the CMS-1450 14x Type of Bill. As such, the CAA, 2023 
amendments to the data reporting period will delay using updated 
private payor rate data to set revised CLFS payment rates for CDLTs 
that are not ADLTs.
    Due to unforeseen changes in private payor rates due to shifts in 
market-based pricing for laboratory tests and the unpredictable nature 
of test volumes and their impact on calculating updated CLFS payment 
rates based on the weighted median of private payor rates, it is 
uncertain whether the delay in data reporting will result in a 
measurable budgetary impact. In other words, to assess the impact of 
delayed reporting and subsequent implementation of updated CLFS rates, 
we will need to calculate weighted medians of private payor rates based 
on new data and compare the revised rates to the current rates. As 
such, we believe that we will only know the impact of the delay in data 
reporting after collecting actual updated applicable information from 
applicable laboratories and calculating the updated CLFS rates.
    Regarding the conforming changes to our requirements for the phase-
in of payment reductions, we note that for CYs 2024 through 2026, 
payment may not be reduced by more than 15 percent as compared to the 
amount established for the preceding year. Based on data reported in 
the 2017 data collection period, we estimate 14.8 percent (191) of 
tests on the CLFS may be subject to the full 15 percent phase-in 
reduction in CY 2024.

[[Page 79492]]

8. Pulmonary Rehabilitation (PR), Cardiac Rehabilitation (CR) and 
Intensive Cardiac Rehabilitation (ICR) Expansion of Supervising 
Practitioners
    As outlined in section III.E. of this final rule, we are finalizing 
the proposed revisions to Sec. Sec.  410.47 (PR) and 410.49 (CR/ICR) to 
codify the statutory changes made in section 51008 of the Bipartisan 
Budget Act of 2018 (Pub. L. 115-123, enacted February 9, 2018) (BBA of 
2018) which permit other specific types of practitioners to supervise 
these services effective January 1, 2024. The amendments add to the 
types of practitioners who may supervise PR, CR and ICR programs to 
also include a physician assistant (PA), nurse practitioner (NP) or 
clinical nurse specialist (CNS). Accordingly, we are finalizing 
additions and revisions to the PR and CR/ICR regulations to reflect 
these statutory amendments.
    To assess the potential impact from expanding the types of 
practitioners that may supervise PR/CR/ICR we searched the literature 
for articles that evaluated the utilization rates of PR, CR and ICR to 
determine the historical utilization trends of these services as well 
as known barriers to utilization. Based on historical utilization 
trends as well as barriers to utilization discussed in the literature, 
we do not expect the changes to make a significant impact on the 
Medicare program.
    Nishi et al. (2016) investigated the number of Medicare 
beneficiaries with COPD who received PR from January 1, 2003, to 
December 31, 2012. Their results included both individuals who had 
experienced hospitalizations for COPD and those who were outpatients 
only. The number of unique patients with COPD who initially 
participated in PR during the study period was 2.6 percent in 2003 
(before conditions of coverage at Sec.  410.47 were established) and 
2.88 percent in 2012 (after conditions of coverage at Sec.  410.47 were 
established).\556\ In 2019, Spitzer, et al. published an article based 
on Medicare claims data from 2012, finding that 2.7 percent of eligible 
Medicare beneficiaries received PR within 12 months of hospitalization 
with COPD.\557\ Using claims data from fee-for-service Medicare 
beneficiaries hospitalized for COPD in 2014, Lindenauer et al. (2020) 
reported that only 3 percent initiated PR within 1 year of their 
hospital discharge.\558\ Taken together, this data informs us that 
utilization of PR in the Medicare population is very low.
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    \556\ Nishi SP, Zhang W, Kuo YF, Sharma G. Pulmonary 
Rehabilitation Utilization in Older Adults With Chronic Obstructive 
Pulmonary Disease, 2003 to 2012. J Cardiopulm Rehabil Prev. 
2016;36(5):375-382. doi:10.1097/HCR.0000000000000194.
    \557\ Spitzer KA, Stefan MS, Priya A, et al. Participation in 
pulmonary rehabilitation after hospitalization for chronic 
obstructive pulmonary disease among Medicare beneficiaries. Ann Am 
Thorac Soc. 2019;16:99-106.DOI: 10.1513/AnnalsATS.201805-332OC. 
PMID: 30417670; PMCID: PMC6344454.
    \558\ Lindenauer PK, Stefan MS, Pekow PS, et al. Association 
Between Initiation of Pulmonary Rehabilitation After Hospitalization 
for COPD and 1-Year Survival Among Medicare Beneficiaries. JAMA. 
2020;323(18):1813-1823. doi:10.1001/jama.2020.4437.
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    Million Hearts[supreg] 2027, a national initiative co-led by the 
Centers for Disease Control and Prevention (CDC) and CMS to prevent 1 
million preventable cardiovascular disease (CVD) events in the next 5 
years,\559\ includes a goal of increasing use of CR and states that CR 
participation rates remain low, ranging from 19 percent to 34 
percent.\560\ Fleg and colleagues (2020) report that less than 25 
percent ``of eligible patients participate in CR'' with a smaller 
proportion completing 36 sessions as recommended.\561\ In their 2022 
article, Varghese and colleagues state that less than 30 percent of 
eligible patients participate in CR in the United States.\562\ Husaini 
and colleagues (2022) analyzed a sample of Medicare fee-for-service 
claims between 2012 and 2016 and reported that within 1 year of a 
qualifying event, 16 percent of patients completed one or more CR 
session and 0.1 percent of patients completed one or more ICR sessions. 
They observed an increase of combined CR and ICR utilization from 14 
percent (patients with qualifying events in 2012) to 18 percent 
(patients with qualifying events in 2015).\563\ Taken together, this 
data informs us that utilization of CR and ICR is low, although not as 
low as PR.
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    \559\ https://millionhearts.hhs.gov/about-million-hearts/index.html.
    \560\ https://millionhearts.hhs.gov/about-million-hearts/optimizing-care/cardiac-rehabilitation.html.
    \561\ Fleg JL, Keteyian SJ, Peterson PN, Benzo R, Finkelstein J, 
Forman DE, Gaalema DE, Cooper LS, Punturieri A, Joseph L, Shero S, 
Zieman S. Increasing Use of Cardiac and Pulmonary Rehabilitation in 
Traditional and Community Settings: OPPORTUNITIES TO REDUCE HEALTH 
CARE DISPARITIES. J Cardiopulm Rehabil. Prev. 2020 Nov;40 (6):350-
355. doi: 10.1097/HCR.0000000000000527. PMID: 33074849; PMCID: 
PMC7644593.
    \562\ Varghese MS, Beatty AL, Song Y, et al., Cardiac 
Rehabilitation and the COVID-19 Pandemic: Persistent. Declines in 
Cardiac Rehabilitation Participation and Access Among US Medicare 
Beneficiaries. Circ Cardiovasc Qual Outcomes. 2022;15:e009618. DOI: 
10.1161/CIRCOUTCOMES.122.009618.
    \563\ Husaini M, Deych E, Racette SB, et al. Intensive Cardiac 
Rehabilitation Is Markedly Underutilized by Medicare Beneficiaries: 
RESULTS FROM A 2012-2016 NATIONAL SAMPLE. J Cardiopulm Rehabil Prev. 
2022 May 1;42(3):156-162. doi: 10.1097/HCR.0000000000000632. Epub 
2021 Sep 9. PMID: 34508035.
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    Underutilization of PR, CR and ICR has been attributed to numerous 
factors as described by Fleg et al. ``including a lack of referral or 
strong recommendation from a physician and inadequate follow-up or 
facilitation of enrollment after referral. Financial issues such as 
limited or absent health insurance coverage and the inability to afford 
copayments, even when insured, also limit CR/PR participation as do 
conflicting work and home responsibilities and distance and 
transportation difficulties. Social and cultural factors, including the 
lack of gender and racial diversity among CR/PR staff, language and 
cultural barriers, and lack of program availability and access are 
additional challenges . . . Many eligible patients are also commonly 
perceived as too frail . . .'' \564\ Husaini et al. (2022) reinforce 
the impact of similar factors in CR underuse. They cite ``lower 
reimbursements relative to cost and variability in access'', physician 
``skepticism over benefit and a primary emphasis on cardiac medications 
and procedures'', and patient ``reluctance or inability to commit 3-6 
hr/wk for 8-12 wk to CR, logistical (transportation, work, etc) or 
financial impediments, a preference for exercise/rehabilitation at 
home, fear of failure, and physical limitations.'' \565\
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    \564\ Fleg JL, Keteyian SJ, Peterson PN, Benzo R, Finkelstein J, 
Forman DE, Gaalema DE, Cooper LS, Punturieri A, Joseph L, Shero S, 
Zieman S. Increasing Use of Cardiac and Pulmonary Rehabilitation in 
Traditional and Community Settings: OPPORTUNITIES TO REDUCE HEALTH 
CARE DISPARITIES. J Cardiopulm Rehabil. Prev. 2020 Nov;40 (6):350-
355. doi: 10.1097/HCR.0000000000000527. PMID: 33074849; PMCID: 
PMC7644593.
    \565\ Husaini M, Deych E, Racette SB, et al. Intensive Cardiac 
Rehabilitation Is Markedly Underutilized by Medicare Beneficiaries: 
RESULTS FROM A 2012-2016 NATIONAL SAMPLE. J Cardiopulm Rehabil Prev. 
2022 May 1;42(3):156-162. doi: 10.1097/HCR.0000000000000632. Epub 
2021 Sep 9. PMID: 34508035.
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    While the expansion of supervision requirements to include 
nonphysician practitioners could offer greater flexibility for PR and 
CR programs to operate, the barriers to utilization as described by 
Fleg and colleagues (2020) and Husiani and colleagues (2022) are 
widespread and complex and low participation in PR, CR and ICR has 
remained steady for many years. We do not believe the expansion of 
supervising practitioners is likely to address these barriers. 
Therefore, we do not anticipate any significant increase in utilization 
of PR, CR and ICR services and subsequent impact to the Medicare 
program or interested parties.

[[Page 79493]]

9. Modifications Related to Medicare Coverage for Opioid Use Disorder 
(OUD) Treatment Services Furnished by Opioid Treatment Programs (OTPs)
    As outlined in section III.F. of this final rule, we are allowing 
periodic assessments to be furnished via audio-only communication when 
two-way audio-video communications technology is not available to the 
beneficiary through the end of CY 2024, to the extent that it is 
authorized by SAMHSA and DEA at the time the service is furnished and 
all other applicable requirements are met.
    We believe the Part B cost impact of this flexibility for the use 
of telecommunications will be minimal because we do not expect that 
these flexibilities will increase the frequency with which medically 
necessary assessments are furnished.
10. Medicare Shared Savings Program
a. General Impacts
    As of January 1, 2023, 10.9 million Medicare beneficiaries receive 
care from a health care provider in one of the 456 ACOs participating 
in the Shared Savings Program, the largest value-based care program in 
the country. The modifications to Shared Savings Program policies we 
are finalizing with this final rule advance Medicare's overall value-
based care strategy of growth, alignment, and equity, with many 
provisions overlapping these categories. Many of the policies in this 
final rule are incremental refinements to the broader changes finalized 
in the CY 2023 PFS final rule (87 FR 69777 through 69968). Those 
changes were designed to reverse recent trends where program 
participation had plateaued, higher spending populations were 
increasingly underrepresented in the program since the change to 
regionally adjusted benchmarks, and access to ACOs appeared inequitable 
as evidenced by data indicating underserved populations were less 
likely to be assigned to a Shared Savings Program ACO, and to encourage 
growth of ACOs in underserved communities.
    The changes to the Shared Savings Program regulations finalized 
with the CY 2023 PFS final rule were designed to increase program 
participation for new ACOs through the AIP option intended to promote 
health equity and provide ACOs greater choice in the pace of 
progression to performance-based risk; sustain program participation by 
reducing the effect of ACO performance on benchmark updates and 
benchmark rebasing; mitigate the bias in regional expenditure 
calculations that benefits ACOs electing prospective assignment; 
strengthen incentives for ACOs serving high-risk and high dual 
populations; improve the risk adjustment methodology to better account 
for medically complex, high-cost beneficiaries while continuing to 
guard against coding initiatives; increase opportunities for low 
revenue ACOs in the BASIC track to share in savings by allowing ACOs 
that do not meet the minimum savings rate (MSR) requirement to share in 
savings at a lower rate; encourage ACOs to transition more quickly to 
all-payer quality measure reporting; update the ACO beneficiary 
assignment methodology; and reduce administrative burden on ACOs. The 
changes to Shared Savings Program policies in this final rule include 
modifications designed to further these goals in concert with 
implementation of certain changes finalized in the CY 2023 PFS final 
rule, which are applicable for agreement periods beginning on January 
1, 2024, and in subsequent years.
    On average, updated benchmarks would marginally increase as a 
result of the modifications to the calculation of the regional 
component of the blended update factor used to update the historical 
benchmark between benchmark year (BY) 3 and the performance year (PY) 
by capping an ACO's regional service area risk score growth through use 
of an adjustment factor to provide more equitable treatment for ACOs 
and for symmetry with the cap on ACO risk score growth (section 
III.G.4.b. of this final rule). This change is expected to increase the 
regional update factor amount in certain cases where an ACO may operate 
in a regional service area with rapid change in the average prospective 
HCC risk score for the FFS assignable beneficiary population. The 
current methodology for calculating the regional update factor risk 
adjusts county-level FFS expenditures in an ACO's regional service area 
by Medicare enrollment type by dividing average county-level FFS 
expenditures for assignable beneficiaries in the county by the average 
prospective HCC risk score for both the performance year and BY3. The 
expenditure growth between BY3 and the performance year calculated 
using risk-adjusted regional expenditures could therefore be reduced by 
large increases in average prospective HCC risk scores in the ACO's 
regional service area that would only be partly offset by the increase 
in prospective HCC risk score growth for the ACO's assigned beneficiary 
population due to the cap on ACO assigned beneficiary prospective HCC 
risk score growth when updating the benchmark between BY3 and the 
performance year. The adjustment we are adopting in this final rule, 
applicable for agreement periods beginning on January 1, 2024, and in 
subsequent years, will effectively strengthen the regional portion of 
the three-way blended update factor and help to limit losses ACOs may 
face when operating in regional service areas with high risk score 
growth and a beneficiary population that becomes more medically complex 
between BY3 and the performance year, increasing incentives for ACOs to 
form or continue participation in such areas. By utilizing a market 
share adjusted cap to account for ACO market share in the ACO's 
regional service area, the adjustment will still retain a disincentive 
against coding intensity for ACOs that may have a high market share in 
their region and consequently have greater influence on regional 
service area risk score changes. We expect this feature of the 
methodology will help dissuade such ACOs from attempting to 
artificially increase their benchmark by selectively serving lower risk 
beneficiaries and increasing the intensity of diagnoses submitted for 
those beneficiaries.
    Analyses outlined in section III.G.4.b.(2) of this final rule, 
surrounding Tables 38 and 39, provide the basis for estimating the 
impact for the cap on regional service area risk score growth. Analysis 
of average prospective HCC risk score changes at the Hospital Referral 
Region (HRR) level over an extended 2007 to 2021 historical period 
consistently indicated that risk score changes would be highly unlikely 
to exceed the cap in the first two years of an ACO's agreement period 
but will increase somewhat as the 5-year agreement period progresses. 
The analysis also notably showed that average prospective HCC risk 
score variation increased markedly in 2020 and 2021 with the COVID-19 
PHE.\566\ The 11 percent of ACOs simulated to be impacted by the 
adjustment in PY 2021 (a mix of ACOs with 2-year and 3-year gaps 
between their respective BY3 and the simulated PY 2021) is therefore 
anticipated to overstate variation expected in agreement periods that 
start on January 1, 2024 or later.
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    \566\ Public use data on Medicare Geographic Variation--by 
Hospital Referral Region, used for this analysis, is available at 
https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-geographic-comparisons/medicare-geographic-variation-by-hospital-referral-region.
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    Based on the simulation in the context of the longer-run HRR data, 
we project that starting in 2024 the adjustment will impact less than 1 
percent of ACOs in PY1 of an agreement

[[Page 79494]]

period, between 5 to 7 percent of ACOs by PY3, and up to 10 to 15 
percent of ACOs by PY5. The adjustment for ACOs that are simulated to 
be impacted is relatively small, increasing updated benchmarks by about 
0.2 percent up to 0.4 percent on average by PY5, but with the potential 
for up to a net adjustment of about 1.5 percent in extreme scenarios. 
The estimated cost from additional shared savings payments resulting 
from these adjustments totals $370 million over 10 years as shown in 
Table 123.
[GRAPHIC] [TIFF OMITTED] TR16NO23.167

    A material, albeit uncertain impact, is also estimated for the (a) 
use of a rolling 3-year historical period instead of contemporary 
performance to calculate the 40th percentile of the MIPS Quality 
performance category scores starting in PY 2024 and (b) use of the 
higher of the ACO's health equity adjusted quality performance score or 
the 40th percentile MIPS Quality performance category score across all 
MIPS Quality performance scores if a measure that is used to calculate 
the MIPS Quality performance category score is excluded or does not 
have a benchmark. It is likely that MIPS Quality performance will 
improve at least marginally over time and therefore the historical 
performance could produce a target that effectively is lower than the 
contemporary 40th percentile stipulated at baseline. The effective 
reduction in the threshold when using the historical MIPS scores, 
combined with the `higher of' approach when a measure is excluded or 
lacking a benchmark, are assumed to effectively reduce the quality 
target by 0 to 5 percentage points (mode 1.5 percentage points), which 
would produce an estimated $110 million in additional shared savings 
payments over 10 years, as shown in the Table 124.
[GRAPHIC] [TIFF OMITTED] TR16NO23.168

    The impact of the policies to mitigate the impact of the negative 
regional adjustment on the benchmark is also estimated to be material. 
In the CY 2023 PFS final rule, CMS finalized changes applicable for 
agreement periods beginning on January 1, 2024, and in subsequent 
years, that would reduce the cap on negative regional adjustments from 
5 percent to 1.5 percent and provide an offset factor to gradually 
decrease the negative regional adjustment amount as an ACO's proportion 
of dually eligible Medicare and Medicaid beneficiaries increases or its 
weighted average prospective HCC risk score increases, or both. 
Removing the regional adjustment entirely, when the ACO's regional 
adjustment amount (expressed as a single per capita value) is negative, 
will incrementally increase benchmarks for higher spending ACOs 
(increasing shared savings payments) but will also improve the 
incentive for higher spending ACOs to join the Shared Savings Program 
and drive down unnecessary spending. For a high cost estimate we 
conservatively assume no new participation is generated in response to 
this change and estimate the higher benchmarks would generate about 
$1.8 billion in additional shared savings payments partly offset by 
about $1.6 billion in reduced spending in response to improved 
incentives. For a mean estimate we additionally assume 10 percent 
growth in participation from new high spending ACOs leading to about 
$490 million net savings over 10 years.\567\ For a low cost estimate we 
instead assume 20 percent growth in

[[Page 79495]]

participation from high spending ACOs leading to about $1.2 billion in 
net savings over 10 years. Table 125 shows these estimates over the 
2024-2033 window.
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    \567\ Elimination of overall negative regional adjustments would 
likely generate participation growth from ACOs that would have faced 
significant negative adjustments despite the changes from the CY 
2023 PFS final rule to reduce the impact of the negative regional 
adjustment, but also from other prospective high spending ACOs that 
may have difficulty estimating the relief they will ultimately 
receive from the offsets applicable to agreement periods beginning 
on January 1, 2024, and in subsequent years. Eliminating the overall 
negative regional adjustment entirely will materially improve the 
business case for participation from ACOs in the former category and 
may at least optically improve the business case for ACOs in the 
latter category without actually incurring cost to the program by 
increasing their benchmarks.
[GRAPHIC] [TIFF OMITTED] TR16NO23.169

    Use of the CMS-HCC risk adjustment model(s) applicable to the 
calendar year corresponding to the performance year to calculate a 
Medicare FFS beneficiary's prospective HCC risk score for the 
performance year, and for each benchmark year of the ACO's agreement 
period for agreement periods beginning January 1, 2024, and in 
subsequent years, is anticipated to remove a potential bias that may 
otherwise reduce benchmarks particularly for ACOs with beneficiaries 
exhibiting higher average renormalized risk scores at baseline. An 
increase in average shared savings payments to ACOs that would have 
participated regardless of this modification is expected to ultimately 
be more than offset by additional savings from increased participation 
from ACOs serving high risk beneficiaries that would have otherwise 
dropped out or avoided entering the Shared Savings Program under the 
current approach to calculating prospective HCC risk scores. Net 
savings are expected to be greater at the end of the 10-year scoring 
window because residual savings from added participation would grow, 
whereas benchmarks would not be as impacted in the later part of the 
scoring window because there is lower likelihood that later agreement 
periods would have been impacted by changes in the CMS HCC risk 
adjustment methodology. Table 126 shows these estimates over the 2024-
2033 window.
[GRAPHIC] [TIFF OMITTED] TR16NO23.170

    An overall net impact is difficult to quantify for the changes in 
section III.G.3.a. of this final rule, to incorporate use of a new 
third step in the step-wise beneficiary assignment methodology and the 
changes to how we identify the assignable beneficiary population. These 
changes are not currently estimated to have a net impact on program 
spending in either direction. Impacts on benchmark calculations for 
individual ACOs would likely be mixed and of relatively limited 
magnitude. The changes could allow some ACOs to increase efficiency by 
utilizing more non-physician practitioners in delivering primary care 
by reducing the risk of their beneficiaries being assigned to other 
ACOs. On the other hand, these changes could marginally increase shared 
savings payments to ACOs for efficiencies that currently accrue 
entirely to the program as spillover effects on beneficiaries unable to 
be assigned. The overall impact is currently anticipated to be roughly 
neutral. We will continue to analyze data on the impact of these 
changes on existing ACOs and will monitor effects of these policies in 
the future.
    The remaining changes to the Shared Savings Program regulations are 
not estimated to have an impact on program spending at the aggregate 
level. These changes include modifying the definition of primary care 
services for purposes of determining beneficiary assignment, 
recalculating the prior savings adjustment for changes in the amount of 
savings earned by an ACO in a benchmark year due to compliance action 
taken to address avoidance of at-risk beneficiaries or changes in the 
amount of savings or losses for a benchmark year as a result of the 
issuance of a revised initial determination of financial performance, 
expanding quality reporting options to include Medicare CQMs, requiring 
reporting of the MIPS Promoting Interoperability performance category 
for all ACO participants, ACO providers/suppliers, and ACO 
professionals that are MIPS eligible clinicians, QPs, or Partial QPs, 
unless otherwise excluded, and using beneficiary counts instead of 
person years in health equity adjustment calculations, as well as 
changes to further refine AIP policies, revise program eligibility 
requirements, and make technical changes.

[[Page 79496]]

b. Compliance With Requirements of Section 1899(i)(3) of the Act
    Certain policies, including both existing policies and new policies 
adopted in section III.G. of this final rule, rely upon the authority 
granted in section 1899(i)(3) of the Act to use other payment models 
that the Secretary determines will improve the quality and efficiency 
of items and services furnished under the Medicare program, and that do 
not result in program expenditures greater than those that would result 
under the statutory payment model. The following policies require the 
use of our authority under section 1899(i) of the Act: the 
modifications to the calculation of regional component of the three-way 
blended update factor to cap regional service area risk score growth 
for symmetry with the ACO risk score growth cap, as described in 
section III.G.4.b. of this final rule and the refinements to AIP 
policies as described in section III.G.5. of this final rule. Further, 
certain existing policies adopted under the authority of section 
1899(i)(3) of the Act that depend on use of the assigned population and 
assignable beneficiary populations will be affected by the addition of 
a new third step of the beneficiary assignment methodology and the 
revisions to the definition of assignable beneficiary described in 
section III.G.3. of this final rule, including the following: the 
amount of advance investment payments; factors used in determining 
shared losses for ACOs under two-sided risk models (including 
calculation of the variable MSR/MLR based on the ACO's number of 
assigned beneficiaries, and the applicability of the extreme and 
uncontrollable circumstances policy for mitigating shared losses for 
ACOs under two-sided risk models); and calculation of the ACPT, 
regional and national components of the three-way blended benchmark 
update factor. When considered together, these changes to the Shared 
Savings Program's payment methodology are expected to improve the 
quality and efficiency of items and services furnished under the 
Medicare program by improving the ability for ACOs to sustain effective 
participation in regions with changing populations and increasing the 
overall proportion of Medicare beneficiaries assigned to ACOs, and are 
not expected to result in a situation in which the payment methodology 
under the Shared Savings Program, including all policies adopted under 
the authority of section 1899(i) of the Act, results in more spending 
under the program than would have resulted under the statutory payment 
methodology in section 1899(d) of the Act.
    In the CY 2023 PFS final rule we estimated that the projected 
impact of the payment methodology that incorporates all finalized 
changes from that final rule would result in $4.9 billion in greater 
program savings compared to a hypothetical baseline payment methodology 
that excludes the policies that require section 1899(i)(3) of the Act 
authority (see 87 FR 70195 and 70196). The marginal impact of the 
changes adopted in this final rule is estimated to be $330 million 
lower net spending over the 10- year window for all new policies 
combined, including the cap on an ACO's regional service area risk 
score growth, the addition of a new third step to the beneficiary 
assignment methodology, and the revised approach to identify the 
assignable beneficiary population. Therefore, we believe the relatively 
minor changes to program spending arising from the policies adopted in 
this final rule will not change our assessment that the payment 
methodology adopted in the CY 2023 PFS final rule satisfies the 
requirement under section 1899(i)(3)(B) of the Act.
    We will continue to reexamine this projection in the future to 
ensure that the requirement under section 1899(i)(3)(B) of the Act that 
an alternative payment model not result in additional program 
expenditures continues to be satisfied. In the event that we later 
determine that the payment model that includes policies established 
under section 1899(i)(3) of the Act no longer meets this requirement, 
we would undertake additional notice and comment rulemaking to make 
adjustments to the payment model to assure continued compliance with 
the statutory requirements.
11. Medicare Part B Payment for At-Home Preventive Vaccine 
Administration Services
    In section III.H. of this final rule, we finalized the policy to 
maintain the additional payment when a COVID-19 vaccine is administered 
in a beneficiary's home under certain circumstances, and to extend this 
payment to the administration of a pneumococcal, hepatitis B or 
influenza vaccines.
    We estimate the impact of maintaining the additional payment for 
in-home COVID-19 vaccine administrations and to expand the policy to 
the administration of all Part B preventive vaccines. For this 
estimate, we analyzed CY 2021-2022 utilization of HCPCS code M0201 for 
the providers and suppliers that billed it, along with their 
utilization of the relevant preventive vaccine administration codes. 
During this period, the in-home additional payment was billed about 
200,000 times by roughly 1,500 different providers and suppliers. For 
those providers or suppliers who administered COVID-19 vaccine in the 
home in 2021-2022, HCPCS code M0201 was billed about 2 percent of the 
time they administered any COVID-19 vaccination. Total Medicare 
payments for this service in 2021 and 2022 were $4 million and $3 
million, respectively.
    While we expect that in-home administrations of COVID vaccines will 
continue into CY 2024, we note that the overall utilization of the 
COVID-19 vaccine was significantly lower in 2022 than in 2021, and 
future utilization is unknown. Further, if we apply the prevalence of 
the utilization of HCPCS code M0201 for in-home administration of the 
COVID-19 vaccine to the utilization of the other three Part B 
preventive vaccinations, it will result in higher spending of roughly 
$1-2 million. Therefore, the overall estimated impact of this final 
policy is increased spending of less than $5 million in 2024. We note 
that our analysis assumed that there will be no additional providers or 
suppliers who will decide to begin providing these vaccines at home for 
CY2024, given that COVID-19 PHE ended on May 11, 2023.
12. Effects of Proposals Relating to the Medicare Diabetes Prevention 
Program Expanded Model
a. Effects on Beneficiaries
    We proposed to modify certain Medicare Diabetes Prevention Program 
(MDPP) expanded model policies to: (1) Extend the flexibilities allowed 
during the PHE for the COVID-19 1135 waiver event by 4 years (or until 
December 31, 2027), (2) update the MDPP payment structure to pay for 
beneficiary attendance on a fee-for-service basis while retaining the 
diabetes risk reduction performance payments, (3) remove the 
requirement for MDPP interim preliminary recognition and replace it 
with CDC preliminary recognition, and (4) remove most references to, 
and requirements of, the Ongoing Maintenance Sessions given that 
eligibility for these services will end on December 31, 2023. We 
anticipate that these changes will have a positive impact on 
beneficiaries' access to MDPP services by increasing the number of MDPP 
eligible organizations that enroll in Medicare as MDPP suppliers and, 
more importantly, increasing beneficiary access to the Set

[[Page 79497]]

of MDPP services by allowing them continued access to MDPP through a 
live in-person or virtual classroom (or a combination of both 
modalities). The changes will also remove barriers specific to 
attending these classes solely in-person, which may include a lack of 
MDPP suppliers in certain communities and challenges related to 
beneficiary logistics concerning course attendance.
    These modifications address MDPP supplier and beneficiary needs 
based upon available monitoring and evaluation data received to date, 
feedback from Medicare Advantage plans and existing MDPP suppliers, and 
feedback from beneficiary focus groups. The changes are also in 
response to comments from interested parties made through public 
comments in response to prior rulemaking.
    During the initial rulemaking for the MDPP expanded model, we 
sought to ensure that MDPP will be delivered in-person, in a classroom-
based setting, and within an established period of service to maintain 
consistency with the original DPP model test. At the time, priority was 
placed on establishing a structured expanded model that, when delivered 
within the confines of the rule, will create the least risk of fraud, 
waste, and abuse, increase the likelihood of success, and maintain the 
integrity of the data collected for evaluation purposes.
    However, circumstances such as the PHE for COVID-19 led us to make 
changes to the MDPP expanded model through implementation of an 
Emergency Policy for MDPP that allows for temporary flexibilities while 
prioritizing availability and continuity of services for MDPP suppliers 
and MDPP beneficiaries impacted by such section 1135 waiver events. For 
example, in the CY 2021 PFS, we finalized the regulations in the March 
31st COVID-19 IFC to amend the MDPP expanded model to revise certain 
MDPP policies during the COVID-19 PHE as well as any future 1135 waiver 
events where such 1135 waiver event may cause a disruption to in-person 
MDPP service delivery. These flexibilities allowed beneficiaries to 
either continue to have access to MDPP through participation in virtual 
sessions, pause an in-person MDPP class and resume with the most recent 
attendance session of record, or restart MDPP from the beginning in 
accordance with the March 31st COVID-19 IFC (85 FR 19230).
    When establishing these flexibilities, we could not predict that 
the COVID-19 PHE would continue for over 3 years. Although beneficiary 
participation decreased significantly during the initial year of the 
COVID-19 PHE, MDPP participation has slowly increased since 2021. As 
this additional modality of delivery has helped improve supplier access 
to beneficiaries, removing the PHE flexibilities and suppliers' ability 
to deliver MDPP virtually after 3 years will not only be disruptive to 
suppliers, it may in-fact be detrimental to the operations of the MDPP 
expanded model.
    During the COVID-19 PHE, we permitted virtual delivery of the Set 
of MDPP services by MDPP suppliers who were recognized by the CDC with 
Diabetes Prevention Recognition Program (DPRP) in-person delivery mode, 
but did not permit suppliers who were only recognized by the CDC with 
either online or distance learning delivery modes. Although we 
finalized in the CY 2021 PFS that suppliers had to be prepared to 
return to in-person delivery when the PHE ended, the PHE lasted for 
over 39 months. Therefore, returning to a solely in-person, pre-PHE 
delivery model may not be as simple for some suppliers.
    Post-PHE, many beneficiaries and suppliers have reported the desire 
to continue utilizing virtual delivery of MDPP for a wide range of 
reasons. Maintaining suppliers' ability to offer both synchronous 
virtual (distance learning) and in-person MDPP may increase beneficiary 
uptake of these services. It is important to note that permitting 
virtual delivery of MDPP throughout the PHE has not resulted in a spike 
in MDPP utilization. A reason for a lack of beneficiary participation 
may be tied to the fact that suppliers still had to maintain the 
ability to deliver in-person services (rent or own physical space), 
while some suppliers were unfortunately unable to pivot to virtual 
delivery during the COVID-19 PHE for a variety of reasons.
    Current data depict that the most impactful MDPP results correspond 
to attending MDPP sessions virtually or through utilizing a hybrid 
approach (attending classes both virtually and in-person). Interim MDPP 
evaluation data illustrated that average participant weight loss is 5.1 
percent since the expanded model launched on April 1, 2018, surpassing 
the expanded model's weight loss goal of 5 percent. In addition, the 
interim evaluation data show that, 53 percent of MDPP participants 
attained the 5 percent weight-loss goal, and 24.6 percent attained the 
9 percent weight-loss goal.\568\ Aligning with the Diabetes Prevention 
Program (DPP) model test \569\ and studies on the National 
DPP,570 571 MDPP participants who attended more sessions 
lost more weight. For example, among beneficiaries who attended at 
least 9 sessions, 64 percent met the 5 percent weight loss goal and 30 
percent met the 9 percent weight loss goal. For MDPP participants 
impacted by the COVID-19 PHE, evaluation data confirm significantly 
increased weight loss accompanied with a higher number of sessions 
attended by participants completing the expanded model in 2021, with 
these participants attending primarily virtual sessions or a mixture of 
virtual and in-person sessions.
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    \568\ MDPP 2nd Annual Evaluation Report.
    \569\ RTI International. Evaluation of the Health Care 
Innovation Awards: Community Resource Planning, Prevention, and 
Monitoring: THIRD ANNUAL REPORT. March 2017. https://downloads.cms.gov/files/cmmi/hcia-crppm-thirdannrptaddendum.pdf.
    \570\ Knowler WC, Barrett-Connor E, Fowler SE, et al. Reduction 
in the incidence of type 2 diabetes with lifestyle intervention or 
metformin. N Engl J Med. 2002;346(6):393-403. doi:10.1056/
NEJMoa012512.
    \571\ Diabetes Prevention Program Research Group. Long-term 
effects of lifestyle intervention or metformin on diabetes 
development and microvascular complications over 15-year follow-up: 
the Diabetes Prevention Program Outcomes Study. Lancet Diabetes 
Endocrinol. 2015;3(11):866-875. doi:10.1016/S2213-8587(15)00291-0.
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    To date, there have been no preliminary indications that the 
synchronous virtual delivery of MDPP has limited supplier instruction 
or beneficiary success, as defined by achievement of the 5 percent 
weight loss goal. However, it is too early to determine the impact of 
synchronous virtual delivery of MDPP on other outcomes such as cost-
savings or incidence of diabetes. MDPP has been fundamentally limited 
by low beneficiary participation and corresponding small sample sizes. 
We believe that an increase in supplier uptake, which may be 
accomplished through our proposal to maintain more options of MDPP 
delivery modalities, will result in an increase in beneficiary 
enrollment. This will be critical to conducting robust programmatic 
evaluations, including a potential future certification of the 
synchronous virtual delivery of MDPP.
    To assist with our ability to improve monitoring and evaluation of 
the synchronous virtual delivery of MDPP, we have proposed a new HCPCS 
G-code specific to distance learning. Additionally, extending the 
flexibilities allowed during the PHE for COVID-19 by 4 years will 
improve MDPP eligible organizations' MDPP service delivery 
opportunities due to the use of multiple modalities.
b. Effects on the Market
    While we acknowledge that additional changes will likely be

[[Page 79498]]

necessary to improve beneficiary access to MDPP, we anticipate that the 
enhancements proposed in this rule are likely to result in an increase 
of MDPP suppliers and increased beneficiary access to the Set of MDPP 
services. We anticipate that this will assist in contributing to a 
reduction of the incidence of diabetes among eligible Medicare 
beneficiaries, and in particular, those residing in underserved 
communities. Currently, there are approximately 786 in-person 
organizations nationally that are eligible to become MDPP suppliers 
based on their preliminary or full CDC Diabetes Prevention Recognition 
Program (DPRP) status. However, only 25 percent of eligible in-person 
organizations are participating in MDPP, and only one-third of MDPP 
suppliers have submitted MDPP-related claims. Through updating the 
payment structure to one that is similar to those of existing CMS 
Medicare Preventive Services such as the Intensive Behavioral 
Counseling for Obesity, the MDPP claims submission process may be more 
intuitive for existing Medicare suppliers. In addition, we anticipate 
that simplifying the MDPP payment structure will address some of the 
complexities related to the process for submitting claims, while 
encouraging more suppliers to submit claims for MDPP due to a reduced 
set of codes.
    Since MDPP was established through the CY 2017 PFS, we have 
consistently heard from interested parties that we should include 
virtual delivery of MDPP as part of the expanded model test, which 
would increase beneficiary access to the Set of MDPP services while 
providing flexibility of where both a beneficiary may take the course 
and from where a supplier may deliver the course. Although we did not 
allow for a fully virtual delivery of MDPP until the COVID-19 PHE, we 
did allow a limited number of virtual make-up sessions, which could be 
delivered either synchronously or asynchronously. The rationale for 
allowing a limited number of virtual make-up sessions was due to the 
fact that the data used to certify MDPP were based upon in-person 
delivery, thereby fully virtual delivery was arguably outside the scope 
of certification.
    The COVID-19 PHE led CMS to establish MDPP flexibilities that 
allowed fully virtual delivery of the Set of MDPP services by 
suppliers. We established several emergency flexibilities within the 
IFC-1 that removed the limit on the number of virtual makeup sessions, 
and in the CY 2021 PFS, we finalized the MDPP flexibilities from the 
IFC-1 while establishing the MDPP Emergency Policy that allowed for 
virtual delivery of MDPP, including virtual weight collection. However, 
the CY 2021 PFS stated that MDPP suppliers must retain the capacity to 
deliver the Set of MDPP services in-person, precluding organizations 
with CDC DPRP recognition solely in the distance learning or online 
modalities from participating in MDPP during the COVID-19 PHE. 
Interested parties commented that some beneficiaries may have limited 
access or ability to use the technology required for participation in 
virtual MDPP sessions.
    In the CY 2022 PFS, although outside the scope of rule, interested 
parties recommended that we continue the virtual option following the 
end of the COVID-19 PHE to assist in increasing access to MDPP, 
especially for those with transportation needs as well as for 
beneficiaries in rural and low-income communities, who may suffer from 
a lack of in-person suppliers. As a result of these recommendations, in 
this rule, we proposed to extend the PHE flexibilities, specific to 
allowing synchronous virtual delivery of MDPP, also known as distance 
learning.
    Currently, there are numerous large geographic gaps of MDPP 
supplier locations, and synchronous virtual delivery may be part of the 
solution to increasing the accessibility of MDPP to more beneficiaries. 
It is unclear how the market will respond to the extension of the PHE 
flexibilities allowed during the COVID-19 PHE, especially since we are 
still requiring suppliers to have and maintain an in-person DPRP 
recognition, but we believe organizations will be ready to engage in 
the delivery of the Set of MDPP services either in-person, through 
distance learning, or through a combination of in-person and distance 
learning. We also believe that having more flexibility in how the Set 
of MDPP services are delivered will make MDPP more accessible to 
beneficiaries, particularly those who live in rural areas or in 
communities with gaps in MDPP supplier locations.
c. Payment for MDPP Services
    Regulations at Sec.  414.84 specify MDPP suppliers may be eligible 
to receive payments for furnishing MDPP services and meeting 
performance targets related to beneficiary weight loss and/or 
attendance. However, we have consistently heard from suppliers and 
interested parties that the MDPP performance-based payment structure 
has been confusing to some suppliers, including those new to Medicare 
as well as existing suppliers. Approximately 37 percent of MDPP 
suppliers have submitted FFS claims for MDPP.\572\ Confusion with 
claims submission has been due, in part, to the MDPP payment structure, 
which pays for performance-based milestones versus paying for 
traditional fee-for-service. The performance-based payment structure 
requires 15 HCPCS G-codes if including ongoing maintenance sessions, 
and 11 G-codes for the 12-month MDPP service period. Therefore, we 
proposed to shift this payment structure to pay for attendance on a 
fee-for-service basis while retaining the diabetes risk reduction 
performance milestones, for example 5 percent and 9 percent weight loss 
as well as the maintenance of the 5 percent weight loss in months 7-12. 
This streamlined payment structure will allow suppliers to receive a 
more consistent set of payments for their delivery of the Set of MDPP 
services and reduce the number of G-codes for easier billing.
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    \572\ Unpublished data from Acumen LLC, Quarter 4 2022 Quarterly 
Monitoring Report to CMS.
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    We anticipate that this updated payment structure will reduce the 
upfront beneficiary retention costs while motivating eligible suppliers 
to enroll in Medicare to become MDPP suppliers and provide the Set of 
MDPP services to eligible Medicare beneficiaries. In the current MDPP 
payment structure, suppliers submit claims after the 1st, 4th, and 9th 
sessions attended during the core sessions interval, and following 
attendance of the two (2) sessions during each of the core maintenance 
intervals. Although the per session payment of $25 is less than the 
current per session payment of $38, suppliers will receive up to 22 
payments for attendance in the payment structure compared to seven 
attendance-based payments, for participants who began participation in 
2022 or later, or 11 attendance-based payments for participants whose 
first core session was in 2021 or earlier. The total attendance-based 
payments will increase by $54 to $550 in the payment structure, 
compared to $496 in the current one.
    This payment schedule will not only eliminate gaps in payment by 
providing smaller but more frequent per-session payments, it will also 
reduce or eliminate some of the coding challenges related to the number 
of existing HCPCS codes. We proposed to decrease the one-time 
performance payments for beneficiary achievement of the 5 percent and 9 
percent weight loss goals as well as proposed a new HCPCS G-code for 
the maintenance of the 5 percent weight

[[Page 79499]]

loss during months 7-12. The total maximum payment of $768 consists of 
the attendance-based payments and the weight loss performance payments. 
Although the maximum payment of $768 over a one-year service period is 
the same as the current maximum payment, we believe this simplified 
payment structure will lead to fewer claims rejections while 
encouraging more suppliers to submit MDPP claims for the beneficiaries 
they serve, as well as motivate more eligible organizations enroll in 
Medicare to participate in MDPP.
d. Effects on the Medicare Program
(a) Estimated 10-Year Impact of MDPP
    There are two changes to the Medicare Diabetes Prevention Program 
(MDPP) which are relevant to this impact analysis. Both changes will be 
implemented in 2024: Simplifying the MDPP payment schedule; and 
allowing specified Public Health Emergency (PHE) flexibilities to 
continue for 4 years after the PHE ends--namely, allowing for 
synchronous virtual delivery of the Set of MDPP services.
    Table 127 shows the estimated impact (in millions) of these two 
changes on Medicare spending:
[GRAPHIC] [TIFF OMITTED] TR16NO23.171

(b) Assumptions/Notes
     Simplifying the payment schedule will lead to fewer claim 
denials and more participation from MDPP suppliers. For example, only 
55-62 percent of FFS participants listed in the supplier crosswalks 
have an associated MDPP claim over the past 2 years, meaning that 
organizations have submitted data to the CDC as part of their Diabetes 
Prevention Recognition Program (DPRP) requirements, and also have FFS 
claims submitted for the same participants for the same sessions 
recorded in the DPRP data. The payment schedule will reduce the number 
of HCPCS codes to from 15 to 6 and eliminate some of the coding issues. 
It will also eliminate the gaps in payment by providing smaller but 
more frequent per-session payments.
     The average payment per MDPP participant will increase by 
$150. The new payment schedule will likely lead to more successful 
claim payment submissions and will motivate MDPP providers to retain 
participating beneficiaries for longer periods of time.
     In 2022, 551 FFS claims were paid for the initial MDPP 
session, compared with 514 in 2021. According to counts of new FFS 
participants, there have been about 700 new entrants per year in recent 
years. With the implementation of a simpler payment schedule and the 
extension of PHE flexibilities, we assume that new participation will 
be more in line with claim payments for HCPCS code G9873 and will 
increase to 1,000 in 2024 and 1,250 during the following years until 
the extended flexibilities end. We estimated that there will be 500 new 
(in-person only) participants each year starting in 2029.
     Since the start of the PHE, synchronous virtual delivery 
of MDPP services has been more prevalent than in-person delivery. 
However, given the coding/reporting issues during the PHE, it is 
difficult to determine how many beneficiaries are still receiving MDPP 
services in-person. Without the changes, we assume that new 
participation will be capped at 400 beneficiaries per year.
     For preventing diabetes progression, synchronous virtual 
delivery of the Set of MDPP services has the same level of 
effectiveness as in-person delivery. Following 3 years of delivering 
MDPP almost solely virtually, suppliers and beneficiaries have become 
adept at utilizing virtual delivery, as many providers in numerous 
healthcare settings have shifted to utilizing technology. Furthermore, 
preliminary MDPP data collected during the PHE indicates that 
beneficiaries have achieved similar weight loss and attendance goals as 
participants in both the in-person DPP test and MDPP participants who 
enrolled in MDPP prior to the pandemic. This assumption is revisited in 
the Sensitivity Analysis section.
(c) Sensitivity Analysis
    On March 14, 2016, the Office of the Actuary (OACT) published a 
certification memorandum setting out the conditions for expansion of 
the Medicare Diabetes Prevention Program (MDPP), which can be found at 
https://www.cms.gov/Research-Statistics-Data-and-Systems/Research/ActuarialStudies/Downloads/Diabetes-Prevention-Certification-2016-03-14.pdf. Assumptions about the 10-year cost impacts of virtual delivery 
of MDPP services takes into account the assumptions of the original 
certification, and adjusts for diabetes costs in 2023 dollars, and 
trends those costs over the next 10 years.
    Since both the effectiveness and the future participation level of 
synchronous virtual delivery of MDPP services are largely unknown, 
Table 128 shows 10-year cost impacts (in millions) of varying levels of 
effectiveness of the virtual delivery of the Set of MDPP services 
relative to the in-person delivery of the Set of MDPP services, paired 
with varying levels of virtual MDPP participation.
[GRAPHIC] [TIFF OMITTED] TR16NO23.172


[[Page 79500]]


    As indicated in Table 128, virtual delivery of MDPP services is 
estimated to produce savings when it is at least 50 percent as 
effective as in-person delivery.
13. Appropriate Use Criteria for Advanced Diagnostic Imaging
    Section 1834(q)(2) of the Act, as added by section 218(b) of the 
Protecting Access to Medicare Act (Pub. L. 113-93, April 1, 2014) 
(PAMA), directs CMS to establish a program to promote the use of 
appropriate use criteria (AUC) for applicable imaging services 
furnished in an applicable setting.
    As discussed in detail in section III.J. of this final rule, since 
2015, we have taken a thoughtful, stepwise approach that maximized 
engagement and involvement of interested parties to implement the 
statutory provisions set forth in section 1834(q), as added by section 
218(b) of the PAMA, using notice and comment rulemaking. As codified at 
Sec.  414.94, we established the first two components of the AUC 
statutory requirements--establishment of AUC and mechanisms for 
consultation. We began to build the parameters for the fourth 
component, outlier identification and prior authorization, leading to 
prior authorization, by establishing the priority clinical areas 
(PCAs). We began implementing the third component, the AUC consultation 
and reporting requirement, using the ongoing educational and operations 
testing period. However, as explained previously in this final rule, at 
this time, we have exhausted all reasonable options for fully 
operationalizing the AUC program consistent with the statutory 
provisions as prescribed in section 1834(q)(B) of the Act directing CMS 
to require real-time claims-based reporting to collect information on 
AUC consultation and imaging patterns for advanced diagnostic imaging 
services to ultimately inform outlier identification and prior 
authorization. As a result, we are finalizing our proposal to pause 
implementation of the AUC program for reevaluation and to rescind and 
reserve for future use the current AUC program regulations at Sec.  
414.94.
    In the CY 2019 PFS final rule (83 FR 59452), we performed an RIA 
for this program and updated that RIA in the CY 2022 PFS final rule (86 
FR 64996). The estimated impacts in the CY 2022 PFS final rule were as 
follows:
     Cost to ordering clinicians of required AUC consultation: 
$51,039,109 annually.
     Cost to Medicare beneficiaries for additional office visit 
time: $54,789,518 annually.
     Cost to ordering clinicians of transmitting consultation 
information: $94,495,192 annually.
     Cost to furnishing clinicians to update processes to 
report AUC information: $1,851,356,888 (one time).
     Potential savings to Medicare program from decrease in 
imaging utilization: $700,000,000 annually.
    The prior savings estimate is no longer an accurate reflection of 
savings that could be achieved and CMS will not realize the estimated 
$700,000,000 annual savings because, as described in section III.J. of 
this final rule, the AUC program cannot be implemented as written in 
statute; therefore, expected savings are negligible.
    Table 129 includes the previous AUC program-related activities and 
their corresponding impact estimates from the CY 2022 PFS rule.
[GRAPHIC] [TIFF OMITTED] TR16NO23.173

14. Medicare and Medicaid Provider and Supplier Enrollment Changes
    In this section, we outline the impact of our Medicare provider 
enrollment revocation provisions and our Medicaid termination database 
proposal. For all provider enrollment proposals not referenced in this 
section, we have determined that they will not have an economic impact.
a. Medicare Revocation Reasons
    As outlined in section III.K. of this final rule, we proposed 
several new or expanded revocation reasons in Sec.  424.535(a).
    First, we proposed to expand Sec.  424.535(a)(1) to include 
instances where the provider or supplier is non-compliant with the 
enrollment requirements in Title 42. Paragraph (a)(1) would no longer 
be restricted to non-compliance with the provisions of 42 CFR part 424, 
subpart P.
    Second, new Sec.  424.535(a)(15) will give CMS the authority to 
revoke enrollment if the provider or supplier, an owning or managing 
employee or organization thereof, or an officer or director thereof has 
had a civil judgment under the False Claims Act (31 U.S.C. 3729-3733) 
imposed against them within the previous 10 years.
    Third, we proposed in new Sec.  424.535(a)(23) that CMS may revoke 
an IDTF's, DMEPOS supplier's, OTP's, or HIT supplier's, or MDPP's 
enrollment based on a violation of any standard or condition in, 
respectively, Sec. Sec.  410.33(g), 424.57(c), 424.67(b) or (e), 
424.68(c) or (e), or 424.205(b) or (d).
    Fourth, Sec.  424.535(a)(16) would permit CMS to revoke enrollment 
if a provider or supplier, or any owner, managing employee or 
organization, officer, or director thereof, has been convicted of a 
misdemeanor under Federal or State law within the previous 10 years 
that CMS deems detrimental to the best

[[Page 79501]]

interests of the Medicare program and its beneficiaries.
    For reasons outlined in section III.K. of this final rule, we are 
finalizing the first three revocation proposals, but not proposed Sec.  
424.535(a)(16).
    Based on CMS statistics concerning the average annual amount of 
Medicare payments a provider or supplier receives, we project a figure 
of $50,000. We note that we have recently used this figure when 
estimating the potential savings associated with several new revocation 
reasons.\573\ For purposes of consistency and accuracy, we will use 
this $50,000 amount in this final rule.
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    \573\ For example, see the final rule published in the Federal 
Register on November 18, 2022 (87 FR 69404), titled Medicare and 
Medicaid Programs; CY 2023 Payment Policies Under the Physician Fee 
Schedule and Other Changes to Part B Payment and Coverage Policies; 
Medicare Shared Savings Program Requirements; Implementing 
Requirements for Manufacturers of Certain Single-dose Container or 
Single-use Package Drugs To Provide Refunds With Respect to 
Discarded Amounts; and COVID-19 Interim Final Rules''.
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    Table 130 outlines the estimated annual number of revocations that 
would ensue with these three revocation proposals:
[GRAPHIC] [TIFF OMITTED] TR16NO23.174

    These revocations will represent a savings to the Federal 
Government because Trust Fund dollars will no longer be paid to the 
revoked providers and suppliers. Accordingly, we projected an annual 
savings to the Federal Government of $750,000 ($50,000 x 15 
revocations).
b. Medicaid Termination Database
    As outlined in section III.K. of this final rule, we proposed 
certain provisions in 42 CFR part 455 concerning the length of time a 
provider remains in the Medicaid termination database and how this 
interacts with the termination periods that States impose upon 
terminated providers. We do not believe these proposals involve any 
additional impact or burden on providers or States. In fact, it could 
result in a reduction of burden because a provider's potential length 
of time in the termination database would be capped at 10 years, 
although we have no data available with which to assist us in 
calculating the possible burden reduction. As a result, since we are 
uncertain of how much of the burden will be reduced, we solicited 
public comments from the public to aid in understanding how to measure 
said burden reduction.
    We received no comments regarding our revocation savings estimate 
or any burden reduction associated with our Medicaid termination 
database proposals.
15. Expand Diabetes Screening and Diabetes Definitions
    As outlined in section III.L. in this final rule, we are finalizing 
our proposal to: (1) expand coverage of diabetes screening tests to 
include the Hemoglobin A1C test (HbA1c) test, (2) expand and simplify 
the frequency limitations for diabetes screening, and (3) simplify the 
regulatory definition of ``diabetes'' for diabetes screening, Medical 
Nutrition Therapy (MNT) and Diabetes Outpatient Self-Management 
Training Services (DSMT).
    As we described in the PFS proposed rule, we anticipate that 
expanding coverage of diabetes screening to include the HbA1c test and 
expanding and simplifying the frequency limitations for diabetes 
screening to result in some additional service utilization, but we also 
anticipate the additional utilization may be balanced, in part, by 
potential long term benefits and savings resulting from increased 
prevention and early detection (allowing for less invasive and more 
effective treatment). As outlined earlier, Medicare currently covers 
the Fasting Plasma Glucose (FPG) test and the Glucose Tolerance Test 
(GTT) for diabetes screening. The HbA1c test does not require fasting 
and is more convenient than the currently covered FPG and GTT. We also 
proposed to expand and simplify the frequency limitations for diabetes 
screening by aligning to the statutory limitation of ``not more often 
than twice within the 12-month period following the date of the most 
recent diabetes screening test of that individual.''
    As described in the PFS proposed rule, we estimate our final rule 
to expand diabetes screening to result in approximately $68.5 million 
in additional annual expenditures for the Medicare Program. Our 
estimate is based on the following assumptions. Based on calendar year 
2022 actual experience, approximately 27.3 percent of beneficiaries had 
a blood panel test that did not include the HbA1c test. Medicare 
currently pays approximately $9.50 per HbA1c test for diabetes 
management. The Medicare statutory and regulatory eligibility factors 
for an individual at risk for diabetes (section 1861(yy)(2) of the Act, 
42 CFR 410.18(e)) cover much of the current Medicare beneficiary 
population. We assume that approximately 7.6 million potential 
additional HbA1c tests for diabetes screening to be billed under our 
proposal in calendar year 2024 and that the HbA1c test would be billed 
with a blood panel 95 percent of the time. Our estimate does not 
reflect secondary effects of the policies, such as increased 
utilization of preventive screening services, additional follow-up 
services, and potential offsetting savings (including prevention and 
more effective treatment through early detection) that may result from 
these coverage expansions. Secondary effects are difficult to predict, 
may materialize many years after the intervention and may, in part, 
offset one another.
    As described in the PFS proposed rule, we do not anticipate that 
our proposal to simplify and expand the regulatory definition of 
``diabetes'' for diabetes screening, MNT and DSMT to result in a 
significant economic impact on the Medicare program. As outlined 
earlier, we proposed to remove the regulatorily codified clinical test 
requirements from the definition of ``diabetes'' for diabetes 
screening, MNT and DSMT and proposed a shortened version of the 
existing definition that will simply define diabetes as diabetes 
mellitus, a condition of abnormal glucose metabolism. We believe that 
our proposal will empower health care

[[Page 79502]]

professionals to apply clinically accurate and appropriate criteria and 
that we can ensure certain safeguards through medical coding and claims 
processing instructions. We do not anticipate our proposal to simplify 
and expand the regulatory definition of ``diabetes'' for diabetes 
screening, MNT and DSMT to result in a significant economic impact on 
the Medicare Program because the regulatory simplification will not 
otherwise change requirements or conditions of coverage and payment.
16. Requirement for Electronic Prescribing for Controlled Substances 
for a Covered Part D Drug Under a Prescription Drug Plan or an MA-PD 
Plan (Section 2003 of the SUPPORT Act)
    In section III.M. of this final rule, we finalized several updates 
to the CMS EPCS Program. We removed the same entity exception at Sec.  
423.160(a)(5)(i) from the CMS EPCS Program and to add ``subject to the 
exemption in paragraph (a)(3)(iii) of this section'' to Sec.  
423.160(a)(5). Under this provision, prescriptions that are prescribed 
and dispensed within the same legal entity are included in CMS EPCS 
Program compliance calculations as part of the 70 percent compliance 
threshold at Sec.  423.160(a)(5). This provision provides flexibility 
to prescribers and dispensing pharmacies that are the same entity to 
choose either of the electronic standards available at Sec.  
423.160(a)(3)(iii) to conduct e-prescribing appropriate for their 
internal systems without us having to exclude these prescriptions 
completely from the CMS EPCS Program. This provision will affect 
prescriptions where the prescriber and the dispensing pharmacy are part 
of the same legal entity. Due to the limitations in identifying these 
prescriptions in the Prescription Drug Event (PDE) data, the ability to 
quantify the impact of this proposal is unknown. Please see section 
III.M. of this final rule for additional discussion of this provision.
    We specified how we count prescriptions for the compliance 
calculation by using the unique identifier given to a prescription by 
the pharmacy in the measurement year and included in the Part D claims 
data. We will count renewals as an additional prescription in the CMS 
EPCS Program compliance threshold calculation, and we will not count 
refills as an additional prescription in the CMS EPCS Program 
compliance threshold calculation unless the refill is the first 
occurrence of the unique prescription in the measurement year. If each 
refill included on the original prescription were counted as a separate 
prescription, we believe there will be an incremental impact on small 
prescribers. Preliminary analysis of 2021 Part D data shows that 
approximately 23,000 prescribers will no longer qualify for the small 
prescriber exception and that approximately 6,900 additional 
prescribers will be noncompliant.
    We finalized updates to the CMS EPCS Program recognized emergency 
exception and waiver exception previously found at Sec.  
423.160(a)(5)(iii) and (iv), and now codified at Sec.  
423.160(a)(5)(ii) and Sec.  423.160(a)(5)(iii) respectively (as 
finalized in this final rule). We finalized the proposal to have 
discretion to determine which emergencies trigger the recognized 
emergency exception starting in the 2024 measurement year and specified 
that prescribers to whom the exception applies will be excepted from 
the CMS EPCS Program requirements for the entire measurement year. We 
modified how we have previously defined ``extraordinary circumstance'' 
for purposes of the waiver exception. We finalized that an 
``extraordinary circumstance'' means a situation outside of the control 
of a prescriber that prevents the prescriber from electronically 
prescribing a Schedule II-V controlled substance that is a Part D drug 
and does not exclude ``cases of an emergency or disaster.'' In cases of 
extraordinary circumstances, we finalized the timeframe that would be 
covered by a waiver authorized under the CMS EPCS Program to be the 
entire measurement year. We finalized that a prescriber has a period of 
60 days from the date of the notice of non-compliance to request a 
waiver. Approved waivers will apply to prescriptions written by a 
prescriber for the entire measurement year, and the waiver will expire 
on December 31 of the applicable measurement year.
    Although we are modifying the situations in which a prescriber can 
apply for an extraordinary circumstances waiver and limiting the 
recognized emergencies exception that applies to the CMS EPCS Program, 
we do not anticipate these proposals to affect many clinicians compared 
to the current policies. First, we believe that the provision for CMS 
to identify which emergencies trigger the recognized emergency 
exception will still capture the vast majority of emergencies or 
disasters that affect a prescriber's ability to achieve EPCS compliance 
and will remove any need for additional prescribers to apply for a 
waiver. Second, some prescribers who experience an emergency may still 
meet the 70 percent compliance threshold by the end of the emergency 
period and will not need to apply for a waiver exception. Finally, we 
are unable to quantify the additional number of potential disasters or 
emergencies prescribers might experience due to variability in the 
number of disasters and emergencies in a given measurement year. 
Therefore, we are not increasing our assumption that 100 waiver 
requests will be submitted to the CMS EPCS program, as we outlined in 
the CY 2022 PFS final rule (86 FR 65562).
    We finalized our policy to continue sending non-compliance notices 
to prescribers identified as non-compliant with the CMS EPCS Program 
for any individual measurement year, and we do not believe that causes 
additional costs or will require additional time. Please see section 
III.M. of this final rule for additional discussion on this provision. 
We do not anticipate the provisions to have any incremental impact on 
the cost or time associated with prescriber compliance with the 
electronic prescribing for controlled substances requirement or the 
cost to interested parties. We did not receive any public comments on 
our impact assumptions.
17. Changes to the Regulations Associated With the Ambulance Fee 
Schedule and the Medicare Ground Ambulance Data Collection System 
(GADCS)
    As outlined in section III.N. of this final rule, section 4103 of 
the CAA amended section 1834(l)(12)(A) and (l)(13) of the Act to extend 
the payment add-ons set forth in those subsections through December 31, 
2024. The ambulance extender provisions are enacted through legislation 
that is self-implementing. A plain reading of the statute requires only 
a ministerial application of the mandated rate increase and does not 
require any substantive exercise of discretion on the part of the 
Secretary. As a result, there are no policy proposals associated with 
these legislative provisions legislative provisions. We have estimated 
cost of these provisions to be $50 million in 2023, $100 million in 
2024, and $40 million in 2025 and the Congressional Budget Office 
(CBO)'s estimated cost of these provisions was $55 million in 2023, $91 
million in 2024, and $29 million in 2025 (https://www.cbo.gov/system/files/2023-01/PL117-328_1-12-23.pdf, p. 17).
    We did not receive any public comments on the impacts of the 
ambulance extender provisions. In this final rule, we are finalizing 
our

[[Page 79503]]

proposals only to revise the dates in Sec.  414.610(c)(1)(ii) and 
(c)(5)(ii) to conform the regulations to these self-implementing 
statutory requirements.
    In addition, as outlined in section III.N. of this final rule, we 
proposed the following changes to the Medicare Ground Ambulance Data 
Collection Instrument: Adding the ability to address partial year 
responses from ground ambulance organizations, introducing a minor edit 
to improve the reporting consistency of hospital-based ambulance 
organizations, and four technical corrections to typos. The changes and 
clarifications aimed to reduce burden on respondents, improve data 
quality, or both.
    While we believe that these changes and clarifications will be well 
received by the ground ambulance interested parties, we do not believe 
that these changes will have any substantive impact on the cost or time 
associated with completing the Medicare Ground Ambulance Data 
Collection Instrument. We noted that the overall length of the Medicare 
Ground Ambulance Data Collection Instrument will be the same as 
previously finalized (84 FR 62888) with these changes. Additionally, 
some of the instructions which we proposed to add are intended to 
improve clarity and may therefore reduce the time the ground ambulance 
organizations spend addressing the questions.
    We did not receive any public comments on the impacts of our 
proposed changes to the Medicare Ground Ambulance Data Collection 
Instrument. In this final rule, we are finalizing our proposed changes 
to the Medicare Ground Ambulance Data Collection Instrument.
18. Hospice CoP Changes
a. Permitting MFT and MCH To Serve as Members of the Interdisciplinary 
Group (IDG)
    Under the Medicare Program in accordance with Subtitle C, Section 
4121 of the CAA 2023, we proposed conforming regulations text changes 
to permit MFT or MHC to serve as members of the IDG. These changes will 
require hospices to include one SW, MFT or MHC to serve as a member of 
the IDG. Hospices will have the flexibility to determine which 
discipline(s) are appropriate to serve on the IDG.
b. Modification of the Hospice Personnel Requirements With the Addition 
of MFT and MHC
    Under the Medicare Program in accordance with Subtitle C, Section 
4121 of the CAA 2023, we proposed conforming regulations text changes 
to permit MFT or MHC to serve as members of the IDG. With the addition 
of MFT and MHC into the hospice CoPs, it is important to include these 
new disciplines into the personnel qualifications at Sec.  418.114. 
However, in section III.C. of this rule, we proposed to add both MHC 
and MFT to the provider requirements under 42 CFR subpart B Medical and 
Other Health Services at Sec. Sec.  410.53 and 410.54. Therefore, to 
avoid duplication and confusion between the CoP and the provider 
requirements under the Medical and Other Health Services provision, we 
added both MFT and MHC to the requirements at Sec.  418.114(b)(9) and 
(10) and referencing the new requirement at Sec. Sec.  410.53 and 
410.54 respectively. We do not expect any increase in burden for this 
modification. In addition, we do not expect the changes for this 
provision to cause any appreciable amount of expense or anticipated 
saving and we do not believe this standard will impose any additional 
regulatory burden.
19. RFI: Histopathology, Cytology, and Clinical Cytogenetics 
Regulations Under the Clinical Laboratory Improvement Amendments (CLIA) 
of 1988
    We published this RFI in the proposed rule to seek comments from 
interested parties. There is no impact for this RFI.
20. Basic Health Program Provisions
    In this final rule, we updated the requirements for a BHP Blueprint 
revision. We also are finalizing our proposal to allow a State with a 
BHP to suspend its BHP, if a State elects and specified conditions are 
met, and are providing requirements related to a BHP suspension. We 
also finalized our proposal to update the annual report content and 
timing, if a BHP is suspended. We finalized our proposal for accessible 
notices. Finally, we finalized our proposed changes related to an 
individual's appeals rights. We do not anticipate that these provisions 
will impose any additional regulatory burden.
21. A Social Determinants of Health Risk Assessment in the Annual 
Wellness Visit
    As described in section III.S., we are finalizing our proposal to 
exercise our authority in section 1861(hhh)(2)(I) of the Act to add 
elements to the Annual Wellness Visit (AWV) by adding a new Social 
Determinants of Health (SDOH) Risk Assessment as an optional, 
additional element with an additional payment. We proposed that the 
SDOH Risk Assessment be separately payable with no beneficiary cost 
sharing when furnished as part of the same visit with the same date of 
service as the AWV. Our final rule builds upon our separate proposal 
described earlier to establish a stand-alone G code (G0136) for SDOH 
Risk Assessment furnished in conjunction with an Evaluation and 
Management (E/M) visit. See sections III.E. and III.S. of this final 
rule for additional information on coding, pricing, and additional 
conditions of payment for the new SDOH Risk Assessment service. As 
described in the proposed rule, we anticipate our final policy to add a 
SDOH Risk Assessment as an optional, additional element with additional 
payment within the AWV to result in some additional service 
utilization, but we also anticipate the additional utilization may be 
balanced, in part or in whole, by potential long term benefits and 
savings resulting from a more effective AWV and increased prevention 
and early detection (allowing for less invasive and more effective 
treatment). We do not anticipate that the addition of an optional SDOH 
Risk Assessment to the AWV will result in a significant impact to the 
Medicare Program.
22. Updates to the Quality Payment Program
    In this section, we estimated the overall and incremental impacts 
of the Quality Payment Program policies in this rule. We estimated 
participation, final scores, and payment adjustment for clinicians 
participating through traditional MIPS, MVPs, and the Advanced APMs. We 
also presented the incremental impacts to the number of expected 
Qualified Participants (QPs) and associated APM Incentive Payments that 
result from our policies relative to a baseline model that reflects the 
status quo in the absence of any modifications to the previously 
finalized policies.

a. Overall MIPS Modeling Approach and Data Assessment

(1) MIPS Modeling Approach

    For this final rule, we used a similar modeling approach as the CY 
2024 PFS proposed rule (88 FR 52717 through 52718). We created two MIPS 
RIA models: a baseline and final policy model. Our baseline model 
includes previously finalized policies that will be in effect for the 
CY 2024 performance period/2026 MIPS payment year in the absence of any 
of the newly finalized policies in this final rule. Examples of 
previously finalized policies included in the baseline model are an 
updated methodology for calculating the

[[Page 79504]]

complex patient bonus, and an increase in the data completeness 
threshold for quality measures. The final policies model builds off the 
baseline model and incorporates the MIPS policies that we are 
finalizing for the CY 2024 performance period/2026 MIPS payment year 
included in this final rule. The aim of the baseline and policy models 
is to estimate the incremental impacts of the specific policies in this 
final rule.
    Our modeling approach utilizes the same scoring engine that is used 
to determine MIPS payment adjustments. This modeling approach enables 
our model to align as much as possible with actual MIPS scoring and 
minimizes differences between our projections and policy 
implementation. There are still some limitations to our model due to 
data limitations and assumptions. These limitations are discussed later 
in this RIA.
(2) Data Used To Estimate Future MIPS Performance
    In the CY 2024 PFS proposed rule (88 FR 52718) we indicated that 
once the CY 2022 performance period submissions data became available, 
we would assess if it were an appropriate source of data to use to 
estimate participation, final scores, and payment adjustments in this 
RIA.
    After reviewing the CY 2022 performance period data we determined 
that it was the most appropriate and accurate source to use for our 
estimation of clinician performance for several reasons. First, the 
data is the most recently available data and is more likely to reflect 
current physician performance and behaviors in the program. Secondly, 
during the CY 2022 performance period we did not apply an automatic EUC 
policy, and this data is the most likely to reflect post-PHE 
participation in the program. Finally, in the CY 2024 PFS proposed rule 
(88 FR 52719) we indicated our use of a ``2019 data supplement to our 
2021 data to estimate participation more accurately. We indicated that 
this approach had several limitations. Specifically, while using the 
``2019 data supplement'' allowed us to estimate participation we relied 
on the 2021 data to estimate performance. In this final rule, by using 
the data from the 2022 MIPS performance period we avoid the need to use 
this supplement, present the most current data, and align our 
participation, final scoring, and payment adjustment analysis around 
the same common data set. For these reasons we used 2022 MIPS 
performance period data as the basis of our RIA baseline and final 
policies models.
b. APM Incentive Payments to QPs in Advanced APMs and Other Payer 
Advanced APMs
    For payment years from 2019 through 2025, through the Medicare 
Option, eligible clinicians who have a sufficient percentage of their 
Medicare Part B payments for covered professional services or Medicare 
patients through Advanced APMs will be QPs for the applicable QP 
Performance Period for a year and the corresponding payment year. In 
payment years 2019 through 2024 these QPs will receive a lump-sum APM 
Incentive Payment equal to 5 percent of their estimated aggregate paid 
amounts for covered professional services furnished during the calendar 
year immediately preceding the payment year. In payment year 2025, QPs 
will receive a lump-sum APM Incentive Payment equal to 3.5 percent 
payment of their estimated aggregate paid amounts for covered 
professional services furnished during CY 2024. Beginning in payment 
year 2021, in addition to the Medicare Option, eligible clinicians may 
become QPs through the All-Payer Combination Option. The All-Payer 
Combination Option allows eligible clinicians to become QPs by meeting 
the QP payment amount or patient count threshold through a pair of 
calculations that assess a combination of both Medicare Part B covered 
professional services furnished or patients through Advanced APMs and 
services furnished or patients through Other Payer Advanced APMs. 
Eligible clinicians who become QPs for a year are not subject to MIPS 
reporting requirements and payment adjustments. Eligible clinicians who 
do not become QPs but meet a lower threshold to become Partial QPs for 
the year may elect to report to MIPS and, if they elect to report, will 
then be scored under MIPS and receive a MIPS payment adjustment. 
Partial QPs are not eligible to receive the APM Incentive Payment.
    If an eligible clinician does not attain either QP or Partial QP 
status, and is not excluded from MIPS on another basis, the eligible 
clinician will be subject to the MIPS reporting requirements and will 
receive the corresponding MIPS payment adjustment.
    Beginning in payment year 2026, the update to the PFS CF for 
services that are furnished by clinicians who achieve QP status for a 
year is 0.75 percent, while the update to the PFS CF for services that 
are furnished by clinicians who do not achieve QP status for a year is 
0.25 percent. Thus, eligible clinicians who are QPs for the year will 
receive differentially higher PFS payment rates than those who are not 
QPs. We incorporated this change in our baseline and final policies 
model.
    In addition, the thresholds to achieve QP status beginning in the 
2024 QP Performance Period will increase to 75 percent for the payment 
amount method, and 50 percent for the patient count method. Overall, we 
estimated that for the 2024 QP Performance Period between 316,767 and 
407,272 eligible clinicians will become QPs, and therefore be excluded 
from MIPS reporting requirements and payment adjustments.
    In section the CY 2023 proposed rule (88 FR 52617), we proposed to 
make QP determinations at the individual level for each unique NPI 
associated with an eligible clinician participating in an Advanced APM. 
In section IV.A.4.m.(2) of this final rule we stated that we were not 
finalizing this policy as proposed. Therefore, we do not implement this 
change in either the baseline or final policies models.
    We projected the number of eligible clinicians that will be QPs, 
and thus excluded from MIPS, using several sources of information. 
First, the projections are anchored in the most recently available 
public information on Advanced APMs. The projections reflect Advanced 
APMs that will be operating during the 2024 QP Performance Period, as 
well as some Advanced APMs anticipated to be operational during the 
2024 QP Performance Period. The projections also reflect an estimated 
number of eligible clinicians that will attain QP status through the 
All-Payer Combination Option. The following APMs are expected to be 
Advanced APMs for the 2024 QP Performance Period:
     Bundled Payments for Care Improvement Advanced Model;
     Comprehensive Care for Joint Replacement Payment Model 
(CEHRT Track);
     ACO REACH Model (formerly Global and Professional Direct 
Contracting) Model;
     Kidney Care Choices Model (Comprehensive Kidney Care 
Contracting Options, Professional Option and Global Option);
     Maryland Total Cost of Care Model (Care Redesign Program; 
Maryland Primary Care Program);
     Medicare Shared Savings Program (Level E of the BASIC 
Track and the ENHANCED Track);
     Primary Care First (PCF) Model; and,
     Vermont All-Payer ACO Model (Vermont Medicare ACO 
Initiative).

[[Page 79505]]

     Making Care Primary (MCP) tracks 2 and 3
    We used the Participation Lists and Affiliated Practitioner Lists, 
as applicable, (see 42 CFR 414.1425(a) for information on the APM 
Participant Lists and QP determinations) for the 2022 QP performance 
period third snapshot QP determination date to estimate the number of 
QPs, total Part B paid amounts for covered professional services, and 
the aggregate total of APM Incentive Payments for the 2024 QP 
Performance Period. We examined the extent to which Advanced APM 
participants will meet the QP Thresholds of having at least 75 percent 
of their Part B covered professional services or at least 50 percent of 
their Medicare beneficiaries furnished Part B covered professional 
services through the APM Entity.
c. Estimated Number of MIPS Eligible Clinicians in the CY 2024 
Performance Period/2026 MIPS Payment Year
(1) Initial Population of Clinicians Included in the RIA Baseline and 
Final Policies Models
    For this final rule, we applied the same assumptions as in the CY 
2024 PFS proposed rule (88 FR 52719) to estimate our initial population 
of clinicians based on CY 2022 performance period/2024 MIPS payment 
year data.
    Our analysis found that there were 1,820,899 clinicians who had PFS 
claims in this initial population.
    In the CY 2024 PFS proposed rule (88 FR 52719), we explained our 
use of the CY 2021 final reconciled eligibility determination file. 
This file reconciles eligibility from two determination periods and 
aligns with the CY 2022 performance period submissions data on which we 
based this model. In this final rule, we used the final reconciled 2022 
eligibility determination file which aligns with CY 2022 performance 
period submissions data.
    This initial population of clinicians was used to determine 
eligibility using the processes described in the following sections.
(2) Estimated Number of MIPS Eligible Clinicians After Applying 
Eligibility Assumptions
(a) Methods and Assumptions Used To Estimate Eligibility
    After identifying the clinician population with PFS claims we 
applied the same eligibility assumptions and determination process 
described in the CY 2024 PFS proposed rule (88 FR 52719) except that we 
did not use the ``2019 data supplement'' and instead we based eligility 
determinations on the CY 2022 performance period data.
    In the CY 2024 PFS proposed rule (88 FR 52617) we proposed 
calculate QP determinations at the individual level for each unique NPI 
associated with an eligible clinician participating in an Advanced APM. 
As discussed in section IV.A.4.m.(2) of this final rule, we are not 
finalizing this policy as proposed. Therefore, we are not finalizing 
any modifications to MIPS eligibility requirements and the same 
eligibility assumptions apply to both the baseline and final policies 
model.
    For our RIA model, we established the ``required eligibility'' 
category, which means the clinician exceeds the low-volume threshold in 
all three criteria and is subject to a payment adjustment. We base this 
estimate on the CY 2022 performance period data described above which 
includes the three low volume criteria. Within this category we divide 
clinicians into two groups-- clinicians who report data and clinicians 
who do not report data.
    Our next two eligibility assumptions concern clinicians and groups 
who may participate in MIPS but are not required to. First, we estimate 
group eligibility. These are the clinicians who, in our data, have a 
group submission and their group exceeds the low-volume threshold in 
all three criteria. Next, we apply our opt-in eligibility assumptions. 
Individuals or groups who exceed the low-volume threshold in one 
criterion but not all three may elect to opt-in. Based on the 2022 data 
described above we determine which individuals opted-in to MIPS and for 
the purposes of our model estimate that these clinicians will continue 
to opt-in to MIPS.
    After applying the criteria mentioned above, we next estimate the 
number of ``Potentially MIPS Eligible'' clinicians. These clinicians 
are not included in our total number of MIPS eligible clinicians. These 
are clinicians who are not MIPS eligible individually but who could 
either opt-in because they exceed the low volume threshold in at least 
one criterion but not all three or who could report as part of a group 
which exceeds all three low volume criteria.
    Finally, we estimate the number of clinicians who are neither MIPS 
eligible nor potentially MIPS eligible. First, we estimate the number 
of MIPS eligible clinicians who are below all three low-volume criteria 
(both as an individual and as a group) again using the CY 2022 
performance period data as described above.
    Next, we estimate the number of QPs who are not MIPS eligible. In 
section VI.E.22.b. of this final rule, we estimated a range of QPs. For 
the purposes of our RIA population, we estimate a specific number of 
QPs. This is because it is necessary to establish a specific population 
of clinicians to use to simulate the impacts of our final policies on 
participation, final scores, and payment adjustments. Finally, we 
estimate the number of clinicians who are excluded for other reasons 
including that they are a non-eligible clinician type, or newly 
enrolled in Medicare.
    After applying these assumptions to our initial population, we 
estimate 686,650 MIPS eligible clinicians with $4.90 billion in allowed 
charges. However, this number could be as high as 1,270,806 MIPS 
eligible clinicians and $6.25 billion allowed charges if all 
potentially MIPS eligible \574\ clinicians either opt-in or report as a 
group. This is an extremely unlikely scenario, but it quantifies the 
range of possible MIPS eligible clinicians in our initial population.
---------------------------------------------------------------------------

    \574\ We define potentially MIPS eligible clinicians as those 
clinicians who are not required to participate in MIPS but may 
either opt-in or join a group that exceeds the low-volume threshold 
in all three criteria.
---------------------------------------------------------------------------

(b) MIPS Eligibility Estimates
    Eligibility among many clinicians is contingent on submission to 
MIPS as a group or election to opt-in: therefore, we will not know the 
number of MIPS eligible clinicians who submit until the submission 
period for the CY 2023 performance period is closed. For the remaining 
analysis, we use the estimated population of 686,650 MIPS eligible 
clinicians described in previously in this section of the final rule. 
Table 131 summarizes our eligibility estimates for the final policies 
model after applying our assumptions discussed previously.
BILLING CODE 4120-01-P

[[Page 79506]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.175

BILLING CODE 4120-01-C
d. Modeling Approach and Methods for MIPs Value Pathways (MVPs) and 
Traditional MIPS
(1) Summary of Approach
    In this final rule, we present several proposals which impact the 
measures and activities, the performance category scores, final score 
calculation, and the MIPS payment adjustment of MIPS eligible 
clinicians. We outline these changes in more detail in section 
VII.E.22.d. of this final rule as we

[[Page 79507]]

describe our methodology to estimate MIPS payments for the CY 2024 
performance period/2026 MIPS payment year. We then present the impact 
of the finalized policies in the CY 2024 performance period/2026 MIPS 
payment year and then compare select metrics to the baseline model, 
which only incorporates previously finalized policies for the CY 2024 
performance period/2026 MIPS payment year. By comparing the baseline 
model to the policies model, we are able to estimate the incremental 
impact of the policies for the CY 2024 performance period/2026 MIPS 
payment year.
    MIPS eligible clinician's final scores are calculated based on the 
clinician's performance on measures and activities under the four MIPS 
performance categories: quality, cost, improvement activities, and 
Promoting Interoperability. MIPS eligible clinicians can participate in 
the four MIPS performance categories as an individual, group, virtual 
group, APM Entity, clinicians participating in MIPS through the APM 
Performance Pathway (APP), or through an MVP. MIPS APM participants can 
participate in the APP as an individual, group, virtual group, APM 
Entity and are only scored on three MIPS performance categories: 
quality, improvement activities, and Promoting Interoperability. For 
each of the performance categories we construct a simulation which 
applies the final policies for those performance periods as applicable 
to the CY 2022 MIPS performance period/2024 MIPS payment year data on 
which we base our model.
    In the CY 2022 PFS final rule (86 FR 65394 through 65397), we 
finalized policies at Sec.  414.1365 for implementing MIPS Value 
Pathways beginning in the CY 2023 performance period/2025 MIPS payment 
year. We incorporate MVP participation and scoring rules in this RIA 
where applicable as described in the following section.
(2) Methodology To Assess Impact for MIPS Value Pathways
    In this RIA, we take a similar approach to modeling MVP 
participation and scoring as described in the CY 2022 PFS final rule 
(87 FR 70204), incorporating changes to our policies model as described 
in this section.
(a) MVP Participant Assumptions
    At Sec.  414.1365(b), we require MVP Participants (which can be a 
group, individual, subgroup, or APM entity) to register prior to 
submitting an MVP. As we do not yet have information on who will 
register, we assume for purposes of this model, that MVP Participants 
are MIPS eligible individual clinicians or groups that currently submit 
at least four quality measures that are in an MVP. For these MVP 
Participants, we calculate both an MVP and a traditional MIPS score and 
take the highest score consistent with the existing scoring hierarchy 
which was finalized in the CY 2023 PFS final rule (86 FR 65537). For 
the baseline model, we used the quality measures finalized for MVPs in 
the CY 2023 PFS final rule Appendix 3: MVP Inventory.
    In section IV.A.4.a. and Appendix 3: MVP Inventory of this final 
rule, we finalized modifications to the 12 existing MVPs finalized in 
the CY 2022 PFS final rule (86 FR 65998 through 66031) and CY 2023 PFS 
final rule (87 FR 70037) and the consolidation of the previously 
finalized Promoting Wellness and Optimizing Chronic Disease Management 
MVPs into a single consolidated primary care MVP titled Value in 
Primary Care.
    In Appendix 3: MVP Inventory of this final rule, we finalized the 
inclusion of 5 new MVPs:
     Focusing on Women's Health;
     Prevention and Treatment of Infectious Disease Including 
Hepatitis C and HIV;
     Quality Care in Mental Health and Substance Use Disorder;
     Quality Care for Ear, Nose, and Throat (ENT); and
     Rehabilitative Support for Musculoskeletal Care.
    For the policies model, we incorporated the quality measure 
revisions for the existing MVPs and use the quality measures to model 
scores for the new MVPs in Appendix 3: MVP Inventory of this final 
rule.
    Our MVP Participant assumptions have limitations: we are not 
incorporating subgroups due to a lack of data, not all of the assumed 
participants may elect to register for an MVP, and we may have 
additional clinicians or groups register for an MVP. However, we 
believe this is a reasonable approach to simulate the impact of MVPs 
and we sought comment on this assumption but did not receive any 
feedback.
(b) MVP Scoring Methods and Assumptions
    We simulate an MVP score using the same data sources as we did for 
traditional MIPS. We scored according to Sec.  414.1365(d) and (e) 
using the MVP reporting requirements listed in Sec.  414.1365(c) with 
one exception. We did not restrict the improvement activities to the 
activities listed in the MVP inventory. We believed this would lower 
our estimated MVP score as clinicians and groups were not required to 
select from a limited inventory in the CY 2021 performance period (upon 
which our model is based). Therefore, we scored any improvement 
activities the MVP Participants submitted in 2021 as if those 
improvement activities are in the MVP inventory.
(3) Methodology To Assess Impact for Traditional MIPS
    To estimate the impact of the policies on MIPS eligible clinicians, 
we generally used the CY 2022 performance period's submissions data, 
including data submitted or calculated for the quality, cost, 
improvement activities, and Promoting Interoperability performance 
categories.
    We supplemented this information with the most recent data 
available for CAHPS for MIPS and CAHPS for ACOs, administrative claims 
data for the new quality performance category measures, and other data 
sets. We calculated a hypothetical final score for the CY 2024 
performance period/2026 MIPS payment year for the baseline and policies 
scoring models for each MIPS eligible clinician using score estimates 
for quality, cost, Promoting Interoperability, and improvement 
activities performance categories, and our final scoring policies.
(a) Methodology To Estimate the Quality Performance Category Score
    We estimated the quality performance category score using a 
methodology like the one described in the CY 2023 PFS final rule (87 FR 
70205) for the baseline and policies RIA models for the CY 2024 
performance period/2026 MIPS payment year.
    To create the baseline policies RIA model, which does not reflect 
the policies that we are finalizing in this rule, we made the following 
modifications to the CY 2023 PFS final rule final policies model to 
reflect the previously finalized quality performance category policies 
for the CY 2024 performance period/2026 MIPS payment year:
     As outlined in the CY 2023 PFS final rule (87 FR 70049), 
we increased the data completeness criteria threshold to at least 75 
percent for CY 2024 and CY 2025 performance periods/2026 and 2027 MIPS 
payment years.
    For the policies model, we did not implement any changes to the 
quality performance category relative to the baseline model because we 
use 2021 data and cannot simulate the addition of new measures.

[[Page 79508]]

(b) Methodology To Estimate the Cost Performance Category Score
    We estimated the cost performance category score using a 
methodology similar to the methodology described in the CY 2023 PFS 
final rule (87 FR 70205) for the baseline and the proposed policies RIA 
models.
    For this final rule, the baseline policies RIA model included the 
same method used for the final policies RIA model in the CY 2023 PFS 
final rule (87 FR 70205). The policies finalized in the CY 2023 PFS 
final rule are now part of the CY 2024 proposed rule baseline. The 
final policies RIA model incorporated and implemented the following 
changes:
     In section IV.A.4.f.(2)(a) of this final rule, we are 
finalizing the addition of 5 new episode-based cost measures and the 
removal of the Simple Pneumonia with Hospitalization measure, from the 
cost performance category beginning with CY 2024 performance period/
2026 MIPS payment year.
     In section IV.A.4.g.(1)(d)(i) of this final rule, we are 
finalizing the proposed cost improvement scoring methodology in CY 2024 
PFS proposed rule (88 FR 52595 through 52596).
    For the RIA models we:
     Calculated the current year (PY 2024) cost performance 
category score,
     Calculated the cost improvement score over the previous 
year's cost performance category score.
    Calculated the final individual MIPS-eligible clinicians and 
groups' cost performance category score by adding the cost improvement 
score to the current year (PY 2024) cost performance category score.
(c) Methodology To Estimate the Facility-Based Measurement Scoring
    A limitation of using data from the CY 2021 performance period is 
that we are not able to estimate facility-based scores because there 
are no Hospital Value-Based Purchasing total performance scores 
calculated for the performance period due the COVID-19 PHE. However, 
for clinicians who did not participate in MIPS during the CY 2021 
performance period, we did use the 2019 data supplement to identify 
final scores based on the CY 2019 performance period submission and 
these scores include facility-based scores.
(d) Methodology To Estimate the Promoting Interoperability Performance 
Category Score
    We estimated the baseline Promoting Interoperability performance 
category score by using the same methodology that we used in the CY 
2023 PFS final rule (87 FR 70206) final policies. We incorporated the 
final policies model from that rule into our baseline model. In section 
IV.A.4.f.(4)(f) of this final rule, we proposed to only continue 
reweighting Clinical Social Workers in the promoting interoperability 
category. On this basis, we removed reweighting for the following 
clinicians: Audiologist (Billing Independently), Certified Clinical 
Nurse Specialist, Certified Registered Nurse Anesthetist (CRNA), 
Clinical Psychologist, Nurse Practitioner, Occupational Therapist in 
Private Practice, Physical Therapist in Private Practice, Physician 
Assistant, Registered Dietician/Nutrition Professional, and Speech 
Language Pathologists. This is incorporated into our policies model. We 
used the following scoring weights for the Promoting Interoperability 
objectives and measures:
     ePrescribing objective is worth a total of 20 maximum 
points,
     Health Information Exchange (HIE) objective is worth a 
total of 30 total maximum points,
     Provider to Patient Exchange measure is worth a total of 
25 maximum points, and
     Public Health and Clinical Data Exchange objective is 
worth a total of 25 maximum points.
    We did not incorporate changes to the performance period or measure 
level changes because we are not able to model this using data for the 
CY 2021 performance period.
(e) Methodology To Estimate the Improvement Activities Performance 
Category Score
    For the baseline and policies model we used the same method to 
estimate the improvement activities performance category score as 
described in the CY 2023 PFS final rule (87 FR 70206).
(f) Methodology To Estimate the Complex Patient Bonus Points
    For the baseline and policies RIA model, we used the previously 
established method to calculate the complex patient bonus as described 
in the CY 2022 PFS final rule (86 FR 64996).
(g) Methodology To Estimate the Final Score
    We did not propose any changes for how we calculated the MIPS final 
score. Our baseline and policies RIA models assigned a final score for 
each TIN/NPI by multiplying each estimated performance category score 
by the corresponding performance category weight, adding the products 
together, multiplying the sum by 100 points, adding the complex patient 
bonus, and capping at 100 points.
    For the baseline policies RIA model, we applied the performance 
category weights and redistribution weights finalized in the CY 2022 
PFS final rule (86 FR 65519 through 65524).
    For both models, after adding any applicable bonus for complex 
patients, we reset any final scores that exceeded 100 points to equal 
100 points. For MIPS eligible clinicians who were assigned a weight of 
zero percent for any performance category, we redistributed the weights 
according to Sec.  414.1380(c).
    For the purposes of this model, if a clinician received a 
reweighting of their final score under our extreme and uncontrollable 
in the CY 2022 performance period (which was the performance period of 
the data source used in our model) we continue to apply that 
reweighting in the CY 2023 performance period by assigning them a 
neutral score equal to the performance threshold. Although it is 
unlikely (but possible) that the exact same clinicians will apply for 
and receive EUC reweighting in both the CY 2022 MIPS performance 
period/CY 2024 MIPS payment year (which our data is based on) and the 
CY 2024 MIPS performance period/CY 2026 payment year (which we are 
simulating) we believe that this assumption accurately reflects future 
clinician behavior for two reasons. First, while the exact same 
clinicians may not receive EUC reweighting 2 years in a row, we believe 
that this assumption allows us to quantify the impact of the EUC on a 
population level. In other words, even if the same clinicians to not 
apply for and receive EUC reweighting 2 years in a row, the absolute 
number of EUC reweighting and the characteristic of practices who 
receive an EUC reweighting is likely to remain similar. Secondly, if we 
were to not assign reweighting to those clinicians many of them would 
receive a very low final score because they did not submit data during 
the year in which they received an EUC reweighting. We do not believe 
that it is realistic to assume that, in the absence of an EUC 
reweighting, those clinicians would continue to not submit data. For 
these reasons, clinicians who received an EUC reweighting in the CY 
2022 MIPS performance period/CY 2024 MIPS payment year also are 
assigned an EUC reweighting in our CY 2024 MIPS performance period/CY 
2026 MIPS payment year. These clinicians are assigned a score of the 
performance threshold (75) in our model because this

[[Page 79509]]

corresponds with a neutral (0 percent) payment adjustment.
(h) Methodology To Estimate the MIPS Payment Adjustment
    For the baseline and proposed policies RIA models, we applied the 
hierarchy as finalized in the CY 2022 PFS final rule (86 FR 65536 
through 65537) to determine which final score should be used for the 
payment adjustment for each MIPS eligible clinician when more than one 
final score is available. We then calculated the parameters of an 
exchange function in accordance with the statutory requirements related 
to the linear sliding scale, budget neutrality, and minimum and maximum 
adjustment percentages.
    For the baseline model, we applied the performance threshold of 75 
points finalized in the CY 2023 PFS final rule (87 FR 70097). In the CY 
2024 proposed rule (88 FR 52598 through 52600), we proposed a 
performance threshold of 82 points for the CY 2024 performance period/
2026 MIPS payment year; however, as described in section IV. of this 
final rule, we are not finalizing that policy as proposed. Therefore, 
for both the baseline and final policies models we used a performance 
threshold of 75 to calculate the exchange function used for MIPS 
payment adjustments. We note that the results of this exchange are not 
identical between the baseline and final policies model. This is 
because the scaling factor used to determine positive adjustments is 
dependent on the total dollar amount of negative payment adjustments 
and those adjustments differ slightly as final scores are not identical 
between both models.
    For both the baseline and policies models, we used these resulting 
parameters to estimate the positive or negative MIPS payment adjustment 
based on the estimated final score and the allowed charges for covered 
professional services furnished by the MIPS eligible clinician.
(4) Simulation Results and Projected Impact to MIPS Eligible Clinicians
    Based on the methodology described in the proceeding sections we 
created a baseline and final policies simulation. Using this 
simulation, we estimate the impact of the policies finalized in this 
rule on clinician eligibility, final scores, and payment adjustments
(a) Impact to Clinician Eligibility
    In section VI.E.22.c.(2)(a) of this final rule, we noted that we 
are not proposing any modification to clinician eligibility and 
therefore there is no difference in the total number of MIPS eligible 
clinicians between our models.
(b) Impact to Clinician's Final Scores
    Table 132 shows the median final score by practice size and the 
percentage of MIPS eligible clinicians of each practice size with a 
positive or neutral or negative adjustment.

[[Page 79510]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.176

    The median final score is 83.46 in our baseline model and 83.40 in 
our final policies model. Across all practices sizes there is minimal 
to no difference in median final scores for the baseline and final 
policies model. Additionally, the percentage of clinicians receiving a 
positive or neutral adjustment\575\ varies little between the two 
models with slight variation for medium and large practices. We project 
that 78.40 percent of clinicians will receive a positive or neutral 
adjustment in the baseline model and 78.37 percent of clinicians will 
receive a positive or neutral adjustment in the final policies model. 
The largest difference (0.03 percentage points) in the proportion of 
clinicians with a positive or neutral adjustment between the baseline 
and final policies model occurs among large practices. Figure 4 shows 
the distribution of final scores for all clinicians. Note that there 
are a relatively large number of MIPS eligible clinicians with a final 
score of 75. As stated in section VI.E.22.d.(3)(g) of this final rule, 
clinicians who have their final score reweighted under our extreme and 
uncontrollable circumstances (EUC) policy are assigned a final score of 
exactly the performance threshold (75). Overall, the distribution is 
skewed to the right indicating that

[[Page 79511]]

clinicians tend to receive final scores on the higher end of the 
distribution.
---------------------------------------------------------------------------

    \575\ In other words, clinicians who received a score between 
the performance threshold (75) and 100.
[GRAPHIC] [TIFF OMITTED] TR16NO23.177

(i) Impact to Small and Solo Practices
    18,867 MIPS eligible clinicians or 2.7 percent of all MIPS eligible 
clinicians are solo practitioners in both the baseline and final 
policies models. The median final score for solo practitioners is 
exactly equal to the performance threshold in both the baseline and 
final policies model. As stated in section VI.E.22.d.(3)(g) of this 
final rule, clinicians receiving reweighting under our extreme and 
uncontrollable circumstances policy are assigned a final score exactly 
equal to the performance threshold. These clinicians are why the median 
final score for solo practitioners is exactly 75.
    While the proportion of solo practitioners receiving a negative 
payment adjustment and the median final score of solo practitioners 
does not vary much between the baseline and final policies models, 
these practitioners do have a lower median final score than other 
practice sizes. This is largely due to the fact that many of these solo 
practitioners do not submit data to MIPS despite being MIPS eligible 
clinicians. Our analysis indicates that 49.55 percent of solo 
practitioners submit data to MIPS\576\ compared to 93.70 percent of all 
clinicians. The median final score in our final policies model is 75.00 
for all solo practitioner but for solo practitioners who submit data 
the median final score is 85.28 which is slightly higher than the 
median final score for all clinicians who submit data which is 84.75. 
These findings indicate that the lower final scores among solo 
practitioners is likely due to not reporting data to MIPS.
---------------------------------------------------------------------------

    \576\ Submitting data to MIPS is defined as any interaction with 
MIPS. Including beginning a submission but not finishing.
---------------------------------------------------------------------------

    Small practices, defined as groups with a range between 2 and 15 
clinicians, have a median final score of 82.36 in both the baseline and 
final policies model. This is slightly but not substantially less than 
the overall median final score of 83.40. Among small practices who 
submit data the median final score is 87.29 in the final policies model 
(and 87.30 in the baseline). This is significantly higher than the 
median final score for all clinicians who submit data which is 84.74. 
This indicates that small practices perform similarly to other practice 
sizes but may have slightly more clinicians who do not submit data than 
medium and large practices. Table 133 shows the percentage of 
clinicians by practice size who either do or do not submit data to MIPS 
and the corresponding median final score. Note that the median final 
score for non-engaged clinicians is 75 for all practice sizes except 
solos for whom it is 0. This indicates that many of the clinicians who 
belong to a small, medium, or large practice do not submit data to MIPS 
possibly because they are being reweighted under our extreme and 
uncontrollable circumstances policy but that many solo practitioners 
who do not submit data are doing so despite not being eligible for the 
EUC reweighting policy. A large majority of all practice sizes except 
solo practitioners do submit data to MIPS. It is possible that the 
small percentage who do not are primarily clinicians who have received 
reweighting under our extreme and uncontrollable circumstances policy. 
As shown in Figure 5 clinicians who do not submit data have a final 
score tend to either have a final score of 0 or a final score of 
exactly 75. This indicates that there are two ``types'' of clinicians 
who do not submit data: those who receive reweighting under the EUC 
policy and those who do not and receive a final score of approximately 
zero. This is true across all practice sizes, however solo 
practitioners are the only practice size

[[Page 79512]]

where more clinicians receive a score of 0 than of 75 which is why the 
median final score of MIPS eligible clinicians for that group is 0.
[GRAPHIC] [TIFF OMITTED] TR16NO23.178

[GRAPHIC] [TIFF OMITTED] TR16NO23.179

(ii) Impact to Rural Providers
    In our data we assign rural practitioners a special status. 
Analysis of this group of clinicians indicates that their final scores 
are similar to the overall population of MIPS Eligible Clinicians 
across all practice sizes. Table 134 shows the median final score and 
the percentage of eligible clinicians with a positive or neutral or 
negative adjustment by practice size.

[[Page 79513]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.180

    The median final score for all rural practitioners is 82.58 in our 
baseline model and 82.57 in our final policies model. This is slightly 
lower than the median final score for all practitioners which is 84.86 
in our baseline model and 84.75 in our final policies model. A larger 
portion of Solo rural practitioners receive a positive adjustment than 
solo practitioners generally. As shown in Table 135, 53.72 percent of 
all solo practitioners receive a positive or neutral adjustment. Among 
rural practitioners 64.85 percent of solo practitioners receive a 
positive adjustment. A similar proportion of medium practices receive a 
positive adjustment among rural practitioners and our overall 
population but medium practices have a slightly larger median payment 
adjustment. Large practices are the only practice size where rural 
practitioners score measurably worse in our model. Among large rural 
practices 75.50 percent of MIPS eligible clinicians receive a positive 
or neutral payment in our final policies model compared 80.51 percent 
of all large practices. Overall rural practitioners perform similarly 
or better in our simulation compared to all practitioners with the 
exception of larger rural practitioners who perform slightly worse.
(iii) Impact to Safety Net Providers
    In the CY 2023 PFS final rule (87 FR 70094) we finalized our 
complex patient bonus methodology. This bonus is composed of two 
distinct calculations which are added together: Medical Complexity and 
Social Risk. Medical Complexity is determined based on a MIPS eligible 
clinicians Hierarchical Conditions Categories risk score and social 
risk is determined based on the proportion of a MIPS eligible 
clinicians Medicare patient population who are dually eligible for both 
Medicare and Medicaid.
    To assess the impact of our finalized polices on these clinicians 
we compared the performance of clinicians who received the complex 
patient bonus with our overall population. We refer to this group of 
clinicians (those who have received the complex patient bonus) as 
``safety net providers'' for the purpose of this analysis. The results 
of this analysis are in Table 135.

[[Page 79514]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.181

    Across every practice size safety net provers perform very 
similarly to our overall population of MIPS eligible clinicians.
(c) Impact to Clinicians Payment Adjustments
    In section IV.A.4.h.(2) of this final rule we state that we are not 
finalizing an increase in the performance threshold. However, payment 
adjustments still differ slightly between the baseline and final 
policies model. This is because final scores are slightly different, 
and the parameters of the exchange function used to determine payment 
adjustments depends on the final score distribution of MIPS eligible 
clinicians. However, the difference between the payment adjustment 
function in the baseline and final rule is negligible. Figure 6 shows 
the payment adjustment function for the baseline and final rule. Since 
these functions are virtually identical these two lines overlap.
[GRAPHIC] [TIFF OMITTED] TR16NO23.182

    Payment adjustments range from -9 percent to a maximum of 2.985 
percent in the baseline and 2.989 percent in our final policies model. 
We project redistributing $491 million in both the baseline and final 
policies models.

[[Page 79515]]

    We also report the median positive and negative payment adjustments 
by practice size.
[GRAPHIC] [TIFF OMITTED] TR16NO23.183

    For solo practitioners the median negative payment adjustment is 
equal to the maximum negative adjustment of -9.00 percent. As discussed 
in section VI.E.22.(4)(b)(i) of this final rule, this is largely due to 
the fact that many of these solo practitioners do not submit data to 
MIPS despite being MIPS eligible clinicians. Our analysis indicates 
that 49.55 percent of solo practitioners submit data to MIPS \577\ 
compared to 93.70 percent of all clinicians. In Table 137, we report 
the proportion of clinicians with either did or did not submit data 
with the maximum negative adjustment (-9 percent).
---------------------------------------------------------------------------

    \577\ Submitting data to MIPS is defined as any interaction with 
the MIPS program.

---------------------------------------------------------------------------

[[Page 79516]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.184

    While the median negative adjustment is the maximum (-9 percent) 
for solo practitioners only 2.86 percent of solo practitioners who 
submit data receive the maximum negative adjustment. In contrast, 67.17 
percent of solo practitioners who do not submit data receive the 
maximum negative adjustment.
    The median positive adjustment for solo practitioners is 2.08 
percent which is higher than the median positive adjustment for any 
other practice size. This indicates that, while many solo practitioners 
do not submit data to MIPS, those solo practitioners who do report data 
to MIPS and receive a positive adjustment receive a higher median 
adjustment than other practice sizes. As shown in Table 138, 11.97 
percent of solo practitioners who submit data to MIPS receive the 
maximum positive adjustment. This is larger than the other practice 
sizes which indicates that the solo practitioners who do submit data 
perform as well or better than the rest of the population of clinicians 
who submit data.

[[Page 79517]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.185

e. Additional Impacts from Outside Payment Adjustments
(1) Burden Overall
    In addition to policies affecting the payment adjustments, we are 
finalizing several policies that have an impact on burden in the CY 
2024 performance period/2026 MIPS payment year. In section V.B.11. of 
this final rule, we outline estimates of the costs of data collection 
that includes both the effect of policy updates and adjustments due to 
the use of updated data sources. For each provision included in this 
final rule which impacts our estimate of collection burden, the 
incremental burden for each is summarized in Table 139. We also 
provided additional burden discussions that we are not able to 
quantify.
BILLING CODE 4120-01-C

[[Page 79518]]

[GRAPHIC] [TIFF OMITTED] TR16NO23.186

(2) Additional Impacts to Clinicians
(a) Impact on Third Party Intermediaries
    In section IV.A.4.k. of this final rule, we proposed to: (1) add 
requirements for third party intermediaries to obtain documentation; 
(2) add requirements for third party intermediaries to submit data in 
the form and manner specified by CMS; (3) specify the use of a 
simplified self-nomination process for existing QCDRs and qualified 
registries; (4) add requirements for QCDRs and qualified registries to 
provide measure numbers and identifiers for performance categories; (5) 
Add a requirement for QCDRs and qualified registries to attest that 
information on the qualified posting is correct; (6) Modify 
requirements for QCDRs and qualified registries to support MVP 
reporting; (7) Specify requirements for a transition plan for QCDRs and 
qualified registries; (8) Specify requirements for data validation 
execution reports; (9) Add additional criteria for rejecting QCDR 
measures; (10) Add a requirement for QCDR measure specifications to be 
displayed throughout the performance period and data submission period; 
(10) eliminate the Health IT vendor category; (11) Add failure to 
maintain updated contact information as criteria for remedial action; 
(12) Revise corrective action plan requirements; (13) Specify the 
process for publicly posting remedial action; and (14) Specify the 
criteria for audits. Due to the technical nature of these changes, we 
are unable to quantify the burden for third party intermediaries during 
the CY 2024 performance period/2026 MIPS payment year. We refer readers 
to section IV.A.4.k. of this final rule for additional information on 
changes to the third party intermediary requirements.
(b) Compare Tools: Public Reporting
    As discussed in section IV.A.4.1. of this final rule, we are 
finalizing our proposals to: (1) use the most recent codes at the time 
the data are refreshed that identify a clinician as furnishing services 
via telehealth; (2) update the PDC Utilization Data File Policy, remove 
the PUF subset file from the PDC and only keep the utilization data 
file that reflects the information on clinician profile pages in the 
PDC; (3) modify the Procedure Grouping Policy for Publicly Reporting 
Utilization Data as proposed. Specifically, in addition to Restructured 
BETOS and code sources used in MIPS, we may use alternate sources to 
create clinically meaningful and appropriate procedural categories, 
particularly when no relevant grouping exists; and (4) incorporate 
Medicare Advantage data to FFS procedure volume counts and amend Sec.  
422.310(f)(3) to add a new paragraph

[[Page 79519]]

(iv) authorizing CMS to release aggregated risk adjustment data before 
the reconciliation for the applicable payment year has been completed 
if CMS determines that releasing aggregated data is necessary and 
appropriate for activities to support administration of the Medicare 
program. While the Compare tool provisions do not increase the burden 
of collections, we note that the PRA package may require relevant 
modification to reflect the Compare tool's new uses and public display. 
We refer readers to section IV.A.4.l. of this final rule for additional 
details on the changes to public reporting on Compare tools.
(c) Data Completeness Criteria for the Quality Measures, Excluding the 
Medicare CQMs
    As discussed in section IV.A.4.f.(1)(d) of this final rule, we are 
finalizing to maintain the data completeness criteria threshold at 75 
percent for the CY 2025 and 2026 performance periods/2027 and 2028 MIPS 
payment years. We are not finalizing our proposal to increase the data 
completeness criteria threshold by 5 percent from 75 percent to 80 
percent for the CY 2027 performance period/2029 MIPS payment year. We 
believe that the policy to maintain the threshold for data completeness 
at 75 percent for the CY 2025 and 2026 performance periods/2027 and 
2028 MIPS payment years is consistent with the existing data 
completeness criteria and therefore, will not result in additional 
burden to the applicable interested parties. We refer readers to 
section IV.A.4.f.(1)(d) of this final rule for additional information 
on the data completeness threshold criteria.
(d) Modifications to the Improvement Activities Inventory
    As discussed in section IV.A.4.f.(2)(b)(ii) of this final rule, we 
are finalizing changes to the improvement activities Inventory for the 
CY 2024 performance period/2026 MIPS payment year and future years as 
follows: adding five new improvement activities; modifying one existing 
improvement activity; and removing three previously adopted improvement 
activities. We refer readers to Appendix 2: Improvement Activities of 
this final rule for further details. We do not believe these changes to 
the improvement activities inventory will significantly impact time or 
financial burden on interested parties because MIPS eligible clinicians 
are still required to submit the same number of activities and the per 
response time for each activity is uniform. We do not expect these 
changes to the improvement activities inventory to affect our currently 
approved information collection burden estimates in terms of neither 
the number of estimated respondents nor the burden per response. We 
anticipate most clinicians performing improvement activities, to comply 
with existing MIPS policies, will continue to perform the same 
activities under the policies in this final rule because previously 
finalized improvement activities continue to apply for the current and 
future years unless otherwise modified per rulemaking (82 FR 54175). 
Most of the improvement activities in the Inventory remain unchanged 
for the CY 2024 performance period/2026 MIPS payment year. We refer 
readers to section IV.A.4.f.(3)(b)(ii) of this final rule for 
additional information on changes to the improvement activities 
Inventory.
(3) Update to CEHRT Definition for the Medicare Promoting 
Interoperability Program and the Quality Payment Program
    As discussed in section III.R. of this final rule, we are 
finalizing our proposal to update the definitions of CEHRT for the 
Medicare Promoting Interoperability Program for eligible hospitals and 
CAHs and for the MIPS Promoting Interoperability performance category. 
Under this provision, we will revise the definitions of CEHRT for the 
Medicare Promoting Interoperability Program at Sec.  495.4, and for the 
Quality Payment Program at Sec.  414.1305. Specifically, we are 
finalizing the proposal to add a reference to the ``Base EHR 
Definition'' where the regulatory text refers to the ``2015 Edition 
Base EHR definition,'' remove ``2015 Edition'' where we reference 
``2015 Edition health IT certification criteria,'' and add a cross-
reference to health IT certification criteria at Sec.  170.315. We also 
are finalizing the proposal to specify that technology meeting the 
CEHRT definitions must meet ONC's certification criteria at Sec.  
170.315, ``as adopted and updated by ONC.'' We believe that these 
revisions to the CEHRT definitions will ensure that updates to the 
definition at Sec.  170.102 and updates to applicable health IT 
certification criteria in Sec.  170.315 will be incorporated into CEHRT 
definitions, without requiring additional regulatory action by CMS. 
Finally, we noted that while this provision is consistent with the 
approach in ONC's HTI-1 proposed rule (88 FR 23746 through 23917), we 
do not believe that ONC must finalize their proposed revisions for us 
to be able to finalize the changes in this section for our regulatory 
definitions of CEHRT. These changes will not impact EHR requirements in 
the CY 2024 EHR reporting period or the CY 2024 performance period, and 
therefore we predict that it will have no impact on clinicians.
f. Assumptions & Limitations
    In our MIPS eligible clinician assumptions, we assumed that 
clinicians who elected to opt-in for the CY 2021 Quality Payment 
Program and submitted data will continue to elect to opt-in for the CY 
2023 performance period/2025 MIPS payment year. It is difficult to 
predict whether clinicians will elect to opt-in to participate in MIPS 
with the policies.
    As discussed in section VI.E.22.c. of this final rule, we are 
unable to predict which specific clinicians would receive reweighting 
under our extreme and uncontrollable circumstances policies in the CY 
2024 Performance period/CY 2026 Payment Year and so we make the 
assumption that those clinicians who received the reweighting under our 
extreme and uncontrollable circumstances policy are representative of 
the number and attributes of clinicians who will receive reweighting 
under this policy in the future.
    In addition to the limitations described throughout the methodology 
sections, to the extent that there are year-to-year changes in the data 
submission, volume, and mix of services provided by MIPS eligible 
clinicians, the actual impact on total Medicare revenues will be 
different from those shown in Table 132.
    We received public comments on the Regulatory Impact Analysis for 
the Quality Payment Program.
    The following is a summary of the comments we received and our 
responses.
    Comment: Several commenters requested that CMS analyze the impact 
of QP policy changes, including the QP determination policy proposal 
and proposed change to the QP threshold, in the Regulatory Impact 
Analysis of the rule. Commenters were interested in how these policy 
changes would impact the engagement of specific types of practices and 
patient populations such as rural clinicians, ACOs, and specialists in 
the program.
    Response: We thank these commenters for their feedback on the 
regulatory impact analysis. We note that our analysis incorporates QP 
policy changes. This is described in more detail in section 
VI.E.22.c.(2) of this final rule. We also note that, as stated in 
section IV.A.4.m.(2) of this final rule we are not finalizing the 
change in individual level QP determination proposed in the CY 2024 PFS 
proposed

[[Page 79520]]

rule. We note that we describe the overall impact to rural clinicians 
in section VI.E.22.d.(4)(b)(ii) of this final rule. We are continuously 
refining and improving the model used for this regulatory impact 
analysis and will consider the specific suggestions raised by these 
commenters in future iterations.

F. Alternatives Considered

    This final rule contains a range of policies, including some 
provisions related to specific statutory provisions. The preceding 
preamble provides descriptions of the statutory provisions that are 
addressed, identifies those policies when we exercise agency 
discretion, presents rationale for our policies, and, where relevant, 
alternatives that were considered. For purposes of the payment impact 
on PFS services of the policies contained in this final rule, we 
present above the estimated impact on total allowed charges by 
specialty.
1. Alternatives Considered Related to the O/O E/M Visit Inherent 
Complexity Add-On Separate Payment
    We considered alternatives to our policy to make separate payment 
for the O/O E/M visit inherent complexity add-on code, including 
proposing to maintain our current utilization assumptions. Maintaining 
our current utilization assumption as finalized in CY 2021 would result 
in an estimated impact or change to the CF of -3.2 percent (Table 140). 
However, maintaining the CY 2021 policy utilization assumption would 
not reflect our limitation on billing of the O/O E/M visit inherent 
complexity add-on code for services billed with modifier 25 which is 
used to indicate that the service is billed on the same day as a minor 
procedure or another E/M visit by the same practitioner. It seems 
likely that visits reported with payment modifiers have resources 
sufficiently distinct from stand-alone office/outpatient E/M visits (85 
FR 84571). Interested parties unlikely to bill for the O/O E/M visit 
inherent complexity add-on code have continued to express concerns 
about potential associated reductions to the CF and redistributive 
impacts among specialties. Our proposal to better target the add-on 
code would partially allay those concerns. Under our proposed 
utilization assumption for CY 2024, we estimated the effect of making 
separate payment for the O/O E/M visit complexity add-on code to be -
2.0 percent.
[GRAPHIC] [TIFF OMITTED] TR16NO23.187

    We also considered proposing not to make separate payment for the 
O/O E/M visit inherent complexity add-on code for CY 2024, continuing 
to consider the utilization data, and solicited comment on not making 
separate payment until CY 2025 instead of CY 2024.
    While doing so would reduce the change to the CF and the 
redistributive impacts among specialties our concerns about capturing 
the work associated with visits that are part of ongoing, comprehensive 
primary care and/or care management for patients with a single, 
serious, or complex chronic condition would remain present.
    We received public comments on these proposals. Generally, 
commenters who believed that E/M visits that are associated with 
medical care services that serve as the continuing focal point for all 
needed health care services or with medical care services that are part 
of ongoing care related to a patient's single, serious or complex 
condition expressed support for our proposal. Commenters who believed 
that the code was duplicative or some who believed that the negative 
impact on the conversion factor outweighed the benefit opposed the 
code. Many commenters across the board recommended lowering utilization 
estimates in the proposed rule. For a summary of the comments we 
received and our responses see section II.F.2, of this final rule. 
After consideration of public comments, we are finalizing as proposed.
    We believe separate payment for the O/O E/M visit inherent 
complexity add-on code will improve accuracy in payment for resource 
costs inherent to primary care and other medical care services that are 
part of ongoing care for a patient's single, serious or complex 
condition in the office setting. This will be particularly important 
for people without access to such care. We also believe that utilizing 
high-value preventive services and promoting healthy behaviors 
leveraged by these kinds of longitudinal patient relationships could 
result in positive patient outcomes and positive health equity impacts. 
Primary care practitioners and other practitioners who rely heavily on 
these visit codes and will use the add-on code will likely raise strong 
objections if CMS does not propose to make separate payment for a code 
that is intended to address long-standing distortions in PFS payment 
that CMS has repeatedly acknowledged through notice and comment 
rulemaking.
2. Alternatives to Provider Enrollment Provisions
    We did not consider alternatives to our provider enrollment 
provisions. We believe these changes are necessary to help ensure that 
payments are made only to qualified providers and suppliers and/or to 
increase the efficiency of the Medicare and Medicaid provider 
enrollment processes.
3. Alternatives Considered Medicare Diabetes Prevention Program
    No alternatives were considered. The MDPP flexibilities resulting 
from the PHE for COVID-19 lasted over 3 years of the initial 5 years of 
the expanded model. During this time, supplier and beneficiary 
expectations changed, resulting in the synchronous virtual delivery of 
healthcare services becoming normalized. Requiring the MDPP expanded 
model to return to primarily in-person services following over 3 years 
of synchronous virtual delivery may have an extremely negative impact 
for both MDPP suppliers and beneficiaries, which could threaten the 
success of the entire expanded model.
4. Alternatives Considered for the Quality Payment Program
    For purposes of the payment impact on the Quality Payment Program, 
we view the performance threshold as a critical factor affecting the 
distribution of payment adjustments. We ran separate policies RIA 
models based on the actual mean for the CY 2019 performance period/2021 
MIPS payment year with a performance

[[Page 79521]]

threshold of 86. This model has the same mean and median final score as 
our policies RIA model since the performance threshold does not change 
the final score. In our analysis of the alternative performance 
threshold of 86, 56.09 percent of all MIPS eligible clinicians who 
submitted data will receive a negative payment adjustment.
    In the CY 2024 PFS proposed rule (88 FR 52598 through 52598), we 
proposed to increase the performance threshold to 82 points. In section 
IV.A.4.h.(2) of this final rule, we indicated that we are not 
finalizing this increase. Under the performance threshold of 82 we 
project that 46.67 percent of all MIPS eligible clinicians would 
receive a negative payment adjustment.
    We also reported the findings for the baseline RIA model which 
describes the impact for the CY 2024 performance period/2026 MIPS 
payment year if this proposal is not finalized. The baseline RIA model 
has a median final score of 83.46. We estimated that $491 million will 
be redistributed based on the budget neutrality requirement. The 
baseline includes a maximum payment adjustment of 2.98 percent. In 
addition, 21.60 percent of MIPS eligible clinicians would receive a 
negative payment adjustment.

G. Impact on Beneficiaries

1. Medicare Shared Savings Program Provisions
    As noted previously in this final rule, the cap on an ACO's 
regional service area risk score growth is expected to increase the 
incentive for ACOs to participate in regions with high risk score 
growth, improving the incentive for ACOs to join and/or sustain 
participation when serving regions with increasingly medically complex 
beneficiaries. Similarly, the use of a uniform approach to calculating 
both BY and PY prospective HCC risk scores using the same CMS-HCC risk 
adjustment model(s) is anticipated to increase participation (and 
reduce the potential for attrition) particularly from ACOs serving 
greater proportions of complex beneficiaries exhibiting high risk 
scores. Mitigating the impact of the negative regional adjustments on 
benchmarks is expected to increase participation from ACOs serving up 
to 500,000 new assigned beneficiaries per year. The revised definition 
of assignable beneficiary is expected to allow more than 760,000 
additional beneficiaries to be included in the population of assignable 
beneficiaries, many of whom would be eligible to be assigned to ACOs. 
Taken together, these provisions are expected to increase participation 
in the Shared Savings Program over the 2024-2033 period by roughly 10 
to 20 percent.
    ACOs have been found to perform better on certain patient-
experience and performance measures than physician groups participating 
in the MIPS. In addition, ACOs continued to achieve better average 
performance rates than comparably sized MIPS group practices on all 10 
of the CMS WI measures and had higher scores on the CAHPS for MIPS 
patient experience survey in PY 2022. ACO performance was statistically 
better on 6 out of 10 CMS WI measures compared to comparably sized MIPS 
group practice reporters in PY 2022. Those measures include diabetes 
control, blood pressure control, breast cancer screening, colorectal 
cancer screening, depression screening and follow-up, and tobacco 
screening and cessation intervention.
    Increased participation in the Shared Savings Program will extend 
ACO care coordination and quality improvement to segments of the 
beneficiary population that potentially have more to benefit from care 
management.
2. Quality Payment Program
    There are several changes in this final rule that are expected to 
have a positive effect on beneficiaries. In general, we believe that 
many of these changes, including the MVP and subgroup provisions, if 
finalized, will lead to meaningful feedback to beneficiaries on the 
type and scope of care provided by clinicians. Additionally, 
beneficiaries could use the publicly reported information on clinician 
performance in subgroups to identify and choose clinicians in 
multispecialty groups relevant to their care needs. Consequently, we 
anticipate the policies in this final rule will improve the quality and 
value of care provided to Medicare beneficiaries. For example, several 
of the new quality measures include patient-reported outcome-based 
measures, which may be used to help patients make more informed 
decisions about treatment options. Patient-reported outcome-based 
measures provide information on a patient's health status from the 
patient's point of view and may also provide valuable insights on 
factors such as quality of life, functional status, and overall disease 
experience, which may not otherwise be available through routine 
clinical data collection. Patient-reported outcome-based measured are 
factors frequently of interest to patients when making decisions about 
treatment.
3. Medicare Diabetes Prevention Program
    The changes will have a positive impact on eligible MDPP 
beneficiaries, as it increases the accessibility of MDPP, particularly 
among beneficiaries residing in rural and underserved areas of the US, 
where access to a supplier offering in-person Set of MDPP services may 
not exist or be geographically feasible.

H. Estimating Regulatory Familiarization Costs

    If regulations impose administrative costs on private entities, 
such as the time needed to read and interpret this rule, we should 
estimate the cost associated with regulatory review. Due to the 
uncertainty involved with accurately quantifying the number of entities 
that will review the rule, we assumed that the total number of unique 
commenters on this year's proposed rule will be the number of reviewers 
of last year's proposed rule. We acknowledged that this assumption may 
understate or overstate the costs of reviewing this rule. It is 
possible that not all commenters will review this year's proposed rule 
in detail, and it is also possible that some reviewers will choose not 
to comment on the proposed rule. For these reasons we believe that the 
number of commenters will be a fair estimate of the number of reviewers 
of this year's proposed rule.
    We also recognized that different types of entities are in many 
cases affected by mutually exclusive sections of this rule, and 
therefore for the purposes of our estimate we assume that each reviewer 
reads approximately 50 percent of the rule.
    Using the wage information from the BLS for medical and health 
service managers (Code 11-9111), we estimate that the cost of reviewing 
this rule is $123.06, including overhead and fringe benefits https://www.bls.gov/oes/current/oes_nat.htm. Assuming an average reading speed, 
we estimate that it would take approximately 8.0 hours for the staff to 
review half of this rule. For each facility that reviews the rule, the 
estimated cost is $984.48 (8.0 hours x $123.06). Therefore, we 
estimated that the total cost of reviewing this regulation is 
21,677,265 ($984.48 x 22,019 reviewers on this year's proposed rule).
    As for the Medicare Diabetes Prevention Program, given that we 
tried to align this rule as much as possible with the CDC DPRP 
Standards, there should be minimal regulatory familiarization costs. 
This rule impacts only enrolled MDPP suppliers and

[[Page 79522]]

eligible beneficiaries who have started the MDPP program or are 
interested in enrolling in MDPP.

I. Accounting Statement

    As required by OMB Circular A-4 (available at https://www.whitehouse.gov/wp-content/uploads/legacy_drupal_files/omb/circulars/A4/a-4.pdf), in Tables 138 through 140 (Accounting 
Statements), we have prepared an accounting statement. This estimate 
includes growth in incurred benefits from CY 2023 to CY 2024 based on 
the FY 2024 President's Budget baseline.
[GRAPHIC] [TIFF OMITTED] TR16NO23.188

[GRAPHIC] [TIFF OMITTED] TR16NO23.189

[GRAPHIC] [TIFF OMITTED] TR16NO23.190

J. Conclusion

    The analysis in the previous sections, together with the remainder 
of this preamble, provided an initial Regulatory Flexibility Analysis. 
The previous analysis, together with the preceding portion of this 
preamble, provides an RIA. In accordance with the provisions of 
Executive Order 12866, this regulation was reviewed by the Office of 
Management and Budget.
    Chiquita Brooks-LaSure, Administrator of the Centers for Medicare & 
Medicaid Services, approved this document on October 27, 2023.

List of Subjects

42 CFR Part 405

    Administrative practice and procedure, Diseases, Health facilities, 
Health professions, Medical devices, Medicare, Reporting and 
recordkeeping requirements, Rural areas, and X-rays.

42 CFR Part 410

    Diseases, Health facilities, Health professions, Laboratories, 
Medicare, Reporting and recordkeeping requirements, Rural areas, X-
rays.

42 CFR Part 411

    Diseases, Medicare, Reporting and recordkeeping requirements.

42 CFR Part 414

    Administrative practice and procedure, Biologics, Diseases, Drugs, 
Health facilities, Health professions, Medicare, Reporting and 
recordkeeping requirements.

42 CFR Part 415

    Health facilities, Health professions, Medicare, Reporting and 
recordkeeping requirements.

42 CFR Part 418

    Health facilities, Hospice care, Medicare, Reporting and 
recordkeeping requirements.

[[Page 79523]]

42 CFR 422

    Administrative practice and procedure, Health facilities, Health 
maintenance organizations (HMO), Medicare, Penalties, Privacy, 
Reporting and recordkeeping requirements.

42 CFR Part 423

    Administrative practice and procedure, Emergency medical services, 
Health facilities, Health maintenance organizations (HMO), Health 
professionals, Medicare, Penalties, Privacy, Reporting and 
recordkeeping requirements.

42 CFR Part 424

    Health facilities, Health professions, Medicare Reporting and 
recordkeeping requirements.

42 CFR Part 425

    Administrative practice and procedure, Health facilities, Health 
professions, Medicare, Reporting and recordkeeping requirements.

42 CFR Part 455

    Fraud, Grant programs--health, Health facilities, Health 
professions, Investigations,
    Medicaid, Reporting and recordkeeping requirements.

42 CFR Part 489

    Health facilities, Medicare, Reporting and recordkeeping 
requirements.

42 CFR Part 491

    Grant programs-health, Health facilities, Medicaid, Medicare, 
Reporting and recordkeeping requirements, Rural areas.

42 CFR Part 495

    Administrative practice and procedure, Health facilities, Health 
maintenance organizations (HMO), Health professions, Health records, 
Medicaid, Medicare, Penalties, Privacy, Reporting and recordkeeping 
requirements.

42 CFR Part 498

    Administrative practice and procedure, Health facilities, Health 
professions, Medicare Reporting and recordkeeping requirements.

42 CFR Part 600

    Administrative practice and procedure, Health care, Health 
insurance, Intergovernmental relations, Penalties, Reporting and 
recordkeeping requirements.

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services amends 42 CFR chapter IV as set forth below:

PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED

0
1. The authority citation for part 405 continues to read as follows:

    Authority:  42 U.S.C. 263a, 405(a), 1302, 1320b-12, 1395x, 
1395y(a), 1395ff, 1395hh, 1395kk, 1395rr, and 1395ww(k).


0
2. Section 405.400 is amended by revising the definition of 
``Practitioner'' to read as follows:


Sec.  405.400  Definitions.

* * * * *
    Practitioner means a physician assistant, nurse practitioner, 
clinical nurse specialist, certified registered nurse anesthetist, 
certified nurse midwife, clinical psychologist, clinical social worker, 
marriage and family therapist, mental health counselor, registered 
dietitian or nutrition professional, who is currently legally 
authorized to practice in that capacity by each State in which he or 
she furnishes services to patients or clients.
* * * * *

0
3. Section 405.800 is amended by adding paragraph (d) to read as 
follows:


Sec.  405.800  Appeals of CMS or a CMS contractor.

* * * * *
    (d) Scope of supplier. For purposes of this subpart, the term 
``supplier'' includes all of the following:
    (1) The individuals and entities that qualify as suppliers under 
Sec.  400.202 of this chapter.
    (2) Physical therapists in private practice.
    (3) Occupational therapists in private practice.
    (4) Speech-language pathologists.

0
4. In Sec.  405.2401amend paragraph (b) by adding the definitions of 
``Marriage and family therapist (MFT)'' and ``Mental health counselor 
(MHC)'' in alphabetical order to read as follows:


Sec.  405.2401  Scope and definitions.

* * * * *
    (b) * * *
    Marriage and family therapist (MFT) means an individual who meets 
the applicable education, training, and other requirements of Sec.  
410.53 of this chapter.
* * * * *
    Mental health counselor (MHC) means an individual who meets the 
applicable education, training, and other requirements of Sec.  410.54 
of this chapter.
* * * * *

0
5. Section 405.2411 is amended by revising paragraphs (a)(4), (a)(6), 
and (b)(2) to read as follows:


Sec.  405.2411  Scope of benefits.

    (a) * * *
    (4) Services and supplies furnished as incident to the services of 
a nurse practitioner, physician assistant, certified nurse midwife, 
clinical psychologist, clinical social worker, marriage and family 
therapist, or mental health counselor.
* * * * *
    (6) Clinical psychologist, clinical social worker, marriage and 
family therapist, and mental health counselor services as specified in 
Sec.  405.2450.
    (b) * * *
    (2) Covered when furnished during a Part A stay in a skilled 
nursing facility only when provided by a physician, nurse practitioner, 
physician assistant, certified nurse midwife, clinical psychologist, 
clinical social worker, marriage and family therapist, or mental health 
counselor employed or under contract with the RHC or FQHC at the time 
the services are furnished;
* * * * *

0
6. Section 405.2413 is amended by revising paragraph (a)(5) to read as 
follows:


Sec.  405.2413  Services and supplies incident to a physician's 
services.

    (a) * * *
    (5) Furnished under the direct supervision of a physician, except 
that services and supplies furnished incident to Transitional Care 
Management, General Care Management, the Psychiatric Collaborative Care 
Model, and behavioral health services can be furnished under general 
supervision of a physician when these services or supplies are 
furnished by auxiliary personnel, as defined in Sec.  410.26(a)(1) of 
this chapter.
* * * * *

0
7. Section 405.2415 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(3), and (a)(5) and
0
b. Adding paragraphs (b)(6) and (7).
    The revisions and additions read as follows:


Sec.  405.2415  Incident to services and direct supervision.

    (a) Services and supplies incident to the services of a nurse 
practitioner, physician assistant, certified nurse midwife, clinical 
psychologist, clinical social worker, marriage and family therapist, or 
mental health counselor are payable under this subpart if the service 
or supply is all of the following:
* * * * *
    (3) Furnished as an incidental, although integral part of 
professional services furnished by a nurse practitioner, physician 
assistant,

[[Page 79524]]

certified nurse-midwife, clinical psychologist, clinical social worker, 
marriage and family therapist, or mental health counselor.
* * * * *
    (5) Furnished under the direct supervision of a nurse practitioner, 
physician assistant, or certified nurse-midwife, except that services 
and supplies furnished incident to Transitional Care Management, 
General Care Management, the Psychiatric Collaborative Care model, and 
behavioral health services can be furnished under general supervision 
of a nurse practitioner, physician assistant, or certified nurse-
midwife, when these services or supplies are furnished by auxiliary 
personnel, as defined in Sec.  410.26(a)(1) of this chapter.
    (b) * * *
    (6) Marriage and family therapist.
    (7) Mental health counselor.
* * * * *

0
8. Section 405.2446 is amended by revising paragraphs (b)(5) and (6) to 
read as follows:


Sec.  405.2446  Scope of services.

* * * * *
    (b) * * *
    (5) Clinical psychologist, clinical social worker, marriage and 
family therapist, and mental health counselor services specified in 
Sec.  405.2450.
    (6) Services and supplies furnished as incident to the services of 
a clinical psychologist, clinical social worker, marriage and family 
therapist, or mental health counselor, as specified in Sec.  405.2452.
* * * * *

0
9. Section Sec.  405.2448 is amended by revising paragraphs (a)(2) 
introductory text and (a)(2)(i) to read as follows:


Sec.  405.2448  Preventive primary services.

    (a) * * *
    (2) Are furnished by a or under the direct supervision of a 
physician, nurse practitioner, physician assistant, certified nurse 
midwife, clinical psychologist, clinical social worker, marriage and 
family therapist, or mental health counselor employed by or under 
contract with the FQHC.
    (i) By a or under the direct supervision of a physician, nurse 
practitioner, physician assistant, certified nurse midwife, clinical 
psychologist, clinical social worker, marriage and family therapist, or 
mental health counselor; or
* * * * *

0
10. Section 405.2450 is amended by revising the section heading and 
paragraphs (a) introductory text, (a)(2), (a)(3), and (c) to read as 
follows:


Sec.  405.2450  Clinical psychologist, clinical social worker, marriage 
and family therapist, and mental health counselor services.

    (a) For clinical psychologist, clinical social worker, marriage and 
family therapist, or mental health counselor professional services to 
be payable under this subpart, the services must be--
* * * * *
    (2) Of a type that the clinical psychologist, clinical social 
worker, marriage and family therapist, or mental health counselor who 
furnishes the services is legally permitted to perform by the State in 
which the service is furnished;
    (3) Performed by a clinical social worker, clinical psychologist, 
marriage and family therapist, or mental health counselor who is 
legally authorized to perform such services under State law or the 
State regulatory mechanism provided by the law of the State in which 
such services are performed; and
* * * * *
    (c) The services of clinical psychologists, clinical social 
workers, marriage and family therapist, or mental health counselors are 
not covered if State law or regulations require that the services be 
performed under a physician's order and no such order was prepared.

0
11. Section 405.2452 is amended by revising the section heading, and 
paragraphs (a) introductory text, (a)(3), (a)(5) and (b) to read as 
follows:


Sec.  405.2452  Services and supplies incident to clinical 
psychologist, clinical social worker, marriage and family therapist, 
and mental health counselor services.

    (a) Services and supplies incident to a clinical psychologist's, 
clinical social worker's, marriage and family therapist's, and mental 
health counselor's services are reimbursable under this subpart if the 
service or supply is --
* * * * *
    (3) Furnished as an incidental, although integral part of 
professional services furnished by a clinical psychologist, clinical 
social worker, marriage and family therapist, or mental health 
counselor;
* * * * *
    (5) Furnished under the direct supervision of a clinical 
psychologist, clinical social worker, marriage and family therapist, or 
mental health counselor.
    (b) The direct supervision requirement in paragraph (a)(5) of this 
section is met only if the clinical psychologist, clinical social 
worker, marriage and family therapist, or mental health counselor is 
permitted to supervise such services under the written policies 
governing the FQHC.

0
12. Section 405.2463 is amended by--
0
a. Adding paragraphs (a)(1)(i)(I) and (a)(1)(i)(J);
0
b. Revising paragraph (b)(3) introductory text;
0
c. Redesignating paragraph (b)(3)(iii) as paragraph (b)(3)(v); and
0
d. Adding paragraphs (b)(3)(iii) and (b)(3)(iv).


Sec.  405.2463  What constitutes a visit.

    (a) * * *
    (1) * * *
    (i) * * *
    (I) Marriage and family therapist.
    (J) Mental health counselor.
* * * * *
    (b) * * *
    (3) Visit-Mental health. A mental health visit is a face-to-face 
encounter or an encounter furnished using interactive, real-time, audio 
and video telecommunications technology or audio-only interactions in 
cases where the patient is not capable of, or does not consent to, the 
use of video technology for the purposes of diagnosis, evaluation or 
treatment of a mental health disorder, including an in-person mental 
health service, beginning January 1, 2025, furnished within 6 months 
prior to the furnishing of the telecommunications service and that an 
in-person mental health service (without the use of telecommunications 
technology) must be provided at least every 12 months while the 
beneficiary is receiving services furnished via telecommunications 
technology for diagnosis, evaluation, or treatment of mental health 
disorders, unless, for a particular 12-month period, the physician or 
practitioner and patient agree that the risks and burdens outweigh the 
benefits associated with furnishing the in-person item or service, and 
the practitioner documents the reasons for this decision in the 
patient's medical record, between an RHC or FQHC patient and one of the 
following:
* * * * *
    (iii) Marriage and family therapist.
    (iv) Mental health counselor.
* * * * *

0
13. Section 405.2464 is amended by revising paragraph (c) to read as 
follows:


Sec.  405.2464  Payment rate.

* * * * *
    (c) Payment for care management services. For chronic care 
management services furnished between January 1, 2016 and December 31, 
2017, payment to RHCs and FQHCs is at the physician

[[Page 79525]]

fee schedule national non-facility payment rate. For care management 
services furnished between January 1, 2018 and December 31, 2023, 
payment to RHCs and FQHCs is at the rate set for each of the RHC and 
FQHC payment codes for care management services. For general care 
management services furnished on or after January 1, 2024, the payment 
amount is based on a weighted average of the services that comprise 
HCPCS code G0511 using the most recently available PFS utilization 
data.
* * * * *

0
14. Section 405.2468 is amended by revising paragraphs (b)(1), (b)(3), 
and (d)(2)(ii) to read as follows:


Sec.  405.2468  Allowable costs.

* * * * *
    (b) * * *
    (1) Compensation for the services of a physician, physician 
assistant, nurse practitioner, certified nurse-midwife, visiting 
registered professional or licensed practical nurse, clinical 
psychologist, clinical social worker, marriage and family therapist, 
and mental health counselor who owns, is employed by, or furnishes 
services under contract to a FQHC or RHC.
* * * * *
    (3) Costs of services and supplies incident to the services of a 
physician, physician assistant, nurse practitioner, nurse-midwife, 
qualified clinical psychologist, clinical social worker, marriage and 
family therapist, or mental health counselor.
* * * * *
    (d) * * *
    (2) * * *
    (ii) Services of physicians, physician assistants, nurse 
practitioners, nurse-midwives, visiting nurses, qualified clinical 
psychologists, clinical social workers, marriage and family therapists, 
and mental health counselors.
* * * * *

0
15. Section 405.2469 is amended by revising paragraph (d) to read as 
follows:


Sec.  405.2469  FQHC supplemental payments.

* * * * *
    (d) Per visit supplemental payment. A supplemental payment required 
under this section is made to the FQHC when a covered face-to-face 
encounter or an encounter furnished using interactive, real-time, audio 
and video telecommunications technology or audio-only interactions in 
cases where beneficiaries do not wish to use or do not have access to 
devices that permit a two-way, audio/video interaction for the purposes 
of diagnosis, evaluation or treatment of a mental health disorder 
occurs between a MA enrollee and a practitioner as set forth in Sec.  
405.2463. Additionally, beginning January 1, 2025, there must be an in-
person mental health service furnished within 6 months prior to the 
furnishing of the telecommunications service and that an in-person 
mental health service (without the use of telecommunications 
technology) must be provided at least every 12 months while the 
beneficiary is receiving services furnished via telecommunications 
technology for diagnosis, evaluation, or treatment of mental health 
disorders, unless, for a particular 12-month period, the physician or 
practitioner and patient agree that the risks and burdens outweigh the 
benefits associated with furnishing the in-person item or service, and 
the practitioner documents the reasons for this decision in the 
patient's medical record.

PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS

0
16. The authority citation for part 410 continues to read as follows:

    Authority:  42 U.S.C. 1302, 1395m, 1395hh, 1395rr, and 1395ddd.


0
17. Section 410.10 is amended by revising paragraph (l) and adding 
paragraphs (z) and (aa) to read as follows:


Sec.  410.10  Medical and other health services: Included services.

* * * * *
    (l) Pneumococcal, influenza, and COVID-19 vaccines (or monoclonal 
antibodies used for preexposure prophylaxis of COVID-19) and their 
administration.
* * * * *
    (z) Marriage and Family Therapist services, as provided in Sec.  
410.53.
    (aa) Mental Health Counselor services, as provided in Sec.  410.54.

0
18. In Sec.  410.15 amend paragraph (a) by:
0
a. In the definition of ``First annual wellness visit providing 
personalized prevention plan services'':
0
i. Redesignating paragraph (xiii) as paragraph (xiv); and
0
ii. Adding a new paragraph (xiii).
0
b. In the definition of ``Subsequent annual wellness visit providing 
personalized prevention plan services'':
0
i. Redesignating paragraph (xi) as paragraph (xii); and
0
ii. Adding a new paragraph (xi).
    The additions read as follows:


Sec.  410.15  Annual wellness visits providing Personalized Prevention 
Plan Services: Conditions for and limitations on coverage.

    (a) * * *
    First annual wellness visit providing personalized prevention plan 
services * * *
    (xiii) At the discretion of the health professional and 
beneficiary, furnish a Social Determinants of Health Risk Assessment 
that is standardized, evidence-based, and furnished in a manner that 
all communication with the patient is appropriate for the beneficiary's 
educational, developmental, and health literacy level, and is 
culturally and linguistically appropriate.
* * * * *
    Subsequent annual wellness visit providing personalized prevention 
plan services * * *
    (xi) At the discretion of the health professional and beneficiary, 
furnish a Social Determinants of Health Risk Assessment that is 
standardized, evidence-based, and furnished in a manner that all 
communication with the patient is appropriate for the beneficiary's 
educational, developmental, and health literacy level, and is 
culturally and linguistically appropriate.
* * * * *

0
19. Amend Sec.  Sec.  410.18 by:
0
a. In paragraph (a):
0
(i) Revising the definition of ``Diabetes''; and
0
(ii) Removing the definition of ``Pre-diabetes''.
0
b. Redesignating paragraph (c)(3) as paragraph (c)(4) and adding a new 
paragraph (c)(3); and
0
c. Revising paragraph (d).
    The revisions and addition read as follows:


Sec.  410.18  Diabetes screening tests.

    (a) * * *
    Diabetes means diabetes mellitus, a condition of abnormal glucose 
metabolism.
* * * * *
    (c) * * *
    (3) Hemoglobin A1C test.
* * * * *
    (d) Amount of testing covered. Medicare covers two tests within the 
12-month period following the date of the most recent diabetes 
screening test of that individual.
* * * * *

0
20. Section 410.32 is amended by revising paragraphs (a)(2) and 
(b)(3)(ii) to read as follow:

[[Page 79526]]

Sec.  410.32  Diagnostic x-ray tests, diagnostic laboratory tests, and 
other diagnostic tests: Conditions.

    (a) * * *
    (2) Application to nonphysician practitioners. Nonphysician 
practitioners (that is, clinical nurse specialists, clinical 
psychologists, clinical social workers, marriage and family therapists, 
mental health counselors, nurse-midwives, nurse practitioners, and 
physician assistants) who furnish services that would be physician 
services if furnished by a physician, and who are operating within the 
scope of their authority under State law and within the scope of their 
Medicare statutory benefit, may be treated the same as physicians 
treating beneficiaries for the purpose of this paragraph.
* * * * *
    (b) * * *
    (3) * * *
    (ii) Direct supervision in the office setting means the physician 
(or other supervising practitioner) must be present in the office suite 
and immediately available to furnish assistance and direction 
throughout the performance of the procedure. It does not mean that the 
physician (or other supervising practitioner) must be present in the 
room when the procedure is performed. Through December 31, 2024, the 
presence of the physician (or other practitioner) includes virtual 
presence through audio/video real-time communications technology 
(excluding audio-only).
* * * * *

0
21. Section Sec.  410.33 is amended by revising paragraph (g)(2) to 
read as follows:


Sec.  410.33  Independent diagnostic testing facility.

* * * * *
    (g) * * *
    (2) Provides complete and accurate information on its enrollment 
application. Changes in ownership, changes of location (including 
additions and deletions of locations), changes in general supervision, 
and adverse legal actions must be reported to the Medicare fee-for-
service contractor on the Medicare enrollment application within 30 
calendar days of the change. All other changes to the enrollment 
application must be reported within 90 days.
* * * * *

0
22. Amend Sec.  410.47 by:
0
a. In paragraph (a):
0
i. Adding the definition of ``Nonphysician practitioner'' in 
alphabetical order;
0
ii. Revising the definitions of ``Pulmonary rehabilitation''
0
iii. Removing the definition of ``Supervising physician'' and adding, 
in alphabetical order, a definition for ``Supervising practitioner'';
0
b. Revising paragraphs (b)(3)(ii)(A) and (d) introductory text; and
0
c. Removing paragraph (d)(3).
    The addition and revisions read as follows:


Sec.  410.47  Pulmonary rehabilitation program: Conditions of coverage.

    (a) * * *
    Nonphysician practitioner means a physician assistant, nurse 
practitioner, or clinical nurse specialist as those terms are defined 
in section 1861(aa)(5)(A) of the Act.
* * * * *
    Pulmonary rehabilitation means a physician or nonphysician 
practitioner supervised program for COPD and certain other chronic 
respiratory diseases designed to optimize physical and social 
performance and autonomy.
    Supervising practitioner means a physician or nonphysician 
practitioner that is immediately available and accessible for medical 
consultations and medical emergencies at all times items and services 
are being furnished to individuals under pulmonary rehabilitation 
programs.
    (b) * * *
    (3) * * *
    (ii) * * *
    (A) A physician or nonphysician practitioner immediately available 
and accessible for medical consultations and emergencies at all times 
when items and services are being furnished under the program. This 
provision is satisfied if the physician or nonphysician practitioner 
meets the requirements for direct supervision for physician office 
services, at Sec.  410.26 of this subpart; and for hospital outpatient 
services at Sec.  410.27 of this subpart.
* * * * *
    (d) Supervising practitioner standards. Physicians or nonphysician 
practitioners acting as the supervising practitioner must possess all 
of the following:
* * * * *

0
23. Amend Sec.  410.49 by:
0
a. In paragraph (a):
0
i. Revising the definitions of ``Cardiac rehabilitation'' and 
``Intensive cardiac rehabilitation (ICR) program'';
0
ii. Adding the definition of ``Nonphysician practitioner'' in 
alphabetical order; and
0
iii. Removing the definition of ``Supervising physician'' and adding, 
in alphabetical order, the definition of ``Supervising practitioner'';
0
b. Revising paragraphs (b)(3)(ii) and (e) introductory text; and
0
c. Removing paragraph (e)(3).
    The revisions and addition read as follows:


Sec.  410.49  Cardiac rehabilitation program and intensive cardiac 
rehabilitation program: Conditions of coverage.

    (a) * * *
    Cardiac rehabilitation (CR) means a physician or nonphysician 
practitioner supervised program that furnishes physician prescribed 
exercise, cardiac risk factor modification, psychosocial assessment, 
and outcomes assessment.
* * * * *
    Intensive cardiac rehabilitation (ICR) program means a physician or 
nonphysician practitioner supervised program that furnishes cardiac 
rehabilitation and has shown, in peer-reviewed published research, that 
it improves patients' cardiovascular disease through specific outcome 
measurements described in paragraph (c) of this section.
* * * * *
    Nonphysician practitioner means a physician assistant, nurse 
practitioner, or clinical nurse specialist as those terms are defined 
in section 1861(aa)(5)(A) of the Act.
* * * * *
    Supervising practitioner means a physician or nonphysician 
practitioner that is immediately available and accessible for medical 
consultations and medical emergencies at all times items and services 
are being furnished to individuals under cardiac rehabilitation and 
intensive cardiac rehabilitation programs.
    (b) * * *
    (3) * * *
    (ii) All settings must have a physician or nonphysician 
practitioner immediately available and accessible for medical 
consultations and emergencies at all times when items and services are 
being furnished under the program. This provision is satisfied if the 
physician or nonphysician practitioner meets the requirements for 
direct supervision for physician office services, at Sec.  410.26 of 
this subpart; and for hospital outpatient services at Sec.  410.27 of 
this subpart.
* * * * *
    (e) Supervising practitioner standards. Physicians or nonphysician 
practitioners acting as the supervising practitioner must possess all 
of the following:
* * * * *

0
24. Add Sec.  410.53 to subpart B to read as follows:

[[Page 79527]]

Sec.  410.53  Marriage and family therapist services.

    (a) Definition: marriage and family therapist. For purposes of this 
part, a marriage and family therapist is defined as an individual who -
    (1) Possesses a master's or doctor's degree which qualifies for 
licensure or certification as a marriage and family therapist pursuant 
to State law of the State in which such individual furnishes the 
services defined as marriage and family therapist services;
    (2) After obtaining such degree, has performed at least 2 years or 
3,000 hours of post master's degree clinical supervised experience in 
marriage and family therapy in an appropriate setting such as a 
hospital, SNF, private practice, or clinic; and
    (3) Is licensed or certified as a marriage and family therapist by 
the State in which the services are performed.
    (b) Covered marriage and family therapist services. Medicare Part B 
covers marriage and family therapist services.
    (1) Definition: marriage and family therapist services means 
services furnished by a marriage and family therapist (as defined in 
paragraph (a) of this section) for the diagnosis and treatment of 
mental illnesses (other than services furnished to an inpatient of a 
hospital), which the marriage and family therapist is legally 
authorized to perform under State law (or the State regulatory 
mechanism provided by State law) of the State in which such services 
are furnished. The services must be of a type that would be covered if 
they were furnished by a physician or as an incident to a physician's 
professional service and must meet the requirements of this section.
    (2) Exception. The following services are not marriage and family 
therapist services for purposes of billing Medicare Part B under the 
MFT and MHC statutory benefit category:
    (i) Services furnished by a marriage and family therapist to an 
inpatient of a Medicare-participating hospital.
    (ii) [Reserved]
    (c) Prohibited billing. (1) A marriage and family therapist may not 
bill Medicare for the services specified in paragraph (b)(2) of this 
section.
    (2) A marriage and family therapist or an attending or primary care 
physician may not bill Medicare or the beneficiary for the consultation 
that is required under paragraph(b)(2) of this section.

0
25. Add Sec.  410.54 to subpart B to read as follows:


Sec.  410.54  Mental health counselor services.

    (a) Definition: mental health counselor. For purposes of this part, 
a mental health counselor is defined as an individual who--
    (1) Possesses a master's or doctor's degree which qualifies for 
licensure or certification as a mental health counselor, clinical 
professional counselor, professional counselor under the State law of 
the State in which such individual furnishes the services defined as 
mental health counselor services;
    (2) After obtaining such a degree, has performed at least 2 years 
or 3,000 hours of post master's degree clinical supervised experience 
in mental health counseling in an appropriate setting such as a 
hospital, SNF, private practice, or clinic; and
    (3) Is licensed or certified as a mental health counselor, clinical 
professional counselor, professional counselor by the State in which 
the services are performed.
    (b) Covered mental health counselor services. Medicare Part B 
covers mental health counselor services.
    (1) Definition: Mental health counselor services means services 
furnished by a mental health counselor (as defined in paragraph (a) of 
this section) for the diagnosis and treatment of mental illnesses 
(other than services furnished to an inpatient of a hospital), which 
the mental health counselor is legally authorized to perform under 
State law (or the State regulatory mechanism provided by State law) of 
the State in which such services are furnished. The services must be of 
a type that would be covered if they were furnished by a physician or 
as an incident to a physician's professional service and must meet the 
requirements of this section.
    (2) Exception. The following services are not mental health 
counselor services for purposes of billing Medicare Part B:
    (i) Services furnished by a mental health counselor to an inpatient 
of a Medicare-participating hospital.
    (ii) [Reserved]
    (c) Prohibited billing. (1) A mental health counselor may not bill 
Medicare for the services specified in paragraph (b)(2) of this 
section.
    (2) A mental health counselor or an attending or primary care 
physician may not bill Medicare or the beneficiary for the consultation 
that is required under paragraph(b)(2) of this section.

0
26. Section 410.57 is amended by revising paragraph (c) to read as 
follows:


Sec.  410.57  Preventive vaccines.

* * * * *
    (c) Medicare Part B pays for the COVID-19 vaccine (or monoclonal 
antibodies used for pre-exposure prophylaxis of COVID-19) and its 
administration.
* * * * *

0
27. Section 410.59 is amended by revising paragraphs (a)(3)(ii) and 
(c)(2) to read as follows:


Sec.  410.59  Outpatient occupational therapy services: Conditions.

* * * * *
    (a) * * *
    (3) * * *
    (ii) By, or under the direct supervision (or as specified 
otherwise) of, an occupational therapist in private practice as 
described in paragraph (c) of this section; or
* * * * *
    (c) * * *
    (2) Supervision of occupational therapy services. Except as 
otherwise provided in this paragraph, occupational therapy services are 
performed by, or under the direct supervision of, an occupational 
therapist in private practice. All services not performed personally by 
the therapist must be performed by employees of the practice, directly 
supervised by the therapist, and included in the fee for the 
therapist's services. Remote therapeutic monitoring services may be 
performed by an occupational therapy assistant under the general 
supervision of the occupational therapist in private practice; services 
performed by an unenrolled occupational therapist must be under the 
direct supervision of the occupational therapist.
* * * * *

0
28. Section 410.60 is amended by revising paragraphs (a)(3)(ii) and 
(c)(2) to read as follows:


Sec.  410.60  Outpatient physical therapy services: Conditions.

* * * * *
    (a) * * *
    (3) * * *
    (ii) By, or under the direct supervision (or as specified 
otherwise) of, a physical therapist in private practice as described in 
paragraph (c) of this section; or
* * * * *
    (c) * * *
    (2) Supervision of physical therapy services. Except as otherwise 
provided in this paragraph, physical therapy services are performed by, 
or under the direct supervision of, a physical therapist in private 
practice. All services not performed personally by the therapist must 
be performed by employees of the practice, directly

[[Page 79528]]

supervised by the therapist, and included in the fee for the 
therapist's services. Remote therapeutic monitoring services may be 
performed by a physical therapist assistant under the general 
supervision of the physical therapist in private practice; services 
performed by an unenrolled physical therapist must be under the direct 
supervision of the physical therapist.
* * * * *


Sec.  410.67  [Amended]

0
29. In Sec.  410.67 in paragraph (b) amend paragraph (vii) in the 
definition of ``Opioid use disorder treatment service'' by removing the 
reference ``through the end of CY 2023'' and adding in its place the 
reference ``through the end of CY 2024''.

0
30. Section 410.72 is amended by revising paragraph (d) to read as 
follows:


Sec.  410.72  Registered dietitians' and nutrition professionals' 
services.

* * * * *
    (d) Professional services. Except for DSMT services furnished as, 
or on behalf of, an accredited DSMT entity, registered dietitians and 
nutrition professionals can be paid for their professional MNT services 
only when the services have been directly performed by them.
* * * * *

0
31. Section 410.78 is amended by--
0
a. Adding paragraphs (b)(2)(x) through (xii);
0
b. Revising paragraphs (b)(3)(xiv) introductory text, (b)(4)(iv)(D), 
and (e)(1); and
0
c. Adding paragraph (e)(3).
    The additions and revisions read as follows:


Sec.  410.78  Telehealth services.

* * * * *
    (b) * * *
    (2) * * *
    (x) Any distant site practitioner who can appropriately bill for 
diabetes self-management training services may do so on behalf of 
others who personally furnish the services as part of the DSMT entity.
    (xi) A marriage and family therapist as described in 410.53.
    (xii) A mental health counselor as described in 410.54.
    (3) * * *
    (xiv) The home of a beneficiary for the purposes of diagnosis, 
evaluation, and/or treatment of a mental health disorder for services 
that are furnished during the period beginning on the first day after 
the end of the emergency period as defined in our regulation at Sec.  
400.200 and ending on December 31, 2024 except as otherwise provided in 
this paragraph. Payment will not be made for a telehealth service 
furnished under this paragraph unless the following conditions are met:
    (4) * * *
    (iv) * * *
    (D) Services furnished on or after January 1, 2025 for the purposes 
of diagnosis, evaluation, and/or treatment of a mental health disorder. 
Payment will not be made for a telehealth service furnished under this 
paragraph unless the physician or practitioner has furnished an item or 
service in person, without the use of telehealth, for which Medicare 
payment was made (or would have been made if the patient were entitled 
to, or enrolled for, Medicare benefits at the time the item or service 
is furnished) within 6 months prior to the initial telehealth service 
and within 6 months of any subsequent telehealth service.
* * * * *
    (e) * * *
    (1) A clinical psychologist and a clinical social worker, a 
marriage and family therapist (MFT), and a mental health counselor 
(MHC) may bill and receive payment for individual psychotherapy via a 
telecommunications system, but may not seek payment for medical 
evaluation and management services.
* * * * *
    (3) The distant site practitioner who reports the DSMT services may 
bill and receive payment when a professional furnishes injection 
training for an insulin-dependent patient using interactive 
telecommunications technology when such training is included as part of 
the DSMT plan of care referenced at Sec.  410.141(b)(2).
* * * * *

0
32. Amend Sec.  410.79 by:
0
a. In paragraph (b):
0
i. Adding the definition of ``Combination delivery'' in alphabetical 
order;
0
ii. Removing the definition of ``Core maintenance session interval'';
0
iii. Adding the definitions of ``Distance learning'', ``Extended 
flexibilities'', ``Extended flexibilities period'', and ``Full-Plus CDC 
DPRP recognition'' in alphabetical order;
0
iv. Revising the definitions of ``Make-up session'', ``MDPP services 
period'', and ``MDPP session''
0
v. Adding the definition ``Online delivery'' in alphabetical order;
0
vi. Removing the definition of ``Ongoing maintenance sessions'';
0
vii. Adding the definition of ``Virtual session'' in alphabetical 
order.
0
b. Removing paragraphs (c)(1)(ii) and (iii);
0
c. Redesignating paragraph (c)(1)(iv) as paragraph (c)(1)(ii);
0
d. Revising paragraphs (c)(2)(i)(A) and (B);
0
e. Removing and reserving paragraph (c)(2)(ii);
0
f. Revising paragraph (c)(3)(i);
0
g. Removing and reserving paragraph (c)(3)(ii); removing paragraph 
(c)(3)(iii), removing and reserving paragraphs (d)(2)(iii)(B) and 
(d)(3)(ii);
0
h. Revising paragraphs (e)(3)(iv) introductory text, (e)(3)(iv)(D), 
(e)(3)(iv)(F)(1) and (2).
    The additions and revisions read as follows:


Sec.  410.79  Medicare Diabetes Prevention Program expanded model: 
Conditions of coverage.

* * * * *
    (b) * * *
    Combination delivery. MDPP sessions that are delivered by trained 
Coaches and are furnished in a manner consistent with the DPRP 
Standards for distance learning and in-person sessions for each 
individual participant.
* * * * *
    Distance learning refers to an MDPP session that is delivered by 
trained Coaches via remote classroom and is furnished in a manner 
consistent with the DPRP Standards for distance learning sessions. The 
Coach provides live (synchronous) delivery of session content in one 
location and participants call-in or video-conference from another 
location.
    Extended flexibilities refer to the flexibilities as described in 
paragraphs (e)(3)(iii) and (iv) of this section.
    Extended flexibilities period refers to the 4-year period (January 
1, 2024 to December 31, 2027) for the Extended flexibilities to apply.
* * * * *
    Full-Plus CDC DPRP recognition refers to organizations that have 
met the Full CDC DPRP recognition, and at the time full recognition is 
achieved, has met the following retention criterion: Eligible 
participants in the evaluation cohort must have been retained at the 
following percentages: A minimum of 50 percent at the beginning of the 
fourth month since the cohorts held their first sessions; A minimum of 
40 percent at the beginning of the seventh month since the cohorts held 
their first sessions; and A minimum of 30 percent at the beginning of 
the tenth month since the cohorts held their first sessions.
* * * * *
    Make-up session means a core session or a core maintenance session 
furnished

[[Page 79529]]

to an MDPP beneficiary when the MDPP beneficiary misses a regularly 
scheduled core session or core maintenance session.
    MDPP services period means the time period, beginning on the date 
an MDPP beneficiary attends his or her first core session, over which 
the Set of MDPP services is furnished to the MDPP beneficiary, to 
include the core services period described in paragraph (c)(2)(i) and, 
subject to paragraph (c)(3) of this section.
    MDPP session means a core session or a core maintenance session.
* * * * *
    Online delivery refers to an MDPP session that is delivered online 
for all participants and is furnished in a manner consistent with the 
DPRP Standards for online sessions. The program is experienced through 
the internet via phone, tablet, laptop, in an asynchronous classroom 
where participants are experiencing the content on their own time 
without a live Coach teaching the content. However, live Coach 
interaction should be provided to each participant no less than once 
per week during the first 6 months and once per month during the second 
6 months. Emails and text messages can count toward the requirement for 
live coach interaction as long as there is bi-directional communication 
between coach and participant.
* * * * *
    Virtual session refers to an MDPP session that is not furnished in 
person and that is furnished in a manner consistent with the DPRP 
standards for distance learning sessions.
    (c) * * *
    (2) * * *
    (i) * * *
    (A) Up to 16 core sessions offered at least 1 week apart during 
months 1 through 6 of the MDPP services period; and
    (B) Up to 6 core maintenance sessions offered at least 1 month 
apart during months 7 through 12 of the MDPP services period
    (ii) [Reserved]
    (3) * * *
    (i) The MDPP services period ends upon completion of the core 
services period described in paragraph (c)(2)(i) of this section.
* * * * *
    (e) * * *
    (3) * * *
    (iv) The virtual session limits described in paragraphs (d)(2) and 
(d)(3)(i) and (ii) of this section do not apply, and MDPP suppliers may 
provide all MDPP sessions virtually, through distance learning or a 
combination of in-person or distance learning, during the PHE as 
defined in Sec.  400.200 of this chapter or applicable 1135 waiver 
event. If the beneficiary began the MDPP services period virtually, or 
changed from in-person to virtual services during the Extended 
flexibilities period, a PHE as defined in Sec.  400.200 of this chapter 
or applicable 1135 waiver event, he/she may continue to receive the Set 
of MDPP services virtually even after the PHE or 1135 waiver event has 
concluded, until the end of the beneficiary's MDPP services period, so 
long as the provision of virtual services complies with all of the 
following requirements:
* * * * *
    (D) Virtual sessions are furnished in a manner consistent with the 
DPRP standards for distance learning sessions.
* * * * *
    (F) * * *
    (1) Up to 16 virtual sessions offered weekly during the core 
session period, months 1 through 6 of the MDPP services period;
    (2) Up to 6 virtual sessions offered monthly during the core 
maintenance session interval periods, months 7 through 12 of the MDPP 
services period.
* * * * *


Sec.  410.130  [Amended]

0
33. Amend Sec.  410.130 in the definition of ``Diabetes'' by removing 
the text ``diagnosed using the following criteria: A fasting blood 
sugar greater than or equal to 126 mg/dL on two different occasions; a 
2 hour post-glucose challenge greater than or equal to 200 mg/dL on 2 
different occasions; or a random glucose test over 200 mg/dL for a 
person with symptoms of uncontrolled diabetes''.


Sec.  410.140  [Amended]

0
34. Amend Sec.  410.140 in the definition of ``Diabetes'' by removing 
the text ``diagnosed using the following criteria: A fasting blood 
sugar greater than or equal to 126 mg/dL on two different occasions; a 
2-hour post-glucose challenge greater than or equal to 200 mg/dL on 2 
different occasions; or a random glucose test over 200 mg/dL for a 
person with symptoms of uncontrolled diabetes''.

0
35. Amend Sec.  410.150 by adding paragraphs (b)(21) and (22) to read 
follows:


Sec.  410.150  To whom payment is made.

* * * * *
    (b) * * *
    (21) To a marriage and family therapist on the individual's behalf 
for marriage and family therapist services.
    (22) To a mental health counselor on the individual's behalf for 
mental health counseling services.

0
36. Section 410.152 is amended by:
0
a. Revising paragraphs (b) introductory text, (h)(2) and (h)(3), (h)(4) 
introductory text, (h)(5); and
0
b. Adding paragraphs (m) and (n).
    The revisions and additions read as follows:


Sec.  410.152  Amounts of payment.

* * * * *
    (b) Basic rules for payment. Except as specified in paragraphs (c) 
through (h) and (m) and (n) of this section, Medicare Part B pays the 
following amounts:
* * * * *
    (h) * * *
    (2) For the administration of a COVID-19 vaccine:
    (i) Effective January 1, 2022, for administration of a COVID-19 
vaccine, $40 per dose.
    (ii) For services furnished on or after January 1 of the year 
following the year in which the Secretary ends the March 27, 2020 
Emergency Use Authorization declaration for drugs and biologicals 
(issued at 85 FR 18250) pursuant to section 564 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bbb-3), for administration of a 
COVID-19 vaccine, an amount equal to the amount that would be paid for 
the administration of a preventive vaccine described in paragraph 
(h)(1) of this section.
    (3) Subject to conditions specified in this paragraph, in addition 
to the payment described in paragraph (h)(1) or (2) of this section, an 
additional payment for preventive vaccine administration in the 
patient's home:
    (i) Effective January 1, 2022 for administration of a COVID-19 
vaccine in the home, an additional payment of $35.50.
    (ii) Effective January 1, 2024, for the administration of one or 
more of the preventive vaccines described in paragraphs (h)(1) and (2) 
of this section in the home, a payment equal to that of the payment in 
paragraph (h)(3)(i) of this section.
    (iii) An additional payment for preventive vaccine administration 
in the home can be made if:
    (A) The patient has difficulty leaving the home, or faces barriers 
to getting a vaccine in settings other than their home.
    (B) The sole purpose of the visit is to administer one or more 
preventive vaccines.

[[Page 79530]]

    (C) The home is not an institution that meets the requirements of 
sections 1861(e)(1), 1819(a)(1), or 1919(a)(1) of the Act, or 
Sec. Sec.  409.42(a) of this subchapter.
    (4) The payment amount for the administration of a preventive 
vaccine described in paragraphs (h)(1) and (2) of this section, and the 
additional payment for the administration of a preventive vaccine in 
the home as described in paragraph (h)(3) of this section, is adjusted 
to reflect geographic cost variations:
* * * * *
    (5) For services furnished on or after January 1, 2023, the payment 
amount for administration of a preventive vaccine described in 
paragraphs (h)(1) and (2) of this section, and the additional payment 
for the administration of a preventive vaccine in the home as described 
in paragraph (h)(3) of this section, is updated annually using the 
percentage change in the Medicare Economic Index (MEI), as described in 
section 1842(i)(3) of the Act and Sec.  405.504(d) of this subchapter.
* * * * *
    (m) Amount of payment: Rebatable drugs. In the case of a rebatable 
drug (as defined in section 1847A(i)(2)(A) of the Act), including a 
selected drug (as defined in section 1192(c) of the Act), furnished by 
providers on or after April 1, 2023, in a calendar quarter during which 
the payment amount for such drug as specified in section 
1847A(i)(3)(A)(ii)(I)(aa) or (bb), as applicable, exceeds the 
inflation-adjusted amount (as defined in section 1847A(i)(3)(C) of the 
Act) for such drug, Medicare Part B pays, subject to the deductible, 
the difference between the allowed payment amount determined under 
section 1847A of the Act and 20 percent of the inflation-adjusted 
amount, which is applied as a percent to the payment amount for such 
calendar quarter.
    (n) Amount of payment: Insulin furnished through an item of durable 
medical equipment. For insulin furnished on or after July 1, 2023 
through an item of durable medical equipment (as defined in Sec.  
414.202), Medicare Part B pays the difference between the applicable 
payment amount for such insulin and the coinsurance amount, with the 
coinsurance amount not to exceed $35 for a month's supply.

PART 411--EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE 
PAYMENT

0
37. The authority citation for part 411 continues to read as follows:

    Authority:  42 U.S.C. 1302, 1395w-101 through 1395w-152, 1395hh, 
and 1395nn.


0
38. Section 411.15 is amended by:
0
a. Revising paragraph (i)(3)(i)(A); and
0
b. Adding paragraph (i)(3)(i)(E).
    The revision and addition read as follows:


Sec.  411.15  Particular services excluded from coverage.

* * * * *
    (i) * * *
    (3) * * *
    (i) * * *
    (A) Dental or oral examination performed as part of a comprehensive 
workup prior to, and medically necessary diagnostic and treatment 
services to eliminate an oral or dental infection prior to, or 
contemporaneously with, the following Medicare-covered services: organ 
transplant, hematopoietic stem cell transplant, bone marrow transplant, 
cardiac valve replacement, valvuloplasty procedures, chemotherapy when 
used in the treatment of cancer, chimeric antigen receptor (CAR) T-cell 
therapy when used in the treatment of cancer, and administration of 
high-dose bone-modifying agents (antiresorptive therapy) when used in 
the treatment of cancer.
* * * * *
    (E) Dental or oral examination performed as part of a comprehensive 
workup prior to, medically necessary diagnostic and treatment services 
to eliminate an oral or dental infection prior to or contemporaneously 
with, and medically necessary diagnostic and treatment services to 
address dental or oral complications after, treatment of head and neck 
cancer using radiation, chemotherapy, surgery, or any combination of 
these.
* * * * *

PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES

0
39. The authority citation for part 414 continues to read as follows:

    Authority:  42 U.S.C. 1302, 1395hh, and 1395rr(b)(l).


0
40. Section 414.53 is added to read as follows:


Sec.  414.53  Fee schedule for clinical social worker, marriage and 
family therapist, and mental health counselor services.

    The fee schedule for clinical social worker, marriage and family 
therapist, and mental health counselor services is set at 75 percent of 
the amount determined for clinical psychologist services under the 
physician fee schedule.

0
41. Amend Sec.  414.84 by:
0
a. In paragraph (a):
0
i. Adding the definition of ``Attendance payment'' in alphabetical 
order;
0
ii. Revising the definition of ``Performance goal'';
0
b. Revising paragraph (b) introductory text;
0
c. Removing paragraphs (b)(1) through (5);
0
d. Redesignating paragraphs (b)(6) and (7) as paragraphs (b)(1) and 
(2), respectively;
0
e. Revising newly redesignated paragraphs (b)(1) paragraph heading and 
(b)(1)(i);
0
f. Adding paragraph (b)(1)(iii);
0
g. Revising newly redesignated paragraphs (b)(2) paragraph heading and 
(b)(2)(i);
0
h. Redesignating paragraphs (c) and (d) as paragraphs (d) and (e), 
respectively;
0
i. Adding new paragraph (c); and
0
j. Revising newly redesignated paragraphs (d)(1) and (e).
    The additions and revisions read as follows:


Sec.  414.84  Payment for MDPP Services.

    (a) * * *
    Attendance payment means a payment that is made to an MDPP supplier 
for furnishing services to an MDPP beneficiary when the MDPP 
beneficiary attends an MDPP core or core maintenance session. CMS will 
allow up to 22 sessions (alone or in combination with other codes, not 
to exceed 22 sessions in a 12- month timeframe).
* * * * *
    Performance goal means a weight loss goal that an MDPP beneficiary 
must achieve during the MDPP services period for an MDPP supplier to be 
paid a performance payment.
* * * * *
    (b) Performance payment. CMS makes one or more types of performance 
payments to an MDPP supplier as specified in this paragraph (b). Each 
type of performance payment is made only if the beneficiary achieves 
the applicable performance goal. Certain performance goals are allowed 
only once per MDPP beneficiary and include the performance goals in 
paragraphs (b)(1)(i) and (b)(2)(i) of this section. A performance 
payment is made only on an assignment-related basis in accordance with 
Sec.  424.55 of this chapter, and MDPP suppliers must accept the 
Medicare allowed charge as payment in full and may not bill or collect 
from the beneficiary any amount. CMS will make a performance payment

[[Page 79531]]

only to an MDPP supplier that complies with all applicable enrollment 
and program requirements and only for MDPP services that are furnished 
by an eligible coach, on or after his or her coach eligibility start 
date and, if applicable, before his or her coach eligibility end date. 
As a condition of payment, the MDPP supplier must report the NPI of the 
coach who furnished the session on the claim for the MDPP session. The 
two types of performance payments are as follows:
    (1) Performance Goal 1: Achieves the required minimum 5-percent 
weight loss. * * *
    (i) For a core session or core maintenance session, as applicable, 
furnished January 1, 2024 through December 31, 2024 the amount is $145.
* * * * *
    (iii) If the beneficiary maintains the required minimum weight loss 
during a core maintenance session, as measured in-person or described 
in Sec.  410.79(e)(3)(iii) the amount is $8.
    (2) Performance Goal 2: Achieves 9-percent weight loss. * * *
    (i) For a core session or core maintenance session, as applicable, 
furnished January 1, 2024 through December 31, 2024. $25.
* * * * *
    (c) Attendance payment: Attends a core session or core maintenance 
session. CMS makes a payment to an MDPP supplier if an MDPP beneficiary 
attends a core session or core maintenance session. An attendance 
payment is made only on an assignment-related basis in accordance with 
Sec.  424.55 of this chapter, and MDPP suppliers must accept the 
Medicare allowed charge as payment in full and may not bill or collect 
from the beneficiary any amount. CMS will make an attendance payment 
only to an MDPP supplier that complies with all applicable enrollment 
and program requirements and only for MDPP services that are furnished 
by an eligible coach, on or after his or her coach eligibility start 
date and, if applicable, before his or her coach eligibility end date. 
As a condition of payment, the MDPP supplier must report the NPI of the 
coach who furnished the session on the claim for the MDPP session.
    (1) The first core session attended, which initiates the MDPP 
services period, and that first core session was furnished by that 
supplier.
    (2) For the Extended flexibilities period described in Sec.  
410.79(e)(2)(iii), the distance learning HCPCS G-code applies for any 
Set of MDPP services that are delivered by distance learning, as 
described in Sec.  410.79(b).
    (3) Medicare pays for up to 22 sessions in a 12-month period. The 
amount of this payment is determined as follows:
    (i) For a core session or core maintenance session furnished 
January 1, 2024 through December 31, 2024. $25.
    (ii) [Reserved]
    (d) * * *
    (1) For core session or core maintenance session, as applicable, 
furnished January 1, 2024 through December 31, 2024 the amount is $25.
* * * * *
    (e) Updating performance payments, attendance payments, and the 
bridge payment. The performance payments, attendance payments, and 
bridge payment will be adjusted each calendar year by the percent 
change in the Consumer Price Index for All Urban Consumers (CPI-U) 
(U.S. city average) for the 12-month period ending June 30th of the 
year preceding the update year. The percent change update will be 
calculated based on the level of precision of the index as published by 
the Bureau of Labor Statistics and applied based on one decimal place 
of precision. The annual MDPP services payment update will be published 
by CMS transmittal.


Sec.  414.94  [Removed and Reserved]

0
42. Remove and reserve Sec.  414.94.

0
43. Amend Sec.  414.502 by revising the definitions of ``Data 
collection period'' and ``Data reporting period'' to read as follows:


Sec.  414.502  Definitions.

* * * * *
    Data collection period is the 6 months from January 1 through June 
30, during which applicable information is collected and that precedes 
the data reporting period, except that for the data reporting period of 
January 1, 2024 through March 31, 2024, the data collection period is 
January 1, 2019 through June 30, 2019.
    Data reporting period is the 3-month period, January 1 through 
March 31, during which a reporting entity reports applicable 
information to CMS and that follows the preceding data collection 
period, except that for the data collection period of January 1, 2019 
through June 30, 2019, the data reporting period is January 1, 2024 
through March 31, 2024.
* * * * *


Sec.  414.504  [Amended]

0
44. Amend Sec.  414.504 in paragraph (a)(1) by removing the reference 
``January 1, 2023'' and adding in its place the reference ``January 1, 
2024''.

0
45. Amend Sec.  414.507 by--
0
a. Revising paragraph (d) introductory text and paragraph (d)(6); and
0
b. Adding paragraph (d)(9).
    The revisions and addition read as follows:


Sec.  414.507  Payment for clinical diagnostic laboratory tests.

* * * * *
    (d) Phase-in of payment reductions. For years 2018 through 2026, 
the payment rates established under this section for each CDLT that is 
not a new ADLT or new CDLT, may not be reduced by more than the 
following amounts for--
* * * * *
    (6) 2023-0.0 percent of the payment rate established in 2022.
* * * * *
    (9) 2026--15 percent of the payment rate established in 2025.
* * * * *


Sec.  414.610  [Amended]

0
46. In Sec.  414.610 amend paragraphs (c)(1)(ii) introductory text and 
(c)(5)(ii) by removing the date ``December 31, 2022'' and adding in its 
place the date ``December 31, 2024''

0
47. Section 414.902 is amended by adding the definitions of 
``Applicable five-year period'', ``Low volume dose'', ``New refund 
quarter'', ``Qualifying biosimilar biological product'', and ``Updated 
refund quarter'' in alphabetical order to read as follows:


Sec.  414.902  Definitions.

* * * * *
    Applicable five-year period means:
    (1) For a qualifying biosimilar biological product for which 
payment has been made under section 1847A(b)(8) of the Act as of 
September 30, 2022, the 5-year period beginning on October 1, 2022; and
    (2) For a qualifying biosimilar biological product for which 
payment is first made under section 1847A(b)(8) of the Act during a 
calendar quarter during the period beginning October 1, 2022 and ending 
December 31, 2027, the 5-year period beginning on the first day of such 
calendar quarter during which such payment is first made.
* * * * *
    Low volume dose means, with respect to determination of whether an 
increased applicable percentage is warranted, an FDA-labeled dose of a 
drug for which the volume removed from the vial or container containing 
the labeled dose does not exceed 0.4 mL.
* * * * *
    New refund quarter means a calendar quarter that is included in a 
report

[[Page 79532]]

described in Sec.  414.940(a) that is sent in the first year following 
the year in which the calendar quarter occurs.
* * * * *
    Qualifying biosimilar biological product means a biosimilar 
biological product (as described in section 1847A(b)(1)(C) of the Act) 
with an average sales price (as described in section 1847A(b)(8)(A)(i) 
of the Act) less than the average sales price of the reference 
biological for a calendar quarter during the applicable 5-year period.
* * * * *
    Updated refund quarter means a calendar quarter that is included in 
a report described in Sec.  414.940(a) that is sent in the second year 
following the year in which the calendar quarter occurs.
* * * * *

0
48. Section 414.904 is amended by revising paragraphs (e)(4) and (j) to 
read as follows:


Sec.  414.904  Average sales price as the basis for payment.

* * * * *
    (e) * * *
    (4) Payment amount in a case where the average sales price during 
the first quarter of sales is unavailable. During an initial period 
(not to exceed a full calendar quarter) in which data on the prices for 
sales of the drug are not sufficiently available from the manufacturer 
to compute an average sales price:
    (i) In general. Except as provided in paragraph (e)(4)(ii) of this 
section,
    (A) For dates of service before January 1, 2019, the payment amount 
for the drug is based on the wholesale acquisition cost or the Medicare 
Part B drug payment methodology in effect on November 1, 2003.
    (B) For dates of service on or after January 1, 2019, the payment 
amount for the drug is an amount not to exceed 103 percent of the 
wholesale acquisition cost or based on the Medicare Part B drug payment 
methodologies in effect on November 1, 2003.
    (ii) Limitation on payment amount for biosimilar biological 
products during initial period. For dates of service on or after July 
1, 2024, the payment amount for a biosimilar biological product (as 
defined in Sec.  414.902) during the initial period is the lesser of 
the following:
    (A) The payment amount for the biosimilar biological product as 
determined under clause (e)(4)(i)(B) of this section or
    (B) 106 percent of the amount determined under section 
1847A(b)(1)(B) of the Act for the reference biological product (as 
defined in Sec.  414.902).
* * * * *
    (j) Biosimilar biological products--(1) In general. Except as 
provided in paragraph (j)(2), effective January 1, 2016, the payment 
amount for a biosimilar biological product (as defined in Sec.  
414.902), for all NDCs assigned to such product, is the sum of the 
average sales price of all NDCs assigned to the biosimilar biological 
products included within the same billing and payment code as 
determined under section 1847A(b)(6) of the Act, and 6 percent of the 
amount determined under section 1847A(b)(4) of the Act for the 
reference biological product (as defined in Sec.  414.902).
    (2) Temporary increase in Medicare Part B payment for qualifying 
biosimilar biological products. In the case of a qualifying biosimilar 
biological product (as defined in Sec.  414.902) that is furnished 
during the applicable 5-year period (as defined in Sec.  414.902) for 
such product, the payment amount for such product with respect to such 
period is the sum determined under as determined under section 
1847A(b)(6) of the Act and 8 percent of the amount determined under 
section 1847A(b)(4) of the Act for the reference biological product (as 
defined in Sec.  414.902).

0
49. Section 414.940 is amended by--
0
a. Redesignating paragraph (a)(1)(iii) as paragraph (a)(1)(iv).
0
b. Adding new paragraph (a)(1)(iii).
0
c. Revising paragraphs (a)(3), (b)(1) and (2), (c), and (d);
0
d. Redesignating paragraphs (e) and (f) as paragraphs (f) and (g), 
respectively; and
0
e. Adding new paragraph (e).
    The revisions and additions read as follows:


Sec.  414.940  Refund for certain discarded single-dose container or 
single-use package drugs.

    (a) * * *
    (1) * * *
    (iii) Reports will include information in paragraphs (a)(1)(i) and 
(ii) of this section for new refund quarters and updated refund 
quarters (as defined at Sec.  414.902).
* * * * *
    (3) Report Timing. Reports are sent once annually.
    (b) * * *
    (1) Refund amounts for which the manufacturer is liable, pursuant 
to this paragraph, must be paid by December 31 of the year in which the 
report described in paragraph (a) of this section is sent, except that 
refund amounts for which the manufacturer is liable, pursuant to this 
paragraph, for amounts in the initial report for calendar quarters in 
2023 must be paid no later than February 28, 2025.
    (2) In the case that a disputed report results in a refund amount 
due, refund amounts that the manufacturer is liable for pursuant to 
this paragraph shall be paid no later than the dates specified in 
paragraph (b)(1) of this section or 30 days following the resolution of 
the dispute, whichever is later.
* * * * *
    (c) Refund amount. The amount of the refund specified in this 
paragraph is with respect to a refundable single-dose container or 
single-use package drug of a manufacturer assigned to a billing and 
payment code (except as provided in paragraph (c)(4) of this section) 
for:
    (1) A new refund quarter (as defined at Sec.  414.902) beginning on 
or after January 1, 2023, an amount equal to the estimated amount (if 
any) by which:
    (i) The product of the total number of units of the billing and 
payment code for such drug that were discarded during such new refund 
quarter; and the amount of payment determined for such drug or 
biological under section 1847A(b)(1)(B) or (C) of the Act, as 
applicable, for such new refund quarter;
    (ii) Exceeds an amount equal to the applicable percentage of the 
estimated total allowed charges for such drug for the new refund 
quarter.
    (2) The refund amount owed by a manufacturer for an updated refund 
quarter (as defined at Sec.  414.902) beginning on or after January 1, 
2023, an amount equal to the estimated amount (if any) by which:
    (i) The product of the total number of units of the billing and 
payment code for such drug that were discarded during such updated 
refund quarter; and the amount of payment determined for such drug or 
biological under section 1847A(b)(1)(B) or (C) of the Act, as 
applicable, for such quarter.
    (ii) Exceeds the difference of:
    (A) An amount equal to the applicable percentage of the estimated 
total allowed charges for such a drug during the updated refund 
quarter; and
    (B) The refund amount already paid for such refundable drug for 
such quarter.
    (3) Negative refund amount for an updated refund quarter. If the 
refund amount described in paragraph (c)(2) of this section is 
negative, the amount will be netted from refunds owed for other updated 
and new refund quarters included in the same report as such updated 
refund quarter.
    (4) Exception when there are multiple manufacturers. If there is 
more than one

[[Page 79533]]

manufacturer of a refundable single-dose container or single-use 
package drug for a quarter, the refund amount for which a manufacturer 
is liable is an amount equal to the estimated amount (if any) by 
which--
    (i) The product of the amount calculated in paragraph (c)(1) of 
this section and the percentage of billing unit sales (of the 
applicable billing and payment code attributed to the National Drug 
Code; exceeds:
    (ii) The product of the amount in paragraph (c)(2) of this section 
and percentage of billing unit sales of the applicable billing and 
payment code attributed to the National Drug Code.
    (iii) The number of billing unit sales for each NDC is the reported 
number of NDCs sold (as submitted in the ASP report to CMS each 
quarter) multiplied by the billing units per package for such NDC.
    (d) Applicable percentage. For purposes of paragraph (c) of this 
section, and except as provided in paragraph (e) of this section, the 
applicable percentage is:
    (1) 10 percent, unless specified otherwise in this section.
    (2) 35 percent for a drug that is reconstituted with a hydrogel and 
has variable dosing based on patient-specific characteristics.
    (3) 90 percent for a drug with a low volume dose (as defined at 
Sec.  414.902) contained within 0.1 mL or less.
    (4) 45 percent for a drug with a low volume dose (as defined in 
Sec.  414.902) contained within 0.11 mL up to 0.4 mL.
    (5) 26 percent for a drug designated an orphan drug under section 
526 of the Federal Food, Drug, and Cosmetic Act for a rare disease or 
condition (or diseases or conditions) and approved by the FDA only for 
one or more indications within such designated rare disease or 
condition (or diseases or conditions) and is furnished to fewer than 
100 unique beneficiaries per calendar year. A drug is furnished to 
fewer than 100 unique beneficiaries per calendar year when one of the 
following two conditions is met:
    (i) The number of unique beneficiaries to whom the drug is 
furnished is less than 100 during the calendar year in which the refund 
quarter occurs; or
    (ii) Either:
    (A) In the case of a drug for which 3 or more years of data is 
available, the average of unique beneficiaries per year to whom the 
drug is furnished during the calendar year in which the refund quarter 
occurs and the 2 previous calendar years is less than 100; or
    (B) In the case of a drug for which at least 2 but less than 3 
years of data is available, the average of unique beneficiaries per 
year to whom the drug is furnished during the calendar year in which 
the refund quarter occurs and the previous calendar year is less than 
100.
    (e) Application process for increased applicable percentage. 
Manufacturers may submit an application to CMS requesting consideration 
of an increased applicable percentage for purposes of paragraph (c) of 
this section because of the drug's unique circumstances. The process 
for submitting such an application is as follows:
    (1) Application. An application must include:
    (i) A written request that a drug be considered for an increased 
applicable percentage based on its unique circumstances;
    (ii) FDA-approved labeling for the drug, or, if the drug is not 
approved by the February 1 application deadline described in paragraph 
(e)(2) of this section, documentation of FDA acceptance of the 
application for review;
    (iii) Justification for the consideration of an increased 
applicable percentage based on such unique circumstances; and
    (iv) Justification for the requested applicable percentage.
    (2) Application timeline. An application must be submitted in a 
form and manner specified by CMS by February 1 of the calendar year 
prior to the year the increased applicable percentage would apply. An 
application for a drug that is not FDA-approved by February 1 must have 
FDA approval by August 1 and the manufacturer must notify and submit 
the FDA-approved label to CMS by September 1 of the calendar year prior 
to the year the increased applicable percentage would apply.
    (3) Application processing. Following a review of timely 
applications, CMS will summarize its analyses of applications and 
propose appropriate increases in rulemaking. If adopted, the increased 
applicable percentage will be the applicable percentage for purposes of 
paragraph (c) of this section beginning as of the following January 1.
* * * * *

0
50. Section 414.1305 is amended by--
0
a. In the definition of ``Attestation'', by removing the term ``MIPS 
eligible clinician or group'' and adding in its in place the term 
``MIPS eligible clinician, subgroup, or group''.
0
b. In the definition of ``Certified Electronic Health Record Technology 
(CEHRT)'', by revising paragraphs (2) introductory text and (2)(ii) 
introductory text, and adding paragraph (3);
0
c. By revising the definition of ``Collection type'';
0
d. By adding the definition of ``Qualified posting''.
0
e. In the definition of ``Submitter type'', by removing both instances 
of the term ``MIPS eligible clinician, group, Virtual Group, APM 
Entity'' and adding in their places the term ``MIPS eligible clinician, 
group, Virtual Group, subgroup, APM Entity''.
    The revisions and addition read as follows:


Sec.  414.1305  Definitions.

* * * * *
    Certified Electronic Health Record Technology (CEHRT)* * *
* * * * *
    (2) For 2019 and subsequent years, EHR technology (which could 
include multiple technologies) certified under the ONC Health IT 
Certification Program that meets the 2015 Edition Base EHR definition, 
or subsequent Base EHR definition (as defined in 45 CFR 170.102), and 
has been certified to the ONC health IT certification criteria as 
adopted and updated in 45 CFR 170.315--
* * * * *
    (ii) Necessary to report on applicable objectives and measures 
specified for MIPS including the following:
* * * * *
    (3) For purposes of determinations under Sec. Sec.  414.1415 and 
414.1420, beginning for CY 2024, EHR technology (which could include 
multiple technologies) certified under the ONC Health IT Certification 
Program that meets--
    (i) The 2015 Edition Base EHR definition, or subsequent Base EHR 
definition (as defined in 45 CFR 170.102); and
    (ii) Any such ONC health IT certification criteria adopted or 
updated in 45 CFR 170.315 that are determined applicable for the APM, 
for the year, considering factors such as clinical practice area, 
promotion of interoperability, relevance to reporting on applicable 
quality measures, clinical care delivery objectives of the APM, or any 
other factor relevant to documenting and communicating clinical care to 
patients or their health care providers in the APM.
* * * * *
    Collection type means a set of quality measures with comparable 
specifications and data completeness criteria, as applicable, 
including, but not limited to: Electronic clinical quality measures 
(eCQMs); MIPS clinical quality measures (MIPS CQMs); QCDR measures; 
Medicare Part B claims measures; CMS Web Interface measures (except as 
provided in paragraph (1) of

[[Page 79534]]

this definition, for the CY 2017 through CY 2022 performance periods/
2019 through 2024 MIPS payment years); the CAHPS for MIPS survey 
measure; administrative claims measures; and Medicare Clinical Quality 
Measures for Accountable Care Organizations Participating in the 
Medicare Shared Savings Program (Medicare CQMs).
* * * * *
    Qualified posting means the document made available that lists 
qualified registries or QCDRs available by CMS for use by MIPS eligible 
clinicians, groups, subgroups, virtual groups, and APM Entities.
* * * * *

0
51. Section 414.1320 is amended by--
0
a. Revising paragraph (h) introductory text; and
0
b. Adding paragraph (i).
    The addition and revision read as follow:


Sec.  414.1320  MIPS performance period.

* * * * *
    (h) For purposes of the 2024 MIPS payment year and the 2025 MIPS 
payment year, the performance period for:
* * * * *
    (i) For purposes of the 2026 MIPS payment year and each subsequent 
payment year, the performance period for:
    (1) The Promoting Interoperability performance category is a 
minimum of a continuous 180-day period within the calendar year that 
occurs 2 years prior to the applicable MIPS payment year, up to and 
including the full calendar year.
    (2) [Reserved]

0
52. Section 414.1325 is amended by revising paragraphs (a)(1), (c) 
introductory text, and (d) to read as follows.


Sec.  414.1325  Data submission requirements.

    (a) * * *
    (1) Except as provided in paragraph (a)(2) of this section, or 
under Sec.  414.1370 or Sec.  414.1365(c), as applicable, individual 
MIPS eligible clinicians, groups, virtual groups, subgroups, and APM 
Entities must submit data on measures and activities for the quality, 
improvement activities, and Promoting Interoperability performance 
categories in accordance with this section. Except for the Medicare 
Part B claims submission type, the data may also be submitted on behalf 
of the individual MIPS eligible clinician, group, virtual group, 
subgroup, or APM Entity by a third party intermediary described at 
Sec.  414.1400.
* * * * *
    (c) Data submission types for groups, virtual groups, subgroups, 
and APM Entities. Groups, virtual groups, subgroups, and APM Entities 
may submit their MIPS data using:
* * * * *
    (d) Use of multiple data submission types. Beginning with the 2021 
MIPS payment year as applicable to MIPS eligible clinicians, groups, 
and virtual groups, beginning with the 2023 MIPS payment year as 
applicable to APM Entities, and beginning with the 2025 MIPS payment 
year as applicable to subgroups, MIPS eligible clinicians, groups, 
virtual groups, APM Entities, and subgroups may submit their MIPS data 
using multiple data submission types for any performance category 
described in paragraph (a)(1) of this section, as applicable; provided, 
however, that the MIPS eligible clinician, group, virtual group, APM 
Entity, or subgroup uses the same identifier for all performance 
categories and all data submissions.

0
53. Section 414.1335 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(1), (a)(3) paragraph 
heading, and (a)(3)(i); and
0
b. Adding paragraph (a)(4).
    The revisions and additions read as follows:


Sec.  414.1335  Data submission criteria for the quality performance 
category.

    (a) Criteria. A MIPS eligible clinician, group, virtual group, 
subgroup, or APM Entity must submit data on MIPS quality measures in 
one of the following manners, as applicable:
    (1) For Medicare Part B claims measures, MIPS CQMs, eCQMs, or QCDR 
measures. (i) Except as provided in paragraph (a)(1)(ii) of this 
section, submits data on at least six measures, including at least one 
outcome measure. If an applicable outcome measure is not available, 
reports one other high priority measure. If fewer than six measures 
apply to the MIPS eligible clinician, group, virtual group, or APM 
Entity, reports on each measure that is applicable.
    (A) For eCQMs, the submission of data requires the utilization of 
CEHRT, as defined at Sec.  414.1305.
    (B) [Reserved]
    (ii) A MIPS eligible clinician, group, virtual group, and APM 
Entity that report on a specialty or subspecialty measure set, as 
designated in the MIPS final list of quality measures established by 
CMS through rulemaking, must submit data on at least six measures 
within that set, including at least one outcome measure. If an 
applicable outcome measure is not available, report one other high 
priority measure. If the set contains fewer than six measures or if 
fewer than six measures within the set apply to the MIPS eligible 
clinician, group, virtual group, or APM Entity, report on each measure 
that is applicable.
    (A) For eCQMs, the submission of data requires the utilization of 
CEHRT, as defined at Sec.  414.1305.
    (B) [Reserved]
* * * * *
    (3) For the CAHPS for MIPS survey measure. (i) For the 12-month 
performance period, a group, virtual group, subgroup, or APM Entity 
that participates in the CAHPS for MIPS survey must use a survey vendor 
that is approved by CMS for the applicable performance period to 
transmit survey measures data to CMS.
* * * * *
    (4) For Medicare CQMs. (i) A MIPS eligible clinician, group, and 
APM Entity reporting on the Medicare CQMs (reporting quality data on 
beneficiaries eligible for Medicare CQMs as defined at Sec.  425.20) 
within the APP measure set and administering the CAHPS for MIPS Survey 
as required under the APP.
    (ii) [Reserved]
* * * * *

0
54. Section 414.1340 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(2), (3), and (4);
0
b. Revising paragraph (b) introductory text;
0
c. Adding paragraphs (b)(2)(i) and (ii) and (b)(3)(i) and (ii);
0
d. Revising paragraphs (b)(4) and (d); and
0
e. Adding paragraph (e).
    The revisions and additions read as follows:


Sec.  414.1340  Data completeness criteria for the quality performance 
category.

    (a) MIPS eligible clinicians, groups, virtual groups, subgroups, 
and APM Entities submitting quality measures data on QCDR measures, 
MIPS CQMs, or eCQMs must submit data on:
* * * * *
    (2) At least 60 percent of the MIPS eligible clinician, group, and 
virtual group's patients that meet the measure's denominator criteria, 
regardless of payer for MIPS payment years 2020 and 2021.
    (3) At least 70 percent of the MIPS eligible clinician, group, and 
virtual group's patients that meet the measure's denominator criteria, 
regardless of payer for MIPS payment years 2022, 2023, 2024, and 2025.

[[Page 79535]]

    (i) Applicable to an APM Entity for MIPS payment years 2023, 2024, 
and 2025.
    (ii) Applicable to a subgroup for MIPS payment year 2025.
    (4) At least 75 percent of the MIPS eligible clinician, group, 
virtual group, subgroup, and APM Entity's patients that meet the 
measure's denominator criteria, regardless of payer for MIPS payment 
years 2026, 2027, and 2028.
    (b) MIPS eligible clinicians, groups, virtual groups, subgroups, 
and APM Entities submitting quality measure data on Medicare Part B 
claims measures must submit data on:
* * * * *
    (2) * * *
    (i) Applicable to virtual groups starting with MIPS payment year 
2020.
    (ii) [Reserved]
    (3) * * *
    (i) Applicable to APM Entities starting with MIPS payment year 2023 
and subgroups starting with MIPS payment year 2025.
    (ii) [Reserved].
* * * * *
    (4) At least 75 percent of the applicable Medicare Part B patients 
seen during the performance period to which the measure applies for 
MIPS payment years 2026, 2027, and 2028.
* * * * *
    (d) APM Entities, specifically Medicare Shared Savings Program 
Accountable Care Organizations meeting reporting requirements under the 
APP, submitting quality measure data on Medicare CQMs must submit data 
on:
    (1) At least 75 percent of the applicable beneficiaries eligible 
for the Medicare CQM, as defined at Sec.  425.20, who meet the 
measure's denominator criteria for MIPS payment years 2026, 2027, and 
2028.
    (2) [Reserved]
    (e) If quality data are submitted selectively such that the 
submitted data are unrepresentative of a MIPS eligible clinician, 
group, virtual group, subgroup, or APM Entity's performance, any such 
data would not be true, accurate, or complete for purposes of Sec.  
414.1390(b) or Sec.  414.1400(a)(5).

0
55. Section 414.1350 is amended by revising paragraphs (c)(4) through 
(6) and adding paragraph (c)(7) to read as follows:


Sec.  [thinsp]414.1350  Cost performance category.

* * * * *
    (c) * * *
    (4) For the procedural episode-based measures specified beginning 
with and after the CY 2019 performance period/2021 MIPS payment year, 
the case minimum is 10, unless otherwise specified for individual 
measures. Beginning with the CY 2022 performance period/2024 MIPS 
payment year, the case minimum for Colon and Rectal Resection 
procedural episode-based measure is 20 episodes.
    (5) For the acute inpatient medical condition episode-based 
measures specified beginning with and after CY 2019 performance period/
2021 MIPS payment year, the case minimum is 20, unless otherwise 
specified for individual measures.
    (6) For the chronic condition episode-based measures specified 
beginning with and after the CY 2022 performance period/2024 MIPS 
payment year, the case minimum is 20, unless otherwise specified for 
individual measures.
    (7) For the care setting episode-based measures specified beginning 
with and after the CY 2024 performance period/2026 MIPS payment year, 
the case minimum is 20, unless otherwise specified for individual 
measures.
* * * * *

0
56. Section 414.1360 is amended by revising paragraph (a) introductory 
text to read as follows:


Sec.  414.1360  Data submission criteria for the improvement activities 
performance category.

    (a) For purposes of the transition year of MIPS and future years, 
MIPS eligible clinicians, subgroups, or groups must submit data on MIPS 
improvement activities in one of the following manners:
* * * * *

0
57. Section 414.1365 is amended by--
0
a. Revising paragraphs (e)(2)(ii) introductory text and (e)(3); and
0
b. Adding paragraphs (e)(4)(i) and (ii).
    The revisions and addition read as follow:


Sec.  414.1365  MIPS Value Pathways.

* * * * *
    (e) * * *
    (2) * * *
    (ii) Subgroups. For an MVP Participant that is a subgroup, any 
reweighting applied to its affiliated group will also be applied to the 
subgroup. In addition, for the CY 2023 performance period/2025 MIPS 
payment year, if reweighting is not applied to the affiliated group, 
the subgroup may receive reweighting in the following circumstances 
independent of the affiliated group:
* * * * *
    (3) Facility-based scoring. If an MVP Participant, that is not an 
APM Entity or a subgroup, is eligible for facility-based scoring, a 
facility-based score also will be calculated in accordance with Sec.  
414.1380(e).
    (4) * * *
    (i) For subgroups, the affiliated group's complex patient bonus 
will be added to the final score.
    (ii) [Reserved]

0
58. Section 414.1375 is amended by revising paragraph (b)(2)(ii)(C), 
and adding paragraph (b)(2)(ii)(D) to read as follows:


Sec.  414.1375  Promoting Interoperability (PI) performance category.

* * * * *
    (A) * * *
    (B) * * *
    (C) Beginning with the 2024 MIPS payment year through the 2025 MIPS 
payment year, submit an attestation, with either an affirmative or 
negative response, with respect to whether the MIPS eligible clinician 
completed the annual self-assessment under the SAFER Guides measure 
during the year in which the performance period occurs.
    (D) Beginning with the 2026 MIPS payment year, submit an 
affirmative attestation regarding the MIPS eligible clinician's 
completion of the annual self-assessment under the SAFER Guides measure 
during the year in which the performance period occurs.
* * * * *

0
59. Section 414.1380 is amended by--
0
a. Revising paragraphs (a)(1)(i) and (ii), (b)(1)(v)(A), (b)(2)(iv)(A), 
(B), (C) and (E), (b)(3)(i), and (c)(2)(i)(A)(4)(iii);
0
b. Adding paragraphs (c)(2)(iv);
0
c. In paragraph (c)(3)(v) removing the term ``MIPS eligible clinicians, 
groups, subgroups, APM Entities and virtual groups'' and adding in its 
place the term ``MIPS eligible clinicians, groups, APM Entities and 
virtual groups;'' and
0
d. In paragraph (c)(3)(vi) removing the term ``MIPS eligible 
clinicians, groups, and subgroups'' and adding in its place the term 
``MIPS eligible clinicians and groups''.
    The revisions and additions read as follow:


Sec.  414.1380  Scoring.

    (a) * * *
    (1) * * *
    (i) For the quality performance category, measures are scored 
between zero and 10 measure achievement points. Performance is measured 
against benchmarks. Prior to the CY 2023 performance period/2025 MIPS 
payment year, measure bonus points are available for submitting high-
priority measures and submitting measures using end-to-end electronic 
reporting. Measure bonus points are available for small practices that 
submit data on at

[[Page 79536]]

least 1 quality measure. Beginning with the 2020 MIPS payment year, 
improvement scoring is available in the quality performance category.
    (ii) For the cost performance category, measures are scored between 
1 and 10 points. Performance is measured against a benchmark. Beginning 
with the 2025 MIPS payment year, improvement scoring is available in 
the cost performance category.
* * * * *
    (b) * * *
    (1) * * *
    (v) * * *
    (A) High priority measures. Subject to paragraph (b)(1)(v)(A)(1) of 
this section, for the CY 2017 through 2021 MIPS performance periods/
2019 through 2023 MIPS payment years, MIPS eligible clinicians receive 
2 measure bonus points for each outcome and patient experience measure 
and 1 measure bonus point for each other high priority measure. 
Beginning in the 2021 MIPS payment year, MIPS eligible clinicians do 
not receive such measure bonus points for CMS Web Interface measures. 
Beginning in the 2022 performance period/2024 MIPS payment year, MIPS 
eligible clinicians will no longer receive these measure bonus points.
* * * * *
    (2) * * *
    (iv) * * *
    (A) The cost improvement score is determined at the category level 
for the cost performance category.
    (B) The cost improvement score is calculated only when data 
sufficient to measure improvement are available. Sufficient data are 
available when a MIPS eligible clinician or group participates in MIPS 
using the same identifier in 2 consecutive performance periods and is 
scored on the cost performance category for 2 consecutive performance 
periods. If the cost improvement score cannot be calculated because 
sufficient data are not available, then the cost improvement score is 
zero.
    (C) The cost improvement score is determined at the category-level 
by subtracting the cost performance category score from the previous 
performance period from the cost performance category score from the 
current performance period, then by dividing the difference by the cost 
performance category score from the previous performance period, and 
multiplying the result with the maximum available cost improvement 
score.
* * * * *
    (E) The maximum cost improvement score for the 2020, 2021, 2022, 
2023, and 2024 MIPS payment year is zero percentage points. The maximum 
cost improvement score beginning with the 2025 MIPS payment year is 1 
percentage point.
* * * * *
    (3) * * *
    (i) For MIPS eligible clinicians participating in APMs, the 
improvement activities performance category score is at least 50 
percent. MIPS eligible clinicians participating in APMs must attest to 
having completed an improvement activity or submit data for the quality 
and Promoting Interoperability performance categories in order to 
receive such credit.
* * * * *
    (c) * * *
    (2) * * *
    (i) * * *
    (A) * * *
    (4) * * *
    (iii) For the 2024 through 2026 MIPS payment years, the MIPS 
eligible clinician is a clinical social worker. In the event that a 
MIPS eligible clinician submits data for the Promoting Interoperability 
performance category, the scoring weight specified in paragraph (c)(1) 
of this section will be applied and its weight will not be distributed.
* * * * *
    (iv) If CMS has granted an application for a hardship exception or 
any other type of exception to a MIPS eligible clinician under 
paragraph (c)(2)(i)(A)(6) or (c)(2)(i)(C)(2) of this section, or has 
identified a MIPS eligible clinician in a CMS-designated region as 
being affected by an automatic extreme and uncontrollable circumstances 
event under paragraph (c)(2)(i)(A)(8) or (c)(2)(i)(C)(3) of this 
section, CMS will not apply the improvement activities score described 
in paragraph (b)(3)(i) of this section to the MIPS eligible clinician's 
score.
* * * * *

0
60. Section 414.1385 is amended--
0
a. In paragraph (a) by removing the term ``MIPS eligible clinician or 
group'' and adding in its in place the term ``MIPS eligible clinician, 
virtual group, subgroup, or group;''
0
b. In paragraph (a)(1) by removing the term ``MIPS eligible clinician 
or group'' and adding in its place the term ``MIPS eligible clinician, 
virtual group, subgroup, or group;''
0
c. By revising paragraph (a)(2);
0
d. In paragraph (a)(3) by removing the term ``MIPS eligible clinician 
or group'' and adding in its place the term ``MIPS eligible clinician, 
virtual group, subgroup, or group;''
0
e. By revising paragraph (a)(5); and
0
f. In paragraph (a)(6) by removing the term ``MIPS eligible clinician 
or group'' and adding in its place the term ``MIPS eligible clinician, 
virtual group, subgroup, or group''.
    The revisions read as follows:


Sec.  414.1385  Targeted review and review limitations.

    (a) * * *
    (2) All requests for targeted review must be submitted during the 
targeted review request submission period, which begins on the day CMS 
makes available the MIPS final score, and ends 30 days after 
publication of the MIPS payment adjustment factors for the MIPS payment 
year. The targeted review request submission period may be extended as 
specified by CMS.
* * * * *
    (5) A request for a targeted review may include additional 
information in support of the request at the time it is submitted. If 
CMS requests additional information from the MIPS eligible clinician, 
virtual group, subgroup. or group that is the subject of a request for 
a targeted review, the information must be provided and received by CMS 
within 15 days of CMS' request. Non-responsiveness to CMS' request for 
additional information may result in a final decision based on the 
information available, although another non-duplicative request for 
targeted review may be submitted before the end of the targeted review 
request submission period.
* * * * *

0
61. Section 414.1400 is amended by--
0
a. Revising paragraphs (a)(1)(iii), (a)(2)(i), (a)(2)(ii)(A), (a)(3), 
and (b)(1)(ii);
0
b. Adding paragraphs (b)(1)(iii);
0
c Revising paragraphs (b)(2), (b)(3)(v)(E)(1) and (2);
0
d. Adding paragraphs (b)(3)(ix) through (xvii);
0
e. Revising paragraph (b)(4)(i)(B);
0
f. Adding paragraphs (b)(4)(i)(C) and (b)(4)(iv)(O) and (P);
0
g. Revising paragraph (e)(1) introductory text;
0
h. Adding paragraph (e)(1)(i)(F);
0
i. Revising paragraph (e)(1)(ii);
0
j. Adding paragraphs (e)(2)(iv) and (v);
0
k. Revising paragraphs (e)(3) and (4) and (f).
    The additions and revisions read as follows:


Sec.  414.1400  Third party intermediaries.

    (a) * * *
    (1) * * *
    (iii) Before the CY 2025 performance period/2027 payment year, 
Health IT vendor;
* * * * *
    (2) * * *
    (i) To be approved as a third party intermediary, an organization 
must meet the following requirements:

[[Page 79537]]

    (A) The organization's principal place of business and the location 
in which it stores data must be in the U.S.
    (B) The organization must have the ability to indicate the source 
of any data it will submit to CMS if the data will be derived from 
CEHRT, a QCDR, qualified registry, or health IT vendor.
    (C) The organization must certify that it intends to provide 
services throughout the entire performance period and applicable data 
submission period.
    (ii) * * *
    (A) Whether the organization failed to comply with the requirements 
of this section for any prior MIPS payment year for which it was 
approved as third party intermediary, including past compliance; and
* * * * *
    (3) For third-party intermediary program requirements:
    (i) All data submitted to CMS by a third party intermediary on 
behalf of a MIPS eligible clinician, group, virtual group, subgroup, or 
APM Entity must be certified by the third party intermediary as true, 
accurate, and complete to the best of its knowledge. Such certification 
must be made in a form and manner and at such time as specified by CMS.
    (ii) All data submitted to CMS by a third party intermediary must 
be submitted in the form and manner specified by CMS.
    (A) The submission of data on measures by a third party 
intermediary to CMS must include data on all of the MIPS eligible 
clinician's patients, regardless of payer, unless otherwise specified 
by the collection type.
    (B) [Reserved]
    (iii) If the clinician chooses to opt-in to participate in MIPS in 
accordance with Sec.  414.130, the third party intermediary must be 
able to transmit that decision to CMS.
    (iv) Prior to discontinuing services to any MIPS eligible 
clinician, group, virtual group, subgroup, or APM Entity during a 
performance period, a third party intermediary must support the 
transition of such MIPS eligible clinician, group, virtual group, 
subgroup, or APM Entity to an alternate third party intermediary, 
submitter type, or, for any measure on which data has been collected, 
collection type according to a CMS approved transition plan by a date 
specified by CMS. The transition plan must address the following 
issues, unless different or additional information is specified by CMS:
    (A) The issues that contributed to the withdrawal mid-performance 
period or discontinuation of services mid-performance period.
    (B) Impacted entities:
    (1) The number of clinicians, groups, virtual groups, subgroups or 
APM entities (inclusive of MIPS eligible, opt-in and voluntary 
participants) that would need to find another way to report.
    (2) As applicable, identify any QCDRs that were granted licenses to 
QCDR measures which would no longer be available for reporting due to 
the transition.
    (C) The steps the third party intermediary will take to ensure that 
the clinicians, groups, virtual groups, subgroups, or APM Entities 
identified in paragraph (a)(3)(iv)(B)(1) of this section are notified 
of the transition in a timely manner, and successfully transitioned to 
an alternate third party intermediary, submitter type, or, for any 
measure or activity on which data has been collected, collection type, 
as applicable.
    (D) A detailed timeline that outlines timing for communications, 
the start of the transition, and completion of the transition of these 
clinicians, groups, virtual groups, subgroups, or APM Entities.
    (E) The third party intermediary must communicate to CMS that the 
transition was completed by the date included in the detailed timeline.
    (v) As a condition of its qualification and approval to participate 
in MIPS as a third party intermediary, a third party intermediary must:
    (A) Make available to CMS the contact information of each MIPS 
eligible clinician, group, virtual group, subgroup, or APM Entity on 
behalf of whom it submits data. The contact information must include, 
at a minimum, the MIPS eligible clinician, group, virtual group, 
subgroup, or APM Entity phone number, address, and, if available, 
email.
    (B) Retain all data submitted to CMS for purposes of MIPS for 6 
years from the end of the MIPS performance period.
    (C) Upon request, provide CMS with any records or data retained in 
connection with its operation as a third party intermediary for up to 6 
years from the end of the MIPS performance period.
    (vi) Beginning with the 2023 MIPS payment year, third party 
intermediaries must attend and complete training and support sessions 
in the form and manner, and at the times, specified by CMS.
    (b) * * *
    (1) * * *
    (ii) Beginning with the CY 2023 performance period/2025 MIPS 
payment year, QCDRs and qualified registries must support MVPs that are 
applicable to the MVP participant on whose behalf they submit MIPS 
data. QCDRs and qualified registries may also support the APP. A QCDR 
or qualified registry must support all measures and activities included 
in the MVP with the following exceptions:
    (A) If an MVP is intended for reporting by multiple specialties, a 
QCDR or a qualified registry are required to report those measures 
pertinent to the specialty of its MIPS eligible clinicians.
    (B) If an MVP includes a QCDR measure, it is not required to be 
reported by a QCDR other than the measure owner.
    (iii) Beginning with the CY 2023 performance period/2025 MIPS 
payment year, A QCDR or qualified registry must support subgroup 
reporting.
    (2) Self-nomination. For the CY 2019 performance period/2021 MIPS 
payment year and future years, an existing QCDR or qualified registry 
that is in good standing may use the Simplified Self-Nomination process 
form during the self-nomination period, from July 1 and September 1 of 
the CY preceding the applicable performance period.
    (3) * * *
    (v) * * *
    (E) * * *
    (1) Uses a sample size of at least 3 percent of a combination of 
the individual MIPS eligible clinicians, groups, virtual groups, 
subgroups and APM entities for which the QCDR or qualified registry 
will submit data to CMS, except that the sample size may be no fewer 
than a combination of 10 individual clinicians, groups, virtual groups, 
subgroups and APM entities, no more than a combination of 50 individual 
clinicians, groups, virtual groups, subgroups and APM entities.
    (2) Uses a sample that includes at least 25 percent of the patients 
of each individual clinician, group, virtual group, subgroup or APM 
entity in the sample, except that the sample for each individual 
clinician, group, virtual group, subgroup or APM entity must include a 
minimum of 5 patients and need not include more than 50 patients.
* * * * *
    (ix) During the self-nomination period, a QCDR or a qualified 
registry must submit to CMS quality measure numbers, Promoting 
Interoperability identifiers, improvement activity identifiers and MVP 
titles.
    (x) A QCDR or a qualified registry must be able to submit to CMS 
data for at least six quality measures including at least one outcome 
measure.

[[Page 79538]]

    (A) If no outcome measure is available, a QCDR or qualified 
registry must be able to submit to CMS results for at least one other 
high priority measure.
    (B) [Reserved]
    (xi) A QCDR or a qualified registry must submit to CMS risk-
adjusted measure results when submitting data for measures that include 
risk adjustment in the measure specification.
    (xii) A QCDRs or qualified registry must enter into appropriate 
Business Associate Agreements with MIPS eligible clinicians to collect 
and process their data.
    (xiii) A QCDR or a qualified registry must maintain records of 
their authorization to submit data to CMS for the purpose of MIPS 
participation for each NPI whom the QCDR or qualified registry will 
submit data to CMS for. The records must:
    (A) Be annually obtained by the QCDR or qualified registry at the 
time the clinician or group enters into an agreement with the QCDR or 
qualified registry for the submission of MIPS data to the QCDR or 
qualified registry.
    (B) Be signed by an eligible clinician, if reporting individually, 
or by an authorized representative of the reporting group, subgroup, 
Virtual Group, or APM Entity.
    (C) Records of the authorization must be maintained for 6 years 
after the performance period ends.
    (xiv) A QCDR or a qualified registry must attest that the 
information listed on the qualified posting is accurate.
    (xv) A QCDR or a qualified registry must provide to CMS, upon 
request, the data submitted by the QCDR or qualified registry for 
purposes of MIPS.
    (xvi) A QCDR or qualified registry must attest to the following:
    (A) A QCDR or a qualified registry must attest that it has required 
each MIPS eligible clinician on whose behalf it reports to provide the 
QCDR or qualified registry with all documentation necessary to verify 
the accuracy of the data on quality measures that the eligible 
clinician submitted to the QCDR or qualified registry.
    (B) A QCDR or qualified registry must also attest that it has 
required each MIPS eligible clinician to permit the QCDR or qualified 
registry to provide the information described in paragraph 
(b)(3)(xviii)(A) of this section to CMS upon request.
    (xvii) A QCDR or a qualified registry must accept and maintain 
clinician data by January 1 of the applicable performance period.
    (4) * * *
    (i) * * *
    (B) For a QCDR measure, the entity must submit for CMS approval 
measure specifications including: Name/title of measure, descriptions 
of the denominator, numerator, and when applicable, denominator 
exceptions, denominator exclusions, risk adjustment variables, and risk 
adjustment algorithms. In addition, no later than 15 calendar days 
following CMS posting of all approved specifications for a QCDR 
measure, the entity must publicly post the CMS-approved measure 
specifications for the QCDR measure (including the CMS-assigned QCDR 
measure ID) and provide CMS with a link to where this information is 
posted. The approved QCDR measure specifications must remain published 
through the performance period and data submission period.
    (C) For a QCDR measure, the QCDR must provide, if available, data 
from years prior before the start of the performance period.
* * * * *
    (iv) * * *
    (O) QCDR measures submitted after self-nomination.
    (P) More than 30 QCDR measures are submitted by a single QCDR.
* * * * *
    (e) * * *
    (1) If CMS determines that a third party intermediary has ceased to 
meet one or more of the applicable criteria for approval, failed to 
comply with the program requirements of this section, has submitted a 
false certification under paragraph (a)(3) of this section, or has 
submitted data that are inaccurate, unusable, or otherwise compromised, 
CMS may take one or more of the following remedial actions after 
providing written notice to the third party intermediary:
    (i) * * *
    (F) Once the issue has been resolved, the detailed final resolution 
and an update, if any, to the monitoring plan provided pursuant to 
Sec.  414.1400(e)(1)(i)(C).
    (ii) Publicly disclose as follows:
    (A) For the purposes of the CY 2025 performance period/2027 MIPS 
payment year and prior reporting periods and payment years, publicly 
disclose the entity's data error rate on the CMS website until the data 
error rate falls below 3 percent.
    (B) Beginning with the CY 2025 performance period/2027 MIPS payment 
year, publicly disclose on the CMS website that CMS took remedial 
action against or terminated the third party intermediary.
    (2) * * *
    (iv) The third party intermediary has not maintained current 
contact information for correspondence.
    (v) The third party intermediary is on remedial action for 2 
consecutive years.
    (3) A data submission that contains data inaccuracies affecting the 
third party intermediary's clinicians may lead to remedial action/
termination of the third party intermediary for future program year(s) 
based on CMS discretion.
    (4) For purposes of this paragraph (e), CMS may determine that 
submitted data are inaccurate, unusable, or otherwise compromised, if 
the submitted data includes, without limitation, TIN/NPI mismatches, 
formatting issues, calculation errors, or data audit discrepancies.
* * * * *
    (f) Auditing of entities submitting MIPS data. Third party 
intermediaries may be randomly selected for compliance evaluation or 
may be selected at the suggestion of CMS if there is an area of concern 
regarding the third party intermediary. For example, areas of concern 
could include, but are not limited to: high data errors, support call 
absences, delinquent deliverables, remedial action status, clinician 
concerns regarding the third party intermediary, a continuing pattern 
of Quality Payment Program Service Center inquiries or support call 
questions, and/or CMS concerns regarding the third party intermediary.

0
62. Section 414.1405 is amended by adding paragraph (b)(9)(iii) to read 
as follows:


Sec.  414.1405  Payment.

* * * * *
    (b) * * *
    (9) * * *
    (iii) The performance threshold for the 2025 MIPS payment year is 
75 points. The prior period to determine the performance threshold is 
the 2019 MIPS payment year.
* * * * *

0
63. Section 414.1415 is amended by revising paragraph (a) to read as 
follows:


Sec.  414.1415  Advanced APM criteria.

    (a) Use of certified electronic health record technology (CEHRT)--
(1) Required use of CEHRT. To be an Advanced APM, an APM must:
    (i) For QP Performance Periods ending with 2018, require at least 
50 percent, or for QP Performance Periods beginning with 2019 and 
ending with 2024, 75 percent, of eligible clinicians in each 
participating APM Entity group, or for APMs in which hospitals are the 
APM Entities, each hospital, to use CEHRT to document and communicate 
clinical care to their patients or health care providers;

[[Page 79539]]

    (ii) For QP Performance Periods prior to 2019, for the Shared 
Savings Program, apply a penalty or reward to an APM Entity based on 
the degree of the use of CEHRT of the eligible clinicians in the APM 
Entity; and
    (iii) For QP Performance Periods beginning with 2025, require use 
of CEHRT as defined at paragraph (3) under CEHRT at Sec.  414.1305.
    (2) [Reserved].
* * * * *

0
64. Section 414.1420 is amended by revising paragraph (b) to read as 
follows:


Sec.  414.1420  Other payer advanced APM criteria.

* * * * *
    (b) Use of CEHRT. To be an Other Payer Advanced APM:
    (1) CEHRT must be used, for QP Performance Periods ending with 
2019, by at least 50 percent; and for QP Performance Periods for 2020 
through 2024, by at least 75 percent, of participants in each 
participating APM Entity group, or each hospital if hospitals are the 
APM Entities, in the other payer arrangement to document and 
communicate clinical care; and
    (2) For QP Performance Periods beginning on or after January 1, 
2024, use of CEHRT (as defined in Sec.  414.1305, paragraph (3) in the 
definition of ``Certified Electronic Health Record Technology 
(CEHRT)''), must be a requirement of participation in the APM.
* * * * *

0
65. Section 414.1430 is amended by--
0
a. Revising paragraph (a)(1)(iv);
0
b. Adding paragraph (a)(1)(v);
0
c. Revising paragraph (a)(2)(iv);
0
d. Adding paragraph (a)(2)(v);
0
e. Revising paragraph (a)(3)(iv);
0
f. Adding paragraph (a)(3)(v);
0
g. Revising paragraph (a)(4)(iv);
0
h. Adding paragraph (a)(4)(v); and
0
i. Revising paragraph (b)(1)(i)(A) and (B), (b)(2)(i)(A) and (B), 
(b)(3)(i)(A) and (B), (b)(4)(i)(A) and (B).
    The revisions and additions read as follows:


Sec.  [thinsp]414.1430  Qualifying APM participant determination: QP 
and partial QP thresholds.

    (a) * * *
    (1) * * *
    (iv) 2025: 50 percent.
    (v) 2026 and later: 75 percent.
    (2) * * *
    (iv) 2025: 40 percent.
    (v) 2026 and later: 50 percent.
    (3) * * *
    (iv) 2025: 35 percent.
    (v) 2026 and later: 50 percent.
    (4) * * *
    (iv) 2025: 25 percent.
    (v) 2026 and later: 35 percent.
    (b)
    (1) * * *
    (i) * * *
    (A) 2021 through 2025: 50 percent.
    (B) 2026 and later: 75 percent.
* * * * *
    (2) * * *
    (i) * * *
    (A) 2021 through 2025:40 percent.
    (B) 2026 and later: 50 percent.
* * * * *
    (3) * * *
    (i) * * *
    (A) 2021 through 2025: 35 percent.
    (B) 2026 and later: 50 percent.
* * * * *
    (4) * * *
    (i) * * *
    (A) 2021 through 2025: 25 percent.
    (B) 2026 and later: 35 percent.
* * * * *

0
66. Section 414.1450 is amended by--
0
a. Adding paragraphs (a)(1)(i) and (ii); and
0
b. Revising paragraph (b)(1).
    The addition and revision read as follows:


Sec.  414.1450  APM incentive payment.

    (a) * * *
    (i) For payment years 2019 through 2025, CMS makes a lump sum 
payment to QPs in the amount described in paragraph (b) of this section 
in the manner described in paragraphs (d) and (e) of this section.
    (ii) [Reserved]
* * * * *
    (b) * * *
    (1) For payment years 2019 through 2024, the amount of the APM 
Incentive Payment is equal to 5 percent or, with respect to payment 
year 2025, 3.5 percent of the estimated aggregate payments for covered 
professional services as defined in section 1848(k)(3)(A) of the Act 
furnished during the calendar year immediately preceding the payment 
year. CMS uses the paid amounts on claims for covered professional 
services to calculate the estimated aggregate payments on which CMS 
will calculate the APM Incentive Payment.
* * * * *

PART 415--SERVICES FURNISHED BY PHYSICIANS IN PROVIDERS, 
SUPERVISING PHYSICIANS IN TEACHING SETTINGS, AND RESIDENTS IN 
CERTAIN SETTINGS

0
67. The authority for part 415 continues to read as follows:

    Authority:  42 U.S.C. 1302 and 1395hh.


0
68. Amend Sec.  415.140 in paragraph (a) by revising the definition of 
``Substantive portion'' to read as follows:


Sec.  415.140  Conditions of payment: Split (or shared) visits.

    (a) * * *
    Substantive portion means more than half of the total time spent by 
the physician and nonphysician practitioner performing the split (or 
shared) visit, or a substantive part of the medical decision making 
except as otherwise provided in this paragraph. For critical care 
visits, substantive portion means more than half of the total time 
spent by the physician and nonphysician practitioner performing the 
split (or shared) visit.
* * * * *

PART 418--HOSPICE CARE

0
69. The authority citation for part 418 continues to read as follow:

    Authority:  42 U.S.C. 1302 and 1395hh.


0
70. Section 418.56 is amended by revising paragraph (a)(1)(iii) to read 
as follows:


Sec.  418.56  Condition of participation: Interdisciplinary group, care 
planning, and coordination of services.

* * * * *
    (a) * * *
    (1) * * *
    (iii) A social worker, marriage and family therapist, or a mental 
health counselor.
* * * * *

0
71. Section 418.114 is amended by adding paragraphs (b)(9) and (10) to 
read as follows:


Sec.  418.114  Condition of participation: Personnel qualifications.

* * * * *
    (b) * * *
    (9) Marriage and family counselor as defined at Sec.  410.53.
    (10) Mental health counselor as defined at Sec.  410.54.
* * * * *

PART 422--MEDICARE ADVANTAGE PROGRAM

0
72. The authority citation for part 422 is revised to read as follows:

    Authority: 42 U.S.C. 1302, 1306, 1395w-22 through 1395w-28, and 
1395hh.


0
73. Section 422.310 is amended by adding paragraph (f)(3)(iv) to read 
as follows:


Sec.  422.310  Risk adjustment data.

* * * * *
    (f) * * *
    (3) * * *

[[Page 79540]]

    (iv) CMS determines that releasing aggregated data before 
reconciliation is necessary and appropriate to support activities or 
authorized uses under paragraph (f)(1)(vii) of this section.
* * * * *

PART 423--VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT

0
74. The authority citation for part 423 continues to read as follows:

    Authority:  42 U.S.C. 1302, 1306, 1395w-101 through 1395w-152, 
and 1395hh.


0
75. Section 423.160 is amended by--
0
a. Revising paragraph (a)(5) introductory text;
0
b. Removing paragraph (a)(5)(i);
0
c. Redesignating paragraphs (a)(5)(ii) through (iv) as paragraphs 
(a)(5)(i) through (iii), respectively and revising newly redesignated 
paragraph (a)(5)(ii).
    The revisions read as follows:


Sec.  423.160  Standards for electronic prescribing.

    (a) * * *
    (5) Beginning on January 1, 2021, prescribers must, except in the 
circumstances described in paragraphs (a)(5)(i) through (iii) of this 
section, conduct prescribing for at least 70 percent of their Schedule 
II, III, IV, and V controlled substances that are Part D drugs 
electronically using the applicable standards in paragraph (b) of this 
section, subject to the exemption in paragraph (a)(3)(iii) of this 
section. Prescriptions written for a beneficiary in a long-term care 
facility will not be included in determining compliance until January 
1, 2025. Compliance actions against prescribers who do not meet the 
compliance threshold based on prescriptions written for a beneficiary 
in a long-term care facility will commence on or after January 1, 2025. 
Compliance actions against prescribers who do not meet the compliance 
threshold based on other prescriptions will commence on or after 
January 1, 2023. Prescribers will be exempt from this requirement in 
the following situations:
* * * * *
    (ii) Prescriber has an address in PECOS in the geographic area of 
an emergency or disaster declared by a Federal, State, or local 
government entity. If a prescriber does not have an address in PECOS, 
prescriber has an address in NPPES in the geographic area of an 
emergency or disaster declared by a Federal, State, or local government 
entity. Starting in the 2024 measurement year, CMS will identify which 
emergencies or disasters qualify for this exception.
* * * * *

PART 424--CONDITIONS FOR MEDICARE PAYMENT

0
76. The authority for part 424 continues to read as follows:

    Authority:  42 U.S.C. 1302 and 1395hh.


0
77. Section 424.205 is amended by--
0
a. In paragraph (a), by removing the definition of ``MDPP interim 
preliminary recognition'';
0
b. Revising paragraph (b)(1);
0
c. Removing paragraph (c);
0
d. Redesignating paragraphs (d) through (i) as paragraphs (c) through 
(h), respectively; and
0
e. Revising newly designated paragraph (c)(1);
0
f. Removing newly redesignated paragraph (c)(10)(iii);
0
g. Revising newly redesignated paragraph (c)(14);
0
h. Revising newly redesignated paragraphs (f)(2)(i);
0
i. Removing newly redesignated paragraph (f)(5)(iii);
0
j. Redesignating newly redesignated paragraphs (f)(5)(iv) and (v) as 
paragraphs (f)(5)(iii) and (iv), respectively;
0
k. Revising newly redesignated paragraph (f)(5)(iii) and paragraph 
(g)(1)(i)(C).
    The revisions read as follows:


Sec.  424.205  Requirements for Medicare Diabetes Prevention Program 
suppliers.

* * * * *
    (b) * * *
    (1) Has either preliminary, full, full plus CDC DPRP recognition.
* * * * *
    (c) * * *
    (1) The MDPP supplier must have and maintain preliminary, full, or 
full plus CDC DPRP recognition.
* * * * *
    (14) The MDPP supplier must submit performance data for MDPP 
beneficiaries who ever attended ongoing maintenance sessions with data 
elements consistent with the CDC's DPRP standards for data elements 
required for the core services period.
* * * * *
    (f) * * *
    (2) * * *
    (i) Documentation of the type of session, whether a core session, a 
core maintenance session, an in-person make-up session, or a virtual 
make-up session.
* * * * *
    (5) * * *
    (iii) Has achieved at least a 9-percent weight loss percentage as 
measured in accordance with Sec.  410.79(e)(3)(iii) of this chapter 
during a core session or core maintenance session furnished by that 
supplier, if the claim submitted is for a performance payment under 
Sec.  414.84(b)(7) of this chapter.
* * * * *
    (g) * * *
    (1) * * *
    (i) * * *
    (C) An MDPP supplier that does not satisfy the requirements in 
paragraph (b)(1) of this section may become eligible to bill for MDPP 
services again if it successfully achieves preliminary, full, or full 
plus CDC DPRP recognition, and successfully enrolls again in Medicare 
as an MDPP supplier after any applicable reenrollment bar has expired.
* * * * *

0
78. Section 424.210 is amended by revising paragraphs (b)(2) and (d)(1) 
to read as follows:


Sec.  424.210  Beneficiary engagement incentives under the Medicare 
Diabetes Prevention Program expanded model.

* * * * *
    (b) * * *
    (2) The item or service must be reasonably connected to the CDC-
approved National Diabetes Prevention Program curriculum furnished to 
the MDPP beneficiary during a core session or core maintenance session 
furnished by the MDPP supplier.
* * * * *
    (d) * * *
    (1) Attendance at core sessions or core maintenance sessions.
* * * * *

0
79. Section 424.502 is amended by--
0
a. Revising the definition of ``Authorized official''; and
0
b. Adding the definitions of ``Indirect ownership interest,'' and 
``Supplier'' in alphabetical order.
    The revision and additions read as follows:


Sec.  424.502  Definitions.

* * * * *
    Authorized official means an appointed official (for example, chief 
executive officer, chief financial officer, general partner, chairman 
of the board, or direct owner) to whom the organization has granted the 
legal authority to enroll it in the Medicare program, to make changes 
or updates to the organization's status in the Medicare program, and to 
commit the organization to fully abide by the statutes, regulations, 
and program instructions of the Medicare program. For purposes of this 
definition only, the term ``organization'' means the enrolling entity 
as identified by its legal business name and tax identification number.
* * * * *
    Indirect ownership interest means as follows:

[[Page 79541]]

    (1)(i) Any ownership interest in an entity that has an ownership 
interest in the enrolling or enrolled provider or supplier.
    (ii) Any ownership interest in an indirect owner of the enrolling 
or enrolled provider or supplier.
    (2) The amount of indirect ownership interest is determined by 
multiplying the percentages of ownership in each entity. For example, 
if A owns 10 percent of the stock in a corporation that owns 80 percent 
of the provider or supplier, A's interest equates to an 8 percent 
indirect ownership interest in the provider or supplier and must be 
reported on the enrollment application. Conversely, if B owns 80 
percent of the stock of a corporation that owns 5 percent of the stock 
of the provider or supplier, B's interest equates to a 4 percent 
indirect ownership interest in the provider or supplier and need not be 
reported.
* * * * *
    Supplier means, for purposes of this subpart, all of the following:
    (1) The individuals and entities that qualify as suppliers under 
Sec.  400.202.
    (2) Physical therapists in private practice.
    (3) Occupational therapists in private practice.
    (4) Speech-language pathologists.
* * * * *

0
80. Section 424.516 is amended by revising paragraphs (d)(1)(iii) and 
(e)(1) to read as follows:


Sec.  424.516  Additional provider and supplier requirements for 
enrolling and maintaining active enrollment status in the Medicare 
program.

* * * * *
    (d) * * *
    (1) * * *
    (iii) A change, addition, or deletion of a practice location.
* * * * *
    (e) * * *
    (1) Within 30 days for a change of ownership or control (including 
changes in authorized official(s) or delegated official(s)) or a 
change, addition, or deletion of a practice location;
* * * * *

0
81. Section 424.530 is amended by revising paragraph (a)(1) and adding 
paragraphs (a)(16), (17) and (18) to read as follows:


Sec.  424.530  Denial of enrollment in the Medicare program.

    (a) * * *
    (1) Noncompliance. The provider or supplier is determined to not be 
in compliance with the enrollment requirements described in this title 
42, or in the enrollment application applicable for its provider or 
supplier type, and has not submitted a plan of corrective action as 
outlined in part 488 of this chapter.
* * * * *
    (16) [Reserved]
    (17) False Claims Act (FCA). (i) The provider or supplier, or any 
owner, managing employee or organization, officer, or director of the 
provider or supplier, has had a civil judgment under the FCA (31 U.S.C. 
3729 through 3733) imposed against them within the previous 10 years.
    (ii) In determining whether a denial under this paragraph is 
appropriate, CMS considers the following factors:
    (A) The number of provider or supplier actions that the judgment 
incorporates (for example, the number of false claims submitted).
    (B) The types of provider or supplier actions involved.
    (C) The monetary amount of the judgment.
    (D) When the judgment occurred.
    (E) Whether the provider or supplier has any history of final 
adverse actions (as that term is defined in Sec.  424.502 of this 
chapter).
    (F) Any other information that CMS deems relevant to its 
determination.
    (18) Supplier standard or condition violation. (i) The independent 
diagnostic testing facility is non-compliant with any provision in 
Sec.  410.33(g).
    (ii) The DMEPOS supplier is non-compliant with any provision in 
Sec.  424.57(c).
    (iii) The opioid treatment program is non-compliant with any 
provision in Sec.  424.67(b).
    (iv) The home infusion therapy supplier is non-compliant with any 
provision in Sec.  424.68(c).
    (v) The Medicare diabetes prevention program is non-compliant with 
any provision in Sec.  424.205(b) or (d).
* * * * *

0
82. Section 424.535 is amended by--
0
a Revising paragraphs (a)(1) introductory text;
0
b. Adding paragraph (a)(15);
0
c. Revising paragraph (a)(17) introductory text;
0
d. Redesignating paragraphs (a)(17)(i) through (vi) as paragraphs 
(a)(17)(i)(A) through (F);
0
e. Adding paragraph (a)(17)(ii);
0
f. Adding paragraph (a)(23); and
0
g. Revising paragraphs (e) and (g).
    The additions and revisions read as follows:


Sec.  424.535  Revocation of enrollment in the Medicare program.

    (a) * * *
    (1) Noncompliance. The provider or supplier is determined to not be 
in compliance with the enrollment requirements described in this title 
42, or in the enrollment application applicable for its provider or 
supplier type, and has not submitted a plan of corrective action as 
outlined in part 488 of this chapter. The provider or supplier may also 
be determined not to be in compliance if it has failed to pay any user 
fees as assessed under part 488 of this chapter.
* * * * *
    (15) False Claims Act (FCA). (i) The provider or supplier, or any 
owner, managing employee or organization, officer, or director of the 
provider or supplier, has had a civil judgment under the FCA (31 U.S.C. 
3729 through 3733) imposed against them within the previous 10 years.
    (ii) In determining whether a revocation under this paragraph is 
appropriate, CMS considers the following factors:
    (A) The number of provider or supplier actions that the judgment 
incorporates (for example, the number of false claims submitted).
    (B) The types of provider or supplier actions involved.
    (C) The monetary amount of the judgment.
    (D) When the judgment occurred.
    (E) Whether the provider or supplier has any history of final 
adverse actions (as that term is defined in Sec.  424.502).
    (F) Any other information that CMS deems relevant to its 
determination.
* * * * *
    (17) Debt referred to the United States Department of Treasury. (i) 
The provider or supplier failed to repay a debt that CMS appropriately 
referred to the United States Department of Treasury. In determining 
whether a revocation under this paragraph (a)(17) is appropriate, CMS 
considers the following factors:
* * * * *
    (ii) Paragraph (17)(i) of this paragraph does not apply to the 
following situations:
    (A) The provider's or supplier's Medicare debt has been discharged 
by a bankruptcy court; or
    (B) The administrative appeals process concerning the debt has not 
been exhausted or the timeframe for filing such an appeal (at the 
appropriate level of appeal) has not expired.
* * * * *
    (23) Supplier standard or condition violation. (i) The independent 
diagnostic testing facility is non-compliant with any provision in 42 
CFR 410.33(g).

[[Page 79542]]

    (ii) The DMEPOS supplier is non-compliant with any provision in 
Sec.  424.57(c).
    (iii) The opioid treatment program is non-compliant with any 
provision in Sec.  424.67(b) or (e).
    (iv) The home infusion therapy supplier is non-compliant with any 
provision in Sec.  424.68(c) or (e).
    (v) The Medicare diabetes prevention program is non-compliant with 
any provision in Sec.  424.205(b) or (d).
* * * * *
    (e) Reversal of revocation. If the revocation was due to adverse 
activity (sanction, exclusion, or felony) against the provider's or 
supplier's owner, managing employee, managing organization, officer, 
director, authorized or delegated official, medical director, 
supervising physician, or other health care or administrative or 
management services personnel furnishing services payable by a Federal 
health care program, the revocation may be reversed if the provider or 
supplier terminates and submits proof that it has terminated its 
business relationship with that party within 15 days of the revocation 
notification.
* * * * *
    (g) Effective date of revocation. (1) Except as described in 
paragraphs (g)(2) and (g)(3) of this section, a revocation becomes 
effective 30 days after CMS or the CMS contractor mails notice of its 
determination to the provider or supplier.
    (2) Except as described in paragraph (g)(3) of this section, the 
revocation effective dates in the situations identified in this 
paragraph (g)(2) are as follows:
    (i) For revocations based on a Federal exclusion or debarment, the 
date of the exclusion or debarment.
    (ii) For revocations based on a felony conviction, the date of the 
felony conviction.
    (iii) For revocations based on a State license suspension or 
revocation, the date of the license suspension or revocation.
    (iv) For revocations based on a CMS determination that the 
provider's or supplier's practice location is non-operational, the date 
on which the provider's or supplier's practice location was no longer 
operational (per CMS' or the CMS contractor's determination).
    (v) For revocations based on a State license surrender in lieu of 
further disciplinary action, the date of the license surrender.
    (vi) For revocations based on termination from a Federal health 
care program other than Medicare (for example, Medicaid), the date of 
the termination.
    (vii) For revocations based on termination of a provider agreement 
under part 489 of this chapter, and as applicable to the type of 
provider involved, the later of the following:
    (A) The date of the provider agreement termination; or
    (B) The date that CMS establishes under Sec.  489.55.
    (viii) For revocations based on Sec.  424.535(a)(23), the effective 
dates are as follows:
    (A) If the standard or condition violation involves the suspension, 
revocation, or termination (or surrender in lieu of further 
disciplinary action) of the provider's or supplier's Federal or State 
license, certification, accreditation, or MDPP recognition, the 
effective date is the date of the license, certification, 
accreditation, or MDPP recognition suspension, revocation, termination, 
or surrender.
    (B) If the standard or condition violation involves a non-
operational practice location, the effective date is the date the non-
operational status began.
    (C) If the standard violation involves a felony conviction of an 
individual or entity described in Sec.  424.67(b)(6)(i), the effective 
date is the date of the felony conviction.
    (D) For all standard violations not addressed in paragraphs (A) 
through (C), the effective date in paragraph (g)(1) applies if the 
effective date in paragraph (g)(3) does not.
    (3) If the action that resulted in the revocation occurred prior to 
the effective date of the provider's or supplier's enrollment, the 
effective date of the revocation is the same as the effective date of 
enrollment.
* * * * *

0
83. Section 424.541 is added to read as follows:


Sec.  424.541  Stay of enrollment.

    (a)(1) CMS may stay an enrolled provider's or supplier's enrollment 
if the provider or supplier:
    (i) Is non-compliant with at least one enrollment requirement in 
Title 42; and.
    (ii) Can remedy the non-compliance via the submission of, as 
applicable to the situation, a Form CMS-855, Form CMS-20134, or Form 
CMS-588 change of information or revalidation application.
    (2) During the period of any stay imposed under this section, the 
following apply:
    (i) The provider or supplier remains enrolled in Medicare;
    (ii)(A) Except as stated in paragraph (a)(2)(ii)(B) of this 
section, claims submitted by the provider or supplier with dates of 
service within the stay period will be rejected.
    (B) Notwithstanding paragraph (a)(2)(ii)(A), claims submitted by 
the provider or supplier with dates of service within the stay period 
are eligible for payment (and may be resubmitted by the provider or 
supplier within applicable timeframes specified in Title 42) if:
    (1) CMS or its contractor determines that the provider or supplier 
has resumed compliance with all Medicare enrollment requirements in 
Title 42; and
    (2) The stay ends (as described in subsection (a)(5) of this 
section) on or before the 60th day of the stay period.
    (3) A stay of enrollment lasts no longer than 60 days from the 
postmark date of the notification letter, which is the effective date 
of the stay.
    (4) CMS notifies the affected provider or supplier in writing of 
the imposition of the stay.
    (5) A stay of enrollment ends on the date on which CMS or its 
contractor determines that the provider or supplier has resumed 
compliance with all Medicare enrollment requirements in Title 42 or the 
day after the 60-day stay period expires, whichever occurs first.
    (b)(1) If a provider or supplier receives written notice from CMS 
or its contractor that the provider or supplier is subject to a stay 
under this section, the provider or supplier has 15 calendar days from 
the date of the written notice to submit a rebuttal to the stay as 
described in paragraph (b) of this section.
    (2) CMS may, at its discretion, extend the 15-day time-period 
referenced in paragraph (b)(1) of this section.
    (3) Any rebuttal submitted pursuant to paragraph (b) of this 
section must:
    (i) Be in writing.
    (ii) Specify the facts or issues about which the provider or 
supplier disagrees with the stay's imposition and/or the effective 
date, and the reasons for disagreement.
    (iii) Submit all documentation the provider or supplier wants CMS 
to consider in its review of the stay.
    (iv) Be submitted in the form of a letter that is signed and dated 
by the individual supplier (if enrolled as an individual physician or 
nonphysician practitioner), the authorized official or delegated 
official (as those terms are defined in Sec.  424.502), or a legal 
representative (as defined in 42 CFR 498.10). If the legal 
representative is an attorney, the attorney must include a statement 
that he or she has the authority to represent the provider or supplier; 
this statement is sufficient to constitute notice of such authority. If

[[Page 79543]]

the legal representative is not an attorney, the provider or supplier 
must file with CMS written notice of the appointment of a 
representative; this notice of appointment must be signed and dated by, 
as applicable, the individual supplier, the authorized official or 
delegated official, or a legal representative.
    (4) The provider's or supplier's failure to submit a rebuttal that 
is both timely under paragraph (b)(1) of this section and fully 
compliant with all of the requirements of paragraph (b)(3) of this 
section constitutes a waiver of all rebuttal rights under this section.
    (5) Upon receipt of a timely and compliant stay rebuttal, CMS 
reviews the rebuttal to determine whether the imposition of the stay 
and/or the effective date thereof are correct.
    (6) A determination made under paragraph (b) of this section is not 
an initial determination under 42 CFR 498.3(b) and therefore not 
appealable.
    (7) Nothing in paragraph (b) of this section requires CMS to delay 
the imposition of a stay pending the completion of the review described 
in paragraph (b)(5) of this section.
    (8)(i) Nothing in paragraph (b) of this section requires CMS to 
delay the imposition of a deactivation or revocation, pending the 
completion of the review described in paragraph (b)(5) of this section.
    (ii)(A) If CMS deactivates the provider or supplier during the 
stay, any rebuttal to the stay that the provider or supplier submits 
that meets the requirements of paragraph (b) of this section is 
combined and considered with the provider's or supplier's rebuttal to 
the deactivation under Sec.  424.546 if CMS has not yet made a 
determination on the stay rebuttal pursuant to this section.
    (B) In all cases other than that described in paragraph 
(b)(8)(ii)(A) of this section, a stay rebuttal that was submitted in 
compliance with the requirements of paragraph (b) of this section is 
considered separately and independently of any review of any other 
rebuttal or, for revocations, appeal under 42 CFR part 498.

0
84. Section 424.555 is amended by revising paragraph (b) to read as 
follows:


Sec.  424.555  Payment liability.

* * * * *
    (b) No payment may be made for otherwise Medicare covered items or 
services furnished to a Medicare beneficiary by a provider or supplier 
if the billing privileges of the provider or supplier are deactivated, 
denied, or revoked, or if the provider or supplier is currently under a 
stay of enrollment (except as stated in Sec.  424.541(a)(2)(ii)(B)). 
The Medicare beneficiary has no financial responsibility for expenses, 
and the provider or supplier must refund on a timely basis to the 
Medicare beneficiary any amounts collected from the Medicare 
beneficiary for these otherwise Medicare covered items or services.
* * * * *

PART 425--MEDICARE SHARED SAVINGS PROGRAM

0
85. The authority citation for part 425 continues to read as follows:

    Authority: 42 U.S.C. 1302, 1306, 1395hh, and 1395jjj.


0
86. Section 425.20 is amended--
0
a. By revising the definitions of ``Assignable beneficiary'' and 
``Assignment window'';
0
b. In the definition of ``At-risk beneficiary'' by--
0
i. Removing the periods at the end of paragraphs (5) and (6), and 
adding in their places semicolons; and
0
ii. Revising paragraph (7);
0
c. By adding the definitions of ``Beneficiary eligible for Medicare 
CQMs'' and ``Expanded window for assignment'' in alphabetical order;
0
d. In the definition of ``Experienced with performance-based risk 
Medicare ACO initiatives'' by revising paragraph (2);
0
e. In the definition of ``Inexperienced with performance-based risk 
Medicare ACO initiatives'' by revising paragraph (2);
0
f. In the definition of ``Rural health center'' by--
0
i. Removing the word ``center'' and adding in its place the word 
``clinic''; and
0

0
ii. Removing the phrase ``under Sec.  405.2401(b)'' and adding in its 
place the phrase ``under Sec.  405.2401(b) of this chapter''.
    The revisions and additions read as follows:


Sec.  425.20  Definitions.

* * * * *
    Assignable beneficiary means a Medicare fee-for-service beneficiary 
who receives at least one primary care service with a date of service 
during a specified 12-month assignment window from a Medicare-enrolled 
physician who is a primary care physician or who has one of the 
specialty designations included in Sec.  425.402(c). For performance 
year 2025 and subsequent performance years, a Medicare fee-for-service 
beneficiary who does not meet this requirement but who meets both of 
the following criteria will also be considered an assignable 
beneficiary--
    (1) Receives at least one primary care service with a date of 
service during a specified 24-month expanded window for assignment from 
a Medicare-enrolled physician who is a primary care physician or who 
has one of the specialty designations included in Sec.  425.402(c).
    (2) Receives at least one primary care service with a date of 
service during a specified 12-month assignment window from a Medicare-
enrolled practitioner who is one of the following:
    (i) A physician assistant (as defined at Sec.  410.74(a)(2) of this 
chapter).
    (ii) A nurse practitioner (as defined at Sec.  410.75(b) of this 
chapter).
    (iii) A clinical nurse specialist (as defined at Sec.  410.76(b) of 
this chapter).
* * * * *
    Assignment window means the 12-month period used to assign 
beneficiaries to an ACO, or to identify assignable beneficiaries, or 
both.
    At-risk beneficiary * * *
    (7) Is entitled to Medicare because of disability; or
* * * * *
    Beneficiary eligible for Medicare CQMs means a beneficiary 
identified for purposes of reporting Medicare CQMs for ACOs 
participating in the Medicare Shared Savings Program (Medicare CQMs), 
who is either of the following:
    (1) A Medicare fee-for-service beneficiary (as defined at Sec.  
425.20) who -
    (i) Meets the criteria for a beneficiary to be assigned to an ACO 
described at Sec.  425.401(a); and
    (ii) Had at least one claim with a date of service during the 
measurement period from an ACO professional who is a primary care 
physician or who has one of the specialty designations included in 
Sec.  425.402(c), or who is a physician assistant, nurse practitioner, 
or clinical nurse specialist.
    (2) A Medicare fee-for-service beneficiary who is assigned to an 
ACO in accordance with Sec.  425.402(e) because the beneficiary 
designated an ACO professional participating in an ACO as responsible 
for coordinating their overall care.
* * * * *
    Expanded window for assignment means the 24-month period used to 
assign beneficiaries to an ACO, or to identify assignable 
beneficiaries, or both that includes the applicable 12-month assignment 
window and the preceding 12 months.
    Experienced with performance-based risk Medicare ACO initiatives * 
* *
    (2) Forty percent or more of the ACO's ACO participants 
participated in a performance-based risk Medicare ACO

[[Page 79544]]

initiative, or in an ACO that deferred its entry into a second Shared 
Savings Program agreement period under a two-sided model under Sec.  
425.200(e), in any of the 5 most recent performance years. An ACO 
participant is considered to have participated in a performance-based 
risk Medicare ACO initiative if the ACO participant TIN was or will be 
included in financial reconciliation for one or more performance years 
under such initiative during any of the 5 most recent performance 
years.
* * * * *
    Inexperienced with performance-based risk Medicare ACO initiatives 
* * *
    (2) Less than 40 percent of the ACO's ACO participants participated 
in a performance-based risk Medicare ACO initiative, or in an ACO that 
deferred its entry into a second Shared Savings Program agreement 
period under a two-sided model under Sec.  425.200(e), in each of the 5 
most recent performance years. An ACO participant is considered to have 
participated in a performance-based risk Medicare ACO initiative if the 
ACO participant TIN was or will be included in financial reconciliation 
for one or more performance years under such initiative during any of 
the 5 most recent performance years.
* * * * *

0
87. Section 425.106 is amended by revising paragraph (c)(5) to read as 
follows:


Sec.  425.106  Shared governance.

* * * * *
    (c) * * *
    (5)(i) In cases in which the composition of the ACO's governing 
body does not meet the requirements of paragraph (c)(2) of this 
section, the ACO must describe why it seeks to differ from these 
requirements and how the ACO will provide meaningful representation in 
ACO governance by Medicare beneficiaries.
    (ii) For agreement periods beginning before January 1, 2024, in 
cases in which the composition of the ACO's governing body does not 
meet the requirements of paragraph (c)(3) of this section, the ACO must 
describe why it seeks to differ from these requirements and how the ACO 
will involve ACO participants in innovative ways in ACO governance.
* * * * *

0
88. Section 425.204 is amended by--
0
a. In paragraph (c)(3)(ii), by removing the reference ``(c)(2)'' and 
adding in its place the reference ``Sec.  425.106(c)(2)''; and
0
b. Revising paragraph (c)(3)(iii).
    The revision reads as follows:


Sec.  425.204  Content of the application.

* * * * *
    (c) * * *
    (3) * * *
    (iii) If seeking an exception to the requirement at Sec.  
425.106(c)(3), for agreement periods beginning before January 1, 2024, 
why the ACO is unable to meet the requirement and how it will involve 
ACO participants in innovative ways in ACO governance.
* * * * *

0
89. Section 425.302 is amended by revising paragraph (a)(3)(iii) to 
read as follows:


Sec.  425.302  Program requirements for data submission and 
certifications.

    (a) * * *
    (3) * * *
    (iii) For performance years starting on January 1, 2019 through 
2024, the percentage of eligible clinicians participating in the ACO 
that use CEHRT to document and communicate clinical care to their 
patients or other health care providers meets or exceeds the applicable 
percentage specified by CMS at Sec.  425.506(f).
* * * * *

0
90. Section 425.308 is amended by adding paragraph (b)(9) to read as 
follows:


Sec.  425.308  Public reporting and transparency.

* * * * *
    (b) * * *
    (9) For performance year 2025 and subsequent performance years, the 
total number of ACO participants, ACO providers/suppliers, and ACO 
professionals that are MIPS eligible clinicians, Qualifying APM 
Participants (QPs), or Partial Qualifying APM Participants (Partial 
QPs) (each as defined at Sec.  414.1305 of this chapter) that earn a 
MIPS performance category score for the MIPS Promoting Interoperability 
performance category as set forth in Sec.  425.507 that is comprised of 
the following--
    (i) The number of ACO participants, ACO providers/suppliers, and 
ACO professionals that meet the requirements of Sec.  425.507(a) and 
are not excluded under Sec.  425.507(b) for the applicable performance 
year; and
    (ii) The number of ACO participants, ACO providers/suppliers, and 
ACO professionals that are excluded under Sec.  425.507(b) that 
voluntarily reported and received a MIPS Promoting Interoperability 
performance category score for the applicable performance year.
* * * * *

0
91. Section 425.316 is amended by revising paragraphs (e)(2) 
introductory text and (e)(2)(i) to read as follows:


Sec.  425.316  Monitoring of ACOs.

* * * * *
    (e) * * *
    (2) If CMS determines that an ACO participating in advance 
investment payments became experienced with performance-based risk 
Medicare ACO initiatives during its first or second performance year of 
its agreement period or that the ACO became a high revenue ACO during 
any performance year of its agreement period, CMS--
    (i) Will cease payment of advance investment payments no later than 
the quarter after the ACO became experienced with performance-based 
risk Medicare ACO initiatives or became a high revenue ACO.
* * * * *

0
92. Section 425.400 is amended--
0
a. By revising paragraph (a)(2)(ii);
0
b. In paragraph (a)(3)(i), by removing the phrase ``most recent 12 
months'' and adding in its place the phrase ``most recent 12 or 24 
months, as applicable,'';
0
c. By revising paragraph (c)(1)(vii) introductory text;
0
d. By adding paragraph (c)(1)(viii); and
0
e. By revising paragraphs (c)(2)(i) introductory text and (c)(2)(ii).
    The revisions and addition read as follows:


Sec.  425.400  General.

    (a) * * *
    (2) * * *
    (ii) Assignment will be updated quarterly based on the most recent 
12 or 24 months of data, as applicable, under the methodology described 
in Sec. Sec.  425.402 and 425.404.
* * * * *
    (c) * * *
    (1) * * *
    (vii) For the performance year starting on January 1, 2023 as 
follows:
* * * * *
    (viii) For the performance year starting on January 1, 2024, and 
subsequent performance years as follows:
    (A) CPT codes:
    (1) 96160 and 96161 (codes for administration of health risk 
assessment).
    (2) 96202 and 96203 (codes for caregiver behavior management 
training).
    (3) 97550, 97551, and 97552 (codes for caregiver training 
services).
    (4) 99201 through 99215 (codes for office or other outpatient visit 
for the evaluation and management of a patient).

[[Page 79545]]

    (5) 99304 through 99318 (codes for professional services furnished 
in a nursing facility; professional services or services reported on an 
FQHC or RHC claim identified by these codes are excluded when furnished 
in a SNF).
    (6) 99319 through 99340 (codes for patient domiciliary, rest home, 
or custodial care visit).
    (7) 99341 through 99350 (codes for evaluation and management 
services furnished in a patient's home).
    (8) 99354 and 99355 (add-on codes, for prolonged evaluation and 
management or psychotherapy services beyond the typical service time of 
the primary procedure; when the base code is also a primary care 
service code under this paragraph (c)(1)(viii)).
    (9) 99406 and 99407 (codes for smoking and tobacco-use cessation 
counseling services).
    (10) 99421, 99422, and 99423 (codes for online digital evaluation 
and management).
    (11) 99424, 99425, 99426, and 99427 (codes for principal care 
management services).
    (12) 99437, 99487, 99489, 99490 and 99491 (codes for chronic care 
management).
    (13) 99439 (code for non-complex chronic care management).
    (14) 99483 (code for assessment of and care planning for patients 
with cognitive impairment).
    (15) 99484, 99492, 99493 and 99494 (codes for behavioral health 
integration services).
    (16) 99495 and 99496 (codes for transitional care management 
services).
    (17) 99497 and 99498 (codes for advance care planning; services 
identified by these codes furnished in an inpatient setting are 
excluded).
    (B) HCPCS codes:
    (1) G0019 and G0022 (codes for community health integration 
services).
    (2) G0023 and G0024 (codes for principal illness navigation 
services).
    (3) G0101 (code for cervical or vaginal cancer screening).
    (4) G0136 (code for social determinants of health risk assessment 
services).
    (5) G0317, G0318, and G2212 (codes for prolonged office or other 
outpatient visit for the evaluation and management of a patient).
    (6) G0402 (code for the Welcome to Medicare visit).
    (7) G0438 and G0439 (codes for the annual wellness visits).
    (8) G0442 (code for alcohol misuse screening service).
    (9) G0443 (code for alcohol misuse counseling service).
    (10) G0444 (code for annual depression screening service).
    (11) G0463 (code for services furnished in ETA hospitals).
    (12) G0506 (code for chronic care management).
    (13) G2010 (code for the remote evaluation of patient video/
images).
    (14) G2012 and G2252 (codes for virtual check-in).
    (15) G2058 (code for non-complex chronic care management).
    (16) G2064 and G2065 (codes for principal care management 
services).
    (17) G2086, G2087, and G2088 (codes for office-based opioid use 
disorder services).
    (18) G2211 (code for visit complexity inherent to evaluation and 
management services add-on).
    (19) G2214 (code for psychiatric collaborative care model).
    (20) G3002 and G3003 (codes for chronic pain management).
    (C) Primary care service codes include any CPT code identified by 
CMS that directly replaces a CPT code specified in paragraph 
(c)(1)(viii)(A) of this section or a HCPCS code specified in paragraph 
(c)(1)(viii)(B) of this section, when the assignment window (as defined 
in Sec.  425.20) for a benchmark or performance year includes any day 
on or after the effective date of the replacement code for payment 
purposes under FFS Medicare.
    (2) * * *
    (i) Except as otherwise specified in paragraph (c)(2)(i)(A)(2) of 
this section, when the assignment window or applicable expanded window 
for assignment (as defined in Sec.  425.20) for a benchmark or 
performance year includes any month(s) during the COVID-19 Public 
Health Emergency defined in Sec.  400.200 of this chapter, in 
determining beneficiary assignment, we use the primary care service 
codes identified in paragraph (c)(1) of this section, and additional 
primary care service codes as follows:
* * * * *
    (ii) Except as otherwise specified in paragraph (c)(2)(i)(A)(2) of 
this section, the additional primary care service codes specified in 
paragraph (c)(2)(i) of this section are applicable to all months of the 
assignment window or applicable expanded window for assignment (as 
defined in Sec.  425.20), when the assignment window or applicable 
expanded window for assignment includes any month(s) during the COVID-
19 Public Health Emergency defined in Sec.  400.200 of this chapter.

0
93. Section 425.402 is amended--
0
a. By revising paragraph (b)(1);
0
b. By adding paragraph (b)(5);
0
c. By revising paragraph (c) introductory text; and
0
d. In paragraph (e)(2)(ii)(A), by removing the reference ``Sec.  
425.400(a)(4)(ii)'' and adding in its place the reference ``Sec.  
425.226(a)(1)''.
    The revisions and addition read as follows:


Sec.  425.402  Basic assignment methodology.

* * * * *
    (b) * * *
    (1) Identify all beneficiaries that had at least one primary care 
service during the applicable assignment window with a physician who is 
an ACO professional in the ACO and who is a primary care physician as 
defined under Sec.  425.20 or who has one of the primary specialty 
designations included in paragraph (c) of this section.
* * * * *
    (5) For performance year 2025 and subsequent performance years, CMS 
employs the following third step to assign Medicare fee-for-service 
beneficiaries who were not identified by the criterion specified in 
paragraph (b)(1) of this section:
    (i) Identify all beneficiaries who had at least one primary care 
service with a non-physician ACO professional in the ACO during the 
applicable assignment window.
    (ii) For the beneficiaries identified in paragraph (b)(5)(i) of 
this section, identify those beneficiaries that had at least one 
primary care service with a physician who is an ACO professional in the 
ACO and who is a primary care physician as defined under Sec.  425.20 
or who has one of the primary specialty designations included in 
paragraph (c) of this section during the applicable expanded window for 
assignment.
    (iii) Identify all primary care services furnished to beneficiaries 
identified in paragraph (b)(5)(ii) of this section by ACO professionals 
in the ACO who are primary care physicians as defined under Sec.  
425.20, non-physician ACO professionals, and physicians with specialty 
designations included in paragraph (c) of this section during the 
applicable expanded window for assignment.
    (iv) A beneficiary identified in paragraph (b)(5)(ii) of this 
section is assigned to the ACO if the allowed charges for primary care 
services furnished to the beneficiary by ACO professionals in the ACO 
who are primary care physicians, physicians with specialty designations 
included in paragraph (c) of this section, or non-physician ACO 
professionals during the applicable expanded window for assignment are 
greater than the allowed charges for primary care services furnished by 
primary care physicians, physicians with specialty designations

[[Page 79546]]

as specified in paragraph (c) of this section, nurse practitioners, 
physician assistants, and clinical nurse specialists who are--
    (A) ACO professionals in any other ACO; or
    (B) Not affiliated with any ACO and identified by a Medicare-
enrolled billing TIN.
    (c) ACO professionals considered in the second and third step of 
the assignment methodology in paragraphs (b)(4) and (5) of this section 
include physicians who have one of the following primary specialty 
designations:
* * * * *

0
94. Section 425.506 is amended by revising paragraph (f) introductory 
text to read as follows:


Sec.  425.506  Incorporating reporting requirements related to adoption 
of certified electronic health record technology.

* * * * *
    (f) For performance years starting on January 1, 2019 through 2024, 
ACOs in a track that--
* * * * *

0
95. Section 425.507 is added to subpart F to read as follows:


Sec.  425.507  Incorporating Promoting Interoperability requirements 
related to the Quality Payment Program for performance years beginning 
on or after January 1, 2025.

    (a) For performance years beginning on or after January 1, 2025, 
unless otherwise excluded under paragraph (b) of this section, an ACO 
participant, ACO provider/supplier, and ACO professional that is a MIPS 
eligible clinician, Qualifying APM Participant (QP), or Partial 
Qualifying APM Participant (Partial QP) (each as defined at Sec.  
414.1305 of this chapter) must satisfy all of the following:
    (1) Report the MIPS Promoting Interoperability performance category 
measures and requirements to MIPS according to 42 CFR part 414 subpart 
O at the individual, group, virtual group, or APM entity level.
    (2) Earn a performance category score for the MIPS Promoting 
Interoperability performance category at the individual, group, virtual 
group, or APM entity level.
    (b) An ACO participant, ACO provider/supplier, or ACO professional 
is excluded from the requirements specified in paragraph (a) of this 
section in accordance with applicable policies that exclude or 
otherwise exempt eligible clinicians from reporting the MIPS Promoting 
Interoperability performance category as set forth in 42 CFR part 414 
subpart O, provided however, that an ACO participant, ACO provider/
supplier, or ACO professional cannot be excluded from the requirements 
specified in paragraph (a) solely on the basis of being a QP or Partial 
QP. Applicable exclusions may include:
    (1) Low volume threshold as set forth at Sec.  414.1310(b)(1)(iii) 
of this chapter.
    (2) Eligible clinician as defined at Sec.  414.1305 of this chapter 
who is not a MIPS eligible clinician as set forth in Sec.  
414.1310(b)(2) of this chapter.
    (3) Reweighting of the MIPS Promoting Interoperability performance 
category to zero percent of the final score in accordance with 
applicable policies set forth at Sec.  414.1380(c)(2) of this chapter.

0
96. Section 425.512 is amended--
0
a. By revising paragraph (a)(2);
0
b. In paragraph (a)(5)(i) introductory text, by removing the phrase 
``paragraph (a)(2) of this section'' and adding in its place the phrase 
``paragraphs (a)(2) and (a)(7) of this section'';
0
c. By revising paragraphs (a)(5)(i)(A)(2), (a)(5)(iii)(A) and (B);
0
d. By adding paragraph (a)(7);
0
e. In paragraph (b)(1)--
0
i. By adding a new first sentence;
0
ii. By removing the reference ``paragraph (b)(2)'' and adding in its 
place the reference ``paragraph (b)(3)'';
0
f. By redesignating paragraphs (b)(2) and (3) as paragraphs (b)(3) and 
(4), respectively;
0
g. By adding new paragraph (b)(2);
0
h. By revising the newly redesignated paragraph (b)(3)(ii)(B);
0
i. In newly redesignated paragraph (b)(3)(iii), by removing the phrase 
``paragraph (b)(2)(ii) of this section'' and adding in its place the 
phrase ``paragraph (b)(3)(ii) of this section'';
0
j. By revising newly redesignated paragraph (b)(3)(iv)(A);
0
k. In newly redesignated paragraph (b)(3)(iv)(B), by removing the 
phrase ``paragraph (b)(2)(iv)(A) of this section'' and adding in its 
place the phrase ``paragraph (b)(3)(iv)(A) of this section'';
0
l. In newly redesignated paragraph (b)(3)(v)--
0
i. By removing the phrase ``paragraph (b)(2)(iv)(B) of this section'' 
and adding in its place the phrase ``paragraph (b)(3)(iv)(B) of this 
section'';
0
ii. By removing the phrase ``paragraph (b)(2)(iii) of this section'' 
and adding in its place the phrase ``paragraph (b)(3)(iii) of this 
section'';
0
iii. By removing the phrase ``paragraph (b)(2)(iv) of this section'' 
and adding in its place the phrase ``paragraph (b)(3)(iv) of this 
section'';
0
m. In newly redesignated paragraph (b)(4) introductory text, by 
removing the phrase ``paragraphs (b)(1) and (b)(2) of this section'' 
and adding in its place the phrase ``paragraphs (b)(1) through (b)(3) 
of this section'';
0
n. By revising newly redesignated paragraph (b)(4)(i); and
0
o. By revising paragraph (c)(3).
    The revisions and additions read as follows:


Sec.  425.512  Determining the ACO quality performance standard for 
performance years beginning on or after January 1, 2021.

    (a) * * *
    (2) For the first performance year of an ACO's first agreement 
period under the Shared Savings Program, the ACO will meet the quality 
performance standard if it meets the requirements under this paragraph 
(a)(2).
    (i) For performance years 2022 and 2023. If the ACO reports data 
via the APP and meets the data completeness requirement at Sec.  
414.1340 of this subchapter and the case minimum requirement at Sec.  
414.1380 of this subchapter on the ten CMS Web Interface measures or 
the three eCQMs/MIPS CQMs, and the CAHPS for MIPS survey, for the 
applicable performance year.
    (ii) For performance year 2024. If the ACO reports data via the APP 
and meets the data completeness requirement at Sec.  414.1340 of this 
subchapter on the ten CMS Web Interface measures or the three eCQMs/
MIPS CQMs/Medicare CQMs, and the CAHPS for MIPS survey (except as 
specified in Sec.  414.1380(b)(1)(vii)(B) of this subchapter), and 
receives a MIPS Quality performance category score under Sec.  
414.1380(b)(1) of this subchapter, for the applicable performance year.
    (iii) For performance year 2025 and subsequent performance years. 
If the ACO reports data via the APP and meets the data completeness 
requirement at Sec.  414.1340 of this subchapter on the three eCQMs/
MIPS CQMs/Medicare CQMs, and the CAHPS for MIPS survey (except as 
specified in Sec.  414.1380(b)(1)(vii)(B) of this subchapter), and 
receives a MIPS Quality performance category score under Sec.  
414.1380(b)(1) of this subchapter, for the applicable performance year.
* * * * *
    (5) * * *
    (i) * * *
    (A) * * *
    (2) If the ACO reports the three eCQMs/MIPS CQMs in the APP measure 
set, meeting the data completeness requirement at Sec.  414.1340 of 
this subchapter for all three eCQMs/MIPS CQMs, and achieving a quality 
performance score equivalent to or

[[Page 79547]]

higher than the 10th percentile of the performance benchmark on at 
least one of the four outcome measures in the APP measure set and a 
quality performance score equivalent to or higher than the 40th 
percentile of the performance benchmark on at least one of the 
remaining five measures in the APP measure set.
* * * * *
    (iii) * * *
    (A) For performance year 2024, the ACO does not report any of the 
ten CMS Web Interface measures, any of the three eCQMs/MIPS CQMs/
Medicare CQMs and does not administer a CAHPS for MIPS survey (except 
as specified in Sec.  414.1380(b)(1)(vii)(B) of this subchapter) under 
the APP.
    (B) For performance year 2025 and subsequent years, the ACO does 
not report any of the three eCQMs/MIPS CQMs/Medicare CQMs and does not 
administer a CAHPS for MIPS survey (except as specified in Sec.  
414.1380(b)(1)(vii)(B) of this subchapter) under the APP.
* * * * *
    (7) For performance years 2024 and subsequent performance years, if 
an ACO reports all of the required measures, meeting the data 
completeness requirement at Sec.  414.1340 of this subchapter for each 
measure in the APP measure set and receiving a MIPS Quality performance 
category score as described at Sec.  414.1380(b)(1) of this subchapter, 
CMS will use the higher of the ACO's health equity adjusted quality 
performance score or the equivalent of the 40th percentile MIPS Quality 
performance category score across all MIPS Quality performance category 
scores, excluding entities/providers eligible for facility-based 
scoring, for the relevant performance year when the ACO meets either of 
the following:
    (i) The ACO's total available measure achievement points used to 
calculate the ACO's MIPS Quality performance category score is reduced 
under Sec.  414.1380(b)(1)(vii)(A) of this subchapter.
    (ii) At least one of the eCQMs/MIPS CQMs/Medicare CQMs does not 
have a benchmark as described at Sec.  414.1380(b)(1)(i)(A) of this 
subchapter.
    (b) * * *
    (1) For performance year 2023. * * *
    (2) For performance year 2024 and subsequent performance years. For 
an ACO that reports the three eCQMs/MIPS CQMs/Medicare CQMs in the APP 
measure set, meeting the data completeness requirement at Sec.  
414.1340 of this subchapter for all three eCQMs/MIPS CQMs/Medicare 
CQMs, and administers the CAHPS for MIPS survey (except as specified in 
Sec.  414.1380(b)(1)(vii)(B) of this subchapter), CMS calculates the 
ACO's health equity adjusted quality performance score as the sum of 
the ACO's MIPS Quality performance category score for all measures in 
the APP measure set and the ACO's health equity adjustment bonus points 
calculated in accordance with paragraph (b)(3) of this section. The sum 
of these values may not exceed 100 percent.
    (3) * * *
    (ii) * * *
    (B) Values of zero for each measure that CMS does not evaluate 
because the measure is unscored or the ACO does not meet the case 
minimum or the minimum sample size for the measure.
* * * * *
    (iv) * * *
    (A) (1) CMS determines the proportion ranging from zero to one of 
the ACO's assigned beneficiary population for the performance year that 
is considered underserved based on the highest of either of the 
following:
    (i) The proportion of the ACO's assigned beneficiaries residing in 
a census block group with an Area Deprivation Index (ADI) national 
percentile rank of at least 85. An ACO's assigned beneficiaries without 
an available numeric ADI national percentile rank are excluded from the 
calculation of the proportion of the ACO's assigned beneficiaries 
residing in a census block group with an ADI national percentile rank 
of at least 85.
    (ii) The proportion of the ACO's assigned beneficiaries who are 
enrolled in the Medicare Part D low-income subsidy (LIS); or are dually 
eligible for Medicare and Medicaid.
    (2) CMS calculates the proportions specified in paragraph 
(b)(3)(iv)(A)(1)(ii) of this section as follows:
    (i) For performance year 2023, the proportion of the ACO's assigned 
beneficiaries who are enrolled in the Medicare Part D LIS or are dually 
eligible for Medicare and Medicaid divided by the total number of the 
ACO's assigned beneficiaries' person years.
    (ii) For performance year 2024 and subsequent performance years, 
the proportion of the ACO's assigned beneficiaries with any months 
enrolled in LIS or dually eligible for Medicare and Medicaid divided by 
the total number of the ACO's assigned beneficiaries.
* * * * *
    (4) * * *
    (i) In determining whether the ACO meets the quality performance 
standard as specified under paragraphs (a)(4)(i)(A), (a)(5)(i)(A)(1), 
(a)(5)(i)(B), and (a)(7) of this section.
* * * * *
    (c) * * *
    (3) If CMS determines the ACO meets the requirements of paragraph 
(c)(1) of this section and the ACO reports quality data via the APP, 
CMS calculates the ACO's quality score as follows:
    (i) For performance years 2021 and 2022, if the ACO reports quality 
data via the APP and meets data completeness and case minimum 
requirements, CMS will use the higher of the ACO's quality performance 
score or the equivalent of the 30th percentile MIPS Quality performance 
category score across all MIPS Quality performance category scores, 
excluding entities/providers eligible for facility-based scoring, for 
the relevant performance year.
    (ii) For performance year 2023, if the ACO reports quality data via 
the APP and meets data completeness and case minimum requirements, CMS 
will use the higher of the ACO's health equity adjusted quality 
performance score or the equivalent of the 30th percentile MIPS Quality 
performance category score across all MIPS Quality performance category 
scores, excluding entities/providers eligible for facility-based 
scoring, for the relevant performance year.
    (iii) For performance year 2024 and subsequent performance years, 
if the ACO reports quality data via the APP and meets the data 
completeness requirement at Sec.  414.1340 of this subchapter and 
receives a MIPS Quality performance category score under Sec.  
414.1380(b)(1) of this subchapter, CMS will use the higher of the ACO's 
health equity adjusted quality performance score or the equivalent of 
the 40th percentile MIPS Quality performance category score across all 
MIPS Quality performance category scores, excluding entities/providers 
eligible for facility-based scoring, for the relevant performance year.
* * * * *


Sec.  425.600  [Amended]

0
97. Amend Sec.  425.600 in paragraph (f)(4)(ii) by removing the 
reference ``425.656(d)'' and adding in its place the reference 
``425.656(e)''.


Sec.  425.601  [Amended]

0
98. Amend Sec.  425.601 in paragraph (a) introductory text by removing 
the reference ``Sec.  425.226(a)(1)'' and adding in its place the 
reference ``Sec.  425.400(a)(4)(ii)''.

[[Page 79548]]

Sec.  425.611  [Amended]

0
99. Amend Sec.  425.611 in paragraph (c)(2)(iii) by removing the 
reference ``Sec.  425.652(a)(8)(iv)'' and adding in its place the 
reference ``Sec.  425.658(c)(1)(ii)''.

0
100. Section 425.630 is amended--
0
a. By revising paragraphs (b)(2) and (3), (e)(3), (f) introductory 
text, and (g)(4);
0
b. In paragraph (h)(1)(i), by removing ``or'' at the end of the 
paragraph;
0
c. In paragraph (h)(1)(ii), by removing ``.'' at the end of the 
paragraph, and adding in its place ``; or''; and
0
d. By adding paragraph (h)(1)(iii) and paragraph (i).
    The revisions and additions read as follows:


Sec.  425.630  Option to receive advance investment payments.

* * * * *
    (b) * * *
    (2) CMS has determined that the ACO is eligible to participate in 
the Shared Savings Program.
    (3) The ACO is inexperienced with performance-based risk Medicare 
ACO initiatives during its first 2 performance years and participates 
in the BASIC track's glide path as follows:
    (i) For performance year 1, the ACO must participate in Level A of 
the BASIC track's glide path.
    (ii) For performance year 2, the ACO may participate in Level A of 
the BASIC track's glide path (in accordance with Sec.  
425.600(a)(4)(i)(C)(3)) or Level B.
    (iii) For performance years 3 through 5, the ACO may participate in 
Level A of the BASIC track's glide path (in accordance with Sec.  
425.600(a)(4)(i)(C)(3)), or Levels B through E.
* * * * *
    (e) * * *
    (3) Duration for spending payments. An ACO may spend an advance 
investment payment over its entire agreement period. An ACO must repay 
to CMS any unspent funds remaining at the end of the ACO's agreement 
period, except if the ACO terminated its current participation 
agreement under Sec.  425.220 at the end of performance year 2 or later 
and immediately enters a new agreement period to continue its 
participation in the Shared Savings Program, the ACO must spend its 
advance investment payments within 5 performance years of when it first 
received advance investment payments and repay to CMS any unspent funds 
remaining at the end of that fifth performance year.
* * * * *
    (f) Payment methodology. An ACO receives two types of advance 
investment payments: a one-time payment of $250,000 and quarterly 
payments calculated pursuant to the methodology defined in paragraph 
(f)(2) of this section. CMS notifies in writing each ACO of its 
determination of the amount of advance investment payment and the 
notice will inform the ACO of its right to request reconsideration 
review in accordance with the procedures specified in subpart I of this 
part. If CMS does not make any advance investment payment, the notice 
will specify the reason(s) why and inform the ACO of its right to 
request reconsideration review in accordance with the procedures 
specified in subpart I of this part.
* * * * *
    (g) * * *
    (4) If an ACO terminates its participation agreement during the 
agreement period in which it received an advance investment payment, 
the ACO must repay all advance investment payments it received, unless 
the ACO terminated its current participation agreement under Sec.  
425.220 at the end of performance year 2 or later during the agreement 
period in which it received advance investment payments and immediately 
enters a new agreement period to continue its participation in the 
program. CMS will provide written notification to the ACO of the amount 
due and the ACO must pay such amount no later than 90 days after the 
receipt of such notification.
* * * * *
    (h) * * *
    (1) * * *
    (iii) Voluntarily terminates its participation agreement in 
accordance with Sec.  425.220(a).
* * * * *
    (i) Reporting information on advance investment payments. The ACO 
must report information on its receipt of and use of advance investment 
payments, as follows:
    (1) The ACO must publicly report information about the ACO's use of 
advance investment payments for each performance year, in accordance 
with Sec.  425.308(b)(8).
    (2) In a form and manner and by a deadline specified by CMS, the 
ACO must report to CMS the same information it is required to publicly 
report under Sec.  425.308(b)(8).


Sec.  425.650  [Amended]

0
101. Amend Sec.  425.650 in paragraph (a) by removing the references 
``Sec. Sec.  425.601, 425.602, and 425.603'' and adding in their place 
the references ``Sec. Sec.  425.601, 425.602, 425.603, and 425.659''.

0
102. Section 425.652 is amended--
0
a. In paragraph (a) introductory text, by removing the reference 
``Sec.  425.226(a)(1)'' and adding in its place the reference ``Sec.  
425.400(a)(4)(ii)'';
0
b. By revising paragraphs (a)(5)(v)(A), (a)(8), (a)(9) introductory 
text, and (a)(9)(ii);
0
c. In paragraph (a)(9)(iv), by removing the reference ``Sec.  
425.400(a)(4)(ii)'' and adding in its place the reference ``Sec.  
425.226(a)(1)'';
0
d. In paragraph (a)(9)(v), by removing the phrase ``, or a combination 
of these two adjustments'';
0
e. By adding paragraphs (a)(9)(vi) and (b)(2)(ii)(C); and
0
f. By revising paragraph (b)(2)(iv)(A).
    The revisions and additions read as follows:


Sec.  425.652  Establishing, adjusting, and updating the benchmark for 
agreement periods beginning on January 1, 2024, and in subsequent 
years.

    (a) * * *
    (5) * * *
    (v) * * *
    (A) Calculating the county-level share of assignable beneficiaries 
that are assigned to the ACO for each county in the ACO's regional 
service area. The assignable population of beneficiaries is identified 
for BY3 using the assignment window or expanded window for assignment 
that is consistent with the beneficiary assignment methodology selected 
by the ACO for the performance year according to Sec.  
425.400(a)(4)(ii).
* * * * *
    (8) Except as provided in paragraph (a)(8)(iii) of this section, 
adjusts the historical benchmark based on the ACO's regional service 
area expenditures (as specified under Sec.  425.656), or for savings 
generated by the ACO, if any, in the 3 most recent years prior to the 
start of the agreement period (as specified under Sec.  425.658). CMS 
does all of the following to determine the adjustment, if any, applied 
to the historical benchmark:
    (i) Computes the regional adjustment in accordance with Sec.  
425.656 and the prior savings adjustment in accordance with Sec.  
425.658.

[[Page 79549]]

    (ii) If an ACO is not eligible to receive a prior savings 
adjustment under Sec.  425.658(b)(3)(i), and the regional adjustment, 
expressed as a single value as described in Sec.  425.656(d), is 
positive, the ACO will receive an adjustment to its benchmark equal to 
the positive regional adjustment amount. The adjustment will be 
calculated as described in Sec.  425.656(c) and applied separately to 
the following populations of beneficiaries: ESRD, disabled, aged/dual 
eligible Medicare and Medicaid beneficiaries, and aged/non-dual 
eligible Medicare and Medicaid beneficiaries.
    (iii) If an ACO is not eligible to receive a prior savings 
adjustment under Sec.  425.658(b)(3)(i), and the regional adjustment, 
expressed as a single value as described in Sec.  425.656(d), is 
negative or zero, the ACO will not receive an adjustment to its 
benchmark.
    (iv) If an ACO is eligible to receive a prior savings adjustment 
and the regional adjustment, expressed as a single value as described 
in Sec.  425.656(d), is positive, the ACO will receive an adjustment to 
its benchmark equal to the higher of the following:
    (A) The positive regional adjustment amount. The adjustment will be 
calculated as described in Sec.  425.656(c) and applied separately to 
the following populations of beneficiaries: ESRD, disabled, aged/dual 
eligible Medicare and Medicaid beneficiaries, and aged/non-dual 
eligible Medicare and Medicaid beneficiaries.
    (B) The prior savings adjustment. The adjustment will be calculated 
as described in Sec.  425.658(c) and applied as a flat dollar amount to 
the following populations of beneficiaries: ESRD, disabled, aged/dual 
eligible Medicare and Medicaid beneficiaries, and aged/non-dual 
eligible Medicare and Medicaid beneficiaries.
    (v) If an ACO is eligible to receive a prior savings adjustment and 
the regional adjustment, expressed as a single value as described in 
Sec.  425.656(d), is negative or zero, the ACO will receive an 
adjustment to its benchmark equal to the prior savings adjustment. The 
adjustment will be calculated as described in Sec.  425.658(c) and 
applied as a flat dollar amount to the following populations of 
beneficiaries: ESRD, disabled, aged/dual eligible Medicare and Medicaid 
beneficiaries, and aged/non-dual eligible Medicare and Medicaid 
beneficiaries.
    (9) For the first performance year during the term of the agreement 
period, the ACO's benchmark is adjusted for the following, as 
applicable: For changes in values used in benchmark calculations in 
accordance with Sec.  425.316(b)(2)(ii)(B) or (C) due to compliance 
action to address avoidance of at-risk beneficiaries or as a result of 
issuance of a revised initial determination under Sec.  425.315. For 
the second and each subsequent performance year during the term of the 
agreement period, the ACO's benchmark is adjusted for the following, as 
applicable: For the addition and removal of ACO participants or ACO 
providers/suppliers in accordance with Sec.  425.118(b), for a change 
to the ACO's beneficiary assignment methodology selection under Sec.  
425.226(a)(1), for a change to the beneficiary assignment methodology 
specified in subpart E of this part, for a change in the CMS-HCC risk 
adjustment methodology used to calculate prospective HCC risk scores 
under Sec.  425.659, and for changes in values used in benchmark 
calculations in accordance with Sec.  425.316(b)(2)(ii)(B) or (C) due 
to compliance action to address avoidance of at-risk beneficiaries or 
as a result of issuance of a revised initial determination under Sec.  
425.315. To adjust the benchmark, CMS does the following:
* * * * *
    (ii) Redetermines the regional adjustment amount under Sec.  
425.656 according to the ACO's assigned beneficiaries for BY3, and 
based on the assignable population of beneficiaries identified for BY3 
using the assignment window or expanded window for assignment that is 
consistent with the beneficiary assignment methodology selected by the 
ACO for the performance year according to Sec.  425.400(a)(4)(ii).
* * * * *
    (vi) Redetermines factors based on prospective HCC risk scores 
calculated for benchmark years by calculating the prospective HCC risk 
scores using the CMS-HCC risk adjustment methodology that applies for 
the calendar year corresponding to the applicable performance year in 
accordance with Sec.  425.659(b)(1).
* * * * *
    (b) * * *
    (2) * * *
    (ii) * * *
    (C) Multiply the growth rate calculated in this paragraph 
(b)(2)(ii) by a regional risk score growth cap adjustment factor 
computed as described in Sec.  425.655.
* * * * *
    (iv) * * *
    (A) Calculating the county-level share of assignable beneficiaries 
that are assigned to the ACO for each county in the ACO's regional 
service area. The assignable population of beneficiaries is identified 
for the performance year using the assignment window or expanded window 
for assignment that is consistent with the beneficiary assignment 
methodology selected by the ACO for the performance year according to 
Sec.  425.400(a)(4)(ii).
* * * * *

0
103. Section 425.654 is amended by revising paragraph (a)(1)(i) to read 
as follows:


Sec.  425.654  Calculating county expenditures and regional 
expenditures.

    (a) * * *
    (1) * * *
    (i) Determines average county fee-for-service expenditures based on 
expenditures for the assignable population of beneficiaries in each 
county in the ACO's regional service area. The assignable population of 
beneficiaries is identified for the relevant benchmark or performance 
year using the assignment window or expanded window for assignment that 
is consistent with the beneficiary assignment methodology selected by 
the ACO for the performance year according to Sec.  425.400(a)(4)(ii).
* * * * *

0
104. Section 425.655 is added to subpart G to read as follows:


Sec.  425.655  Calculating the regional risk score growth cap 
adjustment factor.

    (a) General. This section describes the methodology for calculating 
the regional risk score growth cap adjustment factor that will be 
applied to the regional growth rate component of the three-way blend 
used to update the historical benchmark as described in Sec.  
425.652(b) for agreement periods beginning on January 1, 2024, and in 
subsequent years.
    (b) Calculating county risk scores. CMS does all of the following 
to determine county prospective HCC and demographic risk scores for use 
in calculating the ACO's regional risk scores:
    (1) Determines average county prospective HCC and demographic risk 
scores for the assignable population of beneficiaries in each county in 
the ACO's regional service area. The assignable population of 
beneficiaries is identified for the relevant benchmark or performance 
year using the assignment window or expanded window for assignment that 
is consistent with the beneficiary assignment methodology selected by 
the ACO for the performance year according to Sec.  425.400(a)(4)(ii).
    (2) Makes separate risk score calculations for each of the 
following populations of beneficiaries:
    (i) ESRD.

[[Page 79550]]

    (ii) Disabled.
    (iii) Aged/dual eligible Medicare and Medicaid beneficiaries.
    (iv) Aged/non-dual eligible Medicare and Medicaid beneficiaries.
    (c) Calculating regional risk scores. CMS calculates an ACO's 
regional prospective HCC and demographic risk scores by:
    (1) Weighting the county-level risk scores determined under 
paragraph (b) of this section according to the ACO's proportion of 
assigned beneficiaries in the county, determined by the number of the 
ACO's assigned beneficiaries in the applicable population (according to 
Medicare enrollment type) residing in the county in relation to the 
ACO's total number of assigned beneficiaries in the applicable 
population (according to Medicare enrollment type) for the relevant 
benchmark or performance year for each of the following populations of 
beneficiaries:
    (i) ESRD.
    (ii) Disabled.
    (iii) Aged/dual eligible Medicare and Medicaid beneficiaries.
    (iv) Aged/non-dual eligible Medicare and Medicaid beneficiaries.
    (2) Aggregating the values determined under paragraph (c)(1) of 
this section for each population of beneficiaries (according to 
Medicare enrollment type) across all counties within the ACO's regional 
service area.
    (d) Determining aggregate growth in regional risk scores. CMS 
determines aggregate growth in regional prospective HCC and demographic 
risk scores by:
    (1) Determining growth in regional prospective HCC and demographic 
risk scores determined in paragraph (c) of this section (expressed as a 
ratio of the performance year regional risk score to the BY3 regional 
risk score) for each of the following populations of beneficiaries:
    (i) ESRD.
    (ii) Disabled.
    (iii) Aged/dual eligible Medicare and Medicaid beneficiaries.
    (iv) Aged/non-dual eligible Medicare and Medicaid beneficiaries.
    (2) Determines the aggregate growth in regional risk scores by 
calculating a weighted average of the growth in regional prospective 
HCC risk scores or demographic risk scores, as applicable, across the 
populations described in paragraph (d)(1) of this section. When 
calculating the weighted average growth in prospective HCC risk scores 
or demographic risk scores, as applicable, the weight applied to the 
growth in risk scores for each Medicare enrollment type is equal to the 
product of the ACO's regionally adjusted historical benchmark 
expenditures for that enrollment type and the ACO's performance year 
assigned beneficiary person years for that enrollment type.
    (e) Determining the cap on regional risk score growth. CMS 
determines the cap on regional prospective HCC risk score growth by:
    (1) Computing the sum of the aggregate growth in regional 
demographic risk scores as determined in paragraph (d)(2) of this 
section and 3 percentage points.
    (2) Calculating the ACO's aggregate market share by calculating the 
weighted average of the share of assignable beneficiaries in the ACO's 
regional service area that are assigned to the ACO for the performance 
year as determined in Sec.  425.652(b)(2)(iv) across the populations 
described in Sec.  425.652(b)(1). In calculating this weighted average, 
the weight applied to the share for each Medicare enrollment type is 
equal to the ACO's performance year assigned beneficiary person years 
for that enrollment type.
    (3) Adding to the sum computed in paragraph (e)(1) of this section 
an amount equal to the product of:
    (i) The ACO's aggregate market share as determined in paragraph 
(e)(2) of this section.
    (ii) The difference between the aggregate growth in regional 
prospective HCC risk scores as determined in paragraph (d)(2) of this 
section and the sum determined in paragraph (e)(1) of this section. 
This difference is subject to a floor of zero.
    (f) Determining the regional risk score growth cap adjustment 
factor. CMS determines the regional risk score growth cap adjustment 
factor for each Medicare enrollment type to be applied in calculating 
the regional growth rate described in Sec.  425.652(b) by comparing the 
aggregate growth in regional prospective HCC risk scores determined in 
paragraph (d)(2) of this section and, if applicable, the growth in 
regional prospective HCC risk scores for individual Medicare enrollment 
types as determined in paragraph (d)(1) of this section with the cap 
determined in paragraph (e) of this section.
    (1) If the aggregate growth in regional prospective HCC risk scores 
determined in paragraph (d)(2) of this section does not exceed the cap 
on regional risk score growth determined in paragraph (e) of this 
section, CMS will set the regional risk score growth cap adjustment 
factor equal to 1 for each of the following populations of 
beneficiaries:
    (i) ESRD.
    (ii) Disabled.
    (iii) Aged/dual eligible Medicare and Medicaid beneficiaries.
    (iv) Aged/non-dual eligible Medicare and Medicaid beneficiaries.
    (2) If the aggregate growth in regional prospective HCC risk scores 
determined in paragraph (d)(2) of this section exceeds the cap 
determined in paragraph (e) of this section, CMS will compare the 
growth in regional prospective HCC risk scores for each Medicare 
enrollment type as determined in paragraph (d)(1) of this section with 
the cap on regional risk score growth determined in paragraph (e) of 
this section.
    (i) If the growth in regional prospective HCC risk scores for the 
enrollment type determined in paragraph (d)(1) of this section does not 
exceed the cap on regional risk score growth determined in paragraph 
(e) of this section, CMS will set the regional risk score growth cap 
adjustment factor for that enrollment type equal to 1.
    (ii) If the growth in regional prospective HCC risk scores 
determined in paragraph (d)(1) for the enrollment type exceeds the cap 
on regional risk score growth determined in paragraph (e) of this 
section, CMS will set the regional risk score growth cap adjustment 
factor for that enrollment type equal to the growth in regional 
prospective HCC risk scores for the enrollment type determined in 
paragraph (d)(1) of this section divided by the cap on regional risk 
score growth determined in paragraph (e) of this section.

0
105. Section 425.656 is amended--
0
a. By revising paragraph (b)(3);
0
b. In paragraph (c)(2), by removing the phrase ``paragraph (d) of this 
section'' and adding in its place the phrase ``paragraph (e) of this 
section'';
0
c. By redesignating paragraphs (d) and (e) as paragraphs (e) and (f), 
respectively;
0
d. By adding new paragraph (d);
0
e. In newly redesignated paragraph (e)(5)(ii), by removing the phrase 
``paragraph (d)(5)(i) of this section'' and adding in its place the 
phrase ``paragraph (e)(5)(i) of this section'';
0
f. In newly redesignated paragraph (e)(5)(iv), by removing the phrase 
``paragraphs (d)(1) through (3)'' and adding in its place the phrase 
``paragraphs (e)(1) through (3)''; and
0
g. In newly redesignated paragraph (f) introductory text, by removing 
the phrase ``paragraphs (b) through (d)'' and adding in its place the 
phrase ``paragraphs (b) through (e)''.
    The revision and addition read as follows:

[[Page 79551]]

Sec.  425.656  Calculating the regional adjustment to the historical 
benchmark.

* * * * *
    (b) * * *
    (3) Adjusts for differences in severity and case mix between the 
ACO's assigned beneficiary population for BY3 and the assignable 
population of beneficiaries for the ACO's regional service area for 
BY3. The assignable population of beneficiaries is identified for BY3 
using the assignment window or expanded window for assignment that is 
consistent with the beneficiary assignment methodology selected by the 
ACO for the performance year according to Sec.  425.400(a)(4)(ii).
* * * * *
    (d) Expression of the regional adjustment as a single value. (1) 
CMS expresses the regional adjustment as a single value by taking a 
person-year weighted average of the Medicare enrollment type-specific 
regional adjustment values determined in paragraph (c) of this section.
    (2) CMS uses the regional adjustment expressed as a single value 
for purposes of determining the adjustment, if any, that will be 
applied to the benchmark in accordance with Sec.  425.652(a)(8).
* * * * *

0
106. Section 425.658 is amended--
0
a. In paragraph (b)(3)(i), by removing the sentence ``The ACO will 
receive the regional adjustment to its benchmark as described in Sec.  
425.656.'';
0
b. By revising paragraph (c) and adding paragraphs (d) and (e).
    The revision and additions read as follows:


Sec.  425.658  Calculating the prior savings adjustment to the 
historical benchmark.

* * * * *
    (c) Calculate the per capita prior savings adjustment. (1) If an 
ACO is eligible for the prior savings adjustment as determined in 
paragraph (b)(3) of this section, the prior savings adjustment will 
equal the lesser of the following:
    (i) 50 percent of the pro-rated average per capita amount computed 
in paragraph (b)(3)(ii) of this section.
    (ii) 5 percent of national per capita expenditures for Parts A and 
B services under the original Medicare fee-for-service program in BY3 
for assignable beneficiaries identified for the 12-month calendar year 
corresponding to BY3 using data from the CMS Office of the Actuary and 
expressed as a single value by taking a person-year weighted average of 
the Medicare enrollment type-specific values.
    (2) [Reserved]
    (d) Applicability of the prior savings adjustment. CMS compares the 
per capita prior savings adjustment determined in paragraph (c)(1) of 
this section with the regional adjustment, expressed as a single value 
as described in Sec.  425.656(d), to determine the adjustment, if any, 
that will be applied to the ACO's benchmark in accordance with Sec.  
425.652(a)(8).
    (e) Recalculation of the prior savings adjustment during an 
agreement period. (1) The ACO's prior savings adjustment is 
recalculated for changes to the ACO's savings or losses for a 
performance year used in the prior savings adjustment calculation in 
accordance with Sec.  425.316(b)(2)(ii)(B) or (C) due to compliance 
action to address avoidance of at-risk beneficiaries or as a result of 
issuance of a revised initial determination under Sec.  425.315.
    (2) For a new ACO identified as a re-entering ACO, the prior 
savings adjustment is recalculated for changes to savings or losses for 
a performance year used in the prior savings adjustment calculation, if 
the savings or losses of the ACO in which the majority of the new ACO's 
participants were participating change in accordance with Sec.  
425.316(b)(2)(ii)(B) or (C) due to compliance action to address 
avoidance of at-risk beneficiaries or as a result of issuance of a 
revised initial determination under Sec.  425.315.

0
107. Section 425.659 is added to subpart G to read as follows:


Sec.  425.659  Calculating risk scores used in Shared Savings Program 
benchmark calculations.

    (a) General. CMS accounts for differences in severity and case mix 
of the ACO's assigned beneficiaries and assignable beneficiaries (as 
defined under Sec.  425.20) in calculations used in establishing, 
adjusting, and updating the ACO's historical benchmark.
    (b) Prospective Hierarchical Condition Category (HCC) risk score 
calculation. In determining Medicare FFS beneficiary prospective HCC 
risk scores for a performance year and each benchmark year of the ACO's 
agreement period, CMS does the following:
    (1) CMS specifies the CMS-HCC risk adjustment methodology used to 
calculate prospective HCC risk scores for Medicare FFS beneficiaries 
(as defined under Sec.  425.20) for use in Shared Savings Program 
calculations as follows:
    (i) In calculating risk scores for Medicare FFS beneficiaries for a 
performance year, CMS applies the CMS-HCC risk adjustment methodology 
applicable for the corresponding calendar year.
    (ii) For agreement periods beginning before January 1, 2024, CMS 
applies the CMS-HCC risk adjustment methodology for the calendar year 
corresponding to the benchmark year in calculating risk scores for 
Medicare FFS beneficiaries for each benchmark year of the agreement 
period.
    (iii) For agreement periods beginning on January 1, 2024, and in 
subsequent years, CMS applies the CMS-HCC risk adjustment methodology 
for the calendar year corresponding to the performance year, as 
specified under paragraph (b)(1)(i) of this section, in calculating 
risk scores for Medicare FFS beneficiaries for each benchmark year of 
the agreement period.
    (2) CMS does the following to calculate the prospective HCC risk 
scores identified in paragraph (b)(1) of this section for a benchmark 
or performance year:
    (i) Removes the Medicare Advantage coding intensity adjustment, if 
applicable.
    (ii) Renormalizes prospective HCC risk scores by Medicare 
enrollment type (ESRD, disabled, aged/dual eligible Medicare and 
Medicaid beneficiaries, and aged/non-dual eligible Medicare and 
Medicaid beneficiaries) based on the national assignable FFS population 
for the relevant benchmark or performance year.
    (iii) Calculates the average prospective HCC risk score by Medicare 
enrollment type (ESRD, disabled, aged/dual eligible Medicare and 
Medicaid beneficiaries, and aged/non-dual eligible Medicare and 
Medicaid beneficiaries).

0
108. Section 425.702 is amended--
0
a. In paragraph (c)(1)(ii) introductory text, by removing the phrase 
``process development'' and adding in its place the phrase ``protocol 
development'';
0
b. By revising paragraph (c)(1)(ii)(A)(3); and
0
c. By adding paragraph (c)(1)(iii).
    The revision and addition read as follows:


Sec.  425.702  Aggregate reports.

* * * * *
    (c) * * *
    (1) * * *
    (ii) * * *
    (A) * * *
    (3) Beneficiary identifier.
* * * * *
    (iii) For performance year 2024 and subsequent performance years, 
CMS, upon the ACO's request for the data for purposes of population-
based activities relating to improving health or reducing growth in 
health care costs, protocol development, case management, and care 
coordination, provides the ACO with information about its fee-for-
service population.

[[Page 79552]]

    (A) The following information is made available to ACOs regarding 
beneficiaries eligible for Medicare CQMs as defined at Sec.  425.20:
    (1) Beneficiary name.
    (2) Date of birth.
    (3) Beneficiary identifier.
    (4) Sex.
    (B) Information in the following categories, which represents the 
minimum data necessary for ACOs to conduct health care operations work, 
is made available to ACOs regarding beneficiaries eligible for Medicare 
CQMs as defined at Sec.  425.20:
    (1) Demographic data such as enrollment status.
    (2) Health status information such as risk profile and chronic 
condition subgroup.
    (3) Utilization rates of Medicare services such as the use of 
evaluation and management, hospital, emergency, and post-acute 
services, including the dates and place of service.
* * * * *

PART 455--PROGRAM INTEGRITY: MEDICAID

0
109. The authority citation for part 455 continues to read as follows:

    Authority:  42 U.S.C. 1302.


0
110. Section 455.416 is amended by revising paragraph (c) to read as 
follows:


Sec.  455.416  Termination or denial of enrollment.

* * * * *
    (c) Must deny enrollment or terminate the enrollment of any 
provider that is terminated on or after January 1, 2011, under title 
XVIII of the Act and under the Medicaid program or CHIP of any other 
State, and is currently included in the termination database under 
Sec.  455.417.
* * * * *

0
111. Section 455.417 is added to read follows:


Sec.  455.417  Termination periods and termination database periods.

    (a)(1) Subject to paragraph (c) of this section, a provider remains 
in the termination notification database referenced in section 1902(ll) 
of the Act for a period that is the lesser of:
    (i) The length of the termination period imposed by the State that 
initially terminated the provider or the reenrollment bar (as described 
in Sec.  424.535(c) of this chapter) imposed by the Medicare program in 
the case of a Medicare revocation; or
    (ii) 10 years (for those Medicaid or CHIP terminations that are 
greater than 10 years).
    (2) All other State Medicaid agencies or CHIPs must terminate or 
deny the provider from their respective programs (pursuant to Sec.  
455.416(c)) for at least the same length of time as the termination 
database period described in paragraph (a)(1) of this section.
    (b)(1) Nothing in paragraph (a) of this section prohibits:
    (i) The initially terminating State from imposing a termination 
period of greater than 10 years consistent with that State's laws, or
    (ii) Another State from terminating the provider, based on the 
original State's termination, for a period:
    (A) Of greater than 10 years; or
    (B) That is otherwise longer than that imposed by the initially 
terminating State.
    (2) The period established under paragraph (b)(1)(ii) of this 
section must be no shorter than the period in which the provider is to 
be included in the termination database under paragraph (a) of this 
section.
    (c)(1) If the initially terminating State agency or the Medicare 
program reinstates the provider prior to the end of the termination 
period originally imposed by the initially terminating State agency or 
Medicare, CMS removes the provider from the termination database after 
the reinstatement has been reported to CMS.
    (2) If the provider is removed from the database pursuant to 
paragraph (c)(1), CMS may immediately reinclude the provider in the 
database (with no interval between the 2 periods) if a basis for doing 
so exists under part 455 or 424 of this chapter.
    (d) For purposes of this section only, terminations under Sec.  
455.416(c) are not considered ``for cause'' terminations and therefore 
need not be reported to CMS for inclusion in the termination database.

PART 489--PROVIDER AGREEMENTS AND SUPPLIER APPROVAL

0
112. The authority citation for part 489 continues to read as follows:

    Authority:  42 U.S.C. 1302, 1395i-3, 1395x, 1395aa(m), 1395cc, 
1395ff, and 1395hh.


0
113. Section 489.30 is amended by--
0
a. Revising paragraph (b)(1); and
0
b. Adding paragraphs (b)(6) and (7).
    The revision and additions read as follows:


Sec.  489.30  Allowable charges: Deductibles and coinsurance.

* * * * *
    (b) * * *
    (1) The basic allowable charges are the Part B annual deductible 
and 20 percent of the customary (insofar as reasonable) charges in 
excess of that deductible, except as specified in paragraphs (b)(6) and 
(7) of this section.
* * * * *
    (6) In the case of a rebatable drug (as defined in section 
1847A(i)(2)(A) of the Act), including a selected drug (as defined in 
section 1192(c) of the Act), furnished on or after April 1, 2023, in a 
calendar quarter in which the payment amount for such drug as specified 
in section 1847A(i)(3)(A)(ii)(I)(aa) or (bb), as applicable, exceeds 
the inflation-adjusted amount (as defined in section 1847A(i)(3)(C) of 
the Act) for such drug, the basic allowable charges are the Part B 
annual deductible and 20 percent of the inflation-adjusted payment 
amount for the rebatable drug in excess of that deductible, which is 
applied as a percent to the payment amount for such calendar quarter.
    (7) In the case of insulin furnished on or after July 1, 2023 
through an item of durable medical equipment covered under section 
1861(n) of the Act, the coinsurance amount shall not exceed $35 for a 
month's supply of such insulin each calendar month. This limitation on 
the coinsurance amount shall apply for the duration of the calendar 
month in which the date of service (or services) occurs. In addition, 
the coinsurance amount shall not exceed $105.00 for 3 months' supply of 
insulin. This limitation on the coinsurance amount shall apply for the 
duration of the calendar month in which the date of service (or 
services) occurs and the 2 following calendar months.

PART 491--CERTIFICATION OF CERTAIN HEALTH FACILITIES

0
114. The authority citation for part 491 continues to read as follows:

    Authority:  42 U.S.C. 263a and 1302.


0
115. Section 491.2 is amended by--
0
a. Adding the definitions of ``Certified nurse-midwife (CNM)'', 
``Clinical psychologist (CP)'', ``Clinical social worker'', ``Marriage 
and family therapist'', and ``Mental health counselor'' in alphabetical 
order; and
0
b. Revising the definition of ``Nurse practitioner''.
    The additions and revisions read as follows:


Sec.  491.2  Definitions.

* * * * *
    Certified nurse-midwife (CNM) means an individual who meets the 
applicable education, training, and other requirements at Sec.  
410.77(a) of this chapter.
    Clinical psychologist (CP) means an individual who meets the 
applicable

[[Page 79553]]

education, training, and other requirements of Sec.  410.71(d) of this 
chapter.
    Clinical social worker means an individual who meets the applicable 
education, training, and other requirements at Sec.  410.73(a) of this 
chapter.
* * * * *
    Marriage and family therapist means an individual who meets the 
applicable education, training, and other requirements at Sec.  410.53 
of this chapter.
    Mental health counselor means an individual who meets the 
applicable education, training, and other requirements at Sec.  410.54 
of this chapter.
    Nurse practitioner means a person who meets the applicable State 
requirements governing the qualifications for nurse practitioners, and 
who meets at least one of the following conditions:
    (1) Is certified as a nurse practitioner by a recognized national 
certifying body that has established standards for nurse practitioners 
and possesses a master's or doctoral degree in nursing practice; or
    (2) Has satisfactorily completed a formal 1 academic year 
educational program that:
    (i) Prepares registered nurses to perform an expanded role in the 
delivery of primary care;
    (ii) Includes at least 4 months (in the aggregate) of classroom 
instruction and a component of supervised clinical practice; and
    (iii) Awards a degree, diploma, or certificate to persons who 
successfully complete the program; or
    (3) Has successfully completed a formal educational program (for 
preparing registered nurses to perform an expanded role in the delivery 
of primary care) that does not meet the requirements of paragraph (2) 
of this definition, and has been performing an expanded role in the 
delivery of primary care for a total of 12 months during the 18-month 
period immediately preceding the effective date of this subpart.
* * * * *

0
116. Section 491.8 is amended by revising paragraphs (a)(3) and (6) to 
read as follows:


Sec.  491.8  Staffing and staff responsibilities.

    (a) * * *
    (3) The physician assistant, nurse practitioner, certified nurse-
midwife, clinical social worker, clinical psychologist, marriage and 
family therapist, or mental health counselor member of the staff may be 
the owner or an employee of the clinic or center, or may furnish 
services under contract to the clinic or center. In the case of a 
clinic, at least one physician assistant or nurse practitioner must be 
an employee of the clinic.
* * * * *
    (6) A physician, nurse practitioner, physician assistant, certified 
nurse-midwife, clinical social worker, clinical psychologist, marriage 
and family therapist, or a mental health counselor is available to 
furnish patient care services at all times the clinic or center 
operates. In addition, for RHCs, a nurse practitioner, physician 
assistant, or certified nurse-midwife is available to furnish patient 
care services at least 50 percent of the time the RHC operates.
* * * * *

PART 495--STANDARDS FOR THE ELECTRONIC HEALTH RECORD TECHNOLOGY 
INCENTIVE PROGRAM

0
117. The authority citation for part 495 continues to read as follows:

    Authority:  42 U.S.C. 1302 and 1395hh.


0
118. In Sec.  [thinsp]495.4 amend the definition of ``Certified 
electronic health record technology (CEHRT)'' by revising paragraph (2) 
introductory text to read as follows:


Sec.  495.4  Definitions.

* * * * *
    Certified electronic health record technology (CEHRT) * * *
    (2) For 2019 and subsequent years, EHR technology (which could 
include multiple technologies) certified under the ONC Health IT 
Certification Program that meets the 2015 Edition Base EHR definition, 
or subsequent Base EHR definition (as defined at 45 CFR 170.102) and 
has been certified to the ONC health IT certification criteria, as 
adopted and updated in 45 CFR 170.315-
* * * * *

PART 498--APPEALS PROCEDURES FOR DETERMINATIONS THAT AFFECT 
PARTICIPATION IN THE MEDICARE PROGRAM AND FOR DETERMINATIONS THAT 
AFFECT THE PARTICIPATION OF ICFs/IID AND CERTAIN NFs IN THE 
MEDICAID PROGRAM

0
119. The authority citation for part 498 continues to read as follows:

    Authority:  42 U.S.C. 1302, 1320a-7j, and 1395hh.


0
120. In Sec.  498.2 amend the definition of ``Supplier'' by revising 
paragraph (6) to read as follows:


Sec.  498.2  Definitions.

* * * * *
    Supplier * * *
    (6) For purposes of this part, a physical therapist in private 
practice, an occupational therapist in private practice, or a speech-
language pathologist.
* * * * *

PART 600--ADMINISTRATION, ELIGIBILITY, ESSENTIAL HEALTH BENEFITS, 
PERFORMANCE STANDARDS, SERVICE DELIVERY REQUIREMENTS, PREMIUM AND 
COST SHARING, ALLOTMENTS, AND RECONCILIATION

0
121. The authority citation for part 600 continues to read as follows:

    Authority:  Section 1331 of the Patient Protection and 
Affordable Care Act of 2010 (Pub. L. 111-148, 124 Stat. 119), as 
amended by the Health Care and Education Reconciliation Act of 2010 
(Pub. L. 111--152, 124 State. 1029).


0
122. Section 600.125 to revised read as follows:


Sec.  600.125  Revisions to a certified BHP Blueprint.

    (a) Submission of revisions. A State may seek to revise its 
certified Blueprint in whole or in part at any time through the 
submission of a revised Blueprint to HHS. A State must submit a revised 
Blueprint to HHS whenever necessary to reflect--
    (1) Changes in Federal law, regulations, policy interpretations, or 
court decisions that affect provisions in the certified Blueprint;
    (2) Significant changes that alter core program operations under 
600.145(f) or the BHP benefit package; or
    (3) Changes to enrollment, disenrollment, and verification policies 
described in the certified Blueprint.
    (b) Submission and effective dates. The effective date of a revised 
Blueprint may not be earlier than the first day of the quarter in which 
an approvable revision is submitted to HHS. A revised Blueprint is 
deemed received when HHS receives an electronic copy of a cover letter 
signed by the Governor or Governor's designee and a copy of the 
currently approved Blueprint with proposed changes in track changes.
    (c) Timing of HHS review. (1) A revised Blueprint will be deemed 
approved unless HHS, within 90 calendar days after receipt of the 
revised Blueprint, sends the State--
    (i) Written notice of disapproval; or
    (ii) Written notice of additional information it needs in order to 
make a final determination.
    (2) If HHS requests additional information, the 90-day review 
period for HHS action on the revised Blueprint--

[[Page 79554]]

    (i) Stops on the day HHS sends a written request for additional 
information or the next business day if the request is sent on a 
Federal holiday or weekend; and
    (ii) Resumes on the next calendar day of the original 90-day review 
period after HHS receives a complete response from the State including 
all the requested additional information, unless the information is 
received after 5 p.m. eastern standard time on a day prior to a non-
business day or any time on a non-business day, in which case the 
review period resumes on the following business day.
    (3) The 90-day review period cannot stop or end on a non-business 
day. If the 90th calendar day falls on a non-business day, HHS will 
consider the 90th day to be the next business day.
    (4) HHS may send written notice of its need for additional 
information as many times as necessary to obtain the complete 
information necessary to review the revised Blueprint.
    (5) HHS may disapprove a Blueprint that is not consistent with 
section 1331 of the ACA or the regulations set forth in this Part at 
any time during the review process, including when the 90-day review 
clock is stopped due to a request for additional information.
    (d) Continued operation. The State is responsible for continuing to 
operate under the terms of the existing certified Blueprint until and 
unless--
    (1) The State adopts a revised Blueprint by obtaining approval by 
HHS under this section;
    (2) The State follows the procedures described in Sec.  600.140(a) 
for terminating a BHP;
    (3) The State follows the procedures described in Sec.  600.140(b) 
for suspending a BHP;
    (4) The Secretary withdraws certification of a BHP under 600.142.
    (e) Withdrawal of a revised Blueprint. A State may withdraw a 
proposed Blueprint revision during HHS' review if the State has not yet 
implemented the proposed changes and provides written notice to HHS.
    (f) Reconsideration of decision. HHS will accept a State request 
for reconsideration of a decision not to certify a revised Blueprint 
and provide an impartial review against the standards for certification 
if requested.
    (g) Public health emergency. For the Public Health Emergency, as 
defined in Sec.  400.200 of this chapter, the State may submit to the 
Secretary for review and certification a revised Blueprint, in the form 
and manner specified by HHS, that makes temporary significant changes 
to its BHP that are directly related to the Public Health Emergency and 
would increase enrollee access to coverage. Such revised Blueprints may 
have an effective date retroactive to the first day of the Public 
Health Emergency and through the last day of the Public Health 
Emergency, or a later date if requested by the State and certified by 
HHS. Such revised Blueprints are not subject to the public comment 
requirements under Sec.  600.115(c).

0
123. Section 600.135 is amended by revising the section heading and 
paragraph (a) to read as follows:


Sec.  600.135  Notice and timing of HHS action on an initial BHP 
Blueprint submission.

    (a) Timely response. HHS will act on all initial Blueprint 
certification requests in a timely manner.
* * * * *

0
124. Section 600.140 is amended by adding introductory text and 
paragraphs (b) and (c) to read as follows:


Sec.  600.140  State termination or suspension of a BHP.

    A State that no longer wishes to operate a BHP may terminate or 
suspend its BHP.
* * * * *
    (b) If a State decides to suspend its BHP, or to request an 
extension of a previously-approved suspension, the State must:
    (1) Submit to the Secretary a suspension application or a 
suspension extension application, as applicable. The suspension or 
suspension extension application must:
    (i) Demonstrate that the benefits BHP-eligible individuals will 
receive during the suspension are at least equal to the benefits 
provided under the certified BHP Blueprint in effect on the effective 
date of suspension;
    (ii) Demonstrate that the median actuarial value of the coverage 
provided to the BHP-eligible individuals during the suspension is no 
less than the median actuarial value of the coverage under the 
certified BHP Blueprint in effect on the effective date of suspension;
    (iii) Demonstrate that the premiums imposed on BHP-eligible 
individuals during the suspension are no higher than the premiums 
charged under the certified BHP Blueprint in effect on the effective 
date of suspension, except that premiums imposed during the suspension 
may be adjusted for inflation, as measured by the Consumer Price Index;
    (iv) Demonstrate that the eligibility criteria for coverage during 
the suspension is not more restrictive than the criteria described in 
Sec.  600.305;
    (v) Describe the period, not to exceed 5 years, that the State 
intends to suspend its BHP or to extend a previously-approved 
suspension;
    (vi) Be submitted at least 9 months in advance of the proposed 
effective date of the suspension or extension, except States seeking to 
suspend a BHP in 2024 must submit an application within 30 days of the 
effective date of this provision; and
    (vii) Include an evaluation of the coverage provided to BHP 
eligible individuals during the suspension period, if the State is 
seeking an extension.
    (2) Resolve concerns expressed by HHS and obtain approval by the 
Secretary of the suspension or suspension extension application. 
Suspensions may not be in effect prior to approval by HHS, except for 
States seeking to suspend a BHP in 2024.
    (3) At least 90 days prior to the effective date of the suspension, 
provide written notice to all enrollees and participating standard 
health plan offerors that it intends to suspend the program, if the 
enrollees will experience a change in coverage, or standard health plan 
offerors will experience a change in the terms of coverage. The notices 
to enrollees must include information regarding the State's assessment 
of their eligibility for all other insurance affordability programs in 
the State. Notices must meet the accessibility and readability 
standards at 45 CFR 155.230(b).
    (4) Within 12 months of the suspension effective date, submit to 
HHS the data required by Sec.  600.610 to complete the financial 
reconciliation process with HHS.
    (5) Submit the annual report required by Sec.  600.170(a)(2), 
describing the balance of the trust fund, and any interest accrued on 
such amount.
    (6) Annually, remit to HHS any interest that has accrued on the 
balance of the BHP trust fund during the suspension period in the form 
and manner specified by HHS.
    (7) At least 9 months before the end of the suspension period 
described in paragraph (b)(1)(iv) of this section, or earlier date 
elected by the State, the State must submit to HHS a transition plan 
that describes how the State will reinstate its BHP consistent with the 
requirements of this part, or terminate the program in accordance with 
paragraph (a) of this section. The State must meet the noticing 
requirements of paragraph (b)(3) of this section prior to terminating 
or reinstating the BHP.
    (c) The Secretary may withdraw approval of the suspension plan, if 
the terms of paragraph (b) of this section are not met, if the State 
ends implementation of the alternative

[[Page 79555]]

coverage program for any reason, or if HHS finds significant evidence 
of beneficiary harm, financial malfeasance, fraud, waste, or abuse by 
the BHP agency or the State consistent with Sec.  600.142 of this part. 
If HHS withdraws the approved suspension plan, the State must reinstate 
its BHP under the terms of this part, or terminate the program under 
paragraph (a) of this section.
    (1) The Secretary may withdraw approval of a suspension under this 
section only after the Secretary provides the State with notice of the 
findings upon which the Secretary is basing the withdrawal; a 
reasonable period for the State to address the finding; and an 
opportunity for a hearing before issuing a final finding.
    (2) The Secretary must make every reasonable effort to work with 
the State to resolve proposed findings without withdrawing approval of 
a suspension and in the event of a decision to withdraw approval, will 
accept a request from the State for reconsideration.
    (3) The effective date of an HHS determination withdrawing approval 
of the suspension plan shall not be earlier than 120 days following 
issuance of a final finding under paragraph (d)(1) of this section.
    (4) Within 30 days following a final finding under paragraph (d)(1) 
of this section, the State must submit a transition plan to HHS.

0
125. Section 600.145 is amended by revising paragraphs (a) and (f)(2) 
to read as follows:


Sec.  600.145  State program administration and operation.

    (a) Program operation. The State must implement its BHP in 
accordance with:
    (1) The approved and fully certified State BHP Blueprint, any 
approved modifications to the State BHP Blueprint and the requirements 
of this chapter and applicable law; or
    (2) The approved suspension application described in Sec.  600.140.
* * * * *
    (f) * * *
    (2) Eligibility and health services appeals as specified in 
600.335.
* * * * *

0
126. Section 600.170 amended by revising paragraph (a) to read as 
follows:


Sec.  600.170  Annual report content and timing.

    (a) Content. (1) The State that is operating a BHP must submit an 
annual report that includes any evidence of fraud, waste, or abuse on 
the part of participating providers, plans, or the State BHP agency 
known to the State, and a detailed data-driven review of compliance 
with the following:
    (i) Eligibility verification requirements for program participation 
as specified in Sec.  600.345.
    (ii) Limitations on the use of Federal funds received by the BHP as 
specified in Sec.  600.705.
    (iii) Requirements to collect quality and performance measures from 
all participating standard health plans focusing on quality of care and 
improved health outcomes as specified in sections 1311(c)(3) and (4) of 
the Affordable Care Act and as further described in Sec.  600.415.
    (iv) Requirements specified by the Secretary at least 120 days 
prior to the date of the annual report as requiring further study to 
assess continued State compliance with Federal law, regulations and the 
terms of the State's certified Blueprint, based on a Federal review of 
the BHP pursuant to Sec.  600.200, and/or a list of any outstanding 
recommendations from any audit or evaluation conducted by the HHS 
Office of Inspector General that have not been fully implemented, 
including a statement describing the status of implementation and why 
implementation is not complete.
    (2) A State that has suspended its BHP under Sec.  600.140(b) of 
this part must submit an annual report that includes the following:
    (i) The balance of the BHP trust fund and any interest accrued on 
that balance;
    (ii) An assurance that the coverage provided to individuals who 
would be eligible for a BHP under Sec.  600.305 of this part continues 
to meet the standards described in Sec.  600.140(b)(1)(i), (ii), and 
(iii) of this part; and
    (iii) Any additional information specified by the Secretary at 
least 120 days prior to the date of the annual report.
* * * * *

0
127. Section 600.330 is amended by adding paragraph (f) to read as 
follows:


Sec.  600.330  Coordination with other insurance affordability 
programs.

* * * * *
    (f) Accessibility. Eligibility notices must be written in plain 
language and be provided in a manner which ensures individuals with 
disabilities are provided with effective communication and takes steps 
to provide meaningful access to eligible individuals with limited 
English proficiency.

0
128. Section 600.335 is amended by--
0
a. Revising paragraph (b);
0
b. Redesignating paragraph (c) as paragraph (d); and
0
c. Adding new paragraph (c).
    The revision and addition read as follows:


Sec.  600.335  Appeals.

* * * * *
    (b) Appeals process. Individuals must be given the opportunity to 
appeal the following actions through the appeals rules of the State's 
Medicaid program, unless granted an exception under paragraph (c) of 
this section:
    (1) BHP eligibility determinations; and
    (2) Delay, denial, reduction, suspension, or termination of health 
services, in whole or in part, including a determination about the type 
or level of service, after individuals exhaust appeals or grievances 
through the BHP standard health plans.
    (c) Exception. Subject to HHS approval, a state may request to 
follow an appeals process for BHP eligibility determinations and health 
service matters that differs from the State's Medicaid program. In its 
request, the State must provide a clear description of the 
responsibilities and functions delegated to such an entity and ensure 
that:
    (1) The State has oversight of any entity delegated the authority 
to administer appeals;
    (2) The agency to which eligibility determinations or appeals 
decisions are delegated complies with all relevant Federal and State 
law, regulations and policies; and
    (3) The agency to which eligibility determinations or appeals 
decisions are delegated informs applicants and beneficiaries how they 
can directly contact and obtain information from the agency.
* * * * *

Xavier Becerra,
Secretary, Department of Health and Human Services.
 BILLING CODE 4120-01-P

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[FR Doc. 2023-24184 Filed 11-2-23; 4:15 pm]