[Federal Register Volume 88, Number 150 (Monday, August 7, 2023)]
[Proposed Rules]
[Pages 52262-53197]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-14624]



[[Page 52261]]

Vol. 88

Monday,

No. 150

August 7, 2023

Part II

Book 2 of 2 Books

Pages 52261-53348





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; Proposed Rule

  Federal Register / Vol. 88 , No. 150 / Monday, August 7, 2023 / 
Proposed Rules  

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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-P]
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: Proposed rule.

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SUMMARY: This major proposed 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: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on September 11, 
2023.

ADDRESSES: In commenting, please refer to file code CMS-1784-P.
    Comments, including mass comment submissions, must be submitted in 
one of the following three ways (please choose only one of the ways 
listed):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-1784-P, P.O. Box 8016, 
Baltimore, MD 21244-8016.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-1784-P, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

FOR FURTHER INFORMATION CONTACT:  
[email protected], for any issues not identified 
below. Please indicate the specific issue in the subject line of the 
email.
    Michael Soracoe, (410) 786-6312, and Morgan Kitzmiller, (410) 786-
1623, for issues related to practice expense, work RVUs, conversion 
factor, and PFS specialty-specific impacts.
    Kris Corwin, (410) 786-8864, for issues related to the comment 
solicitation on strategies for updates to practice expense data 
collection and methodology.
    [email protected], for issues related to 
caregiver training services, community health integration services, 
social determinants of health risk assessment, and principal illness 
navigation services.
    Larry Chan, (410) 786-6864, for issues related to potentially 
misvalued services under the PFS.
    Kris Corwin, (410) 786-8864, Patrick Sartini, (410) 786-9252, and 
Larry Chan, (410) 786-6864, for issues related to direct supervision 
using two-way audio/video communication technology, telehealth, and 
other services involving communications technology.
    Tamika Brock, (312) 886-7904, for issues related to teaching 
physician services.
    Lindsey Baldwin, (410) 786-1694, Regina Walker-Wren, (410) 786-
9160, Erick Carrera, (410) 786-8949, or 
[email protected], for issues related to 
advancing access to behavioral health.
    [email protected], for issues related to PFS 
payment for evaluation and management services.
    Morgan Kitzmiller, (410) 786-1623, for issues related to geographic 
practice cost indices (GPCIs).
    Zehra Hussain, (214) 767-4463, or 
[email protected], for issues related to payment 
of skin substitutes.
    Pamela West, (410) 786-2302, for issues related to supervision of 
outpatient therapy services, KX modifier thresholds, diabetes self-
management training (DSMT) services, and DSMT telehealth 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, Ariana Pitcher, 
[email protected], Rasheeda Arthur, (410) 786-3434, 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 and FQHC Conditions for Certification or Coverage.
    Kianna Banks (410) 786-3498 and Cara Meyer (667) 290-9856, for 
issues related to RHCs and FQHCs definitions of staff.
    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, 
[email protected], or [email protected], for issues 
related to Medicare coverage of opioid use

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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, (667) 290-8833, or [email protected], 
for inquiries 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.
    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).
    Richard Jensen, (410) 786-6126, for inquiries related to 
Alternative Payment Models (APMs).

SUPPLEMENTARY INFORMATION: 
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the comment period on the following 
website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to 
view public comments. CMS will not post on Regulations.gov public 
comments that make threats to individuals or institutions or suggest 
that the commenter will take actions to harm an individual. CMS 
continues to encourage individuals not to submit duplicative comments. 
We will post acceptable comments from multiple unique commenters even 
if the content is identical or nearly identical to other comments.
    Addenda Available Only Through the Internet on the CMS Website: The 
PFS Addenda along with other supporting documents and tables referenced 
in this proposed 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 proposed rule, refer to item CMS-1784-P. Readers with 
questions related to accessing any of the Addenda or other supporting 
documents referenced in this proposed rule and posted on the CMS 
website identified above should contact 
[email protected].
    CPT (Current Procedural Terminology) Copyright Notice: Throughout 
this proposed 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

    This major annual rule proposes to revise payment polices under the 
Medicare PFS and makes other policy changes, including proposals to 
implement 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 proposed 
rule includes proposals regarding other Medicare payment policies 
described in sections III. and IV. of this proposed rule.
    This rulemaking proposes to update 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 would also update 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 would make changes to the hospice personnel 
requirements. This rulemaking would also seek to further advance 
Medicare's overall value-based care strategy of growth, alignment, and 
equity through the Medicare Shared Savings Program (MSSP) 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 would also update the Ambulance Fee Schedule 
regulations to implement division FF, section 4103 of the CAA 2023 
regarding the ground ambulance extenders provisions and would also 
provide further changes and clarifications to the

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Medicare Ground Ambulance Data Collection System.
    This rulemaking would also update 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 proposed rule, we are proposing to establish 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 proposed 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 proposed 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 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 (section II.J.)
 Proposals on Medicare Parts A and B Payment for Dental 
Services Inextricably Linked to Specific Covered Medical 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.)
 Proposed 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.)
3. Summary of Costs and Benefits
    We have determined that this proposed rule is economically 
significant. For a detailed discussion of the economic impacts, see 
section VII., Regulatory Impact Analysis, of this proposed rule.

II. Provisions of the Proposed 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 proposed 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

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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 
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 cross-walking 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 cross-walked PE/
HR, we instead used the PPIS based PE/HR. We use cross-walks for 
specialties that did not participate in the PPIS. These cross-walks 
have been generally established through notice and comment rulemaking 
and are available in the file titled ``CY 2024 PFS proposed rule PE/
HR'' 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.
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

[[Page 52266]]

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 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 
proposed 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 proposed 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 52983) 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

[[Page 52267]]

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.
    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.
(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 proposed 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).
(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 1.

[[Page 52268]]

[GRAPHIC] [TIFF OMITTED] TP07AU23.000

     Cross-walk certain low volume physician specialties: 
Cross-walk the utilization of certain specialties with relatively low 
PFS utilization to the associated specialties.
     Physical therapy utilization: Cross-walk 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 52269]]

accordingly. Table 2 details the manner in which the modifiers are 
applied.
[GRAPHIC] [TIFF OMITTED] TP07AU23.001

    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 
proposed 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 proposed 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 proposed 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 52270]]

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 
refer 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 3.
[GRAPHIC] [TIFF OMITTED] TP07AU23.002

    We are not proposing 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 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 implementation of the 
finalized CY

[[Page 52271]]

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 said 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 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 are not proposing 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 
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 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.
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 
proposed 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

[[Page 52272]]

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 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 and 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 2023, 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 cross-walked to 
the new listing of clinical labor activity codes. These lists are 
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.
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 1300 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 are proposing 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 are listed 
in the valuation of specific codes section of the preamble under Table 
14, CY 2024 Invoices Received for Existing Direct PE Inputs.

[[Page 52273]]

    We are not proposing 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 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 are not proposing 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% since the supply and equipment pricing 
update concluded in CY 2022, and as such we are maintaining the current 
price for these supply items.
(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 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 
cross-walked 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

[[Page 52274]]

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 
cross-walked 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 4.
[GRAPHIC] [TIFF OMITTED] TP07AU23.003

(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 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).

[[Page 52275]]

(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 is 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:
BILLING CODE 4120-01-C

[[Page 52276]]

[GRAPHIC] [TIFF OMITTED] TP07AU23.004


[[Page 52277]]


[GRAPHIC] [TIFF OMITTED] TP07AU23.005

    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).
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 are 
proposing to add the correct 20 minutes of intraservice work time to 
CPT code 86153 for CY 2024.
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 that 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 2011-2014 
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

[[Page 52278]]

PPIS data for certain specialties (76 FR 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 2016-2022 (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 to 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 
remind 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 remind 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. Request for Information
    We continue 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. 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 continue 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 are issuing a follow-up solicitation for 
general information. We seek 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 seek 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 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 request 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?

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

[[Page 52279]]

potentially misvalued codes, and to make appropriate adjustments.
    As discussed in section II.E. of this proposed 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 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

[[Page 52280]]

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 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'').\1\ 
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.
---------------------------------------------------------------------------

    \1\ 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 has nominated CPT code 59200 again, and provided the 
same reasoning as to why this code is potentially misvalued.

[[Page 52281]]

    Specifically, the current nominee recommends 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 has 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 supply costs of CPT code 59200 by 
a factor of five and represent an enormous increase in the direct costs 
for the service.
    We do not agree that CPT code 59200 is potentially misvalued, and 
we do not agree with interested parties that the use of the Dilapan-S 
supply would be typical for this 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 will expand both Medicare spending and cost sharing for 
any beneficiary who receives 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 do agree with the nominator 
that CPT code 59200 is much more frequently reported in the Medicaid 
population, and therefore, we suggest that interested parties submit a 
request for new and separate Medicaid payments to Medicaid.
    We are not proposing to consider this code as potentially misvalued 
for CY 2024, though we welcome comments on this nomination for further 
consideration. We are soliciting comments on CPT code 59200 and whether 
the absence of supply item Dilapan-S makes the nonfacility/office 
Medicare payment for this service potentially misvalued.
(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) has been nominated as 
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 are 
seeking separate direct PE inputs for this service to better account 
for valuation when performed in the nonfacility/office setting. These 
PE amounts for CPT code 27279 are expected to be approximately 
$21,897.63 in total, which is the Medicare outpatient payment amount 
for CY 2023.
    The nominator claims that CPT code 27279 can 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 describes Kyphoplasty as ``a 
percutaneous minimally invasive procedure depositing poly methyl 
methacrylate via canula into vertebral bodies near neural structures.'' 
The nominator states 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. One sample invoice for 
$17,985.00 with three units of the itemized supply item IFuse-3D 
Implant 7.0 mm x 55 mm, US ($5,995.00 per unit) was submitted with this 
nomination to illustrate the high direct PE costs for CPT code 27279, 
should CMS value this code in the nonfacility/office setting.
    We are concerned about whether this 090 day surgical service can be 
safely and effectively furnished in the non-facility/office setting 
(for example, in an office-based surgical suite). We welcome comments 
on the nomination of CPT code 27279 for consideration as potentially 
misvalued.
(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. 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 codes. The nominator disagrees with these 
values and asserts 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

[[Page 52282]]

office setting (with many of these infections being health care-
associated infections and antibiotic-resistant bacterial infections). 
It should be noted that these new requests did not offer appreciably 
new information relative to last year's nomination/consideration.
    The nominator seeks 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 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 has 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 6 for a 
comparison of work RVU values for CY 2022, CY 2023, and of those 
requested by the nominator).
[GRAPHIC] [TIFF OMITTED] TP07AU23.006

    After consideration of this nomination and their requests for 
higher work RVUs for CPT codes 99221, 99222, and 99223, we are 
proposing to maintain the values that we finalized for these codes in 
the CY 2023 PFS final rule (87 FR 69588). Even so, we welcome comments 
on the nomination of these codes 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 zero 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 disagrees with the current direct PE of supply item SC085, 
``Tubing set, plasma exchange'' at $186.12 per item, and believes that 
this should be worth $248.77 per item with CPT code 36514, using a 
quantity of one item. The nominator believes that supply item SC084, 
``Tubing set, blood warmer,'' that 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. Sample invoices (not actual invoices) 
were submitted for illustration and support. We welcome comments on the 
nomination of these codes as potentially misvalued, or not.
(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 payment for CPT code 44204 
(Laparoscopy, surgical; colectomy, partial, with anastomosis), which is 
a higher amount. 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, as compared 
to 428.5 minutes in total for CPT code 44205. The 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 with regard to 
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 PEs, with 
CPT code 44204 involving more time and resources (and having a higher 
payment, accordingly). For these reasons, we are not inclined to agree 
that CPT code 44205 is potentially misvalued when compared to CPT code 
44204, or to modify this payment differential by paying a higher amount 
for CPT code 44205. We are soliciting feedback regarding the nomination 
of CPT code 44205 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. These two add-
on codes were part of our code review in the cardiac ablation code 
family in the CY 2022 (86 FR 65108) and CY 2023 (87 FR 69516) final 
rules.
    The nominator reiterates 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 7.00 work RVUs. We 
disagreed with this value in CY 2022, and we continue to believe that a 
work RVU of 5.50 is appropriate for the 60 minutes of physician service 
time for both codes. We see no reason to reconsider our valuation of 
CPT codes 93655 and

[[Page 52283]]

93657 for CY 2022 or CY 2023, and we do not consider these codes to be 
potentially misvalued now. We are not proposing to nominate these codes 
as potentially misvalued for CY 2024.
(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)) as potentially misvalued due to the PE 
items listed for this code, which were last reviewed in 2009. There is 
no physician work/professional component associated with this code. The 
nominator states that the technology behind this code has changed 
considerably over the last 14 years, and that the listed equipment 
items for CPT code 94762, EQ212 ``pulse oxymetry recording software 
(prolonged monitoring)'' and EQ353 ``Pulse oximeter 920 M Plus'' 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) costing $99.00 each, derived from two 
sample invoices (not actual invoices) that were 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 retains equipment item EQ212 
``pulse oxymetry recording software (prolonged monitoring)'', and 
replaces equipment item EQ353 with ED021, a ``computer, desktop, w-
monitor.'' Payment for CPT code 94762 is currently $25.75 in the 
nonfacility office setting. There were 122,207 allowed service claims 
for CPT code 94762 in CY 2021. The facility payment amount for CPT code 
94762 under the Medicare Hospital Outpatient Prospective Payment System 
(OPPS) is currently $145.43.
    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, requesting that CMS update PE items for this code, which 
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). This is a 
$25.68 difference in this supply item's cost.
    The nominator excludes 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 includes 
ED021 (``computer, desktop, w-monitor'') in the PE for this code. We 
note that we have not previously included ED021 as a specialized 
equipment item dedicated to this function (and EQ212 ``pulse oxymetry 
recording software (prolonged monitoring)'' is also not included in the 
PE for CPT code 95800, as it is 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 includes a 
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 this data. CMS currently pays a total of $150.80 
for CPT code 95800 in the non-facility office setting, and there were 
53,793 allowed services for this code in CY 2021.
    There is not 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 has requested the practice expense 
changes discussed above as support for their argument that these CPT 
codes are potentially misvalued (See Table 7.)
BILLING CODE 4120-01-P

[[Page 52284]]

[GRAPHIC] [TIFF OMITTED] TP07AU23.007

    We welcome comments as to whether or not these codes are 
potentially misvalued.
(8) CPT Codes 0596T and 0597T
    An interested party has 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 due to MAC pricing, which is determined on a case-by-case 
basis. These temporary CPT category III codes are all procedure status 
``C'' (contractor priced), and the interested party is seeking status 
``A'' (for active payment status) to account for physician work, 
nonfacility PE, and professional liability costs. The nominator states 
that the MAC-determined payment amounts have been inappropriately low, 
and do not account for the time and the work that the physician expends 
for these services, or for all of the PE costs associated with the 
Vesiflo inFlow System. For CPT code 0596T, the nominator expects a 
physician to spend 60 minutes of work on installing this Vesiflo inFlow 
System. The nonfacility office PE items include 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, making up 
about 99 percent of the total cost of supplies.
    For CPT code 0597T, the nominator expects a physician to spend 25 
minutes of work replacing this Vesiflo inFlow System. The nonfacility 
office PE items include a power table, a mayo stand, an examination 
light, clinical labor time of a RN/LPN/MTA totaling to 38 minutes, and 
a list of supplies summing to $505.30, primarily from the inflow device 
of $495.00, making up about 98 percent of the total cost of supplies. A 
sample invoice is included in this nomination (as opposed to an actual 
invoice).
    We welcome comments as to whether or not these two temporary 
category II CPT codes, CPT codes 0596T and 0597T, are potentially 
misvalued, and whether these codes should remain contractor priced or 
not.

[[Page 52285]]

(9) CPT Code 93000
    An interested party has 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 adequately 
compensate practitioners for their PE item costs for: (1) $6.10 for EKG 
leads; (2) $21.19 for a nurse visit of typically 5 minutes time (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). 
The interested party is asking for the grouping of these services to be 
valued at $35.64 (the actual sum of these inputs is $34.93). No 
invoices or other evidence were provided for consideration.
    For CY 2023, the national payment amounts under the PFS for CPT 
codes 93000, 93010, and 99211 in the nonfacility office setting are as 
follows:
     CPT code 93000; total RVUs 0.43 x CF $33.8872 = $14.57.
     CPT code 93010; total RVUs 0.24 x CF $33.8872 = $8.13.
     CPT code 99211; total RVUs 0.69 x CF $33.8872 = $23.38.
     Sum total $46.08.
    After consideration, we are not proposing to nominate CPT code 
93000 as potentially misvalued for CY 2024. The sum of a mix of 
services is not a persuasive indication that one code--in this case, 
CPT code 93000--is potentially misvalued.
(10) 19 Therapy codes
    An interested party has nominated 19 therapy codes as potentially 
misvalued. These 19 therapy codes were last reviewed by CMS in the CY 
2018 PFS final rule (82 FR 53073 through 53074). The interested party 
stated 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 might have had 
inappropriate multiple procedure payment reductions (MPPR) applied to 
their PE clinical labor time entries. The nominators are now seeking 
correction for those clinical labor time entries, which, if adjusted in 
accordance with the recommendations of the nominators, would likely 
result in slightly higher or nominally changed payments for the 19 
therapy codes.
    We have reviewed the clinical labor time entries for these 19 
therapy codes, and we are now reconsidering the values established in 
the CY 2018 final rule. We do not believe that MPPR should be applied 
to these 19 nominated therapy codes' clinical labor time entries 
(listed in Table 8), and as a result, we would like the AMA RUC HCPAC 
recommendations from January 2017 to be re-reviewed. We recommend 
nomination of these 19 codes as potentially misvalued for CY 2024, and 
we welcome comments on this nomination.
[GRAPHIC] [TIFF OMITTED] TP07AU23.008


[[Page 52286]]


BILLING CODE 4120-01-C

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 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 above. In this proposed rule, we are 
considering 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

[[Page 52287]]

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 proposed 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 9.
BILLING CODE 4120-01-P

[[Page 52288]]

[GRAPHIC] [TIFF OMITTED] TP07AU23.009


[[Page 52289]]


[GRAPHIC] [TIFF OMITTED] TP07AU23.010

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, we find that none of the 
requested services listed in Table 9 1 met the Category 1 criterion.
(1) Cardiovascular Procedures
    We received a request to permanently add CPT code 93793 
(Anticoagulant management for a patient taking warfarin, must include 
review and interpretation of a new home, office, or lab international 
normalized ratio (INR) test result, patient instructions, dosage 
adjustment (as needed), and scheduling

[[Page 52290]]

of additional test(s), when performed)) to the Medicare Telehealth 
Services List. We do 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 do 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 are not proposing to add 
this service to the Medicare Telehealth Services List on a Category 1 
basis.
(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 welcome 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 are not proposing to include these services permanently on 
the Medicare Telehealth Services List on a Category 1 basis. We are 
instead proposing to continue to include these services on the Medicare 
Telehealth Services List through CY 2024. We would 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 (e.g., 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 (e.g., 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 (e.g., 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, 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

[[Page 52291]]

the Category 2 criterion. We are proposing to keep these services on 
the Medicare Telehealth Services List for CY 2024. 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.
(4) Therapy
    We received requests to add Therapy Procedures: CPT codes 97110, 
97112, 97116; Physical Therapy Evaluations: CPT codes 97161-97164; 
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 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 are not proposing 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 are proposing 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.
(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

[[Page 52292]]

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 reiterate 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 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 are not proposing to add these services to the list on a 
permanent basis at this time, but we are proposing that they would 
remain available on the Medicare Telehealth Services List through CY 
2024.
(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 are not proposing to add these health and well-being coaching 
services to the Medicare Telehealth Services List on a permanent basis, 
but we are proposing 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 note 
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. As a reminder, 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

[[Page 52293]]

coaching only requires a few hours of training, and few articles 
submitted to CMS discuss the intensity of health coach training at all. 
The pre-publication metanalysis submitted for review draws less than 
definitive conclusions about ``potential benefits'' of health and well-
being coaching and hedges that 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 are sufficient to serve as a basis for adding the codes to 
the Medicare Telehealth Services List on a temporary basis, and we 
appreciate the thoughtful and transparent way the submission lays 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. Therefore, we are 
proposing to add the services to the Medicare Telehealth Services List 
on a temporary basis.
(7) CMS Proposal To Add New Codes to the List
    In addition to the health and wellbeing coaching services submitted 
as requests, we are proposing to add HCPCS code GXXX5 (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 GXXX5 to the list is contingent 
upon finalizing the service code description that we propose in section 
II.E of this proposed rule. We refer readers to the proposal in section 
II.E for further background. We are proposing that HCPCS code GXXX5, if 
finalized as proposed, 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 this proposed 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, the 
use of two-way interactive audio-video technology, as a substitute to 
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 this proposed rule, we are proposing 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 believe it describes a 
service that is sufficiently similar to services currently on the 
Telehealth list, specifically E/M services, and that this service be 
added on a permanent basis.
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 needed flexibilities 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 in order 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), 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

[[Page 52294]]

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 classification approach could address 
the confusion we have noticed from interested parties submitting 
requests during the PHE. Our proposal would restore the simple binary 
that existed with Category 1 and 2, without displacing or disregarding 
the flexibility of Category 3. We propose to simply classify and 
consider additions to the Medicare Telehealth Services List as either 
permanent, or provisional.
    At bottom, 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 propose 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 discuss 
these proposed changes in detail 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 
propose 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 are proposing 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.\2\ (87 FR 69449). We anticipate that 
Step 1, if finalized, will 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

[[Page 52295]]

code, that is equivalent to an in-person service.
---------------------------------------------------------------------------

    \2\ 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 propose that, if we find that a service identified in a 
submission is not separately payable under the PFS, we would not 
conduct any further review of that service. We would identify the code 
submitted for consideration and explain that we are not proposing 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 are proposing 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 note 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 are proposing 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

[[Page 52296]]

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 are proposing 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 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 propose 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. For example, in a future year, if a 
code that would otherwise exist under the current categories as a 
finalized Category 2 permanent code, and was subsequently replaced or 
revised by a successor code, CMS would ensure any revisions did not 
alter results under Steps 1-3, and add the successor code using this 
Step 4. We further propose 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. If Step 4 is not met, then we propose 
to continue to Step 5.
    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 
propose 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 remind 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

[[Page 52297]]

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 are proposing 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 
steps 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 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
    We note 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 asked CMS to 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. This proposal intends 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 anticipate that our approach 
would generally remain consistent with this particular point of 
flexibility if this proposal is 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 are soliciting comments on our proposed analysis procedures for 
additions to, removals from, or changes in status for services on the 
Medicare Telehealth Services List.
d. Consolidation of the Categories for Services Currently on the 
Medicare Telehealth Services List
    We are also proposing to consolidate Categories 1, 2, and 3, as 
proposed above, for all services that are currently on the Medicare 
Telehealth Services List. For CY 2024, we are proposing 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 that 
redesignations in this calendar year would help ease confusion in 
future years, including in the event that there is subsequent 
legislation regarding Medicare telehealth services.
    Further, 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. We propose 
not to 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 would avoid 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

[[Page 52298]]

and provisional status. We do not assign provisional status when it is 
improbable that the code would ever achieve permanent status.
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; 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 proposed 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 proposed 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 proposed 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 propose 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 proposed 
rule for our proposal to implement similar changes for RHC and FQHC 
mental health visits.
(3) Originating Site Requirements
    Section 4113(a)(2) of the CAA, 2023 amends 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. We would not issue any program

[[Page 52299]]

instructions or proposals to limit or modify telehealth originating 
sites for CY 2023 or CY 2024. The list of telehealth originating sites 
remains as listed in our regulation at Sec.  410.78(b)(3).
(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 are proposing 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.
(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).
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 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, 
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

[[Page 52300]]

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, throughout 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 would then 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 believe their practice expenses (PEs) are more accurately 
reflected by the non-facility rate.
    Therefore, we are proposing that, beginning in CY 2024, claims 
billed with POS 10 (Telehealth Provided in Patient's Home) 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.
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 
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,\3\ 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 are proposing to once again remove these telehealth 
frequency limitations beginning CY 2024. We are proposing to remove the 
telehealth frequency limitations for the following codes:
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    \3\ https://www.cms.gov/files/document/physicians-and-other-clinicians-cms-flexibilities-fight-covid-19.pdf.
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    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

[[Page 52301]]

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 are proposing to remove the frequency limitations for these 
codes for the duration of CY 2024, which will align 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.
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

[[Page 52302]]

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 are 
proposing 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 are proposing 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).
    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 are soliciting comment on whether we 
should consider extending the definition of direct supervision to 
permit virtual presence beyond December 31, 2024. Specifically, we are 
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 are also interested in potential program integrity concerns 
such as overutilization or fraud and abuse that interested parties may 
have in regard to this policy.
    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 are soliciting 
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.
(1) Supervision of 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 refer 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 
applies 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 have 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 have 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 have 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 proposed rule, we are concerned that an abrupt 
transition to our pre-PHE policy may present a barrier to access to 
many services, and we understand that practitioners have 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 telehealth service. 
Given these considerations and in alignment with the telehealth 
policies that were extended under the provisions of the CAA, 2023, we 
are proposing 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 
Medicare telehealth service for which payment is sought, through audio/
video real-time communications technology,

[[Page 52303]]

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 telehealth 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 are 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 are exercising this enforcement discretion through December 31, 
2023, as we consider our virtual presence policies for services 
involving teaching physicians and residents further through our 
rulemaking process for CY 2024. 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.
    We seek comment and information to help us consider how telehealth 
services can 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 anticipate 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 invite 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 without creating risks to patient care or 
increasing opportunities for fraud.
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 solicited 
from a comment period 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.

[[Page 52304]]

(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 are proposing to 
clarify that the data collection minimums apply to existing RPM and RTM 
code families for CY 2024.
    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 propose 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. We are proposing to clarify 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.

[[Page 52305]]

    We are soliciting comment on the above proposals and clarifications 
and request 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.
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 
telehealth services and will remain actively priced through 2024. CPT 
codes 98966-98968, however, describe telephone assessment and 
management services provided by a qualified non-physician healthcare 
professional, and they are not telehealth services. We are proposing 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), which 
permits the provision of telehealth services through audio-only 
telecommunications through the end of 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. The 
proposed MEI increase for CY 2024 is 4.5 percent and is based on the 
expected historical percentage increase of the 2017-based MEI. For the 
final rule, we propose to update the MEI increase for CY 2024 based on 
historical data through second quarter of 2023.
    Therefore, for CY 2024, the proposed payment amount for HCPCS code 
Q3014 (Telehealth originating site facility fee) is $29.92. Table 10 
shows the Medicare telehealth originating site facility fee and the 
corresponding MEI percentage increase for each applicable time period.
[GRAPHIC] [TIFF OMITTED] TP07AU23.011


[[Page 52306]]


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 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

[[Page 52307]]

to beneficiaries in their homes consistent with the accessibility of 
these services when furnished by professionals via Medicare telehealth, 
we are proposing 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 are seeking 
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 are seeking 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 are 
broadly considering 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 are soliciting 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.

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 discussed in 
section II.C. of this 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

[[Page 52308]]

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 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 contain a general discussion of 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 note 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

[[Page 52309]]

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 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.
    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 13 contains a list of codes and 
descriptors for which are proposing 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 proposed 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 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 13 details 
our refinements of the RUC's direct PE recommendations at the code-
specific level. In section II.B. of this proposed 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.

[[Page 52310]]

In this proposed rule, we also note that many of the refinements listed 
in Table 12 of the proposed rule resulted in changes under the $0.35 
threshold and were 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 proposed 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 refer 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 proposed 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 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 15 and 16 detail the invoices received for new 
and existing items in the direct PE database. As discussed in section 
II.B. of this proposed 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 15 and 16 also include the number of 
invoices received

[[Page 52311]]

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 note 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 proposed 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 the 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 proposed rule for purposes of this cap. Beginning 
for CY 2024, we are proposing 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), 7X000 
(Ultrasound, intraoperative thoracic aorta (e.g., epiaortic), 
diagnostic), 7X001 (Intraoperative epicardial cardiac (eg, 
echocardiography) ultrasound for congenital heart disease, diagnostic; 
including placement and manipulation of transducer), 7X002 
(Intraoperative epicardial cardiac (e.g., echocardiography) ultrasound 
for congenital heart disease, diagnostic; placement, manipulation of 
transducer, and image acquisition only), 7X003 (Intraoperative 
epicardial cardiac (e.g.,)echocardiography) ultrasound for congenital 
heart disease, diagnostic; interpretation and report only), 9X000 
(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)), 9X002 
(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)), 9X003 (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)), 9X004 (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 9X005 (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

[[Page 52312]]

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 are proposing to add 
it to the OPPS cap list for CY 2024.
4. Valuation of Specific Codes for CY 2024
(1) Dorsal Sacroiliac Joint Arthrodesis (CPT Code 2X000)
    In September 2022, CPT deleted category III CPT code 0775T 
(Arthrodesis, sacroiliac joint, percutaneous, with image guidance, 
includes placement of intra-articular implant(s) (eg, bone 
allograft[s], synthetic device[s]) and created a new Category I CPT 
code 2X000 (Arthrodesis, sacroiliac joint, percutaneous, with image 
guidance, including placement of intra-articular implant(s) (eg, 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 2X000 that the clinical nature of CPT codes 27279 
and 27280 is extensively disparate from 2X000 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 are proposing the RUC-recommended work RVU of 7.86 for CPT code 
2X000. We are also proposing the RUC-recommended direct PE inputs 
without refinement.
(2) Vertebral Body Tethering (CPT Codes 2X002, 2X003, and 2X004)
    At the September 2022 CPT Panel meeting, two new Category I CPT 
codes, 2X002 (Anterior thoracic vertebral body tethering, including 
thoracoscopy, when performed; up to 7 vertebral segments) and 2X003 
(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, 2X004 
(Revision (eg, 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 are proposing the RUC-recommended work RVUs of 32.00 for CPT 
code 2X002, 35.50 for CPT code 2X003, and 36.00 for CPT code 2X004. We 
are also proposing the RUC-recommended direct PE inputs without 
refinement.
(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 are proposing 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 disagree with the April 2022 
RUC-recommended survey median work RVU of 7.50 and are proposing the 
survey (with experience) 25th percentile work RVU of 6.88. We note 
that, of the 46 ZZZ-codes with an intraservice time of 60 minutes, only 
four have a work RVU higher than the RUC-recommended 7.50.
    We note 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 (eg, 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

[[Page 52313]]

22860, therefore, we believe the proposed survey (with experience) 25th 
percentile work RVU of 6.88 for CPT 22860 is more appropriate than the 
RUC recommended work RVU.
    We are proposing the RUC-recommended direct PE inputs for both 
codes without refinement.
(4) Phrenic Nerve Stimulation System (CPT Codes 3X008, 3X009, 3X010, 
3X011, 3X012, 3X013, 3X014, 3X015, 9X045, 9X046, 9X047, and 9X048)
    In September 2022, the CPT Editorial Panel created eight new 
Category I CPT codes to describe 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 are proposing the RUC-recommended work RVU for all 12 codes in 
the Phrenic Nerve Stimulation System family. We are proposing a work 
RVU of 9.50 for CPT code 3X008 (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 3X009 (Insertion of phrenic nerve stimulator 
transvenous sensing lead), a work RVU of 9.55 for CPT code 3X010 
(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 3X011 (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 3X012 
(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 3X013 
(Repositioning of phrenic nerve stimulator transvenous lead(s)), a work 
RVU of 6.05 for CPT code 3X014 (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 3X015 (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 9X045 (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 system), a work RVU of 1.82 for CPT code 9X047 
(Interrogation and programming of implanted phrenic nerve stimulator 
system during a polysomnography), and a work RVU of 0.43 for CPT code 
9X048 (Interrogation, without programming of implanted phrenic nerve 
stimulator system).
    We are proposing to refine the CA039 Post-operative visits (total 
time) for CPT code 3X014 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 are also 
proposing to refine the equipment time for the exam table (EF023) 
equipment from 36 minutes to 53 minutes for CPT code 3X014 to conform 
to this proposed change in clinical labor time. For all other codes, we 
are proposing the direct PE inputs as recommended by the RUC without 
refinement.
(5) Posterior Nasal Nerve Ablation (CPT Codes 30117, 30118, 3X016, and 
3X017)
    In September 2022, the CPT Editorial Panel created two new 
endoscopy codes for ablation of the posterior nasal nerve: CPT code 
3X016 (Nasal/sinus endoscopy, surgical; with destruction by 
radiofrequency ablation, posterior nasal nerve), and CPT code 3X017 
(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, 3X016 and 3X017, 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 
3X016 and 3X017.
    We are proposing the RUC-recommended work RVU of 3.91 for CPT code 
30117. We are proposing 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 are proposing to remove 
this clinical labor as it would be duplicative with the communications 
already taking place under the CA036 activity code. We are proposing 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 disagree with the RUC-recommended work RVU of 9.55 for CPT code 
30118 and are proposing 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 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 note 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 disagree 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 disagree 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 are also proposing 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 proposed 
work RVU of 7.75 is supported by the reference CPT codes

[[Page 52314]]

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 proposed 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 are proposing 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 are proposing 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 are proposing the RUC-recommended work RVU of 2.70 for CPT codes 
3X016 and 3X017. Both CPT codes 3X016 and 3X017 are endoscopic 
procedures; therefore, we are proposing 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 3X016 and 3X017 are not add-on codes, and both have a 0-day 
global period. The endoscopic base code that we are assigning to CPT 
codes 3X016 and 3X017 is used in a specific type of multiple procedure 
payment reduction that applies to some endoscopy codes.
    We are proposing to refine the RUC-recommended direct PE inputs for 
both CPT codes 3X016 and 3X017. For CPT code 3X016, 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 3X017.
    For CPT code 3X017, 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 
3X016 and 3X017, we propose 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 3X016 and 3X017.
(6) Cystourethroscopy With Urethral Therapeutic Drug Delivery (CPT Code 
5X000)
    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 5X000 
(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 5X000.
    We are proposing the RUC-recommended work RVU of 3.10 for CPT code 
5X000. We are also proposing the RUC-recommended direct PE inputs for 
CPT code 5X000 without refinement.
    Since this is an endoscopic procedure, we propose CPT code 52000 
(Cystourethroscopy (separate procedure)) as the endoscopic base code 
for CPT code 5X000 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 5X000 is not an add-on code, it has a 0-day 
global period. The endoscopic base code that we are assigning to CPT 
code 5X000 is a specific type of multiple procedure payment reduction 
that applies to some endoscopy codes.
(7) Transcervical RF Ablation of Uterine Fibroids (CPT Code 5X005)
    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 5X005 
(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 5X005 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 
5X005 showed that the survey 25th percentile work RVU of 7.21 
appropriately recognizes the work involved in this service.
    We are proposing the RUC-recommended work RVU of 7.21 for CPT code 
5X005. The RUC recommends that CPT code 5X005 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 5X005 in future rulemaking as needed, based on 
our annual review process discussed in the background section of this 
proposed rule.
    CPT code 5X005 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 are proposing 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 
proposing the RUC-recommended direct PE inputs without refinement.
(8) Suprachoroidal Injection (CPT Code 6X000)
    In September 2022, the CPT Editorial Panel introduced category I 
CPT code 6X000 as a new code. CPT code 6X000 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 6X000 replaces temporary

[[Page 52315]]

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 6X000 
(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 6X000 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 are proposing the RUC-recommended work RVU of 1.53 for CPT code 
6X000. We are also proposing the RUC-recommended direct PE inputs for 
the code without refinement.
(9) Skull Mounted Cranial Neurostimulator (CPT Codes 619X1, 619X2, and 
619X3)
    In February 2022, the CPT Editorial Panel created codes 619X1, 
619X2, and 619X3 to describe Skull-Mounted Cranial Neurostimulator, and 
these codes were surveyed for the October 2022 RUC meeting.
    We are proposing the RUC-recommended work RVU of 25.75 for CPT code 
619X1 (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 619X2 (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 619X3 (Removal of skull-
mounted cranial neurostimulator pulse generator or receiver with 
cranioplasty, when performed).
    We are proposing the RUC-recommended direct PE inputs for CPT codes 
619X1, 619X2, and 619X3 without refinement.
(10) Spinal Neurostimulator Services (CPT Codes 63685, 63688, 64XX2, 
64XX3, and 64XX4)
    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 are proposing the RUC-recommended work RVUs of 5.19 and 4.35, 
respectively. We are proposing the RUC-recommended direct PE inputs for 
CPT codes 63685 and 63688 without refinement.
    We agree with the RUC recommended contractor pricing for CPT codes 
64XX2 (Insertion or replacement of percutaneous electrode array, 
peripheral nerve, with integrated neurostimulator including imaging 
guidance, when performed; initial electrode array), 64XX3 (Insertion or 
replacement of percutaneous electrode array, peripheral nerve, with 
integrated neurostimulator including imaging guidance, when performed; 
each additional electrode array), and 64XX4 (Revision or removal of 
neurostimulator electrode array, peripheral nerve, with integrated 
neurostimulator); and we are proposing contractor pricing for these 
three codes.
(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 are 
proposing the RUC-recommended work RVUs of 5.10 and 3.79, respectively.
    We are requesting clarification on the direct PE inputs for CPT 
code 64590 in the non-facility setting. Specifically, we believe 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 believe that 48 
minutes of equipment time for EQ114 is appropriate and matches the 
clinical labor time; therefore, we are proposing 48 minutes for the 
EQ114 equipment for CPT code 64590. We also believe 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 are proposing 84 minutes of equipment time for 
EQ209 for CPT code 64590.
    We are proposing the remaining RUC-recommended direct PE inputs for 
CPT code 64590 without refinement. We are also proposing the RUC-
recommended direct PE inputs for CPT code 64595 without refinement.
(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 are proposing the RUC-recommended work RVUs for all 
three CPT codes. We are proposing 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 are also proposing the 
RUC-recommended direct PE inputs for CPT codes 65778, 65779, and 65780 
without refinement.
(13) Fractional Flow Reserve With CT (CPT Code 7X005)
    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). For the PFS, we typically assign 
contractor pricing for Category III codes since they are temporary 
codes assigned to emerging technology and services. However, we

[[Page 52316]]

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 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 
(7X005) to report non-invasive estimate of coronary fractional flow 
reserve derived from augmentative software analysis of the dataset from 
a coronary computed tomography angiography. CPT code 7X005 (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 7X005 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 the overall relative resource costs for this service while 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 type of 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).
    We are therefore proposing to maintain the previous valuation 
crosswalk to the technical component of CPT code 93457 for the new 
FFRCT code 7X005. 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 to serve as a proxy for valuation. We are specifically 
crosswalking the technical component of CPT code 7X005 to the technical 
component of CPT code 93457; we are proposing the RUC-recommended work 
RVU of 0.75 for the professional component of CPT code 7X005, and the 
global component will be comprised of their sums as usual. We also note 
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).
(14) Ultrasound Guidance for Vascular Access (CPT Code 76937)
    In order to specify the insertion of a peripherally inserted 
central venous catheter (PICC), the CPT Editorial Panel decided to 
create two new codes: CPT 36572 and CPT 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 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 are proposing the RUC-recommended work RVU of 0.30 for CPT 
76937. We are also proposing the RUC-recommended direct PE inputs for 
CPT 76937.
(15) Neuromuscular Ultrasound (CPT Codes 76881, 76882, and 76883)
    Since their creation in 2011, CPT codes 76881 (Ultrasound, complete 
joint (i.e., 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

[[Page 52317]]

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 are 
proposing 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 note that the old intraservice time of 11 minutes 
was used in error when calculating the standard equipment time for 
ED053. Therefore, we disagree with the RUC-recommended equipment time 
of 13.5 minutes and are proposing 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 disagree 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 are proposing 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 refer 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 and we are not proposing 
any changes to the work RVU for CPT codes 76881, 76882, and 76883.
(16) Intraoperative Ultrasound Services (CPT Codes 76998, 7X000, 7X001, 
7X002, and 7X003)
    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 
76998 until the code was no longer needed, or until it was clear what 
the final dominant use of 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 
code 76998 by cardiothoracic surgeons and cardiologists.
    After utilization was removed from 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 code 76998 to be surveyed. CPT codes 7X000 
(Ultrasound, intraoperative thoracic aorta (e.g., epiaortic), 
diagnostic), 7X001 (Intraoperative epicardial cardiac (e.g., 
echocardiography) ultrasound for congenital heart disease, diagnostic; 
including placement and manipulation of transducer, image acquisition, 
interpretation and report), 7X002 (Intraoperative epicardial cardiac 
(e.g., echocardiography) ultrasound for congenital heart disease, 
diagnostic; placement, manipulation of transducer, and image 
acquisition only), 7X003 (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 disagree with the RUC-recommended work RVU of 1.20 for CPT code 
76998 and are proposing the total time ratio work RVU of 0.91. The RUC 
recommended a 7-minute total time decrease for CPT code 76998. We agree 
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 proposed 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

[[Page 52318]]

be reflected in decreases to work RVUs. We disagree 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 7X000 through 7X003. Instead, we are proposing 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 note that the 
proposed 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 are proposing 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 7X000. We are also proposing the RUC-recommended 
work times for CPT codes 7X001 and 7X002 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 are proposing the RUC-recommended work 
times for CPT code 7X003 with the exception of the intraservice time. 
We are proposing 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 7X001 and 7X002. Therefore, we are proposing 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 
7X003.
    Due to the CPT code descriptor for CPT code 7X001, we believe that 
the appropriate work for this service is reflected in the combined work 
of CPT codes 7X002 and 7X003. We note 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 note that the Summary of Recommendations for 7X001 through 7X003 
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 7X001 through 
7X003 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 7X001 that equals the combined work RVUs of CPT 
codes 7X002 and 7X003.
    Therefore, we disagree with the RUC-recommended work RVUs of 1.90, 
1.20, and 1.55 for CPT codes 7X001, 7X002, and 7X003, respectively. We 
are proposing a work RVU of 1.62 for CPT code 7X001 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 note that this crosswalk is strongly supported by 
total time ratios between CPT code 7X001 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 note that this is supported by a 
total time ratio to the current time and work RVU for the code that 
cardiothoracic surgeons currently use to report this service prior to 
the creation of CPT code 7X001, 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 proposed work RVU for CPT code 76998 of 0.91 ((40/22) * 0.91 = 
1.65). We note that a work RVU of 1.62 for CPT code 7X001 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 7X001 is broken down into service parts by 
CPT code 7X002 and 7X003 to allow for multiple providers to perform 
different parts of the whole service done by one provider (represented 
by 7X001), 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 7X002 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 7X003 represents 
interpretation and report

[[Page 52319]]

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 
disagree with the RUC's recommendation to assign work RVUs for CPT 
codes 7X002 and 7X003 that sum to more than the aggregate work RVU for 
CPT code 7X001. Therefore, we are proposing a work RVU of 1.08 for CPT 
code 7X002 and a work RVU of 0.54 for CPT code 7X003, which sum to the 
proposed aggregate work RVU of 1.62 for CPT code 7X001. The proposed 
work RVUs for CPT code 7X002 and 7X003 were calculated by taking the 
aggregate work RVU of the whole service, represented by CPT code 7X001, 
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 7X002 represents two of the three service 
parts performed by a cardiothoracic surgeon, we allotted \2/3\ rds of 
the aggregated work RVU for CPT code 7X001, equaling 1.08 (1.62 * \2/3\ 
= 1.08). Because CPT code 7X003 represents one of the three service 
parts performed by a cardiologist, we allotted \1/3\ rd of the 
aggregated work RVU for CPT code 7X001, 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 invite comments 
on additional ways to break down the aggregate work RVU of CPT code 
7X001 to adequately account for the cardiothoracic surgeon and 
cardiologist's time and intensity to perform CPT codes 7X002 and 7X003, 
but we believe that the work RVUs should sum to no more than the 
aggregate work RVU for CPT code 7X001 based on similarly broken down 
code families that represent the more widely used intraoperative TEE 
procedures. The RUC did not recommend and we are not proposing any 
direct PE inputs for the five codes in the Intraoperative Ultrasound 
family.
(17) Percutaneous Coronary Interventions (CPT Code 9X070)
    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 9X070 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 are proposing the RUC-recommended work RVU of 2.97 for CPT code 
9X070 (Percutaneous transluminal coronary lithotripsy). The RUC did not 
recommend and we are not proposing any direct PE inputs for this 
facility-based add-on service.
(18) Auditory Osseointegrated Device Services (CPT Codes 926X1 and 
926X2)
    In February 2022, the CPT Editorial Panel created CPT code 926X1 
(Diagnostic analysis, programming, and verification of an auditory 
osseointegrated sound processor, any type; first 60 minutes) and 926X2 
(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 926X2 serves as the add-on code for base CPT code 926X1.
    We are proposing the RUC-recommended work RVU of 1.25 for CPT code 
926X1 and 0.33 for CPT 926X2. We are also proposing the RUC-recommended 
direct PE inputs for both codes. Additionally, because audiologists 
provide these services, we are proposing to add CPT codes 926X1 and 
926X2 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.
(19) Venography Services (CPT Codes 9X000, 9X002, 9X003, 9X004, and 
9X005)
    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 
9X000 (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 9X000 (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 proposes a work RVU of 1.20 for 10 minutes of 
intra-service time and total time. We are proposing the AMA RUC 
recommended work RVU of 1.20 with 10 minutes of intra-service time and 
total time for CPT code 9X000.
    For CPT code 9X002 (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 proposes a work 
RVU of 1.13 for 10 minutes of intra-service time and total time. We 
note that this code has the same number of minutes as CPT code 9X000, 
but with a lower recommended work RVU. We are proposing the AMA RUC 
recommended work RVU of 1.13 with 10 minutes of intra-service time and 
total time for CPT code 9X002.
    For CPT code 9X003 (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 proposes a work RVU of 1.43 for 12 
minutes of intra-service time and total time. We note that this code 
has two additional minutes than CPT code 9X000 which is 20 percent more 
in physician time than the 10 minutes from CPT code 9X000. We are 
proposing the AMA RUC recommended work RVU of 1.43 with 12 minutes of 
intra-service time and total time for CPT code 9X003.
    For CPT code 9X004 (Venography for congenital heart defect(s), 
including catheter placement, and radiological supervision and 
interpretation; venovenous collaterals originating at or

[[Page 52320]]

above the heart (e.g., from innominate vein) (List separately in 
addition to code for primary procedure)), the AMA RUC proposes a work 
RVU of 2.11 for 16 minutes of intra-service time and total time. We 
note that this code has six additional minutes more than CPT code 9X000 
(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 9X004, 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 9X000. Therefore, we are proposing a work RVU 
of 1.92 along with 16 minutes of intra-service time and total time for 
CPT code 9X004.
    For CPT code 9X005 (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 proposes a work RVU of 2.13 
for 17 minutes of intra-service time and total time. We note that this 
code has seven additional minutes more than CPT code 9X000 (10 
minutes), which is 70 percent more physician time than CPT code 9X000. 
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 9X005, 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 9X000. Therefore, we are proposing 
a work RVU of 2.04 along with 17 minutes of intra-service time and 
total time for CPT code 9X005.
    The RUC did not recommend and we are not proposing any direct PE 
inputs for the five codes in the Venography Services family.
(20) General Behavioral Health Integration Care Management (CPT Code 
99484, and HCPCS Code G0323)
    We are proposing to refine the work RVU of both CPT code 99484 and 
HCPCS code G0323, as proposed (see section II.J.1.c of this proposed 
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 proposing the direct PE 
inputs as recommended by the RUC without refinement. We are also 
proposing 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 G0507 (replaced in 2018 by CPT 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 proposed 
rule, for proposed 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 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 proposing 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 as proposed (section II.J.1.c. of this proposed rule) closely 
mirror those described by CPT code 99484. As we are proposing 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 G0323 as proposed (section 
II.J.1.c. of this proposed rule). As such we propose to value HCPCS 
code G0323, as proposed (section II.J.1.c. of this proposed rule), 
based on a direct crosswalk to the work values and direct PE inputs for 
CPT code 99484, as proposed, previously in this section.
    We continue to believe that there is a systemic undervaluation of 
work estimates for behavioral health services. We are proposing values 
for CY 2024 that we believe will more accurately value the work 
involved in delivering behavioral health services.
(21) 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

[[Page 52321]]

time, work RVUs, or direct PE inputs for these services for CY 2024.
    We are proposing 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 are proposing the RUC-recommended direct PE inputs for 
these codes without refinement.
(22) Pelvic Exam (CPT Code 9X036)
    In September 2022, the CPT Editorial Panel created a new CPT code 
for reporting a pelvic exam--CPT code 9X036. 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 9X036 (Pelvic Exam) captures the 
4 minutes of clinical staff time associated with chaperoning a pelvic 
exam.
    We are proposing the RUC-recommended direct-PE inputs for CPT code 
9X036 without refinement. As a PE-only service, the RUC did not 
recommend and we are not proposing a work RVU for this code.
(23) Hyperthermic Intraperitoneal Chemotherapy (HIPEC) (CPT Codes 9X034 
and 9X035)
    In September 2022, the CPT Editorial Panel created two time-based 
add-on Category I CPT codes 9X034 (Intraoperative hyperthermic 
intraperitoneal chemotherapy (HIPEC) procedure, including separate 
incision(s) and closure, when performed; first 60 minutes) and 9X035 
(Intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC) 
procedure, including separate incision(s) and closure, when performed; 
each additional 30 minutes). CPT codes 9X034 and 9X035 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 9X034 and 9X035 are 
inaccurate and that the codes should be resurveyed for 2025. Therefore, 
the RUC recommended contractor pricing for CPT codes 9X034 and 9X035 
and that they be referred to the CPT Editorial Panel for revision.
    We are proposing to contractor price CPT codes 9X034 and 9X035 for 
CY 2024.
(24) 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 two 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 have 
been divided into quarters.
    There has been a change in the dominant specialty providing this 
service, which is now primarily performed by family medicine. There has 
also been 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 is 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 agree with the specialties that the intra-service time is now 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 are proposing 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 two-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 two-hour session. The RUC recommends 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 at the same time. We note that it has 
been standard for one patient to receive treatment at a time and the 
current 15 minutes for CA021 is based on a time ratio to the CY 2015 
RUC-recommended direct PE inputs for CPT code 99183; therefore, we 
disagree with this RUC recommendation and are proposing to refine the 
recommended intra-service CA021 clinical labor time to maintain the 
current 15 minutes. This is to reflect the 2015 PFS final rule where 
``we used the RUC recommended direct PE inputs for 99183 and adjusted 
them to align with the 30 minute treatment interval'' (79 FR 67677). 
Each PE input is prorated for four units of G0277 being provided in one 
typical two-hour session. Since CPT code 99183 (Physician or other 
qualified health care professional attendance and supervision of 
hyperbaric oxygen therapy, per session) is a 120-minute code with 60-
minute intra-service time, all PE inputs in HCPCS code G0277 are 
prorated for four units being performed.
    To conform to these changes in clinical labor time, we are also 
proposing to refine the equipment time for the EQ362 (HBOT air break 
breathing apparatus demand system (hoses, masks, penetrator, and demand 
valve)) and EQ131 (hyperbaric chamber) equipment items from the 
recommended 39.75 minutes to 23.25 minutes. This is a result of the 15-
minute intra-service time, as opposed to the RUC recommendation of 30 
minutes of intra-service time.
(25) 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

[[Page 52322]]

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 
93299 (84 FR 62777-62778). 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 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 are proposing to delete HCPCS code G2066 
and propose 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 are proposing 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 are not proposing 
any changes to the work RVUs for CPT codes 93297 and 93298.
(26) 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 describe 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 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), and 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).
    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 describe 
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. While we did not establish 
payment for the new caregiver behavior management training codes in the 
CY 2023 PFS final rule, we indicated that we believed 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 health-related 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 (e.g., 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://

[[Page 52323]]

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 believe it is 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 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; nonphysician 
practitioner 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 believe 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 have 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 who is treating a patient 
and expending resources to train a caregiver who is assisting or acting 
as a proxy for the patient. However, we continue to explore these 
issues and would appreciate public comments on all aspects of the CTS 
proposals.
    In this proposed rule for CY 2024, we include a proposed definition 
of ``caregiver'' for purposes of CTS, discuss the circumstances under 
which patients may benefit from care involving caregivers, and propose 
that CTS may meet the conditions for Medicare payment when treating 
practitioners identify a need to involve and train caregivers to assist 
the patient in carrying out a treatment plan. We also propose values 
for each of the CTS codes.
(1) Definition of a Caregiver
    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 services, 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 are including a 
guardian in this definition when warranted. For CTS, when we say 
``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 
is established for the patient by the treating physician or 
practitioner and assists 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.
(2) Patients Who Benefit From Care Involving Caregivers
    We believe that a patient-centered treatment plan should 
appropriately account for clinical circumstances where the treating 
practitioner believes the involvement of a caregiver 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 circumstances 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 examples of 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 require assistance with 
challenging behaviors in order 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 in this section above, 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 are seeking 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 
service codes. We are seeking comment on this issue and whether payment 
is currently available for CTS through other Federal or other programs.

[[Page 52324]]

(3) Reasonable and Necessary CTS
    We believe 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, including, but not limited to, the examples specified previously 
in this proposed rule.
    As provided in the code descriptors, treating practitioners may 
train caregivers in a group setting with other caregivers who are 
involved in care for patients with similar needs for assistance to 
carry out a treatment plan. Training for all of the caregivers for the 
patient could occur simultaneously, and the applicable CTS codes (CPT 
code 96202, 96203, and 9X017) would be billed once per beneficiary. We 
are seeking comment on this issue. We also seek comment on whether 
payment is currently available for CTS through other Federal or other 
programs. We are considering 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 are seeking 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.
(4) Proposals
    For CY 2024, we propose to establish an active payment status for 
CPT codes 96202 and 96203 (caregiver behavior management/modification 
training services) and CPT codes 9X015, 9X016, and 9X017 (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. As 
discussed previously in this section, we believe 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 (see examples previously mentioned in this section under 
``Patients Who Benefit from Care Involving Caregivers'').
    We are seeking public comment on this definition of `caregiver' for 
purposes of CTS and are interested if there are any additional elements 
of a caregiver that we should consider incorporating in this proposed 
CTS caregiver definition. We think that our proposed definition would 
allow for holistic care of the patient with those who know and 
understand the patient, their condition, and their environment.
    We propose that payment may be made for CTS services when the 
treating practitioner identifies a need to involve and train one or 
more caregivers to assist the patient in carrying out a patient-
centered treatment plan. We further propose that because CTS services 
are furnished outside the patient's presence, the treating practitioner 
must obtain the patient's (or representative's) consent for the 
caregiver to receive the CTS. We further propose 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.
    We are proposing to require the full 60 minutes of time to be 
performed in order to report CPT code 96202. The add on code, CPT code 
96203, may be reported once 75 minutes of total time is performed. We 
are interested in and seeking 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 are soliciting public comment on each of our proposals for CTS.
b. Coding
(1) Behavior Management/Modification Training for Guardians/Caregivers 
of Patients With a Mental or Physical Health Diagnosis (CPT Codes 96202 
and 96203)
    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 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.
(a) 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 is represented in the group session being billed for CPT 
code 96202. The RUC noted that this recommendation is based upon a 
median group size of six caregivers and includes 10 minutes pre-time, 
60 minutes intra-time, and 20

[[Page 52325]]

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 is also based upon a median group size of six. We are proposing 
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 are also proposing 
the RUC-recommended direct PE inputs for these codes.
    Finally, we note that the RUC recommendation included information 
suggesting that the RUC intends to review the valuation of these 
services again soon.
(2) Caregiver Training in Strategies and Techniques To Facilitate the 
Patient's Functional Performance (CPT Codes 9X015, 9X016, and 9X017)
    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), and 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 (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 use of equipment or assistive devices, or interventions 
focusing on motor, process, and communication skills.
(a) Valuation
    The RUC recommended work values for CPT codes 9X015, 9X016, and 
9X017 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 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 9X015, a work RVU of 0.54 for 9X016, and a work RVU 
of 0.23 per specific patient represented in the group service being 
billed for CPT code 9X017.
    We are proposing the RUC-recommended work RVU 1.00 for CPT code 
9X015, the RUC-recommended work RVU of 0.54 for 9X016, and the RUC-
recommended work RVU of 0.23 per identified patient service for CPT 
code 9X017. The RUC noted that the recommendation for 9X017 is based on 
a median group size of five caregivers. We are also proposing the RUC-
recommended direct PE inputs for these codes.
    Finally, we note that the RUC recommendation included information 
suggesting that the RUC intends to review the valuation of these 
services again soon. We are proposing to designate 9X015, 9X016, and 
9X017 as ``sometimes therapy''. This means that the services of 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.
    We are proposing to accept RUC recommendations as stated previously 
in this section for these codes.
(27) 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 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 that are 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, and as such, we 
believe it is

[[Page 52326]]

underutilized and undervalued. Accordingly, we are proposing 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 proposed new codes would also support the CMS pillars 
\4\ 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.\5\
---------------------------------------------------------------------------

    \4\ CMS Strategic Plan [verbar] CMS.
    \5\ 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/.
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    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 are considering 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, there is no separately enumerated 
statutory Medicare benefit category that 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 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 a number of 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 that 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.\6\ 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.'' \7\ 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).
---------------------------------------------------------------------------

    \6\ 2021 CPT Codebook, p. 16.
    \7\ 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.\8\ 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 are impacting the ability to provide 
medically necessary care, such as appropriate treatment or diagnostic 
services after an office visit or following discharge from a facility.
---------------------------------------------------------------------------

    \8\ 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 health-related social needs and 
risks, and formulate diagnosis and treatment plans that take these 
needs into account. 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 are proposing 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. This section of our proposed rule 
lays out the proposed codes and their proposed valuation, and describes 
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 have 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 are 
proposing to establish separate coding and payment for community health 
integration (CHI) services. We are proposing 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 are proposing 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.

[[Page 52327]]

    We propose 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 will 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 believe 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 prior to 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 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 (cms.gov)).
    We are also seeking 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 also proposed in this 
rule. 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 were to allow an AWV 
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).
    For purposes of assigning a supervision level for these ``incident 
to'' services, we are proposing 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). 
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 this proposal, the phrase or term ``problem addressed'' refers 
to 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 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 discussed later in 
this section), we propose 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 are proposing to adopt CPT's examples of SDOH, with additional 
examples. Specifically, we are proposing 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 generally is limited to items and services that are reasonable 
and necessary for the

[[Page 52328]]

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 propose the following specific codes and descriptors:
    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, 
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).
    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 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 are 
appropriate and reflect typical service times, and whether a frequency 
limit is relevant for the add-on code, we are seeking 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 are also seeking 
comment to better understand the typical duration of CHI services, in 
terms of the number of months for which practitioners furnish the 
services.
    We are proposing 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 are proposing 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, patient and 
family capacity-building, service coordination and system navigation,

[[Page 52329]]

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 are proposing these competencies because they reflect 
professional consensus regarding appropriate core competencies for 
CHWs, applied to this context.\9\ We are seeking 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.
---------------------------------------------------------------------------

    \9\ https://chwtraining.org/c3-project-chw-skills/.
---------------------------------------------------------------------------

    We are proposing to require that time spent furnishing CHI services 
for purposes of billing HCPCS codes GXXX1-2 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 are proposing to require the SDOH 
need(s) to be recorded in the patient's 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.
    Since CHI services are community-based and involve connecting the 
patient with local resources in their community, and are highly 
personalized, e.g., 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 a portion might 
be performed via two-way audio. We are seeking to confirm our 
understanding of where and how these services would be typically 
provided (e.g., in-person, audio-video, two-way audio).
    We are seeking public comment, in particular, 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 are not proposing to require consent for CHI services, 
since we believe these services typically would involve direct patient 
contact, and largely be provided in-person. However, if we hear 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 in our final rule.
    We are proposing 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. While we are proposing to allow CHI 
services to be performed by auxiliary personnel under a contract with a 
third party, we wish to be clear, 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 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 CHI services, as we propose to 
define them, could be fully performed; and therefore, in such cases, 
CHI services should not be billed (see 81 FR 80249). 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, 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 
CHI services. We understand that many CBOs provide social services and 
do other work that is beyond the scope of CHI services, but we believe 
they are well-positioned to develop relationships with practitioners 
for providing reasonable and necessary CHI services.
    Because we are concerned about potential fragmentation that could 
occur in addressing specific SDOH, we are proposing that only one 
practitioner per beneficiary per calendar month could bill for CHI 
services. This would allow

[[Page 52330]]

the patient to have a single point of contact for all their CHI 
services during a given month.
    We are proposing 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 propose that CHI services could not be billed while the patient 
is under a home health plan of care under Medicare Part B, since we 
believe 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 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 CHI services will neatly overlap with any other coverage 
for patients who are dually eligible for Medicare and Medicaid. 
However, we are seeking 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 seek 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.
c. Proposed CHI Services Valuation
    For HCPCS code GXXX1, we are proposing 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 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 GXXX1. We are, 
therefore, proposing a work time of 25 minutes for HCPCS code GXXX1, 
based on this same crosswalk to CPT code 99490. We are also proposing 
to use this crosswalk to establish the direct PE inputs for HCPCS code 
GXXX1.
    For HCPCS code GXXX2, we are proposing 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 incurred when the billing practitioner 
furnishes CHI services. Therefore, we are proposing a work RVU of 0.70 
and a work time of 20 minutes for HCPCS code GXXX2.
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 \10\ 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,\11\ as well as the CMS Framework for Health 
Equity.\12\
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    \10\ https://aspe.hhs.gov/sites/default/files/documents/e2b650cd64cf84aae8ff0fae7474af82/SDOH-Evidence-Review.pdf.
    \11\ https://aspe.hhs.gov/sites/default/files/documents/aabf48cbd391be21e5186eeae728ccd7/SDOH-Action-Plan-At-a-Glance.pdf.
    \12\ https://www.cms.gov/files/document/cms-framework-health-equity-2022.pdf.
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ii. Proposed 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,13 14 15 organizational 
strategic plans,\16\ and provider training modules.\17\ Previously in 
this section of our proposed rule, we discuss 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

[[Page 52331]]

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 are proposing to establish a 
code to separately identify and value a SDOH risk assessment that is 
furnished in conjunction with an E/M visit.
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    \13\ https://www.aafp.org/about/policies/all/social-determinants-health-family-medicine-position-paper.html.
    \14\ https://doi.org/10.7326/M17-2441.
    \15\ https://nam.edu/social-determinants-of-health-201-for-health-care-plan-do-study-act/.
    \16\ https://www.ama-assn.org/system/files/2021-05/ama-equity-strategic-plan.pdf.
    \17\ https://edhub.ama-assn.org/steps-forward/module/2702762.
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    We are proposing a new stand-alone G code, GXXX5, 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 are proposing GXXX5 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 propose 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:
     Administration of a standardized, evidence-based \18\ 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.
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    \18\ https://health.gov/healthypeople/tools-action/browse-evidence-based-resources/types-evidence-based-resources.
---------------------------------------------------------------------------

    ++ 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 \19\ tool, the Protocol for Responding to & Assessing 
Patients' Assets, Risks & Experiences (PRAPARE) \20\ tool, and 
instruments identified for Medicare Advantage Special Needs Population 
Health Risk Assessment.\21\
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    \19\ https://innovation.cms.gov/files/worksheets/ahcm-screeningtool.pdf.
    \20\ https://www.nachc.org/research-and-data/prapare/.
    \21\ CMS-10825.
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    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 is seeking 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'' \22\ (Z55-Z65) which are used to 
document SDOH data to facilitate high-quality communication between 
providers. We are proposing GXXX5 have a duration of 5-15 minutes for 
the administration of an SDOH risk assessment tool, billed no more 
often than once every 6 months. We propose 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.
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    \22\ https://www.cms.gov/files/document/z-codes-data-highlight.pdf.
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iii. Proposed Valuation for SDOH Risk Assessment GXXX5
    We propose 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 GXXX5. HCPCS code G0444 has an 
intraservice time of 15 minutes, and the physician work is of similar 
intensity to our proposed HCPCS code GXXX5. Therefore, we are proposing 
a work time of 15 minutes for HCPCS code GXXX5 based on this same 
crosswalk to G0444. We are also proposing to use this crosswalk to 
establish the direct PE inputs for HCPCS code GXXX5.
    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 are proposing 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 are seeking comment on 
where and how these services would be typically provided, along with 
other aspects of the proposed SDOH assessment service.
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.\23\ 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

[[Page 52332]]

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

    \23\ See for example, https://view.ons.org/3hjHjc and https://www.accc-cancer.org/docs/projects/pdf/patient-navigation-guide.
---------------------------------------------------------------------------

    For CY 2024, we are proposing 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. We are proposing 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.\24\ 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.\25\ Some measure serious illness 
by the amount of urgent health care use (911 calls, emergency 
department visits, repeated hospitalizations) and polypharmacy.\26\ The 
navigation services such patients need are similar to CHI services (as 
discussed 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 are proposing for PIN services a parallel set of services to the 
proposed 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.
---------------------------------------------------------------------------

    \24\ https://pubmed.ncbi.nlm.nih.gov/29125784/.
    \25\ https://www.ajmc.com/view/serious-illness-a-high-priority-for-accountable-care.
    \26\ https://www.ajmc.com/view/serious-illness-a-high-priority-for-accountable-care.
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ii. Proposed Principal Illness Navigation (PIN) Service Definition
    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.
    We propose 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

[[Page 52333]]

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 are also seeking 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 annual wellness visit (AWV) that may or may 
not include the optional SDOH risk assessment also proposed in this 
rule. 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 were to allow an 
AWV furnished by a health care practitioner other than a physician or 
practitioner to serve as the initiating visit for PIN services, the PIN 
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).
    For purposes of assigning a supervision level for payment, we are 
proposing 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 propose 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 E/M visit. ``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 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, pages. 6 
through 8).
    For purposes of PIN services, we propose 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 are proposing to adopt CPT's examples of SDOH, 
with additional examples. Specifically, we are proposing 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. 
Since Medicare payment is limited to items and services that are 
reasonable and necessary for the diagnosis or treatment of illness or 
injury, with respect to addressing SDOH need(s), the focus of PIN 
services would need to be on addressing particular SDOH need(s) that 
are interfering with, or presenting a barrier to, diagnosis or 
treatment of the serious, high-risk condition.
    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

[[Page 52334]]

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.
    GXXX4--Principal Illness Navigation services, additional 30 minutes 
per calendar month (List separately in addition to GXXX3).
    To help inform whether our proposed descriptor times are 
appropriate and reflect typical service times, and whether a frequency 
limit is relevant for the add-on code, we are seeking comment on the 
typical amount of time practitioners spend per month furnishing PIN 
services. We are also seeking 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 are proposing that all auxiliary personnel who provide PIN 
services must be certified or trained to provide all included PIN 
service elements, 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.\27\ Approximately 48 States have 
professional certification programs for peer support specialists 
providing services to patients with substance use or mental health 
conditions, which is required for billing peer support specialists' 
services to Medicaid. For substance use and mental health conditions, 
SAMHSA recently published National Model Standards for Peer Support 
Certification.\28\
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    \27\ https://resumecat.com/blog/patient-navigator-certifications.
    \28\ https://peerrecoverynow.org/product/comparative-analysis-of-state-requirements-for-peer-support-specialist-training-and-certification-in-the-us/ and https://store.samhsa.gov/sites/default/files/pep23-10-01-001.pdf.
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    In States that do not have applicable licensure, certification, or 
other laws or regulations, we are proposing to require auxiliary 
personnel providing PIN services to be trained to provide them. 
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 are proposing these competencies because we 
believe they reflect professional consensus regarding appropriate core 
competencies, adjusted to this context.\29\ We are seeking 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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    \29\ 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 are proposing that time spent furnishing PIN services for 
purposes of billing HCPCS codes GXXX3-4 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 (discussed previously in this proposed 
rule), 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 are seeking 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 are seeking public comment in particular 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 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

[[Page 52335]]

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 are not proposing to require consent for PIN 
services, since we believe these services typically would involve 
direct patient contact, and largely be provided in-person. However, if 
we hear 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 are proposing that 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. While we are proposing to allow PIN 
services to be performed by auxiliary personnel under a contract with a 
third party, we wish to be clear, 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 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 propose 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 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 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 are proposing 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 are proposing 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 service (as discussed previously in this proposed 
rule), there are aspects of PIN services, or PIN services for certain 
conditions, that may be covered under a Medicaid program. 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 are seeking 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 seek comment on if 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?
iii. Proposed PIN Services Valuation
    For HCPCS code GXXX3, we are proposing 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

[[Page 52336]]

intraservice time of 25 minutes and the physician work is of similar 
intensity to our proposed HCPCS code GXXX3. Therefore, we are proposing 
a work time of 25 minutes for HCPCS code GXXX3 based on this same 
crosswalk to CPT code 99490. We are proposing to use this crosswalk as 
well to establish the direct PE inputs for HCPCS code GXXX3.
    For HCPCS code GXXX4, we are proposing 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 are 
proposing a work RVU of 0.70 and a work time of 20 minutes for HCPCS 
code GXXX4.
    (28) 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-
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 are proposing 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 11 
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.
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 proposed 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 34078-34079, 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 work dominating the specialty 
(for example, primary care, so-called ``cognitive'' specialty work, or 
global

[[Page 52351]]

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 59628-59535), 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 59636-59645). 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-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 
proceeded to revise and resurvey 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 selection 
of visit level, such as number of body systems reviewed, and to require 
instead that a medically appropriate history and exam are performed. 
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 \30\ (cms.gov).
---------------------------------------------------------------------------

    \30\ https://www.cms.gov/files/document/physician-fee-schedule-pfs-payment-officeoutpatient-evaluation-and-management-em-visits-fact-sheet.pdf.
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    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 refer 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 a considerable number of the Other E/M CPT 
codes, with inpatient and observation visits being combined into a 
single code set, and home and domiciliary visits being 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 the E/M visit. Finally, the RUC 
resurveyed the Other E/M visits and associated prolonged service codes,

[[Page 52352]]

and provided revaluation recommendations to CMS.
    We addressed all of 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, which increased 
their relative valuation in aggregate. However, we stated our belief 
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 note 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 84569-84571). 
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 that are 
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 potential 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 
it would be appropriate to report the O/O E/M visit complexity add-on 
service. 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 that 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 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

[[Page 52353]]

chronic condition or single high-risk disease) and to address the 
majority of patients' 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 
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. Proposal for O/O E/M Visit Complexity Add-On HCPCS Code G2211
    Interested parties have continued to engage with us and provide 
recommendations for implementation of 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 implementation of 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 the 
majority of their services continued to be supportive of HCPCS add-on 
code G2211 (85 FR 84570) and have recommended that we speedily 
implement it. Some of these commenters also recommended 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 are proposing to 
change the status of HCPCS code G2211 to make it separately payable by 
assigning the ``active'' status indicator, effective January 1, 2024. 
After considering feedback we have received from interested parties, 
both through the CY 2021 PFS rulemaking process and during the 
moratorium, we are also proposing 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 are proposing 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 reasons we find persuasive 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 
health care 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. Taking into 
consideration 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 longitudinal care

[[Page 52354]]

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 proportion of visits billed that 
were furnished as consults or for the purpose of obtaining a second 
clinical opinion and excluded these types of visits from our estimates. 
We estimate that when fully adopted, HCPCS code G2211 will be billed 
with 54 percent of all O/O E/M visits. This fully adopted estimate is 
informed by considering uptake of new codes after several years. We 
seek comment on these utilization assumptions and the application of 
this proposed policy for CY 2024.
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 relies 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 the management of 
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 for purposes of updating 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 also seek public comment about the potential range 
of approaches CMS could take to improve the accuracy of valuing 
services. We are especially interested in how we might improve the 
accuracy of valuation for services, and we are seeking information 
about how we might evaluate E/M services with greater specificity, more 
regularly and comprehensively.
    As we consider how CMS can potentially move forward with reforms to 
the way we establish values for E/M and other services, we are 
particularly interested in receiving comments 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?
    We are particularly interested in ways that CMS could potentially 
improve processes and methodologies, and we request that commenters 
provide specific recommendations on ways that we can improve data 
collection and to make better evidence-based and more accurate payments 
for E/M and other services. We are particularly interested in 
recommendations on 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 are also interested in recommendations that would ensure that 
data collection from, and documentation requirements for, physician 
practices are as least burdensome as possible while also maintaining 
strong program integrity requirements. Finally, we are also interested 
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.
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 non-physician practitioner (NPP) provide the service 
together (not necessarily concurrently) and the billing physician 
personally performs a substantive portion of the visit. Commenters were 
generally supportive of our CY 2022 proposals; however, there were 
divided comments with regard to 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. 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 (85 
percent of the PFS).
    For CY 2023, after considering the public comments we received, we 
finalized that we would delay implementation of our definition of the

[[Page 52355]]

substantive portion as more than half of the total practitioner time 
until January 1, 2024. 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. 
To date, we have roughly one year's worth of claims data from the time 
the modifier was instituted 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 are proposing 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 are proposing to maintain the current definition of 
substantive portion for CY 2024 that allows for use of either one of 
the three key components (history, exam, or MDM) or more than half of 
the total time spent to determine who bills the visit. This proposed 
additional delay allows interested parties to have another opportunity 
to comment on this policy, and gives CMS time to consider more recent 
feedback and evaluate whether there is a need for additional rulemaking 
on this aspect of our policy. We are interested in how facilities are 
currently implementing our split (or shared) services policy in their 
workflows and how facilities are currently accounting for services of 
billing practitioners that are performed split (or shared). We are also 
interested in how to better account for the services of the billing 
practitioner in team-based care clinical scenarios. We understand that 
the AMA CPT Editorial Panel is considering revisions to aspects of 
split or shared visits that may impact our policies, but those changes 
may not be finalized before this proposed rule is published. We will 
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 will consider any changes that are made 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 would address any 
changes through future rulemaking.
    We are proposing to amend 42 CFR 415.140 to revise the definition 
of ``substantive portion'' in the interim while we continue to analyze 
and collect information from interested parties and commenters as to 
whether we should permanently modify our current definition. We note 
the current definition of ``substantive portion'' applies for visits 
other than critical care visits furnished in CY 2022 through CY 2024. 
We are amending Sec.  415.140 by removing ``the year 2022 and 2023'' 
and adding in its place ``years 2022 through 2024'' after the phrase 
``For visits other than critical care visits furnished in calendar.'' 
Therefore, the proposed paragraph would specify, for visits other than 
critical care visits furnished in calendar years 2022 through 2024, 
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.

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 proposed 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 
proposed 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;

[[Page 52356]]

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 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 note 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

[[Page 52357]]

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.

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. 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 refer 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 how 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 are soliciting comments on how best to use these approaches 
under our PFS ratesetting methodology as potential methods to establish 
appropriate payment for skin substitute products under the PFS.
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, under the PFS, various sources 
of information have helped inform payment for specific services 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 note in the CY 2011 PFS final rule (75 FR 73205) 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 seek comment on the various cost-gathering approaches discussed 
above that could inform how we establish direct PE inputs for skin 
substitute products and appropriately develop payment rates for 
physician services that involve furnishing skin substitute products.
3. Approaches to Billing
    We acknowledge 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 how 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 how we 
propose 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

[[Page 52358]]

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 costs 
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 seek comment on how these methods discussed above may help 
reflect the resource costs involved with skin substitute products as 
furnished with different skin application procedures.

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 that would 
allow Medicare payment for remote therapeutic monitoring (RTM) 
services, including allowing any RTM service to be furnished under our 
general supervision requirements (87 FR 69649). RTM refers to the use 
of devices to monitor a patient's health or response to treatment using 
non-physiological data (please see 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 are proposing 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 note 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 a 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 are 
proposing to retain the OTPP and PTPP direct supervision requirement 
for unenrolled PTs or OTs by clarifying that the proposed 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 are seeking 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 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. This aligns the regulatory 
text at Sec. Sec.  410.59 and 410.60 with the RTM general supervision 
policy that we finalized in our CY 2023 rulemaking.
    (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 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 66345) 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

[[Page 52359]]

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 found 
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 onsite supervisory visit at least once every 30 
days. We note 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 are 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 at this time, and are soliciting 
comments from the public that we may consider for possible future 
rulemaking. We are 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 with respect to 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. We are, therefore, soliciting public 
comment, along with supporting data, about the questions and concerns 
we highlighted above, for our consideration for possible future 
rulemaking. We are 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 are seeking public comment for our consideration for 
possible future rulemaking regarding any appropriate exceptions to 
allowing general supervision in the furnishing of therapy services.
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 propose to increase the CY 2023 KX 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

[[Page 52360]]

4.5 percent, based on the IHS Global, Inc. (IGI) first quarter 2023 
forecast with historical data through the fourth quarter of 2022.\31\ 
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 are also proposing that if more recent data are 
subsequently available (for example, a more recent estimate of the CY 
2024 2017-based MEI percentage increase) later this year, we would use 
such data, if appropriate, to determine the CY 2024 MEI percentage 
increase and would apply that new estimate to formulate our values in 
the CY 2024 PFS final rule.
---------------------------------------------------------------------------

    \31\ 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.
---------------------------------------------------------------------------

    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 until CY 2028, when it will be updated by the 
percentage increase in the MEI. 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:
    (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.)
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 
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 statute at section 
1861(qq)(2)(A) to bill Medicare on behalf of the entire DSMT entity as 
the DSMT certified provider.

[[Page 52361]]

    Consequently, we propose to amend the regulation at Sec.  410.72(d) 
to clarify that a RD or nutrition professional must personally perform 
MNT services. Additionally, we propose 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 propose 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.
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 proposed 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 are proposing 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 proposed 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 
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 are proposing to revise our policy at 
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.

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 Appropriations Act of 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 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

[[Page 52362]]

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).\32\ 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 at in the Medicare Claims Processing Manual, Pub. 
100-04, Chapter 1, Section 30.3.1.
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    \32\ https://www.govinfo.gov/content/pkg/FR-2023-04-10/pdf/2023-07137.pdf.
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    We also note 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 proposed 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 proposed 
rule.
b. Proposed Changes to Regulations
    Consistent with the changes to the statute described above, we are 
proposing 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 are proposing 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 note 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 are proposing 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 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 are also interested in public comments 
regarding States that have a supervised clinical hour requirement for 
MFT licensure that is less than 2 years.
    We are proposing 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 are also proposing 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 are proposing at Sec.  410.53(b)(2) that the following 
services do not fall under the Medicare Part B benefit category for MFT 
services:

[[Page 52363]]

     Services furnished by a marriage and family therapist to 
an inpatient of a Medicare-participating hospital.
    Similarly, we are proposing 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 are proposing 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 are also interested in public comments regarding States that 
have a supervised clinical hour requirement for MHC licensure that is 
less than 2 years.
    We are proposing 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 are also proposing 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 are proposing 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 are proposing 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 are also proposing 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 are proposing 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 are also proposing 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 are proposing to codify at Sec.  414.53 the 
payment amount for clinical social worker (CSW) services as authorized 
under section 1833(a)(1)(F) 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 are proposing 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 are also proposing 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 proposed rule for a 
discussion of this proposal.
    Additionally, we are proposing 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 would be considered 
Mental Health Counselors and would 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 are seeking information pertaining 
to other types of professionals who may meet the applicable 
requirements for enrollment as mental health counselors. We note 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 of ``interactive telecommunications system.'' 
We propose 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 are proposing 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 note 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

[[Page 52364]]

as an incident to a physician's professional service. The proposed 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 note that consistent with the proposed changes to 
valuation of CPT code 99484 in the Valuation of Specific Codes section 
(section II.E. of this proposed rule), which describes General BHI and 
is the crosswalk code used for valuation of HCPCS code G0323, we are 
also proposing conforming updates to the valuation for work and PE 
inputs for HCPCS code G0323. See section II.E. of this proposed rule 
for further discussion of changes to the valuation for HCPCS code 
G0323.
    We welcome 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.
d. Medicare Enrollment of MFTs and MHCs
    MFTs and MHCs who meet 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 is 
licensed or certified as a MHC, clinical professional counselor, or 
professional counselor by the State in which the services are 
furnished) described in detail above in this section, as finalized, 
will need to enroll in Medicare as MFTs and MHCs in order to submit 
claims for marriage and family therapist services and mental health 
counselor services, respectively, furnished to Medicare beneficiaries. 
Under Sec.  424.510, a provider or supplier must complete, sign, and 
submit to its assigned 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 propose that the MFT and MHC supplier types, 
like most non-physician practitioner types, be subject to limited-risk 
screening under Sec.  424.518, for we have no basis on which to assign 
these suppliers as a class to a higher screening category.
    MFTs and MHCs that meet the proposed 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 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 are proposing 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). 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 provide 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 propose 
that the two new G-codes describing psychotherapy for crisis services 
can be

[[Page 52365]]

billed when the services are furnished in any non-facility place of 
service other than the physician's office setting. We also note 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 are 
proposing to use the same broad definition of the patient's home for 
purposes of these proposed G-codes describing psychotherapy for crisis 
services.
    The proposed 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 are proposing 
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 are 
proposing 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 note 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 subsection (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 are 
proposing 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 note 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 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 are not proposing to do so through 
this rule. CMS anticipates conducting this outreach and education 
through existing communications mechanisms as required by the CAA, 
2023.
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 
proposed implementation of section 4124 in the CY 2024 Outpatient 
Prospective Payment System (OPPS) proposed 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

[[Page 52366]]

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 note 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 note that this NCD was retired on December 8, 2022.\33\
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    \33\ 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 
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.'' \34\ 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.'' \35\ Therefore, we are proposing 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 note 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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    \34\ 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.
    \35\ 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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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,\36\ and worsening behavioral healthcare workforce 
shortages.\37\ 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.\38\ 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.\39\ 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.\40\ 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.\41\ 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.\42\
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    \36\ https://www.kff.org/coronavirus-covid-19/issue-brief/the-implications-of-covid-19-for-mental-health-and-substance-use/.
    \37\ https://bhw.hrsa.gov/sites/default/files/bureau-health-workforce/data-research/behavioral-health-2013-2025.pdf.
    \38\ https://bhw.hrsa.gov/sites/default/files/bureau-health-workforce/data-research/behavioral-health-2013-2025.pdf.
    \39\ Health Resources and Services Administration, Health 
Workforce Shortage Areas, https://data.hrsa.gov/topics/health-workforce/shortage-areas.
    \40\ https://bhw.hrsa.gov/sites/default/files/bureau-health-workforce/data-research/bh-workforce-projections-fact-sheet.pdf.
    \41\ 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.
    \42\ 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

[[Page 52367]]

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 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 \43\ (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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    \43\ 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 above, 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 recognize 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.

[[Page 52368]]

    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.
    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 propose 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) 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 are 
proposing to reestablish in this rule. Our proposed implementation of 
that policy is discussed in section II.F. of this proposed 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 propose to address the need for improvement in valuation for timed 
psychotherapy services based on the proposed valuation for the inherent 
complexity add-on code for office/outpatient E/M services.
    Under this proposal, we would apply an adjustment to the work RVUs 
for the psychotherapy codes payable under the PFS. We propose to base 
this adjustment on the difference in total work RVUs for office/
outpatient E/M visit codes (CPT codes 99202-99205 and 99211-99215) 
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 would result 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 are proposing 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 are proposing 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 are not proposing 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.E of this proposed 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 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 recognize 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. If finalized, the implementation of 
this proposal for CY 2024, concurrent with the proposal to implement 
the inherent complexity add-on code, if finalized, will 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 welcome 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 
described above.
    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

[[Page 52369]]

would implement this change over a 4-year transition, beginning in CY 
2018 and ending in CY 2021. We welcome comments on whether we should 
consider further adjustments to the nonfacility indirect PE for the 
identified outlier codes. Specifically, we request 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.
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 are 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 are proposing 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 described by 
HCPCS codes G2086 and G2087 include two individual psychotherapy 
sessions per month, we are proposing 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 note 
that as described above, we are also proposing to update the work RVUs 
assigned to CPT code 90834 in this proposed rule. If our proposal to 
update the work RVUs for the standalone psychotherapy codes is 
finalized, CPT code 90834 would be assigned a work RVU of 2.35. In that 
case, our proposed 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.
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.\44\ We continue to be interested in hearing feedback 
regarding ways we can continue to expand access to behavioral health 
services. For example, we welcome 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 are seeking 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.
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    \44\ https://www.cms.gov/cms-behavioral-health-strategy.
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    We welcome 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.
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

[[Page 52370]]

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 request 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 seek 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 seek 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?
    ++ 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

[[Page 52371]]

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?

K. Proposals 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 (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, we are proposing to expressly identify 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. At the 
same time, we recognize that there are dental services that are not 
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 would 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.
    We are proposing 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, and substantially related and integral to, 
the clinical success of, other covered services. We are also proposing 
to make non-substantive technical changes to improve clarity of the 
regulation text.
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 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 review 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.45 46 The AHRQ report \47\ 
regarding dental services and the link between medical services is 
available at https://effectivehealthcare.ahrq.gov/products/receiving-chemotherapy-cancer/rapid-review. 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 they are exposed to higher doses/duration of 
chemotherapy.\48\ 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 lead 
to reduced survival rates up to 3 years post-

[[Page 52372]]

treatment.\49\ 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.\50\ 
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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    \45\ 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.
    \46\ National Cancer Institute. NCI Dictionary of Cancer Terms. 
2019. Available at https://www.cancer.gov/publications/dictionaries/cancer-terms.
    \47\ 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/AHRQEPCRAPIDDENTALCANCER.
    \48\ 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.
    \49\ 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.
    \50\ 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, 7 systematic reviews, and 5 practice guidelines that 
outline benefits and harms of pre-treatment dental services and their 
effects on cancer chemotherapy regimens. The studies were selected 
using specific inclusion criteria: a sample of patients beginning 
cancer treatment within two 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.51 52 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.\53\ 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. 54 55 56
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    \51\ 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.
    \52\ 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.
    \53\ 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.
    \54\ 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.
    \55\ 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.
    \56\ 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, 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. (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 certain 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, 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, and substantially related and integral to the 
clinical success of, the 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)

[[Page 52373]]

    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 continue to 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 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 early and monitor dental issues 
and 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 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. 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.
    One submission also recommend 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 
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 in support of the need for screening and treatment 
for oral/dental infections prior to 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 below at section II.K.3. of this proposed 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 the provision of 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

[[Page 52374]]

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 an essential component of medical treatment for 
these individuals who are 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 
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 thank all those who submitted recommendations for clinical 
scenarios for which they believe Medicare payment for dental services 
would be consistent with the policies we codified and clarified in the 
CY 2023 PFS final rule under which Medicare payment could be made for 
dental services when inextricably linked to other covered services. We 
continue 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 
specific 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 and 
medical services, not a specific medical condition, and whether it is 
not clinically advisable to move forward with the medical service 
without having first completed the dental service(s). We remind readers 
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 
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 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. Proposed 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 a primary 
medical service 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 
service(s).
    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. 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 believe the 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 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 propose to amend our regulation at Sec.  
411.15(i)(3)(i)(A) to permit payment under Medicare Parts A and Part B 
for:
    (1) 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, chimeric 
antigen receptor (CAR) T-cell therapy when used in the treatment of 
cancer, and the administration of high-dose bone-modifying agents 
(antiresorptive therapy) when used in the treatment of; and
    (2) 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, CAR T-cell 
therapy when used in the treatment of cancer, and the administration of 
high-dose bone-modifying agents (antiresorptive therapy) when used in 
the treatment of cancer. Furthermore, we propose 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 currently described in our 
regulation at Sec.  411.15(i)(3)(ii).
a. Dental Services Inextricably Linked to Chemotherapy Services When 
Used in the Treatment of Cancer
    In the CY 2023 PFS final rule (87 FR 69663 through 69688), and as 
described in section II.K.1 of this proposed rule, we stated that we 
would continue to study the relationship between dental care and 
medical services that cause immunosuppression in patients, and the risk 
of dental infection and complications that arise because of the 
treatment-induced immunosuppression. As discussed in section II.K.1 of 
this proposed 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

[[Page 52375]]

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 would 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 certain other covered 
services.
    In the CY 2023 PFS final rule (87 FR 69681) and as discussed in 
section II.K.2 of this 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. Additionally, as described in the comments 
received on the CY 2023 PFS proposed rule and summarized in the CY 2023 
PFS final rule (87 FR 69683), commenters suggested that the patient 
population with any cancer receiving chemotherapy treatments required 
dental services that were linked to the clinical success of the 
completion of the chemotherapy treatment. They indicated that 
immunocompromised patients, such as individuals with blood cancers 
(leukemia and lymphoma) or other types of cancers, are at increased 
risk of serious infection that can lead to severe complications and 
adverse outcomes. Commenters provided information showing that 
chemotherapy drugs used for treatment of head and neck cancers can have 
many side effects, including sores and lesions in the mouth and throat 
tissues, difficulty swallowing, bleeding in the mouth, and tooth decay. 
Additionally, commenters stated that, because chemotherapy reduces the 
body's ability to fight opportunistic infections, patients who begin 
chemotherapy with untreated infections (including infections in the 
oral cavity) are at risk of developing a number of complications, 
ranging from fungal or viral infections of the mouth and throat to 
systemic infections or fatal sepsis. Commenters observed that 
complications arising from untreated infections could cause treatment 
interruptions which could compromise the success of the treatment and 
the patient's outcomes. One commenter observed that the need for 
removing oral infection prior to starting chemotherapy is analogous to 
the rationale for providing oral care prior to renal transplant, and 
thus (like a dental exam prior to renal transplant) should be 
considered substantially related and inextricably linked to the 
clinical success of the treatment. Commenters recommended that patients 
receiving chemotherapy for head or neck cancer receive a dental exam 
and stabilization, if applicable. Several commenters noted that 
providing an oral exam prior to starting chemotherapy is the standard 
of care in many cancer centers (87 FR 69681 through 69683).
    Additionally, in the CY 2023 PFS final rule (87 FR 69682), we 
stated that many commenters recommended that we permit payment under 
Medicare Parts A and B for dental services prior to treatment for all 
types of cancer patients instead of just those with head and neck 
cancers; commenters suggested that the linkage between the medical 
services (chemotherapy, with or without radiation) and dental services 
was the same whether the medical services are used to specifically 
treat head and neck cancers or other cancers. Commenters stated that 
the increased risk of infections and sepsis among cancer patients could 
constitute major health setbacks that are costly to treat and can 
compromise the success of the cancer treatment. We reiterated that we 
would continue to review and evaluate information that supports the 
relationship between dental care and covered treatments for cancer 
(including treatments related to conditions not localized in the head, 
neck, or oral cavity), and have continued to study this issue.
    We believe immunosuppression is commonly understood to be a 
suppression or reduction of the body's immune response, which can be 
caused by various factors that increase susceptibility to infections 
and an increased risk of developing certain types of conditions.\57\ 
There is significant and abundant worldwide experience and research 
regarding the care of patients whose medical conditions require 
chemotherapy regimens that induce acute 
immunosuppression.58 59 The treatment of a broad range of 
malignancies often requires the use of 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.60 61 62 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 the treatment of cancer, 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 the treatment of cancer 
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.63 64 If an oral or dental

[[Page 52376]]

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; and 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 65 66
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    \57\ Abbas AK, Lichtman AH, Pillai S. Basic Immunology: 
Functions and Disorders of the Immune System. 5th edition. 
Philadelphia: Elsevier; 2016. Chapter 8, Immune Suppression.
    \58\ 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.
    \59\ 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.
    \60\ 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.
    \61\ 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.
    \62\ 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.
    \63\ 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.
    \64\ 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.
    \65\ 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].
    \66\ 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 entry of oral 
bacteria into the body, potentially increasing the risk of infection 
for the patient and compromising the chemotherapy 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,67 68 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 above, 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.\69\
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    \67\ 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].
    \68\ 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].
    \69\ 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 above in section II.K.1. of this proposed 
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.\70\ 
Additionally, as discussed in section II.K.1. of this proposed 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.71 72
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    \70\ 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.
    \71\ 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.
    \72\ 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.73 74 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.'' \75\ 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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    \73\ 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.
    \74\ 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.
    \75\ 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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    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 inability of the patient 
to complete the course of treatment, thereby potentially reducing 
effectiveness of the therapy)

[[Page 52377]]

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 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.
    We also seek 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. 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 seek 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.
    In summary, 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 chemotherapy services, we believe 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. 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 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. Therefore, 
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.
    We are proposing 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 propose 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 seek comments on all aspects of this 
proposal. Additionally, we note that we are proposing to make payment 
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 proposal is not meant to be limited to cases where chemotherapy in 
the treatment of cancer is provided without the use of other therapies. 
We seek comment on this aspect of the proposal.
b. Dental Services Inextricably Linked to CAR T-Cell Therapy, When Used 
in the Treatment of Cancer
    In the CY 2023 PFS final rule (87 FR 69677), commenters stated that 
individuals receiving CAR T-cell treatment for cancer may also require 
dental services, suggesting that these dental services are inextricably 
linked to covered CAR T-cell medical services, asserting that dental 
and oral services improve clinical outcomes for these types of medical 
services. We also received submissions through the public process 
providing evidence to show that dental services are inextricably linked 
to the clinical success of CAR T-cell medical services and other 
lymphodepleting therapy when used in the treatment of cancer. The 
submissions stated that, because CAR T-cell medical services cause a 
patient to be immunosuppressed, an untreated oral or dental infection 
could complicate or compromise the clinical outcome of the CAR T-cell 
medical service. Two submissions cited research indicating that 
patients undergoing CAR T-cell therapy and other lymphodepleting 
therapy, which is a short course of chemotherapy for the purpose of 
killing off a portion (or all) of the patient's own lymphocytes and/or 
other white blood cells prior to an immunotherapy or a bone marrow 
transplant, experience a higher infection risk in the first 100 days 
post-

[[Page 52378]]

treatment.\76\ Submitters also stressed the need to detect early and 
monitor for dental issues during CAR T-cell therapy in order to avoid 
the increased risk of related infections and complications. These 
submissions also highlighted that clinical practice guidelines 
recommend dental services prior to initiating the CAR T-cell therapy 
and other lymphodepleting therapy in order to eliminate any sources of 
infection before and during treatment.77 78 79 80 81
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    \76\ Wudhikarn K, Palomba ML, Pennisi M, Garcia-Recio M, Flynn 
JR, Devlin SM, Afuye A, Silverberg ML, Maloy MA, Shah GL, Scordo M, 
Dahi PB, Sauter CS, Batlevi CL, Santomasso BD, Mead E, Seo SK, 
Perales MA. Infection during the first year in patients treated with 
CD19 CAR T cells for diffuse large B cell lymphoma. Blood Cancer J. 
2020 Aug 5;10(8):79. doi: 10.1038/s41408-020-00346-7. PMID: 
32759935; PMCID: PMC7405315.
    \77\ Elad S, Raber-Durlacher JE, Brennan MT, Saunders DP, Mank 
AP, Zadik Y, Quinn B, Epstein JB, Blijlevens NM, Waltimo T, Passweg 
JR, Correa ME, Dahll[ouml]f G, Garming-Legert KU, Logan RM, Potting 
CM, Shapira MY, Soga Y, Stringer J, Stokman MA, Vokurka S, Wallhult 
E, Yarom N, Jensen SB. Basic oral care for hematology-oncology 
patients and hematopoietic stem cell transplantation recipients: a 
position paper from the joint task force of the Multinational 
Association of Supportive Care in Cancer/International Society of 
Oral Oncology (MASCC/ISOO) and the European Society for Blood and 
Marrow Transplantation (EBMT). Support Care Cancer. 2015 
Jan;23(1):223-36. Epub 2014 Sep 5. PMID: 25189149; PMCID: 
PMC4328129. doi: 10.1007/s00520-014-2378-x.
    \78\ University of Michigan, CAR-T Cell Patient Dental Clearance 
Instructions, no date. CellularTherapyDentalForm.pdf (umich.edu).
    \79\ Guideline on dental management of pediatric patients 
receiving chemotherapy, hematopoietic cell transplantation, and/or 
radiation. Pediatr Dent, 2008; 30(7 Suppl):219-225.
    \80\ McGuire DB, Correa ME, Johnson J, Wienandts P. The role of 
basic oral care and good clinical practice principles in the 
management of oral mucositis. Support Care Cancer, 2006; 14(6):541-
547. doi:10.1007/s00520-006-0051-8 8.
    \81\ Vendrell Rankin K, Jones DL, Redding SW (Eds.), Oral Health 
in Cancer Therapy: A Guide for Health Care Professionals [3rd 
edition], Baylor Oral Health Foundation and the Cancer Prevention 
and Research Institute of Texas, 2008. https://doi.org/10.1002/9781118416426.ch101.
---------------------------------------------------------------------------

    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, we are persuaded 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. 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 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 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, we are proposing 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 propose 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. We seek comments on all aspects 
of this proposal.
    We also seek 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 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 request comment on what 
specific medical services also involve lymphodepletion and should 
therefore be considered in addition to CAR T-cell therapy. We also 
request additional information regarding how those specific services 
might be impacted by dental infections/conditions. We note 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 are seeking 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 request a description 
of that systematic evidence. Specifically, similar to the evidence we 
requested in the CY 2023 PFS proposed rule, we are looking for medical 
evidence that the provision of certain dental services leads to 
improved healing, improved quality of surgery, and the reduced 
likelihood of readmission and/or surgical revisions, because an 
infection has interfered with the integration of the implant and 
interfered with the implant to the

[[Page 52379]]

skeletal structure. If commenters are able to provide us with 
compelling evidence to support that a dental exam and necessary 
treatment prior to specific other lymphodepleting medical services 
where the treatment may induce immunosuppression for patients with 
cancer, would result in clinically significant improvements in quality 
and safety outcomes, for example, fewer revisions, fewer readmissions, 
more rapid healing, quicker discharge, quicker rehabilitation for the 
patient, then we would consider whether such dental services may be 
inextricably linked to, and substantially related and integral to the 
clinical success of, the specific lymphodepleting medical services for 
patients with cancer.
c. Dental Services Inextricably Linked To Administration of High-Dose 
Bone-Modifying Agents (Antiresorptive Therapy) When Used in the 
Treatment of Cancer
    As discussed above, submissions received through the public process 
we established in the CY 2023 PFS final rule stated that medication-
related osteonecrosis of the jaw (MRONJ) is a serious complication of 
the administration of bone-modifying agents (such as bisphosphonates 
and denosumab, and other biosimilar agents) used when managing certain 
cancers.\82\ MRONJ is a rare occurrence, multifactorial in nature, and 
can have the same clinical presentation in patients who have not been 
exposed to an antiresorptive medication.\83\ that Medicare make payment 
under Parts A and B for dental services for patients where high-dose 
bisphosphonate therapy for cancers is indicated and recommended payment 
for dental services prior to and during antiresorptive therapy or prior 
to, during, and after the use of bone-modifying drugs. Additionally, in 
our internal review of clinical practice guidelines, we noted that one 
professional society provided recommendations regarding dental services 
prior to the initiation of, or during, the administration of high-dose 
bone-modifying agents (antiresorptive therapy) when used in the 
treatment of cancer. Specifically, the Multinational Association of 
Supportive Care in Cancer/International Society of Oral Oncology 
(MASCC/ISOO) and American Society of Clinical Oncology (ASCO) Clinical 
Practice Guideline \84\ states 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 in order to reduce 
complications and manage modifiable risk factors. We believe that this 
practice guideline demonstrate that the standard of care would be to 
address dental infections prior to proceeding with the covered medical 
procedure, including oral care assessments and the completion of 
medically necessary dental procedures prior to the start of the 
administration of high-dose bone-modifying agents (antiresorptive 
therapy) when used in the treatment of cancer, especially as these 
dental concerns and/or procedures may relate to the cancer treatment 
and avoidance of MRONJ.
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    \82\ American Association of Oral and Maxillofacial Surgeons. 
(2022). Medication-related osteonecrosis of the Jawn-2022 update 
(position paper). Available at: https://www.aaoms.org/docs/govt_affairs/advocacy_white_papers/mronj_position_paper.pdf.
    \83\ American Association of Oral and Maxillofacial Surgeons. 
(2022). Medication-related osteonecrosis of the Jawn-2022 update 
(position paper). Available at: https://www.aaoms.org/docs/govt_affairs/advocacy_white_papers/mronj_position_paper.pdf.
    \84\ 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.
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    In summary, 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 are proposing 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). We 
believe that there is an inextricable link between dental and 
administration of high-dose bone-modifying agents (antiresorptive 
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 propose 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 seek 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 propose 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).
    If the proposed policies are finalized, we anticipate making 
conforming changes to the Medicare Benefit Policy Manual (IOM Pub. 100-
02) to reflect the final changes or clarifications. Additionally, if 
finalized, we intend to issue educational and outreach materials to 
inform billing and payment for any policies finalized in the final rule 
We seek comments on these proposals.
d. Proposed Amendments to Regulations Regarding Dental Services 
Inextricably Linked to Treatment for Head and Neck Cancer
    In the CY 2023 PFS final rule, we finalized for CY 2024 that 
payment under Medicare Parts A and B can be made for an oral or dental 
examination as part of a comprehensive workup in either the inpatient 
or outpatient setting, and medically necessary diagnostic and treatment 
services to eliminate an oral or dental infection, prior to and 
contemporaneously with treatments (radiation, chemotherapy, and 
surgery) for head and neck cancer (87 FR 69671, 69677, and 69681-
69682). We note that we stated the policy in some instances

[[Page 52380]]

without explicitly including both ``prior to'' and ``contemporaneously 
with.'' (87 FR 69669, 69681, 69682, and 69687.)
    We also indicated that we wanted to continue to consider various 
aspects of our finalized policy and that we anticipated additional 
clarifying rulemaking on this final policy for CY 2024. In the CY 2023 
PFS final rule we stated that we wanted to examine the clinical data 
and consider whether greater specificity may be needed to describe the 
medical services involved in this type of treatment. We stated that we 
were cognizant of concerns that, absent clear guidelines and 
definitions, beneficiaries, practitioners, and MACs may need additional 
information prior to providing payment under Medicare Parts A and B, 
and without it could lead to inconsistent application of the policy. In 
particular, we stated that it is important to determine whether any 
additional guidance is necessary to identify conditions considered 
``head and neck cancer'' and qualifying covered medical services 
considered within the treatments for these cancers beyond just 
radiation (with or without chemotherapy).
    Upon further study, as pointed out by one submitter, we understand 
that the term ``head and neck cancer'' encompasses a multitude of 
pathologies that often require multi-modality therapies including 
radiation, chemotherapy and surgery. This submitter noted that 
approximately 80 percent of head and neck cancer patients will receive 
radiation therapy at least once during the course of their disease. 
While the majority of head and neck cancers are squamous cell 
carcinomas that originate from the mucosa of the oral cavity, pharynx 
or larynx, they may also arise from the salivary glands, the nasal 
cavities and the paranasal sinuses. They can be locally advanced, 
regionally metastatic to the cervical nodes and can spread to distant 
sites such as the lungs and liver. According to the submitter, 
regardless of origin, the clinical diagnostic and therapeutic 
approaches for head and neck cancers are fundamentally similar, and 
treatment modalities often result in both acute and chronic oral 
toxicities.
    If unaddressed, existing oral or dental infection may compromise 
the delivery of the appropriate modalities of care (radiation, 
chemotherapy, surgery). The standard of care is to address and 
eliminate oral and dental infections prior to the treatment of some (or 
many) head and neck cancers. Additionally, as discussed in section 
II.K.2.a of this proposed rule, the complications caused by treatment-
induced vulnerabilities, which may include infection and 
osteoradionecrosis, can prevent the ability to proceed with the 
primary, covered medical service (that is, can 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); 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.
    As discussed in the CY 2023 final rule, we believe that addressing 
any oral or dental infection prior to the initiation of treatment 
serves to minimize the potential development of the treatment-induced 
complications. Moreover, we believe that these treatment-induced 
complications can occur as a result of and during multiple rounds of 
treatment.
    Therefore, we are proposing to clarify 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.
    In summary, we are proposing 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 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 propose 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). If finalized, we anticipate 
making conforming changes to the Medicare Benefit Policy Manual (IOM 
Pub. 100-02) to reflect the final changes or clarifications. We seek 
comments on all aspects of these proposals.
3. Request for Information on 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).\85\ Specifically, we noted that the replaced 
valve is also at risk of being a seeding source for future 
endocarditis. 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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    \85\ 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

[[Page 52381]]

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.\86\ 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).\87\ 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.\88\ The authors 
noted, however, the lack of scientific evidence on the risk-to-benefit 
ratio for perioperative dental treatment in patients undergoing 
cardiovascular surgery.
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    \86\ 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.
    \87\ 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.
    \88\ Ibid.
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    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 \89\ is available at https://effectivehealthcare.ahrq.gov/products/implantable-cardiovascular-devices/rapid-review.
---------------------------------------------------------------------------

    \89\ 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/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 seek 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 the 
clinical success of other covered medical 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. Above, in section II.K.1.c. of this proposed rule, we have 
described the various types of documentation to support recommendations 
through this process. We are considering, and seek 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 are also 
considering, and seek 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 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 seek comment on whether preoperative and perioperative dental 
services are inextricably linked to any other covered cardiac 
interventions as supported by clinical evidence.

[[Page 52382]]

4. Request for Comment on Dental Services Integral to Specific Covered 
Services To Treat Sickle Cell Disease (SCD) and Hemophilia
    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 
and hemophilia.
    These submissions provided information and references supporting 
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,\90\ many of whom lose a number of teeth, which 
greatly limits nutrition, general well-being, and overall quality of 
life.
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    \90\ 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 Oct 22; 2021:5556708. Doi: 
10.1155/2021/5556708. PMID: 34721900; PMCID: PMC8556080.
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    We seek 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 seek 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 proposed rule.
    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.91 92 93
---------------------------------------------------------------------------

    \91\ 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.
    \92\ 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.
    \93\ 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.
---------------------------------------------------------------------------

    We note that many submitters 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 seek comment on whether certain dental services are inextricably 
linked to certain other covered services for hemophilia, supported by 
clinical evidence as described in section II.K.1.c., above. We seek 
comment identifying such covered services for the treatment of 
hemophilia. We also seek comment specifically on whether dental 
services such as prophylaxis are a standard of care in the management 
of hemophilia.
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. We understand and 
appreciate the interest in such requests. Because the Medicare statute 
generally prohibits payment for dental services payment may only be 
made when the dental services are inextricably linked to, and 
substantially related and integral to the clinical success of, certain 
other covered services. We urge interested parties to consider the 
circumstances under which dental services are inextricably linked to 
specific covered services (not diagnoses) used to treat patients with 
auto-immune conditions or other chronic conditions, supported by 
clinical evidence as described in section II.K.1.c. of this proposed 
rule.
    We have encouraged interested parties who believe certain dental 
services are inextricably linked to certain covered services to use our 
public submission process to provide information on these clinical 
scenarios, supported by clinical evidence or other documentation, as 
discussed in section II.K.1.c. of this proposed rule, such as that it 
would be the standard of care to not proceed with the medical service 
without having completed the dental service. Commenters are welcome to 
submit additional information regarding clinical scenarios presented in 
the CY 2023 PFS rulemaking discussions, which we are not proposing for 
the CY 2024, such as dental services involved with the treatment of 
chronic conditions such as, but not limited to, diabetes (87 FR 69686). 
As summarized above in section II.K.1.c. of this proposed 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 above in section II.K.1.c. of this proposed 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 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

[[Page 52383]]

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.
6. Request for Information on 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 are interested in receiving comments from 
interested parties on ways to best continue to implement these 
policies. Additionally, given comments and questions we have received 
from interested parties through rulemaking and the public submission 
process, we want to provide further clarity on the policies we 
finalized in the CY 2023 PFS final rule. Therefore, we are requesting 
comments on several policies related to 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 
continue 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 
reiterate that such additional services would not be inextricably 
linked to the specific covered services. As such, no Medicare payment 
would be made for the additional services that are not immediately 
necessary to eliminate or eradicate the infection. We further clarify 
that we did not in CY 2023 nor are we proposing in CY 2024 to adjust 
any payment policy for services involving the preparation for, or 
placement of dentures, and maintain that these services are not payable 
under Medicare Parts A and B. We also reiterate 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 more full 
description 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 seek 
comment on the coordination of multiple dental benefits that Medicare 
beneficiaries may have, if and 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 also seek 
comment on approaches utilized by other plans to mitigate issues with 
third party payment, including when Medicare is secondary payer and 
when coordinating with state Medicaid programs. In addition, we note 
there is an informal practice where 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 seek comment on the impact of third-party payers, 
including state Medicaid programs, requiring a Medicare denial 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 seek 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 seek 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 are seeking 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.
    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 the covered primary service. 
We believe the dental and covered services would most often be 
furnished by different professionals, and that in order for the dental 
services to be inextricably linked to the 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

[[Page 52384]]

evidence of coordination between the professionals furnishing the 
primary medical service and dental services should be documented. If 
there is no evidence to support 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). As such, Medicare 
payment for the dental services would be excluded under section 
1862(a)(12) of the statute (though payment for the dental services 
might be available through supplemental health or dental coverage). 
Additionally, we are seeking information regarding the potential impact 
of these payment policies in settings other than inpatient and 
outpatient facilities, such as federally qualified health centers, 
rural health clinics, 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)(3). We will maintain this 
policy and continue to contractor price the dental services for which 
payment is made under Sec.  411.15(i)(3) 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. Recognizing that dental offices may range in the 
services that they provide, from simple office visits to complex 
surgical procedures, dental services will continue to be contractor 
priced. We are seeking comment on what specific information could help 
inform appropriate payment for these dental services (87 FR 69679).
    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 either 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 PFS Relative Value (RVU) 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 seek 
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. Medical and dental 
providers should bill using CDT or Current Procedure Terminology (CPT) 
codes where applicable, and for claims submissions during CY 2023, 
should submit claims using the professional or institutional claim 
forms, as appropriate. Although we propose to continue contractor 
pricing services billed using CDT codes, we are soliciting 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 the submission and processing of dental claims.
    Finally, in order to promote the correct coding and processing of 
Medicare claims, dentists who practice general or specialized dentistry 
currently self-designate their specialty under two specialty codes, 
specialty 19 (oral surgery--dentists only) or specialty 85 
(maxillofacial surgery). We seek comment on whether additional 
specialty codes should be considered for use in Medicare, and if so, 
what are the other specific specialties that should be included. We 
also seek comment on whether these specialty codes may impact the 
coordination of benefits with a third-party payer. Finally, we 
recognize that issues could occur related to coordination of benefits 
for dual eligible beneficiaries, for example beneficiaries with 
hemophilia, and we seek comment on how to best coordinate a potential 
payment policy in this area with respect to state Medicaid plans or 
private insurance. We also seek 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.

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 are proposing to codify this 
provision in regulation.
     Section 11403 of the IRA makes changes to the payment 
limit for certain

[[Page 52385]]

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,94 95 as permitted under 
section 1847A(c)(5)(C) of the Act. We are now proposing conforming 
changes to regulatory text to reflect these provisions.
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    \94\ https://www.cms.gov/files/document/r11496cp.pdf.
    \95\ https://www.cms.gov/medicare/medicare-fee-for-service-part-b-drugs/mcrpartbdrugavgsalesprice.
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    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.\96\ We are proposing conforming changes to 
regulatory text.
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    \96\ 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.\97\ We are now proposing 
to codify this provision in a manner that is consistent with the 
program instruction for 2023.
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    \97\ 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
    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 have a 
WAC-based payment determined 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 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 
are proposing to amend Sec.  414.904(e)(4) to reflect this statutory 
change.
    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 propose to codify these changes to section 1847A(c)(4) of the 
Act at Sec.  414.904. Specifically, we are proposing 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 are also proposing 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.
b. Temporary Increase in Medicare Part B Payment for Certain Biosimilar 
Biological Products
    Consistent with section 1847A(b)(8) of the Act, Medicare Part B 
payment limit for a biosimilar is its ASP plus 6 percent of the 
reference biological product. 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. 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.
    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 ``qualifying 
biosimilar biological product'' (hereinafter referred to as 
``qualifying biosimilars'') 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) of the Act defines the applicable 5-year period for 
a qualifying biosimilar for which payment has been made using ASP (that 
is, payment under section 1847A(b)(8) of the Act) 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 using ASP 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.\98\
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    \98\ 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.

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[[Page 52386]]

    In this proposed rule, we propose to add definitions of 
``applicable 5-year period'' and ``qualifying biosimilar biological 
product'' at Sec.  414.902 to reflect the definitions in statute, and 
we propose 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).
c. Inflation-Adjusted Beneficiary Coinsurance and Medicare Payment for 
Medicare Part B Rebatable Drugs
    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 
permitted under section 1847A(c)(5)(C) of the Act. As such, we issued 
final 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, 2023.99 100 
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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    \99\ https://www.cms.gov/files/document/medicare-part-b-inflation-rebate-program-initial-guidance.pdf.
    \100\ 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. In this proposed 
rule, we propose 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 
inflation-adjusted payment amount of a Part B rebatable drug exceeds 
the payment amount described in section 1847A(i)(3)(A)(ii)(I) (or, in 
the case of a selected drug, the payment amount described in section 
1847A(b)(1)(B), 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 this proposed rule, we 
propose to codify the Medicare payment for Part B rebatable drugs in 
Sec.  [thinsp]410.152, specifically by adding new paragraph (m).
d. Limitations on Monthly Coinsurance and Adjustments to Supplier 
Payment Under Medicare Part B for Insulin Furnished Through Durable 
Medical Equipment
    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 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.
    Section 11407 of the IRA made three changes to the manner in which 
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,\101\ as required by section 11407(c) of the IRA, for CY 
2023. Section 80 in Chapter 17 and section 140 in Chapter 20 of the 
Medicare Claims Processing Manual will be updated to reflect these 
changes, effective July 1, 2023. To operationalize this provision, 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,\102\ 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, that 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 Medicare Administrative Contractors 
(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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    \101\ https://www.cms.gov/files/document/r11917cp.pdf.
    \102\ https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/bp102c15.pdf.

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[[Page 52387]]

    Here, we propose 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 propose 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 provider payment at Sec.  410.152 by adding paragraph 
(n). In addition, we propose 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 propose 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
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. 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. 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.
    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.
    We are soliciting 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 are 
seeking comment 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 are seeking comment 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 are also soliciting 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 are soliciting 
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 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.
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

[[Page 52388]]

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 \103\ addressing the correct use of these modifiers. We 
adopted a definition of ``refundable single-dose container or single-
use package drug'' at 42 CFR 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 CMS would 
send reports (including information described in section 1847A(h)(1) of 
the Act) for each calendar quarter on an annual basis to all 
manufacturers of refundable drugs (87 FR 69726). We finalized the 
manner in which the refund amount will be calculated at Sec.  
[thinsp]414.940 (87 FR 69731). Regarding drugs with unique 
circumstances for which CMS 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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    \103\ 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 (IRA) (Pub. L. 117-169, 
August 16, 2022) 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 this proposed rule, we propose 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 propose 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 will 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.
    To implement the discarded drug refund in a timely manner, we 
propose 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 proposed rule, would be separate and distinct from the preliminary 
report that we intend to issue by December 31, 2023, that will include 
estimated discarded amounts based on available claims data for the 
first two quarters of CY 2023.)
    With respect to subsequent annual reports, that is, reports for 
quarters in 2024 and thereafter, we intend to align delivery of the 
refund reports with the delivery of Part B and Part D inflation rebate 
reports to the extent practicable. As stated in the initial guidance 
for Part B inflation rebates,\104\ 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. 
Consistent with section 1847A(i)(1)(C) of the Act, CMS may delay 
reporting Part B inflation rebate information for

[[Page 52389]]

calendar quarters in CY 2023 and CY 2024 until September 30, 2025.\105\
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    \104\ https://www.cms.gov/files/document/medicare-part-b-inflation-rebate-program-initial-guidance.pdf.
    \105\ https://www.cms.gov/files/document/medicare-part-b-inflation-rebate-program-initial-guidance.pdf.
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    To align these reports, we propose that, other than for the initial 
refund report, we will send annual refund reports for discarded drug 
refunds for the 4 quarters of a calendar year at or around the time we 
send Part B inflation rebate report 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 send the inflation 
rebate report for Q1 2025, which is required to be sent no later than 
September 30, 2025.
    As 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. An 
evaluation of July 2010 Medicare Part B claims in the Physician/
Supplier-Carrier setting showed that 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 
considered to be final. Since, 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, we propose 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 propose that each report would include information for 8 calendar 
quarters: 4 from the previous calendar year (hereafter, referred to as 
new refund quarters) and 4 from 2 calendar years prior (hereafter, 
referred to as updated refund quarters). We propose 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 proposed 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 that the manufacturer is liable for pursuant to 
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 pursuant to section 1847A(h)(3) of the Act for all 
calendar quarters in 2023 that was not accounted for in the previous 
year's report.
    We are proposing to define ``new refund quarter'' and ``updated 
refund quarter'' at Sec.  414.902 and to revise Sec.  414.940(a)(3) to 
reflect the inclusion of lagged data in reports subsequent to the 
initial refund report. We solicit comment on these proposals. See 
section III.A.3.d. of this rule for the proposed calculation of refund 
amounts for updated refund quarters.
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 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 declined to finalize the deadlines by which 
manufacturer refund obligations are due and those associated with the 
dispute resolution process, as those timelines correspond with the 
dates of the annual refund reports and, as explained above, we declined 
to finalize the timeline for the report in the CY 2023 PFS final rule 
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.
    As described in section III.A.3.b. of this proposed rule, we are 
proposing to issue the initial refund report to manufacturers no later 
than December 31, 2024. Accordingly, we propose 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 believe a payment deadline that is two 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.
    As noted above, we are proposing that we will issue the second 
annual refund report to manufacturers no later than September 30, 2025, 
and once annually thereafter no later than September 30 for every year 
thereafter. Accordingly, we are proposing 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, 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, as described in Sec.  414.940(b)(2), 
whichever is later. We propose to revise Sec.  414.940(b)(1) to reflect 
these dates.
d. Refund Amount
(1) Calculation of Refund Amounts for Updated Quarters
    As discussed in section III.A.3.b. of this proposed rule, we are 
proposing to include information for lagged claims data in all reports 
other than the initial report. In addition, we propose that such 
additional lagged JW modifier data, if any, will be used to calculate 
revisions to the manufacturer refund amount. Specifically, we propose 
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 propose that 
the refund amount owed

[[Page 52390]]

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:
    ++ 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 propose 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 propose to revise Sec.  [thinsp]414.940 by adding new paragraphs 
(c)(2) and (3) to reflect the above proposed method of calculation of 
revisions to the refund amount owed for quarters in the year that is 
two calendar years prior.
(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.
    We stated we will 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 paid 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.
    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, there is a need 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 propose to 
identify such refundable drugs using the ASP sales data reported for 
the calendar quarter for which a refund amount is calculated. 
Furthermore, we propose 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).
    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,\106\ released on February 
9, 2023.
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    \106\ https://www.cms.gov/files/document/medicare-part-b-inflation-rebate-program-initial-guidance.pdf.
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    We propose 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 propose 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;
    ++ 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 below 
in Table 18, there were 3,000 units discarded during the refund 
quarter, 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 would

[[Page 52391]]

be as follows: (3,000)(23.81%)($50)-(21,000)(10%)(23.81%)($50) = refund 
amount of $10,714.50.
[GRAPHIC] [TIFF OMITTED] TP07AU23.028

    The report to manufacturers described in section 1847A(h)(1) of the 
Act and discussed in the previous section III.A.3.b. of this proposed 
rule, in the case that there are multiple manufacturers for a 
refundable drug, 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 that the manufacturer of that NDC is liable for pursuant to 
section 1847A(h)(3) of the Act. We propose that this method of 
calculation apply beginning with calendar quarters in CY 2023 included 
in the initial refund report, which we propose to be sent no later than 
December 31, 2024. We propose that this method of calculation would be 
done for new refund quarters and updated refund quarters.
    We propose 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.
(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.
    After considering input from interested parties provided at the 
town hall and in subsequent meetings, in this proposed rule, we are 
proposing a hybrid approach to determining when it is appropriate to 
increase the applicable percentage for a drug with unique 
circumstances. First, we are proposing two categorical unique 
circumstances along with proposed increased applicable percentages and, 
secondly, we are proposing 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).
    As discussed in the CY 2023 PFS final rule and further discussed at 
the town hall, many interested parties requested CMS 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 agree 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

[[Page 52392]]

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 believe 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 propose an increased applicable percentage for drugs 
with a ``low volume dose.'' We 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 (which is about 8 drops of liquid). 
We propose 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 dose would be contained 
in 0.1 mL, which would not exceed 0.4 mL and would, therefore, be 
considered a low volume dose. We propose 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 propose that for a drug to meet 
these unique circumstances, all labeled doses of the drug would be low 
volume doses. 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. 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 propose 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 propose 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 are proposing 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.107 108 We are not proposing 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 solicit 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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    \107\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211950Orig1s000correctedlbl.pdf.
    \108\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022223,022048lbl.pdf.
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    In the second tier of the low volume dose unique circumstances, we 
propose 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 
propose 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 propose 
to round that number to an applicable percentage of 45 percent for this 
tier.
    In summary, we propose 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 propose 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 note 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 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).
    The second categorical unique circumstances we are proposing is for 
orphan drugs administered to a low volume of unique beneficiaries, 
which we propose to be fewer than 100 unique Medicare fee-for-service 
beneficiaries per calendar year (hereafter referred to as rarely 
utilized orphan drugs); we propose an increased applicable percentage 
of 26 percent for drugs with these unique circumstances. 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

[[Page 52393]]

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,\109\ 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). This analysis of JW modifier data for quarters in 2021 and 
2022 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 addition, based on the 
2021 Medicare Part B Discarded Drug Units data for the three 
aforementioned drugs, the most historical 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 consider 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. 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 do 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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    \109\ 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 propose 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 propose 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 propose 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 one or more indications within such 
designated rare disease or condition (or diseases or conditions). That 
is, all FDA-labeled indications for the drug must be orphan 
indications. In addition, we propose 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 are 
proposing 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 propose to 
round to the nearest percentage.
    We propose that CMS would 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 categorical 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 propose to codify these applicable percentages at Sec.  
[thinsp]414.940(d). Specifically, we propose to add applicable 
percentages for low volume doses by creating new paragraphs (d)(3) and 
(4); and we propose to add applicable percentage for orphan drugs 
administered to fewer than 100 unique beneficiaries per calendar year 
in new paragraph (d)(5). We propose that these applicable percentages 
apply beginning with the initial refund report that we propose to be 
sent no later than December 31, 2024.
    We solicit comments on the proposed categorical unique 
circumstances. Specifically, we solicit 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 solicit comment on the 
increased applicable percentage of 26 percent for rarely utilized 
orphan drugs.
(4) Proposed Application Process for Individual Drugs
    In addition to the two proposed categorical unique circumstances, 
we propose 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 believe manufacturers would 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

[[Page 52394]]

its inclusion in categorical unique circumstances.
    We propose 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 propose 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.
    Section 1847(h)(3)(B)(ii) of the Act requires that any increase to 
applicable percentages for refundable drugs to be made through notice-
and-comment rulemaking. Therefore, we propose 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 would be due to CMS by February 1, 2024). We propose to discuss 
our analyses of applications in the PFS rulemaking immediately 
following the application period, and to communicate in the proposed 
rule whether we consider the drug to have unique circumstances that 
warrant an increased applicable percentage. We would also 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 propose to codify this 
application process for individual unique circumstances in new 
paragraph Sec.  414.940(e).
    We do not consider the following to be unique circumstances 
warranting an increased applicable percentage at this time: 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 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'',\110\ 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 observe 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.\111\ Subsequently, a 
second 30-mg vial size was approved in 2016,\112\ and a third 10-mg 
vial size was approved in June of 2018.\113\ We observe 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 percent after the 
introduction of the third vial size.
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    \110\ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/optimizing-dosage-human-prescription-drugs-and-biological-products-treatment-oncologic-diseases.
    \111\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202714lbl.pdf.
    \112\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202714s012lbl.pdf.
    \113\ https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202714s019lbl.pdf.
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    In addition, we observe that, based on the 2021 discarded drug 
data,\114\ as the number of available package sizes increases, the 
percent discarded decreases (see Table 19). 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.
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    \114\ https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug/medicare-part-b-discarded-drug-units.
[GRAPHIC] [TIFF OMITTED] TP07AU23.029

    We solicit comments from interested parties on the application 
process for individual drug unique circumstances. Specifically, we 
solicit comment on what factors we should use in a framework for 
considering these

[[Page 52395]]

applications, what factors we should use to assess appropriate 
increases to applicable percentages, as well as what types of 
additional or alternative documentation may help us analyze 
justifications for increased applicable circumstances.
e. Clarification for the Definition of Refundable Drug
    As discussed in the CY 2023 PFS final rule (87 FR 69650 through 
69655), CMS aims to create a consistent coding and payment approach for 
the suite of products currently referred to as skin substitutes. On 
January 18, 2023, we held a Town Hall to discuss this issue further and 
to provide an opportunity to further engage interested parties on this 
matter and is soliciting additional comments about skin substitutes in 
this proposed rule. We anticipate addressing coding and payment for 
skin substitutes in future rulemaking. While we consider making changes 
to the Medicare Part B payment policies for such products, we propose 
that billing and payment codes that describe products currently 
referred to as skin substitutes not be counted for purposes of 
identifying refundable drugs for calendar quarters during 2023 and 
2024. We plan to revisit discarded drug refund obligations for skin 
substitutes in future rulemaking.
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. 
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 are clarifying 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.
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.  
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). We propose to correct the textual 
reference in both paragraphs and make additional technical changes to 
streamline the text. See section III.A.3.d.(1) of this proposed rule 
for discussion of additional proposed revisions to these provisions.
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 \115\ 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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    \115\ https://www.cms.gov/medicare/medicare-fee-for-service-payment/hospitaloutpatientpps/downloads/jw-modifier-faqs.pdf.
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    Beginning 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, the policy finalized last 
year exempting self-administered drugs from the JW/JZ modifier policy 
may result in claims rejections absent a modification. Therefore, as we 
continue to believe it is unreasonable to collect discarded drug data 
from beneficiaries, we propose 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.

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 proposed 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.

[[Page 52396]]

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 less 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 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.
    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. Payment 
continues 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 do 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.\116\
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    \116\ https://www.cms.gov/files/document/rural-health-clinics-and-federally-qualified-health-centers-cms-flexibilities-fight-covid-19.pdf.
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    Section 4113(d) of the CAA, 2023 also 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 continue to apply the delay of the in-person requirements 
under Medicare for mental health services furnished by RHCs and FQHCs. 
We note, 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.\117\
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    \117\ https://www.hhs.gov/coronavirus/covid-19-public-health-emergency/index.html.
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    We are proposing 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 proposing to amend paragraph (b)(3) and, at Sec.  
405.2469 ``FQHC supplemental payments,'' we are proposing to amend 
paragraph (d) to include the delay of the in-person requirements for 
mental

[[Page 52397]]

health visits furnished by RHCs and FQHCs through telecommunication 
technology under Medicare beginning January 1, 2025. We note 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.
    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 proposed rule. The CAA, 2023 extends 
the telehealth policies mentioned above and enacted in the CAA, 2022 
through December 31, 2024 if the PHE ends prior to that date.
b. Direct Supervision via Use of Two-Way Audio/Video Communications 
Technology
    As discussed in section II.D.2.a of this proposed rule, under 
Medicare Part B, certain types of services are required to be furnished 
under specific minimum levels of supervision by a physician or 
practitioner. 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.
    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).\118\ When 
discussing direct supervision in RHCs and FQHCs, we noted that in 
general, CMS had 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.\119\
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    \118\ https://www.govinfo.gov/content/pkg/FR-2020-04-06/pdf/2020-06990.pdf.
    \119\ https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf.
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    We believe 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 are 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 believe 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 are proposing 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 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 are soliciting comment on whether we should 
consider extending the definition of direct supervision to permit 
virtual presence beyond December 31, 2024. When compared to 
professionals paid under the PFS, RHCs and FQHCs have a different model 
of care and payment structure. Therefore, we seek comment 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 are also interested in potential program integrity concerns 
such as overutilization or fraud and abuse that interested parties may 
have in regard to this policy.
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 professional services of these 
practitioners. As discussed in section III.B.1.a. of this proposed 
rule, our conforming regulation text is 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 is 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 note 
that section II.J of this proposed 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

[[Page 52398]]

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 are proposing to codify payment 
provisions for MFTs and MHCs under 42 CFR part 405, subpart X beginning 
January 1, 2024. That is, RHC and FQHCs would 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 would 
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 proposed rule, we 
are proposing 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. 
Therefore, to remain consistent with payment policies for professionals 
billing Medicare under the PFS, we propose 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 note that in section II.J of this proposed rule, we are 
proposing 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 are proposing 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 HCPCS code G0511. We believe that this policy 
aligns to our effort to be consistent with the new services that are 
proposed for practitioners billing under the PFS.
    We propose 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 propose to 
amend the section to add definitions for MFT and MHC;
     At Sec.  405.2411, Scope of benefits, we propose 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 propose 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 propose to amend 
the section to include MFT and MHC services to the scope of services;
     At Sec.  405.2448, Preventive primary services, we propose 
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 propose 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 propose 
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 propose to 
amend the section to add MFT and MHC to the list of eligible 
practitioners; and
     At Sec.  405.2468, Allowable costs, we propose to amend 
the section to add MFTs and MHCs where other RHC and FQHC practitioners 
are listed.
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 Outpatient Prospective 
Payment System proposed rule 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.
    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 are 
proposing 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

[[Page 52399]]

general supervision, rather than direct supervision, consistent with 
the policies finalized under the PFS for CY 2023. Accordingly, we are 
proposing 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 note 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.
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 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 note 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

[[Page 52400]]

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] TP07AU23.030

    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). The RTM codes include three practice expense 
(PE)-only codes and two professional work, treatment management codes. 
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 52401]]

[GRAPHIC] [TIFF OMITTED] TP07AU23.031

    Currently, 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.
    Upon further review and in line with our thinking about non-face-
to-face services previously, we are proposing 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. 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.
    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. 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. 
However, we note that under this 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. 
Therefore, we propose 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.
c. Services Addressing Health-Related Social Needs: Community Health 
Integration Services and Principal Illness Navigation Services
(1) Background
    As discussed in section II.E.4.(27) of this proposed rule, in 
recent years, we have sought to recognize significant changes in health 
care practice and 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. 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 
(discussed above in section III.B.4.a. of the proposed rule) 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, we are exploring ways to better identify the resources for

[[Page 52402]]

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, and 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 are proposing to create new coding to expressly 
identify and value these services for PFS payment, and distinguish them 
from current care management services. Therefore, we are considering 
the new coding for purposes of payment to RHCs and FQHCs.
(2) Payment for Community Health Integration (CHI) Services in RHCs and 
FQHCs
    Consistent with the discussion in section II.E.4.(27).b. of this 
proposed rule, there are two new HCPCS codes proposed to describe 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. The requirements for 
the proposed CHI services, as stated in section II.E.4.(27) of this 
proposed rule, are similar to the requirements for the general care 
management services furnished by RHCs and FQHCs. As such, 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 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 CHI as described 
in the 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, 
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
    Consistent with the discussion in section II.E.4.(27).e. of this 
proposed rule, there are two new HCPCS codes proposed to describe PIN 
services. That is 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

[[Page 52403]]

nursing home placement, acute exacerbation/decompensation, functional 
decline, or death. The requirements for the proposed PIN services are 
also similar to the requirements for the general care management 
services furnished by RHCs and FQHCs.
    As such, 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 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 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).
    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. In 
an effort to be consistent with the new services that are being 
proposed for practitioners billing under the PFS, we are proposing to 
include PIN services in the general care management HCPCS code G0511 
when these services are provided by RHCs and FQHCs.
    We note 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 expect that our proposal to add the new codes for CHI and PIN to the 
general care management code would also support the CMS pillars \120\ 
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.
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    \120\ CMS Strategic Plan. https://www.cms.gov/cms-strategic-plan.
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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. Then we 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 discuss above, 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

[[Page 52404]]

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 section III.B.4.b and c. of this proposed rule, we are proposing 
to expand the billable services under HCPCS code G0511 to include RPM, 
RTM, CHI, and PIN. If we continue to calculate HCPCS code G0511 using 
our current approach, we believe 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 are proposing to revise our method for calculating HCPCS 
code G0511 so that payment for general care management is more 
appropriate. Below, we compare our current method to the proposed 
revised approach.
    Based on the current methodology for HCPCS code G0511 as shown in 
Table 22, 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] TP07AU23.032

    As shown in Table 23, 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] TP07AU23.033


[[Page 52405]]


    As demonstrated by comparing Table 22 to Table 23, 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 believe 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 are proposing a revised methodology for the calculation 
by looking at the actual utilization of the services. That is, we are 
proposing to use a weighted average of the services that comprise HCPCS 
code G0511. In order to use a weighted average, there needs to be data 
on the utilization of the services. We do 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 believe 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 would use 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 make up 
HCPCS code G0511. We believe we need 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. Once more data is available, we will revisit the 
valuation of HCPCS code G0511 to include CPM, GBHI, CHI, and PIN as 
necessary.
    Table 24 shows the payment amount using this calculation. The 
national non-facility payment rate associated with each code that 
comprises HCPCS code G0511 can be found in Addendum B of this proposed 
rule. We note that the revised methodology does reduce the payment rate 
for HCPCS code G0511 from its current rate for CY 2023, although not 
significantly.
[GRAPHIC] [TIFF OMITTED] TP07AU23.034

    Therefore, we propose 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 24 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 more accurate representation of the 
payment. We would also update HCPCS code

[[Page 52406]]

G0511 annually based on current data available in the PFS.
    We propose 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 welcome comments 
on this proposed methodology.
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.\121\
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    \121\ 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 or under the direct supervision of the 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 
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. For example, we received comments from 
hospitals, physicians, RHCs, FQHCs, software companies, care management 
companies.
    All comments received expressed support for 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 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 strongly 
encouraged CMS to permanently allow providers to obtain beneficiary 
consent under general supervision.
    We note that, 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, 
CMS clarified its 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 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. 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.
    For purposes of CCM services furnished by RHCs and FQHCs, we are 
proposing to clarify the policy of how RHC and FQHC practitioners can 
obtain beneficiary consent. That is, while we have stated our intent 
since allowing

[[Page 52407]]

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 believe our guidance could be 
clearer. After a review of commenters' concerns, we propose to clarify 
when, how and by whom beneficiary consent for CCM services can be 
obtained. Specifically, 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.
    It is important to reiterate that the importance of obtaining 
advance beneficiary consent to receive CCM services is 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 require 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 believe 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 are 
clarifying 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.
    In order 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 
COVID-19 PHE.
    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 COVID-19 PHE 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).
    Similar to the discussion above regarding obtaining consent for 
CCM, we believe the same philosophy applies to consent for virtual 
communications. In an effort to continue promoting access to timely, 
quality care for Medicare beneficiaries and to align with the PFS, we 
propose 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 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.

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

1. Summary of the Provisions
    Section III.C. of this proposed rule outlines changes to the RHC 
and FQHC CfCs as required in section 4121 of division FF of the 
Consolidated Appropriations Act (Pub. L. 117-328, December 29, 2022) 
(CAA 2023). Specifically, we must implement provisions that would 
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 propose to include definitions of other 
healthcare professionals who are already eligible to provide services 
at RHCs and FQHCs.
2. Proposed Changes to the RHC Conditions for Certification and FQHC 
Conditions for Coverage
a. Definitions (Sec.  491.2)
    According to House Report No. 95-548 (Vol. I), the Rural Health 
Clinic Services Act of 1977 was established to address an inadequate 
supply of physicians available to serve Medicare and Medicaid 
beneficiaries in rural and shortage areas. The establishment of RHCs 
addressed this problem by allowing physicians and certain other 
practitioners in qualifying clinics in rural, medically underserved 
communities to furnish outpatient services to Medicare and Medicaid 
beneficiaries. The Rural Health Clinic Services Act of 1977 (Pub. L. 
95-210, enacted December 13, 1977) enacted section 1861(aa) of the Act 
to extend Medicare entitlement and payment for primary care services 
furnished at an RHC by physicians and certain other practitioners and 
for services and supplies incidental to their services. Other 
practitioners included nurse practitioners (NPs) and physician 
assistants (PAs). Subsequent legislation extended the definition of 
covered RHC services to include the services of clinical psychologists 
(CPs), clinical social workers (CSWs), and certified nurse midwives 
(CNMs).
    Section 4161(a)(2) of the Omnibus Budget Reconciliation Act (OBRA) 
of

[[Page 52408]]

1990 added the definition of ``FQHC services'' to section 1861(aa) of 
the Act as ``services described in section 1861(aa)(l)(A) through (C) 
of the Act,'' which, are RHC services generally provided by physicians, 
NPs, PAs, CPs, CSWs, and CNMs. FQHCs were established to provide 
primary care and preventive services in underserved rural or urban 
areas designated as either a shortage area or an area with a medically 
underserved population, regardless of the patient's ability to pay.
    Section 4121 of division FF of the CAA, 2023 amended section 1861 
of the Act to add a new subsection (lll) and corresponding revisions to 
subsection (s)(2) of such section that establish a new benefit category 
for MFT services and MHC services. Section 4121(b)(1) of the CAA, 2023 
amended section 1861(aa)(1)(B) of the Act to add MFT and MHC services 
as services that can be furnished by RHCs, which is incorporated into 
FQHC services through section 1861(aa)(3) of the Act.
    Section 1861 of the Act authorizes the Secretary to establish the 
requirements that an RHC and FQHC 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.
    In order to reflect the statute, we propose adding conforming 
changes to the CfCs to include MFT and MHC services as proposed in 
section III.B. of this proposed rule to indicate that RHC and FQHCs can 
offer these services under their Medicare certification. At Sec.  
491.2, Definitions, we propose adding a definition of MFTs and MHCs by 
cross-referencing the definitions proposed at Sec. Sec.  410.53 and 
410.54.
    Previously enacted laws extended the definition of covered RHC 
services to include the services of CPs (section 4077(a) of OBRA '87), 
CNMs (section 6213(a) of OBRA '89), and CSWs (section 6213(b) of OBRA 
'89). Note that the CfCs do not currently define CPs, CSWs, or CNMs 
whose services are covered when furnished in an RHC and FQHC, so we 
also propose to add these professionals to Sec.  491.2, Definitions, 
and cross-reference the definitions established in the payment 
requirements at Sec.  410.77(a), Sec.  410.71(d), Sec.  410.73(a) 
respectively.
    We propose revising the existing ``nurse practitioner'' (NP) 
definition at Sec.  491.2. The current definition sets forth education 
and certification requirements. The current requirement at Sec.  
491.2(1) states that an NP must be certified as a primary care NP by 
the American Nurses Association and the National Board of Pediatric 
Nurse Practitioners and Associates. The National Board of Pediatric 
Nurse Practitioners and Associates has changed the organization's name 
since this requirement was first implemented. The American Association 
of Nurse Practitioners (AANP), examined NP graduates from 2019 to 2020 
by certification exam and discovered that 88 percent of licensed NPs in 
the U.S. are educated and prepared in primary care.\122\ The AANP 
considers primary care providers with a population focus on family, 
adult gerontology primary care, psych mental health, pediatric primary 
care, and women's health. We believe that removing specific certifying 
boards from Sec.  491.2(1) will ensure that the requirements reflect 
the breadth of currently available certifications. For awareness, 
examples of certifying boards that focus on an area the AANP considers 
primary care are the American Academy of Nurse Practitioners 
Certification Board (AANPCB), American Nurses Credentialing Center 
(ANCC) Certification Program, Pediatric Nursing Certification Board 
(PNCB), and the National Certification Corporation (NCC).\123\ We 
propose revising the definition of NP at Sec.  491.2(1) to require that 
an NP, be certified as a primary care nurse practitioner at the time of 
provision of services by a recognized national certifying body that has 
established standards for nurse practitioners and possess a master's 
degree in nursing or a Doctor of Nursing Practice (DNP) doctoral 
degree. We have proposed adding the education requirement to clause (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.\124\ We propose to retain paragraphs (2) and 
(3) of the current NP definition, which provides alternative 
certification and education requirements an NP can meet to furnish 
services in an RHC or FQHC if (1) is not met.
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    \122\ https://www.aanp.org/advocacy/advocacy-resource/position-
statements/nurse-practitioners-in-primary-
care#:~:text=Millions%20of%20Americans%20choose%20a,of%20all%20ages%2
0and%20backgrounds.
    \123\ https://www.aanp.org/student-resources/np-certification.
    \124\ 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 are soliciting comments regarding the current definition of NPs 
at Sec.  491.2(1). Specifically, we are interested in feedback on 
whether the definition of NPs should specify that an NP's certification 
be in the area of primary care, or whether this distinction should be 
removed. This would allow all NPs who are certified by a national 
certifying body and meet other applicable requirements to furnish 
services in an RHC or FQHC. We recognize that NPs are one of the 
fastest-growing provider groups to provide primary care, and the number 
of Medicare beneficiaries who receive primary care services from NPs is 
increasing.125 126 According to the March 2023 Medicare 
Payment Policy report, a larger percentage of Medicare beneficiaries 
and privately insured persons living in rural or low-income areas have 
revealed that they rely on NPs or PAs for most, if not all, of their 
healthcare needs. This indicates that NPs and PAs play a crucial role 
in ensuring that underserved populations have access to quality 
healthcare services, despite the challenges of living in areas with 
limited healthcare professionals and resources. The latest report from 
AANP indicates that a significant proportion of NP graduates are 
currently certified in primary care; however, during the 2019-2020 
academic year, approximately 12.9 percent or 45,795 NP graduates 
received certification in non-primary care specialties, including Adult 
Acute Care, Neonatal, and Pediatric Acute Care.\122\ The precise number 
of non-primary care-certified NPs who would furnish their services at 
RHCs and FQHCs if the primary care certification requirement was 
removed remains uncertain at this time.
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    \125\ https://www.bls.gov/careeroutlook/2020/article/careers-for-nurses-opportunities-and-options.htm.
    \126\ https://www.medpac.gov/wp-content/uploads/2022/03/Mar22_MedPAC_ReportToCongress_Ch4_v2_SEC.pdf.
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    With the increasing number of NPs and their crucial role in 
providing quality care, the Consensus Model was developed to tackle the 
issue of inconsistent standards in education, regulation, and practice 
for advanced practice RNs (APRNs) by providing guidance for states to 
adopt uniformity in the regulation of APRN roles, licensure, 
accreditation, certification and education. The aim of the Consensus 
Model is to promote patient safety while providing greater access to

[[Page 52409]]

care by standardizing education, certification, accreditation and 
licensure requirements for APRNs, including NPs.\127\ In order to 
practice in specialized nursing roles, individuals must possess 
specialized knowledge and skills. Therefore, the Consensus Model 
mandates that Advanced Practice Registered Nurses (APRNs) have 
congruent education, certification, and licensure in terms of 
population foci. NPs are required to select between two population foci 
tracks: adult-gerontology and pediatric foci. These foci are further 
distinguished as either primary care or acute care. Although the focus 
of practice centers around the patient's needs rather than the setting, 
NPs possess comprehensive educational training and practical experience 
to cater to patients in primary or acute care.\128\ Primary care NPs 
are trained to offer comprehensive, continuous care for patients with 
most health needs, including chronic conditions. In contrast, acute 
care NPs are equipped to provide restorative care, which involves 
addressing rapidly changing clinical conditions in patients with 
unstable, chronic, and complex acute and critical conditions.
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    \127\ https://www.ncbi.nlm.nih.gov/books/NBK209870/.
    \128\ https://www.aacn.org/~/media/aacn-website/certification/
advanced-practice/adultgeroacnpcompetencies.pdf.
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    The NP scope of practice allows them to provide care to patients 
based on the acuity of the patient's needs, rather than the setting in 
which the services are administered. This implies that an acute care NP 
can offer their services to patients within their scope of practice in 
RHCs and FQHCs, and other settings. NPs increasingly provide services 
to Medicare beneficiaries; however, the scope of benefits between 
primary care and acute care may be different. We seek comments on 
whether the specification of requiring NPs to be certified in primary 
care should remain in the definition at Sec.  491.2.
b. Staffing and Staff Responsibilities (Sec.  491.8)
    Section 1861(aa) of the Act extends Medicare and Medicaid 
entitlement and payment for primary and emergency care services 
furnished at an RHC by physicians and other practitioners and for 
services and supplies incidental to their services. Other practitioners 
include NPs, PAs, CPs, CSWs, and CNMs. 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 MFT and MHCs to 
the list of other practitioners whose services, when provided in RHCs 
and FQHCs, are entitled to payment under the Medicare program. To 
implement these changes, we propose modifying our CfCs to include MFT 
and MHCs as recognized staff for RHC and FQHCs.
    The current requirements at Sec.  491.8, Staffing and staff 
responsibilities, establish staffing requirements for RHC and FQHCs, 
details of physician responsibilities, PA and NP responsibilities, and 
COVID-19 vaccination requirements for staff. We propose revising the 
requirements at Sec.  491.8, Staffing and staff responsibilities. 
Currently, at Sec.  491.8(a)(3), the PA, NP, CNM, CSW, or CP may be the 
owner, employee, or furnish services under contract with the clinic 
(RHC) or center (FQHC). In the case of a clinic, at least one PA or NP 
must be an employee of the clinic. At Sec.  491.8(a)(3), we propose to 
add MFT and MHC to the list, allowing them to be the owner, employee, 
or furnish services under contract to the clinic or center. 
Additionally, Sec.  491.8(a)(6) requires that a physician, PA, NP, CNM, 
CSW, or CP is available to furnish patient care services at all times 
the clinic or center operates. Furthermore, for RHCs, an NP, PA, or CNM 
is available to furnish patient care services at least 50 percent of 
the time the RHC operates. We propose adding MFTs and MHCs to the list 
of other practitioners who can provide services when the clinic or 
center is open and operating. We are also proposing to update Sec.  
491.8(a)(6) to include MFTs and MHCs to the list of other practitioners 
who are eligible to furnish services and who can provide services, 
within the scope of practice, when the clinic or center is open and 
operating.
    Section 1861(aa)(2) and (4) of the Act require 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; however, we expect clinics 
and centers to ensure that the needs of the patient population they 
serve are met. We acknowledge that there are similarities and 
differences between CSWs, MHCs, and MFTs, ranging from offered services 
to experience to scope of practice. CSWs, MHCs, and MFTs have similar 
roles and responsibilities as they relate to counseling and can assist 
patients with the challenges they are facing; however, MHCs and MFTs 
may have a larger emphasis on human development and psychological 
approaches, whereas CSWs often focus on a person's overall social and 
socioeconomic circumstance. Some other services social workers can 
provide are psychosocial assessments, identifying and providing 
community resources to patients, and assisting with communicating with 
other members of their healthcare team. As rural areas are increasingly 
diverse, have significant strengths and unique challenges, and are 
essential in providing care to residents of medically underserved 
communities, RHCs and FQHCs play a key role in identifying the needs of 
their patients and employing mental health professionals. In November 
2022, we published a framework for advancing health care in rural, 
tribal, and geographically isolated communities.\129\ Priorities 
related to rural health included in the framework are advancing health 
equity by addressing health disparities, expanding access to care, and 
engaging with partners and communities. To reduce health disparities 
and achieve positive physical, mental, and behavioral health outcomes, 
providers must address access to affordable and quality food, 
education, employment, housing, and access to the physical and mental 
care they need.\130\ People living in rural areas have less access to 
healthcare and social services, higher unemployment rates, and higher 
poverty rates than urban areas, which impacts a person's physical and 
mental well-being.131 132 133 To meet an individual's 
medical, behavioral, and social service needs, it's important to have 
high-quality staff to address those issues.\134\ A team of diverse 
professionals can address a patient's physical and mental health 
through counseling, case management, and provide resources and 
information to address social determinants of health.\135\
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    \129\ https://www.cms.gov/files/document/cms-geographic-framework.pdf.
    \130\ https://www.jstor.org/stable/pdf/26554276.pdf?refreqid=excelsior%3A3437750e2633ee53aa5c0afe8caae6ea&ab_segments=&origin=&initiator=&acceptTC=1.
    \131\ https://apps.who.int/iris/bitstream/handle/10665/112828/9789241506809_eng.pdf.
    \132\ https://onlinelibrary.wiley.com/doi/10.1111/jmft.12202.
    \133\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4102288/.
    \134\ https://www.chcs.org/media/INSIDE_ICTs_for_Medicare-Medicaid_Enrollees-012216.pdf.
    \135\ https://www.jstor.org/stable/pdf/26554276.pdf?refreqid=excelsior%3A3437750e2633ee53aa5c0afe8caae6ea&ab_segments=&origin=&initiator=&acceptTC=1.
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    Individuals living in rural areas face multiple barriers that 
prevent people from accessing physical and mental health services, 
including but not limited to provider shortages and

[[Page 52410]]

transportation difficulties.\136\ A study from 2015 surveyed mental 
health specialists in nonmetropolitan areas and found that rural 
counties had less than half as many mental health professionals as 
proportional to the population compared to urban areas.\137\ The 
shortage of mental health providers in rural areas also puts a strain 
on generalist providers to diagnose and care for patients seeking care 
for mental health.\138\ In 2017, general practice physicians (including 
NPs and PAs) were the predominant source for treating depression in 
adults living in rural communities.\139\ Of the same population, less 
than 20 percent received treatment from mental health professionals, 
and 32 percent received no treatment. If MFTs and MHCs can provide 
reimbursable services under the Medicare program, the pool of mental 
health professionals who can help address practitioner shortages in 
rural communities can expand.
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    \136\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1851736/.
    \137\ https://aspe.hhs.gov/sites/default/files/2021-07/rural-health-rr.pdf.
    \138\ https://uknowledge.uky.edu/cgi/viewcontent.cgi?article=1013&context=ruhrc_reports.
    \139\ https://uknowledge.uky.edu/cgi/viewcontent.cgi?article=1013&context=ruhrc_reports.
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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. In the June 23, 
2016 Federal Register (81 FR 41036), we published a final rule entitled 
Medicare Clinical Diagnostic Laboratory Tests Payment System (CLFS 
final rule), that 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.\140\
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    \140\ 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 
period of 3 calendar quarters. After the new ADLT initial period, ADLTs 
are

[[Page 52411]]

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 (81 FR 41036 through 41101) and is 
available on the CMS website.\141\
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    \141\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/PAMA-regulations.
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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) (FCAA) 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 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

[[Page 52412]]

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, enacted December 29th, 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 one 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. Proposed Conforming Regulatory Changes
    In accordance with section 4114 of the CAA, 2023, we are proposing 
to make certain conforming changes to the data reporting and payment 
requirements at 42 CFR part 414, subpart G. Specifically, we are 
proposing to revise Sec.  414.502 to update the definitions of both the 
``data collection period'' and ``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 are also proposing 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 are 
proposing to make 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 are proposing 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 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 note 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.

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 are proposing 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

[[Page 52413]]

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. 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 propose additions 
and revisions to language in Sec. Sec.  410.47 and 410.49 as described 
below.
a. Definitions
    We are proposing to add a new term, nonphysician practitioner 
(NPP), to Sec. Sec.  410.47(a) and 410.49(a), which would be defined as 
a PA, NP, CNS as those terms are defined in section 1861(aa)(5)(A) of 
the Act.
    We are proposing 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 are proposing 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 are proposing to amend Sec.  410.47(b)(3)(ii)(A) and Sec.  
410.49(b)(3)(ii) 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 are proposing 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 are also removing 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 are proposing 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. We 
believe these proposed amendments to Sec. Sec.  410.47 and 410.49 would 
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. All other provisions of these regulations would remain 
unchanged.

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

[[Page 52414]]

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 
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 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 are 
continuing to monitor utilization of OUD treatment services furnished 
by OTPs to ensure that Medicare beneficiaries have appropriate access 
to care. For CY 2024, we are proposing 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
    We have finalized several flexibilities for OTPs regarding the use 
of telecommunications, 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 IFC entitled ``Medicare and Medicaid Programs: Policy and 
Regulatory Revisions in Response to the 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

[[Page 52415]]

requirements are met, on a permanent basis.
    Furthermore, in the CY 2023 PFS proposed rule (87 FR 46093), we 
sought comment 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 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 commenter cited a 2020 HHS Issue Brief indicating 
higher utilization of audio-only visits for older adults. Specifically, 
evidence suggests that 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.'' \142\ 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 
services'' at Sec.  410.67(b) of the regulations to reflect these 
changes.
---------------------------------------------------------------------------

    \142\ 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.
---------------------------------------------------------------------------

    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 
(FQHCs) until dates of service on or after January 1, 2025 if the 
COVID-19 PHE ends 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. 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, we are proposing to extend the audio-only flexibilities for 
periodic assessments furnished by OTPs through the end of CY 2024. 
Under this proposal, 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. 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, substance use disorder treatment 
facilities increased telemedicine offerings by 143 percent, and as of 
2021, almost 60 percent of SUD treatment facilities offer 
telehealth.\143\ 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.\144\ Therefore, extending these audio-only 
flexibilities for an additional year may minimize disruptions 
associated with the conclusion of the PHE. Additionally, 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.\145\ 
Other evidence also suggests 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.\146\ 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, 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.
---------------------------------------------------------------------------

    \143\ https://pubmed.ncbi.nlm.nih.gov/34407631/.
    \144\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8250742/.
    \145\ 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.
    \146\ 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 are proposing to revise paragraph (vii) of the 
definition of

[[Page 52416]]

``Opioid treatment services'' 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 
proposed rule for the full policy discussion and additional details 
regarding Medicare payment for IOP services provided by OTPs.

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 Traditional 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 
traditional 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.\147\ 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.\148\ 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.\149\
---------------------------------------------------------------------------

    \147\ 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.
    \148\ 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.
    \149\ 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).
---------------------------------------------------------------------------

    Section III.G. of this proposed rule addresses changes to the 
Shared Savings Program regulations 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 
propose 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, the policy proposals would 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 to propose 
related changes to how we identify assignable beneficiaries used in 
certain Shared Savings Program calculations. Additionally, we are 
proposing updates to the definition of primary care services used for 
purposes of beneficiary assignment to remain consistent with billing 
and coding guidelines. We also propose 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; 
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; 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 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. We are also proposing to refine 
our policies for the newly established advance investment payments 
(AIP) and 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 seek comment 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

[[Page 52417]]

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 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 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 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 Federal Register (85 FR 27573 through 27587) 
(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

[[Page 52418]]

losses for the period of the PHE for COVID-19 starting in January 2020.
    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 Proposals
    In sections III.G.2. through III.G.7. of this proposed rule, we 
propose modifications to the Shared Savings Program's policies, and 
describe comment solicitations. As a general summary, we are proposing 
the following changes to Shared Savings Program policies to:
     Revise the quality reporting and the quality performance 
requirements (section III.G.2. of this proposed 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 proposed rule).
    ++ Update the APP measure set for Shared Savings Program ACOs 
(section III.G.2.c. of this proposed rule).
    ++ Revise the calculation of the health equity adjustment 
underserved multiplier (section III.G.2.d. of this proposed 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 proposed rule).
    ++ Apply a Shared Savings Program scoring policy for suppressed APP 
measures (section III.G.2.f. of this proposed rule).
    ++ Require Spanish language administration of the CAHPS for MIPS 
survey (section III.G.2.g. of this proposed rule).
    ++ Align CEHRT requirements for Shared Savings Program ACOs with 
MIPS (section III.G.2.h. of this proposed rule).
    ++ Solicit comments on MIPS Value Pathway reporting for specialists 
in Shared Savings Program ACOs (section III.G.2.i. of this proposed 
rule).
    ++ Revise the requirement to meet the case minimum requirement for 
quality performance standard determinations (section III.G.2.j. of this 
proposed rule).
     Revise the policies for determining beneficiary assignment 
(section III.G.3 of this proposed rule).
    ++ Modify the step-wise beneficiary assignment methodology and 
approach to identifying the assignable beneficiary population (section 
III.G.3.a of this proposed rule).
    ++ Update the definition of primary care services used in 
beneficiary assignment at Sec.  425.400(c) (section III.G.3.b of this 
proposed rule).
     Revise the policies on the Shared Savings Program's 
benchmarking methodology (section III.G.4 of this proposed 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 proposed 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 
proposed rule).
    ++ 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 
(section III.G.4.d of this proposed rule).
    ++ 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 proposed rule).
     Refine AIP policies, including the following (section 
III.G.5 of this proposed 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 their participation in the Shared 
Savings Program.
    ++ Modify termination policies to specify that CMS would 
immediately terminate advance investment payments

[[Page 52419]]

to an ACO for future quarters if the ACO voluntarily terminates from 
the Shared Savings Program.
    ++ Modify ACO reporting requirements to require ACOs to submit 
spend plan updates to CMS in addition to publicly reporting spend plan 
updates.
    ++ 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 proposed 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 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 proposed 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.
    In addition, we are soliciting comment on potential future 
developments to Shared Savings Program policies (section III.G.8. of 
this proposed 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 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 Shared Savings Program proposals 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 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 proposed 
new policies described in this proposed 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 proposals require the 
use of our authority under section 1899(i) of the Act: the proposed 
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 proposed rule and the refinements to AIP 
policies as described in section III.G.5. of this proposed 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 would be affected by 
the proposed addition of a new third step of the beneficiary assignment 
methodology and the proposed revisions to the definition of assignable 
beneficiary described in section III.G.3. of this proposed rule, 
including the following: the amount of advance investment payments; 
factors used in determining shared losses for ACOs under two-sided 
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 two-sided model ACOs); 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 VII. 
and elsewhere in this proposed rule, these proposed changes 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.
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. Proposal for Shared Savings Program ACOs To Report Medicare CQMs
(1) Background
    In the CY 2021 PFS final rule, CMS 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

[[Page 52420]]

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 de-duplication 
and patients adding or moving insurance coverage (87 FR 65260). In 
public comment 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 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://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. 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 are proposing in 
section IV.A.4.f.(1)(b) of this 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. 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, 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 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, we 
believe that it is appropriate to establish Medicare CQMs as a new 
collection type for Shared Savings Program ACOs only.
    We recognize that Medicare CQMs might not be the 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 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 this 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. Under 
this proposal, in performance year 2025 and subsequent performance 
years as determined by CMS, ACOs would have the option to

[[Page 52421]]

report quality data utilizing the eCQMs, MIPS CQMs, and/or Medicare 
CQMs collection types.
    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.
    We also remain steadfast in our commitment to support providers in 
the transition from traditional MIPS to APMs and Advanced APMs. As 
mentioned above, we acknowledge 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 under this proposal. In supporting providers 
in the transition from traditional MIPS to APMs and Advanced APMs we 
also recognize the corresponding need to support ACOs in the transition 
to all payer/all patient reporting. In addition to the technical 
support 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.
    To facilitate the reporting of Medicare CQMs, we are proposing to 
amend the definition of ``Collection Type'' in section IV.A.4.f.(1)(b) 
of this proposed rule to include the Medicare CQM as an available 
collection type in MIPS for ACOs that participate in the Shared Savings 
Program. We note that the Medicare CQMs collection type would serve as 
a transition collection type and be available as determined by CMS. 
Additionally, we are proposing to establish data submission and 
completeness criteria pertaining to the Medicare CQMs for the MIPS 
quality performance category as discussed in sections 
IV.A.4.f.(1)(c)(i) and IV.A.4.f.(1)(d)(ii) of this proposed rule.
    A Medicare CQM for Accountable Care Organizations Participating in 
the Medicare Shared Savings Program (Medicare CQM) is essentially a 
MIPS CQM reported by an ACO under the APP on only the ACO's Medicare 
fee-for-service beneficiaries, instead of its all payer/all patient 
population. We are proposing to define a beneficiary eligible for 
Medicare CQM 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 fee-for-service 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 PA, NP, or CNS.
     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.
    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 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.
    Our proposed definition for beneficiary eligible for Medicare CQMs 
is intended 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. Similarly, 
we define 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. 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.
    In section IV.A.4.f.(1)(d)(ii)of this proposed rule, we are 
proposing 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 CQM, as proposed at Sec.  
425.20, who meet the measure's denominator criteria. In section 
IV.A.4.f.(1)(d)(ii) of this proposed rule, we are proposing the 
following data completeness criteria thresholds for Medicare CQMs:

[[Page 52422]]

     At least 75 percent for the CY 2024, CY 2025, and CY 2026 
performance periods/2026, 2027, and 2028 MIPS payment years.
     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 and would be available as determined by 
CMS, we are proposing to establish the aforementioned data completeness 
criteria thresholds 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 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.
    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. 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 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 anticipate 
the list of beneficiaries eligible for Medicare CQMs to be shared once 
annually, at the beginning of the quality data submission period. 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 are proposing 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 fee-for-service 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 anticipate including the minimum data necessary to facilitate 
the reporting of Medicare CQMs including beneficiary identifier, 
gender, date of birth and death (if applicable), chronic condition 
subgroup, and the NPIs of the top three frequented providers in the 
ACO. We propose 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. 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 3 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 proposed rule, we are proposing 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 3 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, in order to meet the Shared Savings Program reporting 
requirements:

[[Page 52423]]

     For performance year 2024, an ACO would be required to 
report the 10 measures under the CMS web interface measures, or the 3 
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 3 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), as 
described in section III.G.2.j. of this proposed rule, we propose to 
incorporate Medicare CQMs into the existing quality performance 
standard policies for new ACOs at Sec.  425.512(a)(2)(i), (ii), and 
(iii). Accordingly, we propose 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 3 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 3 eCQMs/MIPS CQMs/Medicare CQMs and 
administers a CAHPS for MIPS survey under the APP.
    Additionally, we propose 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 propose 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 are not proposing 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, CMS is 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 will 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 to this 
proposed rule. 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.
(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 propose that new benchmarks for scoring ACOs on 
the Medicare CQMs under MIPS would be developed in alignment with MIPS 
benchmarking policies. As historical Medicare CQM data would not be 
available at the time this proposal is finalized (if this proposal is 
finalized), we propose 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 
propose 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).
(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 are proposing 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. We are proposing 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.

[[Page 52424]]

(5) Summary of Proposals
    In Table 25 of this proposed rule we summarize the proposed changes 
to the regulation at Sec.  [thinsp]425.512(a)(4) and (5) to reflect the 
proposed changes 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 
proposed), CMS Web Interface) and are updated for each performance 
year.
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[[Page 52425]]

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[[Page 52426]]


c. Proposed APP Measure Set
(1) Background
    We refer readers to Table 26, 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 note 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 26 for each 
measure in the measure set to provide ACOs a list of 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.
(2) Proposed Revisions

[[Page 52427]]

[GRAPHIC] [TIFF OMITTED] TP07AU23.036

    Table 27 includes the proposed eCQM/MIPS CQM measure set for 
performance year 2024 for the Shared Savings Program and outlines the 
measure types, which is relevant for ACOs that may elect to report on 
eCQM/

[[Page 52428]]

MIPS CQMs in order to qualify for the incentive under Sec.  
425.512(a)(4)(i)(B).
[GRAPHIC] [TIFF OMITTED] TP07AU23.037

    Table 28 identifies the preliminary measures for the Universal 
Foundation's adult component.
[GRAPHIC] [TIFF OMITTED] TP07AU23.038

BILLING CODE 4120-01-C
    The CMS Web Interface collection type under the APP includes 10 
measures. We refer readers to Table Group E of Appendix 1 of this 
proposed 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

[[Page 52429]]

workflows of the MIPS CQM collection type.
d. Proposals To Modify 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.(2) of this proposed 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.(2) of this proposed 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 (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) Proposed Revisions
    We propose to revise the underserved multiplier 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 propose 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 advance investment payments 
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 are proposing to 
exclude beneficiaries without a national percentile ADI rank from the 
health equity adjustment underserved multiplier. 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

[[Page 52430]]

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, we propose 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 are not proposing 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 into by Medicare enrollment type (ESRD, disabled, aged/dual 
eligible, and aged non/dual eligible) and it is important to account 
for partial year enrollment to ensure accuracy. The proposed policy 
change would 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 seek comment on these proposals.
e. Proposal To Use 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 
comment 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 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

[[Page 52431]]

the quality performance standard for performance year 2024 and 
subsequent performance years.
    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 one year. At the 
same time, using too many years of data to average scores might include 
a greater number of years that don't reflect current policies.
(2) Proposed Revisions
    For performance year 2024 and subsequent performance years, we 
propose to use historical submission-level MIPS Quality performance 
category scores to calculate the 40th percentile MIPS Quality 
performance category score. Specifically, we propose to 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 
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 this 
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 three 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 acknowledge that 
by using historical benchmarks, the benchmark would not reflect the 
most recent policies, measure specifications, and scores. 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 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 29 
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.

[[Page 52432]]

[GRAPHIC] [TIFF OMITTED] TP07AU23.039

    We seek comment 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. We also seek comment on other 
alternative methodologies we should consider to calculate the 40th 
percentile MIPS Quality performance category score for the quality 
performance standard.
f. Proposal To Apply a Shared Savings Program Scoring Policy for 
Excluded APP Measures
(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.  [thinsp]414.1380(b)(1)(vii)(A)) (85 FR 84725)). In the CY 2021 
PFS final rule (85 FR 84901), we finalized policies at Sec.  
[thinsp]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

[[Page 52433]]

whether and which measures are excluded.
(2) Proposed 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, we are 
proposing 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 are also 
proposing 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 this proposed rule, we 
are proposing 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 
propose 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 are also proposing 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).
    As discussed in section IV.A.4.g.(1)(c)(i) of this proposed rule, 
we are proposing 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. 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 under section IV.A.4.g.(1)(c)(i) of this proposed 
rule. We refer readers to section IV.A.4.g.(1)(c)(i) of this proposed 
rule for further discussion of our proposal to change the MIPS scoring 
policy.
g. Proposal To Require Spanish Language Administration of the CAHPS for 
MIPS Survey
(1) Background
    CMS has created official translations of the CAHPS for MIPS survey 
in 7 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) Proposed Revisions
    As discussed in section IV.A.4.f.(1)(c)(ii) of this proposed rule, 
we are proposing to require Spanish language administration of the 
CAHPS for MIPS survey for MIPS eligible clinicians reporting MIPS. 
Specifically, we are proposing to require MIPS eligible clinicians 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 beginning 
with 2024 survey administration. This should better ensure that we are 
assessing the experience of patients who are Spanish-speaking and with 
limited English proficiency, and is part of our efforts to advance 
health equity. We refer readers to section IV.A.4.f.(1)(c)(ii) of this 
proposed rule for further discussion of our proposal related to the 
CAHPS for MIPS survey. In addition, we are interested in gathering 
information directly from organizations that administer the CAHPS for 
MIPS Survey on whether they consider to request the vendor to 
administer the survey in one or more of the available survey 
translations based on the language preferences of patients. We are 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.
h. Proposals To 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. With 
respect to 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

[[Page 52434]]

records, including using alternative criteria for determining whether 
to make such incentive payments. Pursuant to 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 (42 CFR 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. 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 Periods 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 45 CFR 
170.102 and has been certified as meeting certain other criteria set 
forth in ONC's 2015 Edition health IT certification criteria at 45 CFR 
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.  414.1305to meet the requirements 
set forth in our regulation at Sec.  425.506(f). As discussed in 
section III.R. of this proposed rule, 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 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 is proposing 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 (IT) 
development timelines (88 FR 23750). As further discussed in section 
III.R. of this proposed rule, we are proposing 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
    In order to streamline CEHRT threshold requirements for ACOs and 
align with the Quality Reporting Program's Merit-Based Incentive 
Payment System (MIPS), we propose 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. We further propose, 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.

[[Page 52435]]

    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 propose to codify this new requirement at Sec.  425.507.
    Specifically, we propose that any requirements applicable to MIPS 
eligible clinicians reporting on objectives and measures specified by 
CMS for the MIPS PI category would apply to MIPS eligible clinicians, 
QPs, and Partial QPs participating in an ACO at Sec.  425.507(a). We 
further propose that if any of these requirements for a MIPS eligible 
clinician reporting for the MIPS PI 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 proposed rule, 
we are proposing several modifications to the MIPS PI 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 are proposing 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 PI performance category as an 
individual, group, or virtual group or the ACO reports MIPS PI 
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.
    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 PI 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 PI 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 
PI 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 PI 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 PI 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 PI performance category as described at 
Sec.  414.1380(c)(2)(i)(A)(4).
    We believe that incorporating MIPS PI 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 PI 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, 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, we believe 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 PI category at the 
individual, group, virtual group, or APM entity level for purposes of 
satisfy our proposal at Sec.  425.507, we encourage ACOs to evaluate 
reporting the MIPS PI 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 PI 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 PI 
performance category at the APM entity level, the APM entity PI 
performance category score would be used to generate the APM entity 
level score for purposes of scoring the MIPS PI performance category. 
If the ACO does not report PI at 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 PI performance category. If an eligible clinician 
reports PI at the individual or group level under traditional MIPS or

[[Page 52436]]

the APM Performance Pathway (APP) in addition to reporting the MIPS PI 
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 PI performance 
category score. For more information about reporting the PI 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 https://qpp.cms.gov/resources/resource-library. We anticipate releasing sub-regulatory 
guidance for ACOs that participate in the Shared Savings Program about 
voluntarily reporting the MIPS PI performance category at the APM 
entity level in future performance years.
    We are seeking public comment 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 propose to codify this new requirement at Sec.  425.507.
    We are also seeking public comment on an alternative proposal to 
narrow the proposal to require that ACOs to report the measures and 
requirements under the MIPS PI 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 PI performance category at 
the individual, group, or virtual group level for purposes of 
satisfying our proposal 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 PI 
performance category as discussed above, we also are proposing 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 are proposing to codify this requirement at Sec.  
425.308(b)(9).
    We are proposing 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 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 PI performance category as an individual, group, or 
virtual group or the ACO reports the MIPS PI 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).
(4) Updating Annual Certification Requirements
    As noted in section III.G.2.h.(2) of this proposed rule, we believe 
that incorporating MIPS PI performance category's requirements will 
alleviate confusion for ACOs and the use of CEHRT under the Shared 
Savings Program. Additionally, we find that the MIPS PI performance 
category's reporting requirements are more comprehensive and better 
address the key functions that facilitate better care coordination and 
quality measurement for ACOs. This change would further align the 
Shared Savings Program with the MIPS program and 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.(4). 
of this proposed rule, we are proposing to sunset the Shared Savings 
Program CEHRT threshold requirements and modify Sec.  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 proposed rule, we also propose 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 are proposing 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 are seeking public comment 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

[[Page 52437]]

requirements at Sec.  425.507, 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 also seek comment on our proposal to add a new requirement for 
public reporting in Sec.  425.308(b)(9), requiring that the ACO must 
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.
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 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. 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,\150\ we direct readers to section IV.A.4.a. of 
this proposed rule where we propose to create a primary care MVP. We 
note 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.
---------------------------------------------------------------------------

    \150\ 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.
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    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 this proposed rule, we are soliciting 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

[[Page 52438]]

in the ACO report quality MVPs as described at Sec.  414.1365(c)(1).
    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. 
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 receives a MIPS Quality performance 
category score under Sec.  414.1380(b)(1) to be eligible for bonus 
points.
    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. We are 
seeking feedback 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 are also seeking feedback 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 proposed rule?
     As noted above, providing ACOs with bonus points to their 
health equity adjusted quality performance score 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 seek comment 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 seek comment 
on if and how CMS should consider assessing overall specialty 
performance as part of the APP in the future.
    We note that in section IV.A.1.b.(2) of this proposed 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.
j. Proposal To Revise the Requirement To Meet the Case Minimum 
Requirement for Quality Performance Standard Determinations
(1) Background
    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, for the eCQM/
MIPS CQM 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)).
    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) Proposed Revisions
    In order 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 propose 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. This proposal 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. 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. 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

[[Page 52439]]

was mitigated by the application of the extreme and uncontrollable 
circumstance policy. Specifically, 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.
    Separately, we propose to address a gap in the current rule 
regarding the ``minimum beneficiary sampling requirement'' at Sec.  
414.1380(b)(1)(vii)(B). This provision 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 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. We propose 
revisions to the following regulation text sections:
     At Sec.  425.512(a)(2)(ii) and (iii), we propose 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 propose 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 would meet the quality 
performance standard under the Shared Savings Program, if:
    ++ For performance year 2024, 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 performance year 2025 and subsequent performance years, 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
     At Sec.  425.512(a)(5)(i)(A)(2), we propose to remove the 
phrase ``and the case minimum requirement at Sec.  414.1380 of this 
subchapter.'' As follows: For performance year 2024, under the eCQM/
MIPS CQM reporting incentive, the ACO would meet the quality 
performance standard used to determine eligibility for shared savings 
and to avoid maximum shared losses, as applicable, if the ACO: (1) 
meets the data completeness requirement at Sec.  414.1340 for all three 
eCQMs/MIPS CQMs; (2) achieves 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 (3) 
achieves 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. Therefore, we do not believe that it would 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).
     At Sec.  425.512(c)(3), we propose 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: Under the extreme and uncontrollable circumstances policy, 
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 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, for the relevant performance year.
    We are proposing 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 propose 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 will 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)).

[[Page 52440]]

3. Determining Beneficiary Assignment Under the Shared Savings Program
a. Proposed 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.\151\
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    \151\ See for example, 76 FR 67851, and 83 FR 67863.
---------------------------------------------------------------------------

    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.  [thinsp]425.20 or has one of the primary specialty 
designations specified in Sec.  [thinsp]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, physician assistants, and 
clinical nurse specialists 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, nurse 
practitioners, physician assistants, or clinical nurse specialists 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, nurse 
practitioner, physician assistant, or clinical nurse specialist, 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.  
[thinsp]425.402(c) are greater than the allowed charges for primary 
care services furnished during the assignment window by physicians with 
such 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.  [thinsp]425.20 to mean 
the 12-month period used to assign beneficiaries to an ACO. As 
described in the December 2018 final rule, 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 (83 FR 67861). 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.  [thinsp]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 (nurse practitioners, physician assistants, 
and clinical nurse specialists) in step one of the assignment 
methodology rather than in step two, and to exclude services provided 
by certain physician specialties from step two of the assignment 
process. We refer readers to the November 2011 final rule and the June 
2015 final rule for a discussion of the relevant background and related 
considerations (see 76 FR 67853 through 67858, and 80 FR 32748 through 
32755). Generally, as we have previously explained in rulemaking, 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

[[Page 52441]]

in areas with primary care physician shortages (see, for example, 76 FR 
67853 through 67855; see also 80 FR 32748 and 32754). Further, 
including services furnished by nurse practitioners, physician 
assistants, and clinical nurse specialists in determining where a 
beneficiary has received the plurality of primary care services in step 
one 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), 425.601(a)(10), 425.605(a)(1), 425.610(a)(2), 
425.652(a)(3), and 425.652(a)(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 advance investment payments 
(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)).
     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 nurse 
practitioners, physician assistants, and clinical nurse specialists. As 
specified in Sec.  425.402(e)(1), and subject to Sec.  425.402(e)(2), 
assignment under voluntary alignment supersedes

[[Page 52442]]

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, 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 (see 81 FR 37985 through 37988). 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 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. (Refer to 87 FR 69931.) 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 
fee-for-service 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 fee-for-service expenditures 
based on expenditures for the assignable 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 fee-for-service 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 
fee-for-service 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 fee-for-service 
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 fee-for-
service 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
    CMS has established a goal that 100 percent of beneficiaries 
enrolled in Original Medicare be involved in a care relationship with 
accountability for

[[Page 52443]]

quality and total cost of care by 2030.\152\ CMS has also established 
health equity as a top priority through our CMS Framework for Health 
Equity (2022-2032).\153\ However, CMS believes 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.
---------------------------------------------------------------------------

    \152\ 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.
    \153\ 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 nurse practitioners, physician 
assistants, and clinical nurse specialists. In response to the CY 2023 
PFS proposed rule, a commenter noted that the current claims-based 
assignment methodology creates a barrier for nurse practitioners and 
their patients to participate in ACOs.\154\
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    \154\ 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 
nurse practitioners, physician assistants, or clinical nurse 
specialists would reduce the barriers for underserved beneficiaries to 
be assigned to ACOs. As described in section III.G.3.a.(2)(d) of this 
proposed rule, we have observed from initial modeling of expanding the 
definition of an assignable beneficiary that such an approach could add 
to the national assignable population 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 
assignable population of beneficiaries also had a lower average 
prospective HCC risk score, lower total per capita-year spending, 
higher hospice utilization, and a higher mortality rate than the 
national assignable population under the current definition of an 
assignable beneficiary. 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).\155\
---------------------------------------------------------------------------

    \155\ 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.
---------------------------------------------------------------------------

(2) Proposed Revisions
(a) Overview of Proposed 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. We are 
proposing to use an expanded window for assignment in a new step three 
to the claims-based assignment process to identify additional 
beneficiaries for ACO assignment (described in section 
III.G.3.a.(2)(b). of this proposed rule), and we are proposing 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 this proposed rule). We propose 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.
    To follow is a brief summary of the proposed uses of the expanded 
window for assignment, described in greater detail elsewhere within 
this section of this proposed rule. First, the proposed addition of a 
step three to the beneficiary assignment methodology would occur after 
the current steps one and two and 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 three 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 receive 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 three 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 propose 
that these changes would be effective for the performance year 
beginning on January 1, 2025, and subsequent performance years.
    A number of factors informed our consideration of the duration of 
the expanded window for assignment. 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. Through the 
proposed modifications to the assignment methodology and the definition 
of assignable beneficiary, we seek 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 believe that 
primary care services furnished by nurse practitioners, physician 
assistants, and

[[Page 52444]]

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 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 
two-year beneficiary alignment period in the ACO Realizing Equity, 
Access, and Community Health (REACH) Model and the Next Generation ACO 
(NGACO) Model.\156\
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    \156\ 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.
---------------------------------------------------------------------------

    We also believe it is 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 this section of this proposed rule, we 
use the term assignment window in referencing our identification of 
assignable beneficiaries. Therefore, we are proposing 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.
    We seek comment 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''.
(b) Proposed Revisions To Add a Step Three to the Beneficiary 
Assignment Methodology
    For the performance year beginning on January 1, 2025, and 
subsequent performance years, we propose to revise the step-wise 
beneficiary assignment methodology, as described in Sec.  425.402, to 
include a step three, which 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. Specifically, step three 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 (nurse practitioner, physician assistant, or clinical 
nurse specialist) 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 
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), 
nurse practitioners (as defined at Sec.  410.75(b)), physician 
assistants (as defined at Sec.  410.74(a)(2)), and clinical nurse 
specialists (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, 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 one or two, or proposed step three. 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 one or two would also continue to 
not be assigned to an ACO as these beneficiaries would not be 
considered for assignment in step three. 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.\157\ We propose to continue to apply this approach 
for beneficiaries prospectively assigned at step one, step two, or 
proposed step three. In other words, a beneficiary who is assigned to 
an ACO based on prospective assignment through step one or two or 
proposed step three 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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    \157\ 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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    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

[[Page 52445]]

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 propose 
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. These proposed changes 
are 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.\158\
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    \158\ 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), 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 is 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 nurse 
practitioner, physician assistant, or clinical nurse specialist 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 one and two. 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 anticipate 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 three for prospective assignment that 
differs from the retrospective ACO the beneficiary is currently 
assigned to under steps one or two for preliminary prospective 
assignment with retrospective reconciliation. This precedence of 
prospective assignment follows the current assignment methodology, 
which currently assigns beneficiaries via steps one and two of 
prospective assignment to an ACO that may be different than the ACO to 
which the beneficiary would have been assigned via steps one or two 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 three 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 nurse 
practitioner (as defined at Sec.  410.75(b)), a physician assistant (as 
defined at Sec.  410.74(a)(2)), or a clinical nurse specialist (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 three 
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 in a two-
sided risk model with a variable minimum loss rate, which reflects a 
lower threshold for two-sided risk ACOs 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

[[Page 52446]]

would result in larger loss sharing limit 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 fee-
for-service (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 Advance 
Investment Payments.
     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 propose modifications to subpart E of the Shared Savings Program 
regulations to specify the revised beneficiary assignment methodology. 
We propose to specify the new step three in a new provision at Sec.  
425.402(b)(5). We also propose technical and conforming changes to 
incorporate the revised methodology. We propose to amend Sec.  
425.402(b)(1), describing the existing pre-step of the assignment 
methodology that would remain applicable for step one and step two, 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 
propose to specify that the listed specialties would be considered for 
ACO professionals in step two (as described in Sec.  425.402(b)(4)) and 
the proposed step three (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 propose 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 propose 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.
(c) Proposed Revisions to the Definition of an Assignable Beneficiary
    Consistent with the previously described proposal to use an 
expanded window for assignment in an enhanced step-wise assignment 
methodology, we are proposing 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 
this 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 propose that a Medicare fee-for-
service 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 nurse practitioner (as defined at Sec.  
410.75(b)), physician assistant (as defined at Sec.  410.74(a)(2)), or 
a clinical nurse specialist (as defined at Sec.  410.76(b)).
    The proposed use of an expanded window for assignment would result 
in a greater number of beneficiaries included in the assignable 
population. 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 believe 
it is 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 
(nurse practitioner, physician assistant, and clinical nurse 
specialist), 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.

[[Page 52447]]

     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 fee-for-service 
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 note that 
under this 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 years for 
use in calculations for ACOs that are continuing in agreement periods 
that began before January 1, 2024.
    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 propose technical and conforming changes to provisions in 
subpart G of the Shared Savings Program regulations that refer to the 
assignment window used to identify the assignable beneficiary 
population in order 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 
years. 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 propose 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 propose to specify in the proposed 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 
proposed 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).
    We seek comment on our proposed modifications to the definition of 
assignable beneficiary in Sec.  425.20. We also seek comment 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.

[[Page 52448]]

(d) Simulations To Understand the Potential Effect of Proposed Changes
    To understand the potential impact of using an expanded window for 
assignment in a proposed step 3 of the claims-based assignment 
methodology, we simulated using the proposed definition for an 
assignable beneficiary and proposed step 3 using the set of ACOs and 
data for performance year (PY) 2021. 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. For additional analysis on 
estimated impacts, we also refer commenters to the Regulatory Impact 
Analysis in section VII.E. of this proposed rule. We seek comment on 
the proposed approach discussed in this proposed rule and the potential 
effects of the proposed approach, including its effects modeled in the 
aforementioned simulation and its effects in other scenarios that might 
be considered by commenters. We anticipate 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 we are planning to publish results from 
such additional simulations in the final rule.
    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 had a larger share of 
beneficiaries with disabled Medicare enrollment type, 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 any months of Medicare Part D LIS 
enrollment (refer to Table 30).
[GRAPHIC] [TIFF OMITTED] TP07AU23.040

    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 determined using the 
current definition of assignable beneficiary and assignment

[[Page 52449]]

methodology. 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.
(e) Implementation of Proposed Revisions
    We are proposing 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 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 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 anticipate 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 are proposing to apply this change beginning with the 
performance year starting on January 1, 2025.
    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 
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 believe that the expanded window 
for assignment and proposed step three represent a valuable change that 
would fill an important gap in the current assignment methodology. CMS 
has 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.\159\ In a 
January 2022 article, CMS 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.\160\ Many 
Medicare FFS beneficiaries are currently excluded from the assignable 
and Shared Savings Program assigned populations despite receiving 
primary care from ACO professional nurse practitioners, physician 
assistants, and clinical nurse specialists during the existing 12-month 
assignment window, and these excluded beneficiaries tend to come from 
populations characterized by greater social risk factors. Specifically, 
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 (as described in section 
III.G.3.a.(2)(d) of this proposed rule). 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.
---------------------------------------------------------------------------

    \159\ 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.
    \160\ 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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    In summary, we seek comment 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 three 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. If finalized, the proposed changes would be applicable for the 
performance year beginning on January 1, 2025, and subsequent 
performance years. We welcome comments on any aspects of the proposed 
changes, including the length of the expanded window for assignment. We 
also seek comment 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 fee-for-service 
beneficiaries assigned to an ACO, particularly in underserved 
communities.
b. Proposed 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 Rural Health Clinics (RHCs) and Federally 
Qualified Health Centers (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 
and 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

[[Page 52450]]

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.  
[thinsp]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)(vi)(A) of Sec.  425.400 or a HCPCS code specified in paragraph 
(c)(1)(vi)(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) Proposed 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 are proposing 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 propose 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 Medicare FFS 
payment policy; (6) Community Health Integration services HCPCS codes 
GXXX1 and GXXX2, if finalized under Medicare FFS payment policy; (7) 
Principal Illness Navigation (PIN) services HCPCS codes GXXX3 and 
GXXX4, if finalized under Medicare FFS payment policy; (8) SDOH Risk 
Assessment HCPCS code GXXX5, if finalized under Medicare FFS payment 
policy; (9) Caregiver Behavior Management Training CPT Codes 96202 and 
96203, if finalized under Medicare FFS payment policy; and (10) 
Caregiver Training Services CPT codes 9X015, 9X016, and 9X017, if 
finalized under Medicare FFS payment policy. The following provides 
additional information about the HCPCS codes that we are proposing 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,\161\ 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

[[Page 52451]]

primary care services for purposes of beneficiary assignment.
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    \161\ 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 \162\ 
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 believe 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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    \162\ 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.\163\ 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, it 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. CMS considers these to be a 
preventive health service that can be provided in a primary care 
setting \164\ similar to the annual wellness visit 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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    \163\ 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.
    \164\ 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.
    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. We note 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 believe these services should be considered primary care 
services for purposes of beneficiary assignment.\165\ Additionally, we 
anticipate 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,

[[Page 52452]]

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. We anticipate 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 believe 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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    \165\ 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 recognize 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 this proposed rule, 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 
are proposing to make HCPCS code G2211 separately payable effective 
January 1, 2024. Refer to section II.F. of this proposed rule for 
detailed, technical discussion regarding the description, payment, and 
utilization of these HCPCS codes.
    Since 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 believe 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 this proposed rule, separate coding, payment, service elements 
and documentation requirements for the following Community Health 
Integration (CHI) services are being proposed:
    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:
    ++ 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

[[Page 52453]]

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 proposed in section II.E. of this 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.\166\ 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 proposal 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 proposed rule for detailed, technical 
discussion regarding the proposed description, payment and utilization 
of these HCPCS codes.
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    \166\ CHW Roles As Outlined In The C3 Project available at: 
https://chwtraining.org/c3-project-chw-skills/.
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    Since the proposal described in section II.E. of this proposed rule 
proposes 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 believe 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 believe 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 this proposed rule, new coding for Principal Illness 
Navigation (PIN) services is being proposed. 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.\167\ 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.\168\ The navigation services such 
patients need are similar to CHI services, but Social Determinants of 
Health (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 is being 
proposed. PIN services could be furnished following an initiating E/M 
visit addressing a single high-risk disease.
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    \167\ 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/.
    \168\ 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.
    ++ 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

[[Page 52454]]

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 this 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 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. Refer to section II.E. of this proposed rule for detailed, 
technical discussion regarding the description, payment and utilization 
of these HCPCS codes.
    Since the proposal described in section II.E. of this proposed rule 
proposes 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 
believe 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 believe that these 
services can further the ACO's goal of care coordination and the 
provision of value-based care and should, therefore, 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 believe 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 this proposed rule, 
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.) is being proposed 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. Required elements are 
described in detail in the payment policy proposal described in section 
II.E.
    Under the proposal described in section II.E. of this proposed 
rule, 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. of this proposed rule 
for detailed, technical discussion regarding the description, payment 
and utilization of these HCPCS codes.
    Additionally, the proposal detailed in section III.T of this 
proposed rule proposes to add elements to the Annual Wellness Visit 
(AWV) by adding a new SDOH Risk Assessment as an optional, additional 
element with an additional payment. Under this 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 prevention services education and 
planning.
    Since the proposals described in sections II.E. and III.T. of this 
proposed rule propose 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 believe 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 believe 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 believe 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

[[Page 52455]]

sessions focus on interventions aimed at improving the patient's daily 
life.
    In section II.E. of this proposed rule, an active payment status 
for CPT codes 96202 and 96203 (caregiver behavior management/
modification training services) is being 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 in order to effectuate the desired patient outcomes.
    For purposes of caregiver behavior management/modification training 
services, the proposal requires that a caregiver receiving behavior 
management/modification training services is 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 this proposal, caregiver behavior 
management/modification training services 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. Refer to section II.E. of 
this proposed rule for detailed, technical discussion regarding the 
description, payment and utilization of these HCPCS codes.
    Since the proposal described in section II.E. of this proposed rule 
proposes that these services can 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, chronic care 
management, behavioral health integration services, and virtual check-
in services which are currently included in the list of primary care 
services used for purposes of beneficiary assignment, we believe that 
these services should be included in the definition of primary care 
services for purposes of beneficiary assignment in support of the 
Shared Savings mission to give 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 in order to effectuate the 
desired patient outcomes, especially in medical treatment scenarios 
where the caregiver receiving CTS is necessary to ensure a successful 
treatment outcome for the patient.
    In section II.E., an active payment status for CPT codes 9X015, 
9X016, and 9X017 for CY 2024 under the PFS is proposed. 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 this proposal, 9X015, 9X016, and 9X017 are 
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 proposed rule for detailed, 
technical discussion regarding the description, payment and utilization 
of these HCPCS codes.
    Since the proposal described in section II.E. of this proposed rule 
proposes that these services can 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, chronic care 
management, behavioral health integration services, and virtual check-
in services which are currently included in the list of primary care 
services used for purposes of beneficiary assignment, and we believe 
that these services are reported to Medicare only when furnished in 
conjunction with treatment for particular conditions and reflected in a 
plan of care, we believe they should be included in the definition of 
primary care services for purposes of beneficiary assignment in support 
of the Shared Savings Program mission to give coordinated, high quality 
care to an ACO's Medicare beneficiaries.
    We propose 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 Medicare FFS payment policy; and 9X015, 
9X016,

[[Page 52456]]

and 9X017, if finalized under Medicare FFS payment policy and HCPCS 
codes G0101; G2086, G2087, and G2088; G2211, if finalized under 
Medicare FFS payment policy; GXXX1 and GXXX2, if finalized under 
Medicare FFS payment policy; GXXX3 and GXXX4, if finalized under 
Medicare FFS payment policy; and GXXX5, if finalized under Medicare FFS 
payment policy; as discussed in the preceding paragraphs. We propose 
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 seek comment 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 welcome comments on any 
other existing HCPCS or CPT codes and new HCPCS or CPT codes proposed 
elsewhere in this proposed rule that we should consider adding to the 
definition of primary care services for purposes of assignment in 
future rulemaking.
4. Benchmarking Methodology
a. Overview
    In this section of the proposed rule, we are proposing 
modifications to the benchmarking methodology under the Shared Savings 
Program. We propose a combination of modifications to the Shared 
Savings Program's benchmarking methodology to encourage sustained 
participation by ACOs in the program. Specifically, we are proposing 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 this proposed rule). We are additionally 
proposing to further mitigate the impact of the negative regional 
adjustment to the historical benchmark (section III.G.4.c. of this 
proposed rule). We are also proposing refinements to the prior savings 
adjustment calculation methodology (section III.G.4.d. of this 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 revised initial determination under Sec.  
425.315. Finally, we propose 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 this proposed rule). Our specific 
proposals are discussed in detail in the following sections.
b. Proposal To 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.

[[Page 52457]]

    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 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 \169\ 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)).\170\
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    \169\ 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).
    \170\ 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 31 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.
    Pursuant to 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 \171\ 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 31, 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 31, 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 31 rows 
[C] and [H].
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    \171\ 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 this 
proposed rule.
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    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 \172\ in the county for that Medicare enrollment type 
(refer to Table 31, rows [D] and [I]), determined by the number of the 
ACO's

[[Page 52458]]

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 then aggregate those values for each 
population of beneficiaries (according to Medicare enrollment type) 
across all counties within the ACO's regional service area \173\ (refer 
to Table 31, rows [E] and [J]).
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    \172\ Proportions are calculated using beneficiary person years.
    \173\ 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.
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    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 31, 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] TP07AU23.041

    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 were 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.\174\ 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.\175\
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    \174\ Refer to CY 2021 PFS final rule (85 FR 84784).
    \175\ 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 AC''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

[[Page 52459]]

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 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.\176\ MedPAC, however, 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.177 178
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    \176\ Refer to 86 FR 65304.
    \177\ Refer to 86 FR 65303 through 65305.
    \178\ 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.
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    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. 
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 saying 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.\179\ In 
response to these comments, we indicated that we would continue to 
monitor the impacts of regional risk score growth and may propose 
further refinements to our risk adjustment policies in future 
rulemaking.\180\
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    \179\ Refer to 87 FR 69942 through 69943.
    \180\ Refer to 87 FR 69943.
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(2) Proposed 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, we are proposing 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. 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 fee-for-service 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 propose to follow a similar methodology 
as the one adopted in the CY 2023 PFS final

[[Page 52460]]

rule \181\ for capping ACO risk score growth, codified at Sec.  
[thinsp]425.605(a)(1)(ii) and Sec.  [thinsp]425.610(a)(2)(ii), while 
additionally accounting for an ACO's aggregate 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.
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    \181\ 87 FR 69932 through 69946.
---------------------------------------------------------------------------

    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 believe capping regional risk 
score growth will 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, 
this 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 would 
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 \182\ 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. Note 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.\183\
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    \182\ Consistent with our proposal to revise the definition of 
an assignable beneficiary (refer to section III.G.3.a of this 
proposed rule), we propose 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).
    \183\ 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.
---------------------------------------------------------------------------

     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 \184\ 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).
---------------------------------------------------------------------------

    \184\ 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.\185\
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    \185\ 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.\186\
---------------------------------------------------------------------------

    \186\ 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:

[[Page 52461]]

    -- The aggregate regional prospective HCC risk score growth 
(calculated in step 3), and
    -- 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 32 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 32 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 52462]]

[GRAPHIC] [TIFF OMITTED] TP07AU23.042

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 Medicate 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 52463]]

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.
    We believe 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. At the same time, we believe 
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 the 
ACOs regional service area as discussed in section III.G.4.b.(1) of 
this proposed rule and would therefore 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 33 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] TP07AU23.043

    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 is 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).\187\ 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 have 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 this proposed rule, are 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 believe the market share adjustment to the cap on 
regional risk score growth will limit overly advantaging ACOs with high 
market share if they participate in coding initiatives.
---------------------------------------------------------------------------

    \187\ 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 is 
minimal in BY3 relative to the BY3s in this simulation).
---------------------------------------------------------------------------

    Table 34 displays information on the impact of the market share 
adjustment on the cap on regional risk score growth within our 
simulation 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 52464]]

[GRAPHIC] [TIFF OMITTED] TP07AU23.044

    Based on this data in Table 34, 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 ACO 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.\188\
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    \188\ 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).
---------------------------------------------------------------------------

    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 34, 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. We believe that, while the impact of the 
market share adjustment on the cap on regional risk score growth will 
be small for the majority of ACOs, this market share adjustment is 
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 this 
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 will 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.
    Apart from the market share adjustment, the calculation of the 
proposed cap on regional risk score growth between BY3 and the 
performance year is 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 is 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, 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 achieves the goal of reducing 
the impact of regional risk score growth while leaving the existing 
methodology for calculating risk-adjusted regional expenditures intact.
    As we have explained 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. Therefore, the proposed changes to the regional component of the 
three-way blended update factor described in this section of this 
proposed rule 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 believe the changes to the 
methodology for updating the benchmark that we are 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 believe that the proposed changes to the regional 
component of the update factor would--

[[Page 52465]]

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 believe 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.E.10. of this proposed rule), we believe the proposed changes to 
the regional component of the three-way blended update factor, in 
combination with the other proposals for which we must use our 
authority under section 1899(i)(3) of the Act, would result in a 
marginal impact that is estimated to result in $330 million in lower 
net spending over the 10-year projection window, which supports 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 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 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 propose 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(c) to incorporate a regional risk score growth cap adjustment 
factor. We also propose to add a new section to the regulations at 
Sec.  425.655 to describe the calculation of the adjustment factor.
    We seek comment on the proposed changes to calculation of the 
regional component of the update factor for agreement periods beginning 
on or after January 1, 2024.
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.  425.20) 
in that Medicare enrollment type identified for the 12-month calendar 
year corresponding to BY3 (Sec.  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 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

[[Page 52466]]

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 35 illustrates how the caps to 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] TP07AU23.045

    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 are 
thus 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) \189\ and [B] the ACO's weighted 
average prospective HCC risk score for BY3 taken across the four 
Medicare enrollment types.\190\ 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:
---------------------------------------------------------------------------

    \189\ 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.
    \190\ 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

[[Page 52467]]

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 35 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 36 by 
multiplying the negative regional adjustment for each applicable 
Medicare enrollment type by 1 minus the offset factor or 0.630.
[GRAPHIC] [TIFF OMITTED] TP07AU23.046

    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 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, we believe it is 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 believe 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

[[Page 52468]]

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.\191\ 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.
---------------------------------------------------------------------------

    \191\ 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.
    We believe 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 believe 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. The implementation of this policy 
would allow ACOs to serve the most vulnerable populations while 
lessening the concern of how this may affect their performance in the 
program. We believe 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 believe 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, therefore we believe that 
their participation in the program should not be discouraged.
(2) Proposed Revisions
    In light of these considerations, we are proposing 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 are proposing 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 fee-for-service 
population used to calculate the caps would reflect the revised 
definition of assignable beneficiary that incorporates the expanded 
window for assignment as proposed in section III.G.3.a of this proposed 
rule, if finalized.
     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 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 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

[[Page 52469]]

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).\192\ We believe 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).
---------------------------------------------------------------------------

    \192\ 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 believe this is 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 37 and 38 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 35 
and 36 within this section and has an overall negative regional 
adjustment. The second ACO, ACO B, has an overall positive regional 
adjustment. Table 37 assumes that both ACOs are ineligible for a prior 
savings adjustment, whereas Table 38 shows how the calculation would 
change if both ACOs were eligible for such an adjustment.
BILLING CODE 4120-01-P

[[Page 52470]]

[GRAPHIC] [TIFF OMITTED] TP07AU23.047

    In Table 37, 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.

[[Page 52471]]

[GRAPHIC] [TIFF OMITTED] TP07AU23.048

BILLING CODE 4120-01-C
    In Table 38, 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 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 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

[[Page 52472]]

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 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.
    Overall, we believe 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 might otherwise be subject to a downward 
adjustment to their benchmark due to the negative regional adjustment. 
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. 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 propose 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 propose 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 propose 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 propose 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 this proposed rule). We also 
propose modifications to update certain cross-references within Sec.  
425.656 for accuracy and consistency with the proposed revisions to the 
section.
    We propose to revise Sec.  425.658 to redesignate paragraph (c) as 
paragraph (d). We propose 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 propose 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 propose to make the following conforming changes:
     In Sec.  425.600(f)(4)(ii), we propose 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 propose 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 propose 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 propose to remove the sentence: ``The ACO will receive the 
regional adjustment to its benchmark as described in Sec.  425.656.''
    We seek comment on these proposed changes.
d. Proposal To Modify 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 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.'' Pursuant to 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 final rule, we explained that reinstituting a 
prior savings adjustment would be

[[Page 52473]]

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, 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.
    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, is calculated as 
follows:
     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. CMS 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 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

[[Page 52474]]

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 
as a result of 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 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 CMS determines 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 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) Proposed Revisions
    We are proposing 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 
are proposing 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

[[Page 52475]]

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 are proposing 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 are proposing to modify the process currently described in Sec.  
425.652(a)(9) for adjusting the historical benchmark. Currently, 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),\193\ or changes to the beneficiary 
assignment methodology specified in 42 CFR part 425, subpart E. We are 
proposing 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 three 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 one of the ACO's 
benchmark years. We note 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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    \193\ Refer to section III.G.7.a of this proposed rule for 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 propose to modify the process 
currently 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 are also proposing 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. 
Without this addition there is currently 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 
are proposing 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.
    We believe that, in order to issue adjusted benchmarks and complete 
financial reconciliation in a timely fashion, a need exists 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 are proposing 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 are proposing that for an adjusted 
benchmark due to the two conditions being considered to be used in 
financial reconciliation for a performance year, any determination that 
changes the amount of the ACO's savings or losses in any of the 
benchmark years under Sec. Sec.  425.315 or 425.316(b)(2)(ii)(B) or (C) 
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). Note that if we are 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 
may delay the initial determination of shared savings or shared losses 
for the ACO for the 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 the 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

[[Page 52476]]

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. On balance, we believe 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 note that 
we are 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 recognize 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 propose 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 this 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).
    Below are two examples that illustrate how an ACO could receive an 
adjusted historical benchmark that incorporates additional savings as a 
result of the changes we are 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 are proposing revisions to Sec.  425.652(a)(9) to 
indicate that we 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 are also proposing 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 seek comment on this 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.

[[Page 52477]]

e. Proposal To 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 this 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.\194\
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    \194\ 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 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 
this proposed rule).
     In calculating the regional component of the three-way 
blended update factor, we are proposing 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 this 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 have 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.
    More generally, 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. CMS specifies 
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, CMS solicits comment 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), CMS calculates 
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.

[[Page 52478]]

    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.\195\ 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.\196\
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    \195\ 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.
    \196\ 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.
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    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 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.\197\ 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.
---------------------------------------------------------------------------

    \197\ 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.

[[Page 52479]]

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,\198\ 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 in order to reduce the impact on risk score variation in 
coding between MA and FFS.\199\
---------------------------------------------------------------------------

    \198\ 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.
    \199\ 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.\200\
---------------------------------------------------------------------------

    \200\ 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.\201\
---------------------------------------------------------------------------

    \201\ See id. at 97.
---------------------------------------------------------------------------

    In section III.G.4.e.(3) of this proposed rule, we discuss 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 risk scores. We propose a 
modified approach to making such calculations for agreement periods 
beginning on January 1, 2024, and in subsequent years, in section 
III.G.4.e.(4) of this proposed rule.
(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
    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.\202\ 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.
---------------------------------------------------------------------------

    \202\ 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.\203\
---------------------------------------------------------------------------

    \203\ 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 in order to measure the impact of 
the transition from V24 to V28 on Shared Savings Program ACOs.
---------------------------------------------------------------------------

    CMS 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,

[[Page 52480]]

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 39 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] TP07AU23.049

    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 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 40 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.

[[Page 52481]]

[GRAPHIC] [TIFF OMITTED] TP07AU23.050

    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. The factors discussed in section III.G.4.e.(2) of this 
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) Proposed 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 propose 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 propose 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 Savings Program benchmark calculations and adopt 
the alternative approach to calculating prospective HCC risk scores for 
a performance year and the relevant benchmark years discussed in this 
section of this proposed rule. We propose 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 propose 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. In paragraph (b)(1) of Sec.  425.659, we propose 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 propose:
     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

[[Page 52482]]

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 propose at Sec.  425.659(b)(2) to codify our current practices 
for calculating prospective HCC risk scores for a benchmark or 
performance year. 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 note that at this time we are not proposing to modify the 
current approach to calculating demographic risk scores under the 
Shared Savings Program, as described in section III.G.4.e.(1) of this 
proposed rule.
    We also propose 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. We propose 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 propose 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 propose 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. In the description of the benchmarking methodology 
applicable for agreement periods beginning before January 1, 2024, we 
propose to update the list of referenced sections to include the 
proposed new Sec.  425.659.
    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 
this 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 is informed by the data analysis described in 
section III.G.4.e.(3) of this proposed rule, 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 shows that ACOs with high risk scores would benefit 
from using the proposed approach to calculate BY and PY prospective HCC 
risk scores relative to the current policy. This 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.
    This 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. ACOs in an existing agreement period that includes performance 
year 2024, 2025 or 2026 may benefit from the factors discussed in 
section III.G.4.e.(2) of this 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. These factors would diminish adverse effects of 
using the new CMS-HCC risk adjustment methodology in Shared Savings 
Program calculations.
    If we finalize the proposed approach for agreement periods 
beginning on January 1, 2024, and in subsequent years, we note that an 
ACO in an existing agreement period may choose to terminate its 
participation agreement early in order 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 three 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,\204\ and 
for BY2 (2022) and BY3 (2023) calculated using V24.205 206 
For

[[Page 52483]]

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).
---------------------------------------------------------------------------

    \204\ 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.
    \205\ 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.
    \206\ 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 seek comment 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.
5. Proposed Modifications to Advance Investment Payments 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 payments (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 also 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 advance investment 
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.
    Within this section of this proposed rule, we propose modifications 
to refine AIP policies to better prepare for initial implementation of 
AIP beginning with ACOs entering agreement periods on January 1, 2024. 
In summary, we are proposing 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 (section III.G.5.b of this proposed rule). We are also 
proposing to recoup advance investment payments from shared savings for 
ACOs that wish to early renew to continue their participation in the 
Shared Savings Program (section III.G.5.c of this proposed rule). We 
propose to specify that CMS would terminate advance investment payments 
for future quarters to ACOs that elect to terminate their participation 
in the Shared Savings Program (section III.G.5.d. of this proposed 
rule). We propose to require ACOs to report spend plan updates and 
actual spend information to CMS in addition to publicly reporting such 
information (section III.G.5.e. of this proposed rule). We propose to 
codify that ACOs receiving advance investment payments may seek 
reconsideration review of all payment calculations (section III.G.5.f. 
of this proposed rule). If finalized, these policies would be effective 
beginning January 1, 2024.
b. Proposal To Modify 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 require 
an ACO to remain under a one-sided 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

[[Page 52484]]

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 this 
proposed rule, we propose 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) Proposed Revisions
    We propose 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 propose 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 propose to modify Sec.  425.316(e)(2) to 
specify that CMS would 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. Pursuant to Sec.  
425.316(e)(2)(ii), CMS may take compliance action against such ACOs. We 
also propose 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 shared savings over the remaining performance years of 
its agreement period as prescribed in Sec.  425.630(g). We propose 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 the smaller amounts of downside 
risk available in levels C-E of the BASIC track. Given that the option 
to receive advance investment payments was designed for ACOs that are 
new to the Shared Savings Program, low revenue, and inexperienced with 
risk, it does not align with broader program goals to permit ACOs of 
such size or capitalization to take on the high levels of downside risk 
in the ENHANCED track during their first agreement period in the Shared 
Savings Program. 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 propose to amend the eligibility criteria 
specified in Sec.  425.630(b) as follows. We propose 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

[[Page 52485]]

Program.'' Further, we propose 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 them experienced with performance-based risk Medicare ACO 
initiatives starting with the third year of its first agreement period. 
Specifically, we propose 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(h)(2)(i) 
and Sec.  425.226(a)(2)(i)) beginning with PY3.
    Under this proposed modification, CMS would continue to recoup from 
future shared savings. In contrast to what is required under existing 
Sec.  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.  425.216 and 425.218, and CMS may seek repayment 
of advance investment payments as set forth at Sec.  425.316(e).
    We seek comment on our proposals to amend AIP policies and require 
that all AIP ACOs 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.
c. Proposal To Modify 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 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.
    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) Proposed Revisions
    We propose 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.
    We propose 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 
propose 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 
subject to compliance actions under Sec. Sec.  425.216 and 425.218.
    Section 425.630(e)(3) specifies that an ACO may spend an advance 
investment payment over its entire agreement period and must repay to 
CMS any unspent funds remaining at the end of the ACO's agreement 
period. We propose 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. 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

[[Page 52486]]

duration of spending advance investment payments was discussed in the 
CY 2023 PFS final rule (87 FR 69801).
    We believe 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. We believe 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 payment 
funds they received and being able to enter a new agreement with the 
Shared Savings Program. Some policy changes are applicable to new 
agreement periods, and we believe ACOs approved for AIP should have the 
opportunity to enter a new agreement to experience those changes. This 
proposed modification, if finalized, would be effective January 1, 
2024.
    We seek comment on the proposed changes to Sec.  425.630(e)(3) and 
Sec.  425.630(g)(4).
d. Proposal To Amend 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 an ACO that will need to be repaid upon termination.
(2) Proposed Revisions
    We propose 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 propose 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 are 
also proposing conforming changes to the punctuation of the list of 
factors in paragraphs (h)(1)(i) and (ii) of Sec.  425.630. If 
finalized, these proposed changes would be effective January 1, 2024.
    In summary, if finalized, CMS will cease paying advance investment 
payments to an ACO that voluntarily terminates its participation in the 
Shared Savings Program if the ACO will not immediately enter a new 
agreement period. In accordance with Sec.  425.630(g)(4), the ACO would 
still be obligated to repay all advance investment payments within the 
90-days after receiving notice of the amount due to CMS. We seek 
comment on this proposal.
e. Proposal To Require 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, we propose 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 propose 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 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 believe 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. CMS 
believes 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, 
CMS expects 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.

[[Page 52487]]

    If finalized, these proposed changes would be effective January 1, 
2024. We seek comment on these proposals.
f. Proposal To Permit 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 pursuant to subpart I of part 
425 (Sec.  425.630(f)). However, we did not specify that an ACO could 
request reconsideration of the advance investment payment amount 
received.
(2) Proposed Revisions
    We propose to permit an ACO to request a reconsideration review for 
all advance investment payment quarterly payment calculations, not just 
instances where no payments are distributed. We propose to revise Sec.  
425.630(f) to provide that CMS would notify in writing each ACO of its 
determination of the amount of advance investment payment 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 subpart I of the regulations. We seek comment on this 
proposal.
6. Shared Savings Program Eligibility Requirements
a. Overview
    We are proposing two modifications to the Shared Savings Program 
eligibility requirements that, if finalized, would be implemented on 
January 1, 2024. Specifically, we propose 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 Sec.  
425.106(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) Proposed Revisions
    We continue to believe that ACO participants should drive ACO

[[Page 52488]]

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 the ACOs made adjustments to comply with the 75 percent 
participant control requirement. To date, CMS has not granted an ACO an 
exception to this requirement, despite the flexibility provided in 
current regulation. Accordingly, we believe that there is no reason to 
continue to offer an exception to the requirement, as ACOs have 
demonstrated that they can appropriately meet the 75 percent 
participant control requirement without utilizing this flexibility 
since its establishment in the November 2011 final rule. Thus, we 
propose 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 propose 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.
    We are seeking public comments on the appropriateness of our 
proposed policy refinement and elimination of the exception process. If 
finalized, our proposed modification to Sec.  [thinsp]425.106(c) would 
make no changes to paragraphs (c)(2), (3) and (4). CMS would amend 
Sec.  [thinsp]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, the revised regulation text would 
state: ``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, CMS would 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. Specifically, the revised regulation text would state: 
``If an ACO requests an exception to the governing body requirement in 
Sec.  425.106(c)(2), the ACO must describe--(i) Why it seeks to differ 
from the requirement; and (ii) How the ACO will provide meaningful 
representation in ACO governance by Medicare beneficiaries.'' If 
finalized, this policy would be effective beginning January 1, 2024.
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 propose 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 
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 recognize 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) Proposed Revisions
    We propose 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

[[Page 52489]]

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 propose 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 a performance year under such initiative during any of the 5 most 
recent performance years.'' We also propose a technical correction to 
remove the language ``as defined under this section'' from both 
definitions. We propose that these amendments would become effective on 
January 1, 2024.
    We seek comments on the proposed regulation text.
7. Proposed 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.  
[thinsp]425.226 to govern annual participation elections. 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 67991), we 
also finalized conforming changes to regulations that previously 
identified assignment methodologies according to program 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[thinsp]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.  [thinsp]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.  [thinsp]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 twelve 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

[[Page 52490]]

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 proposed 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), in 
referring 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); Sec.  425.652(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 are proposing to revise in 
this proposed rule. To follow is a description of the five references 
we are proposing to revise and the proposed technical changes to the 
applicable provisions 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 
performance years, CMS adds 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, the provision 
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 reference 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 the ACO's selected assignment methodology. Therefore, we are 
proposing 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 Sec.  425.652(a) (applicable to agreement periods beginning on 
January 1, 2024, and in subsequent years) specifies that in computing 
an ACO's historical benchmark for its first agreement period under the 
Shared Savings Program, CMS determines the per capita Parts A and B 
fee-for-service 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 of Sec.  
425.601(a) and 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. This provision 
is 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, we are proposing to amend the 
introductory text of Sec.  425.601(a) and 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), 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 which are in turn used to 
redetermine the regional adjustment in the event the ACO changes its 
selected assignment methodology. Therefore, we are proposing 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 provision, 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 are proposing 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 seek comments on these proposed technical changes.
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.\207\ 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 Sec.  405.2401(b) to mean a facility that has--
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    \207\ 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

[[Page 52491]]

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.
    This inconsistency between Sec.  425.20, which inaccurately uses 
the word ``center,'' and Sec.  405.2401(b), which accurately uses the 
word ``clinic,'' recently came to our attention. We note 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, 
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 are proposing 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 
would like to clarify 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 propose 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 Title 42, 
Chapter IV of the Code of Federal Regulations. We seek comments on 
these proposed technical changes.
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 finalizing modifications to the proposed definition of at-risk 
beneficiary, we explained that we agreed with commenters that our 
proposed definition 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). We note 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 are proposing 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 
propose 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 seek comment on these proposed 
changes.
d. Updating Terminology in Regulations on Data Sharing With ACOs
    It has 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 are proposing 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.208 209 To accommodate this change from HICN to MBI, 
starting in PY 2018 we revised Shared Savings Program reports providing 
beneficiary-identifiable information under Sec.  [thinsp]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 fee-for-service beneficiary population: (1) 
beneficiary name; (2) date of birth; (3) HICN; and (4) sex. Therefore, 
because CMS has discontinued use of the HICN, we propose to revise 
Sec.  425.702(c)(1)(ii)(A)(3) to refer to ``Beneficiary identifier'' 
instead of ``Health Insurance Claim Number (HICN).'' This change to the 
regulations text will not change the information that is provided to 
ACOs pursuant to Sec.  425.702(c)(1)(ii).
---------------------------------------------------------------------------

    \208\ 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.
    \209\ CMS.gov website, Medicare Beneficiary Identifiers (MBIs), 
at https://www.cms.gov/Medicare/New-Medicare-Card.
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    Further, we propose 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 propose 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 referred to care coordination processes and required 
process development under Sec.  425.112 (see 80 FR 32734 and 32735). We 
do not believe the revision we are proposing 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. This proposed 
revision would also 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) discussed in

[[Page 52492]]

section III.G.2.b.(2) of this proposed rule.
    We seek comment on these proposed changes.
8. Seeking Comments on Potential Future Developments to Shared Savings 
Program Policies
a. Background
    In an article published on the New England Journal of Medicine's 
website on April 27, 2022,\210\ CMS lays out a vision for how 
Accountable Care Organizations (ACOs) participating in the Shared 
Savings Program and in Center for Medicare and Medicaid Innovation 
(Innovation Center) models can help CMS achieve its goal of having all 
beneficiaries in the traditional Medicare program cared for by health 
care providers who are accountable for costs 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 Center for Medicare and Medicaid Innovation (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 address 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.
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    \210\ 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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    CMS adopted several policies as part of the CY 2023 PFS final rule 
to advance these goals, including providing advance shared savings 
payments in the form of advance investment payments 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; support the business case for ACOs serving high-risk and a 
high proportion of dually eligible populations to participate; and 
mitigate 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.
    CMS has 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 fee-for-service 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.\211\ Another option would be to offer a higher risk 
track in the Shared Savings Program, on which CMS requests input below.
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    \211\ Refer to ``Medicare Shared Savings Program Saves Medicare 
More Than $1.6 Billion in 2021 and Continues to Deliver High-quality 
Care''--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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b. Incorporating a Higher Risk Track Than the ENHANCED Track
    Over time, CMS 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 
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 the traditional Medicare program 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 progress more quickly than the 
glide path would require.\212\ The glide path includes five levels 
(Levels A through E). Levels A and B are one-sided models (shared 
savings only); \213\ and Levels C, D, and E are two-sided models 
(shared savings and shared losses) that provide for

[[Page 52493]]

incrementally higher performance-based risk.\214\ An ACO in the 
ENHANCED track operates under a two-sided model, sharing both savings 
and losses with the Medicare program, for all 5 performance years of 
the agreement period.
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    \212\ Refer to Sec.  425.600(a)(4)(i).
    \213\ 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).
    \214\ 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.\215\ For ACOs meeting the 
applicable quality performance standard established under Sec.  
425.512(a)(2) or Sec.  425.512(a)(4)(i) (for PY 2022 and PY 2023) or 
Sec.  425.512(a)(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,\216\ 50 percent for ACOs participating in Levels C, D, or E of 
the BASIC track,\217\ and 75 percent for ACOs participating in the 
ENHANCED track.\218\ 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) or Sec.  
425.512(a)(4)(i) or Sec.  425.512(a)(5)(i), as applicable, but meet the 
alternative quality performance standard described in Sec.  
425.512(a)(4)(ii) (for PY 2023) or Sec.  425.512(a)(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.\219\ 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.\220\
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    \215\ Refer to Sec. Sec.  425.100(b), 425.604(c), 425.605(c), 
425.606(c), 425.610(c).
    \216\ Refer to Sec.  425.605(d)(1)(i)(A), (d)(1)(ii)(A).
    \217\ Refer to Sec.  425.605(d)(1)(iii)(A), (d)(1)(iv)(A), 
(d)(1)(v)(A).
    \218\ Refer to Sec.  425.610(d).
    \219\ Refer to Sec.  425.605(h).
    \220\ 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.\221\ 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).\222\ 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.\223\ 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.\224\
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    \221\ Refer to Sec.  425.100(c).
    \222\ Refer to Sec.  425.605(d); Sec.  425.610(f), (g).
    \223\ Refer to Sec.  425.605(d)(1)(iii)(C), (d)(1)(iv)(C), 
(d)(1)(v)(C).
    \224\ 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, for agreement periods starting 
on January 1, 2024, and in subsequent years, participation in the 
ENHANCED track will be optional (see 87 FR 69818).
    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.\225\ Under 
the 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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    \225\ 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.
---------------------------------------------------------------------------

    Under the ACO REACH Model, REACH ACOs are offered the choice of 
participating under the Global or the Professional Risk Options. As in 
the NGACO Model, under both risk sharing options, the ACO REACH ACO is 
responsible for 100 percent of performance year expenditures for 
services rendered to aligned beneficiaries. Because ACOs electing the 
Global Risk 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 Option, 
the benchmark is reduced by a fixed percentage based on the performance 
year.\226\ The benchmark for ACOs participating in the Professional 
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.
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    \226\ 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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    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

[[Page 52494]]

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). We have 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 gained 
for beneficiaries or CMS.
    Another consideration 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 fee-for-service expenditures by 
enrollment type, which can help to protect ACOs from the impact of 
expenditure outliers (i.e., 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 proposed 
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, CMS 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. 
We are seeking 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.
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.'' Pursuant to 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. We also note that elsewhere in this 
proposed rule, we have 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.
    In the CY 2023 PFS final rule (87 FR 69902), 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, 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 (e.g., 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

[[Page 52495]]

have a scaling factor below 50 percent, which would be less 
advantageous than the policy that we finalized.
    In the CY 2023 PFS final rule (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 
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.
    We are seeking comment 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 are also seeking comment 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.
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.  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 69902), 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 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, 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 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 may 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, 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 believe 
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

[[Page 52496]]

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). CMS declined to implement these suggestions in 
the CY 2023 PFS final rule.
    We seek 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.
e. Promoting ACO and CBO Collaboration
    Section 1899(b)(2)(G) of the Act requires an ACO 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, we finalized two modifications to the care 
coordination processes required of ACOs under Sec.  425.112(b)(4): (1) 
adding a new eligibility requirement under Sec.  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.  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 (80 FR 32725). 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.  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 section Sec.  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.  425.204(c)(ii)).
    Additionally, in previous rulemaking (80 FR 32722), we specified 
that the care coordination processes under Sec.  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 of 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), 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.
    We are seeking comment 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.\227\ 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.
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    \227\ 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.
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    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

[[Page 52497]]

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 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 sector and CBOs providing social services have 
increased in recent years to meet this demand.
    We are seeking comment 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 are also seeking 
comment on potential changes CMS could make to the patient-centered 
care requirements in Sec.  425.112 to strengthen partnerships between 
ACOs and interested parties in the community, including CBOs, to 
address unmet health-related social needs.

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 currently 
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 where 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, 
not specified for Medicare Part B coverage under section 1861(s)(10) of 
the Act 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 the administration of the 
preventive vaccines described under section 1861(s)(10) of the Act are 
finalized 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 describes the 
services to administer an influenza, pneumococcal, and hepatitis B 
vaccine, respectively.
    In the CY 2023 PFS final rule (87 FR 69984), we finalized an annual 
update to 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 Level I Current Procedural Terminology (CPT) codes that describe the 
service to administer COVID-19 vaccines, which we discuss in the next 
section.\228\
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    \228\ https://www.cms.gov/medicare/medicare-part-b-drug-average-sales-price/covid-19-vaccines-and-monoclonal-antibodies.
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    The current payment rates for G0008, G0009, and G0010, as finalized 
in the CY 2023 PFS final rule, can be found on the CMS Seasonal 
Influenza Vaccines Pricing website under Downloads.\229\ The payment 
rates for these services with the annual update applied for CY 2024, 
will be made available at the time of publication of the CY 2024 PFS 
final rule.
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    \229\ https://www.cms.gov/medicare/medicare-fee-for-service-part-b-drugs/mcrpartbdrugavgsalesprice/vaccinespricing.
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b. COVID-19 Vaccine Administration
    In the CY 2022 PFS final rule (86 FR 65181 and 65182), we provide a 
detailed history regarding the determinations of the initial payment 
rates for the administration of the COVID-19 vaccines, and how the 
payment policy evolved to a rate of $40 per dose. We note that in the 
CY 2022 PFS proposed rule (86 FR 39220 through 39224), we included a 
comment solicitation requesting information that specifically 
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, in order 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 in light of the 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 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

[[Page 52498]]

payment would be set at a rate to align with the payment rate for the 
administration of other Part B preventive vaccines, that is, $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, can be found on the CMS COVID-19 Vaccines and 
Monoclonal Antibodies website.\230\ The payment rates for these 
services with the annual update applied for CY 2024, will be made 
available at the time of publication of the CY 2024 PFS final rule.
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    \230\ https://www.cms.gov/medicare/medicare-part-b-drug-average-sales-price/covid-19-vaccines-and-monoclonal-antibodies.
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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 \231\ 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). 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).
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    \231\ https://www.cms.gov/medicare/medicare-part-b-drug-average-sales-price/covid-19-vaccines-and-monoclonal-antibodies.
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    Since announcing the add-on payment for in-home COVID-19 vaccine 
administration in June 2021, we 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). We note 
that in section III.H.3.c. of this proposed rule, we are proposing 
revisions to Sec.  410.152 that relate to this payment policy.
    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 need 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 in receiving vaccinations in their 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 described in 
section III.H.3.b of the final rule, 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 in order to provide us time to 
track utilization and trends associated with its use, in order 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 note 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.c. of this proposed 
rule, we are proposing revisions to Sec.  410.152 that relate to these 
policies.
b. Conditions for Billing HCPCS Code M0201
    In establishing the additional payment for COVID-19 vaccine 
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 provide a detailed discussion

[[Page 52499]]

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 apply when billing for HCPCS 
code M0201: 232 233
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    \232\ https://www.cms.gov/medicare/covid-19/medicare-covid-19-vaccine-shot-payment.
    \233\ https://www.cms.gov/files/document/vaccine-home.pdf.
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     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.\234\
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    \234\ 42 CFR 409.42(a).
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    The 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. Proposals for CY 2024 and Subsequent Years
    Over the past several months, CMS has 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.\235\
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    \235\ Common chronic conditions as identified by the CMS Chronic 
Conditions Data Warehouse, https://www2.ccwdata.org/web/guest/home/.
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    In light of 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, 
it is clear that the in-home additional payment is being 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 propose 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 propose 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 propose 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 this proposed rule are met. We note that several of the 
conditions we established for the in-home additional payment, discussed 
previously in this section of the proposed rule, refer specifically to 
COVID-19. 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.
    Further, since expanding this policy could mean that multiple 
vaccines are administered during the same visit to the home, we propose 
to limit the additional payment to one payment per home visit, even if 
multiple vaccines are administered during the same home visit. We 
emphasize that every vaccine dose that is furnished would still receive 
its own unique vaccine administration payment. We intend to continue to 
monitor utilization of the 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 propose to modify the 
regulations at Sec.  410.152(h) to reflect these policies.
    We seek comment on the policy condition mentioned in section 
III.H.3.b of this proposed rule regarding Medicare payment of the in-
home 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. We invite feedback on the applicability of this policy 
to the proposed policy to make

[[Page 52500]]

the in-home additional payment available for the administration of all 
four Part B preventive vaccines.
    If finalized as proposed, the in-home additional payment for the 
administration of pneumococcal, influenza, and hepatitis B vaccines 
would be effective January 1, 2024, to join the current additional 
payment for the in-home administration of COVID-19 vaccines that is now 
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 proposed in-home additional payment for the 
administration of Part B preventive vaccines that would be effective 
beginning for CY 2024, if finalized, would be geographically adjusted 
based on the PFS GAF, and annually updated by the CY 2024 MEI 
percentage increase. 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 fourth 
quarter 2022. Therefore, we would multiply the CY 2023 in-home 
additional payment amount for Part B preventive vaccine administration 
of $36.85 by the proposed CY 2024 percentage increase in the MEI of 4.5 
percent, which would result in a proposed CY 2024 in-home additional 
payment for Part B preventive vaccine administration of $38.51 ($36.85 
x 1.045 = $38.51). We are also proposing that if more recent data are 
subsequently 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.
    Therefore, in this proposed rule, we propose to amend 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 annually 
updated based upon the percentage change in the MEI. For COVID-19 
vaccines administered in the home January 1, 2023 through December 31, 
2023, the 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 would be extended to include the other three preventive vaccines 
included in the Part B preventive vaccine benefit, and the payment 
amount for all four vaccines would be identical. That is, beginning 
January 1, 2024, the 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 would be 
annually updated using the percentage increase in the MEI and adjusted 
to reflect geographic cost variations using the PFS GAF.
    We solicit comment on these proposals and the proposed amendments 
to the regulation text.
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). At 87 FR 69983, we listed the unique payments rates for 
the administration of COVID-19 monoclonal antibodies in Table 85. We 
note that at the time of the publication of this proposed 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 would 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. We 
now propose 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 propose 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 propose 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 propose 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 proposed 
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 are not proposing 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 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. We would subsequently

[[Page 52501]]

propose coding and payment rates for the administration of that product 
via rulemaking.
    We also note that, for the purposes of the in-home additional 
payment discussed above in section III.H.3.c. of this proposed rule, 
that additional payment is not applicable to the administration of 
monoclonal antibodies for PreP of COVID-19. With regard to monoclonal 
antibodies for PreP of COVID-19, as displayed in Table 85 of the CY2023 
PFS final rule (87 FR 69983), 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. We are proposing the 
following correction, and we are reorganizing other elements of the 
regulation text at Sec.  410.152(h) as we codify the in-home additional 
payment:
     At Sec.  410.152, at paragraph (h)(5), we propose to add 
that the paragraph is effective beginning January 1, 2023.
     At Sec.  410.152, we propose to combine the existing 
paragraph (h)(2) and (h)(3) into a new paragraph (h)(2), with 
subparagraphs (h)(2)(i) and (h)(2)(ii)
     At Sec.  410.152, at a revised paragraph (h)(3), we 
propose new regulations regarding the in-home additional payment for 
preventive vaccine administration, as described in this section of the 
proposed rule in section III.H.3.c.

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) by non-clinical providers, CMS created through rulemaking in the 
CY 2017 PFS final rule, a new MDPP supplier type, 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.
    MDPP is a non-pharmacological behavioral intervention consisting of 
no fewer than 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 \236\ 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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    \236\ 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 DPP 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,\237\ 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, the CDC's National DPP, and DPRP 
Standards, please refer to the CY 2017 \238\ and CY 2018 PFS \239\ 
final rules and the following websites: https://Innovation.cms.gov/initiatives/Health-Care-Innovation-Awards/; https://www.cdc.gov/diabetes/prevention/index.html; and https://www.cdc.gov/diabetes/prevention/pdf/dprp-standards.pdf.
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    \237\ 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.
    \238\ 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.
    \239\ 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 are proposing to amend Sec.  410.79(b) 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 
propose to amend Sec.  410.79(c)(2)(i)(A) and (B) to update the maximum 
number of payable sessions during the MDPP core services period. We 
also propose to amend Sec.  410.79(e)(2) 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. 
Furthermore, we propose to amend Sec.  414.84 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 propose to amend Sec.  
424.205(a) and (c) to remove ``MDPP interim preliminary recognition'' 
and replace it with ``CDC preliminary recognition''.
1. Proposed Changes to Sec.  410.79 by Amending Paragraphs (b), 
(c)(2)(i) and (e)(2)
    The MDPP expanded model was implemented through the rulemaking 
process in two phases in the CY 2017 PFS final rule \240\ and in the CY 
2018 PFS final rule.\241\ Through this proposed rule, we are proposing 
to amend the MDPP expanded model to revise certain

[[Page 52502]]

MDPP policies adopted through previous rulemaking. We are proposing to 
amend Sec.  410.79(b) to remove the definition for the core maintenance 
session interval while adding definitions for Combination delivery, 
Distance learning and Online delivery modalities, among other 
definitions. 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. The core maintenance session interval represents a 
performance interval for attendance-based payments in the current 
payment structure. Given that we are proposing that beneficiary 
attendance be paid on a fee-for-service basis, we propose removing the 
core maintenance session interval to make the payment structure less 
confusing.
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    \240\ https://www.govinfo.gov/content/pkg/FR-2016-11-15/pdf/2016-26668.pdf.
    \241\ https://www.govinfo.gov/content/pkg/FR-2017-11-15/pdf/2017-23953.pdf.
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    In prior rulemaking, we did not formally define the MDPP delivery 
modalities that are considered virtual. In this proposed rule, we 
propose 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.
    We are also proposing 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. In 
the 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. Given that the 2-year MDPP services period 
for those beneficiaries who started MDPP on or before December 31, 2022 
will end on or before December 30, 2024, eligibility for ongoing 
maintenance services will end December 31, 2023 for all beneficiaries.
    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 are 
proposing 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 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.
    Since this payment structure went into effect in 2018, we received 
feedback 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. 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.
    After 5 years of testing the current performance-based payment 
structure, we have determined that the attendance-based performance 
payments are not working. 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. Our monitoring data show that attendance sharply 
drops after the first quarter of the expanded model, which is likely 
after the 9th weekly session has been attended. We believe that our 
current payment structure does not incentivize beneficiary retention. 
As a result, we are proposing fee-for-service payments for beneficiary 
attendance, allowing for up to 22 attendance-based payments versus the 
five that are currently in place. Thus, we propose 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.
    We are proposing to amend the MDPP expanded model to revise certain 
MDPP policies finalized in the CY 2021 PFS final rule. We are proposing 
to extend the flexibilities allowed under the COVID-19 Public Health 
Emergency 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 paragraph. The MDPP regulations provide for the following 
flexibilities during the PHE or an applicable 1135 waiver event:
     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. 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 COVID-19 PHE, as long as the virtual 
services are 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 are proposing that during the Extended flexibilities period, 
MDPP

[[Page 52503]]

suppliers may provide virtual services as long as they are provided in 
a manner consistent with the CDC DPRP standards for distance learning. 
The proposed extension of these flexibilities under Sec.  
410.79(e)(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 proposed period of 
4 years.
    In the May 2, 2023 Federal Register (88 FR 27413), we published a 
notice extending COVID-19 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.cms.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. 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.'' 
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.\242\
---------------------------------------------------------------------------

    \242\ 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.
---------------------------------------------------------------------------

    Additionally, CDC defines online delivery as a yearlong National 
DPP lifestyle change program delivered online for all participants. One 
hundred percent of 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 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.\243\
---------------------------------------------------------------------------

    \243\ 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.
---------------------------------------------------------------------------

    In the CY 2021 PFS final rule (85 FR 84472),\244\ 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, CMS proposes 
to limit virtual delivery to the CDC DPRP definition of ``distance 
learning.'' This proposal is based on the data we have obtained to date 
from the PHE, including anecdotal, monitoring, evaluation, claims, and 
CDC DPRP data, suggesting that the majority of the MDPP virtual 
sessions delivered during the COVID-19 PHE 1135 waiver event were 
distance learning sessions.
---------------------------------------------------------------------------

    \244\ 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.
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    MDPP was certified and established as an in-person service. 
However, in response to the COVID-19 PHE, we established and 
implemented policies that allowed MDPP suppliers to provide MDPP 
services virtually during the PHE, 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 Sec.  
410.79(e)(3)(iv) were satisfied. We believe that distance learning 
allows for a similar live group experience for beneficiaries, but 
delivered only 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.
    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. Given the 3-year duration of the COVID-19 PHE 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 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 are proposing 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.
    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, CMS proposed that MDPP suppliers be allowed to 
provide MDPP services via remote technologies, even though the majority 
of CDC DPRP organizations provided in-person

[[Page 52504]]

delivery at that time.\245\ 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 would propose specific policies in future rulemaking to 
mitigate these risks. In the CY 2017 PFS final rule (81 FR 80459), CMS 
deferred establishing policies related to organizations delivering the 
Set of MDPP services virtually.
---------------------------------------------------------------------------

    \245\ 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. Federal Register, 81(136): 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. ``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, we 
finalized that the Set of MDPP services would be primarily delivered 
in-person, in a classroom-based setting, and within an established 
timeline.
    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, 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.\246\ 
By mid-March 2020, MDPP suppliers were largely 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),\247\ 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 COVID-19 PHE. These flexibilities allowed an unlimited 
number of virtual sessions, waived the once-per-lifetime limit for 
those participating in MDPP when the PHE started, and waived the 5 
percent weight loss requirement to continue with ongoing maintenance 
sessions.
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    \246\ 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.
    \247\ 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 and 
stay-at-home orders during the initial months of the PHE. 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, 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.
    During the COVID-19 PHE, 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.'' 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.
    As stated earlier, we propose to extend the flexibilities allowed 
during the COVID-19 PHE under Sec.  410.79(e)(3)(iii), and (iv) for 4 
years, or through December 31, 2027. We are proposing 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. We recognize that organizations and interested parties may 
be disappointed that we are not proposing 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, 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.

[[Page 52505]]

    MDPP was established as an in-person service since the original DPP 
test and data used in the certification were based on in-person 
delivery. During the COVID-19 PHE, we were able to allow greater use of 
virtual sessions, but the virtual delivery was primarily furnished as a 
virtual classroom. We are also proposing that suppliers may offer a 
combination delivery of MDPP, including both in-person and distance 
learning. We believe that after almost 4 years of having the option to 
deliver the Set of MDPP services through distance learning, between the 
COVID-19 PHE 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 are also proposing 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. 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.
    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 an 
example, allowing virtual sessions will make MDPP more accessible to 
beneficiaries who reside in rural 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 COVID-19 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 are proposing the creation of a 
new HCPCS G-code specific to ``distance learning,'' 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.
    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.\248\ 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. As part of the MDPP 
flexibilities established in response to the COVID-19 PHE, 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.
---------------------------------------------------------------------------

    \248\ 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.
---------------------------------------------------------------------------

    Given the inconsistent use of the virtual modifier as it was 
described in the CY 2018 PFS final rule to document the virtual make-up 
sessions allowed during the PHE as described in Sec.  
410.79(e)(2)(iii), we propose 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. At 
this time, we are not proposing 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.
    MDPP supplier locations have traditionally clustered proximate to 
large metropolitan areas, leaving significant gaps throughout rural 
communities. 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,\249\ we believe that in-person requirements have 
contributed to significant MDPP under-utilization, 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.
---------------------------------------------------------------------------

    \249\ 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. 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. RTI 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 
miles.
    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.\10\
    Additionally, the 2nd evaluation report (p. 32) 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. Therefore, 
by proposing the use of synchronous virtual delivery as an acceptable 
modality for MDPP delivery,

[[Page 52506]]

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.
    Through the CY 2018 PFS final rule, we established important MDPP 
payment policies and program integrity safeguards in order to mitigate 
the risk of fraud, waste, and abuse in MDPP that included the creation 
of supplier enrollment requirements and compliance standards. MDPP 
monitoring activities are performed primarily through an independent 
monitoring contractor, with referrals sent to CMS for further 
investigation or enforcement action, as appropriate. We will continue 
to implement, adapt, and scale the current monitoring strategy for 
indications of fraud, waste, and abuse for both in-person and the 
proposed distance learning modalities. Should we identify excessive 
indicators of fraud, waste, and/or abuse of the synchronous virtual 
delivery of the Set of MDPP services during the extended PHE 
flexibilities period, we may opt to discontinue these flexibilities 
through subsequent rulemaking.
    With these safeguards in-place, 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 especially increase equitable access to 
diabetes preventive services among rural and at-risk populations. 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.
    We propose 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, 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.
    We are proposing to amend Sec.  410.79(b), (c)(2)(i) and (e)(2), 
and seek comment on these proposals.
2. Proposed 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 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.
    We propose to update the payment structure from a performance-based 
attendance and weight loss structure to a hybrid structure that pays 
for attendance on a fee-for-service basis and diabetes risk reduction 
(that is, weight loss), on a performance basis. MDPP, as defined in 
Sec.  410.79(b), consists of up to 16 sessions offered during the core 
sessions phase (Months 1-6) and 6 monthly maintenance sessions offered 
during the core maintenance sessions phase (Months 7-12), (collectively 
the ``core sessions phase''). In the current payment structure, 
suppliers must submit a claim after a participant completes the first, 
fourth, and ninth sessions during the first 6 months, then following 
the second core maintenance session in months 7-9 and in months 10-12 
in the core maintenance sessions phase. Depending on the timing of the 
ninth session attended and the second core maintenance session attended 
by the beneficiary in months 7 to 9, suppliers may have a 4- to 5-month 
gap between attendance-based performance payments in the current MDPP 
payment structure.
    Given consistent supplier and interested party feedback regarding 
the complexity of this payment structure and necessary up-front costs 
incurred by suppliers, we propose to simplify the payment structure and 
pay for attendance on a fee-for-service basis. We propose creating an 
Attendance Payment, which we propose 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 propose 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.
    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 propose paying for up to 22 sessions, 
either in-person or distance learning, or a combination of in-person 
and distance learning, 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 proposing to update the performance goal to mean 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. We are retaining 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 
(that is, achievement of 5 percent weight loss from baseline). Although 
we are proposing to remove the attendance-based performance goal and 
pay for attendance on a fee-for-service basis, we want to continue 
rewarding suppliers

[[Page 52507]]

for successful outcomes for beneficiaries (weight loss), and motivating 
them to not only retain participants, but also deliver a high-quality 
program that achieves better outcomes.
    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 are proposing 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. 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.
    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 41 displays the proposed MDPP payment structure and Table 42 
indicates the current CY 2023 performance payments.
BILLING CODE 4120-01-P
[GRAPHIC] [TIFF OMITTED] TP07AU23.051


[[Page 52508]]


[GRAPHIC] [TIFF OMITTED] TP07AU23.052

BILLING CODE 4120-01-C
    In previous rulemaking, 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 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. As part of the flexibilities established in response to the 
COVID-19 PHE, 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 virtual modifier to indicate when a beneficiary received 
MDPP virtually.
    We are proposing to amend Sec.  414.84(a), (b), (c), and newly 
redesignated paragraphs (d)(1) and (e). We seek comment on these 
proposals.
3. Changes to Sec.  424.205 (a), (b)(1), (c), and Newly Designated 
(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. The DPRP awards 
four categories of recognition: Pending, preliminary, full, and full-
plus. 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:
     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:
     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.
    In the CY 2017 PFS final rule, we indicated that we would align the 
CDC's DPRP and MDPP to the greatest extent possible. When the CY 2018 
PFS 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

[[Page 52509]]

become MDPP suppliers starting January 1, 2018, and approved suppliers 
could start serving Medicare beneficiaries on April 1, 2018.
    When the CY 2018 PFS final rule was issued, the CDC 2015 DPRP 
Standards were still in effect, and 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 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, we 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 at Sec.  [thinsp]424.205(c)(2)(ii) established 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, we wanted suppliers to be able to enroll in Medicare to 
become MDPP suppliers in time for the April 1 MDPP launch.
    Now that the CDC DPRP Standards for preliminary recognition are in 
effect, we propose to remove Sec.  [thinsp]424.205(c) and retire the 
MDPP ``interim preliminary recognition'' standard. We also propose 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, 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 at least 
CDC preliminary recognition.
    To maintain compliance with the current CDC DPRP Standards, 
organizations that enrolled in Medicare as MDPP suppliers based on 
their MDPP interim preliminary recognition 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.
    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 \1\ 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.
    We propose 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 
Sec.  424.205 newly designated paragraph (d)(14), which we are 
retaining for historical recordkeeping and crosswalk purposes. In the 
CY 2022 PFS, 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.
    We are proposing to amend Sec.  424.205 (a), (b)(1), newly 
redesignated paragraphs (c)(1) and (g)(1)(i)(C). We seek comment on 
these proposals.
4. Proposed Changes to Sec.  424.210(b) and (d)
    We propose to amend Sec.  424.210(b) and (d) to remove reference 
to, and requirements of, the Ongoing Maintenance phase described in 
these sections. In the CY 2022 PFS final rule, 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.
    We are proposing to amend its regulation at Sec.  424.210 by 
amending paragraphs (b) and (d). We seek comment on these proposals.

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.
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 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, but 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

[[Page 52510]]

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 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). 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) 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

[[Page 52511]]

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.
    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

[[Page 52512]]

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 \250\ 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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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 proposed 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 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 propose 
to pause implementation of the AUC program for reevaluation, and 
rescind the current AUC program regulations from Sec.  414.94. We 
expect this to be a hard pause to facilitate thorough program 
reevaluation and, as such, we are not proposing 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 
so as 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

[[Page 52513]]

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-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 noted above, 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 discussed above, 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). 
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 cost 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 
\251\ (83 FR 60043). Since this estimate was based on information from 
previous clinical decision support experiences and not Medicare claims

[[Page 52514]]

data or wage estimates, we did not update this estimate in the CY 2022 
PFS final rule.
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    \251\ 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 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 proposed 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, CMS 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.\252\ 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.
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    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.

[[Page 52515]]

    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. Proposal To Rescind Sec.  414.94
    To execute this proposal and provide clarity to interested parties, 
we propose 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 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 want to 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 are proposing to pause efforts to implement the 
AUC program for reevaluation and to rescind the current AUC program 
regulations at Sec.  414.94. We are not proposing a time frame 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.

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 proposed 
rule, we

[[Page 52516]]

propose several changes to our existing Medicare provider enrollment 
regulations.
    (We note that section III.K.2 of this proposed rule 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), CMS 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 from (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 determined based 
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 
believe that several additions and revisions to our revocation policies 
in Sec.  424.535(a) are necessary at this time.
(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 propose 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 believe the scope of Sec.  424.535(a)(1) should be expanded.
(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. However, 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. One case, for 
instance, involved a physician who wrote and filled prescriptions in 
fictitious patients' names to obtain Schedule II controlled substances 
for personal use. The physician pled guilty to a reduced misdemeanor 
charge for attempting to obtain controlled substances by fraud. In 
another situation, an owner of a provider was charged with felony 
assault with a dangerous weapon; the court reduced it to a misdemeanor 
as part of a guilty plea and sentenced the defendant to 2 years of 
probation.
    We believe that our responsibility in overseeing the Medicare 
program requires that we have the ability to take protective action in 
such instances. To this end, we propose 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, have 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) would 
state 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. (This 
example mirrors that in Sec.  424.535(a)(3)(ii)(C) regarding felonies.)
    Our proposal accounts for the fact that some States may classify a 
particular crime as a misdemeanor while others may deem it a felony; in 
other words, the misdemeanors included in proposed Sec.  424.535(a)(16) 
may be treated as felonies in certain States. This reflects our concern 
about the seriousness of these actions. Indeed, merely because 
particular State statutes may designate the aforementioned actions as 
misdemeanors does not, in our view, lessen the risk the latter can pose 
to Medicare and its beneficiaries. It is, in short, the action itself, 
rather than its specific classification under State law, that is of 
principal concern to us.
    We are soliciting comments on this proposal. We specifically are 
seeking feedback on: (1) whether there are any potential unintended 
consequences of our proposal that we are not considering; or (2) any 
guardrails we should consider so as not to create unintended 
consequences for persons with misdemeanor convictions.

[[Page 52517]]

(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. These 
include the following:
     Knowingly presenting, or causing to be presented, a false 
or fraudulent claim for payment or approval.
     Knowingly making, using, or causing to be made or used, a 
false record or statement material to a false or fraudulent claim.
     Conspiring to violate any of the provisions in section 
3729(a)(1) of the FCA.
     Having possession, custody, or control of property or 
money used, or to be used, by the government and knowingly delivering, 
or causing to be delivered, less than all of that money or property.
     Being authorized to make or deliver a document certifying 
receipt of property used, or to be used, by the government and, 
intending to defraud the Government, making or delivering the receipt 
without completely knowing that the information on the receipt is true.
     Knowingly buying, or receiving as a pledge of an 
obligation or debt, public property from an officer or employee of the 
government, or a member of the Armed Forces, who lawfully may not sell 
or pledge property.
     Knowingly making, using, or causing to be made or used, a 
false record or statement material to an obligation to pay or transmit 
money or property to the government, or knowingly concealing or 
knowingly and improperly avoiding or decreasing an obligation to pay or 
transmit money or property to the government.
    Under section 3729(a)(1), a party that is liable under the FCA must 
pay a civil penalty of between $5,000 and $10,000 for each false claim 
(though these amounts are periodically revised for inflation) and 
triple the amount of the government's damages.
    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 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 propose in Sec.  424.535(a)(15) that CMS could 
revoke the enrollment of a provider or supplier 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), however, 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 would 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 note 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 
believe that Sec.  424.535(a)(15) should encompass such situations, 
though 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.
(4) Violation of Provider and Supplier Standards
    Section 410.33(g) lists detailed enrollment standards that 
independent diagnostic testing facilities (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 42 CFR part 424, subpart P with 
which IDTFs, DMEPOS suppliers, OTPs, HIT suppliers, MDPPs, and all 
other provider and supplier types must comply.
    We propose 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 believe a narrower approach that allows us to target 
violations of the aforementioned 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.
(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, CMS considers 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. 
Section 424.535(a)(17)'s purpose is to spur providers and suppliers to 
repay their financial obligations to Medicare; in our view,

[[Page 52518]]

their failure to do so raises doubts as to whether the provider or 
supplier can be a reliable partner of the Medicare program.
    We have 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 
propose 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 propose 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. In our view, 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 believe basic 
fairness to the provider or supplier justifies revised paragraph 
(a)(17)(ii).
    Third, in Sec.  424.535(a)(17)(i) we would 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. Our central 
concern is more with the provider's or supplier's inaction in 
fulfilling its financial obligations to Medicare than with the 
particular status or result of CMS' collection efforts. In other words, 
and as with all of our revocation reasons in Sec.  424.535(a), the 
issue is the provider's or supplier's conduct, which, in the case of 
Sec.  424.535(a)(17), involves the provider's or supplier's failure to 
repay monies it owed to the Federal government. Simply because the debt 
could not be collected and was subsequently ``written off'' does not 
negate the fact that the provider or supplier did not meet its 
responsibility to repay it in the first place. Although the financial 
obligation may no longer constitute a debt because it was ``written 
off'', the core point is that it was a debt at one time but the 
provider did not repay it. Again, it is the provider's non-payment of 
the debt when it was current rather than whether said debt still exists 
that is critical, hence our proposed move away from ``existing debt'' 
to a status that better reflects the provider's inaction irrespective 
of the timing of the debt. In our view, a provider's failure to fulfill 
its financial obligations to the Medicare program: (1) constitutes a 
potential vulnerability to the program; and (2) could well increase the 
likelihood that any of the provider's or supplier's future Medicare 
debts, too, may not be repaid. Our obligation to safeguard the Trust 
Funds, we believe, requires us to have authority to take action to help 
prevent the latter occurrence. For these reasons, we believe our 
proposed change is warranted.
    Nevertheless, we recognize that our proposed revision to Sec.  
424.535(a)(17)(i) might cause concern within the provider community, 
for there could be numerous reasons behind the ``writing off'' of a 
Medicare debt. For example, a provider may have been unable to repay a 
particular debt (that was later written off) because of a severe local 
emergency or natural disaster. While we would retain the authority to 
revoke under paragraph (a)(17)(i), we emphasize that we would still 
apply the aforementioned six factors in all potential revocation cases 
under paragraph (a)(17). Indeed, one of these factors is the 
``reason(s) for the failure to fully repay the debt (to the extent this 
can be determined)'', and we will continue to carefully consider the 
factual circumstances behind the repayment failure so as to ensure 
fairness to the provider or supplier.
(B) Reasons for Denial
    As already discussed, we are proposing new revocation authorities 
in Sec.  424.535(a)(15), (16), and (23). We believe the rationales for 
these revocation reasons are equally applicable to newly enrolling 
providers and suppliers. Our program integrity concerns are the same 
regardless of whether the provider or supplier is already enrolled or 
is attempting to enroll; in either case, we must protect the Trust 
Funds and beneficiaries from problematic parties. Consequently, we 
propose to largely duplicate these new revocation reasons and establish 
concomitant grounds in Sec.  424.530 for denying enrollment as follows.
    First, Sec.  424.530(a)(1), like Sec.  424.535(a)(1), addresses the 
need for compliance with subpart P's enrollment requirements. We 
propose to change this reference from subpart P to title 42. As already 
noted, several sections of title 42 contain enrollment requirements 
outside of those in subpart P and to which the provider or supplier 
must adhere.
    Second, we propose in new Sec.  424.530(a)(16)(i) that CMS may deny 
a provider's or supplier's enrollment application 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. (Section 424.530(a)(16)(ii) would mirror 
proposed Sec.  424.535(a)(16)(ii).) Our concern is that we currently 
have no legal authority to deny enrollment based on misdemeanor 
convictions for behavior that could endanger the Trust Funds or 
Medicare beneficiaries.
    Third, new Sec.  424.530(a)(17) would permit CMS to deny a 
provider's or supplier's enrollment application 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. The same factors for 
consideration in Sec.  424.535(a)(15) would be included in Sec.  
424.530(a)(17). Given our previously stated view that the actions 
identified in section 3729(a)(1) of the FCA involve serious 
misbehavior, we believe proposed Sec.  424.530(a)(17) would help 
protect the integrity of the Medicare program.
    Fourth, and for the same reasons we are proposing new Sec.  
424.535(a)(23), we would duplicate the latter in new denial reason 
Sec.  424.530(a)(18). We must strive to ensure that enrolling IDTFs, 
DMEPOS suppliers, OTPs, HIT suppliers, and MDPPs are legitimate 
providers and suppliers, as evidenced in part by their compliance with 
the standards and conditions applicable to them.
(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. To illustrate, 
assume a supplier's license is revoked on June 1. CMS learns of this 
and mails a revocation notice to the

[[Page 52519]]

supplier on June 15. If we applied the aforementioned ``30 days after 
mailing'' policy, the supplier could bill and be paid for services 
furnished between June 1 and July 15 while unlicensed. Per existing 
Sec.  424.535(g), however, the revocation would be effective June 1, 
meaning all services furnished after that date would be ineligible for 
payment.
    We view Sec.  424.535(g)'s four exceptions as an important program 
integrity protection against improper payments. We do not believe 
providers and suppliers should be paid for services furnished during a 
period of non-compliance. With this principle in mind, we propose a 
number of policy and organizational changes to 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 sub-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 paragraph (g)(3) 
(discussed later in this section of the proposed rule) does not.)
    As with our existing four bases for a retroactive revocation, these 
new grounds would help ensure that providers and suppliers do not 
receive payment for services rendered while non-compliant with 
enrollment requirements. For example, a provider's State license 
surrender would mean that the provider is not appropriately licensed 
(and can thus be revoked under Sec.  424.535(a)(1)) and, accordingly, 
should not be paid by Medicare for furnished services while unlicensed. 
Concerning terminations under another Federal health care program, some 
such programs are occasionally delayed in reporting their actions to 
CMS, during which period CMS continues making payments to the affected 
provider or supplier until CMS receives notice of the termination. Any 
Federal program termination is of concern to us, which is why we 
promulgated a revocation reason based on this action. We believe that 
any such termination that leads to a Medicare revocation should 
consequently be retroactive to the date of the program termination 
since the latter stemmed from conduct that, in our view, was serious 
enough to warrant the subsequent revocation. Likewise, there could be a 
brief administrative time lapse between when a provider agreement is 
terminated and a Medicare revocation is effectuated, meaning that a 
provider without a required provider agreement might still receive 
payments beyond the provider agreement termination date or the date 
that CMS establishes under Sec.  489.55. The aforementioned retroactive 
effective dates involving Sec.  424.535(a)(23), meanwhile, generally 
mirror those currently in Sec.  424.535(g) (for example, felony 
conviction).
    Third, new Sec.  424.535(g)(3) would state 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. To illustrate, suppose an adverse legal action occurred on 
February 1 and the provider was enrolled effective April 1. Although 
CMS was unaware of the action at the time of enrollment, it revoked the 
provider on April 15 upon learning of it. The revocation effective date 
would be April 1 rather than February 1. The aim of Sec.  424.535(g)(3) 
is merely to reiterate that we could not apply a revocation effective 
date that is earlier than the date the provider or supplier is 
enrolled. It is a technical, though, we believe, obvious clarification.
(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. 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 propose to revise Sec.  424.535(e) 
to reduce the 30-day period therein to 15

[[Page 52520]]

days. We are not proposing, for instance, a 5-day period because we 
recognize 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 emphasize that this change would have no impact on a revoked 
provider's or supplier's ability to appeal a revocation under 42 CFR 
part 498. It would only affect the provider's or supplier's utilization 
of Sec.  424.535(e) to reverse the revocation. We are soliciting 
comments on whether 15 days is an appropriate timeframe.
ii. Stay of Enrollment
    CMS may deactivate a provider's or supplier's Medicare billing 
privileges for any of the reasons specified in Sec.  424.540(a). 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). It 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. 
Indeed, we sometimes impose a deactivation instead of a revocation when 
we believe a more modest sanction is warranted.
    Nevertheless, a deactivation can still impose a potential burden on 
a provider or supplier. This is especially true concerning Sec.  
424.540(e), which prohibits a provider or supplier from receiving 
payment for services or items furnished while deactivated. While 
deactivation is a less severe action than a revocation, it may be too 
punitive in certain cases. We believe that a middle ground between a 
deactivation and non-action on our part is warranted. 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 action, inaction, or non-compliance.
    For these reasons, we propose 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 still 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.
    There would be 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. Mere suspicion of or information 
alleging non-adherence is insufficient. Actual non-compliance is 
required. Second, CMS ascertains that the provider or supplier 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 (hereafter collectively 
referenced ``Form CMS-855 change request'' or ``change of information 
application''). 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 believe that using the 
aforementioned, comparatively bright-line Form CMS-855 submission 
standard would furnish clarity as to the types of non-compliance that 
can be remedied under our proposal and the specific vehicle for said 
remedial action.
    When a ``stay period'' is imposed, the provider or supplier would 
not receive payment for services or items furnished during this period. 
These services and items would not be payable because the provider or 
supplier was non-compliant with enrollment requirements and thus not 
entitled to payment, even after the stay concludes. To permit payment 
for these services and items would be contrary to our obligation to 
safeguard the Trust Funds.
    Although we acknowledge that this denial of payment is similar to 
what occurs with a deactivation under Sec.  424.540, there are critical 
differences between the two actions. First, Sec.  424.541 would make 
clear that a stay period lasts no more than 60 days. A deactivation, on 
the other hand, has no finite timeframe, meaning that services and 
items might 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 a reactivation application. A provider or supplier subject to a 
stay could therefore begin receiving payments 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 sum, considerably less 
burdensome for providers and suppliers than completion of a 
reactivation application.
    Indeed, the issue of burden is 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 in a particular case that the 
non-adherence can be fairly quickly corrected via the provider's or 
supplier's submission of updated enrollment data. Although we again 
recognize that payments for services and items furnished during the 
stay would not be covered, we emphasize that this would also be the 
case if CMS instead 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 believe that our stay provision 
would ultimately reduce the burden on providers who would otherwise be 
deactivated or revoked for non-compliance.
    Notwithstanding this, we believe 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 42 CFR 424.546 
and 405.374, respectively), the two actions most akin to a stay. We 
recognize that given the comparatively and rather short time period 
that a stay would typically entail, many stays would have long expired 
by the time a provider or supplier files a rebuttal and CMS makes its 
determination thereon. 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 might forego 
submitting a rebuttal does not mean the process should be unavailable 
to them.
    Consistent with all of the foregoing, we propose a number of 
provisions in Sec.  424.541. In paragraph (a)(1), we propose that CMS 
may stay an enrolled

[[Page 52521]]

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 emphasize that our authority to impose a stay would be 
discretionary. CMS would not be required to stay the provider's or 
supplier's enrollment. We could, for instance, elect to proceed 
directly to a deactivation or revocation (if grounds exist for either) 
without applying a stay as a prerequisite thereto. Our decision as to 
which action is most appropriate would depend upon the facts and 
circumstances of the case at issue.
    In paragraphs (a)(2)(i) and (ii), respectively, we would state that 
during the period of any stay imposed under Sec.  424.541:
     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 propose that a stay of enrollment would 
last no longer than 60 days from the postmark date of the notification 
letter. We believe a 60-day period would give the provider or supplier 
adequate time to submit the required Form CMS-855 change of information 
application.
    In paragraph (a)(4), we propose that CMS must notify the affected 
provider or supplier in writing of the stay's imposition.
    In paragraph (b), we would outline our proposed rebuttal process, 
which, as stated, would largely align with that for deactivations and 
payment suspensions.
    In paragraph (b)(1), we propose 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 as described in Sec.  424.541.
    In paragraph (b)(2), we propose 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 propose 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 propose 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 of 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 propose 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 propose that a determination made under 
paragraph (b) is not an initial determination under Sec.  498.3(b), and 
therefore, not appealable.
    In paragraph (b)(7), we propose 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 propose in paragraph (b)(8) to clarify the interaction between a 
stay and a subsequent deactivation or revocation.
    In paragraph (b)(8)(i), we propose that nothing in paragraph (b) 
would require CMS to delay the imposition of a deactivation or 
revocation pending the completion of the review described in paragraph 
(b)(5) of this section. We believe we must retain the discretion to 
apply a subsequent deactivation or revocation should circumstances 
warrant.
    In paragraph (b)(8)(ii)(A), we propose 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 would 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 propose 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, for revocations, 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 propose to add providers and 
suppliers currently under a stay of enrollment to the categories of 
providers and suppliers falling within the scope of Sec.  424.555(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. As explained below, we propose two sets of regulatory 
revisions regarding practice location changes. First, we propose to 
revise Sec.  424.516(e)(1) to require therein such location changes 
involving providers and suppliers other than the categories previously 
described to be reported within 30 days of the change. Second, we would 
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.
    We have recently discovered instances where certain provider and 
supplier types not addressed in Sec. Sec.  424.57(c)(2), 410.33(g)(2), 
or 424.516(d)(1)(iii), have moved their practice location without 
notifying CMS. This is problematic for two reasons. One is that 
Medicare payments are often based on the provider's or

[[Page 52522]]

supplier's specific geographic location. If we are not timely informed 
of the change in location, CMS 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 might be 
furnishing services from an invalid location, hence resulting in 
improper payments. CMS needs to ensure the accuracy of its payments, 
and being more rapidly advised of critical data like a practice 
location change would help facilitate this. It would also facilitate 
consistency with the aforementioned 30-day requirement in Sec. Sec.  
424.57(c)(2), 410.33(g)(2), and 424.516(d)(1)(iii).
    For purposes of reporting practice location changes, we have 
traditionally included additions and deletions of locations within the 
scope of such changes. There is as much payment safeguard risk with 
belatedly reported additions and deletions as with changes. Paying a 
provider or supplier for services it furnishes at an unreported newly-
established location could involve improper payments because, again, 
CMS does not even know whether the site meets all provider enrollment 
requirements; likewise, CMS could be paying a provider or supplier for 
services related to a location that was deleted and no longer exists. 
To make certain we are more promptly notified of practice location 
additions and deletions, we propose to revise Sec. Sec.  410.33(g)(2), 
424.516(d)(1)(iii), and 424.516(e)(1) to reiterate that these two 
transactions must be reported within 30 days of the addition or 
deletion. (A similar revision to Sec.  424.57(c)(2) is unnecessary 
because all changes to enrollment data (including practice location 
additions, deletion, and changes) must already be reported within 30 
days.)
iv. Definitions
    We are also proposing several new and clarified definitions to help 
explain the meaning of certain provider enrollment concepts.
(A) ``Pattern or Practice''
    Several of our existing Medicare enrollment revocation reasons are 
based upon the provider or supplier engaging in a pattern or practice 
of conduct. These reasons include all of the following:
     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, 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.
    In determining whether such a pattern or practice exists and if a 
revocation under any of these authorities is warranted, CMS considers 
the factors specified in Sec.  424.535(a)(8)(ii), (14), and (21), 
respectively.
    We have received questions from interested parties over the years 
as to what constitutes a pattern or practice under these provisions. We 
have always made these determinations on a case-by-case basis, using 
the above-referenced factors. We do not propose to change this general 
procedure, for it gives us the flexibility we need to address each 
situation on its own facts and circumstances. Every case is different, 
and our factors are designed to account for this. Nonetheless, and to 
furnish elucidation to the provider community, we believe that certain 
minimum regulatory parameters are appropriate. This would be based on 
our past experience in applying Sec.  424.535(a)(8)(ii), (14), and 
(21), our review of the factors therein, and the factual circumstances 
we have encountered in these cases.
    To this end, we propose to establish a definition of ``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.
    We recognize that our minimum threshold of three might appear small 
upon first impression. Yet interested parties should not assume that 
three non-compliant claims, orders, etc. would always trigger a 
revocation. To the contrary, it would often take more than three (and, 
on occasion, considerably more) to warrant revocation action. In only 
the rarest of circumstances would we revoke based on three claims, 
referrals, etc., and these would typically involve egregious non-
compliance by the provider or supplier; we specifically chose three as 
our threshold to account for these isolated instances. We assure the 
provider community that, in every case, we would continue to diligently 
consider the factors outlined in Sec.  424.535(a)(8)(ii), (14), and 
(21) and would treat the provider or supplier fairly given the facts 
presented. Our proposed definition in no way negates the validity or 
importance of these factors; its sole purpose is to furnish greater 
clarity to the provider community.
    To accommodate our definition, we also propose to make several 
technical changes to Sec.  424.535(a)(8)(ii), (14), and (21).
    The introductory paragraph of Sec.  424.535(a)(8)(ii) reads: ``CMS 
determines that the provider or supplier has a pattern or practice of 
submitting claims that fail to meet Medicare requirements. In making 
this determination, CMS considers, as appropriate or applicable, the 
following:''. We are concerned that this language could be construed as 
meaning that so long as the ``pattern or practice'' definition in Sec.  
424.502 is met--that is, at least three non-compliant claims, orders, 
etc., were involved--a Sec.  424.535(a)(8)(ii) revocation must 
automatically follow. As previously discussed, this is untrue. Even if 
the definition's threshold is met, we would then consider the entirely 
separate question of whether a revocation is warranted. In other words, 
the first step in our analysis would be to ascertain whether the 
activity involved qualifies as a ``pattern or practice.'' If (and only 
if) it does, the second step would be to determine, using the specified 
factors, whether the provider or supplier should be revoked. To clarify 
this approach, we propose to change Sec.  424.535(a)(8)(ii)'s opening 
paragraph to state: ``CMS determines that the provider or supplier has 
a pattern or practice of submitting claims that fail to meet Medicare 
requirements and that a revocation on this basis is warranted. In 
determining whether a revocation is warranted, CMS

[[Page 52523]]

considers, as appropriate or applicable, the following:''.
    Language similar to that in existing Sec.  424.535(a)(8)(ii) is 
present in Sec.  424.535(a)(14)(i) and (ii). For the reasons outlined 
in the previous paragraph, we propose to revise the opening of Sec.  
424.535(a)(14)(i) to state: ``The pattern or practice is abusive or 
represents a threat to the health and safety of Medicare beneficiaries, 
or both, and CMS determines that a revocation on this basis is 
warranted. In determining whether a revocation is warranted, CMS 
considers the following factors:''. The revised opening of Sec.  
424.535(a)(14)(ii) would read: ``The pattern or practice of prescribing 
fails to meet Medicare requirements and CMS determines that a 
revocation on this basis is warranted. In determining whether a 
revocation is warranted, CMS considers the following factors:''.
    With respect to Sec.  424.535(a)(21), the closing language of the 
first sentence and the entirety of the second sentence reads: ``. . . 
or otherwise fails to meet Medicare requirements. In making its 
determination as to whether such a pattern or practice exists, CMS 
considers the following factors:''. We propose to change this to state: 
``. . . or otherwise fails to meet Medicare requirements, and CMS 
determines that a revocation on this basis is warranted. In determining 
whether a revocation is warranted, CMS considers the following 
factors:''.
(B) Indirect Ownership
    We propose 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 of 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 believe this definition (albeit 
with certain modifications for purposes of clarity and to conform to 
the terminology of part 424, subpart P) would provide the desired 
elucidation. Accordingly, 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. (For 
example, Provider A is owned by Entity B. Entity B is owned by Entity 
C. Entity C would have an indirect ownership interest in (and be an 
indirect owner of) Provider A.)
     Any ownership interest in an indirect owner of the 
enrolling or enrolled provider or supplier. (Using the preceding 
example, if Entity D had an ownership interest in Entity C, Entity D 
would have an indirect ownership interest in Provider A.)
    We would designate this portion of our definition as paragraphs 
(1)(i) and (ii). To further clarify the concept of indirect ownership, 
we propose 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.''
(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 of part 424 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 propose several 
regulatory provisions.
    First, we propose 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 would include within new Sec.  405.800(d) 
the same definition of ``supplier'' we are proposing 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 propose 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.''
(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 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 questioned CMS on 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

[[Page 52524]]

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 propose 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, therefore, the individual could sign CMS provider enrollment 
applications concerning the HHA, hospice, and the SNF. We welcome 
comments on our proposed clarification.
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 December 2022) covers more than 
85 million low-income individuals. States have considerable flexibility 
when administering 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 December 2022) provides health 
care coverage to over 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.\253\ States may also establish their own 
provider enrollment requirements which must be met in addition to the 
applicable Federal provider enrollment requirements. 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.
---------------------------------------------------------------------------

    \253\ 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.
---------------------------------------------------------------------------

    Different States may have different provider enrollment processes 
in operating their Medicaid and CHIP programs. However, all States must 
comply with Federal Medicaid and CHIP provider enrollment requirements, 
including those in part 455, subparts B and E.\254\ For example, under 
subpart B, providers must disclose information regarding, among other 
things, ownership and control of the provider entity, certain business 
transactions, and criminal convictions related to Federal health care 
programs. Under subpart E, States must implement various Medicaid 
provider screening requirements. (In addition, State enrollment 
requirements must be consistent with section 1902(a)(23) of the Act and 
implementing regulations at Sec.  431.51, under which States may set 
reasonable standards relating to the qualifications of providers; 
however, States may not restrict the right of beneficiaries to obtain 
services from any person or entity that is both qualified and willing 
to furnish such services.)
---------------------------------------------------------------------------

    \254\ All of subpart E, and 42 CFR 455.107 in Subpart B, are 
applicable to CHIP under Sec.  457.990.
---------------------------------------------------------------------------

    Another such provision in part 455 to which states must adhere 
involves 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, which include the following:
     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.
     The provider, or a person with an ownership or control 
interest in or who is an agent or managing employee of the provider, 
fails to submit timely or accurate information as required.
     The provider, or any person with a 5 percent or greater 
direct or indirect ownership interest in the provider, fails to submit 
sets of fingerprints in a form and manner to be determined by the State 
Medicaid agency within 30 days of a CMS or a State Medicaid agency 
request.
     The provider fails to permit access to provider locations 
for any site visits under Sec.  455.432.
    Of particular importance, as will be discussed in more detail in 
this section III.K. of this proposed rule 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.
    These termination reasons require States to take action against 
providers that have, for instance, demonstrated an unwillingness or 
inability to meet certain Medicaid or CHIP requirements, or engaged in 
improper conduct. The possibility of being terminated also encourages 
providers to abide by Medicaid and CHIP enrollment rules, thus 
protecting Medicaid and CHIP against improper provider activity. 
Recognizing, however, that special circumstances may exist concerning a 
particular provider (and given the importance of leaving the States 
with as much discretion in their enrollment processes as possible), 
several of the otherwise mandatory termination reasons in Sec.  455.416 
permit the State to forgo termination if the State: (1) determines that 
such an action would not be in the Medicaid program's best interests; 
and (2) documents this decision in writing. Furthermore, States may 
develop additional State-specific reasons for terminating a Medicaid or 
CHIP provider, so long as such reasons (and the enforcement thereof) 
are not inconsistent with the requirements of Sec. Sec.  455.416 and 
431.51.
b. The 21st Century Cures Act's Medicaid and CHIP Provider Enrollment 
Requirements
    The 21st Century Cures Act (Pub. L. 114-255; hereafter referred to 
as the Cures Act) was signed into law on December 13, 2016. The Cures 
Act addresses a variety of nationwide health care issues. Among the 
topics outlined in section 5005 of the Cures Act is Medicaid and CHIP 
provider enrollment and, in particular, Medicaid and CHIP provider 
terminations. For purposes of our proposals in this section III.K., the 
most pertinent provisions in section 5005 of the Cures Act are as 
follows:
     Section 5005(a)(1) of the Cures Act added a new paragraph 
(8) to section

[[Page 52525]]

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 information 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 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 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 sub-regulatory 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.  455.416(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 time 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. 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. 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 previously-mentioned 
termination requirement in Sec.  455.416(c)) has caused confusion among 
the States, provider communities, and other interested parties. 
Accordingly, we propose 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 to Sec.  455.416(c).
ii. Revision to Sec.  455.416(c)
    As previously indicated, under Sec.  455.416(c) the State Medicaid 
agency must deny or terminate the enrollment of any provider that is 
terminated on or after January 1, 2011, under title XVIII of the Act, 
or under the Medicaid program or CHIP of any other State. We propose 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 revision 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, we propose several provisions in 
new Sec.  455.417 as follows:
     In paragraph (a)(1), we propose 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).

[[Page 52526]]

     In paragraphs (b)(1)(i) and (ii), respectively, we propose 
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 would make clear 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).
    To illustrate how paragraphs (a) through (b) would work in 
practice, consider the following examples:
    ++ Example 1: State A, the initially terminating State, terminates 
a provider for a period of 5 years. Under paragraph (a)(1), the 
provider would remain in the termination database for 5 years. Under 
paragraph (b), when State B terminates the provider based on the State 
A termination (under Sec.  455.416(c)), it may impose any termination 
period so long as (under proposed paragraph (b)(2)) it is no shorter 
than the 5-year period in which the provider remains in the termination 
database. (This is because all States must adhere, at a minimum, to the 
termination database period.) However, whatever period State B imposes 
would have no effect on the length of time the provider is to remain in 
the termination database, which is 5 years under the original State's 
(State A's) termination period. If, therefore, State B imposes an 8-
year termination period, the provider would still only remain in the 
termination database for 5 years, but State B could (under its State 
law) prohibit the provider from enrolling in its State B Medicaid 
program or CHIP for another 3 years beyond that period.
    ++ Example 2: State A, the initially terminating State, terminates 
a provider for 15 years. Under paragraph (a)(1), the provider would 
remain in the termination database for only 10 years. Under paragraph 
(b), however, State A may enforce its original 15-year termination 
period imposed on the provider notwithstanding that the provider would 
only remain in the database for 10 years. When State B terminates the 
provider based on the State A termination (under Sec.  455.416(c)), it 
may impose any termination period permitted under its State law so long 
as it is at least the length of the 10-year termination database period 
in this Example 2.
    As indicated in Examples 1 and 2, there is a critical distinction 
between a State-imposed termination period (or a Medicare reenrollment 
bar) and the length of time in which a provider remains in the 
termination database. The former generally involves the period for 
which the provider is prohibited from reenrolling in the initially 
terminating State program or Medicare (in the case of a revocation); 
the latter involves the minimum period in which other States must also 
terminate the provider under Sec.  455.416(c). (Hereafter, the former 
will be referred to as the ``termination period'' or ``reenrollment 
bar'' and the latter the ``termination database period.'')
    Aside from the aforementioned need for clarity, there are several 
other important reasons for proposed Sec.  455.417(a) and (b).
    First, despite our aforementioned concerns about inconsistencies in 
State-imposed termination periods, we are committed to ensuring that 
States have as much discretion as possible in administering their 
respective Medicaid programs. We believe proposed Sec.  455.417(a) and 
(b), taken together, would clarify the duration of the requirement to 
terminate under Sec.  455.416(c) while preserving each State's ability 
to impose whatever termination period it deems appropriate (subject to 
proposed paragraph (b)(2), which designates the termination database 
period as a minimum).
    Second, establishment of a maximum 10-year termination database 
period would address situations where a State imposes an extremely 
lengthy, or even a lifetime, termination period that is far longer 
than: (1) that imposed by other States for the same conduct; or (2) the 
maximum Medicare 10-year reenrollment bar under Sec.  424.535(c), but 
other States wish to permit a provider to reenroll before the initially 
terminating State's reenrollment bar has expired. Moreover, a finite 
termination database period is needed to address instances where the 
initially terminating State establishes an indefinite termination 
period; if the termination remained in the database until that State 
permitted the provider to reenroll, this would essentially cause the 
provider to be barred from the Medicaid program in all States 
indefinitely, regardless of the underlying cause of the termination and 
the circumstances associated therewith. This could be very problematic 
for the provider and perhaps lead to access to care issues in some 
States. Indeed, providers may experience undue burden in these cases 
because even if they can prove that the underlying cause for the 
termination has been resolved, they might remain unable to enroll in 
other States while an indefinite termination remains in the termination 
database. We believe that a maximum 10-year period in the database (if 
the State imposes a termination period of 10 years or longer) would 
give the broadest possible deference to the initially terminating State 
while still providing a consistent and finite period during which other 
States are required to terminate (and continue the termination) or deny 
the provider's enrollment under Sec.  455.416(c).
    In paragraph (c)(1), we propose 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. This proposal is intended to clarify the impact of a 
reinstatement, including those occurring prior to the expiration of the 
original termination period. Such instances of early reinstatement 
might include: (1) resolution of the underlying basis for the original 
termination; or (2) access to care concerns of the originally 
terminating State agency. However, we also propose in Sec.  
455.417(c)(2) 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. This is to emphasize that CMS is not required to afford the 
provider any sort of ``waiting period'' between the expiration of the 
original termination period and the commencement of a new one should 
grounds exist for the imposition of the latter; the new termination 
database period can become effective immediately upon the expiration of 
the prior one.
    Consider the following example of proposed Sec.  455.417(c)(2)'s 
potential applicability. State A initially terminates a provider for 2 
years. Under proposed Sec.  455.417(a), the provider would be included 
in the termination database for 2 years. Under proposed Sec.  
455.417(b), all other States must terminate the provider from their 
Medicaid programs for at least that same time period. Yet Medicare is 
not required to (and elects not to) revoke the provider's Medicare 
enrollment notwithstanding the State A

[[Page 52527]]

termination. Now assume that State A reinstates the provider after 1 
year. Two days before the reinstatement takes effect, though, the 
provider is revoked from Medicare with a 3-year enrollment bar for a 
reason unrelated to the grounds behind the State A termination. Since 
Sec.  455.416(c) requires State A (and all other States) to terminate 
the provider based on the Medicare revocation, CMS may place the 
provider in the termination database for a 3-year period effective 
immediately upon the expiration of the original termination database 
period. This is to ensure that the initial 1-year period runs its full 
course before the beginning of the 3-year termination database. If we 
commenced the 3-year period 2 days before the 1-year period expired, 
the 1-year period would, in effect, have lasted 2 days less than 1 
year; likewise, the 3-year period would essentially be 3 years minus 2 
days. This is due to the 2-day overlap between the two timeframes.
    Aside from clarifying that Medicaid termination periods can run 
consecutively without any break between them, we believe that proposed 
Sec.  455.417(c) would help ensure a seamless transition between the 
two periods and, in the process, prevent problematic Medicaid providers 
from using any gap in periods to bill Medicaid.
    We indicated earlier that, per the statute and MPEC guidance, 
States must report ``for cause'' terminations to CMS for purposes of 
the termination database. We propose in new Sec.  455.417(d) 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. Using Examples 1 and 2 
as previously discussed, this would mean that State B would not have to 
report the terminations in those examples to CMS for termination 
database purposes, although State B would still be required to: (i) 
terminate the provider under Sec.  455.416(c), based on the State A 
termination; and (ii) apply a termination period no shorter than the 
termination database period established under Sec.  455.417(a). The 
goal of proposed Sec.  455.417(d) is to eliminate repetitiveness in 
reporting the same data to CMS so as to ease the burden on States. In 
our view, and under the foregoing example, there is no reason for State 
B (and, for that matter, other States) to expend resources in reporting 
a termination that was already reported by the originally terminating 
State. Furthermore, this would avoid the potential for additional 
confusion regarding the termination database period, in that it would 
ensure that such period is based only on the initial State's 
termination and not on subsequent derivative terminations.

L. Expand Diabetes Screening and Diabetes Definitions

    For CY 2024, we propose 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)).\255\
---------------------------------------------------------------------------

    \255\ The Secretary, as of the date of this proposed rule, has 
not approved additional diabetes screening tests by through a 
national coverage determination.
---------------------------------------------------------------------------

    We propose 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), in consultation with recommendations by 
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 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 propose 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 propose 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 propose 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 recognize 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 would 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 identical to the existing regulatory 
definition of diabetes for screening purposes at Sec.  410.18(a). We 
propose 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 would 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

[[Page 52528]]

1861(s)(2)(S), 1861(qq), 1861(ww)(2)(F) of the Act) and in regulation 
at part 410 subpart H. Section 410.140 describes a number of 
definitions for the purposes of the DSMT benefit, 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 
propose 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 would 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.\256\ 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.\257\ 
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 U.S.\258\ 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.
---------------------------------------------------------------------------

    \256\ CDC website on diabetes at https://www.cdc.gov/diabetes/basics/index.html.
    \257\ 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.
    \258\ 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.\259\ 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).'' \260\ 
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.
---------------------------------------------------------------------------

    \259\ USPSTF website: https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/screening-for-abnormal-blood-glucose-and-type-2-diabetes-october-2015.
    \260\ USPSTF website: https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/screening-for-prediabetes-and-type-2-diabetes.
---------------------------------------------------------------------------

    We recognize that 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.'' \261\ The 
American Association of Clinical Endocrinology (AACE) also recommends 
screening for diabetes and prediabetes with similar tests, including 
HbA1c.\262\
---------------------------------------------------------------------------

    \261\ Diabetes Care 2023;46(Suppl. 1):S19-S40: https://doi.org/10.2337/dc23-S002.
    \262\ 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 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.\263\
---------------------------------------------------------------------------

    \263\ 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

[[Page 52529]]

more often than twice within the 12-month period following the date of 
the most recent diabetes screening test of 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 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 described 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. Proposed Revisions
    We propose 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. As described earlier in our proposal, the 
USPSTF recommended the HbA1C test for diabetes screening in their 
October 2015 and August 2021 revised final recommendation statements. 
We have 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 \264\ and the AACE \265\ in developing our proposal. We look 
forward to further consultation with organizations through the public 
notice and comment rulemaking process and invite public comment on our 
proposal.
---------------------------------------------------------------------------

    \264\ https://diabetesjournals.org/care/article/45/Supplement_1/S17/138925/2-Classification-and-Diagnosis-of-Diabetes.
    \265\ https://www.endocrinepractice.org/article/S1530-891X(22)00576-6/fulltext.
---------------------------------------------------------------------------

    We propose 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 propose to 
remove the 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)). Our proposal to remove the regulatory definition of pre-
diabetes is intended to simplify and expand diabetes screening while 
reducing unnecessary regulatory complexity. 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

[[Page 52530]]

the regulatory definition of pre-diabetes does not reflect a change in 
our position on pre-diabetes screening and treatment as a Medicare 
benefit. In making this proposal we recognize 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.'' \266\ We 
have 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 also consulted 
with the written recommendations of a number of specialty societies and 
the USPSTF in developing our proposal. We acknowledge that the USPSTF, 
ADA and AACE recommend diabetes screening frequency screening of once 
every 3 years.267 268 269 We propose 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 test by 
multiple types of tests or with increased frequency where the 
circumstances of the patient demonstrate a medical necessity. We look 
forward to further consultation with organizations through the public 
notice and comment rulemaking process and invite public comment on our 
proposal.
---------------------------------------------------------------------------

    \266\ USPSTF website: https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/screening-for-prediabetes-and-type-2-diabetes.
    \267\ https://diabetesjournals.org/care/article/43/Supplement_1/S14/30640/2-Classification-and-Diagnosis-of-Diabetes.
    \268\ https://www.endocrinepractice.org/article/S1530-891X(22)00576-6/fulltext.
    \269\ https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/screening-for-prediabetes-and-type-2-diabetes#bootstrap-panel--10.
---------------------------------------------------------------------------

    We propose 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 propose 
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 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 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 consider 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 
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 note 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% 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 \270\ and the ADA.\271\ 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 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 invite public comment on our proposal and alternative considered.
---------------------------------------------------------------------------

    \270\ https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/screening-for-prediabetes-and-type-2-diabetes#bootstrap-panel--6.
    \271\ https://diabetesjournals.org/care/article/43/Supplement_1/S14/30640/2-Classification-and-Diagnosis-of-Diabetes.
---------------------------------------------------------------------------

    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 body of evidence demonstrates strong associations 
between prevalence of diabetes and social factors such as socioeconomic 
status, food environment, and physical environment. The higher 
prevalence of diabetes in Asian persons may be related to differences 
in body composition. A difference in body fat composition in Asian 
persons results in underestimation of risk based on BMI thresholds used 
to define overweight in the US.'' \272\ The HbA1c test does not require 
fasting or drinking an unappetizing glucose solution. 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

[[Page 52531]]

and reduce its complications, which currently occur disproportionately 
in those groups.
---------------------------------------------------------------------------

    \272\ USPSTF website: https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/screening-for-prediabetes-and-type-2-diabetes.
---------------------------------------------------------------------------

5. Summary
    In summary, we propose to exercise our authority in sections 
1861(yy) of the Act to: (1) expand coverage of diabetes screening tests 
to include the HbA1c test; (2) expand and simplify the frequency 
limitations for diabetes screening; and (3) simplify the regulatory 
definition of ``diabetes'' for diabetes screening, MNT and DSMT. We 
believe our proposals will expand access to quality care and improve 
health outcomes for patients through prevention, early detection, and 
more effective treatment. 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. 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.'' \273\ 
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 downstream impacts of serious 
diabetes related complications on health care use.\274\ Their findings 
include:
---------------------------------------------------------------------------

    \273\ 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.
    \274\ 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.
---------------------------------------------------------------------------

     In 2019, there were 8.7 million hospitalizations related 
to diabetes overall. About 71 percent were a result of the patient 
going to the emergency department. Ten percent of the 8.7 million 
hospitalizations had a principal diagnosis of diabetes.
     About 83 percent of hospitalizations occurred among 
patients living in communities in the bottom 50 percent of U.S. income, 
measured using median household income of the patient's zip code, 
underscoring the need for affordable access to treatment for diabetes.
     We also examined potentially avoidable hospitalization 
costs for Medicare and Medicaid beneficiaries with diabetes, 
specifically examining the costs for patients with amputations and 
ketoacidosis. For Medicare in 2020, total costs were $3.8 billion for 
amputations, $5.6 billion for ketoacidosis, and another $1.0 billion 
for patients with both. Medicare paid more than 90 percent of overall 
costs, covering $3.5 billion for amputations, $5.2 billion for 
ketoacidosis, and $936 million for hospitalizations involving both.

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.

[[Page 52532]]

     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 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).
    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). 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.
    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.
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).
    We propose 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. With this proposal, prescribers in the same legal 
entities as the dispensing pharmacy would 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).
    With this proposal, we would no longer need to separately identify 
and apply different methodologies based on whether the prescriber and 
dispensing pharmacy are the same entity. We would 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 would 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),

[[Page 52533]]

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 also to provide 
flexibility where prescriptions are transmitted within the same legal 
entity, we are proposing 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 propose to add ``subject to the 
exemption in paragraph (a)(3)(iii) of this section'' to Sec.  
423.160(a)(5). Under this proposed change, prescriptions that are 
prescribed and dispensed within the same legal entity would 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 would only have to meet the 
applicable standards in Sec.  423.160(b) subject to the exemption in 
Sec.  423.160(a)(3)(iii).
    We seek comment on the proposals to remove the same entity 
exception and expand the available standards for same legal entities 
within the CMS EPCS Program.
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 are now proposing 
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 propose to be 
redesignated to Sec.  423.160(a)(5)(i), as described in section 
III.M.3.b. of 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 would 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.  423.160(a)(5)(iii) is applicable.
    The second exception, codified at Sec.  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 this rule, we are proposing to further modify the recognized 
emergency exception and extraordinary circumstances waiver (which we 
propose to be codified at Sec.  423.160(a)(5)(ii) and (iii), 
respectively, as described in section III.M.3.b. of this rule). We are 
proposing 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 are 
proposing to modify the duration of both exceptions and proposing 
timing requirements for submitting a waiver application.
b. Updating the Circumstances Applicable for the Recognized Emergency 
and Extraordinary Circumstances Waiver Exceptions
    Our current exception for recognized emergencies applies to all 
prescribers with an address in PECOS, or alternatively in NPPES, in the 
geographic area of an emergency or

[[Page 52534]]

disaster declared by a Federal, State, or local government entity. As 
we have implemented this exception, we realize there may be unintended 
consequences to our existing policy. 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 realize 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, CMS 
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).
    We believe that it would 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 would 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 propose to codify at Sec.  423.160(a)(5)(iii), as described 
in section III.M.3.b. of this rule), we are proposing 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 would drop the 
restriction ``other than an emergency or disaster,'' that we previously 
included when discussing this exception. This modification would allow 
prescribers the ability to request a waiver regardless of whether we 
trigger the recognized emergency exception.
    Additionally, we are proposing to modify the recognized emergency 
exception at Sec.  423.160(a)(5)(iii) (which we propose to codify at 
Sec.  423.160(a)(5)(ii), as described in section III.M.3.b. of this 
rule) so that CMS 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 would review each 
emergency situation on a case-by-case basis but would 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, would 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 electronically prescribe Schedule II-V controlled substances 
that are Part D drugs, or vice versa.
    We would 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 invite public comment on the proposals related to circumstances 
applicable for the recognized emergency and extraordinary circumstances 
waiver exceptions.

[[Page 52535]]

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 propose that, 
as a default, prescribers impacted by the CMS EPCS Program recognized 
emergency exception at Sec.  423.160(a)(5)(iii) (which we propose to 
codify at Sec.  423.160(a)(5)(ii), as described in section III.M.3.b. 
of 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 seek comment on the proposed duration for exceptions due to 
recognized emergencies.
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.\275\ In this rule, we are not proposing any modifications on 
the information needed to request a waiver, but we are proposing the 
timeframe that would be covered by a waiver that is authorized under 
the CMS EPCS Program and the timing of waiver requests.
---------------------------------------------------------------------------

    \275\ 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 one year, as determined by the Secretary. 
We propose 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. We are now proposing that a prescriber 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 seek comment on the proposed waiver duration and the proposal 
for the timing and process of applying for waiver in cases of 
extraordinary circumstances.
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 propose to continue the practice of issuing a prescriber 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 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.276 277 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.\2\ 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.
---------------------------------------------------------------------------

    \276\ 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.
    \277\ 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.
---------------------------------------------------------------------------

    Although we are not proposing further non-compliance actions beyond 
the extension of sending notices at this time, we will continue to 
evaluate compliance and prescriber performance

[[Page 52536]]

under the CMS EPCS Program and will consider whether to propose changes 
in future years. We seek public comment on our proposal to continue the 
action of sending notice to prescribers who are identified as non-
compliant.

N. Proposed 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 proposed 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 
CAA, 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. We are proposing 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 application of the mandated 
rate increase, and does not require any substantive exercise of 
discretion on the part of the Secretary.
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, we are proposing 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.
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

[[Page 52537]]

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 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. Proposed 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 are proposing the following further changes and 
clarifications to the Medicare Ground Ambulance Data Collection 
Instrument. The changes and clarifications aim to reduce burden on

[[Page 52538]]

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 are proposing 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 propose 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 rest of the GADCS reporting process as do 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 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 invite comments on this proposal to address partial-year 
responses.
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.
    We are proposing 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 invite comments on this proposal to change the programming note 
after Section 2, Question 9 in the GADCS printable instrument.
3. Typos and Technical Corrections
    We are proposing 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 are proposing 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

[[Page 52539]]

``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 are proposing to change the language in the 
printable instrument to match the text in the web-based GADCS for 
consistency.
     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 are proposing 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 are proposing 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 invite comments on these proposals related to GADCS typos and 
technical corrections.

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 status explicitly 
gives 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 has 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. In order to implement division FF, 
section 4121 of the CAA 2023, we are proposing 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 MHCs or MFTs 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 at least one social worker, MFT, or MHC. In addition, we are 
proposing to modify the hospice personnel qualification at Sec.  
418.114(c) to also include qualifications for an MFT and an MHC.
2. Provisions of the Proposed Regulations
a. Updates to the Hospice CoPs To Permit Mental Health Counselors or 
Marriage and Family Therapists To Serve as Members of the Hospice 
Interdisciplinary Group (Sec. Sec.  418.56 and 418.114)
    The CAA 2023 established the new Medicare benefit category for MFT 
services and MHC services furnished by and directly billed by MFTs and 
MHCs.
    In accordance with the statute, we propose to revise Sec.  
418.56(a)(1)(iii) to specify that the IDG must include a social worker 
(SW), an MFT, or an MHC. In addition, we believe that with the 
introduction of MHC and MFT 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, nurse and the therapist. In 
this rule, we are proposing to add both MHC and MFT to the provider 
requirements under 42 CFR subpart B, Medical and Other Health Services 
at Sec. Sec.  410.54 and 410.53. Therefore, to avoid duplication and 
confusion between the CoP and the Medical and Other Health Services 
requirements, we are proposing to add both MHC and MFT to the 
requirements as new standards at Sec.  418.114(c)(3) and (4) and 
reference the new requirements at Sec. Sec.  410.54 and 410.53, 
respectively.
    We note that the CAA 2023 specifically modified the statute to 
require the hospice interdisciplinary team to include at least one SW, 
MFT or MHC. However, we emphasize that each hospice patient and family 
are different in their needs and goals. Therefore, 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 
preferences and needs of the patient.
    Furthermore, while we believe the role of the SW in hospice is 
unique and paramount to quality hospice care and services as the 
patient and their family approach the end of life, we also understand 
that some patients may benefit from the care and services of an MFT or 
MHC. However, the role and training of the SW, MFT and MHC vary 
greatly. As part of the SW role they offer unique support and services 
to the patient and family such as explaining what hospice care is and 
the role of the hospice team, assisting the patient and family in 
navigating the healthcare system, assisting patients and their family 
in understanding care options as they relate to patient goals and life 
circumstances, and identifying and working with the patient and their 
family to connect the patient to other services that may improve the 
patients quality of life. For example, a SW can make a referral for 
Meals on Wheels or link the patient to the Veteran's Administration 
(VA) and other benefits. The hospice SW can also guide the patient and 
family in applying for financial assistance or resources, such

[[Page 52540]]

as Medicaid, temporary assistance programs for energy or utilities, or 
county assistance programs. In addition, hospice SW are educated to 
assist patients in completing a living will and other advance 
directives, as well as educating patients about health care choices and 
assisting the patient and family in understanding the differences 
between wills and powers of attorney. They assist patients and family 
in deciding what environment is best for the patient to receive care 
and coordinate the many requirements for transferring the patient to 
the most appropriate care setting. For example, the SW will assist the 
patient as they transition from a hospital, assisted living facility or 
nursing home back to their home, or vice versa.
    SW, MFTs and MHCs have some similar roles and responsibilities as 
they relate to counseling. All three of these providers can assist the 
patient and family with issues related to family dynamics, assessing 
situations, strengths, and the patient's support network. They can also 
assist patients and families with navigating the changes and challenges 
at the end of life including grief counseling and coping strategies to 
ease day to day emotions. The SW, MFT, or MHC can also provide age-
appropriate education and emotional support for children and 
grandchildren. Some examples of this include providing activities that 
allow them to express their feelings appropriately, leading support 
groups, and providing individual, couples, and family counseling. The 
addition of the MFT and MHC may also be particularly beneficial for 
individuals living in rural areas who were previously not able to 
access these types of services.
    We acknowledge that there are clear similarities and differences 
between SWs, MFTs and MHCs, ranging from offered services to experience 
to scope of practice. While the services SWs, MFTs, and MHCs provide 
are not interchangeable, each offers unique supports that may be 
valuable to the patient and family based on the situation. Therefore, 
the individual hospice patient's needs, preferences, and goals, should 
guide the determination of which member of the team (SW, MFT or MHC) 
serves as the member of the IDG for that patient. For example, if the 
patient's assessed needs relate to VA benefits, the SW may be the most 
appropriate provider to meet those needs. However, if the patient's 
assessed needs are related to unresolved issues with their spouse, it 
may be appropriate to have MHC or MFT provide services to the patient. 
We believe the ability for hospice patients to receive additional 
mental health services and supports as part of their hospice care may 
empower patients and their families in decision making, thus improving 
the overall health and safety of the patient.
b. Personnel Qualifications (Sec.  418.114)
    As noted above, Division FF, section 4121 of the CAA 2023 requires 
CMS to permit an MHC or MFT to serve as members of the IDG. As 
discussed previously, we are proposing to modify the language at Sec.  
418.56 regarding the composition of the IDG to include MHCs and MFTs.

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.\278\ 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.
---------------------------------------------------------------------------

    \278\ See definition of ``laboratory'', https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493#493.2.
---------------------------------------------------------------------------

    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'') \279\ 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

[[Page 52541]]

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.
---------------------------------------------------------------------------

    \279\ CLIA Interpretive Guidelines: https://www.cms.gov/regulations-and-guidance/legislation/clia/interpretive_guidelines_for_laboratories.
---------------------------------------------------------------------------

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 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,\280\ CMS 
Policy Memo (QSO-22-13-CLIA)
---------------------------------------------------------------------------

    \280\ 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.
---------------------------------------------------------------------------

    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 for specified intervals of time to include a PHE, 
medical condition, or a situation where a pathologist has to examine 
slides away from the primary location.
    Pathologists that currently hold a CLIA certificate are 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 \281\) 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 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.
---------------------------------------------------------------------------

    \281\ See definition of ``laboratory'', https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493#493.2.
---------------------------------------------------------------------------

    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 are soliciting public input and comment on the following areas 
of CLIA: Histopathology; Cytology; and Clinical cytogenetics. The 
topics listed in this RFI are areas that CMS, CDC,

[[Page 52542]]

interested parties, and SA surveyors have identified that may 
potentially be used by CMS for future rulemaking.
a. Histopathology
    We are seeking public 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?
     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 are seeking public 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 are seeking public 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?

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 proposed 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 must be refunded to the Federal government. A State has 
inquired about whether it could ``suspend'' its program for a portion 
of time, so that it could shift BHP enrollees to other coverage with 
comparable benefits and cost sharing, while maintaining its BHP trust 
fund, which it could use if the State were to resume the BHP.
    We see the value in allowing a State currently operating a BHP to 
experiment with other ways of providing coverage that may increase the 
number of people covered while not increasing Federal costs. We propose 
to give a State the option of temporarily ``suspending'' its BHP 
program, while retaining accrued funds in the BHP trust fund for a 
limited period of time. Should the State decide to resume operating its 
BHP, the suspension would allow the State to leverage accrued funds and 
avoid the processes of terminating the program and refunding trust 
funds, and then later having to submit a new BHP application for 
approval. For that reason, under the authority of section 1331(c)(4) of 
the ACA, which requires coordination with other State health programs, 
we are proposing to amend Sec.  600.140 to add an option at paragraph 
(b) for a State to suspend its BHP.
    We propose at Sec.  600.140(b)(1) that States wishing to suspend 
their BHP 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 
propose that the application must be submitted at least 9 months in 
advance of the proposed effective date of the suspension or extension. 
In Sec.  600.140(c), we propose that the State cannot implement the 
suspension or extension without prior approval by the Secretary. 
However, for States seeking to suspend a BHP in the first plan year 
that begins

[[Page 52543]]

following publication of a final rule adopting this proposal, States 
must submit an application within 30 days of the publication of such a 
final rule. HHS will approve or deny such application as expeditiously 
as possible. We propose 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 Sec.  600.140(b)(1)(i) through (v). During 
the period of suspension, BHP enrollees should 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 
propose to require that the suspension and extension application 
demonstrates that the benefits that will be provided to individuals 
that meet the BHP eligibility criteria are at least equivalent to the 
benefits offered in the State's BHP. We propose 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 propose at Sec.  600.140(b)(1)(i) to require that benefits 
provided under the new coverage option must be at least equal to the 
BHP benefits in the certified Blueprint in effect on the effective day 
of suspension. This is the same standard that is used in the Medicaid 
regulations at Sec.  440.330 to determine if a State's alternative 
benefit package is equivalent to the benchmark benefit package. 
Additionally, it is similar to the standard that is used by CHIP at 
Sec.  457.420 to determine if a State's CHIP benefit package is 
equivalent to the benchmark benefit package, although the CHIP standard 
allows for some variation if the State is adding additional benefits as 
required by Title XXI. We note that it would be acceptable to provide 
additional benefits under the new coverage option, such that 
individuals receive more or greater benefits under the new coverage 
option. We considered whether there should be a look back period, such 
that benefits under the new coverage option would be compared to the 
BHP benefits provided under the certified Blueprint in effect for a 
period of time prior to the effective date of the suspension and seek 
comments on this alternative approach.
    In order to determine that the cost sharing required of individuals 
under the new coverage option does not exceed the BHP cost sharing 
levels, we propose 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. This may result in cost sharing for 
individual benefits differing between the BHP and the new coverage 
program, provided the actuarial value of the new coverage options meets 
or exceeds the actuarial value of the BHP standard health plans. 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 
propose 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. We considered whether to 
require that cost sharing under the new coverage option instead meet 
the cost sharing requirements under current regulations at Sec.  
600.520(c) and seek comment on whether this alternative approach should 
be adopted in the final rule.
    Similarly, we propose at Sec.  600.140(b)(1)(iii) to require that 
the premiums charged to individuals under the new coverage option must 
be comparable to BHP standard health plan premiums in effect 
immediately prior to the suspension period, beyond reasonable increases 
due to inflation as measured by the Consumer Price Index (CPI). We 
considered alternative methods for measuring equivalency in premiums. 
First, we considered whether to require that premiums under the new 
coverage option instead meet the premium requirements under Sec.  
600.505(a). Second, we considered whether premiums charged to 
individuals under the new coverage option should instead not exceed the 
premiums in effect on December 31, 2020, as these premiums levels do 
not account for any additional premium tax credit subsidies offered 
under the American Rescue Plan Act or the Inflation Reduction Act. 
Third, we considered whether premium and cost sharing levels, 
considered together, under the new coverage option would be considered 
sufficient, if those levels meet the requirements under a section 1115 
demonstration or section 1332 waiver. We also seek comment on whether 
these alternative approaches should be adopted in the final rule.
    We also considered alternatives to the timing of the comparison of 
benefits and cost sharing in BHP to the new coverage option. 
Specifically, we considered whether benefits and cost sharing under the 
new coverage option should be compared to the benefits and cost sharing 
under the BHP on the date the suspension application is submitted to 
HHS, or some other date. We also seek comment on the potential adoption 
of these alternatives in the final rule.
    Finally, we believe that the suspension period should not result in 
individuals losing coverage, solely due to a change in eligibility 
criteria for the program. Therefore, we are proposing in Sec.  
600.140(b)(1)(iv) that a state must demonstrate in its application that 
the eligibility criteria for coverage during the suspension is not more 
restrictive than the criteria described in Sec.  600.305.
    We believe 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 are 
proposing 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. When the suspension 
period, including any extension period, ends, we propose that the State 
would need to transition the BHP eligible population back to the BHP, 
or terminate the BHP. We propose at Sec.  600.140(b)(7) that at least 9 
months before the end of the suspension period, a State must submit a 
transition plan to HHS that explains how the State will reinstate its 
BHP, or terminate the program under Sec.  600.140(a) of the current 
regulations. The state must also notify the public of this change. 
Under proposed Sec.  600.140(b)(7), a State also could elect to end a 
BHP suspension before the end of the initial or extended suspension 
period by following the same process.
    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. We considered a shorter 
extension period of 2 or 3 years, and allowing multiple

[[Page 52544]]

extension periods given both section 1332 waiver and 1115 
demonstrations can be extended. We seek comment on these alternatives.
    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. 
In the case of alternative coverage provided through a section 1115 
demonstration project or section 1332 waiver, the evaluation and 
application required for such demonstration projects and waivers would 
satisfy this requirement.
    If individuals and/or standard health plans will 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 propose 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).
    In order to calculate a State's BHP payments, the State provides 
CMS an estimate of the number of BHP enrollees it projects will enroll 
in the upcoming BHP program quarter each quarter of program operations. 
We use those estimates to calculate the prospective payment, which is 
deposited in the State's BHP trust fund. Once the State provides us 
with actual enrollment data for those periods, the actual enrollment 
data is used to calculate the final BHP payment amount and make any 
necessary reconciliation adjustments to the prior quarters' prospective 
payment amounts due to differences between projected and actual 
enrollment.
    We believe that having an accurate accounting of the balance of the 
State's trust fund is critical for any State suspending its BHP. 
Therefore, we propose 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 believe that 12 months is a reasonable 
amount of time for a State to submit the actual enrollment data for the 
periods it was operating a BHP.
    One reason it is important for a State to complete the BHP payment 
reconciliation process is to establish a baseline balance for 
calculating interest. Currently, States' BHP trust funds can accrue 
interest, and this interest is retained in the BHP trust fund. However, 
we believe that interest accrued on the BHP trust fund during any 
suspension must be remitted to HHS. Since the State is not operating a 
BHP during the suspension period, suspension should not generate 
additional funds for the State. We propose in Sec.  600.140(b)(6) that 
while the State is not providing BHP coverage, any accrued interest on 
the trust fund must 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 above. We propose in Sec.  600.140(b)(5) to 
require States that suspend their BHP continue to submit an annual 
report during the suspension period. We proposed amendments to Sec.  
600.170(a), which describes the requirements for the annual reports, to 
describe the standards that will apply to States that have suspended 
their BHP. Specifically, we propose to redesignate the introductory 
language in paragraph (a) as paragraph (a)(1), to redesignate 
paragraphs (a)(1) through (a)(4) as paragraphs (a)(1)(i) through 
(a)(1)(iv), and to add a new paragraph Sec.  600.170(a)(2) to require 
that States that have suspended their BHP under Sec.  600.140(b) must 
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.
    If a State does not meet the proposed requirements (that is, 
completing the financial reconciliation process, remitting interest on 
the trust fund, and submitting the required information in its annual 
report), we propose in Sec.  600.140(d) that the Secretary can withdraw 
approval of the suspension. Specifically, we propose that the Secretary 
can withdraw approval of the suspension if the State ends 
implementation of the alternative coverage program for any reason, or 
if the State fails to continue to meet the coverage and cost sharing 
requirements of the alternative coverage program. If the State seeks an 
amendment to the alternative coverage program, the State must inform 
CMS of this proposed change so that CMS may evaluate if the coverage is 
sufficient. In addition, we propose at paragraph (d) that we could also 
withdraw approval if we have significant evidence of harm, financial 
malfeasance, fraud, waste, or abuse consistent with Sec.  600.142. In 
Sec.  600.140(d)(1) through (4), we propose a process for withdrawing 
approval, which mirrors the process for withdrawing certification of a 
BHP Blueprint in Sec.  600.142. Specifically, we propose that the 
Secretary will withdraw approval only after providing 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. We 
propose that the Secretary shall make every reasonable effort to 
resolve proposed findings without withdrawing approval of the 
suspension plan and in the event of a decision to withdraw approval, 
will accept a request from the State for reconsideration. The effective 
date of an HHS determination withdrawing approval of the suspension 
plan would not be earlier than 120 days following issuance of a final 
finding. Within 30 days following a final finding under paragraph 
(d)(1) of this paragraph, the State shall submit a transition plan to 
HHS.
    During the transition period from the BHP to other coverage the 
state may not use funds from the BHP trust fund toward the unwinding of 
the BHP program and transition to the new coverage program. 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. Therefore, Federal funding is not available for administrative 
expenses associated with transitioning BHP enrollees to a new coverage 
program or for costs associated with providing new coverage after the 
transition has occurred. States cannot use Federal BHP funding to cover 
premiums and cost sharing (or additional benefits) for individuals that 
would otherwise be eligible for BHP funding. We solicit comment on 
these proposals.
    We seek comment on the proposed process for suspending a BHP. 
Specifically, we seek comment on how far in advance of suspension a 
state must submit a suspension application to CMS and how far in 
advance of

[[Page 52545]]

suspension CMS must approve or deny the suspension request. We also 
seek comment on duration of time a state may suspend their BHP, without 
terminating the program.
2. Submission and Review of BHP Blueprints
    As noted above, under current Sec.  600.110, States must submit to 
the Secretary and receive certification of a BHP Blueprint describing 
their operational design choices prior to implementation. Under the 
current Sec.  600.125(a) a State that seeks to make significant changes 
to its BHP must submit a revised Blueprint to the Secretary for review 
and certification; however, the current regulation does not specify any 
timeframes for the submission and review of revised Blueprints. The 
current Sec.  600.125(a) also describes a limited number of changes 
under which submission of a revised Blueprint is required. Most 
notably, the current regulation does not require the submission of a 
revised Blueprint in response to changes in Federal law or regulations. 
Additionally, under current Sec.  600.125(a) and (b), any changes made 
in a revised Blueprint can be implemented prospective from the date of 
certification; no changes can be implemented until HHS certifies the 
revised Blueprint.
    We believe that additional parameters are necessary in order 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 propose changes to Sec.  600.125 to establish timeframes 
and procedures for the submission and review of BHP Blueprints, similar 
to the Medicaid and CHIP State plan amendment (SPA) submission and 
review processes. We note that these proposed timeframes only apply to 
the submission and review of revised Blueprints; we are not proposing 
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 believe States need 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 note, however, 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 propose 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 revision is considered received. 
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, CMS may 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 this 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 are also proposing to redesignate paragraph (c) 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 will 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 will be stopped and will 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 will 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. It 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 propose 
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 paragraph (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, except during a 
public health emergency, as described in paragraph (c). We propose to 
revise paragraph (b), redesignated as paragraph (d) in this proposed 
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 propose to apply some of the existing parameters for 
initial Blueprint submissions to Blueprint revisions. In paragraph (e), 
we propose that a State may withdraw the proposed revised Blueprint 
during HHS review if the State has not yet implemented the

[[Page 52546]]

proposed changes and provides written notice to HHS. This proposal 
mirrors current Sec.  600.130 for initial BHP Blueprints. In paragraph 
(f), we propose 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 are proposing to specify timeframes for the submission and 
review of revised BHP Blueprints under Sec.  600.125, we propose to 
revise Sec.  600.135 to apply only to the submission of initial BHP 
Blueprints. Specifically, we propose 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).
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). Although HHS Office for Civil 
Rights regulations at 45 CFR 92.101, which apply to programs such as 
Medicaid, CHIP and BHP, require States to take reasonable steps to 
provide meaningful access for individuals with LEP and to ensure 
effective communication with individuals with disabilities, we believe 
it is important for these obligations to also be described clearly in 
the BHP regulations. Therefore, we are proposing 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.
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. We 
believe all BHP enrollees should be afforded the opportunity to appeal 
not only eligibility determinations but also decisions about health 
services matters. The Exchange rules do not include an opportunity to 
appeal a health services matter, as such appeals are typically handled 
by State Departments of Insurance, as opposed to by the Exchange 
itself. Therefore, we propose in paragraph (b) to remove the option for 
States to conduct their BHP appeals process according to Exchange 
rules. In paragraph (b)(2), we propose 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. We believe that appeals of health services matter, like 
appeals of eligibility determinations, are a core function of a BHP. 
Therefore, in proposed Sec.  600.145(f)(2), we include appeals of 
health services matters as specified in Sec.  600.335 as a core 
operation of a BHP.

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), 
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 42 CFR 495.4, the Quality 
Payment Program at 42 CFR 414.1305, and the Shared Savings Program at 
42 CFR 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 42 CFR 495.4 and 42 CFR 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 in 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 
the Advanced Alternative Payment Models (Advanced APMs) may use 
technology certified to either the existing or updated 2015 Edition 
certification criteria, with the December

[[Page 52547]]

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 in 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 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 (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 
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 in recent years. 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 Interoperability Program and 
eligible clinicians participating in the Quality Payment Program must 
use certified health IT that satisfies the definitions of CEHRT at 42 
CFR 495.4 and 42 CFR 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 proposed rule, we are 
proposing 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.H.-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 proposed rule (88 
FR 27170), 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 48 in section 
IV.A.4.f.(4)(e)(iv) of this proposed 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. Proposed Revisions to Certified Electronic Health Record Technology 
Definitions in Regulatory Text
    We are proposing to revise the definitions of CEHRT in 42 CFR 495.4 
and 42 CFR 414.1305 for the Medicare Promoting Interoperability Program 
and for the Quality Payment Program so these definitions would be 
consistent with the ``edition-less'' approach to health IT 
certification as proposed in the ONC HT-1 proposed rule, should the ONC 
proposal be finalized. First, with respect to references to the ``2015

[[Page 52548]]

Edition Base EHR definition'' defined at 45 CFR 170.102, we are 
proposing to add a reference to the revised name ``Base EHR 
definition,'' proposed in the ONC HTI-1 proposed rule, to ensure, if 
finalized, it is applicable for the CEHRT definitions going forward (88 
FR 23759). Next, we are proposing 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. By removing the 
reference to the ``2015 Edition,'' and pointing to the regulations at 
45 CFR 170.315, we believe this proposal, if finalized, 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 would 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 in order to further simplify our regulatory approach, 
we are proposing 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.
    This proposal would 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 42 CFR 495.4 and 42 CFR 
414.1305, if ONC's applicable regulations are referenced directly in 
our CEHRT definitions. 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.
    It is important to note that this proposal, if finalized, would not 
mean that any update to a certification criterion finalized by ONC 
would 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 note 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 would 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 would allow eligible hospitals, 
CAHs, and MIPS eligible clinicians 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 42 CFR 495.4 and 42 CFR 
414.1305 through separate rulemaking.
    In summary, we are proposing to revise the definitions of CEHRT for 
the Medicare Promoting Interoperability Program at 42 CFR 495.4, and 
for the Quality Payment Program at 42 CFR 414.1305. Specifically, we 
are proposing to add a reference to the revised name of ``Base EHR 
definition,'' proposed in the ONC HTI-1 proposed rule, to ensure, if 
finalized, it is applicable for the CEHRT definitions going forward (88 
FR 23759). We are also proposing 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 also propose 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, if 
finalized, would ensure that updates to the definition at 45 CFR 
170.102 and updates to applicable health IT certification criteria in 
45 CFR 170.315 would be incorporated into the CEHRT definitions, 
without additional regulatory action by CMS.
    Finally, we note 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 are inviting public comment on these proposals.

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. We propose 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. 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 builds upon our 
separate proposal described earlier to establish a stand-alone G code 
(GXXX5) for SDOH Risk Assessment furnished in conjunction with an 
Evaluation and Management (E/M) visit (see section II.E. of this 
proposed 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

[[Page 52549]]

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 \282\ that around 50 percent of an individual's 
health is directly related to SDOH, which is defined by Healthy People 
2030 \283\ 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.
---------------------------------------------------------------------------

    \282\ https://aspe.hhs.gov/sites/default/files/documents/e2b650cd64cf84aae8ff0fae7474af82/SDOH-Evidence-Review.pdf.
    \283\ https://health.gov/healthypeople.
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    Several Federal agencies, including the CDC, AHRQ, ACL, ACF, 
SAMHSA, HRSA, 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.\284\ At CMS, addressing SDOH is an 
essential piece of the CMS Framework for Health Equity,\285\ 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.
---------------------------------------------------------------------------

    \284\ https://aspe.hhs.gov/sites/default/files/documents/aabf48cbd391be21e5186eeae728ccd7/SDOH-Action-Plan-At-a-Glance.pdf.
    \285\ https://www.cms.gov/files/document/cms-framework-health-equity-2022.pdf.
---------------------------------------------------------------------------

    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 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 points out, ``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.'' \286\
---------------------------------------------------------------------------

    \286\ 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 counseling for 
social determinants of health as a means of mitigating the growing 
disparities in health and longevity for underserved older adults.'' 
\287\
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    \287\ 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.
    We note that Sec.  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.

[[Page 52550]]

     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 note 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 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 finalized a 
proposal to include ACP as an optional element (at beneficiary 
discretion) within the AWV. We stated in the final rule we are adding 
ACP as a voluntary, separately payable element of the AWV. We are 
instructing 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
    We propose 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 recognize 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. We have heard 
from interested parties that the current elements of the AWV may not 
directly or adequately identify those SDOH challenges. We propose that 
the SDOH Risk Assessment be separately payable with no beneficiary cost 
sharing when furnished as part of the same visit with the same

[[Page 52551]]

date of service as the AWV. We propose 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 believe 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 recognize that patients with SDOH risks and challenges 
may often also experience communication barriers of various kinds when 
interacting with the health care system. 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). We believe 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 encourage 
partnerships with community-based organizations such as Area Agencies 
on Aging to help address identified social needs. We propose 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 believe our proposal will 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 hope that our proposal will 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 is the development of a 
personalized prevention plan that takes SDOH into account and is truly 
tailored to the individual patient. We invite public comment 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 recognize that SDOH risk assessments are an emerging and 
evolving tool in healthcare and so we do 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 \288\ tool, the Protocol for Responding to & Assessing 
Patients' Assets, Risks & Experiences (PRAPARE) tool,\289\ and 
instruments identified for Medicare Advantage Special Needs Population 
Health Risk Assessment.\290\ We also encourage clinicians, where 
feasible, to select screening instruments that maximize opportunities 
to collect and analyze standardized, quantifiable, and actionable data. 
For instance, clinicians are 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.
---------------------------------------------------------------------------

    \288\ https://innovation.cms.gov/files/worksheets/ahcm-screeningtool.pdf.
    \289\ https://www.nachc.org/research-and-data/prapare/.
    \290\ CMS-10825.
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    Our proposal builds upon our separate proposal described earlier to 
establish a stand-alone G code (GXXX5) for SDOH Risk Assessment 
furnished in conjunction with an E/M visit. See section II.E. for 
additional information on coding, pricing, and additional conditions of 
payment for the proposed new SDOH Risk Assessment service. Upon 
finalization of the CY 2024 PFS, CMS will issue public guidance in the 
Medicare Learning Network, the Medicare & You Handbook, and more 
formal, in-depth policy and payment instructions in the Medicare 
Benefit Policy Manual and the Medicare Claims Processing Manual on the 
CMS website.
    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 by recommending the assessment of SDOH through position or 
discussion papers,291 292 293 organizational strategic 
plans,\294\ and provider training modules,\295\ among others. As 
described earlier in our proposed rule, 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.
---------------------------------------------------------------------------

    \291\ https://www.aafp.org/about/policies/all/social-determinants-health-family-medicine-position-paper.html.
    \292\ https://doi.org/10.7326/M17-2441.
    \293\ https://nam.edu/social-determinants-of-health-201-for-health-care-plan-do-study-act/.
    \294\ https://www.ama-assn.org/system/files/2021-05/ama-equity-strategic-plan.pdf.
    \295\ https://edhub.ama-assn.org/steps-forward/module/2702762.
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    We propose 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 
is

[[Page 52552]]

analogous to our 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 would be an optional element 
within the AWV, there would 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 note 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 are proposing 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 propose 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 propose 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 invite public 
comment on our proposal.
    We have also 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 
invite public comment on this issue for consideration in future 
rulemaking.
4. Summary
    In conclusion, we are proposing to add a new Social Determinants of 
Health (SDOH) Risk Assessment as an optional element within the AWV. We 
are also proposing the SDOH Risk Assessment be paid at 100 percent of 
the fee schedule amount of the risk assessment. We are proposing that 
the new 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 believe our proposal will 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, 
as an additional, optional element in the AWV service.

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 proposed rule sets forth 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 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 2023 performance year receive a 3.5 
percent APM Incentive Payment in the 2025 payment year, and, beginning 
with the 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.
    As we move into the seventh year of the Quality Payment Program, we 
are

[[Page 52553]]

proposing the updates set forth in this section of this proposed rule, 
encouraging continued improvement in clinicians' performance with each 
performance year and drive improved quality of health care through 
payment policy.
    In developing and putting forth these proposals, 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, in order 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 MIPS Value Pathways (MVPs) aligns with many 
of the objectives and goals the CMS National Quality Strategy and the 
Universal Foundation strive to achieve. For example, in an effort to 
align implementation of the measures in the Universal Foundation across 
MIPS and APMs, we are proposing updates to consolidate the Promoting 
Wellness and Managing Chronic Conditions MVPs to align with the adult 
Universal Foundation measure set. We are also exploring the expansion 
of the APM Performance Pathway (APP) reported by clinicians in the 
Shared 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). In our goal to accelerate 
interoperability, we propose to require Shared Savings Program ACO 
clinicians to report the measures and objectives required by the MIPS 
Promoting Interoperability performance category. We are also proposing 
to modify our 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 propose to expand 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 certified EHR technology (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: the Merit-Based Incentive Program 
(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.\296\
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    \296\ CMMI Strategy Refresh. October 20, 2021. https://innovation.cms.gov/strategic-direction-whitepaper.
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(2) Major MIPS Provisions
    We are requesting 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 are 
seeking 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 proposing 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 proposing 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 proposing to codify previously finalized subgroup policies 
in the preamble to regulation text. Additionally, we are proposing 
updates

[[Page 52554]]

to previously finalized subgroup policies to help guide clinicians and 
groups to meaningfully participate in MVPs through subgroup reporting. 
Specifically, we are proposing to update the subgroup policy for 
reweighting of MVP performance categories, update the facility-based 
scoring as well as the complex patient bonus for subgroups under final 
score calculation, and add subgroups to the targeted review regulation 
text.
(c) MIPS Performance Category Measures and Activities
(i) Quality Performance Category
    We are proposing six modifications to the quality performance 
category. First, we propose 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 propose to establish the quality 
performance category data submission criteria for eCQMs that requires 
the utilization of CEHRT. Third, we propose to establish the data 
submission criteria for Medicare CQMs. Fourth, we propose to require 
the administration of the Consumer Assessment of Healthcare Providers 
and Systems (CAHPS) for MIPS Survey in the Spanish translation. Fifth, 
we propose to maintain the data completeness criteria threshold to 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. 
Sixth, we propose to establish the data completeness criteria for 
Medicare CQMs. Finally, we propose to establish a measure set inventory 
of 200 MIPS quality measures.
(ii) Cost Performance Category
    We are proposing to add five new episode-based measures to the cost 
performance category beginning with the CY 2024 performance period/2026 
MIPS payment year. These five proposed measures are Depression, 
Emergency Medicine, Heart Failure, Low Back Pain, and Psychoses and 
Related conditions; several of these have relevance to the CMS 
Behavioral Health Strategy (https://www.cms.gov/cms-behavioral-health-strategy). We are proposing to use a 20-episode case minimum for each 
of these new measures, and are requesting comments on our clarification 
of the indented interpretation of the language on the case minimums 
codified at Sec.  414.1350(c). We are also proposing to remove the 
Simple Pneumonia with Hospitalization episode-based measure beginning 
with the CY 2024 performance period/2026 MIPS payment year. Finally, we 
are proposing 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 proposing 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 being proposed 
relate to CMS Health Equity, Increase All Forms of Accessibility to 
Health Care Services and Coverage. We are also recommending the removal 
of three 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 proposing five policy modifications for the Promoting 
Interoperability performance category. Specifically, we propose 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.2.b. of this proposed 
rule, we are proposing to revise our regulatory definition of CEHRT for 
the 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 proposing updates to our scoring flexibilities policy. We 
are proposing to update the criteria by which we assess the scoring 
impacts of coding changes and apply our scoring flexibilities. We are 
also proposing that eCQM measure specifications would be required to 
include the ability to be truncated to a 9-month performance period.
(ii) Cost Improvement Scoring
    We are proposing two modifications to the cost improvement scoring 
method that was established in the CY 2018 Quality Payment Program 
final rule. First, we are proposing to change improvement scoring from 
a measure-level to a category-level method and to remove the 
statistical significance requirement. Second, we are proposing that the 
maximum cost improvement score is zero percentage points for the 2020 
through 2024 MIPS payment years, and one percentage point beginning 
with the CY 2023 performance period/2025 MIPS payment year.
(e) MIPS Payment Adjustments
    We are proposing to revise our policy for identifying the ``prior 
period'' by which we will establish the performance threshold beginning 
with the CY 2024 performance period/2026 MIPS payment year. 
Specifically, we are proposing to define the ``prior period'' by which 
we establish the performance threshold as three performance periods, 
instead of a single prior performance period, and codify this policy at 
Sec.  414.1405(g)(2). To determine the performance threshold for the CY 
2024 performance period/2026 MIPS payment year, we are proposing to use 
the CY 2017/2019 MIPS payment year through CY 2019 performance period/
2021 MIPS payment year as the prior period. Based on the mean final 
score from that prior period, we are proposing to establish the 
performance threshold as 82 points for the CY 2024 performance period/
2026 MIPS payment year.
(f) MIPS Targeted Review
    We are proposing to add virtual groups and subgroups as being 
eligible to submit a request for targeted review. We are proposing to 
codify this addition at Sec.  414.1385(a).
    We are proposing to amend at Sec.  414.1385(a)(2) with respect to 
the

[[Page 52555]]

timeline for MIPS eligible clinicians, groups, virtual groups, 
subgroups, and APM entities to request a targeted review of our 
calculation of their MIPS payment adjustment factor(s). Specifically, 
we are proposing 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 proposal would 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 proposing to amend Sec.  414.1385(a)(5). Specifically, 
we are proposing 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 proposal would 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 proposed rule, in addition to codifying previously 
finalized policies and proposing to make technical updates for clarity, 
we propose 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 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.
(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 proposing to 
modify the existing policy for public reporting on individual clinician 
and group profile pages, including proposals to revise:
     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 solicit 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 this proposed rule, we are proposing 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 this proposed rule, we are proposing to end 
the use of APM Entity-level QP determinations and instead make all QP 
determinations at the individual eligible clinician level. We are also 
proposing to modify the ``sixth criterion'' under the definition of 
``attribution-eligible beneficiary,'' which is listed at Sec.  
414.1305.\297\ Specifically, we are proposing to include any 
beneficiary who has received a covered professional service furnished 
by the NPI for the purpose of making QP determinations. We are also 
proposing 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 
proposing 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. In section IV.A.4.j. of this proposed 
rule, we are proposing to amend 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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    \297\ 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 this proposed rule, we are proposing 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 are proposing to amend the CEHRT use criterion for 
Advanced APMs at Sec.  414.1415(a)(1)(i) effective beginning for CY 
2024 to no longer apply the 75 percent CEHRT use minimum, 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 also proposing 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).

[[Page 52556]]

2. Definitions
    At Sec.  414.1305, we are proposing to revise the definitions of 
the following terms:
     Attribution-eligible beneficiary;
     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 proposed 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 \298\ 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.\299\ Adoption of the Universal Foundation 
300 301 will focus clinician attention on specific quality 
measures, 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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    \298\ 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.
    \299\ CMS National Quality Strategy. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/CMS-Quality-Strategy.
    \300\ Aligning Quality Measures across CMS. https://www.cms.gov/aligning-quality-measures-across-cms-universal-foundation https://www.cms.gov/aligning-quality-measures-across-cms-universal-foundation.
    \301\ 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 propose in this proposed rule 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. We refer readers 
to section IV.A.4.b. and Appendix 3: MVP Inventory, Table B.11 of this 
proposed rule for our proposed updates to the Promoting Wellness and 
Chronic Disease Management MVPs. We will continue to identify 
additional measures, which may be included in future MVPs, to capture 
aspects of specialist quality in the Universal Foundation.\302\ We also 
refer readers to section III.G.2.c. of this proposed rule for 
discussions on expanding the APM Performance Pathway (APP) reported by 
clinicians in the Shared Savings Program and Advanced APMs to include 
Medicare Clinical Quality Measure (Medicare CQM) collection types and 
further alignment with the Universal Foundation.
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    \302\ Aligning Quality Measures across CMS--The Universal 
Foundation. Jacobs, Schreiber, Seshamani, Tsai, Fowler, and 
Fleisher. https://www.nejm.org/doi/full/10.1056/NEJMp2215539.
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(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.\303\ Specifically, the 
CMS Office of Minority Health released the CMS Framework for Health 
Equity,\304\ 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 \305\ in 2021, which describes the CMS Equity Plan for 
Medicare and progress from 2015 to 2021.
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    \303\ CMS National Quality Strategy. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/CMS-Quality-Strategy.
    \304\ CMS Equity Plan for Improving Quality in Medicare. https://www.cms.gov/About-CMS/Agency-Information/OMH/OMH_Dwnld-CMS_EquityPlanforMedicare_090615.pdf.
    \305\ 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).
(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.\306\ 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 section III.G.2.h. of this proposed 
rule, we propose to require Shared Savings Program ACO clinicians to 
report the measures in the MIPS Promoting Interoperability performance 
category. Additionally, in section III.G.2.h.(2) of this proposed rule, 
we propose to modify our requirements for use of CEHRT for Advanced 
APMs to promote flexibility in adopting CEHRT that is clinically 
relevant to participants, emphasizing the importance of 
interoperability and health information technology. We believe these 
proposals, 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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    \306\ 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). The Quality Payment Program allows for eligible clinicians 
to engage in value-based, patient-centered care via

[[Page 52557]]

two tracks: the Merit-Based Incentive Program (MIPS) and Advanced 
Alternative Payment Models (APMs). MIPS encourages collection and 
submission of data for evidence-based, specialty-specific quality 
measures, completion of practice-based improvement activities, 
consideration of cost measures, and use of certified electronic health 
record (EHR) technology (CEHRT) to support interoperability (81 FR 
77010). APMs are models operating under section 1115A of the Act, the 
Shared Savings Program under section 1899 of the Act (that is, 
Accountable Care Organizations), or a demonstration under section 1866C 
or required by Federal law. 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.\307\ 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.\308\ 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.\309\
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    \307\ 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.
    \308\ 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.
    \309\ Innovation Center Strategy Refresh. https://innovation.cms.gov/strategic-direction-whitepaper.
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    CMS recently established, and is implementing, various strategies 
that are intended to fulfill the potential of Advanced 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 Accountable Care Organizations 
(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.\310\ 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 MIPS, in part, to reduce reporting burden, and 
create new scoring opportunities for MIPS eligible clinicians 
participating in MIPS APMs (85 FR 84720).
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    \310\ CMMI Strategy Refresh. October 20, 2021. https://innovation.cms.gov/strategic-direction-whitepaper.
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(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 in MIPS 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 MVPs with the intention to support clinicians in 
their journey of continuous performance improvement and to reduce 
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 the MIPS program, 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 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 on which that 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 on 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 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 are 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 
are 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 are seeking comment on how we can modify our policies under the 
Quality Payment Program to foster clinicians' continuous performance

[[Page 52558]]

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 request 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?
4. MVP Development, Maintenance, and Scoring
a. Development of New MIPS Value Pathways (MVPs)
    In the in the CY 2023 PFS final rule (87 FR 70035 and 70037), we 
finalized modifications to our MVP development process to include 
feedback from the general public before the notice and comment 
rulemaking process. We will evaluate a submitted candidate MVP through 
the MVP development process, and if we determine it is ``ready'' for 
feedback, we would post a draft version of the submitted candidate MVP 
on the Quality Payment Program (QPP) website (https://qpp.cms.gov) and 
solicit feedback for a 30-day period. The general public would have the 
opportunity to submit feedback on the candidate MVP for CMS's 
consideration through an email inbox. We stated that we would review 
the feedback received, and determine if any changes should be made to 
the candidate MVP prior to potentially including the MVP in a notice of 
proposed rulemaking. If we determine changes should be made to the 
candidate MVP, we would not notify the interested parties who 
originally submitted the candidate MVP for CMS consideration in advance 
of the rulemaking process. We refer readers to the MVP Candidate 
Feedback Process web page, available on the Quality Payment Program 
website, to review the public feedback we received for each candidate 
MVP (https://qpp.cms.gov/mips/candidate-feedback).
    Through our development processes for new MVPs (see 85 FR 84849 
through 84856, 87 FR 70035 through 70037), we aim to gradually develop 
new MVPs that are relevant and meaningful for all clinicians who 
participate in MIPs. In this proposed rule, we are proposing the 
inclusion of five 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
    We continue to develop MVPs based on needs and priorities, as 
described in the MVP Needs and Priorities document at https://qpp-cm-prod-content.s3.amazonaws.com/uploads/1803/MIPS%20Value%20Pathways%20(MVPs)%20Development%20Resources.zip. We 
refer readers to Appendix 3: MVP Inventory, in this proposed rule for 
discussion of each proposed new MVP.
b. MVP Maintenance on Previously Finalized MVPs
    In the CY 2023 PFS final rule (87 FR 70037), we finalized a 
modification to the annual maintenance process for MVPs that were 
previously adopted through notice and comment rulemaking (86 FR 65410). 
Interested parties and the general public may submit their 
recommendations for potential revisions to established MVPs on a 
rolling basis throughout the year. We would then review the submitted 
recommendations and determine whether any are potentially feasible and 
appropriate. We stated that if we identify any submitted 
recommendations that are potentially feasible and appropriate, we would 
host a public facing webinar, open to interested parties and the 
general public through which they may offer their feedback on the 
potential revisions we have identified. We would publish details 
related to the timing and registration process for the webinar through 
our Quality Payment Program Listserv. We held our first MVP maintenance 
webinar in February 2023 (https://youtu.be/4cuZGUr88SA), to discuss any 
feedback we received from interested parties regarding previously 
finalized MVPs.
    In the CY 2022 PFS final rule (86 FR 65998 through 66031), we 
finalized seven MVPs that are available for reporting beginning with 
the CY 2023 performance period/2025 MIPS payment year:
     Advancing Rheumatology Patient Care;
     Coordinating Stroke Care to Promote Prevention and 
Cultivate Positive Outcomes;
     Advancing Care for Heart Disease;
     Optimizing Chronic Disease Management;
     Adopting Best Practices and Promoting Patient Safety 
within Emergency Medicine;
     Improving Care for Lower Extremity Joint Repair; and
     Patient Safety and Support of Positive Experiences with 
Anesthesia.
    In addition, in the CY 2023 PFS final rule (87 FR 70037), we 
finalized five additional MVPs that are available for reporting 
beginning with the CY 2023 performance period/2025 MIPS payment year:
     Advancing Cancer Care;
     Optimal Care for Kidney Health;
     Optimal Care for Neurological Conditions;
     Supportive Care for Cognitive-Based Neurological 
Conditions; and
     Promoting Wellness.
    In this proposed rule, we are proposing modifications to these 
twelve

[[Page 52559]]

MVPs to propose 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 proposed removals of certain improvement activities from 
the improvement activities inventory and the proposed addition of other 
relevant existing quality measures for MVP participants to select from. 
In addition, through the MVP maintenance process, we are proposing 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). (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 to the 
established MVPs.
c. Scoring MVP Performance
    In the CY 2022 PFS final rule, we finalized policies for MVP 
scoring that take 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 the goals of the MVP framework (86 FR 
65419).
    We refer readers to section IV.A.4.g.(1)(c)(i) of this proposed 
rule for proposed policies on MIPS scoring flexibilities in the quality 
performance category scoring; section IV.A.4.g.(1)(d)(i) in this 
proposed rule for the proposed change to scoring improvement in the 
cost performance category; section IV.A.4.f.(3)(b) and Appendix 2: 
Improvement Activities, of this proposal rule for the proposed 
improvement activity ``IA_MVP, Practice-wide quality improvement in the 
MIPS Value Pathway Program (MVP)'' in the improvement activities 
performance category; section IV.A.4.f.(4) in this proposed rule for 
the proposed policies for the Promoting Interoperability performance 
category, 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 section IV.A.4.d. of this proposed 
rule for proposed policies 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.
    We refer readers to section IV.A.4.j. of this proposed rule for 
proposed policies regarding Targeted Review process, including the 
addition of virtual groups to our Targeted Review policies.
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 refer readers to Title 42 
of the Code of Federal Regulations (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 this section, we are proposing to: (1) update the subgroup 
policy for reweighting of MVP performance categories at Sec.  
414.1365(e)(2); (2) update the facility-based scoring and complex 
patient bonus for subgroups under final score calculation at Sec.  
414.1365(e)(3) and (4); (3) update the targeted review policy for 
subgroups at Sec.  414.1385; and (4) codify in our regulations the 
subgroup policies finalized in previous years' rules.
(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 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

[[Page 52560]]

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. We are therefore proposing 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 are proposing 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 request comments on this proposal.
(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 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 
note 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. We would also 
calculate a score for traditional MIPS for this clinician or group and 
assign the higher of the scores. If a facility-based clinician chooses 
to participate in MVP for a MIPS performance period, a facility-based 
score would be calculated as part of traditional MIPS and not as part 
of MVP reporting. Subgroup reporting is limited to MVPs, and subgroup 
reporting is not available for clinicians reporting on measures in 
traditional MIPS. Therefore, we are proposing 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 are requesting comments on this proposal.
(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

[[Page 52561]]

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. For the reason 
stated previously in this section, we are proposing 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 are proposing 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. Similarly, we are proposing 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).
    We are requesting comments on this proposal.
(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 are proposing 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. We are also proposing 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. 
Additionally, we are proposing 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.'' 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. We note that we are proposing additional changes to the 
targeted review process set forth in Sec.  414.1385(a) as further 
described in section IV.A.4.j. of this proposed rule.
    We are requesting comments on the above proposals.
(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 
now propose to correct these errors.
    It is necessary for each of the proposed changes to the policies 
described below to 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, we 
believe that the failure to apply the proposed 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 are proposing to adopt this change 
retroactively pursuant to section 1871(e)(1)(A)(ii). We believe that 
the failure to apply the proposed

[[Page 52562]]

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 are proposing 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 are requesting comments on this proposal.
(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 are 
proposing to adopt this change retroactively pursuant to section 
1871(e)(1)(A)(ii). 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 as described at Sec.  414.1318(c). Therefore, we are proposing 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 are requesting comments on this proposal.
(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 above, we are 
proposing to adopt this change retroactively pursuant to section 
1871(e)(1)(A)(ii). 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 data submission requirements 
established in Sec.  414.1360(a)(2) regarding the reporting of 
improvement activities by subgroups. Therefore, we are proposing 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 are requesting comments on this proposal.
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).
(2) Proposal for the Medicare Clinical Quality Measure for Accountable 
Care Organizations Participating in the Medicare Shared Savings Program
    As discussed in section III.F.2.b.(2) of this proposed rule, we are 
proposing 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 would be available to only ACOs 
participating in the Shared Savings Program. ACOs in the Shared Savings 
Program would have the option to report the Medicare CQM under the APP 
on only their attributed Medicare fee-for-service beneficiaries who 
meet the definition of a ``beneficiary eligible for Medicare CQM(s)'' 
as proposed in section III.F.2.b.(2) of this proposed rule, instead of 
their all payer/all patient population, beginning with the 2024 
performance year. The Medicare CQM would also 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). As discussed in 
section III.F.2.b.(2) of this proposed rule, 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. We 
encourage readers to review additional background on our proposal to 
include the Medicare CQM collection type in the APP measure set 
discussed at section III.F.2.b.(2) of this proposed rule.
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

[[Page 52563]]

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 refer 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 this proposed rule, we are proposing 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 administration of the Consumer Assessment of 
Healthcare Providers and Systems (CAHPS) for MIPS Survey in the Spanish 
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 this 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 
section III.G.2. of this proposed rule, we are proposing to amend the 
definition of the term ``collection type'' to include Medicare CQMs in 
order 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 are 
proposing 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 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 seek 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.
(c) Quality Data Submission Criteria
(i) Data Submission Criteria for Quality Measures
    In this proposed rule, we are proposing technical amendments to 
data submission criteria for MIPS quality measures and proposing 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 are proposing 
technical amendments. We are proposing 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 
are proposing 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 
are proposing 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 are making a grammatical 
correction to Sec.  414.1335(a)(1)(i) to ensure subject-verb agreement. 
We note 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.
    We are proposing technical amendments to the data submission 
criteria for the CAHPS for MIPS Survey measure, which would identify 
the CAHPS for MIPS Survey as a measure in Sec.  414.1335(a)(3). The 
current rule does not reference the CAHPS for MIPS Survey as a measure, 
which is erroneous. Also, we are proposing 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 are proposing 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

[[Page 52564]]

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 are proposing 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 are proposing that the data 
submission criteria for eCQMs requires the utilization of CEHRT, as 
defined in Sec.  414.1305. Furthermore, we are proposing 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 note that the proposal pertaining to the data submission 
criteria for eCQMs requiring the utilization of CEHRT would 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 would 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 note 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 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 this 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 to 
meet the requirement to use CEHRT for eCQMs.
    Lastly, we are proposing to establish data submission criteria for 
the Medicare CQM collection type (as proposed under the APP in section 
III.G.2. of this proposed rule) in Sec.  414.1335(a)(4). Specifically, 
in Sec.  414.1335(a)(4)(i), we are proposing that the data submission 
criteria pertaining to Medicare CQMs would 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 seek 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.
(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 ten 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 via the APM Performance Pathway 
(APP).

[[Page 52565]]

(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 of English survey. However, use of these translations is 
generally voluntary, with the exception of the requirement to 
administer the Spanish translation of the CAHPS for MIPS Survey for 
patients residing in Puerto Rico. 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 CAHPS for MIPS 
Survey translations are an additional cost to the groups, virtual 
group, subgroup, and APM Entities.
    Our analysis of historic CAHPS data indicates that the use of 
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 indicates 
that 406 out of 559 organizations have about one percent to 9 percent 
respondents reporting they speak a language other than English at home, 
and 141 out of 559 organizations have 10 percent or more respondents 
reporting they speak a language other than English at home. Among these 
141 organizations with 10 percent or more respondents reporting they 
speak a language other than English at home, 114 organizations have all 
of their survey responses in English. These data highlight a potential 
gap in the need for and access to a CAHPS for MIPS Survey translation 
within at least 20 percent (114 out of 559 organizations) of the groups 
and Shared Savings Program ACOs administering the 2021 CAHPS for MIPS 
Survey. For the CAHPS for MIPS Survey, the most common non-English 
language spoken at home by patients is Spanish. We analyzed data from 
the U.S. Census Bureau, specifically from the 2021 American Community 
Survey, and found that Spanish is spoken by 61 percent of those who 
speak a language other than English at home.\311\ Among those age 65 
and older who speak a language other than English at home, 49 percent 
speak Spanish. Requiring groups, virtual groups, subgroups, and APM 
Entities to administer the CAHPS for MIPS Survey in English and Spanish 
would therefore address much of the unmet need. The requirement would 
indirectly require vendors to offer the administration of the Spanish 
translation of the CAHPS for MIPS Survey, and would increase costs to 
groups, virtual groups, subgroups, and APM Entities.
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    \311\ 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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    We propose to require the administration of the CAHPS for MIPS 
Survey in the Spanish translation; more specifically, we propose to 
require groups, virtual groups, subgroups, and APM Entities to contract 
with a CMS-approved survey vendor that, in addition to administering 
the survey in English, would administer the Spanish translation to 
Spanish-preferring patients using the procedures detailed in the CAHPS 
for MIPS Quality Assurance Guidelines. Also, we are recommending that 
groups, virtual groups, subgroups, and APM Entities 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, and provide an 
opportunity to better understand their experiences of care and any 
disparities in care.
    Furthermore, the requirement of the administration of the Spanish 
translation and the recommendation of utilizing the other translations 
of the CAHPS for MIPS Survey align with CMS's effort to provide 
culturally and linguistically appropriate services (CLAS), which are 
intended to advance health equity, improve quality, and help eliminate 
health care disparities.\312\ Other CMS-administered CAHPS Surveys, 
such as the Medicare Advantage and Prescription Drug Plan CAHPS, 
require the administration of Spanish translation survey. For the 
fiscal year (FY) 2024 Medicare Hospital Inpatient Prospective Payment 
System (IPPS) and Long Term Care Hospital (LTCH) Prospective Payment 
System (PPS) proposed rule, the PPS-Exempt Cancer Hospital Quality 
Reporting (PCHQR) Program is proposing to require hospitals to collect 
information about the language that the patient speaks while in the 
hospital (whether English, Spanish, or another language), and that the 
official Spanish translation of the Hospital CAHPS Survey be 
administered to all patients who prefer Spanish (88 FR 27114).
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    \312\ Centers for Medicare & Medicaid Services. Achieving Health 
Equity. Available at https://www.cms.gov/Outreach-and-Education/MLN/WBT/MLN1857916-OMH-AHE/OMHAHE/ahe/lesson01/09/index.html.
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    We seek public comment on the proposal to require the 
administration of CAHPS for MIPS Survey in the Spanish translation. In 
addition, we are interested in comments from organizations that 
administer the CAHPS for MIPS Survey on whether 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. If so, we are 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. These comments may inform future rulemaking.
(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

[[Page 52566]]

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,\313\ 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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    \313\ 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 are proposing 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 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 are 
proposing 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 electronic health records (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 continue 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 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 this proposed 
rule, we are proposing 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 
are proposing 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

[[Page 52567]]

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 are proposing 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 are proposing 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 discussed in the 
following section, IV.A.4.f.(1)(d)(ii), of this proposed rule.
    We seek public comment on these proposals.
(ii) Data Completeness Criteria for the Medicare CQMs
    As we propose to establish a new collection type, the Medicare CQMs 
specific to the APM Performance Pathway (APP) as described in section 
III.G.2. of this proposed rule, we are also proposing to establish the 
data completeness criteria thresholds for the Medicare CQMs. 
Specifically, in Sec.  414.1340(d), respectively, we are proposing 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 are proposing 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.
(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 are 
proposing changes to the MIPS quality measure set, as described in 
Appendix 1 of this 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 are proposing a measure set of 200 MIPS quality 
measures in the inventory.
    The new MIPS quality measures that we are proposing to include in 
MIPS for the CY 2024 performance period and future years can be found 
in Table Group A of Appendix 1 of this proposed rule. For the CY 2024 
performance period, we are 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, we develop and maintain specialty measure sets to assist MIPS 
eligible clinicians with selecting quality measures that are most 
relevant to their scope of practice. We are proposing modifications to 
existing specialty sets and new specialty sets as described in Table 
Group B of Appendix 1 of this 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

[[Page 52568]]

Program.\314\ 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 this proposed rule.
---------------------------------------------------------------------------

    \314\ 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 
described in Tables Group A and Group B of Appendix 1 of this proposed 
rule, we refer readers to Table Group C of Appendix 1 of this 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 are proposing 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 refer readers to Table Group DD of Appendix 1 of this 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 this 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 are proposing substantive changes to several MIPS quality 
measures, which can be found in Table Group D of Appendix 1 of this 
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 are proposing 
substantive changes to 59 MIPS quality measures, which includes 3 MIPS 
quality measures proposed to be retained for utilization under MVPs (we 
refer readers to Table Group DD of Appendix 1 of this 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 are proposing 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 this proposed rule.
    We seek 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.
(2) Cost Performance Category
    Section 1848(q)(2)(A) of the Act includes resource use as a 
performance category under the 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 the 
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 this proposed rule, we are proposing to add five new episode-
based measures to the cost performance category beginning with the CY 
2024 performance period/2026 MIPS payment year. These five measures 
are: Depression, Emergency Medicine, Heart Failure, Low Back Pain, and 
Psychoses and Related Conditions. We are proposing that MIPS eligible 
clinicians must meet or exceed a minimum of 20 cases for each of these 
measures to be assessed on such measure, and we are seeking comments on 
our interpretation of the language on the case minima codified at Sec.  
414.1350(c). We are also proposing 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. Finally, we are proposing 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 refer 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.  [thinsp]414.1350(a), we specify cost measures for a 
performance period to assess the performance of MIPS eligible 
clinicians on the cost performance

[[Page 52569]]

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 proposed measures cover clinical topics and MIPS 
eligible clinicians currently with limited or no applicable cost 
measures. As such, these proposed measures would help fill gaps in the 
cost performance category's measure set. In addition, these proposed 
measures would support the transition from traditional MIPS to MIPS 
Value Pathways (MVPs) by allowing for new MVPs to be created and 
enhancing existing MVPs. Further, the addition of these proposed 
measures would address interested parties' feedback about the need for 
more clinically refined episode-based measures in the cost performance 
category. This proposal would 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.
    At a high level, episode-based measures represent the cost to 
Medicare and beneficiaries for the items and services furnished during 
an episode. They aim to compare MIPS eligible clinicians on the basis 
of the cost of care that is clinically related to their treatment and 
management of a patient and provided during the episode's timeframe. 
Specifically, for such measures, we define and measure the cost of care 
for the episode based on the allowed amounts on Medicare claims, which 
include both Medicare trust fund payments and any applicable 
beneficiary deductible and coinsurance amounts. The cost of care for 
these measures includes amounts paid under Medicare Parts A and B, and, 
on a case-by-case basis, Medicare Part D that have been standardized to 
remove price variation from non-clinical factors. The Parts A and B 
payment standardization methodology and the Part D payment 
standardization methodology are available at https://resdac.org/articles/cms-price-payment-standardization-overview. Information about 
how the Part D standardization methodology incorporates rebates into 
standardized amounts is available at https://www.cms.gov/files/document/2023-part-d-rebate-methodology.pdf. We refer the readers to 
section IV.A.4.f.(2)(a)(iii) of this proposed rule for more information 
on the five episode-based measures we are proposing.
    In this proposed rule, we provide detail about the new measures 
that we are proposing to include in the cost performance category 
beginning with the CY 2024 performance period/2026 MIPS payment year. 
In section IV.A.4.f.(2)(a)(ii) of this proposed rule, we summarize the 
timeline for development of these proposed measures, including 
engagement activities undertaken by the measure development contractor. 
In section IV.A.4.f.(2)(a)(iii) of this proposed rule, we summarize the 
proposed new measures that would be included in the cost performance 
category beginning with the CY 2024 performance period/2026 MIPS 
payment year. For the proposed Emergency Medicine episode-based 
measure, we provide detail about the measure's construction, which 
evaluates a MIPS eligible clinician's or clinician group's risk-
adjusted cost of care to Medicare for patients who receive treatment in 
the Emergency Department (ED) setting. In section IV.A.4.f.(2)(b) of 
this proposed rule, we discuss our proposal that MIPS eligible 
clinicians must meet or exceed a minimum of 20 cases for each of these 
proposed measures to be assessed on such measure and request comments 
on our interpretation of case minima regulatory language.
(ii) Overview of Measure Development Process for New Episode-Based 
Measures
    In this section, we describe the development process for the five 
proposed episode-based measures.
    Development of episode-based measures for the cost performance 
category must comply with the statutorily required processes set forth 
in section 1848(r) of the Act. We note that the measure developer uses 
a ``wave'' approach to indicate cycles of measure development where 
clinical expert panels convene to select episode groups to develop into 
cost measures and to provide input on the measures' specifications. All 
five of the proposed measures have been developed with extensive 
engagement from interested parties, including clinicians, persons with 
lived experience, and the general public. The term ``persons with lived 
experience,'' as used in this section IV.A.4.f.(2) of this proposed 
rule, refers to persons and family of persons who have experienced 
these conditions or diseases. Our approach to engagement is outlined in 
the CY 2018 Quality Payment Program final rule (82 FR 53644 through 
53645), the CY 2019 PFS final rule (83 FR 59767 through 59769), and the 
CY 2022 PFS proposed rule (86 FR 39396 through 39397). These processes 
have been refined over time to incorporate feedback from interested 
parties, such as to extend the development timeline from 12 months in 
Wave 2 to 18 months in Waves 3 and 4, and to integrate bidirectional 
conversations between persons with lived experience and clinical 
experts.
    Four of these measures began development in 2020 in Wave 4 of 
development, and one of these measures has been in development and 
refinement since 2018 (as part of Wave 2 of measure development). 
Specifically, the Depression, Emergency Medicine, Heart Failure, and 
Low Back Pain episode-based measures were developed in the Wave 4 cycle 
of measure development through an 18-month process. As a first step, 
the measure development contractor held a public comment period from 
December 2020 through February 2021 to gather feedback on which 
clinical areas to prioritize for development. During the public comment 
period, the measure developer received 36 comments on the candidate 
episode groups for development in Wave 4. This feedback, in conjunction 
with empirical testing by the measure development contractor, was used 
to inform the decision to develop these specific clinical areas--
depression, emergency medicine, heart failure, and low back pain--into 
episode-based measures. The summary of the public comments is available 
in this document https://www.cms.gov/files/document/wave-4-public-comment-summary.pdf.
    Following our decision to develop measures for depression, 
emergency medicine, heart failure, and low back pain, the measure 
development contractor convened four clinician expert panels, comprised 
of a total of 73 members, affiliated with 63 organizations and 
specialty societies. Each panel also incorporated the perspective of 
persons with lived experience following a new approach where their 
input is collected via structured focus groups, interviews or surveys, 
and then summarized and presented to the clinical expert panels.
    Then, the measure development contractor held a national field 
testing period from January 14, 2022 to March 25, 2022. During this 
field testing period, MIPS eligible clinicians and clinician groups 
meeting a minimum threshold of episodes for each measure could review 
field test reports and an episode-level file with detailed

[[Page 52570]]

information to understand the types of services that comprise a large 
or small share of their episode costs. Supplemental materials, such as 
testing information on measures, a Frequently Asked Questions document, 
and mock field test reports were posted publicly for interested 
parties' review. The measure development contractor gathered all 
feedback via a survey and a summary of this feedback from the field 
testing period is available at https://www.cms.gov/files/document/2022-field-testing-feedback-summary-report.pdf.
    The measure development contractor also has a standing technical 
expert panel (TEP), composed of 20 members from different clinical 
areas, academia, health care and hospital administration, and persons 
with lived experience, which provides overarching input on cross-
measure topics, such as testing approaches and methodology. For 
example, the TEP discussed challenges in developing chronic condition 
episode-based measures and ways that the framework can address those 
challenges, provided feedback on the attribution rules (that is, the 
algorithms and the types of codes used in each algorithm) that would 
demonstrate a relationship between a clinician group and a patient with 
a chronic condition(s), and discussed service assignment, risk 
adjustment, and exclusions. This input helped inform the specifications 
for the chronic condition episode-based measure framework, which serves 
as the framework for three of the chronic condition episode-based 
measures (that is, Depression, Heart Failure, and Low Back Pain 
episode-based measures) developed in Wave 4 and being proposed in this 
proposed rule.
    Separately from the other four proposed measures, the Psychoses and 
Related Conditions measure originally had begun development in 2018 as 
part of Wave 2, alongside 10 other episode-based measures. However, 
this measure has not yet been implemented in the cost performance 
category. During the 2018 through 2019 measure development cycle, a 
convened clinical expert workgroup met four times to provide detailed 
input on the measure and the measure was field tested as part of the 
field testing period in 2018. The summaries of the workgroup webinars 
as well as the comments received on the original version of the measure 
during field testing are available on the QPP Cost Measure Information 
page at https://www.cms.gov/Medicare/Quality-Payment-Program/Quality-Payment-Program/Cost-Measures.
    We included the Psychoses and Related Conditions measure in the 
``2018 Measures Under Consideration List'' (https://www.cms.gov/files/document/2018rmuc-listclearancerpt.pdf) and the Measure Application 
Partnership (MAP) reviewed the measure during the 2018-2019 review 
cycle. In December 2018, the MAP Clinician Workgroup provided the 
Psychoses and Related Conditions episode-based measure a preliminary 
recommendation of ``Conditional support for rulemaking,'' on the 
condition of endorsement by a consensus-based entity (CBE). In January 
2019, the MAP Coordinating Committee overturned the MAP Clinician 
Workgroup's recommendation and voted to replace it with a 
recommendation of ``Do not support for rulemaking.'' The MAP 
Coordinating Committee's concerns with the Psychoses and Related 
Conditions measure related to: (1) the measure's attribution model and 
its potential to hold clinicians responsible for costs outside of their 
influence; (2) geographic variation in community resource availability; 
(3) effects of physical comorbidities on measure score; and (4) the 
potential to exacerbate access issues in mental health care. For more 
detail please refer to the final report at http://www.qualityforum.org/Publications/2019/03/MAP_Clinicians_2019_Considerations_for_Implementing_Measures_Final_Report.aspx.
    In the CY 2020 PFS proposed rule (84 FR 40760), we responded to the 
MAP Coordinating Committee's concerns, as we believed that these 
concerns had already been addressed through the development and testing 
processes, and solicited comments as part of the request for 
information (RFI) on the potential use of the original draft version of 
the Psychoses and Related Conditions episode-based measure in the cost 
performance category in a future MIPS performance period.
    The measure development contractor considered the MAP Coordinating 
Committee's comments and responses to the RFI that we received when 
refining the Psychoses and Related Conditions measure in 2021-2022. In 
October 2021, the measure developer reconvened the Psychoses and 
Related Conditions Clinical Expert Workgroup to consider measure 
refinements to address concerns, noting that the measure concept 
continued to be important as it would encourage value in mental health 
care. The details of these refinements are outlined in section 
IV.A.4.f.(2)(a)(iii) of this proposed rule. Then, the measure 
development contractor field tested the Psychoses and Related 
Conditions measure alongside the other four proposed new episode-based 
measures discussed previously in this section of the proposed rule. The 
feedback received during field testing was further discussed by the 
Psychoses and Related Conditions Clinical Expert Workgroup in April 
2022.
    More information about the measure development and interested 
parties engagement process for the five proposed episode-based measures 
for inclusion in the cost performance category is available in 
materials on the QPP Cost Measure Information page at https://www.cms.gov/Medicare/Quality-Payment-Program/Quality-Payment-Program/Cost-Measures. Summaries of the public comment period and clinician 
expert workgroup meetings organized by the measure development 
contractor are also available on the QPP Cost Measure Information page 
at https://www.cms.gov/Medicare/Quality-Payment-Program/Quality-Payment-Program/Cost-Measures.
    Similar to previous years, the measure development contractor has 
continued to engage clinicians and interested parties through the 
standing TEP, public comment periods, measure-specific Clinical Expert 
Workgroups, Person and Family Engagement opportunities, and national 
field testing, as well as conduct extensive education and outreach 
activities. For more information on the methods through which the 
measure development contractor gathered expert input during measure 
development and other interested parties engagement activities, please 
refer to the ``2023 Summary of Cost Measures'' document that is 
available at https://www.cms.gov/files/document/2023-mips-summary-cost-measures.pdf.
    After these extensive measure development and refinement 
activities, we included the five proposed episode-based measures on our 
2022 Measures Under Consideration (MUC) List (available for download at 
https://mmshub.cms.gov/sites/default/files/2022-MUC-Lst.xlsx) to be 
considered for potential use in MIPS. The MAP reviewed the measures 
during the 2022-2023 review cycle. This process involved reviews by the 
MAP Health Equity and MAP Rural Health Advisory Groups, as well as two 
public comment periods. In December 2022, the MAP Clinician Workgroup 
discussed the measures, taking into consideration the input from the 
MAP Health Equity and MAP Rural Health Advisory Groups and the public 
comments. The MAP Clinician Workgroup reached consensus to 
conditionally support all five episode-based measures for rulemaking, 
pending the endorsement of the

[[Page 52571]]

measures by a CBE. The MAP Clinician Workgroup's concerns related to 
the inclusion of Medicare Part D covered items and services in certain 
measures, potential unintended consequences of assessing costs related 
to mental health care, appropriateness of the attribution methodology, 
and request for additional detail on testing into adjusting for social 
determinants of health (for example, geographic location and 
socioeconomic status) and evidence of care stinting. In January 2023, 
the MAP Coordinating Committee upheld the MAP Clinician Workgroup's 
preliminary recommendation. More information about these 
recommendations is available in the 2022-2023 MAP Final Recommendations 
document at https://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&itemID=98102.
    We believe that the concerns raised regarding these proposed 
measures have been addressed during measure development and the MAP 
meetings. Additionally, some interested parties recognized the 
importance of these measures, specifically highlighting the importance 
of episode-based measures assessing mental health care. We agree with 
these interested parties. On these bases, we are proposing all five of 
these episode-based measures for inclusion in the cost performance 
category beginning with the CY 2024 performance period/2026 MIPS 
payment year.
(iii) New Episode-Based Measures Beginning With the CY 2024 Performance 
Period/2026 MIPS Payment Year
    In this section of this proposed rule, we discuss the five new 
episode-based measures, which we propose to add 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 are proposing 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 proposed episode-based 
measures later in this section of the proposed 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, and discuss certain exclusions 
for the Psychoses and Related Conditions and the Emergency Medicine 
measure in further detail in this section of this proposed rule.
    Generally, 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 greater 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 are proposing for CY 2024 
performance period/2026 MIPS payment year and future performance 
periods are listed in the Table 43.
[GRAPHIC] [TIFF OMITTED] TP07AU23.053

    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.

[[Page 52572]]

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 proposed in this rule.
    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.
    As noted in the previous section of this proposed rule, 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 
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 of this measure. 
First, we reduced the length of the episode window reduced from 90 to 
45 days. This shortened episode window helps to ensure that MIPS 
eligible clinicians 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 which 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 which end in

[[Page 52573]]

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 to not 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 proposed 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 proposed specifications for all five proposed episode-based 
measures are available at https://www.cms.gov/Medicare/Quality-Payment-Program/Quality-Payment-Program/Give-Feedback. The specifications 
documents for each proposed 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 proposed 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-Payment-Program/Quality-Payment-Program/Cost-Measures.
    We are seeking public comment on our proposal to add the five 
episode-based measures, which are listed in Table 43.
(b) Reliability and Case Minimum
    In this section of the proposed rule, we discuss the proposed 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. 
Specifically, we propose a 20-episode case minimum for each of the five 
proposed measures based on our analysis of the reliability of each 
measure. We also provide clarification regarding application of our 
regulatory language under Sec.  414.1350(c)(4) through (6). Currently, 
Sec.  414.1350(c)(4) through (6) establishes the case minima for each 
type of episode-based measure (that is, procedural, acute inpatient 
medical condition, and chronic condition, respectively) beginning with 
a certain CY performance period/MIPS payment year specified therein. In 
this proposed rule, we are clarifying that the case minima established 
in Sec.  414.1350(c)(4) through (6) applies to both the episode-based 
measure(s) we specified as beginning in the indicated performance 
period when the applicable regulatory provision was codified and for 
all episode-based measures of the same type that we specify to begin in 
subsequent performance periods, unless we specify otherwise for 
individual measure(s) in future rulemaking. We also note that, 
consistent with our past and current practice, we will continue testing 
the mean reliability of any potential episode-based measures that we 
propose to adopt in future rulemaking before applying the case minimum 
established in these regulations, as described later in this section.
    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 continue 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 note 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 clinicians as 
possible to be able to have their costs evaluated by them. Therefore, 
we consider 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 minimums for this type of episode-
based measures. In this proposed rule, 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 minima.
    We examined the reliability of the five proposed episode-based 
measures, and Table 44 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 proposed case minimum of 20 for each of the episode-
based measures. At a 20-episode case minimum, the mean reliability for 
the

[[Page 52574]]

proposed 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 proposed Emergency Medicine measure 
exceeds 0.4 for both groups and individual clinicians, and all groups 
and individual clinicians meet the 0.4 reliability threshold.
[GRAPHIC] [TIFF OMITTED] TP07AU23.054

    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 are proposing 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 propose to codify the 20-episode case minimum 
for care setting episode-based measures under Sec.  414.1350(c)(7).
    Additionally, as we were reviewing our existing regulatory language 
under Sec.  414.1350(c), we recognized the need to clarify the intended 
interpretation of the language because we acknowledge 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.
    We are proposing to update the regulatory language under Sec.  
414.1350(c)(4) through (6) to more clearly reflect this clarification. 
In addition, we are proposing that this interpretation will also apply 
to Sec.  414.1350(c)(7) for care setting episode-based measures, which 
we are proposing under this section of this proposed rule.
    We believe that it is appropriate to use 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 note 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 minima established for the 
respective measure type under Sec.  414.1350(c), as needed.
    We are inviting comment on our proposals in this section 
IV.A.4.f.(2)(b), including our proposal to adopt these five episode-
based measures in the cost performance category proposals and our 
interpretation of the existing regulatory language on the case minima 
for episode-based measures.
(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 proposed rule, we are proposing 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.
    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.  [thinsp]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.  
[thinsp]414.1380(c)(2)(ii)(D). Therefore, no clinician or clinician 
group was scored on any episode-based measures, including the Simple 
Pneumonia with Hospitalization episode-based measure, for those 2 
years.
    For the CY 2022 performance period/2024 MIPS payment year, we 
announced via email communication

[[Page 52575]]

(subject: 2021 Quality Payment Program Experience Report and 
Infographic Now Available; Policy Update: Excluded MIPS Cost Measure 
for 2022 Performance Period) on June 12, 2023, that in accordance with 
Sec.  414.1380(b)(2)(v)(A), we would suppress the Simple Pneumonia with 
Hospitalization episode-based measure, so that eligible clinicians and 
clinician groups would not be scored on this measure for that 
performance period. This is a direct result of the 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. Specifically, on January 1, 
2021, an ICD-10 diagnosis code for pneumonia due to COVID-19 (J12.82) 
came into effect. Our guidance in the FY 2021 ICD-10-CM Official 
Guidelines for Coding and Reporting stated that this should be coded as 
secondary to COVID-19 (U07.1) (https://www.cms.gov/files/document/2021-coding-guidelines-updated-12162020.pdf). However, these two diagnosis 
codes (J12.82 and U07.1) map to different Medicare Severity Diagnosis 
Related Groups (MS-DRGs). J12.82 maps to the trigger codes for the 
Simple Pneumonia with Hospitalization measure (MS-DRGs 193-195, Simple 
Pneumonia and Pleurisy with MCC, with CC, and without CC/MCC, 
respectively), while U07.1 maps to Respiratory Infections and 
Inflammations (MS-DRGs 177-179, Respiratory Infections and 
Inflammations with MCC, with CC, and without CC/MCC, respectively), 
which are not used in this measure's trigger codes. That is, while this 
cost measure should include pneumonia due to COVID-19, it is unable to 
because it does not use MS-DRGs 177-179 in its trigger logic. For more 
information on the codes used to trigger Simple Pneumonia with 
Hospitalization measure episodes and the measure construction steps in 
general, please refer to the codes list file document available for 
download from the QPP Cost Measure Information page at https://www.cms.gov/Medicare/Quality-Payment-Program/Quality-Payment-Program/Cost-Measures.
    Once sufficient data became available from claims submitted in CY 
2022 for our review and analysis, we conducted empirical testing. This 
empirical testing demonstrated that these coding changes have resulted 
in a marked decrease in the number of Simple Pneumonia with 
Hospitalizations episodes. Specifically, we have seen a significant 
decrease in the number of episodes, by almost half, as a direct result 
of this coding change. 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. Empirical testing 
further showed that this significant decrease has resulted in many 
clinicians no longer meeting the 20-episode case minimum for 
attribution of the measure On these bases, we have excluded the Simple 
Pneumonia with Hospitalization measure from scoring for the CY 2022 
performance period under Sec.  414.1380(b)(2)(v)(A) because (1) these 
coding changes present a significant change external to care; and (2) 
these changes impacted calculation of the cost measures such that it 
would lead to misleading or inaccurate results, as demonstrated by the 
empirical analysis described in this section.
    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 are proposing 
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. In 
other words, because we have already determined that the Simple 
Pneumonia with Hospitalization measure warranted exclusion under Sec.  
414.1380(b)(2)(v)(A) because the coding changes lead to misleading or 
inaccurate results in calculating the measure's score, it would be 
inappropriate to retain this measure for the CY 2024 performance 
period/2026 MIPS payment year as currently specified. This will 
continue to be true while the triggering methodology is specified in a 
way that is incongruous with billing practices. While we are exploring 
substantive changes to the measure's triggering methodology in response 
to the coding changes, the scope of these changes and the potential 
impacts of these changes on other elements of the measure require 
careful consideration and feedback from the Simple Pneumonia with 
Hospitalization Clinician Expert Workgroup and other interested parties 
prior to implementation. Because of these circumstances, we propose to 
remove the Simple Pneumonia with Hospitalization measure as it is 
currently specified from use in MIPS beginning with the CY 2024 
performance period/2026 MIPS payment year.
    We note that we have been comprehensively re-evaluating the Simple 
Pneumonia with Hospitalization measure, given the significant coding 
changes impacting calculation of this measure. The purpose of 
comprehensive re-evaluation is to ensure that measures continue to meet 
criteria for importance, scientific acceptability, and usability in 
line with the CMS Measures Management System Blueprint (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/MMS-Blueprint). In this process, we holistically review 
the measure, seek public comment, and consider whether any changes need 
to be made to measure specifications after a measure has been in use 
for 3 years. A new version of the measure--Respiratory Infection 
Hospitalization--may be considered for implementation in MIPS in future 
years, after undergoing the pre-rulemaking and the notice-and-comment 
rulemaking processes. For more information on the re-evaluation efforts 
of the Simple Pneumonia with Hospitalization episode-based measure or 
other measures, please refer to the documents under the ``Wave 1 cost 
measure comprehensive reevaluation (2022-2023)'' section of the QPP 
Cost Measure Information page at https://www.cms.gov/Medicare/Quality-Payment-Program/Quality-Payment-Program/Cost-Measures.
    We are inviting comments on this proposal.
(d) Proposed Revisions to the Operational List of Care Episode and 
Patient Condition Groups and Codes
    We are proposing revisions to the operational list of care episode 
and patient condition groups and codes to reflect the proposal of any 
new episode-based measures. Section IV.A.4.f.(2)(d) of this proposed 
rule provides context on the statutory requirements for care episode 
and patient condition groups and proposes changes to the operational 
list.
    Section 1848(r) of the Act specifies a series of steps and 
activities for the Secretary to undertake to involve physicians, 
practitioners, and other interested parties in enhancing the 
infrastructure for cost measurement, including for purposes of MIPS and 
APMs. Section 1848(r)(2) of the Act requires the development of care 
episode and patient condition groups,

[[Page 52576]]

and classification codes for such groups, and provides for care episode 
and patient condition groups to account for a target of an estimated 
one-half of expenditures under Medicare Parts A and B (with this target 
increasing over time as appropriate). Sections 1848(r)(2)(E) through 
(G) of the Act require the Secretary to post on the CMS website a draft 
list of care episode and patient condition groups and codes for 
solicitation of input from interested parties, and subsequently, post 
an operational list of such groups and codes. Section 1848(r)(2)(H) of 
the Act requires that not later than November 1 of each year (beginning 
with 2018), the Secretary shall, through rulemaking, revise the 
operational list of care episode and patient condition codes as the 
Secretary determines may be appropriate, and that these revisions may 
be based on experience, new information developed under section 
1848(n)(9)(A) of the Act, and input from physician specialty societies 
and other interested parties.
    For more information about past revisions to the operational list 
that we made as we developed and proposed episode-based measures, we 
refer readers to CY 2020 PFS final rule (84 FR 62968 through 62969) and 
CY 2022 PFS final rule (86 FR 65445 through 65461). The current 
operational list and prior operational lists is available at the QPP 
Cost Measure Information page at https://www.cms.gov/Medicare/Quality-Payment-Program/Quality-Payment-Program/Cost-Measures.
    Additionally, as required by section 1848(r)(2)(I) of the Act, 
information on resource use (or cost) measures currently in use in 
MIPS, cost measures under development and the time-frame for such 
development, potential future cost measure topics, a description of 
engagement with interested parties, and the percent of expenditures 
under Medicare Parts A and B that are covered by cost measures must be 
provided on the website of CMS not later than December 31 of each year.
    In accordance with section 1848(r)(2)(H) of the Act, we are 
proposing 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 discussed in 
section IV.A.4.f.(2)(a)(ii) of this proposed rule. We propose 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 are 
proposing in section IV.A.4.f.(2)(a)(iii) of this 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 
this proposed rule. As described in section IV.A.4.f.(2)(a)(ii), these 
specifications are developed with extensive input from interested 
parties.
    Additionally, we propose 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 this proposed rule, we are 
proposing to remove this episode-based measure from the cost 
performance category, so the codes that define this care episode group 
would no longer need to remain in the operational list.
    Our proposed revisions to the operational list are available on our 
QPP Cost Measure Information page at https://www.cms.gov/Medicare/Quality-Payment-Program/Quality-Payment-Program/Cost-Measures.
    We are inviting comments on this proposal.
(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.
    We are not proposing any changes to the traditional MIPS 
improvement activities policies for the CY 2024 performance period/2026 
MIPS payment year. We are proposing policies for group reporting in 
MIPS Value Pathways (MVPs). In addition, we are proposing 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
    In the CY 2017 Quality Payment Program final rule (81 FR 77190), 
for the transition year of MIPS, we implemented the initial improvement 
activities Inventory consisting of approximately 95 activities (81 FR 
77817 through 77831). We took several steps to ensure the Inventory was 
inclusive of activities in line with statutory and program 
requirements. We discussed that we had conducted numerous interviews 
with highly performing organizations of all sizes and had conducted an 
environmental scan to identify existing models, activities, or measures 
that met all or part of the improvement activities performance 
category, including patient-centered medical homes, the Transforming 
Clinical Practice Initiative (TCPI), CAHPS surveys, and AHRQ's Patient 
Safety Organizations. In addition, we reviewed the CY 2016 PFS final 
rule with comment period (80 FR 71259) and the comments received in 
response to the MIPS and APMs RFI in relation to the improvement 
activities performance category, which sought input on what activities 
could be classified as clinical practice improvement activities 
according to the definition under section 1848(q)(2)(C)(v)(III) of the 
Act.
    For the CY 2018 performance period/2020 MIPS payment year, we 
provided an informal process for submitting new improvement activities 
or modifications for potential inclusion in the comprehensive 
improvement activities Inventory for the Quality Payment Program CY 
2018 performance period/2020 MIPS payment year and future years through 
subregulatory guidance.\315\ In the CY 2018 Quality Payment Program 
final rule (82 FR 53656 through 53659), for the CY 2019 performance 
period/2021 MIPS

[[Page 52577]]

payment year and for future years, we finalized a formal Annual Call 
for Activities process for the addition of possible new activities and 
for possible modifications to current activities in the improvement 
activities Inventory. This process included the requirement to submit a 
nomination form similar to the one we utilized for the CY 2018 
performance period/2020 MIPS payment year (82 FR 53656 through 53659). 
In order to submit a request for a new activity or a modification to an 
existing improvement activity, the interested party must submit a 
nomination form (OMB control # 0938-1314) available at www.qpp.cms.gov 
during the Annual Call for Activities.
---------------------------------------------------------------------------

    \315\ CMS, Annual Call for Measures and Activities: Fact Sheet, 
https://www.cms.gov/Medicare/Quality-IniCtiatives-Patient-Assessment-Instruments/MMS/Downloads/Annual-Call-for-Measures-and-Activities-for-MIPS_Overview-Factsheet.pdf.
---------------------------------------------------------------------------

(ii) Changes to the Improvement Activities Inventory
    In the CY 2018 Quality Payment Program final rule (82 FR 53660), we 
finalized that we would establish improvement activities through 
notice-and-comment rulemaking. We refer readers to Table H in the 
Appendix to the CY 2017 Quality Payment Program final rule (81 FR 77177 
through 77199), Tables F and G in the Appendix to the CY 2018 Quality 
Payment Program final rule (82 FR 54175 through 54229), Tables A and B 
in the Appendix 2 to the CY 2019 PFS final rule (83 FR 60286 through 
60303), Tables A, B, and C in the Appendix 2 to the CY 2020 PFS final 
rule (84 FR 63514 through 63538), Tables A, B, and C in the Appendix 2 
to the CY 2021 PFS final rule (85 FR 85370 through 85377), Tables A, B, 
and C in the Appendix 2 to the CY 2022 PFS final rule (86 FR 65969 
through 65997), and Tables A, B, and C in the Appendix 2 to the CY 2023 
PFS final rule (70633 through 70650) for our previously finalized 
improvement activities Inventories. 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. In the CY 2017 Quality Payment 
Program final rule (81 FR 77539), we codified the definition of 
improvement activities at Sec.  414.1305 to mean an activity that 
relevant MIPS eligible clinicians, organizations, and other relevant 
interested parties identify as improving clinical practice or care 
delivery and that the Secretary determines, when effectively executed, 
is likely to result in improved outcomes.
    We are proposing 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. The proposed new and modified activities 
will help fill gaps we have identified in the Inventory, while the 
removal of three activities will help ensure that the Inventory 
reflects current clinical practice. We note that the proposed removal 
of one activity, IA_BMH_6, titled ``Implementation of co-location PCP 
and MH services,'' in the Behavioral and Mental Health subcategory is 
being proposed in order to ensure that the improvement activities 
Inventory best reflects current clinical practice, and in no way 
reflects a de-emphasis of the ongoing priority CMS is placing on 
behavioral and mental health in general, and on substance use disorder 
in particular. We also note that two of the five proposed new 
activities are in the Behavioral and Mental Health subcategory. We 
refer readers to Appendix 2 of this proposed rule for more details.
    Four of the recommended new improvement activities are in the 
Population Management and the Behavioral and Mental Health 
subcategories. One proposed new activity, IA_PM_XX, titled ``Improving 
Practice Capacity for Human Immunodeficiency Virus (HIV) Prevention 
Services'' would 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 ``Decision Support 
Improves Adherence to Cervical Cancer Screening and Management 
Guidelines'' would 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'' would 
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 being proposed in the 
BMH subcategory, IA_BMH_XX, titled ``Behavioral/Mental Health and 
Substance Use Screening & Referral for Older Adults'' would 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 CMS' Priority 5 for advancing health equity, 
Increase All Forms of Accessibility to Health Care Services and 
Coverage. Therefore, the activities 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 
proposed new improvement activities are the following: IA_PM_XX, titled 
``Improving Practice Capacity for Human Immunodeficiency Virus (HIV) 
Prevention Services''; IA_PM_XX, titled ``Decision Support Improves 
Adherence to 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 proposed 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 proposed IA_MVP activity 
would 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 would expand and 
formalize quality improvement (QI) activities across practices, 
ultimately leading to improvements in quality of

[[Page 52578]]

care and fostering a culture of participation among staff. In addition, 
this activity would 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 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 improvement activity are both required. 
We refer readers to section IV.A.3.b(2). of this proposed rule for more 
information on MVPs.
    We are proposing 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 are proposing to remove three previously finalized 
improvement activities to ensure that the improvement activities 
Inventory best reflects current clinical practice.
(iii) Improvement Activity Reporting Policies
    Regarding group reporting, we are not revising group reporting 
policies for MVPs at this time. In the CY 2020 PFS final rule (84 FR 
62981 through 62988) and codified at Sec.  414.1360(a)(2), we finalized 
the policy that, beginning with the 2020 performance year, each 
improvement activity for which groups and virtual groups submit a yes 
response in accordance with paragraph (a)(1) of Sec.  414.1360 must be 
performed by at least 50 percent of the NPIs billing under the group's 
TIN or virtual group's TINs or that are part of the subgroup, as 
applicable. Additionally, the NPIs must perform the same activity 
during any continuous 90-day period within the same performance year. 
We would like to clarify the relationship between a subgroup's 
successful completion of an improvement activity and its impact on the 
affiliated group. If a subgroup consists of 50 percent or more of the 
clinicians in the affiliated group, and the subgroup attests to 
completing an activity, then the group would receive credit for this 
improvement activity as this meets our standard for a group's 
completion of an improvement activity specified at Sec.  414.1360.
(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 and 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).
    We are proposing that for the CY 2026 MIPS payment year, the 
performance period for the Promoting Interoperability performance 
category is a minimum of any continuous 180-day period within CY 2024, 
up to and including the full CY 2024 (January 1, 2024, through December 
31, 2024). This proposal would minimally increase the information 
collection burden on data submitters.
    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 would 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. In 
order 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 in 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 CY, 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, we are proposing 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 propose to add a new paragraph at 
Sec.  414.1320(i)(1) to reflect our proposed performance period of a 
minimum of a continuous 180-day period within the calendar year

[[Page 52579]]

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.
    We are inviting public comment on 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 the proposed changes to 
the regulation text at Sec.  414.1320.
(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. Section 1848(o)(2)(A) of the Act requires that, to 
be treated as a meaningful EHR user for an EHR reporting period for a 
payment year, a MIPS eligible clinician must be using certified EHR 
technology (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.
    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, in general, 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 section III.R. of this proposed rule, 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 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 is proposing 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 
(IT) development timelines (88 FR 23750). As further discussed in 
section III.R. of this proposed rule, we are proposing to modify the 
definition of CEHRT for purposes of the Quality Payment Program at 
Sec.  414.1305 to no longer refer to year-specific editions, and 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 will remain 
optional and eligible for 10 bonus points for the CY 2021 and CY 2022 
performance periods.
    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, 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: (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 performance period, 
but does write more than 100 permissible prescriptions during the 
performance period. Therefore, we are proposing 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.
    We are inviting public comments on this proposal.
ii. Proposed 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 to reflect this change (87 FR 70075). In an effort to

[[Page 52580]]

more clearly capture the previously established policy finalized in the 
CY 2021 PFS final rule with respect to the e-Prescribing measure, we 
are proposing to revise the measure description as shown in Table 45 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.''
    We are inviting public comments on this proposal.
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. 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, we required MIPS eligible 
clinicians to complete this attestation for this measure, though MIPS 
eligible clinicians are not scored based on their answer to the 
attestation or whether they fully complete 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. Proposed Change to 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, safety 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 implementing the High Priority Practices SAFER Guide's 
recommended practices, MIPS eligible clinicians may be better 
positioned to operate CEHRT 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, we are proposing 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 between clinicians and staff members 
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 are proposing 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 proposal, we are proposing 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 proposed modification is feasible for MIPS eligible 
clinicians to implement, as they have had time 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 note 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 resources 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.
    Therefore, we are proposing 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. Under this 
proposal, 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 not a meaningful user of CEHRT, warranting a 
score of zero for the Promoting Interoperability performance category.
    If our proposal to modify the SAFER Guides measure is finalized, we 
are also proposing 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 propose 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 propose 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.

[[Page 52581]]

    As a reminder, under the SAFER Guides measure, we do not currently 
require, and do 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 (86 FR 65475). We refer readers to Table 45 in 
this proposed 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. We are therefore also proposing 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 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. As previously 
discussed, if our proposal to modify the SAFER Guides measure is 
finalized, this proposed regulatory provision would only be applicable 
for the 2024 MIPS payment year through the 2025 MIPS payment year.
    We are inviting public comments on these proposals.
(e) Requirements for the Promoting Interoperability Performance 
Category for the CY 2024 Performance Period
i. Objectives and Measures for the CY 2024 Performance Period
    For ease of reference, Table 45 lists the objectives and measures 
for the Promoting Interoperability performance category for the CY 2024 
performance period/2026 MIPS payment year as revised to reflect the 
policies proposed in this proposed rule.

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ii. Scoring Methodology for the CY 2024 Performance Period
    Table 46 reflects the scoring methodology for the Promoting 
Interoperability performance category for the CY 2024 performance 
period.
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iii. Exclusion Redistribution
    Many required measures have exclusions associated with them as 
shown on Table 45. 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 46 
do not include the points that will be redistributed in the event that 
a MIPS eligible clinician claims an exclusion. For ease of reference, 
Table 47 shows how points will be redistributed among the objectives 
and measures for the CY 2024 performance period in the event a MIPS 
eligible clinician claims an exclusion.

[[Page 52588]]

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iv. 2015 Edition Health IT Certification Criteria
    For ease of reference, Table 48 lists the objectives and measures 
for the Promoting Interoperability performance category for the CY 2024 
performance period and the associated 2015 Edition health IT 
certification criteria.

[[Page 52589]]

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[[Page 52590]]


(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 Program to earn incentive payments for 
meaningful use of CEHRT or 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 NPs, PAs, CNSs, CRNAs, 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 at the time of this proposed rule, we are proposing 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 making the corresponding 
revisions to the regulatory text at Sec.  414.1380(c)(2)(i)(A)(4)(iii).
    We are inviting public comments on this proposal.
(5) APM Improvement Activities Performance Category Score
(a) Background
    Section 1848(q)(5)(C) of the Act establishes specific scoring rules 
for the improvement activities performance category. Section 
1848(q)(5)(C)(ii) of the Act 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 or groups who participate in 
an APM (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). With respect to MIPS 
eligible clinicians who participate in a MIPS APM for a performance 
period, we stated that they may receive an improvement activity score 
higher than 50 percent (81 FR 30132). Because we had identified all 
MIPS APMs as having met the improvement activity threshold score 
requirement, we noted that all MIPS APM participants will receive a 
score of 100 percent for the improvement activities performance 
category (85 FR 84865, 85031).
(b) Proposal
    It has come to our attention that in the preamble of the CY 2021 
PFS final rule (85 FR 84865) the terminology ``automatic'' 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 
MIPS eligible clinicians that the baseline score represents ``credit'' 
that is ``automatically applied'' in all circumstances.\316\ This is 
not how we intended this provision to function, and we wish to ensure 
that our rules do not automatically grant such ``credit''.\317\ We are 
concerned that absent revisions the application of our current 
regulation may produce unintended or unexpected scoring outcomes for 
MIPS eligible clinicians and groups.
---------------------------------------------------------------------------

    \316\ 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.
    \317\ 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).
---------------------------------------------------------------------------

    In order to prevent such scoring scenarios, we are proposing to 
amend Sec.  414.1380 by revising paragraph (b)(3)(i) to require that, 
in order to initiate the baseline score 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 are also 
proposing to amend Sec.  414.1380 by adding paragraph (c)(2)(iv) to 
provide that we will not apply a baseline score 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 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).
    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 
region affected by an automatic EUC event 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 would initiate or 
prompt the calculation of a baseline

[[Page 52591]]

score for the improvement activities performance category, making the 
improvement activities category eligible for scoring. 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 would 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 composite scores from at least two of 
those four performance categories in order 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. 
We therefore 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.\318\
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    \318\ 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) in order 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. 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. 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. This proposal would 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 would 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 propose 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 seek comment on 
these proposals.
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 this proposed rule we 
are proposing to update our scoring policies consistent with this 
framework. Specifically, we propose 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 are not proposing 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 propose 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 propose 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 refer readers to our regulation at Sec.  414.1380 for our 
current policies on scoring. We request comments on these technical 
update proposals.
(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 refer 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 52592]]

(i) Scoring Flexibility for Changes That Impact Quality Measures During 
the Performance Period
    We refer 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 establish scoring flexibilities policy.
    In the CY 2018 Quality Payment Program final rule (82 FR 53714 
through 53716), we finalized that, beginning with the CY 2018 
performance period, we will assess performance on measures considered 
significantly impacted by ICD-10 coding changes during the performance 
period based only on the first 9 months of the 12-month performance 
period. We stated that our determination as to whether a measure is 
significantly impacted by ICD-10 coding changes would include these 
factors: A more than 10 percent change in codes in the measure 
numerator, denominator, exclusions, and exceptions; clinical guideline 
changes or new products or procedures reflected in ICD-10 code changes; 
and feedback on a measure received from measure developers and stewards 
(82 FR 53714). We stated that 9 months of data is sufficient to assess 
performance when 12 months of data is not available. We finalized that 
we would publish a list of measures requiring 9 months of data on the 
CMS website by October 1st of the performance period if technically 
feasible, but no later than the beginning of the data submission period 
(for example, January 2, 2021 for the CY 2020 performance period) (82 
FR 53716).
    In the CY 2019 Quality Payment Program final rule (83 FR 59845 
through 59847), we finalized policies beginning with the CY 2019 
performance period/2021 MIPS payment year to reduce the total available 
measure achievement points in the quality performance category by 10 
points for MIPS eligible clinicians for each measure submitted that is 
significantly impacted by clinical guideline changes or other changes 
when we believe adherence to the guidelines in the existing measures 
could result in patient harm or otherwise no longer be comparable to a 
historic benchmark. We wanted the flexibility to respond to instances 
in which the clinical evidence and guidelines change and approved 
measures no longer reflect the most up-to- date clinical evidence and 
could even result in a practice that is harmful to patients. We 
finalized expanding the list of reasons that a quality measure may be 
impacted during the performance period in addition to revising when we 
will allow scoring of the measure with a performance period truncation 
(to 9 months of data) or the complete suppression of the measure if 9 
months of data are not available.
    In the CY 2021 PFS final rule (85 FR 84898 through 84901), we 
finalized a consolidation of the CY 2018 and CY 2019 scoring 
flexibilities policies that allowed, beginning with the CY 2021 
performance period/2023 MIPS payment year, truncation of the 
performance period or suppression of a quality measure respectively if 
CMS determines that revised clinical guidelines, measure specifications 
or codes impact clinician's ability to submit information on the 
measure or may lead to potentially misleading results. Based on the 
timing of the changes to clinical guidelines, measure specifications or 
codes, we will assess the measure on 9 months of data, and if 9 
consecutive months of data are not available, we will suppress the 
measure by reducing the total available measure achievement points from 
the quality performance category by 10 points for each measure 
submitted that is impacted.
    In the CY 2022 PFS final rule (86 FR 65491), we finalized a policy 
to expand the situations in which the scoring flexibilities policies 
would be applied. This update revised Sec.  414.1380(b)(1)(vii)(A) to 
change ``significant changes'' to ``significant changes or errors'' and 
to include the omission of codes or inclusion of inactive or inaccurate 
codes. Previous versions of the policy only included changes to codes 
(such as ICD-10, CPT, or HCPCS codes), clinical guidelines, or measure 
specification as impacts outside the control of the clinician and its 
agents and that CMS determines may result in patient harm or misleading 
results and trigger application of this policy.
    In this year's rule, we are proposing two modifications to the 
criteria by which we assess the impacts of ICD-10 coding changes. 
Firstly, we are proposing 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 propose 
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 would 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 would 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 would 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 
would 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)

[[Page 52593]]

could similarly lead to misleading results. These changes would be 
considered significant and therefore trigger our scoring flexibilities 
policy.
    Second, we are proposing 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.
    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 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 are proposing 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 propose 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 
seek comment on our proposal to update the criteria by which be apply 
scoring flexibilities in response to ICD-10 coding changes.
(d) Cost Performance Category Score
(i) Improvement Scoring Methodology
(A) Background
    Section 1848(q)(5)(D)(i) requires that, if sufficient data are 
available to measure a MIPS eligible clinician's improvement in the 
quality and cost performance categories, then our methodology for 
computing the final score must take into account such improvement. In 
the CY 2018 Quality Payment Program final rule (82 FR 53748 through 
53752), we established policies related to measuring improvement in the 
cost performance category at the measure level, an improvement scoring 
methodology for the cost performance category, and a formula for 
calculating the cost performance category percent score to include 
achievement and improvement. These policies were to apply beginning 
with the CY 2018 performance period/2020 MIPS payment year. We codified 
these policies at 42 CFR 414.1380(b)(2)(iii) and (iv) (82 FR 53748 
through 53752, 53957).
    Subsequent to 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 each 
of the second, third, fourth, and fifth years for which the MIPS 
applies to payments (the CY 2018 performance period/2020 MIPS payment 
year through the CY 2021 performance period/2023 MIPS payment year).
    To implement these statutory changes, in the CY 2019 PFS final rule 
(83 FR 35956, 36080 through 36082), we established that 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 is zero percentage points, which we codified at Sec.  
414.1380(a)(1)(ii) and (b)(2)(iv)(E). In the CY 2023 PFS final rule (87 
FR 70091 through 70093, 70228), we stated that we would begin to 
implement cost improvement scoring in the CY 2022 performance period/
2024 MIPS payment year and established that the maximum cost 
improvement score available would be 1 percentage point. We codified 
this policy at Sec.  414.1380(b)(2)(iv)(E). In addition, 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 2019 performance period/2022 MIPS payment year through the CY 2021 
performance period/2023 MIPS payment year 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/). 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). (https://qpp.cms.gov/).
(B) Description of Previously Finalized Cost Improvement Scoring 
Methodology
    As discussed previously in this section, we established several 
policies related to our calculation and application of cost improvement 
scores to MIPS eligible clinicians' final scores in the CY 2018 Quality 
Payment Program final rule (82 FR 53748 through 53752). First, we 
established that we would determine the cost improvement score at the 
individual measure level, instead of the performance category level, 
for the cost performance category (82 FR 53749 through 53750). Second, 
we established our methodology for calculating the cost improvement 
score, generally by comparing the number of cost measures with 
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). Specifically, we established that we would quantify the 
cost improvement score by subtracting the number of cost measures with 
a significant decline from the number of cost measures with a 
significant improvement, and then dividing the result by the number of 
cost measures for which the MIPS eligible clinician or group was scored

[[Page 52594]]

for two consecutive performance periods, and then multiply the 
resulting fraction by the maximum improvement score (82 FR 53750 
through 53752). We further established that we would determine whether 
there was significant improvement or decline in performance 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). Finally, we established that the 
cost improvement score cannot be lower than zero percentage points (82 
FR 53750 through 53752).
    We codified our cost improvement scoring policies at Sec.  
414.1380(b)(2)(iv). These policies governing our cost improvement 
scoring methodology have not been modified since the CY 2018 Quality 
Payment Program final rule.
(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. A t-test 
compares how significant the differences are between group means, which 
are aggregate values, and cannot compare how significant the 
differences are between single values. However, our current cost 
improvement methodology set forth at Sec.  414.1380(b)(2)(iv) requires 
comparing a MIPS eligible clinician's scores for an individual cost 
measure, which are single value points rather than group means. 
Further, the current methodology purports to compare those single value 
points between two consecutive performance periods to determine if 
there has been a statistically significant change (improvement or 
decline) in performance. Therefore, a t-test cannot be applied to the 
single cost measure score data points for consecutive time periods to 
determine if a statistically significant change has occurred, rendering 
our cost improvement scoring methodology mathematically infeasible.
    When we initially developed the cost improvement scoring 
methodology for the cost performance category, there were only two 
population-based cost measures (total per capita cost and Medicare 
Spending per Beneficiary measures), and no episode-based measures. As 
of the CY 2023 performance period/2025 MIPS payment year, there are 23 
episode-based cost measures in addition to the two population-based 
measures. We expect to add additional episode-based measures to the 
cost performance category in future years as MIPS matures.
    We believe that the aggregated nature of the two population-based 
measures influenced our determination regarding the feasibility of 
establishing statistical significance, using a t-test, when we 
developed and established the cost improvement scoring methodology. 
However, although these population-based measures are aggregated 
measures, they are calculated as individual single values in time, and 
not aggregate values which the t-test requires, for a specific 
clinician for each of the two consecutive performance periods. Further, 
considering a method using statistical significance might have been an 
oversight because of the lack of episode-based measures when the cost 
improvement scoring method was developed.
    Because we have not implemented cost improvement scoring since we 
finalized this methodology in the CY 2018 Quality Payment Program final 
rule as discussed in section (4)(a)(iv) of this proposed rule, we 
failed to identify that the currently established cost improvement 
scoring method is not mathematically feasible. 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.
(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. 
To address these three issues, further specified herein, we propose to 
revise this 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.
     Measure level improvement scoring implementation issue: 
The growing number of cost measures brings into question if using the 
current methodology for cost improvement scoring introduces 
complexities to its implementation, which in turn brings into question 
operational feasibility. When the methodology was established, in the 
CY 2018 Quality Payment Program final rule (82 FR 53748 through 53752), 
there were only two cost measures. As of the CY 2023 performance 
period/2025 MIPS payment year, there are 25 cost measures; we expect to 
add additional measures to the cost performance category as MIPS 
matures. 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. Specifically, every measure would need its own workflow and 
testing, which would increase the amount of work to ensure year-over-
year comparisons are accurate and increase risk of calculation or data 
errors. Further, maintaining measure level cost improvement scoring 
would introduce the same operational complexities we see in 
benchmarking measures, particularly when a measure encounters 
significant change from one year to the next--a reality that might 
present in future MIPS performance years. These challenges support our 
proposal to changing improvement scoring from measure level to category 
level for the cost performance category.
     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.
     Fairness of improvement scoring: The episode-based 
measures for the cost performance category 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 of the 
episode-based measures for two consecutive performance periods, making 
year over year improvement scoring at the measure level less viable. 
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.

[[Page 52595]]

Further in the CY 2018 Quality Payment Program final rule (82 FR 53750) 
we received comments in favor of category level assessment for cost 
improvement scoring because of concerns with the inclusion of episode-
based measures and their potential growth for the cost performance 
category. Specifically, the concerns highlighted that determining 
improvement scoring at the measure level might be unfair; it would be 
difficult for all MIPS eligible clinicians to demonstrate improvement 
across all measures. 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.
(E) Proposed Modifications for Cost Improvement Scoring Methodology 
Beginning With the CY 2023 Performance Period/2025 MIPS Payment Year
    In light of both the mathematical and operational feasibility 
issues with our current cost improvement scoring methodology, we are 
proposing two modifications beginning with the CY 2023 performance 
period/2025 MIPS payment year.
    First, we propose 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 propose this modification based on the operational feasibility 
considerations previously discussed. We also propose that, if this 
proposal is finalized, Sec.  414.1380(b)(2)(iv)(A) and (C) would be 
amended to reflect that the cost improvement score will be determined 
at the category level for the cost performance category. In addition, 
we propose that, if this proposal is finalized, Sec.  
414.1380(b)(2)(iv)(B) would be amended to reflect that we would 
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 propose 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 in section IV.A.4.g.(1)(d)(i)(C) of this proposed 
rule, 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 are proposing to remove the statistical significance 
requirement and update the calculation on how we quantify cost 
improvement scoring accordingly. Specifically, at Sec.  
414.1380(b)(2)(iv)(C), we are proposing 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 do not propose any changes to 
this established policy.
    The following is an example to illustrate how the cost improvement 
score will be calculated if our two proposals to modify our cost 
improvement scoring policies are adopted. An individual clinician, 
using the same identifier (TIN A/NPI 1) for two consecutive performance 
periods, has a cost performance category score of 52.00 percent from 
the previous year, and 63.71 percent in the current year. Using our 
proposed change, at Sec.  414.1380(b)(2)(iv)(C), to determine the cost 
improvement score at the category-level, without using statistical 
significance, the first step is to quantify the change between current 
performance period score and the previous performance period score. 
This is 63.71 percent-52.00 percent, which equals 11.71 percent. Then, 
the cost improvement score is determined as follows: ((change between 
current and previous year performance scores/previous year performance 
score))/100. This is ((11.71 percent/52 percent)/100). Therefore, the 
cost improvement score for the current year is 0.23 percentage points.
[GRAPHIC] [TIFF OMITTED] TP07AU23.064

    Based on our current and established policy, set forth at Sec.  
414.1380(b)(2)(iii), the overall cost performance category score for 
current performance period is current year performance score + 
improvement score. This is 63.71 percent + 0.23 percentage point, which 
equals 63.94 percent.
    Lastly, to determine how many points the cost performance category 
contributes to the final score as set forth in Sec.  414.1380(c)(1), 
the current year cost performance category score (63.94 percent) is 
multiplied by the weight of the cost performance category (30 percent 
of the final score) and by 100 to determine the points to the final 
score. The individual clinician would have 63.94 percent x 30 percent x 
100 = 19.18 points cost performance category contribution to the final 
score.
    We are proposing that these two modifications to our cost 
improvement scoring policy would be effective

[[Page 52596]]

beginning with the CY 2023 performance period/2025 MIPS payment year. 
As discussed previously in section IV.A.4.g.(1)(d)(i)(A) of this 
proposed rule, 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 are proposing 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 are proposing 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 proposing 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 are soliciting public comment on these proposals.
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. Specifically, for the 
CY 2017 performance period/2019 MIPS payment year through CY 2022 
performance period/2024 MIPS payment year, section 1848(q)(6)(D)(ii) of 
the Act required that we establish an additional performance threshold 
for determining additional positive MIPS payment adjustment factors 
applicable to MIPS eligible clinicians with exceptional performance. 
Then, for the CY 2017 performance period/2019 MIPS payment year through 
CY 2021 performance period/2023 MIPS payment year, section 
1848(q)(6)(D)(iii) required that we establish a performance threshold 
based on a period prior to such performance periods and take into 
account available data with respect to performance on measures and 
activities that we may use under the four MIPS performance categories 
and other factors determined appropriate by the Secretary. 
Specifically, section 1848(q)(6)(D)(iii) of the Act addressed how we 
would establish a performance threshold for MIPS in its initial years 
prior to having final score data available from prior periods of MIPS. 
Finally, for the CY 2019 performance period/CY 2021 MIPS payment year 
through CY 2021 performance period/2023 MIPS payment year, section 
1848(q)(6)(D)(iv) of the Act required that we methodically increase the 
performance threshold each year to ``ensure a gradual and incremental 
transition'' to the performance threshold we estimated would be 
applicable in the CY 2022 performance period/2024 MIPS payment year. 
Although sections 1848(q)(6)(D)(ii) through (iv) of the Act are no 
longer applicable for establishing the performance threshold for the CY 
2024 performance period/2026 MIPS payment year, these previously 
applicable statutory requirements explain our prior computations of the 
performance threshold that impact our policy considerations for 
establishing the performance threshold for MIPS going forward.
    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 42 
CFR 414.1405(g) that, for the CY 2022 performance period/2024 MIPS 
payment year through the CY 2024 performance period/2026 MIPS

[[Page 52597]]

payment year, the performance threshold would be the mean of the final 
scores for all MIPS eligible clinicians from a prior period. For 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 propose 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 50.
[GRAPHIC] [TIFF OMITTED] TP07AU23.065

(b) Proposal To Modify Our Policy for Establishing the Performance 
Threshold Beginning With the CY 2024 Performance Period/2026 MIPS 
Payment Year
    In previous years, we selected a single performance period when 
selecting a prior period. In this proposed rule, we are reassessing our 
previous interpretation of ``prior period'' as described at section 
1848(q)(6)(D)(i) of the Act.
    Section 1848(q)(6)(D)(i) states that the performance threshold for 
a year shall be the mean or median (as selected by the Secretary) of 
the composite performance scores for all MIPS eligible professionals 
with respect to a ``prior period'' specified by the Secretary. 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.'' For example, section 1848(q)(6)(A) of the 
Act specifies application of a MIPS adjustment factor for ``a year.'' 
Meanwhile, section 1848(q)(4) of the Act specifically defines the term 
``performance period'' for MIPS, requiring that the Secretary shall 
establish ``a performance period (or periods) for a year (beginning 
with 2019)'' and such ``performance period (or periods)'' shall begin 
and end prior to the beginning of such ``year and be as close as 
possible to such year.'' These 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 on that point rather than using the 
unique term, ``prior period.''
    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 believe that the term ``prior period'' can 
refer to a time span other than a single year or performance period as 
long as that ``prior period'' is specified by the Secretary. More 
specifically, given our interpretation that ``prior period'' does not 
require CMS to select a single performance year as the period, we 
propose to add Sec.  414.1405(g)(2) to specify that, beginning with 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 propose 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).
    Recognizing the flexibility of the term, ``prior period,'' we 
reviewed the data we have available from prior MIPS performance 
periods, and believe it would be appropriate to specify a ``prior 
period'' as three performance periods. 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. Using the mean or median 
of final scores of three performance periods would allow us to include 
more scores in the computation of the mean or median, and therefore, 
mitigate the impact of outliers. Further, using three performance 
periods would also smooth out year-to-year fluctuations in the 
performance threshold, developing greater consistency and stability in 
MIPS, and providing more predictability for MIPS eligible clinicians 
who may wish to set MIPS performance goals. Additionally, as more data 
become available, we will consider whether a longer time span than 
three performance periods may be

[[Page 52598]]

appropriate to mitigate outliers and better reflect clinician 
performance trends.
    In the CY 2022 PFS final rule (86 FR 65531 through 65532), we 
stated that, under our interpretation of section 1848(q)(6)(D)(i) of 
the Act at that time, choosing the mean or median from a ``prior 
period'' does not allow us to balance scores from multiple years. 
However, on further reflection, the presence of distinctions in the 
statute between ``prior period'' and ``performance period'' and 
``year'' has prompted us to reevaluate the appropriateness of limiting 
our establishment of the performance threshold based on a single prior 
performance period.
    We request comments on our proposal to use three performance 
periods as the ``prior period'' we use to establish a performance 
threshold and codify the policy at Sec.  414.1405(g)(2).
(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 through 2026 MIPS payment years, we have not specified 
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 to us, 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 51. Based 
on our proposed definition of ``prior period,'' we included means of 
final scores for MIPS eligible clinicians spanning over three 
performance periods within Table 51 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 are not considering the means of the final scores for certain 
prior periods because of issues with the underlying data. First, for 
the CY 2020 through 2021 performance periods/2022 through 2023 MIPS 
payment years for the purpose of establishing the performance threshold 
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 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 this proposed rule and, 
therefore, the mean final score for the CY 2022 performance period/2024 
MIPS payment year is not included for consideration as a potential 
performance threshold value for the CY 2024 performance period/2026 
MIPS payment year.
[GRAPHIC] [TIFF OMITTED] TP07AU23.066

    As shown in Table 51, 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 
propose 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.
    First, as stated above in section IV.A.4.h.(2)(b) of this proposed 
rule, we believe using the mean or median of final scores across three 
performance periods would smooth out year-to-year fluctuations in the 
performance threshold, developing greater consistency and stability in 
MIPS, and providing more predictability for MIPS eligible clinicians 
who may wish to set MIPS performance goals. This would also allow us to 
include more scores in the computation of the mean or median, and 
therefore mitigate the impact of unusual fluctuations in performance 
specific to a 24-month or a 12-month timeframe. For example, since we 
applied extreme and uncontrollable circumstances policies described 
under Sec.  414.1380(c)(2)(i) (85 FR 19277 through 19278) for the CY 
2019 performance period/2021 MIPS payment year, we believe using the 
additional 24 months of data from the CY 2017 and 2018 performance 
periods/2019 and 2020 MIPS payment years will allow us to mitigate any 
potential impact of outliers in computing the mean to establish the 
performance threshold.
    Second, we also believe continuing a gradual and incremental 
increase in the performance threshold by establishing the performance 
threshold for the CY 2024 performance period/2026 MIPS payment year at 
82 will provide stability to MIPS eligible clinicians. This proposed 
performance threshold value would be an increase of nearly 7 points 
from the CY 2023 performance period/2025 MIPS payment year performance 
threshold of 75 points. This increase would be smaller than the 12-to-
15-point increases in previous years, apart from the CY 2023 
performance period/2025 MIPS payment year, during which the performance 
threshold remained the same as the previous year. We note that

[[Page 52599]]

the incremental and gradual increase is no longer required by section 
1848(q)(6)(D)(iv) of the Act. However, we still believe that in the 
long term, the program is served by incremental and gradual changes, 
such as an increase in the performance threshold to best reflect MIPS 
eligible clinicians' recent performance by using data from later years. 
We also believe an incremental and gradual change in the performance 
threshold for the CY 2024 performance period/2026 MIPS payment year is 
appropriate as the PHE for COVID-19 concludes.
    Finally, we also believe the performance threshold of 82 strikes an 
appropriate balance of using more robust data and yet accounting for 
clinician practices that are still recovering from the impacts of the 
COVID-19 PHE. If we were to use more recent data from CY 2018 
performance period/2020 MIPS payment year or CY 2019 performance 
period/2021 MIPS payment year means, the increase would be more 
substantial than the incremental increase to 82.
    The CY 2023 performance period/2025 MIPS payment year is the only 
year for which we did not increase the performance threshold from the 
prior year due to reasons noted in the CY 2023 PFS final rule (87 FR 
70096 through 70100). First, we acknowledged that we removed 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). Second, we stated 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 the reweighting of some 
performance categories if data were not submitted for a MIPS eligible 
clinician. Given the elimination of those transition policies, as well 
as the possibility the performance categories will not be reweighted 
for as many MIPS eligible clinicians for the CY 2023 performance 
period/2025 MIPS payment year, we expected 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. On these bases, we established 
the performance threshold at 75 for the CY 2023 performance period/2025 
MIPS payment year, without any change from the prior year (87 FR 70096 
through 70100).
    However, for the CY 2024 performance period/2026 MIPS payment year, 
we no longer need to account for those reasons stated in CY 2023 PFS 
final rule (87 FR 70096 through 70100) and explained above, and 
therefore, believe it is appropriate to increase the performance 
threshold. For example, the COVID-19 PHE expired on May 11, 2023, 
emphasizing the less unpredictable impact of the COVID-19 PHE on health 
systems' expenditures and resources.\319\ In addition, we no longer 
believe we need to consider MIPS transition policies because they are 
no longer in effect and clinicians have now had several years of 
experience in reporting within MIPS, which has been in effect for seven 
years. Finally, we believe that, as clinicians gain more experience 
within the MIPS program and as more recent data are available, we 
should incorporate more recent data in determining the performance 
threshold. We believe our proposal to use the mean of the final scores 
for the CY 2017 through 2019 performance periods/2019 through 2021 MIPS 
payment years as the prior period for the purpose of determining the 
performance threshold for the CY 2024 performance period/2026 MIPS 
payment year achieves an appropriate balance.
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    \319\ https://aspr.hhs.gov/legal/PHE/Pages/covid19-11Jan23.aspx; 
https://www.nytimes.com/2023/01/30/us/politics/biden-covid-public-health-emergency.html.
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    Under this proposal, and pursuant to the methodology we established 
previously at Sec.  414.1405(g), 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 are proposing corresponding 
changes to Sec.  414.1405(b)(9) to reflect this proposal.
    Alternatively, as an effort to use more recent data, we considered 
using the single 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 
efforts to use more robust data from a longer period of time, we are 
proposing 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 VII.E.23.d.(4) 
of this proposed rule, we estimate that approximately 46 percent of 
MIPS eligible clinicians would receive a negative payment adjustment 
for the CY 2024 performance period/2026 MIPS payment year if the 
policies proposed in this proposed rule are finalized and the 
performance threshold is equal to 82 points. We refer readers to the 
alternatives considered in the RIA in section VII.F.4 of this proposed 
rule 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.
    We are requesting 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 this proposed rule.
(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 82 points, as we have proposed in section 
IV.A.4.h.(2)(c) of the proposed 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

[[Page 52600]]

20.5 points based on the performance threshold of 82 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 82 points (the proposed 
performance threshold for the CY 2024 performance period/2026 MIPS 
payment year) would 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.
[GRAPHIC] [TIFF OMITTED] TP07AU23.067

    Table 52 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 proposed 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.

[[Page 52601]]

[GRAPHIC] [TIFF OMITTED] TP07AU23.068

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. Although we aim to provide feedback for the CY 2022 
performance period/2024 MIPS payment year on or around July 1, 2023, it 
is possible the release date could be later depending on circumstances. 
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

[[Page 52602]]

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 are proposing 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 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 
will provide us with the necessary time to adjudicate the targeted 
reviews and finalize the QP status list by October 1st. If finalized, 
we are proposing to codify this proposed 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.
[GRAPHIC] [TIFF OMITTED] TP07AU23.069

    To further shorten the timeline of the targeted review process for 
the reasons discussed above, we also are proposing to amend Sec.  
414.1385(a)(5). Specifically, we are proposing to require that, if CMS 
requests additional information under the targeted review process, that 
that additional information must be provided to and received by CMS

[[Page 52603]]

within 15 days of receipt of such request. This proposal would 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 are proposing to add virtual groups as being eligible 
to submit a request for targeted review. Finally, as discussed in 
section IV.A.4.d (4) of this proposed rule, we are also proposing to 
add subgroups as being eligible to submit a request for targeted 
review. We are proposing to codify these additions at Sec.  
414.1385(a).
    We invite public comment on these proposals.
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 are 
proposing to codify existing final policy, we incorporate the rationale 
described in these prior rules by reference.
    In this proposed rule, in addition to codifying previously 
finalized policies and making technical updates for clarity, we propose 
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 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.
(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 propose to 
codify these requirements at Sec.  414.1400(b)(3)(xii) and (xiii).
    We invite comments on this proposal.
(c) Requirement To Report in Form and Manner Specified
(i) Criteria for Data Submission
    At Sec.  414.1400(a)(2)(C), we require that all data submitted by a 
third party intermediary must be submitted in the form and manner 
specified by CMS. We are specifying 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

[[Page 52604]]

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 this rule, we 
propose 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. We propose 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). We invite comments on this proposal.
(3) Requirements for QCDRs and Qualified Registries
(a) Background
    As described at Sec.  [thinsp]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 refer readers to Sec.  [thinsp]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.
    As described at Sec.  [thinsp]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 refer readers to Sec.  [thinsp]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 propose to add new language to codify this policy. We propose 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.
    We invite comments on this proposal.
(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 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 are proposing 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. 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 propose 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

[[Page 52605]]

July 1 and September 1 of the CY preceding the applicable performance 
period.'' This proposal would 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 invite comments on this proposal.
(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 propose to codify this previously finalized provision at Sec.  
414.1400(b)(3)(ix). For completion and consistency, we also 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 propose that Sec.  414.1400(b)(3)(ix) would 
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.
    We invite comments on this proposal.
(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 propose to codify this previously 
finalized provision at Sec.  414.1400(b)(3)(x).
    We invite comments on this proposal.
(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 propose 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 propose 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 invite comments on these proposals.
(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 
propose to codify this previously finalized provision at Sec.  
414.1400(b)(3)(xv).
    We invite comments on this proposal.
(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 propose 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. We also propose 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 as we 
have heard from some third party intermediaries that they do not have 
access to the data and depend on clinicians do the audit.
    We invite comments on this proposal.
(viii) Third Party Intermediary Support of MVPs
    In the CY 2022 PFS final rule (86 FR 65543), we finalized a new 
requirement at Sec.  [thinsp]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

[[Page 52606]]

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 are proposing 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. 
The proposed 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 proposed exception to this requirement 
at Sec.  [thinsp]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 proposed exception at Sec.  
[thinsp]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 invite comments on these proposals.
(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 propose 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.
    We invite comments on this proposal.
(x) Duration of Services Provided
    In the CY 2020 PFS final rule (84 FR 63053), we finalized a new 
requirement at Sec.  [thinsp]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 
this rule, we discuss 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 propose 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. We propose to make this change at 
Sec.  [thinsp]414.1400(a)(2)(i)(C) as a result of our proposal to 
divide requirements for self-nomination from programmatic requirements 
as discussed in section IV.A.4.k.(7) of this rule.
    We invite comments on these proposals.
(xi) Transition Plan Requirements
    In the CY 2020 PFS final rule (84 FR 63052 through 63053), we 
finalized a new requirement at Sec.  [thinsp]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 this rule, at Sec.  414.1400, we propose 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 propose to specify 
the contents required in the transition plan in paragraphs 
(a)(3)(iv)(A) through (E). Therefore, we propose 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 propose to 
add Sec.  414.1400(a)(3)(iv)(B), which would 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 would need to find another way to report 
and as applicable, and identify any QCDRs that were granted licenses to 
QCDR measures which would no longer be available for reporting due to 
the transition. We further propose 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 propose 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 propose 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 invite comments on these proposals.
(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.'' We propose to codify this previously finalized provision at 
Sec.  414.1400(b)(3)(xi).
    We invite comments on this proposal.

[[Page 52607]]

(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 propose 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.'' 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 invite comments on this proposal.
(4) Requirements Specific to QCDRs
(a) Background
    As described at Sec.  [thinsp]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 refer readers to Sec.  [thinsp]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 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 propose 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).
    We invite comments on this proposal.
(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 are 
proposing 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. 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 note 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 invite comments on this proposal.
(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

[[Page 52608]]

propose to codify this previously finalized provision at Sec.  
414.1400(b)(4)(i)(C).
    We invite comments on this proposal.
(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 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 
propose 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. 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 believe this addition will 
prevent QCDRs from removing specifications following the initial 
required posting and increase transparency for participants. We also 
propose 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.
    We invite comments on this proposal.
(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 note 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 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 observe today 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 propose to 
eliminate the health IT vendor category beginning with the CY 2025 
performance period and by revising Sec.  414.1400(a)(1)(iii). 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.
    Removing Health IT vendors from the definition of third party 
intermediary will not preclude the vendors from assisting MIPS eligible 
clinicians with reporting under the program. Instead, the vendors may 
still provide their technology for clinicians to directly report under 
MIPS. We believe 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

[[Page 52609]]

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 invite comments on this proposal.
(6) Remedial Action and Termination of Third Party Intermediaries
(a) Background
    We refer readers to Sec.  [thinsp]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 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 propose 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.
    We invite comments on this proposal.
(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 continue to experience issues with third party intermediaries 
that require corrective action plans in 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 propose 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. This proposal will 
minimize risk within the Quality Payment Program by terminating third 
party intermediaries that are consistently deemed as non-compliant.
    We invite comments on this proposal.
(c) Revised Corrective Action Plan Requirements
    As described in Sec.  [thinsp]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 propose 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). We believe 
this additional step will ensure that third party intermediaries 
complete the required actions within the corrective action plan.
    We invite comments on this proposal.
(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 are proposing 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

[[Page 52610]]

notice, we believe 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 propose 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 note 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. We also propose 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. We 
are proposing to remove this policy because we believe it would be 
superseded by the proposal included in Sec.  414.1400(e)(1)(ii)(B).
    We invite comments on these proposals.
(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 invite comment on this proposal.
(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 this rule, we did not establish the reasons we 
have for auditing a particular third party intermediary. We note 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 propose 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. 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 propose 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. We note that this section 
refers to program requirements, which we believe is a more appropriate 
characterization of these requirements.
    We invite comments on these proposals.
(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 propose to make 
the following changes to Sec.  414.1400 to improve clarity as denoted 
below:
     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 
propose 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 discuss new proposals related to these requirements 
in section IV.A.4.k.(3) of this 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 invite comments on these proposals.
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

[[Page 52611]]

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, 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). 
(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, 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.). Among the originally 
proposed policies, we proposed using Place of Service (POS) code 02 
(indicating telehealth) on paid physician and ancillary service (that 
is, carrier) claims or modifier 95 appended on paid claims (87 FR 
46330). During the CY 2023 PFS proposed rule public comment period, we 
received unanimous support for adding a telehealth indicator. One of 
the commenters also brought to our attention a POS coding update, and 
we subsequently finalized a policy of using both POS 02 and POS 10, as 
well as modifier 95 to identify clinicians that furnish telehealth 
services.
    At the time of the CY 2023 PFS proposed rule, we were not aware of 
an update in process for POS Code 02 revising the description from 
``telehealth'' to ``telehealth provided other than in patient's home'' 
for locations in which telehealth services were furnished. In 
connection with this change to POS Code 02, Medicare also adopted the 
then newly added POS Code 10, ``telehealth provided in patient's 
home.'' Since many telehealth visits occur in patients' homes it was 
appropriate and consistent with the intent of our proposal to include 
POS 10 in addition to POS 02 and claims modifier 95 to identify 
clinicians providing telehealth services in our final policy.
    The POS Code 10 comment, described earlier in this section, 
received in response to our proposal in the CY 2023 PFS proposed rule, 
inferred the need to stay current with all types of coding changes that 
occur throughout the year, outside of the annual PFS rulemaking cycle. 
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. Depending on 
how frequently codes are updated, there could be the unintended 
consequence of using the annual rulemaking cycle to adopt updated codes 
that could otherwise be avoided through establishing a coding 
flexibility policy. If we are limited to the codes specifically 
finalized via rulemaking, the codes used to inform the telehealth 
indicator may be incomplete or outdated when we refresh the telehealth 
indicator on clinician profile pages throughout the year, resulting in 
users of the Compare tool receiving incorrect information.
    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. This is particularly important since consumer testing and 1-
800-MEDICARE inquiries have shown that patients and caregivers are 
actively looking for telehealth services, as well as for health equity 
purposes since telehealth is critical to those who live in rural areas, 
lack transportation, or have other limitations.
    For these reasons, we are proposing 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 would use the most 
recent codes at the time the data are refreshed that identify a 
clinician as furnishing services via telehealth. This flexibility is 
consistent with how we use the most current CPT codes, some of which 
are time-limited, to identify clinicians furnishing telehealth 
services. We are proposing that at the time of such a data refresh we 
would 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-initiative. We are seeking comment on this proposal.
(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. The information made 
available must be similar to the physician and other supplier 
utilization data we have historically made available through the 
Medicare Provider Utilization and Payment Data: Physician and Other 
Supplier Public Use File (``PUF'') and shall include information on the 
number of services furnished by the physician or other eligible 
professional under Medicare, which may include information on the most 
frequently furnished services or groupings of services. Section 104(e) 
of the MACRA 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

[[Page 52612]]

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, 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 (87 FR 70111 
through 70113). Until that time, we had gathered utilization data for 
procedures from physician/supplier Medicare Part B non-institutional 
claims on certain services and procedures and published it in the 
Physician and Other Supplier Data PUF. Although these data are useful 
to the healthcare industry, healthcare researchers, and other 
interested parties, this information was presented in a technical 
manner that was not easily accessible or usable by patients, who do not 
frequently visit https://data.cms.gov or understand medical procedure 
coding.
    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. Restructured BETOS is a taxonomy 
that allows for the grouping of procedure codes into clinically 
meaningful categories and subcategories. Additional Restructured BETOS 
information is available at https://data.cms.gov/provider-summary-by-type-of-service/provider-service-classifications/restructured-betos-classification-system. These category sources, as finalized, allow us 
to publicly report procedural utilization data in a meaningful way to 
patients and caregivers rather than showing thousands of rows of 
individual HCPCS data, as we do for the research community in the PDC. 
For example, applying categories enables us to list that a clinician 
performs knee arthroplasties. Using plain language, we would simplify 
the procedure category name to ``knee replacements'' for 
understandability instead of listing each of nine unique procedure 
codes indicating the specifics of exactly which bones and which 
implants were involved.
    Since the publication of the CY 2023 PFS final rule, we conducted 
additional consumer testing and data analysis to prepare and select 
certain procedure-related utilization data for publication. 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.
    We are targeting to release procedure data based on FFS claims on 
clinician profile pages later this year, beginning with 13 priority 
procedure categories identified for public reporting. Details on the 
utilization data publicly reported on clinician profile pages will be 
available on the Care Compare: Doctors and Clinicians Initiative page, 
available at https://www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/care-compare-dac-initiative and on the PDC at 
https://data.cms.gov/provider-data/dataset/eedd-4c6c.
(a) Updating the Provider Data Catalog (PDC) Utilization Data Policy
    As discussed earlier in this section, 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. Moreover, the researcher and clinician 
communities, who are the primary users of the PDC, would appreciate 
having the single downloadable dataset that reflects the same procedure 
utilization data that would appear on clinician profile pages. It would 
also be more efficient to focus resources on maintaining one file 
reflective of clinician profile page utilization data rather than both 
produce that file and duplicate some of the PUF information on the PDC. 
The full CMS PUF of FFS data is still available on https://data.cms.gov 
for researchers and clinicians who are interested in the full set of 
Medicare procedure information at the individual procedure code level. 
To direct researchers to the PUF of Medicare FFS information, we 
currently communicate where to locate the original PUF and the details 
of the updated PDC file 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-initiative.
    Therefore, we propose 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. If this proposal is finalized, 
we

[[Page 52613]]

would 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 seek comment on all aspects of this proposal, including any 
concerns about technical feasibility; our proposed 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 proposals discussed later in 
sections IV.A.4.l.(2)(b) and (2)(c) would also be reflected in the new 
downloadable utilization data file in the PDC if the other proposals 
are finalized as proposed.
(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. We anticipate 
this issue could occur for additional procedures as we continue to 
identify additional priority procedures for public reporting.
    We received a few comments on the CY 2023 PFS proposed rule that 
stated that some of the Restructured BETOS categories may be too broad 
and acknowledged that there is no other existing standard, systematic 
way to group procedures by HCPCS codes (87 FR 70111 and 70112). 
However, we did not receive any suggestions for alternative sources for 
the purpose of grouping procedures during the CY 2023 PFS proposed rule 
public comment period.
    We now propose 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 would 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 are proposing 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 propose 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 are seeking comment on all aspects of our proposal to modify 
existing procedural categorization policy to use alternate sources to 
create clinically meaningful and appropriate procedural categories and 
our proposed approach to engaging with subject matter experts in 
developing procedure categories, as appropriate and technically 
feasible.
(c) Incorporating Medicare Advantage (MA) Data Into Public Reporting
    Between the time of the CY 2023 PFS 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. Specifically, we received several comments on the 
CY 2023 PFS proposed rule from the clinician community who had 
expressed concern about the understandability of the data and that 
limiting procedure data counts to Medicare FFS claims only does not 
reflect the full scope of clinician practice (87 FR 70112). 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 would be 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. For 
example, adding MA encounter data to the initial set of publicly 
reported procedure categories would reduce the low volume clinician-
procedure counts by approximately 12 percent. An additional 10,689 
unique clinicians would have information on their profile pages, since 
they do not have this information based on FFS data alone. These unique 
clinicians account for furnishing 9 percent (10,869/114,243) of the 
combined FFS and MA patient populations from July 1, 2021 to June 30, 
2022.
    Therefore, we are proposing 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

[[Page 52614]]

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 propose 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 are also proposing 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. 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 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 provision 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).
    The aggregated utilization data we propose 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 would be disclosed 
on the website and available for release in the PDC downloadable files. 
The disclosure and release of these 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 encounter data before the applicable 
payment year's reconciliation has been completed except for in 
specified circumstances. Neither of the exceptions applies here. 
Because we propose 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 
proposed 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. Because the Compare tool is reporting 
aggregated counts of procedures, and not at the beneficiary level, 
releasing this data before final reconciliation is appropriate to 
support the administration of the Medicare program. 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

[[Page 52615]]

caregivers with more useful and easily understandable information about 
procedures performed by providers in their search for a clinician. We 
therefore propose to amend Sec.  422.310(f)(3) to include an additional 
exception at (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 would 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 would 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 would 
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 by ensuring the data is more 
reflective of the physician's/clinician's scope of practice.
    We seek comment on all aspects this proposal.
(3) Request for Information: Publicly Reporting Cost Measures
    Section 1848(q)(9)(A)(i) of the Act requires us to publicly report 
MIPS eligible clinicians' final scores and performance category scores 
and authorizes, but does not require, us to publicly report MIPS 
eligible clinicians' performance with respect to each measure or 
activity. In the CY 2017 Quality Payment Program final rule (81 FR 
77390 through 77399), we finalized our policies for publicly reporting 
MIPS eligible clinicians' and groups' final scores, performance 
category scores, and measure-level scores in an easily understandable 
format. Currently, we publicly report certain MIPS performance 
information that meet public reporting standards on clinician, group, 
and Accountable Care Organization (ACO) profile pages of the Compare 
tool (available at https://www.medicare.gov/care-compare/) so Medicare 
patients and caregivers can use it when making healthcare decisions. In 
addition to publicly reporting final scores and performance category 
scores in the PDC, we established a policy to publicly report 
performance on measures, activities, and attestations, from the MIPS 
quality, cost, Promoting Interoperability (previously called Advancing 
Care Information), and improvement activities performance categories 
that meet established public reporting standards (81 FR 77395). We 
codified these public reporting standards in our regulations at Sec.  
414.1395(b), requiring that performance data be statistically valid, 
reliable, accurate, and comparable across collection types, to be 
included in the PDC, available at https://data.cms.gov/provider-data/topics/doctors-clinicians. The data must also resonate with patients 
and caregivers as determined by user testing to be included on the 
Compare tool profile pages.
    As of the time of this proposed rule, data from the CY 2021 
performance period/2023 MIPS payment year regarding MIPS eligible 
clinicians' performance in the quality, improvement activities, and 
Promoting Interoperability performance categories that meet public 
reporting standards are publicly available on Compare tool profile 
pages and in the PDC. However, we have not publicly reported any cost 
measure information from the cost performance category since the 
inception of MIPS for two primary reasons.
    First, in the CY 2019 PFS final rule (83 FR 59910 through 59912), 
we established a policy to delay publicly reporting any new quality and 
cost measures for the first two years they are in MIPS to allow MIPS 
eligible clinicians and groups to gain experience with the new 
measures. We codified this policy in our regulation at Sec.  
414.1395(c). After this period, we would reevaluate the measures to 
determine when and if they are suitable for public reporting (83 FR 
59910 through 59912). Second, we 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, the CY 2020 performance period/
2022 MIPS payment year, as discussed at https://qpp.cms.gov/resources/covid19?py=2020, and the CY 2021 performance period/2023 MIPS payment 
year, as discussed at https://qpp.cms.gov/resources/covid19?py=2021. 
That is, for several years, we provided cost measure scores to 
clinicians for informational purposes only and did not publicly report 
MIPS eligible clinicians' performance in the cost measure category.
    However, given the number of cost measures we have adopted in MIPS 
for at least two years and the PHE ending, we are evaluating ways to 
publicly report performance on cost measures on clinician and group 
profile pages beginning with data from the 2024 performance period/2026 
MIPS payment year being publicly reported in 2026. Public reporting of 
these data would assist patients and caregivers in making healthcare 
decisions. In section IV.A.4.f.(2) of this proposed rule, we are 
proposing, beginning with the CY 2024 performance period/2026 MIPS 
payment year, adoption of five new episode-based cost measures and 
removal of one episode-based cost measure. If our proposal is 
finalized, there would be a total of 25 cost measures--23 Episode-Based 
Cost Measures (EBCMs), Medicare Spending Per Beneficiary (MSPB), and 
Total Per Capita Cost (TPCC)--available for public reporting in CY 
2026, provided they meet public reporting standards as set forth in our 
regulation at Sec.  414.1395. In the CY 2019 PFS final rule (83 FR 
59910 through 59912), we finalized a policy to delay publicly reporting 
any new quality and cost measures for the first 2 years they are in 
MIPS at Sec.  414.1395(c). There are currently 25 cost measures 
available for public reporting at the time of this Request for 
Information, and the 5 cost measures proposed for inclusion in section 
IV.A.4.f.(2) of this rule would not be eligible for public reporting 
until the CY 2026 performance period/2028 MIPS payment year. 
Additionally, by publicly reporting cost measures, we would further our 
goals of transparency, encouraging MIPS eligible clinicians to 
prioritize cost efficiency, and enabling patients and caregivers to 
make informed decisions about clinicians who consider costs as part of 
their care.
    Research suggests that patients and caregivers are interested in 
comparative cost information.\320\ An Agency for

[[Page 52616]]

Healthcare Research and Quality (AHRQ) environmental scan and 
systematic review of all payer claims databases (APCDs) in 2017 found 
there is a need for standardized and transparent cost measures 
reporting, as well as user-friendly interfaces that help patients and 
caregivers make informed healthcare decisions.\321\ Several sources 
highlight the importance of presenting cost information in the context 
of quality metrics to improve healthcare consumers' ability to 
interpret cost data.\322\ \323\ Although there is limited research in 
this area, there is evidence that consumers can make high-value choices 
using cost in combination with other performance data.\324\
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    \320\ Greene, J., & Sacks, R.M. (2018). Presenting Cost and 
Efficiency Measures That Support Consumers to Make High-Value Health 
Care Choices. Health services research, 53 Suppl 1(Suppl 1), 2662-
2681. https://doi.org/10.1111/1475-6773.12839.
    \321\ Agency for Healthcare Research and Quality, All-Payer 
Claims Databases Measurement of Care: Systematic Review and 
Environmental Scan of Current Practices and Evidence (2017) https://www.ahrq.gov/data/apcd/envscan/findings.html.
    \322\ Greene, J., & Sacks, R.M. (2018). Presenting Cost and 
Efficiency Measures That Support Consumers to Make High-Value Health 
Care Choices. Health services research, 53 (Suppl 1), 2662-2681. 
https://doi.org/10.1111/1475-6773.12839.
    \323\ Commonwealth Fund, Hospital Price Transparency: Making It 
Useful for Patients, (2019), available at https://www.commonwealthfund.org/blog/2019/hospital-price-transparency-making-it-useful-patients.
    \324\ Greene, J., & Sacks, R.M. (2018). Presenting Cost and 
Efficiency Measures That Support Consumers to Make High-Value Health 
Care Choices. Health services research, 53 (Suppl 1), 2662-2681. 
https://doi.org/10.1111/1475-6773.12839.
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    During a recent consumer testing session with patients, the 
majority of whom were Medicare beneficiaries and included two retired 
clinicians, several participants noted that they find cost information 
valuable and would use it in conjunction with other information when 
making healthcare decisions. This early finding suggests that this type 
of information is valued by healthcare consumers; additional consumer 
testing with patients and caregivers and input from clinical subject 
matter experts would be beneficial for gathering feedback from the 
population who use the website and ensure that publicly reported MIPS 
cost measures are interpreted correctly and useful to website users. 
Further consumer testing with patients and caregivers would also help 
determine which aspects of cost performance information resonate most 
with them, as well as how to best display and plain language cost 
measure information on clinician and group profile pages.
    We intend to propose in future rulemaking to publicly report MIPS 
cost measures beginning with data from the CY 2024 performance period/
2026 MIPS payment year in CY 2026 on Compare tool clinician and group 
profile pages and in the PDC in 2026. In this Request for Information 
(RFI), we are seeking comment on a number of aspects of how to best 
establish publicly reporting cost measures, as discussed below.
     Potential approaches to reporting MIPS cost measures, 
including whether it is more meaningful to only report aggregated 
episodes or include component-level cost information for the EBCMs. 
Cost measure components are specified in the measure construction for 
each episode type based on input from clinical expert engagement 
activities during the development process and can include services 
related to either clinical treatments or adverse events (for example, 
clinically related diagnostic care, the need to receive post-acute care 
following the initial procedure or hospitalization, and the need to 
visit an emergency room or be readmitted for additional inpatient care 
following the initial procedure or hospitalization). With this context, 
patients would have additional information enabling them to make 
informed healthcare decisions.
    To provide actionable cost measure data, we will test the consumer 
perceptions of the components of cost measures in addition to the 
overall cost measure scores to determine whether they resonate with 
users. We expect that component costs will provide context for patients 
and caregivers to understand the extent to which costs are driven by 
what may be perceived as high-quality care (for example, post-discharge 
follow-up visits) or low-quality care (for example, procedure re-do). 
For example, when comparing clinicians, consumers could assess 
frequency or severity (for example, as measured by above average costs 
associated with clinically related complications).
     Benchmarking and possible comparators as well as how to 
best present this information to provide frames of reference for the 
cost performance information. Cost measures present a unique challenge 
to public reporting as their interpretation is not intuitive to 
consumers. While higher than expected costs may be driven by adverse 
outcomes, overall cost is comprised of care components that consumers 
could perceive as higher quality (for example, follow-up visits) as 
well as lower quality (for example, clinically related emergency 
department visits and re-hospitalizations). As a result, overall costs 
alone do not provide sufficient context about the drivers of those 
costs and may cause consumers more confusion in making a choice about 
where to seek care. Publishing overall costs could also be misleading, 
as previous consumer testing showed that some patients and caregivers 
interpret higher costs as a reflection of higher quality, when in fact 
testing during cost measure development has consistently demonstrated 
that clinicians with higher shares of costly adverse events, such as 
hospital readmission, tend to have worse scores.
    One mechanism of contextualizing cost measure performance is 
through displaying cost measures alongside clinically relevant quality 
measures, resulting in a reflection of value. However, there are two 
main reasons the current structure of MIPS does not consistently 
support this preferred display. First, under the self-selection policy 
for quality measures, MIPS eligible clinicians may select measures on 
which they expect to score best, rather than those that are most 
clinically relevant to their practice. This can result in a clinician 
profile with quality measures that are clinically unrelated to the 
clinician's core practice activities and, therefore, the clinician's 
cost measures. Second, MIPS eligible clinicians have a choice between 
reporting their performance on quality measures as individuals or as 
part of a group. Group-reported quality measure performance cannot be 
disaggregated to the clinician level. Because we calculate cost 
measures independently for all eligible clinicians and groups using 
Medicare claims, performance information is available at both levels. 
When reporting cost measure performance at the clinician level (because 
patients and caregivers using the Compare tool prefer measure 
performance at the most granular level available), we could have cost 
measures on a MIPS eligible clinician's profile page with no 
accompanying quality measures. Given these realities inherent to MIPS, 
there may not always be relevant quality measure information available 
to display alongside cost for a value concept. MIPS Value Pathways 
(MVPs) may mitigate some of these issues, since clinicians would have a 
smaller set of quality measures, some of which could be more related to 
their specialty, for selection, but clinician versus group level 
performance reporting discrepancies would persist.
    Therefore, we have considered several approaches to presenting cost 
measure performance information without assuming related quality 
measures would be available for adjacent display, including reporting 
the ratio of cost to the national average cost and the dollar cost per 
episode. These approaches may result in challenges to interpreting 
meaningful differences in costs. The

[[Page 52617]]

Achievable Benchmark of Care (ABCTM) methodology we 
currently use to star rate performance on publicly reported MIPS 
quality and Promoting Interoperability measures would not be 
appropriate for cost measures, because this method is used for measures 
in which a single direction of performance (for example, higher) is 
universally desirable, which, as discussed previously, is not always 
the case with cost performance. We have also considered an approach to 
display the MIPS eligible clinician's or group's relative position in 
the distribution of the cost measure performance compared to the 
national average we calculate from MIPS cost measures using three 
levels. Doing so, we could determine whether each clinician or group 
performance on each scored cost measure is ``greater than,'' ``less 
than,'' or ``no different'' compared to the national average cost.
    We are inviting comment on this possible approach to publicly 
reporting individual MIPS eligible clinician's or group's performance 
on individual EBCMs, MSPB, and TPCC compared to the average performance 
of all MIPS eligible clinicians nationally. We are also seeking comment 
on considerations for these comparators or benchmarks discussed above, 
particularly whether they would be useful to present or if there are 
any alternatives we have not yet considered.
    To summarize the aspects discussed above in which we request 
additional information, we are seeking comment on the following topics 
related to public reporting of MIPS cost measures on the Compare tool:
     How can we present MIPS cost measures information in a way 
that reflects meaningful outcomes to patients and their caregivers and 
the value of care, rather than cost alone?
     What are the considerations for publicly reporting the 
total episodic cost, component-level costs, or both? Do the component 
costs provide adequate context for patients and their caregivers to 
make informed healthcare decision? What other specific information 
about MIPS cost measures, including the context of quality measures and 
MVPs, should we consider including on the Compare tool?
     What are the considerations for publicly reporting the 
national average cost, ratio of cost to the national average cost, and/
or the dollar cost per episode as possible benchmarks for comparison 
discussed above in this section? What other benchmarks or comparator 
approaches should we consider?
     Are there any considerations for evaluating cost measures 
for public reporting beginning with cost measure data from CY 2024 
performance period/2026 MIPS payment year in the CY 2026?
     What other factors, such as those related to health 
equity, should be taken into consideration?
     We request comment on additional information that we may 
not have considered or discussed above about publicly reporting MIPS 
cost measures, as well as any unintended impacts and/or positive 
outcomes that could result from making this information publicly 
available on the Compare tool.
n. 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 of having all people with Traditional Medicare in 
an accountable care relationship with their health care provider by 
2030, where 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 
a belief that integrating individuals' clinical needs across a spectrum 
of providers and settings will improve patient care and population 
health.
    As we continue to improve the Quality Payment Program, we seek to 
develop, propose, and implement policies that encourage broad clinician 
participation in Advanced APMs. For example, in this section, we are 
proposing 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 will provide a more accurate measure of the actual 
engagement of individual clinicians participating in Advanced APMs. 
This accuracy is important for administration of the Quality Payment 
Program incentives and also 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 one of such dates 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 the 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 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 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), most eligible 
clinicians participating in Advanced APMs receive their QP 
determinations 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 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 for the APM Entity as a 
group outweighed these potential

[[Page 52618]]

scenarios. However, as we previously indicated in a Request for 
Information in the CY 2023 PFS proposed rule (87 FR 46337 through 
46339), we have come to believe that the effects of these types of 
scenarios, including effects that we had not intended or foreseen in 
the 2017 rule, have come to outweigh 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 typically 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. There 
are important reasons that it is not beneficial for an APM Entity to 
exclude specialists and other eligible clinicians who furnish 
relatively fewer services that lead to attribution. In both the 
Medicare Shared Savings Program and in models tested by the Innovation 
Center that the 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 essential for 
achieving this goal. For example, 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.\325\ 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 
determinations. Similarly, it was not our intent to create a policy 
whereby eligible clinicians who are seeing most or all of their 
Medicare patients through an Advanced APM may 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 are 
fully engaged in an Advanced APM may still be unable to earn QP status. 
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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    \325\ https://www.cms.gov/Medicare/Medicare-Fee-for-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 not including 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 directly among 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 attain QP status, some eligible clinicians who furnish 
relatively fewer of their services through that APM Entity may receive 
a disproportionate financial benefit 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 windfall 
financial rewards 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 clinicians in the APM Entity, whether an individual 
eligible clinician furnished a few or many such services. Once an 
eligible clinician receives QP status for a year, the APM Incentive 
Payment is calculated based on paid claims for the individual QP's 
covered professional services across all their TINs in the base year. 
This can allow an eligible clinician with minimal Advanced APM 
participation to receive

[[Page 52619]]

a disproportionately large APM Incentive Payment, which we do not 
believe aligns with the intent of the Quality Payment Program.
    As a result, we have reconsidered our current policy to make most 
QP determinations at the APM Entity level. Instead, we propose 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 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 
calculate 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 change our policy for 
these determinations, but would change the way we make QP 
determinations for all other eligible clinicians. Under the proposal, 
we would calculate 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 calculate 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 provide a more specific measurement of each 
eligible clinician's participation in an Advanced APM. This proposed 
methodology would ensure that those eligible clinicians who 
individually meet a QP threshold would receive QP status and its 
commensurate financial and other benefits. At the same time, it would 
remove 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 be evaluated individually at the 
NPI level, eligible clinicians with lower proportions of payments and 
payments through the Advanced APM Entity would not affect the QP status 
of other eligible clinicians on the APM Entity's Participation List.
(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.\326\
---------------------------------------------------------------------------

    \326\ 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 this proposed rule.
    When making QP determinations at the APM Entity 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 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 clinicians 
(either the individual eligible clinician or all those on the APM 
Entity's Participation List) attain QP status for such year.
[GRAPHIC] [TIFF OMITTED] TP07AU23.070

    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 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

[[Page 52620]]

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 the 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 E/M 
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 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 
the flexibility to determine an appropriate attribution methodology for 
an Advanced APM that falls 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 to beneficiaries 
than do specialists, 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 are furnishing covered professional services to a 
beneficiary but none of those services are among the E/M

[[Page 52621]]

services we use for attribution, that beneficiary would not be 
Attribution-eligible, and therefore, would not be included in our QP 
determination calculation at all, even though they actually are 
receiving covered professional services from an eligible clinician on 
the APM Entity's Participation List.
    We are proposing 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 complements our proposal to no longer conduct APM Entity 
group-level QP determinations and switch to making QP determinations at 
the individual eligible clinician level. We are also concerned that 
retention of the current policy under which E/M services are the 
default basis for attribution and 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.
    In order to create a uniform basis for beneficiary attribution 
across all Advanced APMs, we are proposing 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 simplify and streamline 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 address 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 services, 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 be 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 would 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 would 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) would 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 would 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 would 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 seek 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.
(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.  
[thinsp]414.1430(a) and for the All-Payer Combination Option at Sec.  
[thinsp]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. 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. In 
order 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 under 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

[[Page 52622]]

for the payment amount method or 10 percent under the patient count 
method.
    To conform our regulation with the amendments made by the CAA, 
2023, we propose to amend Sec.  [thinsp]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 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.
BILLING CODE 4120-01-P

[[Page 52623]]

[GRAPHIC] [TIFF OMITTED] TP07AU23.071


[[Page 52624]]


BILLING CODE 4120-01-C
(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 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 propose to incorporate the change made by the CAA, 
2023, by amending the regulation text at Sec.  [thinsp]414.1450 to add 
the payment year 2025 APM Incentive Payment amount of 3.5 percent of 
covered professional services payments. We propose 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 note 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, 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 specified in section 
1848(d)(20) of the Act. The update specified for the conversion factor 
for QPs will be 0.75 percent, while the update for all others will be 
0.25 percent.
(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 have may 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 are 
proposing at section IV.A.4.j. of this 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 this 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 this 
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 are 
proposing to amend the definition of CEHRT at Sec.  414.1305 that would 
apply to Advanced APM participants, and 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 provider organization. 
It is our goal to encourage not only provider ownership of this 
technology, but full adoption and integration of the most advanced 
health information technology (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

[[Page 52625]]

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 eligible 
clinicians participating in APMs, 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 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 APM Entity participating in the APM, 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 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 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 clinicians and maintain consistency across programs, permitting 
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 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).\327\ 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

[[Page 52626]]

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.
---------------------------------------------------------------------------

    \327\ 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).
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(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 each hospital that are APM Entities, 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 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 requirements for use of CEHRT are 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 APM participants 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 our requirement that 
Advanced APMs 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 CHERT 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 achieve Advanced APM status 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 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 70 percent CEHRT use standard has 
been in effect for almost five years, we believe it would be 
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 are proposing 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(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 update 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

[[Page 52627]]

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 proposed 
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 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 
exempt from MIPS, are subject to MIPS reporting requirements and the 
MIPS payment adjustment. Our proposed amendment to the CEHRT definition 
under paragraph (3) at Sec.  414.1305 for Advanced APMs has limited 
effect upon the requirement to participate in MIPS if QP or Partial QP 
status is not achieved. Accordingly, under our proposal, eligible 
clinicians in Advanced APMs would 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.
    In section IV.A.4.f.(4) of this proposed rule, we are also 
proposing other 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 proposed amendments as set forth in section IV.A.4.f.(4) 
of this proposed rule.
    Second, we are proposing to amend our current Advanced APM CEHRT 
use criterion at Sec.  414.1415(a)(1). Specifically, we propose 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 propose 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 are proposing 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 are also proposing to revise Sec.  414.1415 by making non-
substantive technical edits to paragraphs (a)(1)(i) and (a)(1)(ii) to 
improve clarity.
    This proposal 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 proposed 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 what percentage of eligible clinicians meet our 
current CEHRT requirements. We further believe that, under our more 
flexible proposed 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 would 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 seek comment on this proposal.
(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 payment arrangements designed and implemented by 
Other Payers and Medicare 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 are proposing to amend the Other Payer 
Advanced APM criteria at Sec.  414.1420(b) to conform to the changes we 
now propose for the 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 proposed revised definition 
of CEHRT for purposes of Advanced APM determinations. We are also 
proposing to revise Sec.  414.1420(b) by making additional non-
substantive technical edits to improve clarity.
    The changes we are proposing for Medicare Advanced APMs are 
designed to require use of technologically sufficient EHRs, 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 participants as the Medicare Option, and considers 
participation in both Medicare Advanced APMs and Other Payer Advanced 
APMs, we believe we should continue to apply the same CEHRT use

[[Page 52628]]

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 would 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 to obtain clinically unnecessary 
technology simply for purposes of meeting what we now believe to be an 
overly restrictive CEHRT use criterion.
    We seek comment on this proposal.

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 are soliciting public comment (see section VI. of this proposed 
rule) on each of these issues for the following sections of this 
document that contain information collection requirements. Comments, if 
received, will be responded to within the subsequent final rule.

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 54 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.
[GRAPHIC] [TIFF OMITTED] TP07AU23.072

    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 55.

[[Page 52629]]

[GRAPHIC] [TIFF OMITTED] TP07AU23.073

    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 Framework and Best Practices 
\328\ 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 \329\ 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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    \328\ https://aspe.hhs.gov/sites/default/files/migrated_legacy_files//176806/VOT.pdf.
    \329\ https://fred.stlouisfed.org/series/LEU0252881500A.
---------------------------------------------------------------------------

B. Proposed 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 proposed changes will be submitted to OMB for review 
under control number 0938-1435 (CMS-10835).
    As discussed in section III.A. of this proposed 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 proposed rule, we are proposing 
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.
    We are proposing that, 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; (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.
    As discussed in section VII.E.4. of this proposed rule, our 
estimates show a projected 28 billing and payment codes meeting the 
definition of refundable single-dose container or single-use package 
drug with 10 percent or more discarded units, which is the applicable 
percentage specified in section 1847A(h)(3) of the Act. Therefore, we 
anticipate a similar number of drugs could owe a refund under section 
90004 of the Infrastructure Act. Since 25 of those billing codes have 
an estimated annual refund obligation of over $50,000, we expect that, 
initially (that is, the first year the proposed application process is 
available), the manufacturers of those 25 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 would not need to apply again. Therefore, 
subsequent years we would expect a smaller number of applications. When 
evaluating the

[[Page 52630]]

approval dates of these 25 drugs, we find that there is a range of 0 to 
4 drugs per year approved that would 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. If rounded up, we estimate that we 
would typically receive 2 applications per 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 25 applications in the initial year that applications are 
available, we estimate a total burden of 125 hours (25 applications x 5 
hr) per at a cost of $5,218 ($41.74/hr x 125 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).
2. ICRs Regarding the Clinical Laboratory Fee Schedule: Data Reporting 
by Laboratories
    As described in section III.D of this proposed 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 proposed to revise 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 proposed burden estimates under this section of the proposed rule. 
Please refer to section VII.E.7. of this proposed rule for a discussion 
of the impacts associated with the changes described in section III.D. 
of this proposed rule.
3. ICRs Regarding the Medicare Shared Savings Program
    Section 1899(e) of the Act provides that chapter 35 of title 44 
U.S.C., which includes such provisions as the PRA, shall not apply to 
the Shared Savings Program. Accordingly, we are not setting out 
proposed Shared Savings Program burden estimates under this section of 
the preamble. Please refer to section VII.E.10. of this proposed rule 
for a discussion of the impacts associated with the changes to the 
Shared Savings Program as described in section III.G. of this proposed 
rule.
4. ICRs Regarding the Updates to the Medicare Diabetes Prevention 
Program
    In section III.L. of this proposed rule, we propose to extend 
specific Medicare Diabetes Prevention Program (MDPP) flexibilities 
allowed during the PHE for COVID-19 1135 waiver event by 4 years. In 
addition, we are proposing to update the MDPP payment structure to pay 
for beneficiary attendance on a fee-for-service basis while retaining 
the diabetes risk reduction performance payments. Finally, we are 
proposing 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 proposed 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 
proposed 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 proposed rule, we are 
proposing to pause efforts to implement the Appropriate Use Criteria 
(AUC) for Advanced Diagnostic Imaging Services program for reevaluation 
and to rescind 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 propose 
in section III.J. of this proposed 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 would be affected 
by this rule's proposal 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, would be 
rescinded, all three collections would no longer be needed.
    CMS-10570 (OMB 0938-1288) relates to the application and 
qualification process for provider-led entities (PLEs). If we finalize 
the proposal and rescind the current regulations at Sec.  414.94, then 
we will discontinue this collection of information. The following table 
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 proposing to pause 
the AUC program and rescind 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

[[Page 52631]]

(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] TP07AU23.074

    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 proposed 
rule RIA (see section VII. Regulatory Impact Analysis of this proposed 
rule).
6. ICRs for Medicare Provider and Supplier Enrollment
    None of this rule's Medicare and Medicaid provider enrollment 
provisions propose any new, revised, or removed information collection 
requirements or burden. Regarding the proposal to reduce the timeframe 
for reporting practice location changes from 90 days to 30 days, this 
change would not alter the requirement for disclosing the change via 
the applicable Form CMS-855 or Form CMS-20134. It would only revise the 
timeframe in which the change must be reported. Hence, there would 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 are not setting out any proposed burden estimates 
under this section of the rule.
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 proposed changes will be submitted to OMB for review 
under control number 0938-0344 (CMS-R-38).
    In section III.C. of this proposed rule, we implement section 4121 
of the CAA by proposing conforming changes at Sec.  491.8(a)(3) and 
(a)(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 would 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 are proposing 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.\330\ 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

[[Page 52632]]

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.331 332
---------------------------------------------------------------------------

    \330\ https://www.nachc.org/wp-content/uploads/2019/03/BH-Fact-Sheet-3.20.19.pdf.
    \331\ https://qcor.cms.gov/active_nh.jsp?which=12&report=active_nh.jsp&jumpfrom=#pagetop.
    \332\ https://qcor.cms.gov/active_nh.jsp?which=11&report=active_nh.jsp&jumpfrom=#pagetop
---------------------------------------------------------------------------

    Each clinic or center is required by the existing requirement at 
491.9(b)(2) to have at least two clinical professionals (one physician/
administrator at $229.52/hr and one advanced practice provider at 
$119.88/hr) 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 (.25 hr) for 
each clinical professional. In aggregate, we estimate an annual burden 
of 2,071.50 hours (0.25 hr x 8,268 RHC and FQHCs) at a cost of 
$361,891.05 [(1,035.75 hr x $229.52/hr) + (1,035.75 hr x $119.88/hr)].
[GRAPHIC] [TIFF OMITTED] TP07AU23.075

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 proposed rule, we would implement 
subtitle C, section 4121 of the CAA 2023 by proposing conforming 
changes at Sec.  418.56(a)(1)(iii) that would permit MFTs or MHCs, in 
addition to social workers, to serve as members of the IDG. The 
conforming change would require hospices to include at least one SW, 
MFT or MHC to serve as a member of the IDG. Hospices would have the 
flexibility to determine which discipline(s) are appropriate to serve 
on the IDG based on the needs of the patients. We believe that with the 
introduction of MHC and MFT into the hospice CoPs, it is important to 
include these new disciplines into the personnel qualifications at 
Sec.  418.114.
    In this rule we are also proposing 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 are proposing 
to add both MFT and MHC to the requirements at Sec.  418.114(c)(3) and 
(4) and referencing the new requirement at Sec. Sec.  410.53 and 
410.54, respectively.
    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 
proposed revisions to the requirements at Sec. Sec.  418.56(a)(iii) and 
418.114(c)(3) and (4) 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 are not proposing to seek OMB's 
approval for any information collection or recordkeeping activities 
that may be conducted in connection with the proposed revisions to 
Sec. Sec.  418.56(a)(1)(iii) and 418.114(c)(3) and (4), but we request 
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.
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 are not seeking 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

[[Page 52633]]

costs associated with responding to this RFI will be solely at the 
interested party's expense. We note 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 note 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 would 
be required or sought. All submissions become U.S. Government property 
and will not be returned.
10. Basic Health Program (BHP) Provisions
a. Proposed Information Collection Requirements (ICRs)
    The following proposed changes will be submitted to OMB for review 
under OMB control number 0938-1218 (CMS-10510).
(1) ICRs Regarding the BHP Blueprint (Sec.  600.125)
    We propose at Sec.  600.125(a)(1)-(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 note that only Sec.  600.125(a)(1) is a new requirement. 
The requirements under Sec.  600.125(a)(2) and (3) are existing. We 
propose 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 propose 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 estimate that, on average, a State operating a BHP will submit 
one revised Blueprint in response to Sec.  600.125(a)(1) annually. 
Because only two States are currently certified to operate a BHP, we 
are providing the burden estimate for two States. We estimate that the 
proposal under Sec.  600.125(a)(1) will increase State burden. We 
estimate that the proposals under Sec.  600.125(b) and (c) will have no 
impact on State burden. We estimate 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 estimate 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 note 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 propose 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 propose 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.  
[thinsp]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 are providing the burden estimate for two States. We estimate 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 estimate 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 note that this cost will be incurred 100 
percent by the State, as Federal BHP funds cannot be used for program 
administration.
    We propose 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 propose 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 propose 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 propose 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 propose 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 propose at Sec.  600.140(b)(5) that the State must submit 
the annual report required by Sec.  600.170(a)(2). We propose 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 propose 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 
are providing the burden estimate for two States.
    We estimate that, on average, it would 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 estimate 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 estimate that, on average, it would take a Business 
Operations Specialist 30 hours at $80.08/hr and a General Manager 4

[[Page 52634]]

hours at $118.14/hr to submit a suspension extension application to the 
Secretary. In aggregate, we estimate 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 estimate that, on average, it would 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 
estimate 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 estimate 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 estimate 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 estimate that, on average, it would 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 
estimate 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 estimate that it would 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 estimate 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 estimate 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 note that these costs will be 
incurred 100 percent by the State, as Federal BHP funds cannot be used 
for program administration.
b. Burden Summary

[[Page 52635]]

[GRAPHIC] [TIFF OMITTED] TP07AU23.076


[[Page 52636]]


11. The Quality Payment Program (QPP) (42 CFR Part 414 and Section IV. 
of This Proposed Rule)
    The following QPP-specific ICRs reflect changes to our currently 
approved burden due to proposed policy changes in this CY 2024 proposed 
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 proposed 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 proposed revisions in the 
policies associated with the CY 2024 PFS proposed rule and the proposed 
revisions to our currently approved information requests for MIPS and 
Advanced APM ICRs. The proposed estimated burden will be submitted to 
OMB under control number 0938-1314 (CMS-10621). The proposed 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 will be 
submitted under OMB control number 0938-1222 (CMS-10450). We note 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 Proposed 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 proposed policies 
and information collections in this proposed rule. The proposed 
policies in this proposed 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 
proposed policies in this proposed 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 proposed policies will 
result in a net decrease in burden of 4,002 hours and $459,553 for the 
CY 2024 performance period/2026 MIPS payment year. The remaining 
changes to our currently approved burden estimates are proposed 
adjustments due to the revised burden assumptions based on the updated 
data available at the time of publication of this proposed rule. As 
discussed in section VII.E.23.a. of this proposed rule, we are basing 
our estimates on data from the CY 2021 performance period.
    We are proposing to add two new ICRs, ``QCDR full self-nomination 
process'' and ``qualified registry full self-nomination process'' in 
sections V.B.11.c.(2) and V.B.11.c.(3) of this rule to distinctly 
capture the burden for the number of QCDRs and qualified registries 
submitting applications for the simplified and full self-nomination 
process. We note that the proposed addition of these ICRs is not due to 
the proposed policy changes in section IV.A.4.k. of this rule. It is a 
proposed change in our approach in representing the estimated burden 
for the third -party intermediary self-nomination process due to 
availability of updated data.
    We are proposing to remove one ICR, ``nomination of Promoting 
Interoperability measures,'' in section V.B.11.h. of this rule. We note 
that the proposed removal of the ICR is not due to proposed policy 
changes in section IV.A.4.f.(4) of this rule. It is due to a consistent 
decline in the number of submissions received for the ICR.
    We are not proposing any changes or adjustments to the following 
ICRs: Registration for virtual groups; OAuth credentialing and token 
request process; Quality Payment Program identity management 
application process; subgroups registration; submitting Promoting 
Interoperability data; improvement activities submission; nomination of 
MVPs; and opt-out of performance data display on Compare Tools for 
voluntary participants. See section V.B.11. of this proposed 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 2021 performance period/2023 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.
(4) Framework for Understanding the Burden of MIPS Data Submission
    Because of the wide range of information collection requirements 
under MIPS, Table 59 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 59, MIPS eligible clinicians and other clinicians voluntarily 
submitting

[[Page 52637]]

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 for the cost performance 
category is not represented in Table 59.
    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 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(c) of the Act, submissions received 
from eligible clinicians in ACOs are not included in burden estimates 
for this proposed 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).

[[Page 52638]]

[GRAPHIC] [TIFF OMITTED] TP07AU23.077

    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 proposed rule create some additional data collection requirements 
not listed in Table 59. These additional data collections, some of 
which are currently approved by OMB under the control numbers 0938-1314 
(Quality Payment Program, CMS-

[[Page 52639]]

10621) and 0938-1222 (CAHPS for MIPS, CMS-10450), are as follows:
    Additional ICRs related to MIPS third-party intermediaries (see 
section V.B.11. c. of this proposed 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 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 proposed 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 proposed 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 proposed 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)
    Additional ICRs related to MIPS (see section V.B.11.o. of this 
proposed 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 proposed 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)
    This rule does not propose any new or revised collection of 
information requirements or burden related to the virtual group 
election. The virtual group election requirements and burden are 
currently approved by OMB under control number 0938-1343 (CMS-10652). 
Consequently, we are not proposing any changes under that control 
number.
c. ICRs Regarding Third Party Intermediaries (Sec.  414.1400)
    The following proposed 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 rule, we are proposing 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 
proposed changes in the below sections.
    In section IV.A.4.k. of this rule, we are proposing 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) 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) 
specify the process for publicly posting remedial action; and (13) 
specify the criteria for audits. Specifically, we note that the 
proposed policy to eliminate the health IT vendor category beginning 
with the CY 2025 performance period/2027 MIPS payment year, if 
finalized, would not have any impact on the estimated burden for third 
party self-nomination process in the CY 2024 performance period/2026 
MIPS payment year. If the proposed removal of health IT vendor category 
is finalized for the CY 2025 performance period/2027 MIPS payment year, 
we recognize that it could encourage some existing health IT vendors to 
complete the requirements under the qualified registry self-nomination 
process. However, 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. Therefore, we assume that 
there would not be an increase in the number of qualified registries 
that would submit applications for the qualified registry self-
nomination process during the CY 2024 performance period/2026 MIPS 
payment year.
    We assume that the proposed changes to codify previously finalized 
preamble language related to third party intermediaries in the 
regulatory text would 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 the 
above proposed policies and therefore, we are not proposing any 
adjustments to the currently approved burden estimates for third party 
intermediaries. We refer readers to section IV.A.4.k. of this rule for 
details on proposed policies for third party intermediaries. 
Additionally, we refer readers to section VII.E.23.e.(2)(a) of this 
proposed 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,

[[Page 52640]]

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.\333\ 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.
---------------------------------------------------------------------------

    \333\ 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 section V.B.11.c.(2)(a) of this rule, we are 
proposing 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. 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 are proposing to add a new ICR to capture 
the burden for the simplified QCDR self-nomination process. We note 
that the proposed change in estimated burden is not due to policy 
proposals in section IV.A.4.k. of this rule. In order 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. We are not proposing any changes to our estimates for the number 
of existing or borrowed QCDR measures submitted for consideration by 
each QCDR at the time of self-nomination and the average time required 
to submit information for each QCDR measure.
    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) Self-Nomination Process and Other Requirements
    Based on the number of applications that we expect to receive 
during the CY 2023 self-nomination period for the CY 2024 performance 
period/2026 MIPS payment year, we estimate that 45 QCDRs would submit 
applications using the simplified self-nomination process. We note that 
we are not making any changes to 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 60, 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 would be 
$837.54 (8.1hr 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 would be 365 hours (45 
responses x 8.1 hr) at a cost of $37,689 (45 applications x $837.54/
application).
[GRAPHIC] [TIFF OMITTED] TP07AU23.078

    In Table 61, the addition of this new ICR for the CY 2024 
performance period/2026 MIPS payment year would result in an increase 
of 365 hours at a cost of $37,689 for the simplified QCDR self-
nomination process. We note that the proposed increase in burden is due 
to separating the estimated burden for the simplified QCDR self-
nomination process.

[[Page 52641]]

[GRAPHIC] [TIFF OMITTED] TP07AU23.079

(b) Full QCDR Self-Nomination Process and Other Requirements
    Based on the number of applications that we expect to receive 
during the CY 2023 self-nomination period for the CY 2024 performance 
period/2026 MIPS payment year, we estimate that 10 QCDRs would submit 
applications using the full self-nomination process. This is a decrease 
of 53 respondents from the currently approved estimate of 63 for the 
QCDR self-nomination process (87 FR 70139). We note that we are not 
making any changes to 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 62, 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 $1,044.34 (10.1hr 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 would be 101 hours (10 responses x 10.1 hr) at 
a cost of $10,443 (10 applications x $1,044.34/application).
[GRAPHIC] [TIFF OMITTED] TP07AU23.080

    In Table 63, 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 
105 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 results in a 
decrease of 535 hours and $55,350 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.

[[Page 52642]]

[GRAPHIC] [TIFF OMITTED] TP07AU23.081

(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.
    In section IV. of this rule, we are proposing to add that if the 
measure was submitted for consideration 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 active 
requirements or burden estimates because the proposed policy only 
clarifies requirements for rejecting a QCDR measure and will not 
substantively change the currently approved estimated average weighted 
time required for a QCDR to submit information for a QCDR measure at 
the time of self-nomination.
    In section IV. of this rule, we are proposing 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 currently approved burden estimates as result of this change 
because limiting the number of measures submitted during the QCDR self-
nomination process would not substantively change the currently 
approved estimated average weighted time required for a QCDR to submit 
information for a QCDR measure at the time of self-nomination.
    In section IV.A.4.k.(4)(b)(i) of this rule, we are proposing 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 currently approved 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 
currently approved 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 
qualified registries interested in submitting MIPS data to us on behalf 
of MIPS eligible clinicians, groups, or virtual groups need to complete 
a self-nomination process to be considered for approval to do so.
    As described below, in this rule we are proposing 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. 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 are proposing to add a new ICR to 
capture the burden for the qualified registry self-nomination process. 
We note that the proposed change is not due to policy proposals in 
section IV.A.4.k. of this rule. With the addition of a new ICR, we 
believe that we would 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 that we expect to receive 
during the CY 2023 self-nomination period for the CY 2024 performance 
period/2026 MIPS payment year, we estimate that 89 qualified registries 
would submit applications using 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 provide 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 64, 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 would 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 would be 45 hours (89 responses x 0.5 
hr) at a cost of $4,601 (89 applications x $51.70//application).

[[Page 52643]]

[GRAPHIC] [TIFF OMITTED] TP07AU23.082

    In Table 65, the addition of this ICR for the CY 2024 performance 
period/2026 MIPS payment year would result in a change of +45 hours at 
a cost of $4,601 for the simplified qualified registry self-nomination 
process. We note the increase in burden is due to separating the 
estimated burden for the simplified and full qualified registry self-
nomination process.
[GRAPHIC] [TIFF OMITTED] TP07AU23.083

(b) Full Qualified Registry Self-Nomination Process
    Based on the number of applications we expect to receive during the 
CY 2023 self-nomination period for the CY 2024 performance period/2026 
MIPS payment year, we estimate 36 qualified registries would submit 
applications using the full self-nomination process. This is a decrease 
of 96 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 0.5 hours for the simplified qualified registry self-nomination 
process and 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 66, 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 would 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 would be 
72 hours (36 responses x 2 hr) at a cost of $7,445 (36 applications x 
$206.80/application).
[GRAPHIC] [TIFF OMITTED] TP07AU23.084

    In Table 67, 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

[[Page 52644]]

full qualified registry self-nomination process under ``maximum 
burden'' in Table 107 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 192 hours and a decrease of $19,853 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] TP07AU23.085

(4) Third Party Intermediary Plan Audits
    The following proposed 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 equivalent, who have an average labor rate of 
$103.40/hr.
    Based on the number of data validation execution reports submitted 
for the CY 2021 performance period/2023 MIPS payment year, we estimate 
that 33 third party intermediaries (13 QCDRs and 20 qualified 
registries) will submit targeted audits for the CY 2024 performance 
period/2026 MIPS payment year (See Table 68). 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 165 hours (33 
responses x 5 hr/audit) and $17,061 (33 targeted audits x $517/audit) 
to 330 hours (33 responses x 10 hr/audit) and $34,122 (33 targeted 
audits x $1,034/audit) (see Table 69 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.
    Consistent with our assumptions in the CY 2023 PFS final rule for 
the QCDRs and qualified registries (87 FR 70141) that will submit 
participation plans, we estimate that it will take 3 hours for a QCDR 
or qualified registry to submit a participation plan during the self-
nomination process. 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 68, we are not changing our currently approved 
estimate that 75 third party intermediaries [five self-nomination 
participation plans (two QCDRs and three qualified registries) and 70 
QCDR measure participation plans] will submit participation plans for 
the CY 2024 performance period/2026 MIPS payment year.
    In Table 69, we estimate that the cost for a QCDR or a qualified 
registry to submit a participation plan is $310.20 (3 hours x $103.40/
hr). In aggregate, we estimate the total impact associated with QCDRs 
and qualified registries to submit participation plans would be 225 
hours (75 participation plans x 3 hr/plan) at a cost of $23,265 (75 
participation plans x $310.20/plan) (see Table 69 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). In section IV.A.4.k.(6)(b), we are proposing 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 propose to add at Sec.  414.1400(e)(2)(v) that we may 
terminate third party intermediaries that are on remedial action for 
two consecutive years. We are not proposing any changes to our 
currently approved estimated burden due to these proposals 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

[[Page 52645]]

trend would continue for the CY 2024 performance period/2026 MIPS 
payment year. Therefore, we estimate 17 third party intermediaries will 
submit CAPs for the CY 2024 performance period/2026 MIPS payment year. 
This is an increase of seven 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 69, 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 
51 hours (17 CAPs x 3 hr/plan) at a cost of $5,273 (17 CAPs x $310.20/
plan).
(d) Transition Plans
    In the CY 2020 PFS final rule (84 FR 63052 through 63053), we 
established a policy at Sec.  414.1400(a)(4)(vi) which states a 
condition of approval for the third party intermediary is to agree that 
prior to discontinuing services to any MIPS eligible clinician, group 
or virtual group during a performance period, the third party 
intermediary must support the transition of such MIPS eligible 
clinician, group, or virtual group 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 rule, we estimate we will receive five transition plans 
for the CY 2024 performance period/2026 MIPS payment year. This 
adjustment would result in a decrease of five 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 5 hours (5 transition plans x 1 hr/plan) at a cost of $517 (5 hr x 
$103.40/hr). We refer readers to section VII.E.23.e.(2)(a) of this 
proposed rule where we discuss our impact analysis for the transition 
plans submitted by QCDRs and qualified registries.
    In section IV.A.4.k.(6)(c) of this rule, we are proposing at Sec.  
414.1400(e)(1)(i)(F) an additional requirement 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 proposed revision would ensure 
third party intermediaries complete the requirements within the 
communication plan and would not add any additional requirements for a 
third-party intermediary to submit a CAP.
    In section IV.A.4.k.(6)(d) of this rule, we are proposing to add a 
new provision at Sec.  414.1400(e)(1)(ii)(B) that we may publicly 
disclose on the CMS website that CMS took remedial action on the third 
party intermediary or terminated it. We are also proposing 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.
    In section IV.A.4.k.(6)(e) of this rule, we are proposing to modify 
Sec.  414.1400(a)(2)(ii)(A) to state that our consideration can include 
past compliance including remedial actions. We are proposing 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 proposing to redesignate the existing section Sec.  
414.1400(f) (which includes paragraphs (f)(1), (2), and (3)) as 
paragraph (a)(3)(vii) with no changes in the text.
    We do not expect to receive additional information from QCDRs and 
qualified registries during the self-nomination process due to the 
above proposed policies and therefore, are not proposing any 
adjustments to the currently approved burden estimates for third party 
intermediary plan audits. Additionally, we refer readers to section 
VII.E.23.e.(2)(a) of this proposed rule where we discuss the details in 
our impact analysis for these policies.
(e) Final Burden for Third Party Intermediary Plan Audits
    In aggregate, as shown in Table 68, we assume that 130 third party 
intermediaries will submit plan audits (33 targeted audits, 75 
participation plans, 17 CAPs, and 5 transition plans).
[GRAPHIC] [TIFF OMITTED] TP07AU23.086

    In Table 69, 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 
proposed estimated annual burden for the submission of third party 
intermediary plan audits will range from 446 hours to 611 hours at a 
cost ranging from $46,116 (446 hr x $103.40/hr) and $63,177 (611 hr x 
$103.40/hr) (see Table 69).

[[Page 52646]]

[GRAPHIC] [TIFF OMITTED] TP07AU23.087

    In Table 70, 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 +21 hours at a cost of 
+$2,171 for the simplified self-nomination process and +26 hours at a 
cost of +$2,688 for the full self-nomination process.
    We note for the purposes of calculating proposed estimated change 
in burden in Tables 96 through 98 of this rule, we use only estimated 
burden for the plan audits submitted under the full self-nomination 
process.
[GRAPHIC] [TIFF OMITTED] TP07AU23.088

(5) Survey Vendor Requirements
    The following proposed 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 note 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 this rule, we are adjusting the estimated number of vendors that 
will apply to participate as CAHPS for MIPS Survey vendors that were 
previously approved in the CY 2018 Quality Payment Program final rule 
(82 FR 53908). We estimate 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 71, 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

[[Page 52647]]

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] TP07AU23.089

    In Table 72, we illustrate the net change in estimated burden for 
survey vendor requirements using the currently approved burden in the 
CY 2018 QPP 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 would 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.
[GRAPHIC] [TIFF OMITTED] TP07AU23.090

d. ICRs Regarding Open Authorization (OAuth) Credentialing and Token 
Request Process
    This rule is not proposing any new or revised collection of 
information requirements or burden related to the OAuth credentialing 
and token request process. 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 
proposing any changes to the OAuth credentialing and token burden 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 
quality data 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 third snapshot date for the 2022 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 2019 PFS final rule, we finalized limiting the Medicare 
Part B claims collection type to small practices beginning with the CY 
2019 performance period/2021 MIPS payment year and allowing clinicians 
in small practices to report Medicare Part B claims as a group or as 
individuals (83

[[Page 52648]]

FR 59752). We note in this proposed rule, we are using the same CY 2021 
performance period/2023 MIPS payment year submissions data used in the 
2023 PFS Final Rule (87 FR 70145 through 70148).
    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 
proposed 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 2019 performance period/2021 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 2021 performance period/
2023 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 proposed rule because 
sections 1899(e) and 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.\334\
---------------------------------------------------------------------------

    \334\ 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 estimate the burden for collecting data via 
collection type: Medicare Part B claims, QCDR and MIPS CQMs, and eCQMs. 
Additionally, we capture 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.
    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 2021 performance period/2023 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 73 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 approximately 14,402 
clinicians will submit data as individuals using the Medicare Part B 
claims collection type; approximately 11,197 clinicians will submit 
data as individuals using MIPS CQM and QCDR collection type; and 
approximately 17,944 clinicians will submit data as individuals using 
eCQMs collection type. Based on performance data from the CY 2021 
performance period/2023 MIPS payment year, these are decreases of 334, 
261, and 418 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.

[[Page 52649]]

[GRAPHIC] [TIFF OMITTED] TP07AU23.091

    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 73 are not mutually exclusive.
    Table 74 provides our estimated counts 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 2021 performance period/2023 MIPS payment year will continue to 
submit quality data 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 2021 performance period/2023 
MIPS payment year.
    As shown in Table 74, for the CY 2024 performance period/2026 MIPS 
payment year we estimate 6,312 groups and virtual groups will submit 
data for the MIPS CQM and QCDR collection type and 5,402 groups and 
virtual groups will submit for eCQM collection types. These are 
decreases of 146 and 125 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.
    As the data does not exist for APM performance pathway or MIPS 
quality measures for non-ACO APM entities, we assume non-ACO APM 
Entities will participate through traditional MIPS and base our 
estimates on submissions received in the CY 2021 performance period/
2023 MIPS payment year.

[[Page 52650]]

[GRAPHIC] [TIFF OMITTED] TP07AU23.092

    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 estimated 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 propose a measure set of 200 quality measures. The new MIPS 
quality measures proposed 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 75, 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 
proposed rule for additional information.

[[Page 52651]]

[GRAPHIC] [TIFF OMITTED] TP07AU23.093

    For the CY 2024 performance period/2026 MIPS payment year, we are 
proposing 200 measures, a net increase of 2 quality measures across all 
collection types compared to the currently approved estimate of 198 
measures. Specifically, as discussed in section IV.A.4.f.(1)(e) of this 
rule, we are proposing to add 14 new MIPS quality measures, remove 12 
MIPS quality measures, partially remove 3 MIPS quality measures that 
are proposed for removal from traditional MIPS and proposed for 
retention 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.
(3) Quality Payment Program Identity Management Application Process
    This rule does not propose any new or revised collection of 
information requirements or burden related to the identity management 
application process. The identity management application process 
requirements and burden are currently approved by OMB under control 
number 0938-1314 (CMS-10621). Consequently, we are not proposing 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 proposed changes will be submitted to OMB for review 
under control number 0938-1314 (CMS-10621).
    This rule does 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 
79 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 73, we estimate that 14,402 individual clinicians 
will collect and submit quality data via the Medicare Part B claims 
collection type, a decrease of 334 from the currently approved estimate 
of 14,736 (87 FR 70150).
    In Table 76, consistent with our currently approved per response 
time figures and using the updated wage rates in Table 54 of this 
proposed 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 54 of this proposed 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 76, 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 
from 102,974 hours (7.15 hr x 14,402 clinicians) to 204,508 hours (14.2 
hr x 14,402 clinicians). The total annual cost for the CY 2024 
performance period/2026 MIPS payment year ranges from a

[[Page 52652]]

minimum of $12,376,071 to a maximum of $22,874,697.
[GRAPHIC] [TIFF OMITTED] TP07AU23.094

    In Table 77, 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 14,402 (-334) 
results in a total maximum adjustment of -4,743 hours (-334 responses x 
14.2 hr/response) at a cost of -$530,492 (-334 response x $1,588.30/
response). For purposes of calculating total burden associated with 
this proposed rule as shown in Tables 99 through 101, only the maximum 
burden is used.

[[Page 52653]]

[GRAPHIC] [TIFF OMITTED] TP07AU23.095

(5) Quality Data Submission by Individuals and Groups Using MIPS CQM 
and QCDR Collection Types
    The following proposed 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 74 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 73 and 74, based on data from the CY 2021 
performance period/2023 MIPS payment year, for the CY 2024 performance 
period/2026 MIPS payment year, we assume that 17,509 clinicians (11,197 
individuals and 6,312 groups and virtual groups) will submit quality 
data as individuals or groups using MIPS CQM or QCDR collection types. 
This is a decrease of 407 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 78, for the CY 2024 performance period/2026 MIPS payment 
year, in aggregate, we estimate a burden of 159,034 hours [9.083 hr/
response x 17,509 responses] at a cost of $18,201,306 (17,509 responses 
x $1,039.54/response).

[[Page 52654]]

[GRAPHIC] [TIFF OMITTED] TP07AU23.096

    In Table 79, 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 407 respondents from 17,916 to 17,509 for the CY 2024 performance 
period/2026 MIPS payment year results in a decrease of 3,697 hours (-
407 responses x 9.083 hr/response) at a cost of -$423,093 (-407 
responses x $1,039.54/response).
[GRAPHIC] [TIFF OMITTED] TP07AU23.097


[[Page 52655]]


(6) Quality Data Submission by Clinicians and Groups: eCQM Collection 
Type
    The following proposed 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 
84.
    Based on updated data from the CY 2022 performance period/2024 MIPS 
payment year data, we assume that 23,346 clinicians will submit quality 
data using the eCQM collection type for the CY 2024 performance period/
2026 MIPS payment year. This is a decrease of 543 clinicians from the 
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 80, for the CY 2024 performance period/2026 MIPS payment 
year, in aggregate, we estimate a burden of 186,768 hours [8 hr x 
23,346 responses] at a cost of $21,654,816 (23,346 responses x $927.56/
response).

[[Page 52656]]

[GRAPHIC] [TIFF OMITTED] TP07AU23.098

    In Table 81, 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 decrease of 543 respondents from 
23,889 to 23,347 for the CY 2024 performance period/2026 MIPS payment 
year results in a decrease of 4,344 hours (-543 responses x 8 hr/
response) at a cost of -$503,665 (-543 responses x $927.56/response).
[GRAPHIC] [TIFF OMITTED] TP07AU23.099

    (7) ICRs Regarding Burden for MVP Reporting
    The following proposed changes will be submitted to OMB for review 
under 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

[[Page 52657]]

2023 performance period/2025 MIPS payment year (86 FR 65590 through 
65592 and 87 FR 70155).
    In section IV.A.4.b. of this rule, we are proposing to add five new 
MVPs to the MVP Inventory. Additionally, we are proposing 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 sixteen 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 proposed consolidation of the 
measures in the Promoting Wellness and Optimizing Chronic Disease 
Management MVPs into a Value in Primary Care MVP, discussed in section 
IV.A.4.b. of this rule. 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 
proposed rule for additional details on the MVPs proposed 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 assumption in the CY 2023 PFS 
final rule (87 FR 70155) of 20 subgroups that 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 9,015. In Table 82, we 
estimate that it will take 2,254 hours (9,015 responses x 0.25 hr/
response) at a cost of $233,038 (9,015 registrations x $25.85/
registration) for individual clinicians, groups and APM Entities to 
register for MVPs in the CY 2024 performance period/2026 MIPS payment 
year.
[GRAPHIC] [TIFF OMITTED] TP07AU23.100

    In Table 83, 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 
9,015 results in an increase of 1,284 responses. In aggregate, when 
combined with the currently approved per response time estimate, this 
will result in an increase of 321 hours (2,254 hours - 1,933 hours) at 
a cost of $33,192 ($233,038 - $199,846).

[[Page 52658]]

[GRAPHIC] [TIFF OMITTED] TP07AU23.101

    (ii) Burden for Subgroup Registration
    We are not proposing any changes to our previously finalized 
subgroup registration burden. We note that the proposed subgroup 
policies in section IV.A.4.d. of this rule do not impact the currently 
approved burden for subgroup registration. We discuss in detail below, 
the proposed 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 
proposing any changes pertaining to subgroup registration under that 
control number.
    In section IV.A.4.d.(2) of this rule, we are proposing 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 proposed 
modification to the subgroup reweighting policy would not impact the 
currently approved burden for subgroup registration because it would 
not change any requirements related to subgroup registration.
    In section IV.A.4.d.(3) of this rule, we are proposing 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 proposing 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 proposed 
revisions would not impact the currently approved burden for subgroup 
registration since these changes only modify the regulatory text 
relevant to subgroup scoring policies.
    In section IV.A.4.d.(4) of this rule, we are proposing 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 proposed change would 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 
did not propose 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 proposed rule, we 
estimate that 14 percent of the clinicians who participated in MIPS for 
the CY 2021 performance period/2023 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 84, we estimate that 3,801 clinicians and 10 subgroups 
will submit data using eCQMs collection type at $614.45/response (see 
line q for eCQMs); 2,850 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 2,344 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 for the clinicians and 
subgroups submitting data for the MVP quality performance category, we 
estimate a burden of 20,198 hours [5.3 hr x 3,811 (3,801 +10) 
responses] at a cost of $2,341,669 (3,811 responses x $614.45/response) 
for the eCQM collection type, 17,074 hours [5.97 hr x 2,860 (2,443 
+10)] at a cost of $1,955,468 (2,860 responses x $683.73/responses) for 
the

[[Page 52659]]

MIPS CQM and QCDR collection type, and 18,974 hours (9.44 hr x 2,344 
clinician responses) at a cost of $2,474,561 (2,344 responses x 
$1,055.70/response) for the Medicare Part B claims collection type.
[GRAPHIC] [TIFF OMITTED] TP07AU23.102

    Table 85 illustrates the proposed 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 1,284 respondents who will 
submit data for the MVP quality performance category will result in an 
increase of 2,878 hours and $333,633 for the eCQM collection type, an 
increase of 2,430 hours and $278,273 for the CQM and QCDR collection 
type, and an increase of 3,153 hours and $352,599 for the claims 
collection type.

[[Page 52660]]

[GRAPHIC] [TIFF OMITTED] TP07AU23.103

(8) Beneficiary Responses to CAHPS for MIPS Survey
    The following proposed 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 note 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.
    In section IV.A.4.f.(1)(c)(ii) of this proposed rule, we are 
proposing to require Spanish language administration of the CAHPS for 
MIPS Survey. Specifically, we are proposing 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, we are not updating our burden estimates to include the time 
associated with the Spanish version at this time.
    In this rule, we are adjusting the estimated number of 
beneficiaries that will respond to the CAHPS for MIPS survey from the 
previously approved number of beneficiaries in the CY 2021 PFS final 
rule (85 FR 84982 through 84983). For the CY 2024 performance period/
2026 MIPS payment year, we are estimating 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 estimate that an average of 255 beneficiaries will 
respond per group for the CY 2024 performance period/2026 MIPS payment 
year. Therefore, we estimate 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 86, 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.
[GRAPHIC] [TIFF OMITTED] TP07AU23.104

    In Table 87, 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

[[Page 52661]]

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] TP07AU23.105

(9) Group Registration for CAHPS for MIPS Survey
    The following proposed changes will be submitted to OMB for review 
under control number 0938-1222 (CMS-10450). We note 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 this rule, we are adjusting 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 estimate 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 88, 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] TP07AU23.106

    In Table 89, 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 52662]]

[GRAPHIC] [TIFF OMITTED] TP07AU23.107

f. ICRs Regarding the Call for MIPS Quality Measures
    The following proposed changes will be submitted to OMB for review 
under control number 0938-1314 (CMS-10621).
    This rule does 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 are adjusting our burden estimates for the CY 
2024 performance period/2026 MIPS payment year.
    In this rule, we estimate 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 are not 
proposing 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 90, 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] TP07AU23.108

    In Table 91, 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 52663]]

[GRAPHIC] [TIFF OMITTED] TP07AU23.109

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 anticipate 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 
analyze 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 proposed 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 92 summarizes our analysis of the 
estimated burden for MIPS eligible clinicians to apply for reweighting 
of 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).
    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.
    In section IV.A.4.f.(4)(f) of this rule, we are proposing 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 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 are not adjusting our estimated 
number of respondents submitting reweighting applications due to this 
proposal because these proposed 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 are adjusting our burden estimates 
relevant to this ICR. In this proposed 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

[[Page 52664]]

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 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. 
Additionally, we estimate 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 continue to estimate it will take 0.25 
hours for a computer system analyst to complete and submit the 
reweighting application. In Table 92, 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] TP07AU23.110

    In Table 93, we illustrate the proposed 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 proposed 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 93, the proposed 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] TP07AU23.111

(3) Submitting Promoting Interoperability Data
    We are not proposing any new or revised collection of information 
requirements or burden related to the submission of Promoting 
Interoperability performance category data. We note the policy 
proposals in section IV.A.4.f.(4) of this rule related to the 
submission of Promoting Interoperability data do not impact the 
currently approved estimated burden for

[[Page 52665]]

this ICR. We discuss in detail below the proposed policies and our 
reasons for not changing our currently approved burden for submission 
of Promoting Interoperability data. The submission of Promoting 
Interoperability data requirements and burden are currently approved by 
OMB under control number 0938-1314 (CMS-10621). Consequently, we are 
not proposing any submission of Promoting Interoperability changes 
under that control number.
    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.
    In section IV.A.4.f.(4)(b)of this proposed rule, we are proposing 
that for the CY 2026 MIPS payment year, the performance period for the 
Promoting Interoperability performance category is a minimum of any 
continuous 180-day period within CY 2024, up to and including the full 
CY 2024 (January 1, 2024, through December 31, 2024). We are proposing 
to modify the Promoting Interoperability performance category 
performance period that we established under Sec.  414.1320(h)(1) to 
remove subsequent years, include the 2025 MIPS payment year, and add 
Sec.  414.1320(i)(1) to reflect our proposal. We assume MIPS eligible 
clinicians and groups that currently submit data for the Promoting 
Interoperability performance category would utilize the CEHRT for an 
entire calendar year performance period and therefore, the proposed 
increase in the length of the performance period for the Promoting 
Interoperability performance category from 90 to 180 days would not 
create additional burden for MIPS eligible clinicians and groups that 
would 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).
    In section IV.A.4.f.(4)(d)(i)of this rule, we are proposing changes 
to the Query of Prescription Drug Monitoring Program Measure under the 
Electronic Prescribing Objective. Specifically, we are proposing 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. The proposed changes would 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.
    In section IV.A.4.f.(4)(d)(ii) of this rule, we are proposing to 
revise the e-Prescribing measure description in Table 45 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'' to reflect the 
removal of the health IT certification criterion ``drug-formulary and 
preferred drug list checks.'' These proposed revisions would 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.
    In section IV.A.4.f.(4)(d)(iii)of this rule, we are proposing 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'' an annual self-assessment of the 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 note we have captured the estimated 
burden for reporting this measure in the CY 2022 PFS final rule (86 FR 
65599) and the proposed revision would 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.
h. ICRs Regarding the Nomination of Promoting Interoperability Measures
    The following proposed 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 estimate to receive fewer than 10 
responses for this ICR. Therefore, we are proposing to remove the ICR 
for nomination of Promoting Interoperability performance category 
measures.
    As shown in Table 94, we estimate an annual burden of zero hours at 
a cost of $0 for the CY 2024 performance period/2026 MIPS payment year.

[[Page 52666]]

[GRAPHIC] [TIFF OMITTED] TP07AU23.112

    In Table 95, we illustrate the proposed 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 proposed 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.
[GRAPHIC] [TIFF OMITTED] TP07AU23.113

i. ICRs Regarding Improvement Activities Submission (Sec. Sec.  
414.1305, 414.1355, 414.1360, and 414.1365)
    We are not proposing any new or revised collection of information 
requirements or burden related to the submission of improvement 
activity data. We note that the policy proposal in section IV.A.4.f.(3) 
of this proposed rule related to the improvement activities submission 
does not impact our currently estimated burden for this ICR. We discuss 
in detail below the proposed policy and reasons that it does not change 
our currently approved burden for improvement activities submission. 
The improvement activity submission requirements and burden are 
currently approved by OMB under control number 0938-1222 (CMS-10450). 
Consequently, we are not proposing any improvement activity submission 
changes under that control number.
    In section IV.A.4.f.(3)(b)(ii) of this proposed rule, we are 
proposing 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 four 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 proposing to adjust our currently 
approved burden for improvement activities submission as a result of 
this proposal.
j. ICRs Regarding the Nomination of Improvement Activities (Sec.  
414.1360)
    The proposed changes associated with data submission will be 
submitted to OMB for review under control number 0938-1314 (CMS 10621).
    In this rule, based on the actual number of respondents that 
submitted improvement activity nominations, we are proposing 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

[[Page 52667]]

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 96, 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)]).
[GRAPHIC] [TIFF OMITTED] TP07AU23.114

    In Table 97, we illustrate the proposed 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] TP07AU23.115

k. Nomination of MVPs
    This rule does not propose any new or revised collection of 
information requirements or burden related to the nomination of MVPs. 
The requirements and burden for nomination of MVPs are currently 
approved by OMB under control number 0938-1314 (CMS-10621). 
Consequently, we are not proposing 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)
    This rule is not proposing 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. The requirements 
and burden for Partial QP Elections are currently approved by OMB under 
control number 0938-1314 (CMS-10621). Consequently, we are not 
proposing 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)
    This rule is not proposing any new or revised collection of 
information

[[Page 52668]]

requirements related to Other Payer Advanced APM determinations.
(1) Payer-Initiated Process (Sec.  414.1445)
    This rule is not proposing any new or revised collection of 
information requirements related to the Payer-Initiated Process. 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 proposing any changes to the Payer- Initiated 
process under that control number.
(2) Eligible Clinician-Initiated Process (Sec.  414.1445)
    This rule is not proposing any new or revised collection of 
information requirements or burden related to the Eligible Clinician-
Initiated Process. 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 proposing 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)
    This rule is not proposing 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. 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 proposing 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)
    This rule is not proposing 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. 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 proposing 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 99 summarizes this proposed 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 99, 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 discussed 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 626,007 hours at a cost of $70,778,884 
(see Table 99, row b). These represent a decrease of 84,637 hours and a 
decrease of $4,908,246. To understand the burden implications of the 
policies in this rule, we provide 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. This burden estimate of 630,570 hours at 
a cost of $71,317,983 (see Table 99, row c) reflects the availability 
of more accurate data to account for all potential respondents and 
submissions across all the performance categories and more accurately 
reflects the exclusion of QPs from all MIPS performance categories, an 
increase of 4,563 hours and $539,099 (see Table 99, row d). This burden 
estimate is higher than the burden approved for information collection 
related to the CY 2023 PFS final rule due to updated data and 
assumptions. Our total burden estimate for the CY 2024 performance 
period/2026 MIPS payment year is 626,568 hours and $70,858,430 (see 
Table 99, row e), which represents an increase of 561 hours and $79,546 
from the CY 2023 PFS final rule (see Table 99, row f). The difference 
of -4,002 hours (561 hours - 4,563 hours) and -$459,553 ($79,546 - 
$539,099) (see Table 99, row g) between this estimate and the total 
burden shown in Table 99 is the decrease in burden associated with 
impacts of the policies for the CY 2024 performance period/2026 MIPS 
payment year.

[[Page 52669]]

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[GRAPHIC] [TIFF OMITTED] TP07AU23.118

    Table 100 provides the reasons for changes in the estimated burden 
for information collections in the Quality Payment Program segment of 
this proposed rule. We have divided the reasons for our change in 
burden into those related to proposed 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.

[[Page 52672]]

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[[Page 52673]]


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C. Summary of Annual Burden Estimates for Changes

[[Page 52674]]

[GRAPHIC] [TIFF OMITTED] TP07AU23.121

D. Submission of PRA-Related Comments

    We have submitted a copy of this proposed rule to OMB for its 
review of the rule's information collection requirements. The 
requirements are not effective until they have been approved by OMB.
    To obtain copies of the supporting statement and any related forms 
for the proposed collections discussed in this section, please visit 
the CMS website at https://www.cms.gov/regulations-and-guidance/legislation/paperworkreductionactof1995/pra-listing, or call the 
Reports Clearance Office at 410-786-1326.
    We invite public comments on these potential information collection 
requirements. If you wish to comment, please submit your comments 
electronically as specified in the DATES and ADDRESSES section of this 
proposed rule and identify the rule (CMS-1784-P) the ICR's CFR 
citation, and OMB control number.

VI. Response to Comments

    Because of the large number of public comments, we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble, 
and, when we proceed with a subsequent document, we will respond to the 
comments in the preamble to that document.

VII. Regulatory Impact Analysis

A. Statement of Need

    In this proposed rule, we are proposing 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 proposed 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

[[Page 52675]]

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 statutory requirement to 
implement this extension through December 31, 2024.
b. Drugs and Biological Products Paid Under Medicare Part B
    Section III.A.1. of this proposed rule proposes 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.
    Section III.A.3 of this proposed rule proposes 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)
    Section III.B.2. of this proposed rule implements 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. Proposals related to implementation of IOP 
for RHCs and FQHCs are discussed in the CY 2024 OPPS proposed rule.
d. Clinical Laboratory Fee Schedule (CLFS)--Proposed Revisions 
Consistent With Recent Statutory Changes
    Section III.D.5. of this rule proposes 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 delays 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 amends 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 amends 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. 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 this rule, we are proposing 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 proposals 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 need to identify actions for non-compliance in subsequent 
measurement years.
f. 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. We are proposing 
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 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 proposed rule, we are proposing revisions 
to the Medicare Ground Ambulance Data Collection Instrument. The 
changes and clarifications aim to reduce burden on respondents, improve 
data quality, or both.
g. Quality Payment Program
    This proposed rule is also necessary to make changes to the Quality 
Payment Program to move the program forward to

[[Page 52676]]

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
    In section III.A. of this proposed rule, as part of our continued 
implementation, 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. We are proposing the date of the initial 
report to manufacturers, the date for subsequent reports, method of 
calculation when there are multiple manufacturers for a refundable 
drug, increased applicable percentages for 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.2. of this proposed rule, we are proposing to 
continue to define ``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.
    In section III.B.3. of this proposed rule, we are proposing to 
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 proposed rule, we are proposing a 
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 are 
proposing to revise 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 
provisions in this rule and their applicability to RHCs and FQHCs.
    Also, in section III.B.4. of this proposed rule, we are proposing 
to remove the direct supervision requirement for obtaining consent for 
CCM services and virtual communication services furnished in RHCs and 
FQHCs.
c. Pulmonary Rehabilitation (PR), Cardiac Rehabilitation (CR) and 
Intensive Cardiac Rehabilitation (ICR) Expansion of Supervising 
Practitioners
    In section III.E. of this proposed rule, we are proposing 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.
d. Modifications Related to Medicare Coverage for Opioid Use Disorder 
(OUD) Treatment Services Furnished by Opioid Treatment Programs (OTPs)
    As discussed in section III.F. of this proposed rule, we are 
proposing 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.\335\ Therefore, minimizing disruptions to care 
for audio-only periodic assessments may further promote health equity 
and minimize disparities in access to care.
---------------------------------------------------------------------------

    \335\ https://pubmed.ncbi.nlm.nih.gov/33471458/.
---------------------------------------------------------------------------

e. Medicare Shared Savings Program
    In section III. G. of this proposed rule, we are proposing 
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 proposed 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 QPP; 
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

[[Page 52677]]

AIP policies; make updates to other programmatic areas including the 
program's eligibility requirements; and make timely technical changes 
to the regulations for clarity and consistency.
f. Medicare Part B Payment for Preventive Vaccine Administration 
Services
    Section III.H.3 of this proposed rule discusses the implementation 
of policies that impact the payment amount for administration of 
preventive vaccines paid under the Part B vaccine benefit, specifically 
the proposed in-home additional payment for Part B vaccine 
administration. Section III.H.4. of this proposed rule 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.
g. Appropriate Use Criteria (AUC) for Advanced Diagnostic Imaging
    In section III.J. of this proposed rule, we are proposing to pause 
implementation of the AUC program for reevaluation and to rescind 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.
h. Medicare and Medicaid Provider Enrollment
    This proposed rule also proposes several regulatory enhancements to 
our Medicare and Medicaid provider enrollment policies. 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 would assist in protecting the Trust 
Funds and Medicare beneficiaries.
i. Expand Diabetes Screening and Diabetes Definitions
    In section III.L. of this proposed rule, we are proposing 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.\336\ 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.\337\ 
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.\338\ 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.
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    \336\ CDC Website on diabetes at https://www.cdc.gov/diabetes/basics/index.html.
    \337\ 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.
    \338\ 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.
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j. 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 proposed 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.
k. A Social Determinants of Health Risk Assessment in the Annual 
Wellness Visit
    In section III.S. of this proposed rule, we are proposing 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 propose 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 approaches that maximize 
net benefits

[[Page 52678]]

(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 providers, and 
suppliers 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 
proposed 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 603 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, the PFS pays 
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 proposed 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 proposed 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 
proposed rule, we discussed a variety of 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 of the policy changes in the relevant sections of this proposed 
rule. We are unaware of any relevant Federal rules that duplicate, 
overlap, or conflict with this proposed rule. The relevant sections of 
this proposed rule contain a description of 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 
proposed 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 practitioners and other entities 
generally

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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-time 2.50 
percent increase in PFS payment amounts for services furnished on or 
after January 1, 2023, and a one-time 1.25 percent increase in PFS 
payment amounts for services furnished on or after January 1, 2024, and 
required that the supplementary 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 32.7476 
which reflects the -2.17 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 
20.4370 which reflects the same overall PFS adjustments with the 
addition of anesthesia-specific PE and MP adjustments.
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[GRAPHIC] [TIFF OMITTED] TP07AU23.123

    Table 104 shows the payment impact of the policies contained in 
this proposed 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 104 (CY 2023 PFS Estimated Impact 
on Total Allowed Charges by Specialty). The following is an explanation 
of the information represented in Table 104.
     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.

[[Page 52680]]

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[[Page 52681]]


[GRAPHIC] [TIFF OMITTED] TP07AU23.125

    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 the consolidation of 
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 the delivery of health care, 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.
    For this rulemaking cycle, we are providing an additional impact 
table that includes a facility/non-facility breakout of payment 
changes. The following is an explanation of the information represented 
in Table 105.
     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.
BILLING CODE 4120-01-P

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2. CY 2024 PFS Impact Discussion
a. Changes in RVUs
    The most widespread specialty 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 physician 
specialties. These increases can largely be attributed to proposed 
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 that make up these specialties rely primarily on E/M 
services, behavioral health care, or on 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 updates to supply and equipment pricing.
    The estimated impacts for several specialties, including 
anesthesiology, interventional radiology, radiology, vascular and 
thoracic surgery, physical/occupational therapy, and audiologists 
reflect decreases in payments relative to payment to other physician 
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 that make up 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 updates to supply and 
equipment pricing. The estimated impacts also reflect decreases due to 
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 104), 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 104 are based upon aggregate estimated PFS allowed 
charges summed across all services furnished by physicians, 
practitioners, and suppliers within a specialty to arrive at the total 
allowed charges for

[[Page 52687]]

the specialty, and compared to the same summed total from the previous 
calendar year. Therefore, they are averages, and may not necessarily be 
representative of 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 some of the concerns raised about 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 104 (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 104 
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 a similar 41 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 104 reflect changes that 
take place within the pool of total RVUs. The specialty impacts table 
therefore includes any changes in spending which 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 104.
b. Impact
    Column F of Table 104 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 proposed rule website at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/. We selected these 
procedures for sake of illustration from among the procedures most 
commonly furnished by a broad spectrum of specialties. The change in 
both facility rates and the nonfacility rates are shown. For an 
explanation of facility and nonfacility PE, we refer 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.\339\ As part of our efforts to gain insight into how the PFS 
policies could affect health equity, we are considering adding elements 
to our impact analysis which would detail 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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    \339\ Available at https://www.cms.gov/files/document/2022-cms-strategic-framework.pdf.
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    In the FY 2024 IPPS/LTCH PPS proposed rule, (88 FR 27261 through 
27266), 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 proposed 
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 MBISG 
method is used by the CMS Office of Minority Health 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.
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

[[Page 52688]]

some quality and resource use measures even after accounting for 
additional social and functional risk factors.\340\ 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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    \340\ 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.\341\ 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.\342\ Therefore, we believe Z-
codes do not reflect the actual rates of SDOH.
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    \341\ Available at: https://health.gov/healthypeople/priority-areas/social-determinants-health.
    \342\ 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.\343\ The combination of physical and behavioral health conditions 
can exacerbate both conditions and result in poorer outcomes than one 
condition alone.\344\ Additionally, the intersection of behavioral 
health and health inequities is a core aspect of CMS' Behavioral Health 
Strategy.\345\ 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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    \343\ 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.
    \344\ 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.
    \345\ 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.\346\ 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.\347\ 
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.\348\ 
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 note that this is likely an underestimation of 
disability, because it does not account for beneficiaries who became 
disabled after becoming entitled to Medicare.
---------------------------------------------------------------------------

    \346\ Medicare eligibility on the basis of disability is 
discussed in 42 CFR 406.12.
    \347\ https://www.ssa.gov/disability/professionals/bluebook/general-info.htm.
    \348\ https://www.cdc.gov/ncbddd/humandevelopment/health-equity.html#ref.
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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.\349\ 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.
---------------------------------------------------------------------------

    \349\ 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. 
350 351 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.
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    \350\ 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.
    \351\ 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.
---------------------------------------------------------------------------

    Rural status is defined for purposes of 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 available dataset 
designed to capture socioeconomic disadvantage at the neighborhood 
level.\352\ It utilizes data on income, education,

[[Page 52689]]

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.353 354 355 356 357 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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    \352\ https://www.neighborhoodatlas.medicine.wisc.edu/.
    \353\ 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.
    \354\ 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.
    \355\ 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.
    \356\ 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.
    \357\ 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.
---------------------------------------------------------------------------

    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 107 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 107 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 proposed policies.
    In consideration of the differences between IPPS/LTCH and the PFS 
discussed below, we are seeking 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 would impact 
beneficiaries of particular groups. We are also seeking comment about 
how such a framework would allow us to consider developing policies 
that enhance health equity under our existing statutory authority. We 
welcome 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 seek feedback 
about additional categories beyond those described previously that 
should be considered in our analysis, along with potential data 
sources.
    Nature of a service. In the table that details providers in terms 
of the beneficiaries they serve in the IPPS/LTCH PPS proposed 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 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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    \358\ 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] TP07AU23.131

    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

[[Page 52690]]

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 forty 
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 107, the specialty-level services utilized by beneficiaries with 
particular characteristics varies widely. Beneficiaries with the 
characteristics in Table 107 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 
characteristic. 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 risks359 360 361 362
---------------------------------------------------------------------------

    \359\ 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.
    \360\ 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.
    \361\ 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.
    \362\ 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.
---------------------------------------------------------------------------

     Geographic location: specialists and sub-specialists are 
sometimes clustered in urban areas due to higher demand for services 
\363\
---------------------------------------------------------------------------

    \363\ 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.
---------------------------------------------------------------------------

     Differences in referral patterns \364\ from primary care 
physicians and following hospitalizations
---------------------------------------------------------------------------

    \364\ 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.
---------------------------------------------------------------------------

     Differences in providers who can speak the language of 
beneficiaries with Limited English Proficiency \365\
---------------------------------------------------------------------------

    \365\ 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.
---------------------------------------------------------------------------

    The information contained in Table 107 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 proposed policies in this proposed rule.

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BILLING CODE 4120-01-C

D. Impact of Proposed Changes Related to Telehealth Services

    We are proposing to implement 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 proposed rule, we are proposing a refined process for 
considering requests received for addition of services to the Medicare 
Telehealth Services List, which would include a decision on whether the 
services should be proposed for inclusion on the list on either 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 proposal to have an impact on the 
utilization of Medicare Telehealth services beginning in CY 2024 but we 
will continue to monitor utilization of these services. We are 
proposing 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. 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 paying the place of service code had the service 
been furnished in person, we believe that these services furnished via 
telehealth will largely be paid as they are currently. Therefore, we 
believe the impact of this proposal will 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 Proposals for Medicare Parts A and B Payment for Dental 
Services Inextricably Linked to Specific Covered Medical Services
    In section II.K.2. of this proposed rule, we are: (1) proposing to 
allow payment for dental examinations, diagnostic, and treatment 
services prior to and during certain treatments for cancer 
(chemotherapy and CAR-T cell therapy); (2) proposing to allow payment 
for dental examinations, diagnostic, and treatment services prior to 
and during antiresorptive and/or antiangiogenic drug therapy associated 
with the treatment for cancer; and (3) requesting comments on other 
types of cardiovascular interventions (analogous to cardiac valve 
replacements and valvuloplasty procedures) where dental services may be 
inextricably linked to, and substantially related and integral to the 
clinical success of, other cardiovascular covered medical services.
    If we were to finalize the proposal that Medicare Part A and Part B 
payment can be made for oral or dental examination, and necessary 
treatment, performed prior to and during certain cancer treatments or 
drug therapies associated with managing cancer related care, 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 
estimate 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 proposals for CY 2024 (that is, 
chemotherapy/CAR T/bone-modifying agent therapies used in the treatment 
of cancer) who would likely require dental services, and could utilize 
dental services for which services Medicare could pay in CY 2024, if 
these proposals are finalized. The estimated average cost for these 
additional dental services is about $525 per person. 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 $162,000 per year with a 0.2 percent utilization assumption, 
and roughly $800,000 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. We note, however, that 
if we were to finalize, as discussed in section II.K. of this proposed 
rule, payment in other clinical scenarios for dental services 
inextricably linked to, and substantially related and integral to the 
clinical success of, certain covered medical services, we may adjust 
this estimate for the final rule.
    We continue to believe that because we are updating existing 
Medicare payment policies by proposing additional examples of clinical 
scenarios where dental services are inextricably linked to covered 
medical services, as stated in the CY 2023 PFS final rule, it is not 
appropriate to incorporate these budget neutrality adjustments into the 
conversion factor. Additionally, while the impact of access to these 
services to some individuals enrolled in Medicare could be very 
significant, we do not anticipate a significant impact in the context 
of overall spending and utilization under the PFS nor do we anticipate 
significant utilization and spending impact of these policies finalized 
in section II.K.2. of this proposed rule.
    We acknowledge that the actual take-up rate of services could be 
higher than the utilization assumptions included within our current 
estimates. We continue to be open to updating and conducting further 
impact analysis once we have additional data and input from interested 
parties.

[[Page 52699]]

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 restructured 
the E/M visit code sets largely to acknowledge changes in medical 
practice. The AMA RUC has reviewed and provided us 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 
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 propose 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 are proposing 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 propose 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, 
taking into consideration perspectives and information provided by 
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 estimate 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 discussed in section II.J. of this proposed 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 at least 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 of this proposed rule, we are proposing the date of the initial 
report to manufacturers, the date for subsequent reports, method of 
calculation when there are multiple manufacturers for a refundable 
drug, increased applicable percentages for drugs with unique 
circumstances, and a future application process by which manufacturers 
may apply for an increased applicable percentage for a drug.
    For this proposed rule, we reanalyzed 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).\368\ That is, to assess if there was a change in the status of 
the billing and payment codes that were identified in the proposed rule 
as met the definition of refundable single-dose container or single-use 
package drug and have 10 percent or more discarded units, except for 
five drugs with higher applicable percentages finalized in the CY 2023 
final rule or as proposed under this proposed rule.
---------------------------------------------------------------------------

    \368\ https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug/medicare-part-b-discarded-drug-units.
---------------------------------------------------------------------------

    Overall in the 2021 calendar year, Medicare paid nearly $1.56 
billion for discarded amounts of drugs from a

[[Page 52700]]

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 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 proposed in this proposed 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 proposed under this proposed 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 would be approximately $83.1 million in refunds due 
from manufacturers for the calendar year of 2021 ($20.8 million each 
calendar quarter). See Table 108.
BILLING CODE 4120-01-P

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BILLING CODE 4120-01-C
    There are several limitations to this analysis that could 
substantially affect the total quarterly refund. Since new drugs are 
continually being approved,

[[Page 52704]]

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 note that this estimate is 
based on CY 2021 data for discarded drug amounts, which, for reasons 
discussed in the CY 2023 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 \370\ 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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    \370\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-
Part-B-Drugs/McrPartBDrugAvgSalesPrice.
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a. Impacts Related to the Issuance of the Initial Report
    In section III.A.3.b. of this proposed rule, we propose to issue 
the initial refund report to manufacturers, to include all calendar 
quarters for 2023, no later than December 31, 2024. Accordingly, as 
discussed in section III.A.3.c., we propose 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 described in section VII.B.1. of this proposed rule, the 
information collection requirements, we estimate the annual burden per 
applicant to be 5 hours. If we anticipate no more than 25 applications 
per year, the total annual drafting and submitting burden would be 125 
hours (25 applications per year x 5 hours per applicant). We estimate 
an annual cost of this burden to be $4,937.50 ($39.50/hour x 125 
hours).
5. Rural Health Clinics (RHCs) and Federally Qualified Health Centers 
(FQHCs)
    In section III.B.2. of this proposed rule, we are proposing to 
include Remote Patient Monitoring (RPM) and Remote Therapeutic 
Monitoring (RTM) services, and the proposed Community Health 
Integration (CHI) and Principal Illness Navigation (PIN) services if 
finalized, 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 are also proposing to revise 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 are proposing regulation text changes to 
permit MFT and MHCs to provide services furnished at RHCs and FQHCs. 
These changes would 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 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 estimate it will 
take 15 minutes to add the description of MFT and MHC services. We also 
assume that only half of the RHCs and half of the FQHCs would have this 
burden applied to them, for a total burden estimate of $361,891.05. We 
note 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 recognize 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 would not 
incur the burden.
    While this proposed 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

[[Page 52705]]

coverage gap.\371\ 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.\372\ While there is an increasing need for 
mental health services, one barrier to effective treatment is access to 
mental health services.\373\ Ensuring access to mental health care in 
rural communities is challenging as there are fewer mental health 
providers per capita in nonmetropolitan counties.\374\ 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.\375\ 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.\376\ 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.\377\ 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.\378\
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    \371\ https://onlinelibrary.wiley.com/doi/full/10.1002/jcad.12409?casa_token=z412GCn3OuYAAAAA%3AHO3p-cHeiVrLww0dZjTkIcuCbwMxvYtRUo4aj8AwB-tq2w_ZJV11gGpWW-oxilDK3awU0xIc2XKMnKhtAQ#jcad12409-bib-0003.
    \372\ https://onlinelibrary.wiley.com/doi/full/10.1002/jcad.12409?casa_token=z412GCn3OuYAAAAA%3AHO3p-cHeiVrLww0dZjTkIcuCbwMxvYtRUo4aj8AwB-tq2w_ZJV11gGpWW-oxilDK3awU0xIc2XKMnKhtAQ#jcad12409-bib-0005.
    \373\ https://psycnet.apa.org/fulltext/2020-75725-002.html.
    \374\ https://psycnet.apa.org/record/2018-25164-007.
    \375\ https://data.hrsa.gov/topics/health-workforce/shortage-areas.
    \376\ https://data.hrsa.gov/Default/GenerateHPSAQuarterlyReport.
    \377\ https://psycnet.apa.org/fulltext/2020-75725-002.html.
    \378\ 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 proposed rule, we discuss 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 are proposing 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 proposing to 
update certain definitions and 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. 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 proposing to make conforming changes to 
our requirements for the phase-in of payment reductions to reflect the 
CAA, 2023 amendments. Specifically, we are proposing 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 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 discussed in 
section III.D. of this proposed 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 that we are proposing in this rule, 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.
8. Pulmonary Rehabilitation (PR), Cardiac Rehabilitation (CR) and 
Intensive Cardiac Rehabilitation (ICR) Expansion of Supervising 
Practitioners
    As discussed in section III.E. of this proposed rule, we are 
proposing 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 proposing 
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 proposed 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

[[Page 52706]]

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).\379\ 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.\380\ 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.\381\ Taken together, this data informs us that 
utilization of PR in the Medicare population is very low.
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    \379\ 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.
    \380\ 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.
    \381\ 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,\382\ includes a goal of increasing use of CR and states that CR 
participation rates remain low, ranging from 19 percent to 34 
percent.\383\ 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.\384\ In their 2022 
article, Varghese and colleagues state that less than 30 percent of 
eligible patients participate in CR in the United States.\385\ 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).\386\ Taken together, this 
data informs us that utilization of CR and ICR is low, although not as 
low as PR.
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    \382\ https://millionhearts.hhs.gov/about-million-hearts/index.html.
    \383\ https://millionhearts.hhs.gov/about-million-hearts/optimizing-care/cardiac-rehabilitation.html.
    \384\ 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.
    \385\ 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.
    \386\ 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 . . .'' \387\ 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.'' \388\
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    \387\ 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.
    \388\ 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.
9. Modifications Related to Medicare Coverage for Opioid Use Disorder 
(OUD) Treatment Services Furnished by Opioid Treatment Programs (OTPs)
    As discussed in section III.F. of this proposed rule, we are 
proposing 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 Shared Savings Program proposed policies advance 
Medicare's overall value-based care strategy of growth, alignment, and 
equity, with many proposals overlapping these categories. The proposed 
policies in this proposed 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

[[Page 52707]]

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 are 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 
proposed changes to Shared Savings Program policies in this proposed 
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 proposal to modify 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 proposed 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 proposed adjustment, applicable for 
agreement periods beginning on January 1, 2024, and in subsequent 
years, would 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 proposed adjustment would 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. For example, this feature of the 
proposal would 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 described in the section III.G.4.b.(2) of this proposed 
rule, surrounding tables 33 and 34, provide the basis for estimating 
the impact for the proposal to cap 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 proposed cap in the first two years of 
an ACO's agreement period but would 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.\389\ The 11 percent of ACOs simulated 
to be impacted by the proposed 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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    \389\ 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 proposed adjustment would impact 
less than 1 percent of ACOs in PY1 of an agreement 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 109.

[[Page 52708]]

[GRAPHIC] [TIFF OMITTED] TP07AU23.142

    A material, albeit uncertain impact, is also estimated for the 
proposals to (a) use 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) the 
proposal to use 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 measure 
suppression is required. 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' proposal when suppression is necessary, 
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 110.
[GRAPHIC] [TIFF OMITTED] TP07AU23.143

    The impact is also estimated to be material for the proposal to 
mitigate the impact of the negative regional adjustment on the 
benchmark. 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, would incrementally increase benchmarks for higher spending 
ACOs (increasing shared savings payments) but would 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.\390\ For a low cost estimate we 
instead assume 20 percent growth in participation from high spending 
ACOs leading to about $1.2 billion in net savings over 10 years. Table 
111 shows these estimates over the 2024-2033 window.
---------------------------------------------------------------------------

    \390\ Elimination of overall negative regional adjustments, 
under the proposed approach, would likely generate participation 
growth from ACOs that will face 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 overall negative regional adjustment entirely 
would 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.

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[[Page 52709]]

[GRAPHIC] [TIFF OMITTED] TP07AU23.144

    The proposal to specify the 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 proposed 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 112 shows these estimates over the 
2024-2033 window.
[GRAPHIC] [TIFF OMITTED] TP07AU23.145

    An overall net impact is difficult to quantify for the proposed 
changes in section III.G.3.a of this proposed rule, to incorporate use 
of a new third step in the step-wise beneficiary assignment methodology 
and the proposed changes to identification of the assignable 
beneficiary population. These proposed 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 proposed changes could 
allow some ACOs to increase efficiency by utilizing more non-physician 
clinicians in delivering primary care without jeopardizing assignment. 
On the other hand, they could marginally increase shared savings 
payments for efficiencies that currently would 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 potential impact of these proposed 
changes on existing ACOs, and will monitor effects if the proposals are 
finalized and implemented in future agreement periods.
    The remaining proposed changes to the Shared Savings Program 
regulations are not estimated to have an impact on program spending at 
the aggregate level. These proposed 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 MIPS PI 
performance category for all eligible clinicians participating in ACOs, 
and using beneficiary counts instead of person years in health equity 
adjustment calculations, as well as proposals to further refine AIP 
policies, revise program eligibility requirements, and make technical 
changes.
b. Compliance With Requirements of Section 1899(i)(3) of the Act
    Certain policies, including both existing policies and the proposed 
new policies described in this proposed 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

[[Page 52710]]

payment model. The following proposals require the use of our authority 
under section 1899(i) of the Act: the proposed 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 proposed rule and the refinements to AIP policies as described in 
section III.G.5. of this proposed 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, would be affected by the proposed addition of 
a new third step of the beneficiary assignment methodology and the 
proposed revisions to the definition of assignable beneficiary, 
described in section III.G.3. of this proposed rule, including the 
following: the amount of advance investment payments; factors used in 
determining shared losses for ACOs under two-sided 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 
two-sided model ACOs); 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 
proposed changes discussed in this proposed rule is estimated to be 
$330 million lower net spending over the ten year window for all new 
proposals combined, including the proposal to cap an ACO's regional 
service area risk score growth and the proposals to add a new third 
step to the beneficiary assignment methodology and to revise the 
approach to identify the assignable beneficiary population. Therefore, 
we believe the requirements of section 1899(i)(3)(B) of the Act would 
not be violated by these relatively minor changes to program spending.
    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.3.c of this proposed rule, we propose 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 estimated the impact of the proposal to maintain 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 would result in higher spending of roughly 
$1-2 million. Therefore, the overall estimated impact of this proposal 
is increased spending of less than $5 million in 2024. We note that our 
analysis assumed that there would be no additional providers or 
suppliers who would 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 propose to modify certain Medicare Diabetes Prevention Program 
(MDPP) expanded model policies to: (1) Extend the flexibilities allowed 
during the PHE for the COVID-191135 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 proposed 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 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 
proposed changes would 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 proposed modifications address MDPP supplier and beneficiary 
needs based upon available monitoring and evaluation data received to 
date,

[[Page 52711]]

feedback from Medicare Advantage plans and existing MDPP suppliers, and 
feedback from beneficiary focus groups. The proposed 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 would 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, would 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 would 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.\391\ Aligning with the Diabetes Prevention 
Program (DPP) model test \392\ and studies on the National 
DPP,393 394 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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    \391\ MDPP 2nd Annual Evaluation Report.
    \392\ 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.
    \393\ 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.
    \394\ 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.
---------------------------------------------------------------------------

    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 would 
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 
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

[[Page 52712]]

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 are proposing 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 proposed 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.\395\ 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 are 
proposing 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 proposed 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.
---------------------------------------------------------------------------

    \395\ 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 proposed 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 proposed payment structure 
compared to seven attendance-based payments, for participants who began 
participation in 2022 or later, or eleven 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 proposed 
payment structure, compared to $496 in the current one.
    This proposed payment schedule would not only eliminate gaps in 
payment by providing smaller but more frequent per-session payments, it 
would also reduce or eliminate some of the coding challenges related to 
the number of existing HCPCS codes. We have proposed to decrease the 
one-time performance payments for beneficiary achievement of the 5 
percent and 9 percent weight loss goals as well as propose a new HCPCS 
G-code for the maintenance of the 5 percent weight loss during months 
7-12. The proposed total maximum payment of $768 consists of the 
attendance-based payments and the weight loss performance payments. 
Although the proposed 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

[[Page 52713]]

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 proposed changes to the Medicare Diabetes Prevention 
Program (MDPP) which are relevant to this impact analysis. Both changes 
will be implemented in 2024 if finalized: 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 113 shows the estimated impact (in millions) of these two 
proposed changes on Medicare spending:
[GRAPHIC] [TIFF OMITTED] TP07AU23.146

(b) Assumptions/Notes
     Simplifying the payment schedule will lead to fewer claim 
denials and more participation from MDPP suppliers . For example, only 
55-62% 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 proposed 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 estimate 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 proposed 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 114 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] TP07AU23.147


[[Page 52714]]


    As indicated in Table 114, 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 proposed 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 discussed previously in this proposed 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 have proposed to pause implementation of 
the AUC program for reevaluation and to rescind 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 are 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.
    Table 115 also includes the AUC program-related activities and 
their corresponding impact estimates. By pausing efforts to implement 
the AUC program for reevaluation and rescinding the AUC program 
regulation at Sec.  414.94, the Medicare program may not realize the 
estimated savings, and clinicians and beneficiaries will not experience 
the estimated costs.
[GRAPHIC] [TIFF OMITTED] TP07AU23.148

14. Medicare and Medicaid Provider and Supplier Enrollment Changes
    In this section, we discuss the impact of our proposed 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 would not have an 
economic impact.
a. Medicare Revocation Reasons
    As discussed in section III.J of this proposed rule, we are 
proposing several new or expanded revocation reasons in Sec.  
424.535(a).
    First, we propose 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) would 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, 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 interests of the Medicare 
program and its beneficiaries.
    Fourth, we propose in new Sec.  424.535(a)(243) 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), or 
424.68(c) or (e), or 424.205(b) or (d).
    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.\396\ For purposes of

[[Page 52715]]

consistency and accuracy, we propose to use this $50,000 amount in this 
proposed rule.
---------------------------------------------------------------------------

    \396\ 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''.
---------------------------------------------------------------------------

    Table 116 outlines the estimated annual number of revocations that 
would ensue with the four aforementioned revocation proposals:
[GRAPHIC] [TIFF OMITTED] TP07AU23.149

    These revocations would represent a savings to the Federal 
Government because Trust Fund dollars would no longer be paid to the 
revoked providers and suppliers. Accordingly, we project an annual 
savings to the Federal Government of $1,000,000 ($50,000 x 20 
revocations).
b. Medicaid Termination Database
    As discussed in section III.J. of this proposed rule, we are 
proposing 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 are seeking 
public comments from the public to aid in understanding how to measure 
said burden reduction.
15. Expand Diabetes Screening and Diabetes Definitions
    As discussed in section III.L. in this proposed rule, we propose 
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).
    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 described earlier in 
our proposal, 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 propose 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.''
    We estimate our proposal 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 proposed 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.
    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 described earlier, we propose to remove the regulatorily 
codified clinical test requirements from the definition of ``diabetes'' 
for diabetes screening, MNT and DSMT and propose a shortened version of 
the existing definition that would simply define diabetes as diabetes 
mellitus, a condition of abnormal glucose metabolism. We believe that 
our proposal will empower health care 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 would not otherwise change requirements 
or conditions of coverage and payment.

[[Page 52716]]

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 proposed rule, we are proposing several 
updates to the CMS EPCS Program. We are proposing to remove 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 proposal, 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 proposal 
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 proposal would 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.3.b. of this proposed rule for our discussion.
    We are proposing to specify how we count prescriptions for the 
compliance calculation by proposing to use 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 would be an incremental impact 
on small prescribers. 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 noncompliant.
    We are proposing updates to the CMS EPCS Program recognized 
emergency exception and waiver exception presently found at Sec.  
423.160(a)(5)(iii) and (iv) and proposed to be codified at Sec.  
423.160(a)(5)(ii) and Sec.  423.160(a)(5)(iii) respectively. We are 
proposing to have discretion to determine which emergencies trigger the 
recognized emergency exception starting in the 2024 measurement year 
and proposing that prescribers to whom the exception applies would be 
excepted from the CMS EPCS Program requirements for the entire 
measurement year. We are proposing to modify how we have previously 
defined ``extraordinary circumstance'' for purposes of the waiver 
exception. We propose 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 
are proposing the timeframe that would be covered by a waiver 
authorized under the CMS EPCS Program to be the entire measurement 
year. We are proposing that a prescriber 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. 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 proposal for CMS to identify which 
emergencies trigger the recognized emergency exception would still 
capture the vast majority of emergencies or disasters that affect a 
prescriber's ability to achieve EPCS compliance and would 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 would 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 would be 
submitted to the CMS EPCS program, as we discussed in the CY 2022 PFS 
final rule (86 FR 65562).
    We are proposing 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.6. of this proposed rule for our discussion. 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.
17. Proposed Changes to the Regulations Associated With the Ambulance 
Fee Schedule and the Medicare Ground Ambulance Data Collection System 
(GADCS)
    As discussed in section III.N.2. of this proposed 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. 
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 are proposing 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 discussed in section III.N.3. of this proposed 
rule, we are proposing 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 aim 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 would have any substantive impact on the cost or 
time associated

[[Page 52717]]

with completing the Medicare Ground Ambulance Data Collection 
Instrument. We note 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 propose to add are intended to improve clarity 
and may therefore reduce the time the ground ambulance organizations 
spend addressing the questions.
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 are proposing conforming regulations text 
changes to permit MFT or MHC to serve as members of the IDG. These 
proposed changes will require hospices to include at least 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 based on the needs of the patients.
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 are proposing conforming regulations text 
changes to permit MFT or MHC to serve as members of the IDG. With the 
proposed 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 are 
proposing 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 are proposing to add both MHC and MFT to the 
requirements at Sec.  418.114(c)(3) and (4) 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 would impose any additional regulatory burden.
19. RFI: Histopathology, Cytology, and Clinical Cytogenetics 
Regulations Under the Clinical Laboratory Improvement Amendments (CLIA) 
of 1988
    We are publishing this RFI in this proposed rule to seek comments 
from interested parties. There is no impact for this RFI.
20. Basic Health Program Provisions
    In this proposed rule, we are proposing to update the requirements 
for a BHP Blueprint revision. We also propose to allow a State with a 
BHP to suspend its BHP, if necessary, and provide requirements related 
to a BHP suspension. We also propose updates to the annual report 
content and timing, if a BHP is suspended. This proposal includes 
requirements for accessible notices. Finally, we propose changes 
related to an individual's appeals rights. We do not anticipate that 
these provisions would impose any additional regulatory burden.
21. A Social Determinants of Health Risk Assessment in the Annual 
Wellness Visit
    We propose in section III.S. 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 propose 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 proposal builds 
upon our separate proposal described earlier to establish a stand-alone 
G code (GXXX5) for SDOH Risk Assessment furnished in conjunction with 
an Evaluation and Management (E/M) visit. See section II.E. of this 
proposed rule for additional information on coding, pricing, and 
additional conditions of payment for the proposed new SDOH Risk 
Assessment service. We anticipate our proposal 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 would result in a significant impact to the Medicare Program.
22. Updates to the Quality Payment Program
    In this section, we estimate the overall and incremental impacts of 
the Quality Payment Program policies proposed in this rule. We estimate 
participation, final scores, and payment adjustment for clinicians 
participating through traditional MIPS, MVPs, and the Advanced APMs. We 
also present 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 proposed rule we create two MIPS RIA models: a baseline 
and proposed policy model. Our baseline model includes previously 
finalized policies that would be in effect for the CY 2024 performance 
period/2026 MIPS payment year if none of our proposed policies are 
finalized. Examples of previously finalized policies are an updated 
methodology for calculating the complex patient bonus, and an increase 
in the data completeness threshold for quality measures. The proposed 
policies model builds off the baseline model and incorporates the MIPS 
policy proposals for the CY 2024 performance period/2026 MIPS payment 
year included in this proposed rule. The aim of the baseline and 
proposed policy models is to estimate the incremental impacts of the 
policies in this proposed rule. We used a similar approach in the CY 
2023 PFS final rule (87 FR 70199 through 70200).
    As discussed in the CY 2023 PFS 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. The aim of the baseline 
model is to reflect participation, final scores, and payment 
adjustments for the upcoming performance period and associated MIPS 
payment year based on previously finalized policies for the performance 
period and MIPS and MIPS payment year.

[[Page 52718]]

(2) Data Used To Estimate Future MIPS Performance
    In the 2023 PFS final rule (87 FR 70200), we discussed our decision 
to use the submissions data for the CY 2021 performance period to 
estimate eligibility, final scoring, and payment adjustments 
supplemented by CY 2019 performance period data to estimate 
participation and payment adjustments for the sake of estimating the 
size of the budget neutral pool. To mitigate the potential effect of 
the PHE on our engagement estimates for the CY 2024 performance period/
2026 MIPS payment year, for MIPS eligible clinicians who submitted data 
for the CY 2019 performance period and did not submit data for the CY 
2021 performance period, we assigned their participation status and 
final score data from the CY 2023 PFS proposed rule baseline model (87 
FR 46408). This is because the CY 2023 PFS proposed rule baseline model 
(87 FR 46408) is based on submissions data for the CY 2019 performance 
period (hereafter called ``2019 data supplement'').
    We indicated that we believed this approach would reflect data that 
is generally more current while mitigating the impacts of changes in 
reporting behavior during the PHE on our participation estimates. 
Although we believe that this is the best data source to accurately 
model the impact of our proposed policies, the use of data from the CY 
2021 performance period supplemented by data from the CY 2019 
performance period, has the same limitations as discussed in the 2023 
PFS final rule (87 FR 70200). We took a similar approach this year.
    The submissions for the CY 2022 performance period were not 
available in time to assess whether the data for that performance 
period can be used to predict future performance. For the final rule, 
we will evaluate whether it is appropriate to use the CY 2022 
performance period data and whether adjustments to this RIA model based 
on factors such as clinician behavior or performance category data 
availability would need to be made if CY 2022 performance category 
submissions data were used instead.
b. Estimated 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 into our baseline eligibility 
determination. 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 estimate that for the 2024 QP Performance Period 
between 187,000 and 241,000 eligible clinicians will become QPs, and 
therefore be excluded from MIPS reporting requirements and payment 
adjustments.
    In section VII.E.23.b of this proposed rule, 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).
     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.

[[Page 52719]]

c. Estimated Number of MIPS Eligible Clinicians for the CY 2024 
Performance Period/2026 MIPS Payment Year
(1) Clinicians Included in the RIA Baseline and Final Policies Models 
Prior to Applying the Low-Volume Threshold Exclusion
    For this proposed rule, we applied the same assumptions as in the 
CY 2023 PFS final rule (87 FR 70201 through 70202), unless otherwise 
noted. In the CY 2023 PFS final rule (87 FR 70202), we explained that 
we modified some of our assumptions to estimate engagement in MIPS to 
mitigate the effects of potential non-engagement due to the extreme and 
uncontrollable circumstances policies related to the PHE.
    In the CY 2023 PFS final rule (87 FR 70201), we explained our use 
of the final reconciled eligibility determination file. This file 
reconciles eligibility from two determination periods and aligns with 
the CY 2021 performance period submissions data on which we based this 
model. In this proposed rule, we again used the final reconciled 2021 
eligibility determination file which aligns with CY 2021 performance 
period submissions data. We did not propose any modifications to MIPS 
eligibility requirements, therefore the same eligibility assumptions 
apply to both the baseline and proposed policies models. Our analysis 
found that there were 1.7 million clinicians who had PFS claims from 
October 1, 2020 to September 30, 2021. 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 
Assumptions for the Low-Volume Threshold Exclusion and Considering the 
Extreme and Uncontrollable Circumstances Policies Related to COVID-19 
PHE
    The low-volume threshold policy may be applied at the individual 
(TIN/NPI) or group (TIN) levels based on how data are submitted to 
MIPS. Generally, if a clinician or group does not exceed the low-volume 
threshold criteria then that clinician or group is excluded from 
participation in MIPS. The low volume threshold uses three criteria: 
allowed charges, number of Medicare patients who receive covered 
professional services, and number of services provided. A clinician or 
group that exceeds at least one, but not all three low-volume threshold 
criteria may become MIPS eligible by electing to opt-in and 
subsequently submitting data to MIPS, thereby being measured on 
performance and receiving a MIPS payment adjustment.
    We describe below the estimated MIPS eligibility status and the 
associated PFS allowed charges of clinicians in the initial population 
of 1.7 million clinicians for the proposed policies model. We applied 
the same assumptions as in the CY 2023 PFS final rule (87 FR 70201 
through 70202) to apply the low-volume threshold and to determine 
whether clinicians participate in MIPS as a group, virtual group, APM 
entity, or as individuals. In the CY 2023 PFS final rule (87 FR 70202), 
we explained our use of the CY 2019 performance period data to update 
eligibility assumptions to account for the effects of the extreme and 
uncontrollable circumstances (EUC) policy that was applied due to the 
PHE. We noted that the use of CY 2021 performance period data alone 
might overstate the number of clinicians with ``required eligibility'' 
who do not participate in MIPS due to the PHE under the EUC policy and 
therefore may not have submitted data. If we assumed in this RIA model, 
which estimates of CY 2024 performance period/CY 2026 payment year, 
participation and non-participation to be similar to the CY 2019 
performance period, we would likely overstate the number of clinicians 
receiving a negative payment adjustment. Since these clinicians 
actually would have received a neutral score under the CY 2021 
performance period EUC reweighting policy but would receive a negative 
payment adjustment in our simulation.
    As we noted in section VII.E.22 of this RIA, in order to mitigate 
the potential effect of the PHE on our engagement estimates for the CY 
2024 performance period, for MIPS eligible clinicians who submitted 
data for the CY 2019 performance period and did not submit data for the 
CY 2021 performance period, we followed the same process described in 
the CY 2023 PFS final rule (87 FR 70202) and assigned their 
participation status and final score data from the CY 2023 PFS proposed 
rule baseline model (87 FR 46408). This is because the CY 2023 PFS 
proposed rule baseline model (87 FR 46408) is based on the 2019 data 
supplement. We believed these clinicians may participate and perform 
more similarly to the CY 2019 performance period than the CY 2021 
performance period during the CY 2024 performance period.
    We do not have ability to assess the performance of clinicians 
reflected in our 2019 data supplement in our model, so we used the same 
score for this final rule's baseline and proposed policies models. 
Because we used the same score for the baseline and proposed policies 
model, we were not able to assess the incremental impact of policies 
for this group. However, we believe making this adjustment is valuable 
because it helps mitigate the potential effect of overestimating the 
number of clinicians eligible for, and participating in MIPS, versus 
non-participants, which in turn would affect our estimation of the MIPS 
redistribution payment and the size of the budget neutral pool.
    For our RIA model, we established the ``required eligibility'' 
category, which means the clinician exceeds the low-volume threshold in 
all 3 criteria and is subject to a payment adjustment is separated into 
three buckets this year: (1) ``Clinicians who Report''; (2) ``Did not 
report in 2021, but did report in 2019''; and (3) ``Did not report in 
either 2021 or 2019.'' We have done this so that we can isolate both 
the effects of our proposed policies, which are modeled using 2021 
data, the effect of the 2019 data supplement, and model the population 
of clinicians who did not engage in either year. The year refers to 
which population of data we used (that is, the 2021 population of 
clinicians or the 2019 supplement).
(a) MIPS Eligibility Estimates
    Table 117 summarizes our eligibility estimates for the proposed 
policies model after applying our assumptions discussed previously.
    We estimate approximately 122,183 MIPS eligible clinicians have the 
required eligibility criteria and submitted data for at least one 
performance category in MIPS for the CY 2019 and 2021 performance 
periods, 9,906 MIPS eligible clinicians who did not engage in MIPS 
based on 2021 performance period MIPS data but did engage based on 2019 
performance period MIPS data, and 14,289 MIPS eligible clinicians 
counted in our model as ``did not submit in data to MIPS for the CY 
2019 or CY 2021 performance period.'' These are clinicians who did not 
submit data to MIPS for the CY 2019 or CY 2021 performance periods, or 
did not submit data to MIPS for the CY 2021 performance period and do 
not have CY 2019 performance period data.
    We estimate approximately 664,562 MIPS eligible clinicians as 
having ``group eligibility'' in Table 117. ``Group eligibility'' means 
that these clinicians belong to a group that exceeds the low-volume 
threshold. If they were not associated with the group submission, these 
clinicians will not be eligible for MIPS.
    Finally, we estimate about 9,107 clinicians will be eligible for 
MIPS and participate through ``opt-in eligibility''

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through the ``opt-in'' policy. We updated our opt-in policy to reflect 
that a clinician can elect to opt-in into MIPS and will be scored, even 
if they do not submit data to MIPS.
    We estimate a total MIPS eligible clinician population of 
approximately 1,741,607 with $9 billion PFS allowed charges estimated 
to be included in the CY 2024 performance period/2026 MIPS payment 
year.
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BILLING CODE 4120-01-C
    Furthermore, we estimate there will be approximately 185,342 
clinicians who are not MIPS eligible, but could be if the clinician or 
their group elects to

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opt-in. We describe this group as ``Potentially MIPS eligible'' in 
Table 117. These potentially MIPS clinicians would all be included as 
MIPS eligible in the unlikely scenario in which all group practices 
elect to submit data as a group, or clinicians in a group that does not 
submit are eligible to opt-into MIPS individually and choose to do so. 
We do not expect that every potentially MIPS eligible clinician will 
elect to submit data to MIPS. We estimate another 294,729 clinicians 
would be eligible for participation as a group but do not report data. 
These assumptions are important because they quantify the maximum 
number of MIPS eligible clinicians. When this unlikely scenario is 
modeled, we estimate the MIPS eligible clinician population could be as 
high as 1,300,118 clinicians. Finally, we estimate approximately 
123,231 clinicians will not be MIPS eligible because they and their 
group are below the low-volume threshold on all three criteria and 
another approximately 318,258 will not be MIPS eligible for other 
reasons, including 242,422 clinicians with QP status.
    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 820,047 MIPS eligible 
clinicians described above.
c. Estimated Impacts on Payments to MIPS Eligible Clinicians for the CY 
2023 Performance Period/2025 MIPS Payment Year
(1) Summary of Approach for MIPS Value Pathways (MVPs) and Traditional 
MIPS
    In this proposed rule, we present several proposals which impact 
the measures and activities, the performance category scores, final 
score calculation, and the MIPS payment adjustment. We discuss these 
changes in more detail in section VII.E.23.d.(3) of this RIA as we 
describe our methodology to estimate MIPS payments for the CY 2024 
performance period/2026 MIPS payment year. We then present the impact 
of the overall proposed 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 proposed policies model, we are able to estimate 
the incremental impact of the proposed policies for the CY 2024 
performance period/2026 MIPS payment year.
    The payment impact for a MIPS eligible clinician is based on the 
clinician's final score, which is 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 as an 
individual, group, virtual group, APM Entity, clinicians participating 
in MIPS through the APM Performance Pathway (APP) or through an MVP in 
the four MIPS performance categories. 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.
    The average percentage change in total revenues that clinicians 
earn is less than the impact displayed here because MIPS eligible 
clinicians generally furnish services to both Medicare and non-Medicare 
patients; MIPS does not impact payment from non-Medicare patients. In 
addition, MIPS eligible clinicians may receive Medicare revenues for 
services under other Medicare payment systems, such as the Medicare 
Federally Qualified Health Center Prospective Payment System, that will 
not be affected by MIPS payment adjustment factors.
(2) Methodology To Assess Impact for MIPS Value Pathways
    In the CY 2022 PFS final rule (86 FR 65394 through 65397), we 
finalized policies at Sec.  414.1365 for implementing MVPs beginning in 
the CY 2023 performance period/2025 MIPS payment year. 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 proposed policies model as described below.
(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.b and Appendix 3 of this proposed rule, we 
propose 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 section IV.A.4.a of this proposed rule, we are proposing 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 proposed policies model, we incorporate the quality measure 
revisions for the existing MVPs and use the quality measures to model 
scores for the new MVPs in Appendix 3 of this proposed 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 Sec.  
414.1365(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

[[Page 52723]]

as if those improvement activities are in the MVP inventory.
(3) Methodology To Assess Impact for Traditional MIPS
    To estimate the impact of the proposed policies on MIPS eligible 
clinicians, we generally used the CY 2021 performance period's 
submissions data, including data submitted or calculated for the 
quality, cost, improvement activities, and Promoting Interoperability 
performance categories. As discussed in section VII.E.23.a.(2) of this 
proposed rule, we supplemented with 2019 data supplement.
    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 proposed 
policies scoring models for each MIPS eligible clinician using score 
estimates for quality, cost, Promoting Interoperability, and 
improvement activities performance categories, where each are described 
in detail in the following sections.
(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 proposed 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 proposed 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 discussed 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 proposed 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.
(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 proposed 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). Due to technical limitations, we 
did not model cost improvement scoring in the baseline policies RIA 
model.
    The proposed policies RIA model incorporated and implemented the 
following changes:
    In section IV.A.4.f.(2).(a) of this proposed rule, we proposed 5 
new episode-based cost measures.
     In section IV.A.4.g.(1).(c) of this proposed rule, we 
proposed to:
    ++ Determine cost improvement scoring at the category level;
    ++ Modify how to calculate cost improvement scoring and remove 
statistical significance requirement; and
    ++ Set the maximum improvement scoring to 1 percentage point, 
beginning in CY 2023 performance period/2025 MIPS payment year.
(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 proposed rule, we proposed to continue 
reweighting clinical social workers. This is incorporated into our 
proposed policies model. 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 proposed 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 proposed 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 proposed 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).
(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 
section IV.A.4.h.(2) of this proposed rule, we are proposing a

[[Page 52724]]

performance threshold of 82 points for the CY 2024 performance period/
2026 MIPS payment year, which we incorporated into our proposed 
policies model. For both the baseline and proposed 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) Impact of Payments
    We noticed minimal changes to the mean and median final score 
between our baseline and proposed policies models. In our baseline 
model, the mean and median final scores are 73.26 and 79.99 points, 
respectively. In the proposed policies model, the mean final score is 
73.52 and the median final score is 80.53. Many clinicians have scores 
clustered near the proposed performance threshold of 82 points. For 
instance, 51% of clinicians have a final score between 80 and 100 
points and 63.28% of clinicians have final score between 75 and 100 
points. Because so many clinicians have final scores near our proposed 
performance threshold, a small change in actual final scores relative 
to our model would significantly impact the number of clinicians with a 
positive, neutral, or negative adjustment.
    Our proposed policies are expected to increase the number of 
clinicians receiving a negative adjustment from 36.75 percent of 
eligible clinicians to 54.31 percent of eligible clinicians, but 
decrease the average negative adjustment from -2.89 percent to -2.40 
percent. This is because the increased performance threshold will cause 
many clinicians who previously scored slightly above the performance 
threshold to now score slightly below the performance threshold, 
shifting their expected payment from a small positive adjustment to a 
small negative adjustment.
    Among MIPS eligible clinicians who reported data, 35.38 percent 
receive a negative adjustment in our baseline model compared to 52.24 
percent in the proposed policies model. Because many clinicians' scores 
are close to the performance threshold, the payment adjustments for 
these clinicians are fairly small and many negative adjustments are 
much lower in magnitude than the statutory maximum negative adjustment 
of 9 percent. In our proposed policies model, we project the maximum 
negative payment adjustment of negative 9 percent for clinicians with a 
score of 20 points or below compared to a score of 18 in our baseline 
model.
    In our baseline model, 2.13 percent of MIPS eligible clinicians and 
1.41 percent of clinicians who report clinicians receive the max 
negative adjustment. In our proposed rule model, 1.99 percent of MIPS 
eligible clinicians and 1.19 percent of clinicians who report data 
receive the max negative adjustment. This is because, while the range 
of scores subject to the maximum negative adjustment increases slightly 
(from 18 to 20 points), slightly fewer clinicians in our proposed 
policies model have a final score below 20 points compared to the 
baseline model.
    The increase in the number of clinicians receiving a negative score 
will contribute to an increase in the size of the budgetary dollars 
available, as a result of the budget neutral nature of the program. In 
the baseline model, we anticipate redistributing $7.4 million and, in 
the proposed policies model we anticipate, redistributing $8.9 million 
as a result of budget neutrality.
    Because of this increase in the size of the budget neutral pool, 
the size of our positive payment adjustments increases. In our baseline 
model, the average positive payment adjustment is 1.99 percent among 
MIPS eligible clinicians. In the CY 2024 performance period/2026 MIPS 
payment year proposed policies model, the average positive payment 
adjustment is 3.35 percent among MIPS eligible clinicians. The maximum 
positive payment adjustment increased from 4.60 percent in the baseline 
model to 8.82 percent in the proposed rule model.
    We want to highlight that we are primarily using submissions data 
for the CY 2021 performance period to simulate a final score for the CY 
2024 performance period/2026 MIPS payment year, and it is likely that 
there will be changes that we cannot account for at this time. It 
should also be noted that the estimated number of clinicians who do not 
submit data to MIPS may be an overestimate of non-engagement in MIPS 
for the CY 2023 performance period/2025 MIPS payment year. This is 
because the PHE may have resulted in fewer clinicians submitting data 
to MIPS or more clinicians electing to apply for the extreme and 
uncontrollable circumstances policies due to the PHE for the CY 2019 
and CY 2021 performance periods. Therefore, engagement levels in MIPS 
for the CY 2024 performance period/2026 MIPS payment year may differ 
from these reported estimates. We also note this participation data is 
generally based off participation for the CY 2021 performance period/
2023 MIPS payment year, which is associated with a performance 
threshold of 60 points.

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e. Additional Impacts From Outside Payment Adjustments
(1) Burden Overall
    In addition to policies affecting the payment adjustments, we are 
proposing 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 
proposed rule, we outline estimates of the costs of data collection 
that includes both the effect of proposed policy updates and 
adjustments due to the use of updated data sources. For each proposed 
provision included in this proposed rule which impacts our estimate of 
collection burden, the incremental burden for each is summarized in 
Table 121. We also provide proposed additional burden discussions that 
we are not able to quantify.

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(2) Additional Impacts to Clinicians
(a) Impact on Third Party Intermediaries
    In section IV.A.4.k of this rule, we are proposing 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 proposed 
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 V.B.11.c of this rule for additional 
information on proposed changes to the third party intermediary 
requirements.
(b) Compare Tools: Public Reporting
    In section IV.A.4. of this rule, we are proposing 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 place of service (POS) codes 02, 10, or modifier 95 to 
identify telehealth services furnished for the telehealth indicator, we 
would use the most recent codes at the time the data are refreshed. We 
are proposing that at the time of such a data refresh we would publish 
the details of which codes are used for the telehealth indicator 
through education and outreach, such as via a fact sheet, listserv, or 
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-

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initiative. We are proposing to revise the policy to publicly report a 
subset of the Medicare public use file (PUF) on the Provider Data 
Catalog (PDC) to instead provide a single downloadable dataset 
reflecting including the procedure utilization data that would appear 
on clinician profile pages. We are proposing 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 are proposing 
to engage subject matter experts and interested parties through 
periodic requests for feedback using methods outside of rulemaking, 
such as but not limited to 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 are also proposing to publicly report 
aggregated counts of procedures performed by providers based on 
Medicare Advantage (MA) encounter data (also known as MA risk 
adjustment data) in addition to Medicare fee-for-service (FFS) 
utilization data counts; as part of this proposal, we are proposing to 
amend 42 CFR 422.310(f) (the regulation that addresses permissible uses 
and releases of MA risk adjustment data) to permit use of MA encounter 
data in developing the data posted on the Care Compare website and 
release of the MA encounter data as part of the data set that will be 
downloadable from the Care Compare website more quickly than the 
regulation would currently permit releases of MA encounter data. 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.I of this rule for additional information on 
the proposed changes to public reporting on Compare tools.
(c) Data Completeness Criteria for the Quality Measures, Excluding the 
Medicare CQMs
    In section IV.A.5.a.(1) of this proposed rule, we are proposing to 
maintain the data completeness criteria threshold at 75 percent for the 
CY 2025 and 2026 performance periods/2027 and 2028 MIPS payment years, 
and 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 proposed 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, would not result 
in additional burden to the applicable interested parties. We assume 
that the proposed increase in data completeness criteria threshold from 
75 to 80 percent for the CY 2027 performance period/2029 MIPS payment 
year would not result in substantive burden to the applicable 
interested parties We believe that the increase in data completeness 
criteria threshold would reduce burden for clinicians using EHRs and 
eCQMs 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. Additionally, we recognize that 
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 have the logic code of 
their EHRs to be updated to account for the increased data completeness 
criteria threshold. We believe that 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. We refer 
readers to section IV.A.4.f.(1)(d) of this rule for additional 
information on proposed changes to the data completeness threshold 
criteria.
(d) Modifications to the Improvement Activities Inventory
    As discussed in section IV.A.4.f.(3).(b)(ii) of this proposed rule, 
we are proposing 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 proposed rule for further details. We do not believe 
these proposed changes to the improvement activities inventory would 
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 proposed 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, would continue to perform the same activities under the 
policies in this proposed 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) of this rule for additional information on 
proposed changes to the improvement activities Inventory.
(3) Update to CEHRT Definition for the Medicare Promoting 
Interoperability Program and the Quality Payment Program
    In section III.R of this proposed rule, we propose 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 proposal, we would 
revise the definitions of CEHRT for the Medicare Promoting 
Interoperability Program at Sec.  [thinsp]495.4, and for the Quality 
Payment Program at Sec.  [thinsp]414.1305. Specifically, we propose 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 propose 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, if finalized, would ensure that 
updates to the definition at Sec.  170.102 and updates to applicable 
health IT certification criteria in Sec.  170.315 would be incorporated 
into CEHRT definitions, without requiring additional regulatory action 
by CMS. Finally, we note 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 their

[[Page 52730]]

proposed revisions for us to be able to finalize the changes proposed 
in this section for our regulatory definitions of CEHRT. These changes 
would not impact EHR requirements in the CY 2024 EHR reporting period 
or the CY 2024 performance period, and therefore we predict that it 
would have no impact on clinicians.
f. Assumptions & Limitations
    In section VII.E.23.a.(2) of this rule, we outline several 
limitations in using 2021 submissions data for estimating performance 
in the CY 2024 performance period/CY 2026 payment year. In addition, 
because many scores are clustered between the prior performance 
threshold of 75 points and the proposed threshold of 82 points, minor 
variations in actual clinicians final scores relative to our 
estimations could have significant impacts on the proportion of 
clinicians receiving a positive or negative payment adjustment.
    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 proposed policies.
    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 118.

F. Alternatives Considered

    This proposed 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 proposed to 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 
proposed 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 proposed 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 122). However, maintaining the CY 2021 policy utilization 
assumption would not reflect our proposed 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. It seems likely 
that visits reported with payment modifiers have resources that are 
sufficiently distinct from stand-alone office/outpatient E/M visits (85 
FR 84571). Interested parties that are 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 at least partially allay those concerns. Under 
our proposed utilization assumption for CY 2024, we estimate 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] TP07AU23.156

    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 seeking 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 having a single, serious, or complex chronic 
condition would remain present. 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 would be 
particularly important for people without access to such care. We also 
believe that utilization of high-value preventive services, and 
promotion of 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 would use the 
add-on code would likely raise strong objections if CMS did 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 proposed 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

[[Page 52731]]

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 proposed policies 
RIA models based on the actual mean for the CY 2019 performance period/
2021 MIPS payment year with a performance threshold of 86. This model 
has the same mean and median final score as our proposed policies RIA 
model since the performance threshold does not change the final score. 
In our analysis of the alternative performance threshold of 86, 67.20 
percent of MIPS eligible clinicians who submitted data would receive a 
negative payment adjustment.
    We also report 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 including previous 
polices including a performance threshold of 75. The baseline RIA model 
has a mean final score of 73.26 and median final score of 79.99. We 
estimate that $741 million would be redistributed based on the budget 
neutrality requirement. There would be a maximum payment adjustment of 
4.60. In addition, 36.75 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 proposed rule, the proposal to cap 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 proposal to use 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 disenrollment) particularly 
from ACOs serving greater proportions of complex beneficiaries 
exhibiting high risk scores. The proposal to mitigate 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 proposal to revise the definition of an 
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. 
In total these proposals 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 have higher mean 
performance than their MIPS Group counterparts on all 10 of the CMS Web 
Interface measures for PY 2021. This includes higher performance for 
quality measures related to diabetes and blood pressure control; 
depression screening and depression remission rates; breast, colorectal 
and falls risk screening rates; and flu vaccination, tobacco screening 
and smoking cessation, and statin therapy for the treatment and 
prevention of cardiovascular disease.
    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 proposed 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 proposed policies in this proposed rule will improve the 
quality and value of care provided to Medicare beneficiaries. For 
example, several of the proposed 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 proposed changes would 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 acknowledge 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 last 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 
22,978,748 ($984.48 x

[[Page 52732]]

23,341 reviewers on last 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 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 http://www.whitehouse.gov/omb/circulars/a004/a-4.pdf), in Tables 123 through 
125 (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] TP07AU23.157

[GRAPHIC] [TIFF OMITTED] TP07AU23.158

[GRAPHIC] [TIFF OMITTED] TP07AU23.159

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 July 5, 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.

[[Page 52733]]

42 CFR Part 418

    Health facilities, Hospice care, Medicare, Reporting and 
recordkeeping requirements.

42 CFR Part 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 proposes to amend 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 405.800 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
3. Section 405.2401 is amended by adding the definition of ``Marriage 
and family therapist (MFT)'' and ``Mental health counselor (MHC)'' to 
paragraph (b) 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
4. 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
5. 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
6. 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, 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

[[Page 52734]]

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
7. 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
8. 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
9. 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
10. 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
11. 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) 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
12. Section 405.2464 is amended by revising paragraph (c) to read as 
follows:
* * * * *
    (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 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.
* * * * *

[[Page 52735]]

0
13. 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
14. 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
15. The authority citation for part 410 continues to read as follows:

    Authority:  42 U.S.C. 1302, 1395m, 1395hh, 1395rr, and 1395ddd.

0
16. 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
17. 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
18. Amend Sec.  Sec.  410.18 by:
0
a. In paragraph (a):
0
 i. In the definition of ``Diabetes'' 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 two different 
occasions; or a random glucose test over 200 mg/dL for a person with 
symptoms of uncontrolled 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.
* * * * *


Sec.  410.32  [Amended]

0
19. Section 410.32 is amended by revising paragraphs (a)(2) and 
(b)(3)(ii) to read as follow:


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

[[Page 52736]]

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
20. 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
21. 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'' and 
``Supervising physician'';
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
22. 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. Revising the definition of ``Supervising physician'';
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
23. Add Sec.  410.53 to subpart B to read as follows:


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

[[Page 52737]]

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
24. 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, or 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, or 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
25. 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
26. 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
27. 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 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
28. In Sec.  410.67 amend paragraph (vii) in the definition of ``Opioid 
use disorder treatment service'' in paragraph (b) by removing the 
reference ``through the end of CY 2023'' and adding in its place

[[Page 52738]]

the reference ``through the end of CY 2024''.
0
29. 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
30. 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 report 
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
31. 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. By removing paragraphs (c)(1)(ii) and (iii);
0
c. By redesignating paragraph (c)(1)(iv) as paragraph (c)(1)(ii);
0
d. By revising paragraphs (c)(2)(i)(A) and (B);
0
e. By removing and reserving paragraph (c)(2)(ii);
0
f. By revising paragraph (c)(3)(i);
0
g. By 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 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

[[Page 52739]]

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
32. 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
33. 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
34. 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
35. 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.
    (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

[[Page 52740]]

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
36. 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
37. Section 411.15 is amended by revising paragraph (i)(3)(i)(A) to 
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, administration of high-
dose bone-modifying agents (antiresorptive therapy) when used in the 
treatment of cancer, and radiation, chemotherapy, and surgery when used 
in the treatment of head and neck cancer.
* * * * *

PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES

0
38. The authority citation for part 414 continues to read as follows:

    Authority:  42 U.S.C. 1302, 1395hh, and 1395rr(b)(l).

0
39. 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
40. 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 and only once per MDPP beneficiary. 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 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

[[Page 52741]]

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]

0
41. Remove Sec.  414.94.
0
42. Section 414.502 is amended 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
43. 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
44. Section 414.507 is amended 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
45. Amend Sec.  414.610 in 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
46. 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 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
47. 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,

[[Page 52742]]

    (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 five-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
48. 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 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 of this part) contained within 0.1 mL or less.
    (4) 45 percent for a drug with a low volume dose (as defined in 
Sec.  414.902 of

[[Page 52743]]

this part) 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.
    (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;
    (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.
    (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) beginning as of the following January 1.
* * * * *
0
49. 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 ``Attribution-eligible beneficiary'', by 
revising paragraph (6);
0
c. In the definition of ``Certified Electronic Health Record Technology 
(CEHRT)'', by revising paragraphs (2) introductory text and (2)(ii), 
and adding paragraph (3);
0
d. By revising the definition of ``Collection type'';
0
e. By adding the definition of ``Qualified posting''.
0
f. In the definition of ``Submitter type'', by removing the term ``MIPS 
eligible clinician, group, Virtual Group, APM Entity, or third party 
intermediary'' and adding in its place the term the ``MIPS eligible 
clinician, group, Virtual Group, subgroup, APM Entity, or third party 
intermediary.''
    The revisions and addition read as follows:


Sec.  414.1305  Definitions.

* * * * *
    Attribution-eligible beneficiary * * *
* * * * *
    (6) Has a minimum of one claim for covered professional services 
furnished by an eligible clinician who is on the Participation List for 
an Advanced APM Entity at any determination date during the QP 
Performance Period.
* * * * *
    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 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
50. 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
51. 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

[[Page 52744]]

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
52. Section 414.1335 is amended by--
0
a. Revising paragraphs (a) introductory text, (a)(1)(i), (a)(1)(ii), 
(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) * * *
    (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
53. Section 414.1340 is amended by--
0
a. Revising paragraph (a) introductory text;
0
b. Adding paragraphs (a)(2)(i) and (a)(3)(i) and (ii);
0
c. Revising paragraph (a)(4);
0
d. Adding paragraph (a)(5);
0
e. Revising paragraph (b) introductory text;
0
f. Adding paragraphs (b)(2)(i) and (ii) and (b)(3)(i) and (ii);
0
g. Revising paragraph (b)(4);
0
h. Adding paragraph (b)(5);
0
i. Revising paragraph (d); and
0
j. 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.
    (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.
    (5) At least 80 percent of the MIPS eligible clinician, group, 
virtual group, subgroup, or and APM Entity's patients that meet the 
measure's denominator criteria, regardless of payer for MIPS payment 
year 2029.
    (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.
    (5) At least 80 percent of the applicable Medicare Part B patients 
seen during the performance period to which the measure applies for 
MIPS payment year 2029.
* * * * *
    (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) At least 80 percent of the applicable beneficiaries eligible 
for the

[[Page 52745]]

Medicare CQM, as defined at Sec.  425.20, who meet the measure's 
denominator criteria for MIPS payment year 2029.
    (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
54. 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
55. 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
56. 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
57. 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
58. 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 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

[[Page 52746]]

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 percent score 
from the current performance period, and then by dividing the 
difference by the cost performance category score from the previous 
performance period, and by dividing by 100.
* * * * *
    (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
59. 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, 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, 
subgroup, virtual group, 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
60. 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:
    (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.

[[Page 52747]]

    (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.
    (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:

[[Page 52748]]

    (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 two 
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
61. Section 414.1405 is amended by--
0
a. Adding paragraphs (b)(9)(iii); and
0
b. Revising paragraph (g).
    The addition and revision read as follows:


Sec.  414.1405  Payment.

* * * * *
    (b) * * *
    (9) * * *
    (iii) The performance threshold for 2026 MIPS payment year is 82 
points. The prior period to determine the performance threshold is the 
2019 through 2021 MIPS payment years.
* * * * *
    (g) Performance threshold methodology. (1) 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.
    (2) For purposes of establishing a performance threshold as 
identified in Sec.  414.1405(b), beginning with the 2026 MIPS payment 
year, a prior period is a time span of three performance periods.
0
62. 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 2023, 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;
    (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 2024, require use 
of CEHRT as defined at paragraph (3) under CEHRT at Sec.  414.1305.
    (2) [Reserved].
* * * * *
0
63. 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 2023, 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

[[Page 52749]]

    (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
64. Section 414.1425 is amended by adding paragraph (b)(3) to read as 
follows:


Sec.  414.1425  Qualifying APM participant determination: In general.

* * * * *
    (b) * * *
    (3) Individual QP determinations. For QP Performance Periods 
beginning for calendar year 2024, except as provided in paragraph 
(b)(2) of this section and in Sec.  414.1440, QP determinations are 
made individually at the eligible clinician level. To be assessed as a 
QP, an eligible clinician's APM participant identifier must be included 
on the Participation List of an APM Entity participating in an Advanced 
APM on one of the following dates during the QP Performance Period: 
March 31, June 30, or August 31. An eligible clinician included on such 
a Participation List on any one of these dates is assessed as a QP even 
if the eligible clinician is not included on the Participation List at 
one of the prior or later listed dates. CMS performs QP determinations 
for the identified eligible clinicians during the QP Performance Period 
using claims data for services furnished from January 1 through each of 
the respective QP determination dates for which the eligible clinician 
is included on the Participation List: March 31, June 30, and August 
31.
* * * * *
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.  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.


Sec.  415.140  [Amended]

0
68. In Sec.  415.140 in paragraph (a) amend the definition of 
``Substantive portion'' by removing the reference ``year 2022 and 
2023'' and adding in its place the reference ``years 2022 through 
2024''.

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, depending on the preferences and needs of the 
patient.
* * * * *
0
71. Section 418.114 is amended by adding paragraphs (c)(3) and (4) to 
read as follows:


Sec.  418.114  Condition of participation: Personnel qualifications.

* * * * *
    (c) * * *
    (3) Marriage and family counselor as defined at Sec.  410.53.
    (4) 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) * * *
    (iv) CMS determines that releasing aggregated data before 
reconciliation is

[[Page 52750]]

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,'' ``Pattern 
or practice,'' 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.
* * * * *

[[Page 52751]]

    Indirect ownership interest means as follows:
    (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.
* * * * *
    Pattern or practice means:
    (1) For purposes of Sec.  424.535(a)(8)(ii), at least three 
submitted non-compliant claims.
    (2) 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.
    (3) 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.
* * * * *
    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--
0
a. Revising paragraph (a)(1); and
0
b. Adding paragraphs (a)(16), (17), and (18).
    The revision and additions 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) Certain misdemeanors. (i) The provider or supplier, or any 
owner, managing employee or organization, officer, or director of the 
provider or supplier, 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.
    (ii) Offenses under paragraph (a)(16)(i) of this section include, 
but are not limited in scope or severity to, the following:
    (A) 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.
    (B) Assault, battery, neglect, or abuse of a patient (including 
sexual offenses).
    (C) 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.
    (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, (a)(8)(ii) 
introductory text, and (a)(14)(i) introductory text and (ii) 
introductory text;
0
b. Adding paragraphs (a)(15) and (16);
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. Revising paragraph (a)(21) introductory text;
0
g. Adding paragraph (a)(23); and
0
h. 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.
* * * * *

[[Page 52752]]

    (8) * * *
    (ii) CMS determines that the provider or supplier has a pattern or 
practice of submitting claims that fails to meet Medicare requirements 
and that a revocation on this basis is warranted. In determining 
whether a revocation is warranted, CMS considers, as appropriate or 
applicable, the following:
* * * * *
    (14) * * *
    (i) The pattern or practice is abusive or represents a threat to 
the health and safety of Medicare beneficiaries, or both, and CMS 
determines that a revocation on this basis is warranted. In determining 
whether a revocation is warranted, CMS considers the following factors:
* * * * *
    (ii) The pattern or practice of prescribing fails to meet Medicare 
requirements and CMS determines that a revocation on this basis is 
warranted. In determining whether a revocation is warranted, CMS 
considers the following factors:
* * * * *
    (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.
    (16) Certain misdemeanors. (i) The provider or supplier, or any 
owner, managing employee or organization, officer, or director of the 
provider or supplier, 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.
    (ii) Offenses under paragraph (i) include, but are not limited in 
scope or severity to, the following:
    (A) 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.
    (B) Assault, battery, neglect, or abuse of a patient (including 
sexual offenses).
    (C) 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.
    (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.
* * * * *
    (21) Abusive ordering, certifying, referring, or prescribing of 
Part A or B services, items or drugs. The physician or eligible 
professional has a pattern or practice of ordering, 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, and CMS determines that a revocation on this basis is 
warranted. In determining whether a revocation is warranted, CMS 
considers the following factors:
* * * * *
    (23) Supplier standard or condition violation. (i) The independent 
diagnostic testing facility is non-compliant with any provision in 42 
CFR 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) 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 misdemeanor conviction, the date of 
the misdemeanor conviction.
    (vi) For revocations based on a State license surrender in lieu of 
further disciplinary action, the date of the license surrender.
    (vii) For revocations based on termination from a Federal health 
care program other than Medicare (for example, Medicaid), the date of 
the termination.
    (viii) 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:

[[Page 52753]]

    (A) The date of the provider agreement termination; or
    (B) The date that CMS establishes under Sec.  489.55.
    (ix) 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) Claims submitted by the provider or supplier with dates of 
service within the stay period will be denied.
    (3) A stay of enrollment lasts no longer than 60 days from the 
postmark date of the notification letter.
    (4) CMS notifies the affected provider or supplier in writing of 
the imposition of the stay.
    (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 42 CFR 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 
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 Sec.  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. 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 place 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

[[Page 52754]]

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
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 certified 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 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) 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.
* * * * *
0
88. Section 425.204 is amended by revising paragraph (c)(3) to read as 
follows:


Sec.  425.204  Content of the application.

* * * * *
    (c) * * *
    (3) If an ACO requests an exception to the governing body 
requirement in Sec.  425.106(c)(2), the ACO must describe--
    (i) Why it seeks to differ from the requirement; and
    (ii) How the ACO will provide meaningful representation in ACO 
governance by Medicare beneficiaries.
* * * * *
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 
2023, 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) The number of MIPS eligible clinicians, Qualifying APM 
Participants (QPs), and Partial Qualifying APM Participants (Partial 
QPs) (each as defined at Sec.  414.1305 of this chapter) participating 
in the ACO that earn a MIPS performance category score for the MIPS 
Promoting Interoperability performance category at the individual,

[[Page 52755]]

group, virtual group, or APM entity level as set forth in Sec.  
425.507.
* * * * *
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) 99201 through 99215 (codes for office or other outpatient visit 
for the evaluation and management of a patient).
    (4) 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).
    (5) 99319 through 99340 (codes for patient domiciliary, rest home, 
or custodial care visit).
    (6) 99341 through 99350 (codes for evaluation and management 
services furnished in a patient's home).
    (7) 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)).
    (8) 99406 and 99407 (codes for smoking and tobacco-use cessation 
counseling services).
    (9) 99421, 99422, and 99423 (codes for online digital evaluation 
and management).
    (10) 99424, 99425, 99426, and 99427 (codes for principal care 
management services).
    (11) 99437, 99487, 99489, 99490 and 99491 (codes for chronic care 
management).
    (12) 99439 (code for non-complex chronic care management).
    (13) 99457 and 99458 (codes for remote physiologic monitoring).
    (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).
    (18) 9X015, 9X016, and 9X017 (codes for caregiver training 
services).
    (B) HCPCS codes:
    (1) G0101 (code for cervical or vaginal cancer screening).
    (2) G0317, G0318, and G2212 (codes for prolonged office or other 
outpatient visit for the evaluation and management of a patient).
    (3) G0402 (code for the Welcome to Medicare visit).
    (4) G0438 and G0439 (codes for the annual wellness visits).
    (5) G0442 (code for alcohol misuse screening service).
    (6) G0443 (code for alcohol misuse counseling service).
    (7) G0444 (code for annual depression screening service).
    (8) G0463 (code for services furnished in ETA hospitals).
    (9) G0506 (code for chronic care management).
    (10) G2010 (code for the remote evaluation of patient video/
images).
    (11) G2012 and G2252 (codes for virtual check-in).
    (12) G2058 (code for non-complex chronic care management).
    (13) G2064 and G2065 (codes for principal care management 
services).
    (14) G2086, G2087, and G2088 (codes for office-based opioid use 
disorder services).
    (15) G2211 (code for complex evaluation and management services 
add-on).
    (16) G2214 (code for psychiatric collaborative care model).
    (17) G3002 and G3003 (codes for chronic pain management).
    (18) GXXX1 and GXXX2 (codes for community health integration 
services).
    (19) GXXX3 and GXXX4 (codes for principal illness navigation 
services).
    (20) GXXX5 (code for social determinants of health risk assessment 
services).
    (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.

[[Page 52756]]

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 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 2023, 
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, 2024.

    (a) For performance years beginning on or after January 1, 2024, 
unless otherwise excluded under paragraph (b) of this section, all MIPS 
eligible clinicians, Qualifying APM Participants (QPs), and Partial 
Qualifying APM Participants (Partial QPs) (each as defined at Sec.  
414.1305 of this chapter) participating in the ACO 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 as either of the following--
    (i) All MIPS eligible clinicians, QPs, and Partial QPs 
participating in the ACO as an individual, group, or virtual group; or
    (ii) The ACO as an APM entity.
    (2) Earn a performance category score for the MIPS Promoting 
Interoperability performance category at the individual, group, virtual 
group, or APM entity level.
    (b) A MIPS eligible clinician, QP, Partial QP, or ACO as an APM 
entity may be excluded from the requirements set forth in paragraph (a) 
of this section 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) of this chapter;
    (2) Is an eligible clinician as defined at Sec.  414.1305 of this 
chapter 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) of this chapter; 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) 
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 paragraph (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

[[Page 52757]]

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''; and
0
n. 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 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 chapter) 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 chapter) 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 chapter 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 chapter, 
and 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 chapter, 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.
    (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 chapter 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 chapter), 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.
* * * * *
    (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

[[Page 52758]]

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 chapter and receives 
a MIPS Quality performance category score under Sec.  414.1380(b)(1) of 
this chapter, 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)''.


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 paragraphs (h)(1)(iii) and (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 two 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 beginning with the third or fourth 
performance year 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:

[[Page 52759]]

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.
    (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 per capita 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 per capita 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) A 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).
* * * * *

[[Page 52760]]

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.
    (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 equal 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

[[Page 52761]]

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:


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 redesignating paragraph (c) as paragraph (d);
0
c. By adding new paragraph (c);
0
d. By revising newly redesignated paragraph (d); and
0
e. By adding new paragraph (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 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 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 a national assignable FFS population 
for

[[Page 52762]]

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, 
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 fee-for-service population.
    (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 two 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 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

[[Page 52763]]

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 three 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 two 
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 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 410.53 of 
this chapter.
    Mental health counselor means an individual who meets the 
applicable education, training, and other requirements at 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 currently certified as a primary care nurse practitioner by 
a recognized national certifying body that has established standards 
for nurse practitioners and possesses a master's degree in nursing or a 
Doctor of Nursing Practice (DNP) doctoral degree.
* * * * *
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. Section[thinsp]495.4 is amended in 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. Revise Sec.  600.125 to 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

[[Page 52764]]

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--
    (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 an a complete response from the State of 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) through (d) 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 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 for States 
seeking to suspend a BHP in the first plan year that begins following 
publication of this rule must submit an application within 30 days of 
publication of this rule; 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 the first plan year that begins 
following publication of this rule.
    (3) At least 90 days prior to the effective date of the suspension, 
submit 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 needed to complete the financial 
reconciliation process with HHS.
    (5) Submit the annual report required by Sec.  600.170(a)(2), 
describing the

[[Page 52765]]

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 be 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 State cannot implement the suspension or extension of the 
suspension without prior approval by the Secretary.
    (d) 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 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) Withdrawal of approval of a suspension under this section must 
occur 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 (b)(6)(i) of this section.
    (4) Within 30 days following a final finding under paragraph 
(b)(6)(i) 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 revising paragraph (b) to read as 
follows:


Sec.  600.335  Appeals.

* * * * *
    (b) Appeals process. Individuals must be given the opportunity to 
appeal through the appeals rules of the State's Medicaid program:
    (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.
* * * * *

Xavier Becerra,
Secretary, Department of Health and Human Services.
 BILLING CODE 4120-01-P

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[FR Doc. 2023-14624 Filed 7-13-23; 4:45 pm]
 BILLING CODE 4120-01-C